Evaluation of the MiniMed™ 780G System in Type 1 Adult and Pediatric Subjects Utilizing Insulin Fiasp® (Insulin Aspart Injection)
Phase: NA
Conditions: Type 1 Diabetes
Sponsor: Medtronic MiniMed, Inc.

 
Study Title 
Evaluation of the MiniMed™ 780G System in 
Type 1 Adult and Pediatric Subjects Utilizing 
Insulin Fiasp® (Insulin Aspart Injection) 
NCT Number 
NCT05224258 
Document Description 
Clinical Investigation Plan (Version E) 
Document Date 
07-NOV-2023 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 1 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
 
Clinical Investigation Plan 
Clinical Investigation Plan 
(CIP)/Study Title  
Evaluation of the MiniMed™ 780G System in Type 1 Adult and 
Pediatric Subjects Utilizing Insulin Fiasp® (Insulin Aspart Injection) 
CIP Identifier 336 
Health Canada 
Investigational Testing 
Authorization (ITA) 
Application Number 
344299 
Investigational Device 
Exemption (IDE) Number 
G210307 
Study Product Name & 
Study Product Model 
 
MiniMed™ 780G Insulin Pump with software Version 6.7 
(MMT-1884 in US; MMT-1885XCC in Canada) - referred to 
as the study pump throughout this protocol 
 
Guardian™ 4 Sensor (MMT-7040 in US; MMT-7040X1 or 
MMT-7040C4 in Canada) - referred to as the sensor 
throughout this protocol 
 
Guardian 4 Transmitter (MMT-7841 in US; MMT-7841XW4 in 
Canada) 
 
Medtronic Extended infusion set (MMT-430, MMT-431, MMT-
432, MMT-433, MMT-440, MMT-441, MMT-442, and MMT-
443 in US; MMT-430A, MMT-431AH, MMT-431AJ, MMT-
432A, MMT-433AJ, MMT-440A, MMT-441AH, MMT-441AJ, 
MMT-442AH, MMT-442AJ, and MMT-443AJ in Canada) 
 
Medtronic Extended Reservoir (MMT-342) 
 
Fiasp® (insulin aspart injection) 
 
One-Press Serter (MMT-7512 in US; MMT-7512WE in 
Canada) - referred to as the Serter throughout this protocol 
 
Transmitter Charger (MMT-7715) 
 
Tester (MMT-7736L) 
 
Roche Accu-Chek™ Guide Link Glucose Meter (08116083022 
[US], Kit number 08116113198M & Meter number 
08109222001 [Canada]) -referred to as the Accu-Chek 
Guide Link study meter throughout this protocol 
 
Medtronic CareLink™ Personal software (MMT-7333)  
 
Medtronic CareLink system software (MMT-7350)  
 
MiniMed Clinical App (MMT-6103 Android™ app; MMT-6104 
IOS™ app) 
 
MiniMed Mobile App (MMT-6101 Android™ app; MMT-6102 
IOS™ app) 
 
CareLink Clinical App (MMT-6113 Android™ app; MMT-6114 
IOS™ app) 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 2 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
Blue Bluetooth® Low Energy Adapter (ACC-1003911D and 
ACC-1003911F)- referred to as the Blue Adapter in this 
protocol  
 
Ketone meter to be used for blood ketone measurements 
only  
 
Accu-Chek Guide test strips (07453736001 in US; 
00064562312704 in Canada) 
 
Sponsor-provided smartphone, upon request  
Description of CIP This global study (US, Canada, and Australia) will evaluate the 
safety and effectiveness of the MiniMed 780G system in type 1 adult 
and pediatric subjects utilizing Fiasp (insulin aspart injection) in a 
home setting. 
Global Sponsor  
(Funding Source) 
Medtronic MiniMed, Inc.  
(“Medtronic”) 
18000 Devonshire St 
Northridge, CA 91325 
866.948.6633 
 
Local Sponsor Medtronic Australasia Pty. Ltd 
2 Alma Road 
Macquarie Park, NSW 2113 
Australia 
 
Medtronic Canada ULC  
(“Medtronic”) 
99 Hereford St. 
Brampton, Ontario, Canada 
 
Document Version E (Equivalent to Version E.1)   
Version Date 07-NOV-2023 
Document Reference 
Number 
D00459338 
Confidentiality Statement 
The information contained in this document is confidential and the proprietary property of Medtronic. 
Any distribution, copying, or disclosure without the prior written authorization of Medtronic is strictly 
prohibited. Persons to whom the information is disclosed must know that it is confidential and that it 
may not be further disclosed by them. 
Android™ is a trademark of Google LLC. 
Accu-Chek™ is a registered trademark of Roche Diabetes Care, Inc. (“Roche”). 
DreaMed Diabetes is a trademark of DreaMed Diabetes, Ltd. The MiniMed™ 780G system algorithm 
includes technology developed by DreaMed Diabetes. 
 
FoodPrint™ is trademark of Nutrino Health Ltd (“Nutrino”). 
Fiasp® is a registered trademark of Novo Nordisk A/S. 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 3 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Humalog™ is a registered trademark of Eli Lilly and Company. 
IOS™ is a trademark or registered trademark of Cisco. 
NovoLog®/NovoRapid® is a registered trademark of Novo Nordisk A/S. 
The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any 
use of such marks by Medtronic is under license. Other trademarks and trade names are those of their 
respective owners. 
© 2023 Medtronic. All rights reserved.  Medtronic, Medtronic logo and Engineering the extraordinary are 
trademarks of Medtronic. ™Third party brands are trademarks of their respective owners. All other 
brands are trademarks of a Medtronic company. 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 4 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Table of Contents 
Table of Contents ...................................................................................................................... 4 
1. 
Glossary ............................................................................................................................ 10 
2. 
Synopsis ........................................................................................................................... 12 
3. 
Introduction ..................................................................................................................... 30 
  Background ........................................................................................................................ 30 
  Purpose .............................................................................................................................. 30 
4. 
Objectives and Endpoints ................................................................................................. 30 
  Objectives .......................................................................................................................... 30 
  Endpoints ........................................................................................................................... 31 
 
Primary Safety Endpoint ..................................................................................................... 31 
 
Primary Effectiveness Endpoint .......................................................................................... 31 
 
Secondary Effectiveness Endpoint ...................................................................................... 31 
 
Descriptive Endpoints ......................................................................................................... 32 
 
Safety Data Summarized ..................................................................................................... 32 
 
Device Deficiencies ............................................................................................................. 33 
 
Subject Feedback ................................................................................................................ 33 
 
Simulation Data ................................................................................................................... 33 
5. 
Study Design .................................................................................................................... 33 
  Duration ............................................................................................................................. 41 
  Rationale ............................................................................................................................ 41 
6. 
Product Description.......................................................................................................... 41 
  Intended Use ...................................................................................................................... 41 
  General Overview of MiniMed 780G Insulin Pump System Components and Consumables .......... 42 
  MiniMed 780G Insulin Pump ................................................................................................. 46 
  Guardian 4 Sensor ............................................................................................................... 47 
  Guardian 4 Transmitter ........................................................................................................ 48 
  Medtronic Extended Infusion Set .......................................................................................... 48 
  Medtronic Extended Reservoir .............................................................................................. 50 
  Insulin ................................................................................................................................ 50 
  One-Press Serter ................................................................................................................. 50 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 5 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 Charger .............................................................................................................................. 50 
 Tester ................................................................................................................................ 50 
 CareLink Personal Software .................................................................................................. 51 
 CareLink System Software .................................................................................................... 51 
 Roche Accu-Chek Guide Glucose Meter ................................................................................. 52 
 Accessory Applications – 780G system .................................................................................. 52 
 Blue Adapter ....................................................................................................................... 52 
 Ketone Meter ...................................................................................................................... 52 
 Smartphone ........................................................................................................................ 52 
 Consumable Devices ............................................................................................................ 53 
 Anticipated Product Changes ................................................................................................ 53 
 Product Accountability ......................................................................................................... 53 
 
Receipt and Inventory of  Study Devices by Investigational Center ................................... 58 
 
Storage of Study Devices at Investigational Center ............................................................ 58 
 
Dispensing of Study Devices ............................................................................................... 58 
 
Return or Disposal of Study Devices ................................................................................... 59 
7. 
Study Site Requirements ................................................................................................. 59 
  Investigator/Investigational Center Selection ......................................................................... 59 
  Study Site Activation............................................................................................................ 60 
8. 
Selection of Subjects ........................................................................................................ 60 
  Study Population ................................................................................................................. 60 
  Subject Enrollment .............................................................................................................. 61 
  Inclusion Criteria ................................................................................................................. 61 
  Exclusion Criteria................................................................................................................. 62 
9. 
Study Procedures ............................................................................................................. 65 
  Schedule of Events .............................................................................................................. 65 
 
Study Visit Schedule & Scheduled Follow‐Up Visit Windows ............................................. 65 
  Data Collection .................................................................................................................... 85 
  Subject Consent .................................................................................................................. 85 
  Safety Monitoring/Risk Analysis ............................................................................................ 87 
 
Glucose Monitoring Risk ..................................................................................................... 87 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 6 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
Hypoglycemic/Hyperglycemic Risk ..................................................................................... 87 
 
Calibration of CGM Risk ...................................................................................................... 87 
 
Reuse Risk ........................................................................................................................... 87 
 
Sterilization Risk .................................................................................................................. 87 
 
Misuse Risk .......................................................................................................................... 87 
 
Risk of Blood Sample Collection, Contamination from Sampling Techniques .................... 88 
 
HbA1c Risk ........................................................................................................................... 88 
  Glucose and Glycemia Measurements .................................................................................... 88 
 
Daily Blood Glucose ............................................................................................................ 88 
 
Blood Ketone Values ........................................................................................................... 88 
 
Sensor Glucose Values ........................................................................................................ 88 
 
HbA1c .................................................................................................................................. 88 
  Recording Data ................................................................................................................... 89 
  Deviation Handling .............................................................................................................. 89 
 
Documenting Requirements for Study Deviations ............................................................. 90 
 
Reporting Requirements for Study Deviations ................................................................... 90 
 
Analyzing Deviations ........................................................................................................... 91 
  Subject Exit, Withdrawal or Discontinuation ........................................................................... 91 
 
End of Subject Participation in Study/ Completion of Study .............................................. 92 
 
Lost to Follow‐Up ................................................................................................................ 92 
  Study Stopping Rules ........................................................................................................... 93 
10.  Risks and Benefits ............................................................................................................ 93 
 Potential Risks .................................................................................................................... 93 
 Risk Minimization .............................................................................................................. 103 
 Potential Benefits .............................................................................................................. 103 
 Risk-Benefit Rationale ........................................................................................................ 103 
 Risk Determination (US Only) ............................................................................................. 103 
11.  Adverse Events ............................................................................................................... 103 
 Adverse Events ................................................................................................................. 103 
 Definitions and Classification of Adverse Events ................................................................... 104 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 7 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 Reporting of Adverse Events .............................................................................................. 106 
 Notification of Adverse Events ............................................................................................ 107 
 Expedited Safety Reporting Requirements ........................................................................... 108 
 Adverse Event and Device Deficiency Classification .............................................................. 108 
 Causality Assessment ........................................................................................................ 109 
 Anticipated or Unanticipated .............................................................................................. 111 
12.  Data Review Committees ............................................................................................... 111 
 Clinical Events Committee .................................................................................................. 111 
 Data Monitoring Committee ................................................................................................ 113 
13.  Device Deficiencies and Troubleshooting ...................................................................... 117 
14.  Statistical Design and Methods ...................................................................................... 118 
 General Aspects of Analysis ................................................................................................ 118 
 Subject Disposition ............................................................................................................ 118 
 Subject Demographics and Baseline Characteristics .............................................................. 118 
 Analysis Populations and Handling of Missing Data, Error ...................................................... 119 
 Endpoints and Hypotheses ................................................................................................. 119 
 
Primary Safety Endpoint ................................................................................................... 119 
 
Analysis of Effectiveness Endpoint ................................................................................... 120 
 
Descriptive Endpoints ....................................................................................................... 122 
 
Safety Data Summarized ................................................................................................... 123 
 
Device Deficiencies ........................................................................................................... 123 
 
Subject Feedback .............................................................................................................. 123 
 
Simulation Data ................................................................................................................. 123 
 Sample Size Considerations/Sample Size Justification ........................................................... 124 
 
Age 18‐80 .......................................................................................................................... 124 
 
Age 7‐17 ............................................................................................................................ 125 
 
Expected Drop‐out Rates .................................................................................................. 126 
 Final Reports .................................................................................................................... 126 
15.  Ethics .............................................................................................................................. 126 
 Statement(s) of Compliance ............................................................................................... 126 
 Role of the Sponsor’s Representatives ................................................................................. 127 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 8 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 Investigator’s Responsibilities ............................................................................................. 128 
16.  Study Administration ..................................................................................................... 130 
 Training of Clinical Staff ..................................................................................................... 130 
 Monitoring ........................................................................................................................ 131 
 
Accessibility of Investigational Center Staff and Study Materials .................................... 131 
 
Audits and Investigational Center Inspections ................................................................. 131 
 
Investigational Center Disqualification ............................................................................. 131 
 Data Management ............................................................................................................. 132 
 
Electronic Case Report Forms (eCRFs) .............................................................................. 132 
 
CareLink Personal/CareLink System Software .................................................................. 132 
 
Patient Questionnaires ..................................................................................................... 133 
 
Time Windows for Completion and Submission of Case Report Forms ........................... 133 
 
Data Review and Processing ............................................................................................. 133 
 Direct Access to Source Data/Documents ............................................................................ 133 
 Confidentiality ................................................................................................................... 133 
 Liability and Subject Compensation ..................................................................................... 134 
 
Insurance (Canada) ........................................................................................................... 134 
 CIP Amendments .............................................................................................................. 134 
 Investigational Center Compensation .................................................................................. 134 
 Records and Reports ......................................................................................................... 135 
 
Investigator Records ......................................................................................................... 135 
 
Investigator Reporting Responsibilities ............................................................................ 135 
 
Record Retention ....................................................................................................... 137 
 
Suspension or Early Termination ................................................................................. 137 
  Early Investigational Center Suspension or Termination .................................................. 137 
  Subject Follow‐Up In Case of Termination ........................................................................ 138 
 
Study Close-Out ......................................................................................................... 138 
 
Publication and Use of Information .............................................................................. 138 
17.  References ..................................................................................................................... 139 
18.  Appendices ..................................................................................................................... 139 
 Names and addresses ........................................................................................................ 139 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 9 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
Investigational Centers and EC/IRB ................................................................................... 139 
 
Monitor(s) Contact Information ....................................................................................... 140 
 
Clinical Laboratory(ies) Contact Information .................................................................... 140 
 Labeling of Devices ........................................................................................................... 140 
 Sample Consent Materials .................................................................................................. 140 
 Questionnaires .................................................................................................................. 140 
19.  Version History ............................................................................................................... 141 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 10 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
1. Glossary 
 
Abbreviations 
ADE 
Adverse Device Effect 
AID 
Automated Insulin Delivery 
ASADE 
Anticipated Serious Adverse Device Effect 
AE 
Adverse Event 
AHCL 
Advanced Hybrid Closed Loop 
AUC 
Area Under Curve 
BG 
Blood Glucose 
BMI 
Body Mass Index 
CEC 
Clinical Events Committee 
CFR 
Code of Federal Regulations 
CGM 
Continuous Glucose Monitoring 
CIP 
Clinical Investigation Plan 
CRF 
Case Report Form 
CSII 
Continuous Subcutaneous Insulin Infusion 
CTA 
Clinical Trial Agreement 
CV 
Curriculum Vitae 
DD 
Device Deficiency 
DKA 
Diabetic Ketoacidosis 
DMC 
Data Monitoring Committee 
DoH 
Declaration of Helsinki 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
EOS 
End of Study 
ER 
Emergency Room 
FDA 
Food and Drug Administration 
FDAAA 
Food and Drug Administration Amendments Act 
GCP 
Good Clinical Practice 
HbA1c 
Glycosylated hemoglobin 
HIPAA 
Health Insurance Portability and Accountability Act 
IB 
Investigator’s Brochure 
ICH 
International Conference of Harmonization 
ICF 
Informed Consent Form 
ICMJE 
International Committee of Medical Journal Editors 
ID 
Identification 
IDE 
Investigational Device Exemption 
IFU 
Instructions for Use 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
ITA 
Investigational Testing Authorization  
ITT 
Intention to Treat 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 11 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Abbreviations 
IV 
Intravenous 
MCRS 
Medtronic Clinical& Regulatory Solutions 
MDR 
Medical Device Regulation 
NGSP 
National Glycohemoglobin Standardization Program 
PC 
Personal Computer 
PI 
Principal Investigator 
PP 
Per Protocol 
QC 
Quality Control 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SAP 
Sensor Augmented Pump 
SAP 
Statistical Analysis Plan 
SG 
Sensor Glucose 
SI 
Sensor Integrity 
SMBG 
Self-Monitoring of Blood Glucose 
SOP 
Standard Operating Procedure 
SR 
Significant Risk 
TDD 
Total Daily Dose 
TIR 
Time in Range 
TLS 
Transport Layer Security 
TSH 
Thyroid-stimulating hormone 
UADE 
Unanticipated Adverse Device Effect 
USADE 
Unanticipated Serious Adverse Device Effect 
 
 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 12 of 159 

 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
2. Synopsis 
Title 
Evaluation of the MiniMed™ 780G System in Type 1 Adult and Pediatric Subjects 
Utilizing Insulin Fiasp® (Insulin Aspart Injection) 
Clinical Study 
Type 
Safety and Effectiveness Evaluation  
Global 
Sponsor  
 
 
Medtronic MiniMed (“Medtronic”) 
18000 Devonshire St 
Northridge, CA 91325, USA 
866.948.6633 
 
Local 
Sponsor 
Medtronic Australasia Pty. Ltd 
2 Alma Road 
Macquarie Park, NSW 2113 
Australia 
 
Medtronic Canada ULC (“Medtronic”) 
99 Hereford St. 
Brampton, Ontario, Canada L6Y 0R3 
905 460 37211 
 
Indication 
Under 
Investigation 
Labeling for the use of Fiasp (insulin aspart injection) in the MiniMed 780G System 
 
Products 
x 
MiniMed™ 780G Insulin Pump with software Version 6.7 (MMT-1884 in US; 
MMT-1885XCC in Canada) - referred to as the study pump throughout this 
protocol 
x 
Guardian™ 4 Sensor (MMT-7040 in US; MMT-7040X1 orMMT-7040C4 in 
Canada) - referred to as the sensor throughout this protocol 
x 
Guardian 4 Transmitter (MMT-7841 in US; MMT-7841XW4 in Canada) 
x 
Medtronic Extended infusion set (MMT-430, MMT-431, MMT-432, MMT-433, 
MMT-440, MMT-441, MMT-442, and MMT-443 in US; MMT-430A, MMT-
431AH, MMT-431AJ, MMT-432A, MMT-433AJ, MMT-440A, MMT-441AH, 
MMT-441AJ, MMT-442AH, MMT-442AJ, and MMT-443AJ in Canada) 
x 
Medtronic Extended Reservoir (MMT-342) 
x 
Fiasp® (insulin aspart injection) 
x 
One-Press Serter (MMT-7512 in US; MMT-7512WE in Canada) - referred to 
as the Serter throughout this protocol 
x 
Transmitter Charger (MMT-7715) 
x 
Tester (MMT-7736L) 
x 
Roche Accu-Chek™ Guide Link Glucose Meter (08116083022 [US], Kit 
number 08116113198M & Meter number 08109222001 [Canada]) -referred 
to as the Accu-Chek Guide Link study meter throughout this protocol 
x 
Medtronic CareLink™ Personal software (MMT-7333)  
x 
Medtronic CareLink system software (MMT-7350)  
x 
MiniMed Clinical App (MMT-6103 Android™ app; MMT-6104 IOS™ app) 
PI

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 13 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
MiniMed Mobile App (MMT-6101 Android™ app; MMT-6102 IOS™ app) 
 
CareLink Clinical App (MMT-6113 Android™ app; MMT-6114 IOS™ app) 
 
Blue Bluetooth® Low Energy Adapter (ACC-1003911D and ACC-1003911F)- 
referred to as the Blue Adapter in this protocol  
 
Ketone meter to be used for blood ketone measurements only  
 
Accu-Chek Guide test strips (07453736001 in US; 00064562312704 in 
Canada) 
 
Sponsor-provided smartphone, upon request  
 
Purpose 
The purpose of this study is to evaluate the safety and effectiveness of the MiniMed 
780G system in type 1 adult and pediatric subjects utilizing Fiasp (insulin aspart 
injection) in a home setting 
Objective(s) 
The objective of this study is to evaluate the safety and effectiveness of the 
MiniMed 780G system utilizing insulin Fiasp (insulin aspart injection) to support 
product and system labeling. 
Study Design 
 
This global study is a multi-center, single arm study in insulin-requiring adult and 
pediatric subjects with type 1 diabetes on the MiniMed 780G system using Fiasp 
insulin as well as Medtronic Extended infusion set and reservoir. The run-in period 
and study period will be approximately 120 days long.  
 
The period from Visit 1 (consent and screening) through Visit 6 should be 
completed in 30 days. 
 
Companions: 
Subjects will be required to have a companion who resides (or will live) in the same 
building (or home) during the study at night, and also to be physically present in 
the same building, home or location (if not at home) during the exercise and meal 
challenges. A companion should be present during meal challenges and for 4 hours 
following the start of the meal. Companions should be able to check SMBG, give 
glucose and/or administer glucagon.   
 
Run-in Period (Visits 2-6):  
The run-in period begins at Visit 2 and ends once Visit 7 occurs. 
 
The intent of the run-in period will be to allow subjects to become familiar with new 
study devices while using their own insulin, either Humalog™ (insulin lispro 
injection) or NovoLog®/NovoRapid® (insulin aspart solution for injection). During 
the run-in period, study subjects with prior Automated Insulin Delivery (AID) 
control algorithm experience will be using the study pump with the SmartGuard 
feature activated (Auto Correction must remain OFF). and Medtronic Extended 
infusion set and reservoir. Subjects who do not have prior AID algorithm experience 
will use the system in Manual Mode. Before and during run-in period meal 
challenges, SmartGuard must be turned OFF, as noted in Meal Challenge 
instructional materials. 
Note for subjects who have prior experience with the Auto Mode feature in 
Medtronic pumps (670G/770G): The term “Auto Mode” has been replaced by the 
term “SmartGuard” in the 780G pump. 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 14 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
During the run-in period, a 120 mg/dL (6.7 mmol/L) Auto Basal target should be 
set. It is recommended that Active Insulin Time is set to 4 hours.  
 
Note: The Auto Basal target setting and Active Insulin Time should be set as 
recommended above, unless there is a documented safety reason that would not 
permit these settings to be used. 
 
All subjects and their parents/caregivers as well as companions will be trained on 
diabetes management principles, such as the treatment of hyperglycemia and 
hypoglycemia. In addition, there will be training regarding the need to have access 
to and how to use glucose and glucagon in case of hypoglycemia.   
 
Parents/caregivers and companions will be instructed that they should be with the 
subject in the same residence or building overnight. 
 
If the MiniMed Clinical app/MiniMed Mobile app and the CareLink Clinical app are 
being used, parents/caregivers will be instructed that subjects should be connected 
to CareLink via the appropriate Smartphone app for data uploading and push 
notifications for low or high blood sugar when they are apart, e.g., at school, other 
activities. Instructions on the appropriate operation of the apps will be provided. 
 
For study purposes, subjects, companions, and parents/caregivers will be trained 
and/or instructed to perform self-monitoring of blood glucose (SMBG) if subjects 
are experiencing a severe hypoglycemic event, severe hyperglycemic event or 
diabetic ketoacidosis (DKA). Subjects and their parents/caregivers as well as 
companions will also be instructed to check blood ketones using a ketone meter if 
the Accu-Chek Guide Link study meter reading is greater than 300 mg/dL (16.7 
mmol/L). 
 
As a precaution, subjects and their parents/caregivers will be told that they should 
keep their own insulin pump supplies in a safe place and to have back up supplies 
on hand (such as insulin and syringe, or insulin pen) in the event they are asked to 
revert back to their own therapy during the study or experience study pump issues 
(i.e., infusion set occlusion with high glucose).   
 
Subjects and their parents/caregivers will be instructed to insert sensors only in the 
locations that are specified in the User Guide materials. Reminders will be given to 
subjects at each office visit. Information about sensor insertions will be collected on 
an electronic case report form (eCRF) in the study database, i.e., insertion location. 
 
Subjects and their parents/caregivers will be trained on all parts of the device 
system. This training may include access to and use of digital online learning 
content. A training checklist for both subjects and parents/caregivers will be 
implemented and completed.  
 
The completion of emergency response training, including the use of a ketone 
meter, will be documented for companions. Companions may be trained in person 
or remotely. 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 15 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
After completion of training on the study devices, subjects and their 
parents/caregivers may attend additional visits in the days immediately following 
the start of system use, as needed. They may also take advantage of having access 
to the digital learning content.  
 
Study Period (Visits 7-15): 
All subjects will use Fiasp for the remainder of the study and will continue using the 
study pump, with SmartGuard feature enabled (including Auto Correction), infusion 
set and reservoir for approximately 90 days during the study period.  
 
Subjects should use the system with the SmartGuard feature turned on at all times 
with Fiasp. When prompted by the pump, subjects should take appropriate 
measures and follow directions on the pump to remain in or return to the 
SmartGuard feature. During times when subjects are not able to use the 
SmartGuard feature, they should use the system in Manual Mode (e.g., Suspend 
before low and Suspend on low). 
 
During the first 3 weeks (between Visits 7 and 11) of the study period, a 120 mg/dL 
(6.7 mmol/L) Auto Basal target should be set. It is recommended that Active Insulin 
Time is initially set to 4 hours and then titrated towards 2-3 hours or at the 
investigator’s discretion. 
 
During the next 3 weeks (between Visits 11 and 13) of the study period, the Auto 
Basal target setting should be set to 100 mg/dL (5.5 mmol/L). Active Insulin Time is 
recommended to be set to 2-3 hours or at investigator’s discretion. 
 
During the remaining weeks of the study (any time after Visit 13) of the study 
period, the Auto Basal target as well as Active Insulin Time should be set to what is 
best for the individual subject, at investigator’s discretion. 
 
Note: The Auto Basal target setting and Active Insulin Time should be set as 
recommended above, unless there is a documented safety reason that would not 
permit these settings to be used. 
 
 
After completion of training on the SmartGuard function, subjects and their 
parents/caregivers may attend additional visits in the days immediately following 
the start of SmartGuard use, as needed. They may also take advantage of having 
access to the digital learning content. 
 
 
Staged Enrollment: 
The enrollment of subjects 7-17 years of age will not move forward until 10 
subjects 18 years or older have completed 30 days of the study period and the Data 
Monitoring Committee (DMC) has determined that it is safe for 7-17 year olds to be 
enrolled into the study. 
 
SMBG recommendations for 780G system: 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 16 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
With the 780G system and the Guardian 4 CGM, calibration is not required. 
However, a calibration is optional and will occur any time a blood glucose (BG) is 
entered. Occasionally, subjects may receive a notification if the pump needs a BG to 
enter or stay in the SmartGuard feature. Subjects will be instructed to perform 
SMBG if their symptoms do not match the sensor glucose (SG) value (i.e., they 
develop symptoms of hypoglycemia or hyperglycemia, but the SG value does not 
correlate with their symptoms). 
 
Meal and Exercise Challenges: 
All subjects will be asked to participate in meal and exercise challenges during the 
run-in and study period.  
 
All challenges are at least 4 hours in duration, beginning from the time 
when the challenge meals or exercise are started. 
 
There should not be more than one meal challenge on a single day.  
 
Meal and exercise challenges should not be scheduled on the same day 
during the specified time periods.  
 
For example: A study period regular sized or large sized meal challenge should not 
take place on the same day as an exercise challenge. 
 
Subjects will be asked to check BG at the start of the meal/exercise, as well as 2 
hours and 4 hours after the start of the meal/exercise and provide correction insulin 
as necessary. 
 
Throughout the study, it is important for subjects to avoid additional meal/snack or 
exercise up to four hours after the start of the challenge. If additional meal/snack 
or exercise is needed within 4 hours after the start of the challenge, the subject will 
acknowledge that food intake or exercise occurred. Content and timing of the meal 
and exercise, along with BG values, will be recorded on a log provided by the study 
team. 
 
Meal challenges for all subjects (Run-in and Study period):  
The following meal challenges are required during the run-in and study periods: 
 
Two meal challenges during the run-in period with subjects using the system in 
Manual Mode – between Visits 5 and 7 
o 
Regular sized meal with missed meal bolus at lunch 
o 
Large sized meal at breakfast, lunch or dinner 
 
Two meal challenges during the study period with subjects using the system in 
SmartGuard, Auto Basal target set at 120 mg/dL (6.7 mmol/L) – between Visits 
9 and 11 of study period 
o 
Regular sized meal with missed meal bolus at lunch 
o 
Large sized meal at breakfast, lunch or dinner 
 
Two meal challenges during the study period with subjects using the system in 
SmartGuard, Auto Basal target set at 100 mg/dL (5.5 mmol/L) – between Visits 
12 and 13 of study period 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 17 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
o 
Regular sized meal with missed meal bolus at lunch 
o 
Large sized meal at breakfast, lunch or dinner 
 
One meal challenge during the study period with subjects using the system in 
SmartGuard, Auto Basal target set at currently set Auto Basal target – at any 
time after Visit 13 of study period 
o 
Large sized meal at breakfast, lunch or dinner 
Meal challenges should only start if the following conditions are met:  
o 
SMBG at start of meal is < 200 mg/dL (11.1 mmol/L) 
o 
Sensor glucose is available.  
Timing 
Settings/Conditions 
Meal 
Size 
Meal 
Type 
Notes 
Run-in 
Period 
between 
visits 5 
and 7 
Manual Mode only 
Missed meal bolus 
Regular 
sized 
meal 
Lunch 
Meal content, meal size 
and time of meal 
consumption should be 
established so that 
regular sized meal 
challenges during the 
study period can be 
matched  
Run-in 
Period 
between 
visits 5 
and 7 
Manual Mode only 
Large 
sized 
meal 
Breakfast 
Lunch or 
Dinner 
Meal content, meal size 
and time of meal 
consumption should be 
established so that large 
sized meal challenges 
during the study period 
can be matched  
Study 
Period, 
between 
Visits 9 
and 11 
SmartGuard  
(120 mg/dL [6.7 
mmol/L] setpoint) 
Missed Meal bolus 
Regular 
sized 
meal 
Lunch 
Meal content, meal size 
and time of meal 
consumption should 
match regular meal 
taken during run-in and 
the regular meal taken 
at the 100 mg/dL (5.5 
mmol/L) setpoint 
Study 
Period, 
between 
Visits 9 
and 11 
SmartGuard  
(120 mg/dL [6.7 
mmol/L] setpoint) 
Large 
sized 
meal  
Breakfast, 
Lunch or 
Dinner 
Meal content, meal size 
and time of meal 
consumption should 
match meal at Setpoint 
of 100 mg/dL (5.5 
mmol/L) and run-in 
period meal   
Study 
Period, 
between 
Visits 12 
and 13 
SmartGuard  
(100 mg/dL [5.5 
mmol/L] setpoint) 
Missed meal bolus 
Regular 
sized 
meal 
Lunch 
Meal content, meal size 
and time of meal 
consumption should 
match regular meal 
taken during run-in and 
the regular meal taken 
at the 120 mg/dL (6.7 
mmol/L). 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 18 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Study 
Period, 
between 
Visits 12 
and 13 
SmartGuard  
(100 mg/dL [5.5 
mmol/L] setpoint) 
Large 
sized 
meal  
Breakfast 
Lunch or 
Dinner 
Meal content, meal size 
and time of meal 
consumption should 
match meal at Setpoint 
of 120 mg/dL (6.7 
mmol/L) and run-in 
period large sized meal     
Study 
Period 
Any time 
after Visit 
13 
SmartGuard  
(with current Auto 
Basal target setpoint) 
Large 
sized 
meal  
Breakfast 
Lunch or 
Dinner 
Meal content, meal size 
and time of meal 
consumption should 
match large meal at 
Setpoint of 120 mg/dL 
(6.7 mmol/L)/100 mg/dL 
(5.5 mmol/L) and run-in 
period large sized meals 
 
Regular Sized Meal Challenge with Missed Meal Bolus:  
Between Visits 5 and 7 for the run-in period, while subjects are in Manual Mode 
with CGM, they will be asked to consume a meal without administration of a Meal 
Bolus at lunch. The size of the meal should be equivalent to what subjects would 
normally eat at this mealtime.  
During the study period, once at each Auto Basal setpoint (i.e. 120 mg/dL[6.7 
mmol/L] and 100 mg/dL[5.5 mmol/L]), subjects will be asked to consume the same 
regular sized lunch meal that they had during the run-in period. For example, if the 
regular sized meal was consumed without an insulin bolus for the meal at 12 pm 
during the run-in period, that same regular sized meal should be consumed at 
approximately the same time of day at each setpoint during the study period.  
 
Large sized Meal Challenges:   
On large sized meal challenge days, subjects will be instructed to eat at least 1 
meal with at least 50% higher caloric intake including 50% more carbohydrates and 
50% higher in fat. It is recommended that subjects eat food at restaurants or 
consume prepared meals. The FoodPrint™ phone app (as well as questions that will 
be asked by the investigational center staff during visits following meal challenges) 
will be used to collect information about type of food, name of restaurant (if 
applicable), subject confirmation that the meal eaten was different from any meal 
eaten within the last month and subject confirmation that meal size was at least 
50% more than when subjects usually consume in terms of calories, carbohydrates 
and fat. The timing of the meal challenges will be at the investigator’s discretion. 
The subject's parent/caregiver should be physically present in the same building, 
home or location (if not at home) during the meal challenge (and for 4 hours 
following the start of the meal), must be able to check SMBG (in case it is needed), 
and give glucose/administer glucagon as needed.  
 
Exercise Challenge for all subjects (Study Period only):   

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 19 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
The following exercise challenges are required during the study period: 
 
2 exercise challenges at setpoint of 120 mg/dL (6.7 mmol/L, between Visits 9 
and 11 of the study period) 
 
2 exercise challenges at setpoint of 100 mg/dL (5.5 mmol/L, between Visits 12 
and 13 of the study period) 
 
1 exercise challenge at currently set Auto Basal target, at any time after Visit 13 
of the study period 
 
Conditions at start of the exercise challenges: 
 
SG should be present at the start of each exercise challenge 
 
The investigator or his/her staff will determine the minimum BG for each 
subject at the start of each exercise challenge. It will be noted on the subject’s 
exercise log. 
 
 
Timing 
Settings/Conditions 
Exercise 
duration 
Notes 
Study Period, 
between 
Visits 9 and 
11 
SmartGuard  
(120 mg/dL [6.7 
mmol/L] setpoint) 
Min 30 
minutes, up 
to 1.5 
hours 
Challenge must take place on 
days without meal challenge 
Study Period, 
between 
Visits 9 and 
11 
SmartGuard  
(120 mg/dL [6.7 
mmol/L] setpoint) 
Min 30 
minutes, up 
to 1.5 
hours 
Challenge must take place on 
days without meal challenge 
Study Period, 
between 
Visits 12 and 
13 
SmartGuard  
(100 mg/dL [5.5 
mmol/L] setpoint) 
Min 30 
minutes, up 
to 1.5 
hours 
Challenge must take place on 
days without meal challenge 
Study Period, 
between 
Visits 12 and 
13 
SmartGuard  
(100 mg/dL [5.5 
mmol/L] setpoint) 
Min 30 
minutes, up 
to 1.5 
hours 
Challenge must take place on 
days without meal challenge 
Study Period 
Any time 
after Visit 13 
SmartGuard  
(with current Auto 
Basal target setpoint) 
Min 30 
minutes, up 
to 1.5 
hours 
Challenge must take place on 
days without meal challenge 
 
Exercise Challenges Details: 
To fulfill the exercise challenge requirement, subjects will be asked to engage in 0.5 
up to 1.5 hours of physical exercise. During this time, subjects should use either the 
Auto Basal setpoint target of 100 mg/dL (5.5 mmol/L) or 120 mg/dL (6.7 mmol/L) 
(depending on what is required at that time of the study period) unless a subject 
prefers to use the 150 mg/dL (8.3 mmol/L) target before, during and immediately 
after the exercise challenges. The FoodPrint™ phone app (as well as questions that 
will be asked by the investigational center staff during visits following exercise 
challenges) will be used to collect information about exercise type, date, time (start 
and finish of exercise), duration and name of the parents/caregivers/ companion 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 20 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
present. The timing of the exercise challenge will be at the investigator’s discretion. 
A photograph should be taken on each day of the exercise challenges to indicate 
where the exercise took place. Subjects may also use a Smartphone app to 
document their exercise. The subject's parents/caregivers/companion must be 
physically present in the same building, home or location (if not at home) during 
the exercise challenge, must be able to check SMBG (in case it is needed) and give 
glucose/administer glucagon as needed. Examples of types of exercise include, but 
are not limited to: 
 
 
Running 
 
Cycling 
 
Swimming 
 
Hiking 
 
Walking 
 
Games (e.g. Wii interactive video games) 
 
Indoor/outdoor playground (Pediatric subjects) 
 
Yoga/stretching 
 
Any sport activity that involves ongoing physical movement (e.g., 
tennis, golf, basketball, volleyball, soccer)  
 
Dancing  
 
Zumba  
 
Aerobics 
 
Spinning 
 
Sample Size 
and 
Investigational 
Centers 
A total of up to 250 subjects with insulin-requiring type 1 diabetes age 7-80 will be 
enrolled at up to 25 investigational centers across the United States, Canada, and 
Australia in order to have 200 subjects enter the study period. Up to 125 subjects 
will be enrolled in the pediatric age group (7-17 years of age), up to 125 in the 
adult age group (18 years or older): 
 
 
Subject Age Group 
Sub-groups 
Enrollment Goal (N) 
Pediatric 
Age 7 – 17 years 
All Pediatric 
Minimum 100 Subjects 
Age 7 - 13 years 
Minimum 20 Subjects 
Age 14 - 17 years 
Minimum 20 Subjects 
Adult 
Age 18 - 80 years 
N/A 
Minimum 100 Subjects 
 
 
A minimum of 10 subjects and a maximum of 40 subjects is targeted for enrollment 
at each investigational center to ensure that the results from the individual 
investigational center may be pooled for analysis. 
 
Investigational centers will be encouraged to enroll a study population that 
represents a wide variety of backgrounds.   

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 21 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Duration 
The study is anticipated to last approximately 24 months from first investigational 
center initiation to study completion. Individual subject participation is expected to 
be approximately 120 days.  
Inclusion 
Criteria 
1. Age 7 - 80 years at time of screening. 
2. Has a clinical diagnosis of type 1 diabetes: 
a. 14 - 80 years of age: A clinical diagnosis of type 1 diabetes for 2 years 
or more as determined via medical record or source documentation by 
an individual qualified to make a medical diagnosis. 
b. 7 - 13 years of age: A clinical diagnosis of type 1 diabetes for 1 year or 
more as determined via medical record or source documentation by an 
individual qualified to make a medical diagnosis. 
3. Does not require a legally authorized representative to consent on their behalf 
due to mental or intellectual disability. 
4. Subject or parent/caregiver is literate and able to read one of the languages 
offered in the pump. 
5. Subject and/or legally authorized representative is willing to provide informed 
consent for participation. 
6. Is willing to perform fingerstick blood glucose measurements as needed. 
7. Is willing to wear the system continuously throughout the study.  
8. Must have a minimum daily insulin requirement (Total Daily Dose) of greater 
than or equal to 8 units and maximum total daily dose of 250 units or less. 
9. Has a Glycosylated hemoglobin (HbA1c) less than 10% (as processed by 
Central Lab) at time of screening visit. 
Note: All HbA1c blood specimens will be sent to and tested by a National 
Glycohemoglobin Standardization Program (NGSP) certified Central 
Laboratory.  HbA1c testing must follow NGSP standards.   
10. Has thyroid-stimulating hormone (TSH) in the normal range OR if the TSH is 
out of normal reference range the Free T3 is below or within the lab’s reference 
range and Free T4 is within the normal reference range.   
11. Uses pump therapy for greater than 6 months prior to screening (with or 
without CGM experience) 
12. Is willing to upload data from the study pump, must have Internet access, and 
a computer system, or compatible smartphone that meets the requirements for 
uploading the study pump. 
13. Is willing to take one of the following insulins and can financially support the 
use of either of the 2 insulin preparations as required during the run-in period:  
a. Humalog (insulin lispro injection) 
b. NovoLog/NovoRapid (insulin aspart injection) 
14. Is willing to take Fiasp insulin during the study period (supplied via Sponsor). 
 
Exclusion 
Criteria 
1. Has hypersensitivity to insulin aspart or one of the excipients in Fiasp. 
2. Has a history of 2 or more episodes of severe hypoglycemia, which resulted in 
any the following during the 6 months prior to screening: 
a. Medical assistance (i.e., Paramedics, Emergency Room [ER] or 
Hospitalization) 
b. Coma 
c. Seizures 
3. Has been hospitalized or has visited the ER in the 6 months prior to screening 
resulting in a primary diagnosis of uncontrolled diabetes.  

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 22 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
4. Has had DKA in the last 6 months prior to screening visit.  
5. Will not tolerate tape adhesive in the area of sensor placement as assessed by 
a qualified individual. 
6. Has any unresolved adverse skin condition in the area of sensor placement 
(e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection). 
7. Is female of child-bearing potential and result of pregnancy test is positive at 
screening. 
8. Is sexually active female of child-bearing potential and is not using a form of 
contraception deemed reliable by the investigator. 
9. Is female and plans to become pregnant during the course of the study. 
10. Is being treated for hyperthyroidism at time of screening. 
11. Has diagnosis of adrenal insufficiency. 
12. Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 
weeks from time of screening visit, or plans to take any oral, injectable, or IV 
glucocorticoids during the course of the study.  
13. Is using hydroxyurea at time of screening or plans to use it during the study. 
14. Is actively participating in an investigational study (drug or device) wherein 
he/she has received treatment from an investigational study drug or 
investigational study device in the last 2 weeks. 
15. Is currently abusing illicit drugs.  
16. Is currently abusing marijuana. 
17. Is currently abusing prescription drugs. 
18. Is currently abusing alcohol. 
19. Using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 
agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors) at time 
of screening. 
20. Has a history of visual impairment which would not allow subject to participate 
in the study and perform all study procedures safely, as determined by the 
investigator. 
21. Has elective surgery planned that requires general anesthesia during the course 
of the study. 
22. Has sickle cell disease, hemoglobinopathy; or has received red blood cell 
transfusion or erythropoietin within 3 months prior to time of screening.  
23. Plans to receive red blood cell transfusion or erythropoietin over the course of 
study participation. 
24. Is diagnosed with current eating disorder such as anorexia or bulimia. 
25. Has been diagnosed with chronic kidney disease that results in chronic anemia. 
26. Has a hematocrit that is below the normal reference range of lab used.    
27. Is on dialysis. 
28. Has serum creatinine of >2 mg/dL. 
29. Has celiac disease that is not adequately treated as determined by the 
investigator. 
30. Has had any of the following cardiovascular events within 1 year of screening: 
myocardial infarction, unstable angina, coronary artery bypass surgery, 
coronary artery stenting, transient ischemic attack, cerebrovascular accident, 
angina, congestive heart failure, or ventricular rhythm disturbances. 
31. Has had history of cardiovascular event 1 year or more from the time of 
screening without  

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 23 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
a. a normal EKG and stress test within 6 months prior to screening or 
during screening or  
b. clearance from a qualified physician prior to receiving the study devices 
if there is an abnormal EKG or stress test.  
32. Has 3 or more cardiovascular risk factors listed below without a normal EKG 
within 6 months prior to screening or during screening or clearance from a 
qualified physician if there is an abnormal EKG: 
 
Age >35 years 
 
Type 1 diabetes of >15 years’ duration 
 
Presence of any additional risk factor for coronary artery disease 
 
Presence of microvascular disease (proliferative retinopathy or 
nephropathy, including microalbuminuria) 
 
Presence of peripheral vascular disease 
 
Presence of autonomic neuropathy 
33. Is a member of the research staff involved with the study. 
34. Has used a MiniMed 780G pump prior to screening. 
Study Visit 
Schedule 
Subjects may participate in up to 15 planned study visits, as presented below in 
Synopsis Figure 1, for approximately 120 days of device wear. Virtual office visit 
(audio visual) may be performed for office visits in cases where an office visit is not 
possible. For detailed information, see Section 9.1.1. 
 
Visit 1 to Visit 6 should be completed in 30 days. 
 
 
Visit 1 (Office): Consent and screening 
 
Run-In:  
 
Visit 2 (Office/Virtual Office): Start Run-In 
o 
Eligibility has been confirmed  
o 
Start study pump and CGM 
o 
Register and upload study pump in CareLink Personal and CareLink 
system   
 
Visit 3 (Phone): Day 1 after Visit 2 – Required for subjects without CGM or 
closed loop experience; as needed for all others 
o 
Ask subjects and their parents/caregivers if they require 
assistance, e.g., additional training 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports  
 
Visit 4 (Phone): Day 3 after Visit 2 – Required for subjects without CGM or 
closed loop experience; as needed for all others 
o 
Ask subjects and their parents/caregivers  if they require 
assistance, e.g., additional training 
o 
Ask subjects about adverse events and device performance  
o 
Review CareLink reports 
 
Visit 5 (Phone): Day 7 (±2 days) after Visit 2  
o 
Ask subjects and their parents/caregivers  if they require 
assistance, e.g., additional training 
o 
Ask subjects about adverse events and device performance 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 24 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
o 
Review CareLink reports 
o 
Remind subjects about run-in period meal challenge 
 
Visit 6 (Office/Virtual Office): Day 14 (±3 days) after Visit 2 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
o 
Visit 6 and 7 may be combined 
 
Study Period:  
 
Visit 7 (Office/Virtual Office): Start Study Period,  
Day 7 (-7 days) after Visit 6  
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
o 
Start Auto Basal target at 120 mg/dL (6.7 mmol/L) setpoint with 
Active Insulin Time set to 4 hours, titrate towards 2-3 hours or at 
investigator’s discretion 
o 
Turn on SmartGuard with Auto Corrections “ON” 
o 
Instruct subjects about the required meal and exercise challenges 
for both the 100 mg/dL (5.5 mmol/L) and 120 md/dL (6.7 mmol/L) 
setpoint between Visits 9 and 13 of the study period 
 
Visit 8 (Phone): Day 2 after Visit 7 – Required for subjects without CGM or 
closed loop experience; as needed for all others 
o 
Adjust pump settings as needed 
o 
Ask subjects and their parents/caregivers if they require 
assistance, e.g., additional training 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
o 
Remind subjects about meal/exercise challenges for 120 mg/dL 
(6.7 mmol/L) setpoint 
 
Visit 9 (Phone): Day 7 (±2 days) after Visit 7  
o 
Adjust pump settings as needed 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
o 
Remind subjects about meal/exercise challenges for 120 mg/dL 
(6.7 mmol/L) setpoint 
 
Visit 10 (Phone): Day 14 (±3 days) after Visit 7  
o 
Adjust pump settings as needed 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
o 
Instruct subjects about the required meal/exercise challenges for 
120 mg/dL (6.7 mmol/L) setpoint 
 
Visit 11 (Phone): Day 21 (±3 days) after Visit 7  
o 
Adjust pump settings as needed 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
o 
Change Auto Basal target to 100 mg/dL (5.5 mmol/L) setpoint 
with Active Insulin Time set to 2-3 hours or at investigator’s 
discretion 
o 
Remind subjects about meal/exercise challenges for 100 mg/dL 
(5.5 mmol/L) setpoint 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 25 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
Visit 12 (Office/Virtual Office): Day 28 (+7 days) after Visit 7  
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
 
Visit 13 (Phone): Day 44 (±3 days) after Visit 7  
o 
Adjust Auto Basal target with Active Insulin Time at investigator’s 
discretion 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
o 
Remind subjects about meal/exercise challenges  
 
Visit 14 (Office/Virtual Office): Day 60 (+7 days) after Visit 7  
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
 
Visit 15 (Office/Virtual Office): Day 90 (+7 days) after Visit 7  
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
o 
Return study devices 
o 
End of Study (EOS) 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 26 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
Synopsis Figure 1. Visit Schedule 
 
 
Run-in Period
Office
Visit 1
Consent & 
Screening
Office/
Virtual 
Office 
Visit 2
Start Study 
Pump& CGM
Office/Virtual 
Office 
 Visit 7
Day 7 (-7 
days) after 
Visit 6
Visit Schedule
Study Period
Office/Virtual 
Office
Visit 12
Day 28
(+7 days) after 
Visit 7
Phone 
Visit 11
Day 21 
(±3 days) after 
Visit 7
Phone 
Visit 10
Day 14
 (±3 days) after 
Visit 7
Phone
Visit 9
Day 7 (±2 
days) after 
Visit 7
Office/Virtual 
Office
Visit 14
Day 60
(+7 days) 
after Visit 7
Office/Virtual
Office Visit 15
Day 90
(+7 days) after 
Visit 7
EOS
Visit 1 to Visit 6 should be completed in 30 days.
Phone 
Visit 5
Day 7 (±2 
days) after 
Visit 2 
Office/
Virtual 
Office 
Visit 6
Day 14 (±3 
days) after 
Visit 2
Phone 
Visit 3
Day 1 after 
Visit 2
Phone 
Visit 4
Day 3 after 
Visit 2
 
Phone
Visit 8
Day 2 after 
Visit 7
Phone 
Visit 13
Day 44 
(±3 days) after 
Visit 7
 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 27 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Safety and 
Monitoring/Risk Analysis 
Safety monitoring and risk analysis details are described in Section 
9.4. 
Device Deficiencies  
Subject and investigational center reports of device deficiencies (DDs) 
will be collected on electronic Case Report Forms (eCRFs) reported by 
subjects and/or investigational centers for device troubleshooting and 
device complaints. For additional information, see Section 13. 
Statistical Analysis for 
Endpoints and 
Hypothesis 
During Study Period  
 
Safety and effectiveness endpoints will be evaluated independently for 
ages 18-80 and ages 7-17.  
 
Primary Safety Endpoint 
 
Age 18-80: The overall mean change in HbA1c from baseline 
to end of 3-month study period. The goal is to show non-
inferiority with a margin of 0.4% comparing to a threshold of -
0.5% in reducing HbA1c from baseline to end of 3-month 
study period. 
 
Age 7-17: The overall mean change in HbA1c from baseline to 
end of 3-month study period. The goal is to show non-
inferiority with a margin of 0.4% comparing to a threshold of -
0.38% in reducing HbA1c from baseline to end of 3-month 
study period. 
 
 
Primary Effectiveness Endpoint 
 
 
Age 18-80: The mean % of time in range (TIR 70-180 mg/dL 
[3.9 -10.0 mmol/L]) will be estimated and compared to a 
threshold of 73.7% by a non-inferiority test with a margin of 
7.5% and a significance level of 0.025 (one-sided).   
 
Age 7-17: The mean % of time in range (TIR 70-180 mg/dL 
[3.9 -10.0 mmol/L]) will be estimated and compared to a 
threshold of 65.3% by a non-inferiority test with a margin of 
7.5% and a significance level of 0.025 (one-sided).   
  
Secondary Effectiveness Endpoints 
 
Age 18-80: The mean % of time in hypoglycemia (< 54 mg/dL 
[3.0 mmol/L]) will be estimated and compared to a threshold 
of 0.86% by a non-inferiority test with a margin of 2% and a 
significance level of 0.025 (one-sided).  
 
Age 18-80: The mean % of time in range (TIR 70-180 mg/dL 
[3.9 -10.0 mmol/L]) will be estimated and compared to a 
threshold of 73.7% by a simple superiority test and a 
significance level of 0.025 (one-sided).   
 
Age 7-17: The mean % of time in hypoglycemia (< 54 mg/dL 
[3.0 mmol/L]) will be estimated and compared to a threshold 
of 0.71% by a non-inferiority test with a margin of 2% and a 
significance level of 0.025 (one-sided).  

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 28 of 159 

 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
x 
Age 7-17: The mean % of time in range (TIR 70-180 mg/dL 
[3.9 -10.0 mmol/L]) will be estimated and compared to a 
threshold of 65.3% by a simple superiority test and a 
significance level of 0.025 (one-sided).   
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Safety Data Summarized 
x 
Serious Adverse Events (SAE)  
x 
Serious Adverse Device Effects (SADE) 
x 
Unanticipated Adverse Device Effects 
x 
Unanticipated Serious Adverse Device Effect  
x 
Incidence of Severe Hypoglycemia    
x 
Incidence of Severe Hyperglycemia    
x 
Incidence of DKA 
 
 
PI

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 29 of 159 

 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Device Deficiencies 
Descriptive summary will be used to characterize DDs: 
x 
All reports of device issues. 
 
 
 
 
  
Final Report 
The study results will be summarized and presented in the final report. 
 
 
 
PI
PI

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 30 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
3. Introduction 
 Background 
In patients with insulin dependent diabetes mellitus, glycemic control is influenced by numerous factors 
such as insulin dosage, insulin absorption, timing, physiological/ lifestyle factors such as exercise, food 
intake, hormones and illness. These factors may contribute to significant variability in insulin 
requirements, which makes self-management of type 1 diabetes challenging. 
Patients who are using continuous glucose monitoring (CGM), including sensor-augmented pump therapy, 
experience improvements in glycemic control. Advanced sensor-augmented insulin pumps are now being 
used in clinical practice including closed loop systems that automatically adjust the amount of insulin 
delivered to maintain glucose levels near the target value set by the user.1 
The MiniMed 780G system is a closed loop insulin system. In addition to automatically adjusting the 
amount of insulin delivered based on sensor glucose (SG) readings while operating in the SmartGuard 
feature, the MiniMed 780G insulin pump can also automatically deliver correction boluses when the 
system has been delivering at the maximum allowable basal rate and SG remains elevated. This pump is 
currently in commercial distribution in Canada, Australia, and the United States. Previous clinical 
investigations involved the 670G Version 4.0 pump (contains the 780G AHCL algorithm) used in 
combination with the Guardian Sensor (3) glucose sensor, Guardian Link 3 transmitter, Humalog and 
Novolog insulin. This investigation is intended to confirm safety and effectiveness of the 780G insulin 
pump used in combination with Fiasp insulin. Additional details for non-clinical/clinical testing are 
provided in the report of prior investigations/ Investigator’s Brochure (IB). 
 Purpose 
The purpose of this study is to evaluate the safety and effectiveness of the MiniMed 780G system in type 
1 adult and pediatric subjects utilizing Fiasp (insulin aspart injection) in a home setting. 
4. Objectives and Endpoints 
 Objectives 
The objective of this study is to evaluate the safety and effectiveness of the MiniMed 780G system 
utilizing insulin Fiasp (insulin aspart injection) to support product and system labeling. 
 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 31 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 Endpoints 
Safety and effectiveness endpoints will be evaluated independently for ages 18-80 and ages 7-17.  
 Primary Safety Endpoint 
 
Age 18-80: The overall mean change in HbA1c from baseline to end of 3-month study period. 
The goal is to show non-inferiority with a margin of 0.4% comparing to a threshold of -0.5% in 
reducing HbA1c from baseline to end of 3-month study period. 
 
Age 7-17: The overall mean change in HbA1c from baseline to end of 3-month study period. The 
goal is to show non-inferiority with a margin of 0.4% comparing to a threshold of -0.38% in 
reducing HbA1c from baseline to end of 3-month study period. 
 
 Primary Effectiveness Endpoint 
 
Age 18-80: The mean % of time in range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L]) will be 
estimated and compared to a threshold of 73.7% by a non-inferiority test with a margin of 7.5% 
and a significance level of 0.025 (one-sided).   
 
Age 7-17: The mean % of time in range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L]) will be 
estimated and compared to a threshold of 65.3% by a non-inferiority test with a margin of 7.5% 
and a significance level of 0.025 (one-sided).   
 
 Secondary Effectiveness Endpoint 
 
Age 18-80: The mean % of time in hypoglycemia (< 54 mg/dL [3.0 mmol/L]) will be estimated 
and compared to a threshold of 0.86% by a non-inferiority test with a margin of 2% and a 
significance level of 0.025 (one-sided).  
 
Age 18-80: The mean % of time in range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L]) will be 
estimated and compared to a threshold of 73.7% by a simple superiority test and a significance 
level of 0.025 (one-sided).   
 
Age 7-17: The mean % of time in hypoglycemia (< 54 mg/dL [3.0 mmol/L]) will be estimated 
and compared to a threshold of 0.71% by a non-inferiority test with a margin of 2% and a 
significance level of 0.025 (one-sided).  
 
Age 7-17: The mean % of time in range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L]) will be 
estimated and compared to a threshold of 65.3% by a simple superiority test and a significance 
level of 0.025 (one-sided).   
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 32 of 159 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 Safety Data Summarized 
Serious Adverse Events (SAE)  
Serious Adverse Device Effects (SADE) 
Unanticipated Adverse Device Effects 
x 
Unanticipated Serious Adverse Device Effect  
Incidence of Severe Hypoglycemia    
Incidence of Severe Hyperglycemia    
Incidence of DKA 
 
 
 
PI
PI
PI

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 33 of 159 

 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 Device Deficiencies  
Descriptive summary will be used to characterize DDs: 
x 
All reports of device issues. 

 
 
 
 
 

5. Study Design 
 
This global study is a multi-center, single arm study in insulin-requiring adult and pediatric subjects with 
type 1 diabetes on the MiniMed 780G system using Fiasp insulin as well as Medtronic Extended infusion 
set and reservoir. The run-in period and study period will be approximately 120 days long.  
 
The period from Visit 1 (consent and screening) through Visit 6 should be completed in 30 days. 
 
Companions: 
Subjects will be required to have a companion who resides (or will live) in the same building (or home) 
during the study at night, and also to be physically present in the same building, home or location (if not 
at home) during the exercise and meal challenges. A companion should be present during meal 
challenges and for 4 hours following the start of the meal. Companions should be able to check SMBG, 
give glucose and/or administer glucagon.   
 
Run-in Period (Visits 2-6):  
The run-in period begins at Visit 2 and ends once Visit 7 occurs. 
 
The intent of the run-in period will be to allow subjects to become familiar with new study devices while 
using their own insulin, either Humalog™ (insulin lispro injection) or NovoLog®/NovoRapid® (insulin 
aspart solution for injection). During the run-in period, study subjects with prior Automated Insulin 
PI
PI
PI
PI
PI
PI

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 34 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Delivery (AID) control algorithm experience will be using the study pump with the SmartGuard feature 
activated (Auto Correction must remain OFF). and Medtronic Extended infusion set and reservoir. 
Subjects who do not have prior AID algorithm experience will use the system in Manual Mode. Before and 
during run-in period meal challenges, SmartGuard must be turned OFF, as noted in Meal Challenge 
instructional materials. 
Note for subjects who have prior experience with the Auto Mode feature in Medtronic pumps 
(670G/770G): The term “Auto Mode” has been replaced by the term “SmartGuard” in the 780G pump. 
 
During the run-in period, a 120 mg/dL (6.7 mmol/L) Auto Basal target should be set. It is recommended 
that Active Insulin Time is set to 4 hours.  
 
Note: The Auto Basal target setting and Active Insulin Time should be set as recommended above, unless 
there is a documented safety reason that would not permit these settings to be used. 
 
All subjects and their parents/caregivers as well as companions will be trained on diabetes management 
principles, such as the treatment of hyperglycemia and hypoglycemia. In addition, there will be training 
regarding the need to have access to and how to use glucose and glucagon in case of hypoglycemia.   
 
Parents/caregivers and companions will be instructed that they should be with the subject in the same 
residence or building overnight. 
 
If the MiniMed Clinical app/MiniMed Mobile app and the CareLink Clinical app are being used, 
parents/caregivers will be instructed that subjects should be connected to CareLink via the appropriate 
Smartphone app for data uploading and push notifications for low or high blood sugar when they are 
apart, e.g., at school, other activities. Instructions on the appropriate operation of the apps will be 
provided. 
 
For study purposes, subjects, companions, and parents/caregivers will be trained and/or instructed to 
perform self-monitoring of blood glucose (SMBG) if subjects are experiencing a severe hypoglycemic 
event, severe hyperglycemic event or diabetic ketoacidosis (DKA). Subjects and their parents/caregivers 
as well as companions will also be instructed to check blood ketones using a ketone meter if the Accu-
Chek Guide Link study meter reading is greater than 300 mg/dL (16.7 mmol/L). 
 
As a precaution, subjects and their parents/caregivers will be told that they should keep their own insulin 
pump supplies in a safe place and to have back up supplies on hand (such as insulin and syringe, or 
insulin pen) in the event they are asked to revert back to their own therapy during the study or 
experience study pump issues (i.e., infusion set occlusion with high glucose).   
 
Subjects and their parents/caregivers will be instructed to insert sensors only in the locations that are 
specified in the User Guide materials. Reminders will be given to subjects at each office visit. Information 
about sensor insertions will be collected on an electronic case report form (eCRF) in the study database, 
i.e., insertion location. 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 35 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
Subjects and their parents/caregivers will be trained on all parts of the device system. This training may 
include access to and use of digital online learning content. A training checklist for both subjects and 
parents/caregivers will be implemented and completed.  
 
The completion of emergency response training, including the use of a ketone meter, will be documented 
for companions. Companions may be trained in person or remotely. 
 
After completion of training on the study devices, subjects and their parents/caregivers may attend 
additional visits in the days immediately following the start of system use, as needed. They may also take 
advantage of having access to the digital learning content.  
 
Study Period (Visits 7-15): 
All subjects will use Fiasp for the remainder of the study and will continue using the study pump, with 
SmartGuard feature enabled (including Auto Correction), infusion set and reservoir for approximately 90 
days during the study period.  
 
Subjects should use the system with the SmartGuard feature turned on at all times with Fiasp. When 
prompted by the pump, subjects should take appropriate measures and follow directions on the pump to 
remain in or return to the SmartGuard feature. During times when subjects are not able to use the 
SmartGuard feature, they should use the system in Manual Mode (e.g., Suspend before low and Suspend 
on low). 
 
During the first 3 weeks (between Visits 7 and 11) of the study period, a 120 mg/dL (6.7 mmol/L) Auto 
Basal target should be set. It is recommended that Active Insulin Time is initially set to 4 hours and then 
titrated towards 2-3 hours or at the investigator’s discretion. 
 
During the next 3 weeks (between Visits 11 and 13) of the study period, the Auto Basal target setting 
should be set to 100 mg/dL (5.5 mmol/L). Active Insulin Time is recommended to be set to 2-3 hours or 
at investigator’s discretion. 
 
During the remaining weeks of the study (any time after Visit 13) of the study period, the Auto Basal 
target as well as Active Insulin Time should be set to what is best for the individual subject, at 
investigator’s discretion. 
 
Note: The Auto Basal target setting and Active Insulin Time should be set as recommended above, unless 
there is a documented safety reason that would not permit these settings to be used. 
 
 
After completion of training on the SmartGuard function, subjects and their parents/caregivers may 
attend additional visits in the days immediately following the start of SmartGuard use, as needed. They 
may also take advantage of having access to the digital learning content. 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 36 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
 
Staged Enrollment: 
The enrollment of subjects 7-17 years of age will not move forward until 10 subjects 18 years or older 
have completed 30 days of the study period and the Data Monitoring Committee (DMC) has determined 
that it is safe for 7-17 year olds to be enrolled into the study. 
 
SMBG recommendations for 780G system: 
With the 780G system and the Guardian 4 CGM, calibration is not required. However, a calibration is 
optional and will occur any time a blood glucose (BG) is entered. Occasionally, subjects may receive a 
notification if the pump needs a BG to enter or stay in the SmartGuard feature. Subjects will be instructed 
to perform SMBG if their symptoms do not match the sensor glucose (SG) value (i.e., they develop 
symptoms of hypoglycemia or hyperglycemia, but the SG value does not correlate with their symptoms). 
 
Meal and Exercise Challenges: 
All subjects will be asked to participate in meal and exercise challenges during the run-in and study 
period.  
 
All challenges are at least 4 hours in duration, beginning from the time when the challenge meals 
or exercise are started. 
 
There should not be more than one meal challenge on a single day.  
 
Meal and exercise challenges should not be scheduled on the same day during the specified time 
periods.  
 
For example: A study period regular sized or large sized meal challenge should not take place on the 
same day as an exercise challenge. 
 
Subjects will be asked to check BG at the start of the meal/exercise, as well as 2 hours and 4 hours after 
the start of the meal/exercise and provide correction insulin as necessary. 
 
Throughout the study, it is important for subjects to avoid additional meal/snack or exercise up to four 
hours after the start of the challenge. If additional meal/snack or exercise is needed within 4 hours after 
the start of the challenge, the subject will acknowledge that food intake or exercise occurred. Content 
and timing of the meal and exercise, along with BG values, will be recorded on a log provided by the 
study team. 
 
Meal challenges for all subjects (Run-in and Study period):  
The following meal challenges are required during the run-in and study periods: 
 
Two meal challenges during the run-in period with subjects using the system in Manual Mode – 
between Visits 5 and 7 
o 
Regular sized meal with missed meal bolus at lunch 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 37 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
o 
Large sized meal at breakfast, lunch or dinner 
 
Two meal challenges during the study period with subjects using the system in SmartGuard, Auto 
Basal target set at 120 mg/dL (6.7 mmol/L) – between Visits 9 and 11 of study period 
o 
Regular sized meal with missed meal bolus at lunch 
o 
Large sized meal at breakfast, lunch or dinner 
 
Two meal challenges during the study period with subjects using the system in SmartGuard, Auto 
Basal target set at 100 mg/dL (5.5 mmol/L) – between Visits 12 and 13 of study period 
o 
Regular sized meal with missed meal bolus at lunch 
o 
Large sized meal at breakfast, lunch or dinner 
 
One meal challenge during the study period with subjects using the system in SmartGuard, Auto 
Basal target set at currently set Auto Basal target – at any time after Visit 13 of study period 
o 
Large sized meal at breakfast, lunch or dinner 
Meal challenges should only start if the following conditions are met:  
o 
SMBG at start of meal is < 200 mg/dL (11.1 mmol/L) 
o 
Sensor glucose is available.  
Timing 
Settings/Conditions 
Meal 
Size 
Meal 
Type 
Notes 
Run-in 
Period 
between 
visits 5 
and 7 
Manual Mode only 
Missed meal bolus 
Regular 
sized 
meal 
Lunch 
Meal content, meal size 
and time of meal 
consumption should be 
established so that 
regular sized meal 
challenges during the 
study period can be 
matched  
Run-in 
Period 
between 
visits 5 
and 7 
Manual Mode only 
Large 
sized 
meal 
Breakfast 
Lunch or 
Dinner 
Meal content, meal size 
and time of meal 
consumption should be 
established so that large 
sized meal challenges 
during the study period 
can be matched  
Study 
Period, 
between 
Visits 9 
and 11 
SmartGuard  
(120 mg/dL [6.7 
mmol/L] setpoint) 
Missed Meal bolus 
Regular 
sized 
meal 
Lunch 
Meal content, meal size 
and time of meal 
consumption should 
match regular meal 
taken during run-in and 
the regular meal taken 
at the 100 mg/dL (5.5 
mmol/L) setpoint 
Study 
Period, 
between 
Visits 9 
SmartGuard  
(120 mg/dL [6.7 
mmol/L] setpoint) 
Large 
sized 
meal  
Breakfast, 
Lunch or 
Dinner 
Meal content, meal size 
and time of meal 
consumption should 
match meal at Setpoint 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 38 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
and 11 
of 100 mg/dL (5.5 
mmol/L) and run-in 
period meal   
Study 
Period, 
between 
Visits 12 
and 13 
SmartGuard  
(100 mg/dL [5.5 
mmol/L] setpoint) 
Missed meal bolus 
Regular 
sized 
meal 
Lunch 
Meal content, meal size 
and time of meal 
consumption should 
match regular meal 
taken during run-in and 
the regular meal taken 
at the 120 mg/dL (6.7 
mmol/L). 
Study 
Period, 
between 
Visits 12 
and 13 
SmartGuard  
(100 mg/dL [5.5 
mmol/L] setpoint) 
Large 
sized 
meal  
Breakfast 
Lunch or 
Dinner 
Meal content, meal size 
and time of meal 
consumption should 
match meal at Setpoint 
of 120 mg/dL (6.7 
mmol/L) and run-in 
period large sized meal     
Study 
Period 
Any time 
after Visit 
13 
SmartGuard  
(with current Auto 
Basal target setpoint) 
Large 
sized 
meal  
Breakfast 
Lunch or 
Dinner 
Meal content, meal size 
and time of meal 
consumption should 
match large meal at 
Setpoint of 120 mg/dL 
(6.7 mmol/L)/100 mg/dL 
(5.5 mmol/L) and run-in 
period large sized meals 
 
Regular Sized Meal Challenge with Missed Meal Bolus:  
Between Visits 5 and 7 for the run-in period, while subjects are in Manual Mode with CGM, they will be 
asked to consume a meal without administration of a Meal Bolus at lunch. The size of the meal should be 
equivalent to what subjects would normally eat at this mealtime.  
During the study period, once at each Auto Basal setpoint (i.e. 120 mg/dL[6.7 mmol/L] and 100 mg/dL[5.5 
mmol/L]), subjects will be asked to consume the same regular sized lunch meal that they had during the 
run-in period. For example, if the regular sized meal was consumed without an insulin bolus for the meal 
at 12 pm during the run-in period, that same regular sized meal should be consumed at approximately 
the same time of day at each setpoint during the study period.  
 
Large sized Meal Challenges:   
On large sized meal challenge days, subjects will be instructed to eat at least 1 meal with at least 50% 
higher caloric intake including 50% more carbohydrates and 50% higher in fat. It is recommended that 
subjects eat food at restaurants or consume prepared meals. The FoodPrint™ phone app (as well as 
questions that will be asked by the investigational center staff during visits following meal challenges) will 
be used to collect information about type of food, name of restaurant (if applicable), subject confirmation 
that the meal eaten was different from any meal eaten within the last month and subject confirmation 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 39 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
that meal size was at least 50% more than when subjects usually consume in terms of calories, 
carbohydrates and fat. The timing of the meal challenges will be at the investigator’s discretion. The 
subject's parent/caregiver should be physically present in the same building, home or location (if not at 
home) during the meal challenge (and for 4 hours following the start of the meal), must be able to check 
SMBG (in case it is needed), and give glucose/administer glucagon as needed.  
 
Exercise Challenge for all subjects (Study Period only):   
 
The following exercise challenges are required during the study period: 
 
2 exercise challenges at setpoint of 120 mg/dL (6.7 mmol/L, between Visits 9 and 11 of the study 
period) 
 
2 exercise challenges at setpoint of 100 mg/dL (5.5 mmol/L, between Visits 12 and 13 of the study 
period) 
 
1 exercise challenge at currently set Auto Basal target, at any time after Visit 13 of the study period 
 
Conditions at start of the exercise challenges: 
 
SG should be present at the start of each exercise challenge 
 
The investigator or his/her staff will determine the minimum BG for each subject at the start of each 
exercise challenge. It will be noted on the subject’s exercise log. 
 
 
Timing 
Settings/Conditions 
Exercise 
duration 
Notes 
Study Period, 
between 
Visits 9 and 
11 
SmartGuard  
(120 mg/dL [6.7 
mmol/L] setpoint) 
Min 30 
minutes, up 
to 1.5 
hours 
Challenge must take place on 
days without meal challenge 
Study Period, 
between 
Visits 9 and 
11 
SmartGuard  
(120 mg/dL [6.7 
mmol/L] setpoint) 
Min 30 
minutes, up 
to 1.5 
hours 
Challenge must take place on 
days without meal challenge 
Study Period, 
between 
Visits 12 and 
13 
SmartGuard  
(100 mg/dL [5.5 
mmol/L] setpoint) 
Min 30 
minutes, up 
to 1.5 
hours 
Challenge must take place on 
days without meal challenge 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 40 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Study Period, 
between 
Visits 12 and 
13 
SmartGuard  
(100 mg/dL [5.5 
mmol/L] setpoint) 
Min 30 
minutes, up 
to 1.5 
hours 
Challenge must take place on 
days without meal challenge 
Study Period 
Any time 
after Visit 13 
SmartGuard  
(with current Auto 
Basal target setpoint) 
Min 30 
minutes, up 
to 1.5 
hours 
Challenge must take place on 
days without meal challenge 
 
Exercise Challenges Details: 
To fulfill the exercise challenge requirement, subjects will be asked to engage in 0.5 up to 1.5 hours of 
physical exercise. During this time, subjects should use either the Auto Basal setpoint target of 100 
mg/dL (5.5 mmol/L) or 120 mg/dL (6.7 mmol/L) (depending on what is required at that time of the study 
period) unless a subject prefers to use the 150 mg/dL (8.3 mmol/L) target before, during and 
immediately after the exercise challenges. The FoodPrint™ phone app (as well as questions that will be 
asked by the investigational center staff during visits following exercise challenges) will be used to collect 
information about exercise type, date, time (start and finish of exercise), duration and name of the 
parents/caregivers/ companion present. The timing of the exercise challenge will be at the investigator’s 
discretion. A photograph should be taken on each day of the exercise challenges to indicate where the 
exercise took place. Subjects may also use a Smartphone app to document their exercise. The subject's 
parents/caregivers/companion must be physically present in the same building, home or location (if not 
at home) during the exercise challenge, must be able to check SMBG (in case it is needed) and give 
glucose/administer glucagon as needed. Examples of types of exercise include, but are not limited to: 
 
 
Running 
 
Cycling 
 
Swimming 
 
Hiking 
 
Walking 
 
Games (e.g. Wii interactive video games) 
 
Indoor/outdoor playground (Pediatric subjects) 
 
Yoga/stretching 
 
Any sport activity that involves ongoing physical movement (e.g., tennis, golf, basketball, 
volleyball, soccer)  
 
Dancing  

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 41 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
Zumba  
 
Aerobics 
 
Spinning 
 
 
 Duration 
The study is anticipated to last approximately 24 months from first investigational center initiation to 
study completion. Individual subject participation is expected to be approximately 120 days.  
 
 Rationale 
Previous clinical investigations have confirmed the safety and clinical performance of the 780G insulin 
pump when used to delivery Humalog or Novolog/NovoRapid U100 insulin to patients 7- 80 years of age.   
In-silico modeling provided in 10977370DOC (Faster Insulin Aspart [Fiasp] Compared to Insulin Aspart - 
In-Silico Studies with MiniMed 670G HCL) indicates that the use of Fiasp U100 insulin with the MiniMed 
670G pump will result in similar outcomes to those associated with use Humalog or Novolog/NovoRapid 
U100 insulin. These results provide a preliminary confirmation of the safety of using Fiasp with the 780G 
insulin pump. This investigation is intended to provide additional confirmation of the safety of the 780G 
insulin pump used in combination with Fiasp U100 insulin in humans. 
 
 
6. Product Description 
 Intended Use 
The MiniMed 780G system is intended for use by people seven years and older with type 1 diabetes who 
require at least 8 units of insulin per day. 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 42 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
 General Overview of MiniMed 780G Insulin Pump System Components and Consumables 
 
Table 1. MiniMed 780G Insulin Pump: System Components and consumable materials 
 
Device name* 
MDT Model number/ part number 
US 
Device Regulatory 
Status 
Canada 
Device Regulatory Status 
MiniMed 780G Insulin Pump, 
Software Version 6.7 – referred to 
as study pump throughout this 
protocol 
MMT-1884 (US)  
MMT-1885XCC (Canada) 
 
Investigational 
Investigational 
Guardian 4 Sensor- referred to as 
the sensor throughout this protocol 
MMT-7040 (US) 
MMT-7040X1 or  
MMT-7040C4 (Canada) 
 
Non-
Investigational***** 
Investigational 
Guardian 4 Transmitter 
MMT-7841 (US) 
MMT-7841XW4 (Canada) 
 
Non-
Investigational***** 
Investigational 
Medtronic Extended infusion set  
MMT-430, MMT-431, MMT-432, MMT-433, MMT-
440, MMT-441, MMT-442, and MMT-443 (US) 
 
MMT-430A, MMT-431AH, MMT-431AJ, MMT-432A, 
MMT-433AJ, MMT-440A, MMT-441AH, MMT-
441AJ, MMT-442AH, MMT-442AJ, and MMT-443AJ 
(Canada) 
Non-Investigational 
Non-Investigational***** 
Medtronic Extended Reservoir  
MMT-342 
Non-Investigational 
Licensed 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 43 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Device name* 
MDT Model number/ part number 
US 
Device Regulatory 
Status 
Canada 
Device Regulatory Status 
One-Press Serter 
MMT-7512 (US) 
MMT-7512WE (Canada) 
 
Non-Investigational 
Class I Medical Device****  
Charger  
MMT-7715 
Non-Investigational 
Licensed 
Tester  
MMT-7736L 
Non-Investigational 
Licensed 
Medtronic CareLink Personal 
software  
MMT-7333 
Non-Investigational** 
Non-Investigational; Not 
regulated as a medical device 
in Canada 
Medtronic CareLink system 
software  
MMT-7350 
Non-Investigational** 
Non-Investigational; Not 
regulated as a medical device 
in Canada 
Roche Accu-Chek Guide Link 
Glucose Meter- 
referred to as the Accu-Chek 
Guide Link study meter 
throughout this protocol 
08116083022 (US) 
Kit number 08116113198M (Canada) 
Meter model number 08109222001 (Canada) 
 
Non-Investigational 
Non-Investigational 
MiniMed Clinical App 
MMT-6103 Android; MMT-6104 IOS 
Non-
Investigational*** 
Non-Investigational; Not 
regulated as a medical device 
in Canada 
MiniMed Mobile App 
MMT-6101 Android; MMT-6102 IOS 
Non-
Investigational*** 
Non-Investigational; Not 
regulated as a medical device 
in Canada 
CareLink Clinical App  
MMT-6113 Android; MMT-6114 IOS 
Non-
Investigational*** 
Non-Investigational; Not 
regulated as a medical device 
in Canada 
Blue Adapter 
ACC-1003911D and  
ACC-1003911F 
Non-Investigational 
N/A 
Ketone meter 
N/A 
Non-Investigational 
Approved  

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 44 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Drug name* 
MDT Model number/ part number 
US 
Drug Regulatory Status 
Canada 
Drug Regulatory Status 
Fiasp (insulin aspart injection) 
N/A 
Approved  
 
Approved 
 
* For detailed information on the characteristics’ materials, see device instructions for use (IFU). 
** Class I Exempt 
*** Class II Exempt 
**** Does not have an associated license number 
***** The commercial labeled stock will be disbursed after depletion of investigational labeled stock products. 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 45 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
Table 2. Estimated Numbers of Devices Per Subject During The Entire Study 
Item 
Units per Subject  
MiniMed 780G Insulin Pump 
1 
Guardian 4 Sensor  
(Boxes of 5) 
6 
Guardian 4 Transmitter Kit (includes 
serter, charger, and tester) 
1 
Medtronic Extended infusion set 
(Each or Boxes of 10) 
30 each or 3 boxes 
Medtronic Extended Reservoir 
(Boxes of 10) 
6 
Roche Accu-Chek Guide Link Study 
Meter 
1-2 
Ketone Meter  
1-2 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 46 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
 MiniMed 780G Insulin Pump 
The MiniMed 780G Insulin Pump, with software Version 6.7, houses electronics, a pumping mechanism, a 
user interface, and a medication reservoir within the same physical device. The pump communicates via 
Bluetooth® Low Energy wireless communication protocol with the compatible devices in the MiniMed 
780G System. 
In this study, the MiniMed 780G Pump will be used outside of its approved intended use and in 
combination with the following devices: 
 
The MiniMed 780G Pump receives the SG values and sensor integrity (SI) check from the 
Guardian 4 Transmitter, which is connected to the Guardian 4 Sensor. 
 
The MiniMed 780G Pump receives BG values from the Roche’s Accu-Chek Guide Link BG 
meter 
 
The MiniMed 780G Pump transmits data to a compatible consumer electronic device with the 
MiniMed Clinical app/MiniMed Mobile app, to provide a secondary display for passive 
monitoring of CGM and pump data for the user. 
 
The MiniMed 780G Pump also transmits data to CareLink Personal/CareLink system software 
through the Blue Adapter/ MiniMed Clinical app/MiniMed Mobile app. 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 47 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Figure 1. 780G System and Components 
 
 
 Guardian 4 Sensor 
The Guardian 4 sensor, referred to as the sensor in this protocol, is a sensor that contains one 
microelectrode with a thin coating of glucose oxidase beneath several layers of biocompatible membrane. 
The Guardian 4 sensor will be used with the 780G system. The sensor is the latest generation of glucose 
sensor with design changes for supporting improved accuracy. It is intended to penetrate the skin at a 
90-degree angle. The sensor is tubeless. An introducer needle penetrates the skin surface and provides 
support for the sensor microelectrode during insertion. The sensor continuously converts small amounts 
of glucose from the subject’s interstitial fluid into an electronic signal that is received by a transmitter or 
recorder, the strength of which is proportional to the amount of glucose present in the blood. The 
electrode is composed of embedding, signal-conducting and insulating layers. 
 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 48 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 Guardian 4 Transmitter  
The Guardian 4 Transmitter is a portable, electrical current meter intended to process, store, and 
transmit glucose sensor values to the compatible insulin pump. The transmitter sends SG values and SI 
data from the sensor to compatible insulin pumps via a Bluetooth Low Energy wireless communication 
protocol. 
 
 
 Medtronic Extended Infusion Set  
Infusion sets are single-use by patients with diabetes mellitus requiring subcutaneous administered 
insulin to maintain acceptable BG levels. The Medtronic Extended infusion set is an infusion set with a 
pre-loaded inserter, inserted into the subcutaneous tissue of a user, and is connected to a Medtronic 
MiniMed medication reservoir (for use with a Medtronic MiniMed insulin pump). There are three basic 
components of the infusion set:  
1. Catheter hub with cannula and adhesive patch 
2. Tubing 
3. Tubing connector 
The cannula, connected to the catheter hub, is introduced into subcutaneous tissue (i.e., infusion site).  
The tubing connects the catheter hub and the tubing connector to provide the fluid from the medication 
reservoir housed within the insulin pump. 
The device utilizes a new high-performance tubing connector (H-Cap) to replace the current proprietary 
Paradigm connector (P-Cap), an extended wear tubing to replace the current tubing, and an extended 
wear adhesive patch. Figure 2 and Figure 3 illustrate the device and the tubing connectors. 
The Medtronic Extended infusion set enhances patient wear time to 7 days. This is done by maintaining 
insulin formulation stability (including physical, chemical, and microbiological stability) during infusion 
through the pump/infusion set system over extended time (up to 7 days).  

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 49 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Figure 2. Medtronic Extended infusion set 
 
Figure 3. Connector, P-Cap (Left); High-Performance Connector, H-Cap (Right) 
 
 
 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 50 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 Medtronic Extended Reservoir  
The Medtronic Extended Reservoir is indicated for the subcutaneous infusion of insulin from compatible 
Medtronic insulin pumps and Medtronic Extended infusion sets.  
 
 
 Insulin  
Fiasp (insulin aspart injection) is a fast-acting insulin with the same active ingredient as 
Novolog/NovoRapid, used to treat adults and pediatrics with diabetes for the control of high blood sugar.  
Subjects will use their own rapid-acting analogue insulin (Novolog/NovoRapid or Humalog) during the 
run-in period. During the study period, subjects will be provided with Fiasp for use.  
 
 One-Press Serter  
The One-Press Serter, referred to as the Serter in this protocol, is an insertion device that is used to 
ensure correct placement of the sensor into the user’s subcutaneous tissue. Insertion is triggered when 
the two spring loaded buttons on the sides of the Serter are pressed simultaneously. The Serter is 
intended as a single patient, non-sterile, multi-use device.   
 
 
 Charger  
The Charger is used to recharge the transmitter as needed. A fully charged battery provides up to 7 days 
of transmitter use. The system includes a battery charger that will recharge the device according to the 
user guide.  
 
 Tester  
The Tester operates as a sensor simulator creating signal current at a level that is within the range of an 
in-vivo sensor during normal operation. 
 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 51 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 CareLink Personal Software  
Medtronic CareLink Personal software is an internet-based software system which allows the device data 
to be uploaded and reviewed by the subject. The CareLink Personal software allows subjects to upload 
data from Medtronic MiniMed insulin pumps and a range of system-supported, third-party BG meters. The 
data contained in CareLink Personal software is accessible to users using a standard browser, i.e., 
Microsoft® Internet Explorer or Google Chrome, on an Internet enabled personal computer (PC).  
The CareLink Personal software use standard Transport Layer Security (TLS) technology. TLS 
transmission protocol invokes encryption on both ends of the transmissions and is the standard for all 
security-based systems. The encryption remains in effect whether the data is moving to and from the 
client and server in the United States, or to and from a client in another country to the United States. The 
data is secure behind a three-tier industry standard architecture, which places the database behind three 
different firewalls, where each firewall separates a tier: 
 
The internet to the web server; 
 
Web server to the application server; 
 
Application server to the database server. 
 
 
 CareLink System Software  
Medtronic CareLink system software is an internet-based software system which allows the device data to 
be uploaded, viewed and easily evaluated by the physician. The CareLink system software allows 
retrospective review of device data and was developed for use by the investigational center staff. The 
CareLink system software allows the investigational center staff to manage, create, and request for 
approval to link the subject’s account. The data contained in CareLink system software is accessible to 
users using a standard browser, i.e., Microsoft® Internet Explorer or Google Chrome, on an Internet 
enabled PC.  
The CareLink system software use standard TLS technology. TLS transmission protocol invokes 
encryption on both ends of the transmissions and is the standard for all security-based systems. The 
encryption remains in effect whether the data is moving to and from the client and server in the United 
States, or to and from a client in another country to the United States. The data is secure behind a three-
tier industry standard architecture, which places the database behind three different firewalls, where 
each firewall separates a tier: 
 
The internet to the web server; 
 
Web server to the application server; 
 
Application server to the database server. 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 52 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 Roche Accu-Chek Guide Glucose Meter 
The Roche's Accu-Chek Guide Link meter is a home BG meter designed to measure and transmit BG 
values to the compatible insulin pumps via a Bluetooth Low Energy wireless communication protocol. The 
insulin pump then sends the BG values to the transmitter. The transmission of BG values from a 
compatible meter is an optional feature provided as a convenience to the user; it eliminates the need to 
manually enter BG values into the pump. The Accu-Chek Guide Link BG meter is compatible with Roche's 
Accu-Chek Guide test strips.  
 Accessory Applications – 780G system 
The MiniMed Clinical/MiniMed Mobile app is an optional accessory, which receives pump data via 
Bluetooth Low Energy wireless communication from the pump. The MiniMed Clinical app/MiniMed Mobile 
app provides users with the convenience to wirelessly transfer pump data to CareLink Personal/CareLink 
system software and also provides a mirroring display of the pump screen. The MiniMed Clinical/MiniMed 
Mobile app is not designed to control or monitor the performance of the insulin pump nor for direct 
monitoring of pump data. As a mirroring display, the app can provide alerts to the subject via the user 
interface. All alerts must be addressed on the insulin pump.  
The CareLink Clinical app is an optional accessory which receives pump data wirelessly from the CareLink 
server. The CareLink Clinical app provides a mirroring display of the MiniMed Clinical app/MiniMed Mobile 
screen, for remote monitoring by a care partner (e.g., caregiver). The CareLink Clinical app is not 
designed to monitor the performance of the insulin pump nor for direct monitoring of pump data. As a 
mirroring display, the app can provide notifications to the care partner via the user interface.  
 Blue Adapter  
The Blue Adapter is an optional accessory with Bluetooth technology that facilitates the communication 
between a PC and the insulin pump, via a Bluetooth Low Energy wireless communication protocol. The 
Blue Adapter is an off-the-shelf non-medical device intended to transfer data to CareLink server. The Blue 
Adapter does not have any computation, diagnostic, monitoring or therapeutic function/benefit. 
Medtronic will provide the Blue Adapter as a convenience to subjects as an alternative for subjects when 
automatic uploads via the MiniMed Clinical app/MiniMed Mobile app are not possible. 
 Ketone Meter  
The ketone meter can measure both BG (sugar) and blood ß-Ketone. In this study, however, the meter 
will only be used to measure ß-Ketone levels, which will be collected for reporting and review (see 
Investigator/Coordinator binder for details) and as described in the body of this study protocol. This 
meter allows quantification of blood ß-Ketone levels and is the preferred patient method of testing over 
urine testing. 
 Smartphone 
Sponsor may provide a smartphone, upon request. 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 53 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 Consumable Devices 
Glucose meter accessories (e.g., Accu-Chek Guide test strips) and other consumable materials will be 
provided to subjects for use in the study. 
 Anticipated Product Changes 
There are no changes anticipated for any of the products/devices during the course of the study. 
 Product Accountability 
Good clinical research practice requires that investigators and research teams ensure accurate 
accountability for any investigational devices used in a research trial. It is expected that all investigational 
devices will be used in the manner intended during the study and that they will be used only by (on) 
subjects who have consented to participate in the research study and by investigational center staff 
trained on the study. 
Any investigational device being used in clinical research must be strictly accounted for and will not be 
shipped to any investigational center unless all of the necessary approvals (e.g., regulatory authority and 
EC/IRB) have been received.  
The principal investigator (PI) or an authorized designee shall keep records documenting the receipt, use, 
return, and disposal of the investigational devices. Additional details regarding device accountability and 
device disposition requirements are provided in Table 3 (US) and Table 4 (Canada). 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 54 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Table 3. Device Accountability Requirements- US  
Device/Drug 
Record on  
Site 
Received 
eCRF 
Record Disbursement, 
Returned or Not Returned 
from Subject on Subject 
Device Identification 
eCRF 
Subject Return 
Device to 
Investigational 
Center  
Record Returned 
or Not Returned 
to Sponsor on 
Site Returned 
eCRF  
Investigational Center 
Return Device to 
Sponsor at Conclusion 
of Study 
MiniMed 780G Insulin 
Pump with software 
Version 6.7  
(MMT-1884) 
Yes 
Yes 
Yes 
Yes 
Yes 
Guardian 4 Sensor  
(MMT-7040) 
Yes 
Yes 
Yes (Unused) 
No** (Used) 
Yes  
Yes (Unused) 
No** (Used) 
Guardian 4 Transmitter* 
(MMT-7841) 
Yes 
Yes 
Yes 
Yes 
Yes 
Medtronic Extended 
infusion set  
(MMT-430, MMT-431, 
MMT-432, MMT-433, 
MMT-440, MMT-441, 
MMT-442, and MMT-443) 
No 
No 
Yes (Complaint) 
No** (Non-complaint 
used and unused) 
No 
Yes (Complaint) 
No** (Non-complaint 
used and unused) 
Medtronic Extended 
Reservoir  
(MMT-342) 
Yes 
Yes 
Yes (Complaint and 
unused) 
No** (Non-complaint 
used) 
Yes 
Yes (Complaint) 
No** (Non-complaint 
used and unused) 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 55 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Device/Drug 
Record on  
Site 
Received 
eCRF 
Record Disbursement, 
Returned or Not Returned 
from Subject on Subject 
Device Identification 
eCRF 
Subject Return 
Device to 
Investigational 
Center  
Record Returned 
or Not Returned 
to Sponsor on 
Site Returned 
eCRF  
Investigational Center 
Return Device to 
Sponsor at Conclusion 
of Study 
Roche Accu-Chek Guide 
Link Study Meter  
(08116083022*) 
Yes 
Yes 
Yes 
Yes 
No** 
Ketone meter 
No 
No 
Yes 
No 
No** 
Fiasp insulin 
Yes 
Yes 
Yes (unopened vials 
only) 
 
Yes 
No***  
Smartphone, as approved 
for distribution  
Yes 
Yes 
Yes 
Yes 
Yes 
* Devices may be combined and distributed in kits.  
** If subject is unable to dispose, return products to investigational center for disposal.  
If investigational center is unable to dispose, return products to sponsor for disposal. 
*** Insulin leftovers should be destroyed at investigational center. 
 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 56 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Table 4. Device Accountability Requirements- Canada 
Device/Drug 
Record on  
Site 
Received 
eCRF 
Record Disbursement, 
Returned or Not 
Returned from Subject 
on Subject Device 
Identification eCRF 
Subject Return 
Device to 
Investigational 
Center  
Record 
Returned or 
Not Returned to 
Sponsor on Site 
Returned eCRF  
Investigational 
Center Return Device 
to Sponsor at 
Conclusion of Study 
MiniMed 780G Insulin Pump 
with software Version 6.7  
(MMT-1885XCC) 
Yes 
Yes 
Yes 
Yes 
Yes 
Guardian 4 Sensor 
(MMT-7040X1 or MMT-7040C4) 
Yes 
Yes 
Yes (Unused) 
No** (Used) 
Yes  
Yes (Unused) 
No** (Used) 
Guardian 4 Transmitter* 
(MMT-7841XW4) 
Yes 
Yes 
Yes 
Yes 
Yes 
Medtronic Extended infusion 
set  
(MMT-430A, MMT-431AH, 
MMT-431AJ, MMT-432A, MMT-
433AJ, MMT-440A, MMT-
441AH, MMT-441AJ, MMT-
442AH, MMT-442AJ, and MMT-
443AJ) 
Yes 
Yes 
Yes (Complaint and 
unused)  
No** (Non-complaint 
used) 
Yes 
Yes (Complaint and 
unused)  
No** (Non-complaint 
used) 
Medtronic Extended Reservoir  
(MMT-342) 
No 
No 
Yes (Complaint)  
No** (Non-complaint 
used and unused) 
No 
Yes (Complaint)  
No** (Non-complaint 
used and unused) 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 57 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Device/Drug 
Record on  
Site 
Received 
eCRF 
Record Disbursement, 
Returned or Not 
Returned from Subject 
on Subject Device 
Identification eCRF 
Subject Return 
Device to 
Investigational 
Center  
Record 
Returned or 
Not Returned to 
Sponsor on Site 
Returned eCRF  
Investigational 
Center Return Device 
to Sponsor at 
Conclusion of Study 
Roche Accu-Chek Guide Link 
Study Meter  
(Kit number 08116113198M* 
and Meter number 
08109222001) 
Yes 
Yes 
Yes 
Yes 
No** 
Ketone Meter 
No 
No 
Yes 
No 
No** 
Fiasp insulin 
Yes 
Yes 
Yes (unopened vials 
only) 
 
Yes 
No***  
Smartphone, as approved for 
distribution 
Yes 
Yes 
Yes 
Yes 
Yes 
*Devices may be combined and distributed in kits.  
** If subject is unable to dispose, return products to investigational center for disposal. 
If investigational center is unable to dispose, return products to sponsor for disposal. 
*** Insulin leftovers should be destroyed at investigational center 
 
 
 
The investigational center will promptly notify the sponsor of any device handling violation that might impact either the safety and/ or welfare of 
subjects or data integrity.  

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 58 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 Receipt and Inventory of  Study Devices by Investigational Center 
 
Upon receipt of the study devices, investigational center staff will take inventory of the shipment, 
making sure that information on the packing slips/invoices matches exactly the contents of the 
containers, as applicable, including:  
o 
Ship to address 
o 
Reference number 
o 
Device type 
o 
Quantity  
o 
Quantity per package  
o 
Lot number (where applicable) 
o 
Serial number (where applicable) 
 
Ensure that devices and supplies received have not reached or exceeded their expiration date  
 
Sign and date the packing slips/invoices, noting any discrepancies, and file in appropriate study 
binder 
 
Notify the study monitor of any discrepancies 
 
Enter or acknowledge the study device information on the appropriate eCRF in the study database, 
if applicable as described in Table 3 (US) and Table 4 (Canada). 
 Storage of Study Devices at Investigational Center 
Study devices are to be stored in a secure environment with access limited to authorized research 
personnel. Study devices are stored in the appropriate environmental conditions as identified in the 
IFU/user guide/labeling. 
 Dispensing of Study Devices 
Each time a study device and insulin is dispensed to a subject by the investigator or authorized member 
of the research team, eCRF, and/or source documentation will be completed as required. Documentation 
may include:  
 
Dispensing date 
 
Subject identification (ID) 
 
Lot number (where applicable) 
 
Serial number (where applicable) 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 59 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
Device type 
 
Amount dispensed  
 Return or Disposal of Study Devices 
After use by the subject, the investigational center is expected to accept and retain all devices as 
described in Table 3 (US) and Table 4 (Canada). and store them in a secure environment.  If 
containers/units/devices are missing, the reasons should be documented in the applicable eCRF and/or 
source document. If discrepancies between the amounts used by subjects and the amounts expected to 
be returned exist, the reasons should be documented in the applicable eCRF and/or source document.  
Requirements for return of devices by subjects to the investigational center and return of device by the 
investigational center to the sponsor are listed in Table 3 (US) and Table 4 (Canada). The devices 
that are being returned to the investigational center may be returned to the sponsor as subjects complete 
the study, at the study closure or upon sponsor request.   
Other consumable devices (e.g., alcohol wipes, study meter supplies, and tape), and accessories shipped 
in kits, supplies or materials may be returned to the sponsor, they may be retained by investigational 
centers for educational purposes only, or they may be disposed of appropriately by the investigational 
center staff.   
Disposable and consumable devices that have been used by a subject will be disposed of appropriately 
by the subject or the investigational center staff during the conduct of the study.  
All study devices that are required to be entered into the study database and/or source document must 
be accounted for as described above before they are returned to the sponsor.  
Fiasp insulin will be accounted for at the investigational center. Any insulin that is left over will be 
destroyed by participating centers and destruction records will be filed. 
 
7. Study Site Requirements 
 
 Investigator/Investigational Center Selection  
In order to conduct the study, it is required that the investigator and investigational center staff have the 
appropriate medical training. 
 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 60 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
The primary investigator must be a physician who has managed patients on both CGM and insulin pump 
therapy for at least one- year and must be familiar with insulin carbohydrate ratios, insulin sensitivity, 
and treating diabetic emergencies. 
 Study Site Activation 
During the activation process (prior to subject enrollment), Medtronic will train investigational center staff 
who may then train other staff at each investigational center. If new members join the study 
investigational center team, they will receive training on the applicable study requirements relevant to 
their role before contributing to the study. 
Prior to performing study related activities, all regulatory requirements shall be fulfilled, including but not 
limited to the following:  
 
EC/IRB approval (and voting list, as required by local law) of the current version of the CIP 
Informed Consent Form (ICF), and report of prior investigations/IB 
 
Regulatory authority approval or notification (as required per local law) 
 
Fully executed Clinical Trial Agreement (CTA)  
 
Financial disclosure (if applicable)  
 
Curriculum vitae (CV) of investigators 
 
Documentation of delegated tasks 
 
Documentation of study training  
In addition, all participating investigational center staff must be trained on the current version of the CIP 
as well as on the applicable study requirements depending on their role and must be delegated by the PI 
prior to performing delegated study activities.   
Medtronic will provide each study investigational center with documentation of study investigational 
center/investigator subject enrollment readiness; this letter must be received prior to subject enrollment. 
8. Selection of Subjects 
 Study Population 
A total of up to 250 subjects with insulin-requiring type 1 diabetes age 7-80 will be enrolled at up to 25 
investigational centers across the United States, Canada, and Australia in order to have 200 subjects 
enter the study period. Up to 125 subjects will be enrolled in the pediatric age group (7-17 years of age), 
up to 125 in the adult age group (18 years or older): 
 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 61 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Subject Age Group 
Sub-groups 
Enrollment Goal (N) 
Pediatric 
Age 7 – 17 years 
All Pediatric 
Minimum 100 Subjects 
Age 7 - 13 years 
Minimum 20 Subjects 
Age 14 - 17 years 
Minimum 20 Subjects 
Adult 
Age 18 - 80 years 
N/A 
Minimum 100 Subjects 
 
 
A minimum of 10 subjects and a maximum of 40 subjects is targeted for enrollment at each 
investigational center to ensure that the results from the individual investigational center may be pooled 
for analysis. 
 
Investigational centers will be encouraged to enroll a study population that represents a wide variety of 
backgrounds.   
 Subject Enrollment 
Subjects will be considered enrolled in the study upon signing the ICF and assent form (if applicable). 
A subject will be assigned a unique study subject ID via the eCRF, which is a 9-digit code (336XXXXXX).  
The first three digits refer to the CIP number (336), the next three characters refer to the investigational 
center identifier, and the last 3 digits refer to the subject number assigned during Visit 1 (e.g., 
336002001 is subject 001 from investigational center 002). 
The investigator will maintain a log of all subjects enrolled in the clinical study, assigning a subject ID 
linked to their names, and alternative subject ID. 
 Inclusion Criteria 
 
1. Age 7 - 80 years at time of screening. 
2. Has a clinical diagnosis of type 1 diabetes: 
a. 14 - 80 years of age: A clinical diagnosis of type 1 diabetes for 2 years or more as 
determined via medical record or source documentation by an individual qualified to make a 
medical diagnosis. 
b. 7 - 13 years of age: A clinical diagnosis of type 1 diabetes for 1 year or more as determined 
via medical record or source documentation by an individual qualified to make a medical 
diagnosis. 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 62 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
3. Does not require a legally authorized representative to consent on their behalf due to mental or 
intellectual disability. 
4. Subject or parent/caregiver is literate and able to read one of the languages offered in the pump. 
5. Subject and/or legally authorized representative is willing to provide informed consent for 
participation. 
6. Is willing to perform fingerstick blood glucose measurements as needed. 
7. Is willing to wear the system continuously throughout the study.  
8. Must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units 
and maximum total daily dose of 250 units or less. 
9. Has a Glycosylated hemoglobin (HbA1c) less than 10% (as processed by Central Lab) at time of 
screening visit. 
Note: All HbA1c blood specimens will be sent to and tested by a National Glycohemoglobin 
Standardization Program (NGSP) certified Central Laboratory.  HbA1c testing must follow NGSP 
standards.   
10. Has thyroid-stimulating hormone (TSH) in the normal range OR if the TSH is out of normal reference 
range the Free T3 is below or within the lab’s reference range and Free T4 is within the normal 
reference range.   
11. Uses pump therapy for greater than 6 months prior to screening (with or without CGM experience) 
12. Is willing to upload data from the study pump, must have Internet access, and a computer system, 
or compatible smartphone that meets the requirements for uploading the study pump. 
13. Is willing to take one of the following insulins and can financially support the use of either of the 2 
insulin preparations as required during the run-in period:  
a. Humalog (insulin lispro injection) 
b. NovoLog/NovoRapid (insulin aspart injection) 
14. Is willing to take Fiasp insulin during the study period (supplied via Sponsor). 
 
 Exclusion Criteria 
1. Has hypersensitivity to insulin aspart or one of the excipients in Fiasp. 
2. Has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following 
during the 6 months prior to screening: 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 63 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
a. Medical assistance (i.e., Paramedics, Emergency Room [ER] or Hospitalization) 
b. Coma 
c. Seizures 
3. Has been hospitalized or has visited the ER in the 6 months prior to screening resulting in a primary 
diagnosis of uncontrolled diabetes.  
4. Has had DKA in the last 6 months prior to screening visit.  
5. Will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual. 
6. Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis 
herpetiformis, rash, Staphylococcus infection). 
7. Is female of child-bearing potential and result of pregnancy test is positive at screening. 
8. Is sexually active female of child-bearing potential and is not using a form of contraception deemed 
reliable by the investigator. 
9. Is female and plans to become pregnant during the course of the study. 
10. Is being treated for hyperthyroidism at time of screening. 
11. Has diagnosis of adrenal insufficiency. 
12. Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of 
screening visit, or plans to take any oral, injectable, or IV glucocorticoids during the course of the 
study.  
13. Is using hydroxyurea at time of screening or plans to use it during the study. 
14. Is actively participating in an investigational study (drug or device) wherein he/she has received 
treatment from an investigational study drug or investigational study device in the last 2 weeks. 
15. Is currently abusing illicit drugs.  
16. Is currently abusing marijuana. 
17. Is currently abusing prescription drugs. 
18. Is currently abusing alcohol. 
19. Using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, 
canagliflozin (Invokana or other SGLT2 inhibitors) at time of screening. 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 64 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
20. Has a history of visual impairment which would not allow subject to participate in the study and 
perform all study procedures safely, as determined by the investigator. 
21. Has elective surgery planned that requires general anesthesia during the course of the study. 
22. Has sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin 
within 3 months prior to time of screening.  
23. Plans to receive red blood cell transfusion or erythropoietin over the course of study participation. 
24. Is diagnosed with current eating disorder such as anorexia or bulimia. 
25. Has been diagnosed with chronic kidney disease that results in chronic anemia. 
26. Has a hematocrit that is below the normal reference range of lab used.    
27. Is on dialysis. 
28. Has serum creatinine of >2 mg/dL. 
29. Has celiac disease that is not adequately treated as determined by the investigator. 
30. Has had any of the following cardiovascular events within 1 year of screening: myocardial infarction, 
unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, 
cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances. 
31. Has had history of cardiovascular event 1 year or more from the time of screening without  
a. a normal EKG and stress test within 6 months prior to screening or during screening or  
b. clearance from a qualified physician prior to receiving the study devices if there is an 
abnormal EKG or stress test.  
32. Has 3 or more cardiovascular risk factors listed below without a normal EKG within 6 months prior to 
screening or during screening or clearance from a qualified physician if there is an abnormal EKG: 
 
Age >35 years 
 
Type 1 diabetes of >15 years’ duration 
 
Presence of any additional risk factor for coronary artery disease 
 
Presence of microvascular disease (proliferative retinopathy or nephropathy, including 
microalbuminuria) 
 
Presence of peripheral vascular disease 
 
Presence of autonomic neuropathy 
33. Is a member of the research staff involved with the study. 
34. Has used a MiniMed 780G pump prior to screening. 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 65 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
9. Study Procedures 
 Schedule of Events 
Subjects may participate in up to 15 planned study visits, as presented in Figure 4 (Section 9.1.1) for 
approximately 120 days of device wear. Virtual office visit (audio visual) may be performed for office 
visits in cases where an office visit is not possible. The exit visit should occur at the office, unless an 
emergent situation occurs. 
If the subject visits the investigational center outside of the scheduled study visits, a Visit eCRF will be 
completed to document the reason for the unscheduled visit. 
Refer to Section 9.1.1, Table 5 for the Visit Details. 
If subject exits the study early (i.e., before their last scheduled visit), HbA1c requirements that apply to 
the final visit will be completed for subjects who have completed Visit 7. Refer to CIP336 Questionnaire 
Guide for collection of early exit requirements. 
The Exit eCRF and all associated activities should be completed for all subjects who have withdrawn, 
discontinued, or completed the study. 
  Study Visit Schedule & Scheduled Follow-Up Visit Windows 
 
Visit 1 to Visit 6 should be completed in 30 days. 
 
 
Visit 1 (Office): Consent and screening 
 
Run-In:  
 
Visit 2 (Office/Virtual Office): Start Run-In 
o 
Eligibility has been confirmed  
o 
Start study pump and CGM 
o 
Register and upload study pump in CareLink Personal and CareLink system   
 
Visit 3 (Phone): Day 1 after Visit 2 – Required for subjects without CGM or closed loop 
experience; as needed for all others 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 66 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
o 
Ask subjects and their parents/caregivers if they require assistance, e.g., additional 
training 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports  
 
Visit 4 (Phone): Day 3 after Visit 2 – Required for subjects without CGM or closed loop 
experience; as needed for all others 
o 
Ask subjects and their parents/caregivers  if they require assistance, e.g., additional 
training 
o 
Ask subjects about adverse events and device performance  
o 
Review CareLink reports 
 
Visit 5 (Phone): Day 7 (±2 days) after Visit 2  
o 
Ask subjects and their parents/caregivers  if they require assistance, e.g., additional 
training 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
o 
Remind subjects about run-in period meal challenge 
 
Visit 6 (Office/Virtual Office): Day 14 (±3 days) after Visit 2 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
o 
Visit 6 and 7 may be combined 
 
Study Period:  
 
Visit 7 (Office/Virtual Office): Start Study Period,  
Day 7 (-7 days) after Visit 6  
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
o 
Start Auto Basal target at 120 mg/dL (6.7 mmol/L) setpoint with Active Insulin Time set 
to 4 hours, titrate towards 2-3 hours or at investigator’s discretion 
o 
Turn on SmartGuard with Auto Corrections “ON” 
o 
Instruct subjects about the required meal and exercise challenges for both the 100 
mg/dL (5.5 mmol/L) and 120 md/dL (6.7 mmol/L) setpoint between Visits 9 and 13 of 
the study period 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 67 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
Visit 8 (Phone): Day 2 after Visit 7 – Required for subjects without CGM or closed loop 
experience; as needed for all others 
o 
Adjust pump settings as needed 
o 
Ask subjects and their parents/caregivers if they require assistance, e.g., additional 
training 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
o 
Remind subjects about meal/exercise challenges for 120 mg/dL (6.7 mmol/L) setpoint 
 
Visit 9 (Phone): Day 7 (±2 days) after Visit 7  
o 
Adjust pump settings as needed 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
o 
Remind subjects about meal/exercise challenges for 120 mg/dL (6.7 mmol/L) setpoint 
 
Visit 10 (Phone): Day 14 (±3 days) after Visit 7  
o 
Adjust pump settings as needed 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
o 
Instruct subjects about the required meal/exercise challenges for 120 mg/dL (6.7 
mmol/L) setpoint 
 
Visit 11 (Phone): Day 21 (±3 days) after Visit 7  
o 
Adjust pump settings as needed 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
o 
Change Auto Basal target to 100 mg/dL (5.5 mmol/L) setpoint with Active Insulin Time 
set to 2-3 hours or at investigator’s discretion 
o 
Remind subjects about meal/exercise challenges for 100 mg/dL (5.5 mmol/L) setpoint 
 
Visit 12 (Office/Virtual Office): Day 28 (+7 days) after Visit 7  
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
 
Visit 13 (Phone): Day 44 (±3 days) after Visit 7  
o 
Adjust Auto Basal target with Active Insulin Time at investigator’s discretion 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
o 
Remind subjects about meal/exercise challenges  

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 68 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
Visit 14 (Office/Virtual Office): Day 60 (+7 days) after Visit 7  
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
 
Visit 15 (Office/Virtual Office): Day 90 (+7 days) after Visit 7  
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
o 
Return study devices 
o 
End of Study (EOS) 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 69 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
Figure 4. Visit Schedule 
 
 
Run-in Period
Office
Visit 1
Consent & 
Screening
Office/
Virtual 
Office 
Visit 2
Start Study 
Pump& CGM
Office/Virtual 
Office 
 Visit 7
Day 7 (-7 
days) after 
Visit 6
Visit Schedule
Study Period
Office/Virtual 
Office
Visit 12
Day 28
(+7 days) after 
Visit 7
Phone 
Visit 11
Day 21 
(±3 days) after 
Visit 7
Phone 
Visit 10
Day 14
 (±3 days) after 
Visit 7
Phone
Visit 9
Day 7 (±2 
days) after 
Visit 7
Office/Virtual 
Office
Visit 14
Day 60
(+7 days) 
after Visit 7
Office/Virtual
Office Visit 15
Day 90
(+7 days) after 
Visit 7
EOS
Visit 1 to Visit 6 should be completed in 30 days.
Phone 
Visit 5
Day 7 (±2 
days) after 
Visit 2 
Office/
Virtual 
Office 
Visit 6
Day 14 (±3 
days) after 
Visit 2
Phone 
Visit 3
Day 1 after 
Visit 2
Phone 
Visit 4
Day 3 after 
Visit 2
 
Phone
Visit 8
Day 2 after 
Visit 7
Phone 
Visit 13
Day 44 
(±3 days) after 
Visit 7
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 70 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Table 5. Visit Details 
 
 
Run-In Period 
Study Period 
 
Visit 1 
(Office) 
Visit 2 
(Office or 
Virtual 
Office) 
Visit 3* 
and 4* 
(Phone) 
 
Visit 5 
(Phone) 
Visit 6 
(Office 
or 
Virtual 
Office) 
Visit 7 
(Office or 
Virtual 
Office) 
Visit 8* 
(Phone) 
 
Visit 9, 
10 & 11 
(Phone) 
Visit 12 
(Office 
or 
Virtual 
Office) 
Visit 13 
(Phone) 
Visit 14 
(Office 
or 
Virtual 
Office) 
Visit 
15** 
(Office 
or 
Virtual 
Office) 
Visit Window 
Enrollment 
 
Day 1 
and Day 
3 after 
Visit 2 
Day 7 
(±2 
days) 
after 
Visit 2  
Day 14 
(±3 
days) 
after 
Visit 2  
Day 7  
(-7 days) 
after Visit 
6 
Day 2 
after 
Visit 7 
Day 7 
(±2 
days) 
after 
Visit 7  
Day 14 
and Day 
21 (±3 
days) 
after 
Visit 7 
Day 28 
(+7 
days) 
after 
Visit 7 
Day 44 
(±3 
days) 
after 
Visit 7 
Day 60 
(+7 
days) 
after 
Visit 7 
Day 90 
(+7 
days) 
after 
Visit 7 
EOS 
Visit Activities and Data Collection 
 
 
 
 
 
 
 
 
 
 
 
 
Collect consent forms, e.g., ICF, Assent 
form (if applicable), California 
Experimental Subject’s Bill of Rights (if 
applicable), HIPAA form and forms 
required by local regulation 
X 
 
 
 
 
 
 
 
 
 
 
 
Assess subject eligibility to participate in 
the study  
X 
 
 
 
 
 
 
 
 
 
 
 
Measure subject height and weight 
Note: Body mass index (BMI) will be 
calculated automatically in the study 
database, based on height and weight 
measurements entered. 
X 
 
 
 
 
 
 
 
 
 
 
X 
Collect demographic and other baseline 
characteristics according to eCRF 
questions 
X 
 
 
 
 
 
 
 
 
 
 
 
Collect urine test for pregnancy from 
female subjects of child-bearing age or 
capability (Point of Care or local lab) 
X 
 
 
 
 
 
 
 
 
 
 
 
Collect blood sample for HbA1c testing.  
All collected blood specimens will be sent 
to and tested by a NGSP certified Central 
X 
 
 
 
 
 
 
 
 
 
 
X 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 71 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
 
Run-In Period 
Study Period 
 
Visit 1 
(Office) 
Visit 2 
(Office or 
Virtual 
Office) 
Visit 3* 
and 4* 
(Phone) 
 
Visit 5 
(Phone) 
Visit 6 
(Office 
or 
Virtual 
Office) 
Visit 7 
(Office or 
Virtual 
Office) 
Visit 8* 
(Phone) 
 
Visit 9, 
10 & 11 
(Phone) 
Visit 12 
(Office 
or 
Virtual 
Office) 
Visit 13 
(Phone) 
Visit 14 
(Office 
or 
Virtual 
Office) 
Visit 
15** 
(Office 
or 
Virtual 
Office) 
Visit Window 
Enrollment 
 
Day 1 
and Day 
3 after 
Visit 2 
Day 7 
(±2 
days) 
after 
Visit 2  
Day 14 
(±3 
days) 
after 
Visit 2  
Day 7  
(-7 days) 
after Visit 
6 
Day 2 
after 
Visit 7 
Day 7 
(±2 
days) 
after 
Visit 7  
Day 14 
and Day 
21 (±3 
days) 
after 
Visit 7 
Day 28 
(+7 
days) 
after 
Visit 7 
Day 44 
(±3 
days) 
after 
Visit 7 
Day 60 
(+7 
days) 
after 
Visit 7 
Day 90 
(+7 
days) 
after 
Visit 7 
EOS 
Laboratory. HbA1c testing must follow 
NGSP standards. 
Collect specimens for required lab testing: 
Hematocrit, Creatinine, TSH (see lab 
instructions for additional information) 
X 
 
 
 
 
 
 
 
 
 
 
 
Collect information about medical history 
X 
 
 
 
 
 
 
 
 
 
 
 
Collect information about concomitant 
medications  
X 
 
 
 
 
 
 
 
 
 
 
 
Collect any changes to diabetes 
medications during the study 
 
X  
(if 
applicable) 
X  
(if 
applicable) 
X  
(if 
applicable) 
X  
(if 
applicable) 
X 
 (if applicable) 
X  
(if 
applicable) 
X  
(if 
applicable) 
X  
(if 
applicable) 
X  
(if 
applicable) 
X  
(if 
applicable) 
X  
(if 
applicable) 
Confirm subject eligibility results, including 
labs, prior to moving forward with any 
study procedures 
 
X 
 
 
 
 
 
 
 
 
 
 
Assist with Questionnaires - Refer to 
CIP336 Questionnaire Guide for 
administration details.  
 
X 
 
 
 
 
 
 
 
 
 
X 
Provide study subjects with the Accu-Chek 
Guide Link study meter and ketone meter, 
including needed supplies 
 
X 
 
 
As 
needed 
As needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
 
Complete Quality Control (QC) testing of 
the Accu-Chek Guide Link study meter and 
ketone meter per respective user guide 
 
X 
 
 
As 
needed 
As needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 72 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
 
Run-In Period 
Study Period 
 
Visit 1 
(Office) 
Visit 2 
(Office or 
Virtual 
Office) 
Visit 3* 
and 4* 
(Phone) 
 
Visit 5 
(Phone) 
Visit 6 
(Office 
or 
Virtual 
Office) 
Visit 7 
(Office or 
Virtual 
Office) 
Visit 8* 
(Phone) 
 
Visit 9, 
10 & 11 
(Phone) 
Visit 12 
(Office 
or 
Virtual 
Office) 
Visit 13 
(Phone) 
Visit 14 
(Office 
or 
Virtual 
Office) 
Visit 
15** 
(Office 
or 
Virtual 
Office) 
Visit Window 
Enrollment 
 
Day 1 
and Day 
3 after 
Visit 2 
Day 7 
(±2 
days) 
after 
Visit 2  
Day 14 
(±3 
days) 
after 
Visit 2  
Day 7  
(-7 days) 
after Visit 
6 
Day 2 
after 
Visit 7 
Day 7 
(±2 
days) 
after 
Visit 7  
Day 14 
and Day 
21 (±3 
days) 
after 
Visit 7 
Day 28 
(+7 
days) 
after 
Visit 7 
Day 44 
(±3 
days) 
after 
Visit 7 
Day 60 
(+7 
days) 
after 
Visit 7 
Day 90 
(+7 
days) 
after 
Visit 7 
EOS 
Train subjects and their parents/caregivers 
on the use of the Accu-Chek Guide Link 
study meter and ketone meter, refer to 
user guides 
 
X 
 
 
 
 
 
 
 
 
 
 
Train companions on emergency response 
and the use of the ketone meter (refer to 
user guides) 
 
X 
 
 
 
 
 
 
 
 
 
 
Train subjects and their parents/caregivers 
on the use of the 780G pump 
 
X 
 
 
 
 
 
 
 
 
 
 
Start study subjects on the 780G insulin 
pump system  
 
Subjects with prior AID 
experience will be using the 
study pump with SmartGuard 
feature activated (Auto 
Correction OFF). 
 
Subjects who do not have prior 
AID algorithm experience will 
use the system in Manual 
Mode. 
 
 
X 
 
 
 
 
 
 
 
 
 
 
Provide study subjects the Medtronic 
Extended infusion sets, reservoirs, sensors 
and transmitter 
 
X 
 
 
As 
needed 
As needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 73 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
 
Run-In Period 
Study Period 
 
Visit 1 
(Office) 
Visit 2 
(Office or 
Virtual 
Office) 
Visit 3* 
and 4* 
(Phone) 
 
Visit 5 
(Phone) 
Visit 6 
(Office 
or 
Virtual 
Office) 
Visit 7 
(Office or 
Virtual 
Office) 
Visit 8* 
(Phone) 
 
Visit 9, 
10 & 11 
(Phone) 
Visit 12 
(Office 
or 
Virtual 
Office) 
Visit 13 
(Phone) 
Visit 14 
(Office 
or 
Virtual 
Office) 
Visit 
15** 
(Office 
or 
Virtual 
Office) 
Visit Window 
Enrollment 
 
Day 1 
and Day 
3 after 
Visit 2 
Day 7 
(±2 
days) 
after 
Visit 2  
Day 14 
(±3 
days) 
after 
Visit 2  
Day 7  
(-7 days) 
after Visit 
6 
Day 2 
after 
Visit 7 
Day 7 
(±2 
days) 
after 
Visit 7  
Day 14 
and Day 
21 (±3 
days) 
after 
Visit 7 
Day 28 
(+7 
days) 
after 
Visit 7 
Day 44 
(±3 
days) 
after 
Visit 7 
Day 60 
(+7 
days) 
after 
Visit 7 
Day 90 
(+7 
days) 
after 
Visit 7 
EOS 
Train subjects and their parents/caregivers 
on the Medtronic Extended infusion sets, 
reservoirs, sensor and transmitter 
 
X 
 
 
 
 
 
 
 
 
 
 
Start study subjects on CGM, including 
transmitter, sensor and accessories 
 
X 
 
 
 
 
 
 
 
 
 
 
Instruct subjects and their 
parents/caregivers to place the sensor in a 
location that is approved for placement 
per the User guide and study directions, 
as applicable 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Train study subjects and their 
parents/caregivers on the 780G 
SmartGuard features 
 
X 
 
 
 
X 
 
 
 
 
 
 
Start/continue study subjects on 780G 
SmartGuard with Auto Correction (as 
applicable).  
 
During the study period, all 
SmartGuard features should be used 
by all subjects. 
 
 
 
 
 
 
X  
 
 
 
 
 
 
 
 
Instruct subjects and their 
parents/caregivers to switch from pump 
 
X  
 
 
 
 
X  
 
 
 
 
 
 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 74 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
 
Run-In Period 
Study Period 
 
Visit 1 
(Office) 
Visit 2 
(Office or 
Virtual 
Office) 
Visit 3* 
and 4* 
(Phone) 
 
Visit 5 
(Phone) 
Visit 6 
(Office 
or 
Virtual 
Office) 
Visit 7 
(Office or 
Virtual 
Office) 
Visit 8* 
(Phone) 
 
Visit 9, 
10 & 11 
(Phone) 
Visit 12 
(Office 
or 
Virtual 
Office) 
Visit 13 
(Phone) 
Visit 14 
(Office 
or 
Virtual 
Office) 
Visit 
15** 
(Office 
or 
Virtual 
Office) 
Visit Window 
Enrollment 
 
Day 1 
and Day 
3 after 
Visit 2 
Day 7 
(±2 
days) 
after 
Visit 2  
Day 14 
(±3 
days) 
after 
Visit 2  
Day 7  
(-7 days) 
after Visit 
6 
Day 2 
after 
Visit 7 
Day 7 
(±2 
days) 
after 
Visit 7  
Day 14 
and Day 
21 (±3 
days) 
after 
Visit 7 
Day 28 
(+7 
days) 
after 
Visit 7 
Day 44 
(±3 
days) 
after 
Visit 7 
Day 60 
(+7 
days) 
after 
Visit 7 
Day 90 
(+7 
days) 
after 
Visit 7 
EOS 
therapy to manual injections until issue is 
resolved if: 
 
Hospital admission is needed 
for any reason  
 
Glucose is persistently elevated 
(i.e., above 300 mg/dL [16.7 
mmol/L]) and not responding 
to correction boluses and/or 
infusion set change(s) 
 
There is an occlusion alarm 
with elevated glucose, where 
the study subject is not able to 
address the occlusion by 
changing the infusion set 
Adjust pump settings  
 
 
 
 
 
 
As 
needed 
As 
needed 
 
 
 
 
Create an investigational center account in 
the CareLink system software (see 
separate instructions) 
 
X 
 
 
 
 
 
 
 
 
 
 
Create an account for study subjects in 
CareLink Personal (see separate 
instructions) 
 
X 
 
 
 
 
 
 
 
 
 
 
Link the study subjects account to the 
investigational center account 
 
X 
 
 
 
 
 
 
 
 
 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 75 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
 
Run-In Period 
Study Period 
 
Visit 1 
(Office) 
Visit 2 
(Office or 
Virtual 
Office) 
Visit 3* 
and 4* 
(Phone) 
 
Visit 5 
(Phone) 
Visit 6 
(Office 
or 
Virtual 
Office) 
Visit 7 
(Office or 
Virtual 
Office) 
Visit 8* 
(Phone) 
 
Visit 9, 
10 & 11 
(Phone) 
Visit 12 
(Office 
or 
Virtual 
Office) 
Visit 13 
(Phone) 
Visit 14 
(Office 
or 
Virtual 
Office) 
Visit 
15** 
(Office 
or 
Virtual 
Office) 
Visit Window 
Enrollment 
 
Day 1 
and Day 
3 after 
Visit 2 
Day 7 
(±2 
days) 
after 
Visit 2  
Day 14 
(±3 
days) 
after 
Visit 2  
Day 7  
(-7 days) 
after Visit 
6 
Day 2 
after 
Visit 7 
Day 7 
(±2 
days) 
after 
Visit 7  
Day 14 
and Day 
21 (±3 
days) 
after 
Visit 7 
Day 28 
(+7 
days) 
after 
Visit 7 
Day 44 
(±3 
days) 
after 
Visit 7 
Day 60 
(+7 
days) 
after 
Visit 7 
Day 90 
(+7 
days) 
after 
Visit 7 
EOS 
Train subjects and their parents/caregivers 
on the use of CareLink Personal– provide 
relevant set of written instructions 
 
X 
 
 
 
 
 
 
 
 
 
 
Set up 780G system apps, if applicable: 
 
MiniMed Clinical/MiniMed Mobile app 
 
CareLink Clinical app 
 
X (if 
applicable) 
 
 
 
 
 
 
 
 
 
 
If applicable: 
 
Train subjects and their 
parents/caregivers on the use of the 
780G system apps: MiniMed Clinical 
app/MiniMed Mobile app  and 
CareLink Clinical app 
 
X (if 
applicable) 
 
 
 
 
 
 
 
 
 
 
Instruct/Remind subjects and their 
parents/caregivers about the requirement 
to perform meal challenges during the 
run-in period 
SmartGuard should not be activated 
 
 
 
X 
X (If 
needed) 
 
 
 
 
 
 
 
Instruct/Remind subjects and their 
parents/caregivers about the requirement 
to perform meal and exercise challenges 
during the study period 
 
At 120 mg/dL (6.7 mmol/L) Auto 
Basal Setpoint between Visits 7 
and 11 of the study period 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 76 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
 
Run-In Period 
Study Period 
 
Visit 1 
(Office) 
Visit 2 
(Office or 
Virtual 
Office) 
Visit 3* 
and 4* 
(Phone) 
 
Visit 5 
(Phone) 
Visit 6 
(Office 
or 
Virtual 
Office) 
Visit 7 
(Office or 
Virtual 
Office) 
Visit 8* 
(Phone) 
 
Visit 9, 
10 & 11 
(Phone) 
Visit 12 
(Office 
or 
Virtual 
Office) 
Visit 13 
(Phone) 
Visit 14 
(Office 
or 
Virtual 
Office) 
Visit 
15** 
(Office 
or 
Virtual 
Office) 
Visit Window 
Enrollment 
 
Day 1 
and Day 
3 after 
Visit 2 
Day 7 
(±2 
days) 
after 
Visit 2  
Day 14 
(±3 
days) 
after 
Visit 2  
Day 7  
(-7 days) 
after Visit 
6 
Day 2 
after 
Visit 7 
Day 7 
(±2 
days) 
after 
Visit 7  
Day 14 
and Day 
21 (±3 
days) 
after 
Visit 7 
Day 28 
(+7 
days) 
after 
Visit 7 
Day 44 
(±3 
days) 
after 
Visit 7 
Day 60 
(+7 
days) 
after 
Visit 7 
Day 90 
(+7 
days) 
after 
Visit 7 
EOS 
 
At 100 mg/dL (5.5 mmol/L) Auto 
Basal Setpoint between Visits 11 
and 13 of the study period 
 
At current Auto Basal Setpoint at any 
time after Visit 13 of the study 
period 
Start Auto Basal target at 120 mg/dL (6.7 
mmol/L setpoint with Active Insulin Time 
set to 4 hours, titrate towards 2-3 hours or 
at investigator’s discretion. 
 
Turn on SmartGuard with Auto Corrections 
“ON”.    
Note: The Auto Basal target setting and 
Active Insulin Time should be set as 
recommended above, unless there is a 
documented safety reason that would not 
permit these settings to be used. 
 
 
 
 
 
 
X 
 
 
 
 
 
 
Change Auto Basal target to 100 mg/dL 
(5.5 mmol/L) setpoint with Active Insulin 
Time set to 2-3 hours or at investigator’s 
discretion. 
 
 
 
 
 
 
 
 
X 
(Visit 11) 
 
 
 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 77 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
 
Run-In Period 
Study Period 
 
Visit 1 
(Office) 
Visit 2 
(Office or 
Virtual 
Office) 
Visit 3* 
and 4* 
(Phone) 
 
Visit 5 
(Phone) 
Visit 6 
(Office 
or 
Virtual 
Office) 
Visit 7 
(Office or 
Virtual 
Office) 
Visit 8* 
(Phone) 
 
Visit 9, 
10 & 11 
(Phone) 
Visit 12 
(Office 
or 
Virtual 
Office) 
Visit 13 
(Phone) 
Visit 14 
(Office 
or 
Virtual 
Office) 
Visit 
15** 
(Office 
or 
Virtual 
Office) 
Visit Window 
Enrollment 
 
Day 1 
and Day 
3 after 
Visit 2 
Day 7 
(±2 
days) 
after 
Visit 2  
Day 14 
(±3 
days) 
after 
Visit 2  
Day 7  
(-7 days) 
after Visit 
6 
Day 2 
after 
Visit 7 
Day 7 
(±2 
days) 
after 
Visit 7  
Day 14 
and Day 
21 (±3 
days) 
after 
Visit 7 
Day 28 
(+7 
days) 
after 
Visit 7 
Day 44 
(±3 
days) 
after 
Visit 7 
Day 60 
(+7 
days) 
after 
Visit 7 
Day 90 
(+7 
days) 
after 
Visit 7 
EOS 
Note: The Auto Basal target setting and 
Active Insulin Time should be set as 
recommended above, unless there is a 
documented safety reason that would not 
permit these settings to be used. 
 
Adjust the Auto Basal target as well as 
Active Insulin Time should be set to what 
is best for the individual subject, at 
investigator’s discretion. 
 
Note: The Auto Basal target setting and 
Active Insulin Time should be set as 
recommended above, unless there is a 
documented safety reason that would not 
permit these settings to be used. 
 
 
 
 
 
 
 
 
 
 
X 
 
 
Dispense Fiasp 
 
 
 
 
 
X 
 
 
 As 
needed 
 
As 
needed 
 
Dispense study materials (e.g., 
smartphone [upon request and approval], 
reference guides, subject training 
materials, etc.) 
 
X 
 
 
 
 
 
 
 
 
 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 78 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
 
Run-In Period 
Study Period 
 
Visit 1 
(Office) 
Visit 2 
(Office or 
Virtual 
Office) 
Visit 3* 
and 4* 
(Phone) 
 
Visit 5 
(Phone) 
Visit 6 
(Office 
or 
Virtual 
Office) 
Visit 7 
(Office or 
Virtual 
Office) 
Visit 8* 
(Phone) 
 
Visit 9, 
10 & 11 
(Phone) 
Visit 12 
(Office 
or 
Virtual 
Office) 
Visit 13 
(Phone) 
Visit 14 
(Office 
or 
Virtual 
Office) 
Visit 
15** 
(Office 
or 
Virtual 
Office) 
Visit Window 
Enrollment 
 
Day 1 
and Day 
3 after 
Visit 2 
Day 7 
(±2 
days) 
after 
Visit 2  
Day 14 
(±3 
days) 
after 
Visit 2  
Day 7  
(-7 days) 
after Visit 
6 
Day 2 
after 
Visit 7 
Day 7 
(±2 
days) 
after 
Visit 7  
Day 14 
and Day 
21 (±3 
days) 
after 
Visit 7 
Day 28 
(+7 
days) 
after 
Visit 7 
Day 44 
(±3 
days) 
after 
Visit 7 
Day 60 
(+7 
days) 
after 
Visit 7 
Day 90 
(+7 
days) 
after 
Visit 7 
EOS 
Dispense other study supplies as needed 
(e.g., alcohol swabs, adhesive remover, 
etc.) 
 
X 
 
 
As 
needed 
As needed 
 
 
As 
needed 
 
As 
needed 
 
At all visits and/or between visits (if the 
investigational center is contacted), adjust 
insulin settings and insulin dose as needed 
 
X 
As 
needed 
As 
needed 
As 
needed 
As needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
 
Confirm the study pump upload data is 
available in CareLink system software (at 
office visit or day prior if phone or virtual 
office visit) 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Print and review CareLink system reports 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Review surveillance report in Medtronic’s 
secure upload application and review with 
subjects as necessary 
 
 
As 
needed 
As 
needed 
As 
needed 
As needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
Enter data into eCRFs as required 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Schedule next visit day and time 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Collect and destroy Fiasp 
 
 
 
 
 
 
 
 
 
 
 
X 
Collect study devices at study end (see 
device disposition Table 3 [US] and 
Table 4 [Canada] for details) 
 
 
 
 
 
 
 
 
 
 
 
X 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 79 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
 
Run-In Period 
Study Period 
 
Visit 1 
(Office) 
Visit 2 
(Office or 
Virtual 
Office) 
Visit 3* 
and 4* 
(Phone) 
 
Visit 5 
(Phone) 
Visit 6 
(Office 
or 
Virtual 
Office) 
Visit 7 
(Office or 
Virtual 
Office) 
Visit 8* 
(Phone) 
 
Visit 9, 
10 & 11 
(Phone) 
Visit 12 
(Office 
or 
Virtual 
Office) 
Visit 13 
(Phone) 
Visit 14 
(Office 
or 
Virtual 
Office) 
Visit 
15** 
(Office 
or 
Virtual 
Office) 
Visit Window 
Enrollment 
 
Day 1 
and Day 
3 after 
Visit 2 
Day 7 
(±2 
days) 
after 
Visit 2  
Day 14 
(±3 
days) 
after 
Visit 2  
Day 7  
(-7 days) 
after Visit 
6 
Day 2 
after 
Visit 7 
Day 7 
(±2 
days) 
after 
Visit 7  
Day 14 
and Day 
21 (±3 
days) 
after 
Visit 7 
Day 28 
(+7 
days) 
after 
Visit 7 
Day 44 
(±3 
days) 
after 
Visit 7 
Day 60 
(+7 
days) 
after 
Visit 7 
Day 90 
(+7 
days) 
after 
Visit 7 
EOS 
Note: If the visit must be conducted via 
Virtual Office, the blood tests may be 
collected via mobile phlebotomy service. 
Questions To Ask at Study Visits 
 
 
 
 
 
 
 
 
 
 
 
 
Ask if subjects and their 
parents/caregivers have general study-
related questions and concerns 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Ask subjects about the occurrence of 
adverse events.  
 
Record the event on the 
appropriate eCRF, if a study 
subject reports a change in 
health status that results in a 
new medical condition or in a 
deterioration of an existing 
medical condition, such as 
illness or glycemic problems 
 
Instruct subject to call the 
investigational center to report 
any changes to their health 
status (see adverse event 
definition). 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 80 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
 
Run-In Period 
Study Period 
 
Visit 1 
(Office) 
Visit 2 
(Office or 
Virtual 
Office) 
Visit 3* 
and 4* 
(Phone) 
 
Visit 5 
(Phone) 
Visit 6 
(Office 
or 
Virtual 
Office) 
Visit 7 
(Office or 
Virtual 
Office) 
Visit 8* 
(Phone) 
 
Visit 9, 
10 & 11 
(Phone) 
Visit 12 
(Office 
or 
Virtual 
Office) 
Visit 13 
(Phone) 
Visit 14 
(Office 
or 
Virtual 
Office) 
Visit 
15** 
(Office 
or 
Virtual 
Office) 
Visit Window 
Enrollment 
 
Day 1 
and Day 
3 after 
Visit 2 
Day 7 
(±2 
days) 
after 
Visit 2  
Day 14 
(±3 
days) 
after 
Visit 2  
Day 7  
(-7 days) 
after Visit 
6 
Day 2 
after 
Visit 7 
Day 7 
(±2 
days) 
after 
Visit 7  
Day 14 
and Day 
21 (±3 
days) 
after 
Visit 7 
Day 28 
(+7 
days) 
after 
Visit 7 
Day 44 
(±3 
days) 
after 
Visit 7 
Day 60 
(+7 
days) 
after 
Visit 7 
Day 90 
(+7 
days) 
after 
Visit 7 
EOS 
Ask subjects about device performance 
issues and if they called the investigational 
center staff to report them. 
Instruct/Remind subjects to contact the 
investigational center staff in the event 
they experience problems with their study 
devices. 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Ask subjects and their parents/caregivers 
if they require assistance, e.g., additional 
training 
 
 
X 
X 
 
 
X 
 
 
 
 
 
Study Subject General Training and 
Instructions 
 
 
 
 
 
 
 
 
 
 
 
 
Remind subjects and their 
parents/caregivers that the use and wear 
of study devices throughout the study is a 
requirement 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Instruct subjects on carbohydrate (CHO) 
counting as needed (Investigator 
discretion) 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Instruct subjects, their parents/caregivers, 
and companions on diabetes self-
management principles, including the use 
of glucose and glucagon in the event of 
hypoglycemia   
 
X 
 
 
 
 
 
 
 
 
 
 
Instruct subjects, their parents/caregivers, 
and companions (companions: during 
initial training only) that blood ketone 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 81 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
 
Run-In Period 
Study Period 
 
Visit 1 
(Office) 
Visit 2 
(Office or 
Virtual 
Office) 
Visit 3* 
and 4* 
(Phone) 
 
Visit 5 
(Phone) 
Visit 6 
(Office 
or 
Virtual 
Office) 
Visit 7 
(Office or 
Virtual 
Office) 
Visit 8* 
(Phone) 
 
Visit 9, 
10 & 11 
(Phone) 
Visit 12 
(Office 
or 
Virtual 
Office) 
Visit 13 
(Phone) 
Visit 14 
(Office 
or 
Virtual 
Office) 
Visit 
15** 
(Office 
or 
Virtual 
Office) 
Visit Window 
Enrollment 
 
Day 1 
and Day 
3 after 
Visit 2 
Day 7 
(±2 
days) 
after 
Visit 2  
Day 14 
(±3 
days) 
after 
Visit 2  
Day 7  
(-7 days) 
after Visit 
6 
Day 2 
after 
Visit 7 
Day 7 
(±2 
days) 
after 
Visit 7  
Day 14 
and Day 
21 (±3 
days) 
after 
Visit 7 
Day 28 
(+7 
days) 
after 
Visit 7 
Day 44 
(±3 
days) 
after 
Visit 7 
Day 60 
(+7 
days) 
after 
Visit 7 
Day 90 
(+7 
days) 
after 
Visit 7 
EOS 
testing is required every time BG is greater 
than 300 mg/dL (16.7 mmol/L), as 
measured by the Accu-Chek Guide Link 
study meter. 
Instruct subjects and their 
parents/caregivers to consider avoiding 
the use of products containing 
acetaminophen 
If medications containing acetaminophen 
are taken: 
 
Wait until use of the 
medication is stopped before 
using SG to make treatment 
decisions 
 
Use additional BG meter 
readings to verify glucose 
levels 
 
While the SmartGuard feature 
is active, instruct subjects to 
use the temp target feature 
(when used, Auto Correction is 
not available) 
 
Instruct subjects that in case 
of prolonged use of 
acetaminophen, the temp 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 82 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
 
Run-In Period 
Study Period 
 
Visit 1 
(Office) 
Visit 2 
(Office or 
Virtual 
Office) 
Visit 3* 
and 4* 
(Phone) 
 
Visit 5 
(Phone) 
Visit 6 
(Office 
or 
Virtual 
Office) 
Visit 7 
(Office or 
Virtual 
Office) 
Visit 8* 
(Phone) 
 
Visit 9, 
10 & 11 
(Phone) 
Visit 12 
(Office 
or 
Virtual 
Office) 
Visit 13 
(Phone) 
Visit 14 
(Office 
or 
Virtual 
Office) 
Visit 
15** 
(Office 
or 
Virtual 
Office) 
Visit Window 
Enrollment 
 
Day 1 
and Day 
3 after 
Visit 2 
Day 7 
(±2 
days) 
after 
Visit 2  
Day 14 
(±3 
days) 
after 
Visit 2  
Day 7  
(-7 days) 
after Visit 
6 
Day 2 
after 
Visit 7 
Day 7 
(±2 
days) 
after 
Visit 7  
Day 14 
and Day 
21 (±3 
days) 
after 
Visit 7 
Day 28 
(+7 
days) 
after 
Visit 7 
Day 44 
(±3 
days) 
after 
Visit 7 
Day 60 
(+7 
days) 
after 
Visit 7 
Day 90 
(+7 
days) 
after 
Visit 7 
EOS 
target feature can be used 
repeatedly and in succession 
Remind subject and their 
parents/caregivers to bring in both Accu-
Chek Guide Link study meter and ketone 
meter at each required office visit.  
 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
 
Remind subject and their 
parents/caregivers to keep their devices 
charged,  as applicable 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Instruct subjects and parents/caregivers 
regarding the use of the Accu-Chek Guide 
Link study meter to make treatment 
decisions: 
 
When a BG required alert is 
received: 
o 
Clear the alert and 
enter a BG meter 
reading before 
using the SG to 
make treatment 
decisions 
 
When symptoms are present: 
o 
If SG readings are 
not aligned with 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 83 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
 
Run-In Period 
Study Period 
 
Visit 1 
(Office) 
Visit 2 
(Office or 
Virtual 
Office) 
Visit 3* 
and 4* 
(Phone) 
 
Visit 5 
(Phone) 
Visit 6 
(Office 
or 
Virtual 
Office) 
Visit 7 
(Office or 
Virtual 
Office) 
Visit 8* 
(Phone) 
 
Visit 9, 
10 & 11 
(Phone) 
Visit 12 
(Office 
or 
Virtual 
Office) 
Visit 13 
(Phone) 
Visit 14 
(Office 
or 
Virtual 
Office) 
Visit 
15** 
(Office 
or 
Virtual 
Office) 
Visit Window 
Enrollment 
 
Day 1 
and Day 
3 after 
Visit 2 
Day 7 
(±2 
days) 
after 
Visit 2  
Day 14 
(±3 
days) 
after 
Visit 2  
Day 7  
(-7 days) 
after Visit 
6 
Day 2 
after 
Visit 7 
Day 7 
(±2 
days) 
after 
Visit 7  
Day 14 
and Day 
21 (±3 
days) 
after 
Visit 7 
Day 28 
(+7 
days) 
after 
Visit 7 
Day 44 
(±3 
days) 
after 
Visit 7 
Day 60 
(+7 
days) 
after 
Visit 7 
Day 90 
(+7 
days) 
after 
Visit 7 
EOS 
symptoms (e.g., if 
a study subject is 
feeling low while 
the SG reading is 
not low), use the 
meter to confirm 
BG.  
o 
If SG readings 
continue to be 
different from 
symptoms, call the 
study doctor  
Instruct subjects and parents/caregivers to 
refer primary healthcare providers to the 
investigational center staff if they have 
any questions about study devices and 
their functions 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Instruct subjects and their 
parents/caregivers that they should not 
assume that SmartGuard is able to 
prevent all hypoglycemia or all 
hyperglycemia including diabetic 
ketoacidosis 
 
X 
 
 
 
X 
 
 
 
 
 
 
Instruct study subjects and 
parents/caregivers that regular weekly 
uploads of the study pump is required. 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 84 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
 
Run-In Period 
Study Period 
 
Visit 1 
(Office) 
Visit 2 
(Office or 
Virtual 
Office) 
Visit 3* 
and 4* 
(Phone) 
 
Visit 5 
(Phone) 
Visit 6 
(Office 
or 
Virtual 
Office) 
Visit 7 
(Office or 
Virtual 
Office) 
Visit 8* 
(Phone) 
 
Visit 9, 
10 & 11 
(Phone) 
Visit 12 
(Office 
or 
Virtual 
Office) 
Visit 13 
(Phone) 
Visit 14 
(Office 
or 
Virtual 
Office) 
Visit 
15** 
(Office 
or 
Virtual 
Office) 
Visit Window 
Enrollment 
 
Day 1 
and Day 
3 after 
Visit 2 
Day 7 
(±2 
days) 
after 
Visit 2  
Day 14 
(±3 
days) 
after 
Visit 2  
Day 7  
(-7 days) 
after Visit 
6 
Day 2 
after 
Visit 7 
Day 7 
(±2 
days) 
after 
Visit 7  
Day 14 
and Day 
21 (±3 
days) 
after 
Visit 7 
Day 28 
(+7 
days) 
after 
Visit 7 
Day 44 
(±3 
days) 
after 
Visit 7 
Day 60 
(+7 
days) 
after 
Visit 7 
Day 90 
(+7 
days) 
after 
Visit 7 
EOS 
With Bluetooth connection and the 
MiniMed Clinical app/MiniMed Mobile app , 
scheduled uploads are not required for 
subjects with compatible smartphones, as 
they are designed to occur continuously. 
Subjects that do not have compatible 
smartphones will be required to use the 
Blue Adapter to facilitate uploads to their 
computers. 
Instruct subjects and their 
parents/caregivers to give meal bolus of 
insulin 15-20 minutes prior to meals 
during the run-in period 
 
X 
 
 
 
 
 
 
 
 
 
 
Instruct subjects and their 
parents/caregivers to give meal bolus of 
insulin at the start of meals during the 
study period 
 
 
 
 
 
X 
 
 
 
 
 
 
* Required for subjects without CGM or closed loop experience; as needed for all others. 
**When subjects exit the study early, all requirements that are listed for the final visit apply. 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 85 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
 Data Collection 
All data collection and study procedure requirements are described at the subject visits in Section 9.1. 
 Subject Consent 
Informed Consent and assent (if applicable) will be obtained in accordance with ISO14155:2020, the 
Code of Federal Regulations (CFR) Title 21, Part 50 (US only) or Tri-Council Policy Statement, Article 3.2 
(Canada only). Prior to entry into the study, the California Experimental Subject’s Bill of Rights (if 
applicable, US only), the EC (Ethics Committee)/Institutional Review Board (IRB) and Medtronic approved 
ICF form and assent form (if an assent form is required per local regulations) and an Authorization Form 
required by the Health Insurance Portability and Accountability Act (HIPAA; US only) will be presented to 
each subject to review and sign as applicable. The subject and their parent, guardian, or legally 
authorized representative (as applicable) will be given ample time and offered the opportunity to review 
these documents away from the investigational center. 
If the subject is below 18 years of age, he/she should be informed about the study to the extent 
compatible with the subject’s understanding. Per EC/IRB, if the subject could give consent to decisions 
about participation in research, the investigator must obtain that consent in addition to the consent of 
their legally authorized representative or guardian. Consent by a legal guardian or authorized 
representative is only allowed for subjects who are younger than legal age according to their 
state/country requirements.  
The following will be provided to or explained to the subject and their parent, guardian, or legally 
authorized representative by the investigator or designee: the purpose and duration of the study, the 
requirements expected to be adhered to by the subject during the study and the potential risks /potential 
benefits associated with participation in the study. Every attempt will be made to answer the subject’s 
and their parent’s, guardian’s, or legally authorized representative’s questions during the informed 
consent and assent process. The language used shall be as non-technical as possible and must be 
understandable to the subject or their parent, guardian, or legally authorized representative. 
Neither the investigator, nor the investigational center staff shall coerce or unduly influence a subject or 
their parent, guardian, or legally authorized representative to participate or to continue to participate in 
the clinical study. The informed consent/assent process shall not waive or appear to waive the subject’s 
rights. The assent, if required, should be administered according to the investigational center’s Standard 
Operating Procedures (SOPs) and the EC/IRB instructions, as applicable. 
Subjects will complete California Experimental Subject’s Bill of Rights (if applicable, US only), the HIPAA 
Form (US only), and the ICF/assent form. The consenting process must be documented in the subject’s 
source documents. The subject and their parent, guardian, or legally authorized representative will 
receive copies of the fully executed documents. A subject’s participation in study procedures cannot begin 
before the consent process has been properly executed. When the subject decides to participate in the 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 86 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
study, the ICF must be signed and personally dated by the subject and investigator or authorized 
designee, as required by the ICF. A patient contact card will be provided to the subject. 
 
Medtronic will inform the investigators whenever information becomes available that may be relevant to 
the subject’s confirmed participation in the clinical study. The investigator or his/her authorized designee 
should inform the subject and their parent, guardian, or legally authorized representative in a timely 
manner.  
Medtronic will revise the written ICF/assent form whenever new information becomes available that may 
be relevant to the subject’s confirmed participation in the clinical study. The revised information will be 
sent to the investigator for approval by the EC/IRB. After approval by the EC/IRB, a copy of this 
information must be provided to the participating subjects, and the informed consent/assent process as 
described above needs to be repeated. 
If the ICF/assent form is amended during the course of the study, the EC/IRB will determine: 
 
Whether or not active subjects and their parent, guardian, or legally authorized representative 
should be re-consented at their next visit and  
 
Whether or not subjects who have completed the study at the time of the amendment should be 
re-consented .  
Subjects and their parent, guardian, or legally authorized representative will be informed that qualified 
personnel from the investigational center, the sponsor (Medtronic), regulatory authorities such as the 
FDA/Health Canada and/or the EC/IRB, may have access to the clinic records that reveal their identity 
and health care information. 
The investigational center must report the following informed consent/assent violations to their EC (if 
applicable)/IRB and sponsor: 
 
Failure to obtain informed consent/assent from subject and their parent, guardian, or legally 
authorized representative. 
 
Failure to obtain informed consent/assent prior to performing one or more study procedures. 
 
Failure to maintain ICFs/assent forms on file for all subjects who have provided informed 
consent. 
 
Use of an ICF/assent form that has not received approval from the EC/IRB. 
 
Use of an incorrect version of the ICF/assent form. 
 
 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 87 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
 Safety Monitoring/Risk Analysis 
 Glucose Monitoring Risk 
 
Subjects will be instructed to make sure they have clean fingers when performing fingerstick 
glucose testing.  
 
Subjects will have training on diabetes self-management principles.   
 
 
 Hypoglycemic/Hyperglycemic Risk 
Intervention and treatment for hypoglycemia and hyperglycemia is addressed in Section 10.1. 
 
 Calibration of CGM Risk 
When an erroneous glucose value is used to calibrate a CGM, this can result in inaccurate SG values. 
Subjects will be trained on appropriate calibration. 
 
 Reuse Risk 
All study devices will be single patient use.  
 
 Sterilization Risk 
The following devices will be supplied sterilized: 
 
Infusion sets 
 
Insulin reservoirs 
 
Sensors 
 
 Misuse Risk 
Comprehensive training will take place at the initiation visit for investigational center staff regarding the 
operation of the 780G system, to include all of its functional components and all other study devices to 
be used during the study at the investigational center. 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 88 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 Risk of Blood Sample Collection, Contamination from Sampling Techniques 
Detailed mitigations to blood sampling risk are provided in Section 10.1. 
 
 HbA1c Risk 
A Central laboratory will be used for HbA1c testing. 
 
 
 Glucose and Glycemia Measurements 
During the course of the study, the subjects’ BG levels, SG levels, HbA1c, and blood ketones will be 
collected using the methods outlined in this section. 
 Daily Blood Glucose 
Values will be assessed during the study by all subjects using the Accu-Chek Guide Link study meter. The 
control solution test will be performed following the manufacturer’s user guide. Subjects will be trained 
on the use of the Accu-Chek Guide Link study meter per the manufacturer’s instructions.   
 Blood Ketone Values 
Blood ketones will be measured by all subjects using a ketone meter when certain conditions are met:  
 
When a subject is symptomatic for high blood glucose 
 
When sensor glucose displays a glucose value >300mg/dL (16.7 mmol/L), BG should be checked 
by fingerstick and, if BG is >300mg/dL (16.7 mmol/L), blood ketones should be checked. 
The control solution test will be performed following the manufacturer’s user guide. The investigational 
center staff will be trained on the use of the ketone meter per the manufacturer’s instructions. All ketone 
measurements will be reported by study subjects.  
 
 Sensor Glucose Values 
SG data will be collected by subject’s study pump and calibrated by each subject’s Accu-Chek Guide Link 
study meter.  
 HbA1c 
HbA1c is collected at baseline and the end of subjects’ participation; if subjects have completed Visit 7 
and exit early, a HbA1c will be collected. 
 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 89 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
 Recording Data 
Data entered by the investigational center staff will be captured on eCRFs using the Electronic Data 
Capture (EDC) system. Original eCRFs will not be considered as source data and supporting 
documentation will be required. In addition, the subject will complete the questionnaires online via direct 
entry. In case the online link is unavailable, subjects will complete the questionnaire using a paper format 
(this will be source data) and subsequently the investigator or designated investigational center staff will 
enter the responses online. If paper format is used, the investigator or designated investigational center 
staff should maintain the original paper source in the subject’s source file. 
Electronic device data will be collected from the study pump using CareLink Personal/CareLink system 
software. The system uses TLS technology, which encrypts all data it stores (21 CFR Part 11 compliant). 
Certain data points stored in the downloaded information may also be captured on the appropriate eCRF. 
Electronic device data could also be collected by the MiniMed Clinical app/MiniMed Mobile app and the 
CareLink Clinical app. 
The investigator will ensure that all eCRFs are completed promptly, completely, and accurately. Medtronic 
will provide detailed instructions to assist with eCRF completion. In the event of data discrepancies, 
investigational centers will be asked to resolve queries electronically in the EDC system; otherwise, 
irresolvable data-related issues will be routed to the sponsor for review and final disposition. An audit trail 
is maintained in the EDC system to capture any corrections or changes of the eCRFs. System backups for 
data stored in the EDC system will be consistent with Medtronic SOPs. 
Medtronic will only consider eCRFs to be complete when all discrepancies between source data and eCRF 
have been resolved. eCRF content will be reviewed by a study monitor, as described in the Monitoring 
Plan. In addition, specific eCRFs must also be reviewed and electronically signed by the investigator, 
indicating his/her agreement with the accuracy of all recorded data. It is expected that the investigator 
and his/her staff will cooperate with the monitoring team and provide any missing data in a timely 
manner. 
 Deviation Handling 
A deviation is any instance(s) of failure to follow, intentionally or unintentionally, the requirements of the 
CIP. It is expected that the investigator will conduct this clinical trial in compliance with the CIP and all 
applicable regulations governing the conduct of clinical research involving human subjects. Failure to do 
so could result in one or all of the following: 
 
Investigational center disqualification  
 
Notification to the regulatory authorities/EC/IRB depending on the severity of the deviation 
and reporting requirements 
 
The investigator should not implement any deviation from, or changes to, the CIP without agreement by 
the sponsor and prior review and documented approval/favorable opinion from the regulatory authority 
(if applicable) or EC (if applicable)/IRB, except where necessary to eliminate an immediate hazard(s) to 
trial subjects. The use of waivers from the CIP are prohibited in this study. 
 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 90 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
 Documenting Requirements for Study Deviations 
9.7.1.1 Unplanned CIP Deviations 
The investigator may encounter the need to deviate from the CIP when necessary to protect the safety, 
rights or well-being of a subject in an emergency or in unforeseen situations beyond the investigator’s 
control (e.g., subject failure to attend scheduled follow-up visits, inadvertent loss of data due to 
computer malfunction, inability to perform required procedures due to subject illness). 
Deviations from the CIP, regardless of the reason should be documented as soon as possible, after the 
deviation occurs or is identified. This documentation should include deviation date, description of the 
deviation, the reason for deviation, and the corrective action. Refer to Table 9 (US) and Table 10 
(Canada) for reporting timelines for emergency deviations.   
CIP deviations should be reported as follows: 
a) To the EC(if applicable)/IRB for notification/acknowledgement; 
b) To the sponsor and, if required; 
c) To the applicable regulatory authority (reported by sponsor). 
 Reporting Requirements for Study Deviations 
All study deviations must be reported on the eCRF regardless of whether medically justifiable, an 
inadvertent occurrence, or taken to protect the subject in an emergency. The date, description, and 
reason for each deviation will be documented.   
The following examples are deviations that could impact subject safety, affect the integrity of study data 
and/or affect subject’s willingness to participate in the study. These deviations are significant and require 
immediate sponsor notification upon investigator awareness:  
 
 
Failure to obtain informed consent/assent, i.e., there is no documentation of consenting 
 
Informed consent/assent obtained after initiation of study procedures 
 
Continuation of a subject who did not meet all inclusion/exclusion criteria 
 
Performing study procedure not approved by the EC/IRB 
 
Failure to inform EC/IRB and sponsor of reportable AEs (see Section 11) 
 
Investigational study device dispensed without obtaining informed consent/assent 
 
In the event the deviation involves a failure to obtain a subject’s consent, or is made to protect the life or 
physical well-being of a subject in an emergency, the deviation must be reported to Medtronic as well as 
the EC/IRB ,if applicable per local regulations, within five (5) working days. 
 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 91 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
Reporting of all other study deviations should comply with: 
 
EC/IRB policies and/or 
 
local laws and/or 
 
regulatory authority requirements 
 
They must be reported to Medtronic as soon as possible upon the center becoming aware of the 
deviation. Refer to Investigator Reports, Table 9 (US) and  Table 10 (Canada) for specific deviation 
reporting requirements and timeframes for reporting to Medtronic, EC/IRB, and regulatory authority (if 
applicable). 
 
 Analyzing Deviations 
Medtronic is responsible for reviewing deviations, assessing their significance, and identifying any 
additional corrective and/or preventive actions (e.g., amend the CIP, conduct additional training, 
terminate the investigation). Repetitive or serious investigator compliance issues may result in initiation of 
a corrective action plan with the investigator and investigational center, and in some cases, necessitate 
suspending enrollment until the problem is resolved or ultimately terminating the investigator's 
participation in the study.  
 
 Subject Exit, Withdrawal or Discontinuation 
Subjects may choose to withdraw from the study at any time by notifying investigational center staff of 
their intent. 
If a subject chooses to end his or her study participation or if the subject is removed from the study at 
the investigator’s discretion or for failure to meet the study requirements, the reason for withdrawal 
must be documented. All study devices and supplies must be returned (as applicable) and documented 
both in source documents and on an eCRF. Following study exit, subjects will receive standard medical 
care from their own providers. 
A subject will be withdrawn from the study if: 
 
In the opinion of the investigator, the subject’s health or safety would be compromised by 
continuing in the study (e.g., infection at skin site, severe skin reaction to adhesive). 
 
In the opinion of the investigator, it is in the subject’s best interest to discontinue participation in 
the study. 
 
During the course of the study, subject begins using hydroxyurea. 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 92 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
During the course of the study, subject begins participation in another investigational study (drug 
or device). 
 
At the discretion of the investigator: During the study it becomes known that subjects are using a 
non-linked BG meter for SMBG or a system that replaces SMBG. 
 
During the course of the study, subject begins abusing illicit drugs.  
 
During the course of the study, subject begins abusing marijuana. 
 
During the course of the study, subject begins abusing prescription drugs.  
 
During the course of the study, subject begins abusing alcohol. 
 
During the course of the study, subject begins using pramlintide (Symlin), DPP-4 inhibitors, 
liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 
inhibitors). 
 
During the course of the study, subject receives red blood cell transfusion or erythropoietin.       
 
During the course of the study, the subject demonstrates that he/she is not able to comprehend 
instructions for study procedures, as evaluated by the appropriate research staff.  
 
During the study, a subject repeatedly activates SmartGuard feature when instructed otherwise, 
e.g., SmartGuard feature is turned on (as applicable at the discretion of the investigator). 
 
During the course of the study, subject is taking oral, injectable, or IV glucocorticoids  
 
During the study, (female) subject becomes pregnant. 
 
During the study, the subject experiences one severe hypoglycemic episode, if it is related to the 
use of 780G system SmartGuard feature.  
 
During the study, the subject experiences one episode of DKA, if it is related to the use of 780G 
system SmartGuard feature.  
 
During the study, subject has a cardiovascular event or any vascular event such as stroke.   
 
Documentation of the reason(s) leading to subject withdrawal will be kept in the subject’s source 
documentation. 
 
 End of Subject Participation in Study/ Completion of Study  
After the study has been completed (at Visit 15 or in case of early termination), subjects will be exited 
from the study. Subjects will continue to work with their physician after study exit per normal standard of 
care. The clinical investigation is considered completed once the last subject has exited the study. 
 
 Lost to Follow-Up 
If a subject does not return to the site for required follow-up visit(s) and cannot be reached, the 
investigation site personnel should make 3 documented attempts to contact the subject by phone to 
verify if the subject should be considered “lost-to follow up”. In the event the subject is not able to 
perform follow-up visits at the investigation site, subject will be considered “lost to follow up” and this 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 93 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
needs to be documented in the Study Exit eCRF. All efforts will be made by investigation site personnel to 
collect all study devices and supplies back from subject, if applicable. 
 
 
  Study Stopping Rules 
There are no predefined study stopping rules. The study will be stopped if the Data Monitoring 
Committee (DMC) determines that there are significant safety issues. (See DMC Section 12.2.) 
 
 
10. Risks and Benefits 
 Potential Risks 
The potential residual risks and mitigations associated with the devices used during this study are listed 
in Table 6. Risks associated with the commercially available devices used in the study are listed in the 
associated device labeling/user guides/instructions for use or report of prior investigations/ IBs. 
The clinical investigation has been designed to involve as little pain, discomfort, fear and any other 
foreseeable risk as possible for the subjects, and both the risk threshold and the degree of distress are 
specifically defined in the CIP and constantly monitored. 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 94 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
Table 6. Risks, Prevention and Mitigation 
Risk with Fiasp 
Prevention and Mitigation 
 
For a description of risks in Fiasp, refer to the 
links to the insulin label in the next column 
(US and Canada) 
USA:  
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208751 
 
 
Canada: 
https://health-products.canada.ca/dpd-bdpp/info.do?lang=en&code=94775 
Risks with Infusion Sets 
Prevention and Mitigation 
Risks with infusion sets may include:  
 
Localized infection 
 
Skin irritation/redness 
 
Bruising 
 
Discomfort/pain 
 
Bleeding 
 
Irritation 
 
Rash 
 
Hyperglycemia secondary to infusion set 
occlusion or infusion site failure including 
DKA 
 
Hyperglycemia secondary to site falling off 
including DKA 
 
Anxiety associated with insertion 
Prevention and mitigation include: 
 
Follow the provided user guides for insertions and care of infusion sets. 
 
If an infusion site becomes irritated or inflamed, the infusion set will be removed and another 
placed in a new location.  
 
In case of hyperglycemia secondary to infusion set occlusion, remove current infusion set and 
replace with new infusion set and give correction insulin if needed with syringe.  
 
Follow the provided user guides for insulin pump management.   
 
Train prior to study device use on appropriate device use and diabetes management principles and 
instruct to call investigator with problems.  
Risks with Insulin Administration and 
Pumps 
Prevention and Mitigation 
Risks with the use of an insulin infusion pump may 
include the risk of malfunction of the components of 
the system (pump, software, infusion set and 
reservoir) as well as the risk of use error during use 
of the system. DDs or use errors can result in 
Prevention and mitigation include: 
 
Follow the provided user guides & instructions for insulin pump management which includes 
information on infusion set change.   
 
Train prior to study device use on appropriate device use and diabetes management principles and 
instruct to call investigator with problems.  

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 95 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
administration of too much or too little insulin which 
can lead to the following clinical consequences: 
 
 
Hypoglycemia 
 
Hyperglycemia 
 
Diabetic ketoacidosis  
 
Severe hypoglycemia with or without 
associated seizure, coma or death 
 
Kinked cannula leading to hyperglycemia  
 
Infusion set disconnection from pump 
leading to hyperglycemia 
 
Subject removes the reservoir from the 
pump but forgets to disconnect the infusion 
set from the body which results in 
hypoglycemia or severe hypoglycemia  
 
Dislodged cannula leading to hyperglycemia 
 
A pump error may lead to under delivery or 
over-delivery of insulin 
 
Battery failure – no insulin delivered 
 
Instruct to check their meter glucose if their high or low symptoms do not match their sensor alerts 
or SG readings in order to make diabetes treatment decisions.  
 
Instruct to check their meter glucose if there are any concerns that the SG value is not accurate.  
 
Instruct to have glucose and glucagon on hand for hypoglycemia. 
 
Instruct to change infusion set if suspected catheter occlusion or administer insulin with syringe for 
persistent hyperglycemia especially if ketones develop.   
 
Parent(s)/guardian(s)/companion(s) should be present at night with subjects. 
 
Parent(s)/guardian(s) will be trained on study device and diabetes management principles and 
instructed to call investigator with problems.  
 
Companions will be trained on diabetes management principles and emergency response training.  
 
Parent/caregivers and companions should also be present during meal and exercise challenges. 
 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 96 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
Insulin deterioration leading to 
hyperglycemia 
 
Incomplete priming; fails to prime tubing 
and/or cannula, leading to hyperglycemia 
 
Remove a reservoir, without suspending 
and reconnecting after a while resulting in 
a hypoglycemia 
 
Patient not filling pump reservoir when 
needed leading to hyperglycemia 
 
Magnetic resonance imaging resulting in 
pump transmitter malfunction 
 
Inaccurate insulin delivery due to sudden 
altitude changes. 
 
Hypoglycemia or hyperglycemia from 
manual bolus 
 
Hypoglycemia or hyperglycemia from the 
use of the  SmartGuard feature where SG 
values may be used to calculate insulin 
bolus amounts  
 
Hypoglycemia or hyperglycemia from 
computer hacking  
Risks with hyperglycemia may include  
 
Diabetic ketoacidosis  
 
Symptomatic ketosis 
 
Cardiovascular event  
 
Dehydration  
 
Potassium and sodium imbalance 
 
Shock 
 
Altered mental status  
 
Coma  
 
Acidosis 
Prevention and mitigation include: 
 
Follow the provided user guides for insulin pump management.   
 
Parent(s)/guardian(s)/companion(s) should be present at night with subjects. 
 
Parent(s)/guardian(s) will be trained on study device and diabetes management principles and 
instructed to call investigator with problems. 
 
Companions will be trained on diabetes management principles and emergency response training. 
 
Parent/caregivers and companions should also be present during meal and exercise challenges.  
 
Train prior to study device use on appropriate device use and diabetes management principles and 
instruct to call investigator with problems. 
 
Instruct to check their meter glucose if their high symptoms do not match their sensor alerts or SG 
readings in order to make diabetes treatment decisions.  
 
Instruct to check their meter glucose if there are any concerns that the SG value is not accurate.  
 
Alternative method of managing glucose levels will be available (insulin and syringe for example). 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 97 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Risks with hypoglycemia may include: 
 
Seizure  
 
Coma  
 
Altered mental status  
 
Loss of consciousness  
 
Cardiovascular event  
 
Death  
 
Risk of rebound hyperglycemia with ketosis 
Prevention and mitigation include: 
 
Follow the provided user guides for insulin pump management.   
 
Parent(s)/guardian(s)/companion(s) should be present at night with subjects. 
 
Parent(s)/guardian(s) will be trained on study device and diabetes management principles and 
instructed to call investigator with problems.  
 
Companions will be trained on diabetes management principles and emergency response training. 
 
Parent/caregivers and companions should also be present during meal and exercise challenges. 
 
Train prior to study device use on appropriate device use and diabetes management principles and 
instruct to call investigator with problems. 
 
Instruct to check their meter glucose if their low symptoms do not match their sensor alerts or SG 
readings in order to make diabetes treatment decisions.  
 
Instruct to check their meter glucose if there are any concerns that the SG value is not accurate).  
 
Instruct to have glucose and glucagon on hand for hypoglycemia. 
Risk with Sensors  
Prevention and Mitigation 
Risks with sensors may include: 
 
Skin irritation or reaction to adhesives 
 
Bruising 
 
Discomfort 
 
Redness 
 
Bleeding 
 
Pain 
 
Rash 
 
Infection 
 
Irritation from tapes used with glucose-
sensing products 
 
Raised bump 
 
Appearance of a small "freckle-like" dot 
where needle was inserted 
 
Allergic reaction 
 
Syncopal episode secondary to needle 
insertion 
 
Soreness or tenderness 
 
Swelling at insertion site 
 
Sensor fracture, breakage or damage 
 
Minimal blood splatter associated with 
sensor needle removal 
Prevention and mitigation include: 
 
Follow the provided user guides for insertions and care of sensors. 
 
If a sensor site becomes infected or inflamed, the sensor will be removed and another placed in a 
new location. 
 
Instruct to check their meter glucose if their high or low symptoms do not match their sensor 
alerts or SG readings in order to make diabetes treatment decisions.  
 
Instruct to check their meter glucose if there are any concerns that the SG value is not accurate.  
 
Instruct if there are no sensor values, no treatment decisions will be made until a BG is confirmed.  
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 98 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
Residual redness associated with adhesive 
and/ or tapes 
 
Scarring 
 
Scab 
 
Blister 
 
Itchiness 
 
Inflammation 
 
Anxiety 
 
Incorrect SG reading results in incorrect 
diabetes management 
 
Subject over-treating secondary to alarms 
which can result in hyperglycemia or 
hypoglycemia 
Risks with Transmitter 
Prevention and Mitigation 
Risks with transmitter may include: 
 
Skin irritation or reaction to adhesives 
 
Bruising 
 
Discomfort 
 
Redness 
 
Pain 
 
Rash 
 
Infection 
 
Irritation from tapes used with glucose-
sensing products 
 
Raised bump 
 
Allergic reaction 
 
Soreness or tenderness 
 
Residual redness associated with adhesive 
and/ or tapes 
 
Scarring 
 
Scab 
 
Blister 
 
Itchiness 
 
Inflammation 
 
Prevention and mitigation include: 
 
Follow the provided user guides.  
 
Train on the proper use of the transmitters.  
Risks with Serter 
Prevention and Mitigation 
Risks with serters may include: 
Prevention and mitigation include: 
 
Follow the provided user guides for insertions and care of device. 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 99 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
Improper insertion may lead to device 
performance issue  
 
Train on the proper use of the serter and skin preparation prior to insertion. 
Risks with Fingersticks 
Prevention and Mitigation 
Risks with frequent fingerstick testing may include: 
 
Potential risks associated with frequent 
meter testing of BG and blood ketones 
include discomfort and ecchymosis at tips 
of fingers 
 
Potential risks associated with fingerstick 
testing include discomfort and bruising 
Prevention and mitigation include: 
 
Follow the provided user guides for use of the study meter with fingerstick testing. 
 
Train on the proper use of the study meter and fingerstick testing. 
 
Risk with Closed Loop Therapy 
Prevention and Mitigation 
Risks with Closed Loop may include:  
Prevention and mitigation include:  
 
Follow the provided user guides for insulin pump management.   
 
Train prior to study device use on appropriate device use and diabetes management principles and 
instruct to call investigator with problems.  
 
Instruct to check their meter glucose if their high or low symptoms do not match their sensor 
alerts or SG readings in order to make diabetes treatment decisions.  
 
Instruct to check their meter glucose if there are any concerns that the SG value is not accurate.  
 
Instruct if there are no sensor values, no treatments decision will be made until a BG is confirmed.  
 
Instruct to have glucose and glucagon on hand for hypoglycemia. 
 
Instruct to avoid the use of products containing acetaminophen 
 
If acetaminophen is taken, subjects will be instructed to use additional BG meter readings to verify 
their glucose levels.  
 
If acetaminophen is taken, while the SmartGuard feature is active, subjects will be instructed to 
use the temp target feature (when used, Auto Correction is not available).  
 
Instruct subjects that in case of prolonged use of acetaminophen, the temp target feature can be 
used repeatedly and in succession. 
 
Pump has cybersecurity encryptions to prevent hacking.  
 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 100 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
Hypoglycemia 
 
Severe hypoglycemia 
 
Hyperglycemia 
 
Diabetic ketoacidosis  
 
User entry error 
o 
Patient administering boluses by 
entering false carb doses leading to 
hypoglycemia or hyperglycemia 
o 
Patient entering false glucose values 
for any reason leading to hypoglycemia 
and hyperglycemia  
o 
Patient entering false BG values for 
calibration leading to hypoglycemia or 
hyperglycemia 
 
Sensor failure resulting from patient failure 
to calibrate leading to hypoglycemia or 
hyperglycemia 
 
Sensor over-reading resulting in 
hypoglycemia  
 
Sensor under-reading resulting in 
hyperglycemia 
 
Sensor missed transmission, or any other 
fault resulting in no SG value, leading to 
hyperglycemia or hypoglycemia  
 
Voluntary insulin delivery (with the pump 
or with a syringe) immediately prior to 
entering SmartGuard may result in severe 
hypoglycemia despite shutting down insulin 
delivery by the algorithm 
 
Hypoglycemia related to patient taking 
insulin via injection while in Closed Loop 
(SmartGuard) 
 
Hypoglycemia or hyperglycemia related to 
entering or exiting Closed Loop 
(SmartGuard) 
 
Insulin over-delivery due to potential 
interference from acetaminophen 
 
Cyber security hacking into pump 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 101 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Risks with hyperglycemia may include  
 
Diabetic ketoacidosis 
 
Symptomatic ketosis 
 
Cardiovascular event  
 
Dehydration  
 
Potassium and sodium imbalance 
 
Shock 
 
Altered mental status  
 
Coma  
 
Acidosis 
Prevention and mitigation include: 
 
Follow the provided user guides for insulin pump management.   
 
Train prior to study device use on appropriate device use and diabetes management principles and 
instruct to call investigator with problems.  
 
Instruct to check their meter glucose if their high symptoms do not match their sensor alerts or SG 
readings in order to make diabetes treatment decisions.  
 
Instruct to check their meter glucose if there are any concerns that the SG value is not accurate.  
 
Instruct if there are no sensor values, no treatments decision will be made until a BG is confirmed.  
 
Risks with hypoglycemia may include: 
 
Seizure 
 
Coma 
 
Altered mental status 
 
Loss of consciousness 
 
Cardiovascular event  
 
Death   
 
Risk of rebound hyperglycemia with 
ketosis 
Prevention and mitigation include: 
 
Follow the provided user guides for insulin pump management.   
 
Train prior to study device use on appropriate device use and diabetes management principles and 
instruct to call investigator with problems.  
 
Instruct to check their meter glucose if their low symptoms do not match their sensor alerts or SG 
readings in order to make diabetes treatment decisions.   
 
Instruct to check their meter glucose if there are any concerns that the SG value is not accurate.  
 
Instruct if there are no sensor values, no treatment decisions will be made until a BG is confirmed  
 
Instruct to have glucose and glucagon  on hand for hypoglycemia. 
Risk with Acetaminophen Use 
Prevention and Mitigation 
 
Potential risks with acetaminophen may include: 
 
False elevation of SG readings potentially 
resulting in an over-delivery of insulin 
which may cause hypoglycemia. The level 
of inaccuracy depends on the amount of 
acetaminophen active in subject’s body and 
may be different for each subject 
 
Liver damage, liver failure and/or rare but 
fatal liver failure can occur 
 
Skin rash and/or serious and potentially 
fatal skin reactions have been reported  
Prevention and mitigation include: 
 
Follow the user guide  
 
Instruct to avoid the use of products containing acetaminophen. 
 
If acetaminophen is taken, subjects will be instructed to use additional BG meter readings to verify 
their glucose levels. 
 
If acetaminophen is taken, while the SmartGuard™ feature is active, subjects will be instructed to 
use the temp target feature (when used, Auto Correction is not available). 
 
Instruct subjects that in case of prolonged use of acetaminophen, the temp target feature can be 
used repeatedly and in succession. 
 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 102 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
Allergic reactions including those which are 
serious and potentially fatal can occur 
 
Kidney disease 
 
Lowered blood counts (red cells, and white 
cells)  
 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 103 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
 Risk Minimization 
Refer to “Prevention and Mitigation” column in the table under Section 10.1. 
 Potential Benefits 
Subjects are not expected to benefit from participation in this study; however, they may gain increased 
awareness of emerging technologies for diabetes management as a result of their participation. 
 Risk-Benefit Rationale 
The main benefit of this study is that subjects may experience improved glucose control. Since Fiasp 
insulin has not been previously studied with the 780G system in all age groups, there is a theoretical risk 
that the 780G pump’s closed loop algorithm may not maintain the same level of glucose control achieved 
with other insulins although modeling has indicated that use of Fiasp insulin will not result in any clinically 
significant change in clinical outcomes. Additionally, risk related to the pump delivering too much or not 
enough insulin are further minimized through a variety of safety checks that are an integral part of the 
780G closed loop algorithm.  
 Risk Determination (US Only) 
In the opinion of the sponsor, this study is considered to be a significant risk (SR) study. Results of an 
evaluation of the requirements per 21 CFR Part 812.3, led to the SR determination as follows: 
 
The devices present potential for serious risk to subject health, safety, or welfare. 
 
The devices are for a use of substantial importance in treating disease, and presents potential for 
serious risk to subject health, safety, or welfare. 
Therefore, submission of an Investigational Device Exemption (IDE) application to the United States FDA 
is required. 
11. Adverse Events  
 
 Adverse Events 
Throughout the course of the study, investigational centers will make all efforts to remain alert to 
possible reportable adverse events (AEs) or untoward findings. The study personnel will elicit reports of 
AEs from the subject at each visit (including phone calls) starting at the time of signing the informed 
consent documenting the medical diagnosis, date of event start and end, causality (relationship to device 
or procedure), treatment, outcome, assessment of seriousness, and description that includes the details 
of the event.  
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 104 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 Definitions and Classification of Adverse Events 
Medtronic uses the definitions provided in ISO 14155:2020 and 21 CFR 812 for AE definitions. Where the 
definition indicates “device”, it refers to any device used in the study. This might be the device under 
investigation, or any market released component of the system.   
Severe Hypoglycemia is an event requiring assistance of another person due to altered consciousness 
to actively administer carbohydrate, glucagon, or other resuscitative actions. This means that the subject 
was impaired cognitively to the point that he/she was unable to treat himself or herself, was unable to 
verbalize his or her needs, and was incoherent, disoriented and/or combative. 
 
These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma 
glucose measurements may not be available during such an event, but neurological recovery attributable 
to the restoration of plasma glucose to normal is considered sufficient evidence that the event was 
induced by a low plasma glucose concentration.2 
 
 
Severe Hyperglycemia is defined as hyperglycemia (BG greater than [>] 300 mg/dL or 16.7 mmol/L) 
with BG ketones greater than (>) 1.5 mmol/L, and/or accompanied by symptoms of nausea, vomiting or 
abdominal pain.   
The meter and ketone test strips are supplied for the evaluation of ketone monitoring. Only blood 
ketones will be recognized (not urine ketones) for assisting in diagnosis of severe hyperglycemia. The 
monitors/test strips are quality controlled prior to dispensing to subjects. Blood ketones provide 
contemporaneous understanding of ketone levels associated with elevations in glucose.  
 
 
Diabetic Ketoacidosis/DKA diagnostic criteria: BG greater than (>) 250 mg/dL or greater than (>) 
13.9 mmol/L, arterial pH less than (<) 7.3, bicarbonate less than (<) 15 mEq/L, moderate ketonuria or 
ketonemia and requiring treatment within a health care facility.3 
 
Hyperglycemic events will be recorded as DKA if the event includes the presence of all of the following: 
 
Arterial blood pH less than (<) 7.30 or serum bicarbonate less than (<) 15 mEq/L 
 
Blood glucose greater than (>) 250 mg/dL or greater than (>) 13.9 mmol/L 
 
Serum ketones or large/moderate urine ketones 
 
Symptoms such as polyuria, polydipsia, nausea, or vomiting 
 
Treatment provided in a health care facility 
 
 
Adverse Event (AE) (ISO 14155:2020) 
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including 
abnormal laboratory findings) in subjects, users or other persons, whether or not related to the 
investigational medical device and whether anticipated or unanticipated. 
 
Note 1 to entry: This definition includes events related to the investigational medical device or the 
comparator. 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 105 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Note 2 to entry: This definition includes events related to the procedures involved. 
Note 3 to entry: For users or other persons, this definition is restricted to events related to the use of 
investigational medical devices or comparators. 
 
Adverse Device Effect (ADE) (ISO 14155:2020) 
Adverse event related to the use of an investigational medical device.  
Note 1 to entry: This definition includes adverse events resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation, or operation, or any malfunction of the 
investigational medical device. 
Note 2 to entry: This definition includes any event resulting from use error or from intentional misuse 
of the investigational medical device. 
Note 3 to entry: This includes ‘comparator’ if the comparator is a medical device. 
 
 
Serious Adverse Event (SAE) (ISO 14155:2020) 
Adverse event that led to any of the following 
a) death, 
b) serious deterioration in the health of the subject, users, or other persons as defined by one or 
more of the following: 
1. a life-threatening illness or injury, or 
2. a permanent impairment of a body structure or a body function including chronic diseases, or 
3. in-patient or prolonged hospitalization, or 
4. medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function,  
c) foetal distress, foetal death or a congenital abnormality or birth defect including physical or 
mental impairment 
 
Note 1 to entry: Planned hospitalization for a pre-existing condition, or a procedure required by the 
CIP, without serious deterioration in health, is not considered a serious adverse event. 
 
 
 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 106 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
Serious Adverse Device Effect (SADE) (ISO 14155:2020) 
Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse 
event 
Unanticipated Adverse Device Effect (UADE) (21 CFR 812.3(s)) 
Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or 
associated with, a device, if that effect, problem, or death was not previously identified in nature, 
severity, or degree of incidence in the investigational plan or application (including a supplementary plan 
or application), or any other unanticipated serious problem associated with a device that relates to the 
rights, safety, or welfare of subjects. 
 
Unanticipated Serious Adverse Device Effect (USADE) (ISO 14155:2020) 
Serious adverse device effect which by its nature, incidence, severity or outcome has not been identified 
in the current risk assessment. 
Note 1 to entry: Anticipated serious adverse device effect (ASADE) is an effect which by its nature, 
incidence, severity or outcome has been identified in the risk assessment. 
 
 
Serious Health Threat (ISO 14155:2020) 
Signal from any adverse event or device deficiency that indicates an imminent risk of death or a serious 
deterioration in the health in subjects, users or other persons, and that requires prompt remedial action 
for other subjects, users or other persons 
Note 1 to entry: This would include events that are of significant and unexpected nature such that they 
become alarming as a potential serious health hazard or possibility of multiple deaths occurring at short 
intervals. 
 
 
 Reporting of Adverse Events 
The investigator or designee will record ALL AEs and DDs while the subject is enrolled in the clinical study 
(Refer to Section 13 for DDs reporting).  
Each AE needs to be assessed for its device or procedure relatedness. A device related AE is associated 
with the use of the study device (e.g., infection of sensor site or infusion set occlusion resulting in DKA). 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 107 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
A procedure related AE is associated with testing related to the study procedures specified in the CIP 
(e.g., needle (blood draw) insertion pain).  
Examples of device or procedure related AEs include: 
 
Device related (ADE): insertion site infection 
 
Serious adverse device effect: cellulitis at device insertion site requiring hospitalization 
 
Procedure related AE: bruising at needle (blood draw) insertion site 
 
Subjects participating in the study have diabetes and are expected to experience hypoglycemia and or 
hyperglycemia.  These normal events are not expected to be reported to sponsor as this is not 
considered an untoward event, but rather an expected occurrence. Any glycemic excursion that meets 
the protocol definition of severe hypoglycemia, severe hyperglycemia or DKA is considered an untoward 
event and a worsening from the subject’s baseline and would be reported to sponsor on an AE eCRF.  
Baseline medical conditions should only be reported to sponsor on an AE eCRF if there is a worsening 
from the subject’s baseline.  For example, a subject previously diagnosed with asthma is hospitalized for 
severe asthma attack would be a reportable event. 
Adverse events will be documented in the subject source file and reported to sponsor on an eCRF. The 
investigational center is responsible for documentation of AEs including obtaining source documents 
related to the event, such as emergency medical technician/paramedic reports, hospital records 
(admission summary; lab results, test results, discharge summary) or device uploads to support the 
event. Source documents will be reviewed to determine if additional AEs have occurred and require 
reporting. 
Adverse events that have not resolved at the time of the subject’s discontinuation or completion of the 
study should have an “outcome” of Not Recovered/Not Resolved at study end in subject source and on 
an eCRF. The investigator should ensure that subject is aware of any follow-up or additional treatment 
that is required for any ongoing AE at EOS participation; however, there will be no eCRF entry for the 
ongoing follow-up. 
 
 Notification of Adverse Events 
Sponsor Notification: 
The investigational center staff must report all AEs to Medtronic in a timely manner. All severe 
hypoglycemia, DKA, SAE, SADE, and DD with SADE potential should be reported as soon as possible 
(desired within 24 hours of investigator or study coordinator awareness) to Medtronic. For the 
previously mentioned events, the AE eCRF will be completed with all known details as soon as 
possible, this will serve as notification to Medtronic. If the study database cannot be accessed due to 
technical problems, contact the sponsor via email at dl.diabetesclinicalresearchsafety@medtronic.com 
and provide the de-identified known details of the event. Once the access issue has been corrected, 
the event should be entered onto an AE eCRF. 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 108 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Source documents that support the event (e.g., clinic notes, hospital admission and discharge 
records, lab reports, EMT reports, ER/Urgent Care) should be provided to the sponsor via Medtronic’s 
secure upload application.  All source documents/medical records should be redacted of patient 
identifiers (full name, address, etc.) prior to providing to the sponsor. Each source page should be 
identified with the subject ID. 
 
 Expedited Safety Reporting Requirements 
US only: For device studies, investigators are required to submit a report of a UADE to the sponsor and 
the reviewing IRB as soon as possible, but in no event later than 10 working days after the investigator 
first learns of the event (812.150(a)(1)).   
US and Canada: The sponsor will notify the investigator and EC/IRB of any event that results in a 
safety report per regulations to the FDA/Health Canada. Documentation of EC/IRB notification of any 
safety event must be kept at the investigational center and a copy sent to the sponsor. 
It is the responsibility of the investigator to follow their EC/IRB reporting requirements. 
 
 
 Adverse Event and Device Deficiency Classification 
All AEs and DDs will be reviewed by sponsor and will be classified according to the responsibilities as 
outlined below in Table 7. 
Upon sponsor’s receipt of an event, a Safety representative will review the AE/DD for completeness 
and accuracy and when necessary will request clarification and/or additional information from the 
Investigator. 
It is the responsibility of the investigator and sponsor to abide by any additional AE reporting 
requirements stipulated by the IRB/EC responsible for oversight of the study. 
 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 109 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
Table 7. Adverse Event Classification Responsibilities 
What is 
classified?  
Who 
classifies? 
Classification Parameters 
Relatedness 
Investigator 
Device, Procedure  
Sponsor 
Device, Procedure  
Seriousness 
Investigator 
SAE, DD with SADE potential 
Sponsor 
SAE, UADE/USADE, and DD with SADE potential  
Diagnosis 
Investigator 
Based on presenting signs and symptoms and other 
supporting data 
Sponsor 
MedDRA term assigned based on the data provided by 
Investigator 
 
 
 Causality Assessment 
An AE is not automatically related to the study device or procedure simply because the subject is wearing 
the device and participating in the study. The event should be reviewed to determine if the device or study 
procedure could have possibly caused the event and therefore is related to the study device or procedure.  
Causality assessment is the determination of the relationship between an AE and the device being 
studied.  It is expected that the investigational center will review all elements surrounding the AE to 
properly assess the causality of the event to the study device or to a study procedure.  
This review would include the subjects’ description of the event, study device uploads and medical 
records (if applicable) from the treating facility. These records will be made available to sponsor.  
Investigators should classify the relationship between the AE and the study device or study procedures 
using one of the four possible causality categories listed below: 
 
 
Not related: relationship to the device, comparator, or procedures can be excluded when: 
o 
the event has no temporal relationship with the use of the investigational device or the 
procedures related to the application of the investigational device; 
o 
the event does not follow a known response pattern to the medical device (if the 
response pattern is previously known) and is biologically implausible; 
o 
the discontinuation of medical device application or the reduction of the level of 
activation/exposure - when clinically feasible – and reintroduction of its use (or increase 
of the level of activation/exposure), do not impact on the event; 
o 
the event involves a body-site or an organ not expected to be affected by the device or 
procedure; 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 110 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
o 
the event can be attributed to another cause (e.g., an underlying or concurrent illness/ 
clinical condition, an effect of another device, drug, treatment or other risk factors); 
o 
the event does not depend on a false result given by the investigational device used for 
diagnosis, when applicable; 
 
In order to establish the non-relatedness, not all the criteria listed above might be met at the 
same time, depending on the type of device/procedures and the event. 
 
 
 
Possible: the relationship with the use of the investigational device, comparator, or the 
relationship with procedures, is weak but cannot be ruled out completely. Alternative causes are 
also possible (e.g., an underlying or concurrent illness/clinical condition or/and an effect of 
another device, drug or treatment). Cases where relatedness cannot be assessed, or no 
information has been obtained should also be classified as possible. 
 
 
Probable: the relationship with the use of the investigational device, comparator, or the 
relationship with procedures, seems relevant and/or the event cannot reasonably be explained by 
another cause. 
 
 
Causal relationship: the event is associated with the investigational device, comparator, or 
with procedures beyond reasonable doubt when: 
o 
the event is a known side effect of the product category the device belongs to or of 
similar devices and procedures; 
o 
the event has a temporal relationship with investigational device use/application or 
procedures; 
o 
the event involves a body-site or organ that 
 
the investigational device or procedures are applied to; 
 
the investigational device or procedures have an effect on; 
o 
the event follows a known response pattern to the medical device (if the response 
pattern is previously known); 
o 
the discontinuation of medical device application (or reduction of the level of 
activation/exposure) and reintroduction of its use (or increase of the level of 
activation/exposure), impact on the event (when clinically feasible); 
o 
other possible causes (e.g., an underlying or concurrent illness/clinical condition or/and 
an effect of another device, drug or treatment) have been adequately ruled out; 
o 
harm to the subject is due to error in use; 
o 
the event depends on a false result given by the investigational device used for 
diagnosis, when applicable; 
 
In order to establish the relatedness, not all the criteria listed above might be met at the same 
time, depending on the type of device/procedures and the event. 
 
 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 111 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Example: A severe hyperglycemia AE with the following event description would have the 
following causality assessment for device relatedness: 
Improved glucose without an infusion set/site change  
Not related 
Changed infusion set with glucose improvement 
Possible 
Infusion set fell out, bent cannula, occlusion alarm 
Causal relationship 
 
 
 Anticipated or Unanticipated 
If an AE is determined to be related to the study device the sponsor will then assess the event to 
determine if it is anticipated or unanticipated. 
 
Anticipated: the event is identified in the CIP; labeling; report of priors/ IB or user guide. 
 
Unanticipated: the event has not been previously identified in the CIP; labeling; report of 
priors/ IB or user guide. 
 
 
12. Data Review Committees 
 
 Clinical Events Committee 
A clinical events committee (CEC) consisting of external physicians with an expertise in endocrinology and 
the management of diabetes including insulin pumps and CGM will be convened. The CEC will review AEs 
as required per protocol, which include reports of: 
 
Serious adverse event 
 
Serious adverse device effect 
 
Unanticipated adverse device effect 
 
Unanticipated serious adverse device effect 
 
Severe hypoglycemia 
 
Diabetic ketoacidosis 
 
Severe hyperglycemia 
 
During the study, the following steps will be taken for: 
 
Unanticipated adverse device effects (UADE) 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 112 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
Unanticipated Serious Adverse Device Effects (USADE) 
 
Device related DKA  
 
Device related severe hypoglycemia 
US Only: Sponsor will notify Food and Drug Administration (FDA) within approximately 72 hours of 
knowledge of the event and provide updates to those regulatory authorities as information becomes 
available.  
Canada only: Sponsor will notify local regulatory authorities as information becomes available per local 
requirements. 
CEC is to review and adjudicate the event within 10 days from the time that the sponsor is notified. 
The CEC will assess events to determine agreement or disagreement with the investigator classification of 
an event.  
If the CEC disagrees with the investigator’s classification of the event, the rationale will be provided to 
the investigator. If the investigator agrees with the CEC’s adjudication, the CRF documenting the AE will 
be updated accordingly. 
If the investigator does not agree with the CEC’s adjudication classification, both determinations will be 
provided within the final report; however, the CEC’s adjudication will be used for data analysis. The 
disagreement will also be included in reporting to IRBs/ ECs and regulatory authorities, if required. 
 
The CEC may review applicable information for device related AEs which may include: 
 
 
Whether or not the event was unanticipated 
 
Review of sensor data from CareLink Personal/CareLink system software report (when applicable) 
 
Review of pump data from CareLink Personal/CareLink system software report (when applicable) 
 
Misuse of the device by the user 
 
Review of events may require the following information. Final disposition may be delayed based on 
obtaining this information:  
 
 
Monitoring by sponsor at investigational center 
 
Device return and failure analysis 
 
CareLink Personal/CareLink system software upload and review of software reports  
 
Subject clarification to investigational center regarding details about the event 
 
Source documents that support event: Paramedic records; ER records; Lab records; Hospital 
admission and discharge summary   
The following factors should be carefully considered in the CEC’s recommendation to sponsor:  
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 113 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
1. Was the severe hypoglycemia or DKA related to the AHCL algorithm, or was it related to a known 
insulin pump risk?  For example, a question that may be considered in DKA would be whether the 
event was related to an infusion set issue or caused by the AHCL algorithm.  
 
2. Another important consideration would be if the severe hypoglycemia, severe hyperglycemia or 
DKA event was related to a device malfunction versus patient non-compliance. For example, if a 
software anomaly leading to an under-delivery of insulin is discovered versus the subject 
repeatedly ignoring alarms prompting the subject to take action.   
 
3. Severe hypoglycemia, severe hyperglycemia or DKA caused directly by an infusion set issue when 
the study pump is functioning as intended would likely result in acceptance to proceed with the 
study versus severe hypoglycemia or DKA that are directly caused by the AHCL algorithm or a 
device malfunction might stop study enrollment or entire study altogether. 
 
4. It should be noted that the final determination of causality related to 780G system that is made 
by the CEC may include additional factors which the members consider to be clinically relevant 
and important. 
 
 
 Data Monitoring Committee 
A data monitoring committee (DMC) consisting of external physicians with an expertise in 
Endocrinology and the management of insulin-requiring diabetes including CGM, along with an 
external statistician will be convened to review study progress and safety. The Board will convene 
approximately every 90 days. The Board will also meet when ad hoc review is required.  
 
The DMC will perform 4 main functions:  
 
First: DMC will track and trend the overall safety of the study.     
Event rate, defined as number of events per 100 patient years will be reviewed by the DMC with 
respect to the following: 
 
 
 
Event rate of all SAEs   
 
Event rate of severe hypoglycemia 
 
Event rate of severe hyperglycemia 
 
Event rate of DKA 
 
Event rate of device related AEs   
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 114 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
Second: Based on their meetings, DMC will recommend a decision to the sponsor regarding the 
following:  
 
 
Whether or not enrollment should be halted. 
 
Whether or not the entire study will need to be stopped including for those subjects who have 
received study devices already.  
 
Note: If it is decided to withdraw subjects from participation in the study or if the study is stopped, 
subjects will be followed-up in accordance with standard practice by their own providers. 
Third: 
During the study, the following steps will be taken for: 
 
Unanticipated adverse device effects (UADE) 
 
Unanticipated Serious Adverse Device Effects (USADE) 
 
Device related DKA  
 
Device related severe hypoglycemia 
DMC is to meet within 10 days from the time that the CEC adjudicates an event as one of the above. If 
possible, the investigator should be available to answer questions by DMC. 
 
Based on their meeting, DMC will recommend a decision to the sponsor regarding the following:  
 
Whether or not enrollment should be halted. 
 
Whether or not the entire study will need to be stopped including for those subjects who have 
received study devices already.  
 
Note: If it is decided to withdraw subjects from participation in the study or if the study is stopped, 
subjects will be followed-up in accordance with standard practice by their own providers. 
Fourth: The DMC will review Safety data and provide a recommendation to the sponsor regarding 
staged enrollment of pediatric subjects: 
The DMC will provide a recommendation to proceed with the following staged enrollment: 
 
The enrollment of subjects 7-17 years of age will not move forward until 10 subjects 18 years or older 
have completed 30 days of the study period and the Data Monitoring Committee (DMC) has determined 
that it is safe for 7-17 year olds to be enrolled into the study. 
 
General guidance for DMC’s recommendations to sponsor should be based on the following:   
In general, a DMC recommendation regarding study stoppage or resumption of enrollment should be 
made to the sponsor within 1 week of the DMC meeting where the determination is made. However, if 
more data is needed, the DMC may meet again to re-assess their decision within 2 weeks or when 
required data becomes available. 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 115 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
In their recommendation to the sponsor, the DMC may take into account the thresholds listed below for 
the number of subjects experiencing hypoglycemia requiring assistance from another person or DKA to 
identify when the number of subjects experiencing these events exceeds the number that would be 
anticipated for the study population over the duration of this study. These thresholds should be 
interpreted with caution due to potential differences in study populations and study design. 
a. Rates taken from type 1 exchange (Cengiz et. Al, and Weinstock et. Al), are higher than 
the clinical studies STAR 3, 530G adult in-home study (CEP266) and 530G Pediatric in-
home study (CEP287).   
b. Reasons for lower rates of severe hypoglycemia and DKA in the clinical studies 
mentioned could be related to several factors including but not limited to the exclusion of 
those with DKA or severe hypoglycemia, additional attention secondary to mandatory 
study visits, selection bias of motivated patients willing to perform study procedures and 
access to free study devices during the course of the study. 
c. The DMC should consider stopping study if rates of severe hypoglycemia and DKA are 
significantly worse (e.g., higher) in AHCL than rates provided by clinical trials mentioned 
in Table 8.   
d. Age consideration may also be factored in by the DMC.  For example, severe 
hypoglycemia rates in those >25 years may be higher than those 25 years and below.       
e. Should DKA and/or severe hypoglycemia occur early in the study, the DMC should 
consider that the higher event rate may not necessarily represent a significant safety 
concern.   
 
 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 116 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
Table 8. Hypoglycemia/ Hyperglycemia/ DKA Threshold 
Adverse Event 
Reference 
Reference 
Rate > 25 
years old 
Reference 
Rate 
15-25 years 
old 
Reference 
Rate <15 
years old 
Severe 
Hyperglycemia 
events per 100 
patient years 
CER 302 
NA 
NA 
71.64 
 
DKA events per 
100 patient 
years 
STAR 3 
Bergenstal et. al  
SAP arm: 
0.68 
Control arm: 
0 
SAP arm:  
2.7 
Control arm: 
3.6 
SAP arm:  
2.2 
Control arm: 
0 
530G Adult in-home study 
CEP 266 
(MDT on file) 
1.27 
3.4 
N/A 
Pediatric in-home study CEP 
287 
(MDT on file) 
N/A 
N/A 
0 
Type 1 exchange Weinstock 
et. al 
4.8 
N/A 
N/A 
Type 1 exchange Cengiz et. 
al 
N/A 
9.9 
9.9 
 
 
Severe 
hypoglycemia 
per 100 patient 
years 
STAR 3 
Bergenstal et. al  
 
SAP arm: 
16.5 
Control arm: 
20.9 
 
SAP arm:  
5.4 
Control arm: 
3.9 
 
SAP arm:  
10.2 
Control arm: 
3.6 
530G Adult in-home study 
CEP 266 
(MDT on file) 
0.85 
0 
N/A 
530G Pediatric in-home study 
CEP 287 
(MDT on file) 
N/A 
N/A 
1.42 
Type 1 exchange Weinstock 
et. al 
11.8 
N/A 
N/A 
Type 1 exchange Cengiz et. 
al 
N/A 
6.2 
6.2 
 
 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 117 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
Severe hypoglycemia and DKA event rates were taken from the following: 
1. Richard Bergenstal et.al: Effectiveness of Sensor-Augmented Insulin-Pump Therapy in Type 1 
Diabetes. New England Journal of Medicine, 2010; 363:311-20 
 
2. Weinstock et. al: Severe hypoglycemia and diabetic ketoacidosis in adults with type 1 diabetes: 
results from the T1D Exchange clinic registry. J Clin Endocrinol Metab. 2013 Aug;98(8):3411-9. 
 
3. Cengiz et. al: Severe hypoglycemia and diabetic ketoacidosis among youth with type 1 diabetes 
in the T1D Exchange clinic registry. Pediatr Diabetes. 2013 Sep;14(6):447-54. 
4. MDT on file: Statistical Analysis Plan (SAP) for CEP304, 056-F286 
 
13. Device Deficiencies and Troubleshooting 
The subjects will be instructed to contact the investigational center staff for questions or concerns 
regarding study devices. 
All DDs reported directly to the investigational center staff by a subject and those experienced by the 
investigational center staff will be reported on the appropriate eCRF in a timely manner. In addition, an 
eCRF should also be completed by the investigational center staff for each reported DD that did not lead 
to an Adverse Event. A DD that results in an AE should be captured on an AE CRF only. 
Subjects participating in the study are expected to have mild irritation from device wear at times.  Only 
discomfort occurring at a threshold resulting in early removal of the device should be reported as a DD or 
adverse event.   
 
Device Deficiency (ISO 14155:2020) 
A device deficiency is any inadequacy of a medical device with respect to its identity, quality, durability, 
reliability, usability, safety, or performance.  
Note 1 to entry: Device deficiencies include malfunctions, use errors, and inadequacy in the information 
supplied by the manufacturer including labeling.   
Note 2 to entry: This definition includes device deficiencies related to the investigational medical device 
or the comparator.  
Each DD will be assessed for SADE potential defined as: 
A DD that did not lead to an Adverse Event, but could have led to a SADE: 
a) if either suitable action had not been taken, 
b) if intervention had not been made, or 
c) if circumstances had been less fortunate   
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 118 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
To return a study device as part of a DD, the subject is to contact the investigational center staff, and the 
investigational center staff should then follow the study procedures for returning products with DDs. For 
a list of study devices that needs to be return to the sponsor, please consult your study materials. 
 
It is the responsibility of the investigator to follow their EC/IRB reporting requirements. 
 
14. Statistical Design and Methods 
 General Aspects of Analysis 
All data collected from the time of screening until the end of the study will be collected on eCRFs, subject 
questionnaires, and electronically by uploading the various devices. Data and analysis will be summarized 
in a Clinical Study Report. Any deviations from original statistical plan and the rationale will be described 
in the Clinical Study Report. 
 Subject Disposition 
The number of subjects enrolled, completed, and early terminated in the study will be presented.  The 
reasons for discontinuing prior to study completion will be summarized. 
 
 Subject Demographics and Baseline Characteristics 
Subject characteristics, including age, gender, race, ethnicity, medical diagnosis, height, weight, BMI, and 
baseline HbA1c will be summarized by descriptive statistics (mean, standard deviation, minimum, median, 
and maximum) for continuous variables and by counts and percentages for categorical variables. 
 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 119 of 159 

 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
 
 Endpoints and Hypotheses 
Safety and effectiveness endpoints will be evaluated independently for ages 18-80 and ages 7-17.  
 Primary Safety Endpoint 
Age 18-80: 
x 
The overall mean change in HbA1c, ¨μ780G, from baseline to end of 3-month study period will be 
estimated and compared by a non-inferiority test to the threshold of -0.50% with a margin of 
0.4%. A significance level of 0.025 (one-sided) will be used. Analysis will be performed on the 
ITT and PP populations.
The hypothesis of non-inferiority is mathematically expressed as: 
H0: ¨μ780G  -0.50% + 0.4%  
Ha: ¨μ780G < -0.50% + 0.4%  
 
Age 7-17: 
 
x 
The overall mean change in HbA1c, ¨μ780G, from baseline to end of 3-month study period will be 
estimated and compared by a non-inferiority test to the threshold of -0.38% with a margin of 
PI
PI

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 120 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
0.4%. A significance level of 0.025 (one-sided) will be used. Analysis will be performed on the 
ITT and PP populations. 
The hypothesis of non-inferiority is mathematically expressed as: 
H0: ∆µ780G ≥ -0.38% + 0.4%  
Ha: ∆µ780G < -0.38% + 0.4%  
 
 Analysis of Effectiveness Endpoint 
 
14.5.2.1 Primary Effectiveness Endpoint  
 
Age 18-80: 
 
The mean % of time, µ780G, in range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L]) will be estimated 
and compared by a non-inferiority test to the threshold of 73.7% with a margin of 7.5%. A 
significance level of 0.025 (one-sided) will be used. The 7.5%, which is approximately 100 
minutes increase in TIR per day, was also observed from the HCL pivotal trials. It is loosely 
correlated to ~0.5% reduction in A1c as well. Analysis will be performed on the ITT and PP 
populations.  
 
The hypothesis of non-inferiority is mathematically expressed as: 
H0: µ780G ≤ 73.7% – 7.5%  
Ha: µ780G > 73.7% – 7.5% 
Age 7-17: 
 
The mean % of time, µ780G, in range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L]) will be estimated 
and compared by a non-inferiority test to the threshold of 65.3% with a margin of 7.5%.  A 
significance level of 0.025 (one-sided) will be used. The 7.5%, which is approximately 100 
minutes increase in TIR per day, was also observed from the HCL pivotal trials. It is loosely 
correlated to ~0.5% reduction in A1c as well. Analysis will be performed on the ITT and PP 
populations. 
The hypothesis of non-inferiority is mathematically expressed as: 
H0: µ780G ≤ 65.3% – 7.5%  
Ha: µ780G > 65.3% – 7.5% 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 121 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
Pass/Fail Criteria: 
The study pass/fail criteria is based on statistical hypothesis of the primary endpoints. The study for each 
age cohort (age 18-80 and age 7-17) will be considered as success when the evaluation criteria of both 
primary safety and effective endpoints meets the predefined threshold per cohort. 
 
Justification for Exclusion of Particular Information from the testing of the Hypothesis: 
Not Applicable.  
 
14.5.2.2 Analysis of Secondary Effectiveness Endpoints 
 
Age 18-80: 
 
Secondary Effectiveness Endpoint: The mean % time, µ780G, in hypoglycemia (< 54 mg/dL [3.0 
mmol/L]) will be estimated and compared by a non-inferiority test to the threshold of 0.86% 
with a margin of 2%.  A significance level of 0.025 (one-sided) will be used. Analysis will be 
performed on the ITT and PP populations. The 2% came from not more than 30 minutes 
increase in hypoglycemia per day to establish a non-inferiority test. 
 
The hypothesis of non-inferiority is mathematically expressed as: 
H0: µ780G ≥ 0.86% + 2%  
Ha: µ780G < 0.86% + 2% 
 
 
Secondary Effectiveness Endpoint: The mean % of time, µ780G, in range (TIR 70-180 mg/dL [3.9 
-10.0 mmol/L]) will be estimated and compared by a simple superiority test with a significance 
level of 0.025 (one-sided).  Analysis will be performed on the ITT and PP populations. 
 
The hypothesis of superiority is mathematically expressed as: 
H0: µ780G ≤ 73.7%  
Ha: µ780G > 73.7% 
Age 7-17: 
 
Secondary Effectiveness Endpoint: The mean % time, µ780G, in hypoglycemia (< 54 mg/dL [3.0 
mmol/L]) will be estimated and compared by a non-inferiority test to the threshold of 0.71% 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 122 of 159 

 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
with a margin of 2%. A significance level of 0.025 (one-sided) will be used. The 2% came from 
not more than 30 minutes increase in hypoglycemia per day to establish a non-inferiority test. 
Analysis will be performed on the ITT and PP populations. 
The hypothesis of non-inferiority is mathematically expressed as: 
H0: μ780G  0.71% + 2%  
Ha: μ780G < 0.71% + 2% 

x 
Secondary Effectiveness Endpoint: The mean % of time, μ780G, in range (TIR 70-180 mg/dL [3.9 
-10.0 mmol/L]) will be estimated and compared by a simple superiority test with a significance 
level of 0.025 (one-sided).  Analysis will be performed on the ITT and PP populations. 
 
The hypothesis of superiority is mathematically expressed as: 
H0: μ780G 65.3%  
Ha: μ780G > 65.3% 

 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
PI
PI
PI

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 123 of 159 

 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
 
 
 
 
 
 
 
 
 Safety Data Summarized 
Serious Adverse Events (SAE)  
Serious Adverse Device Effects (SADE) 
Unanticipated Adverse Device Effects 
x 
Unanticipated Serious Adverse Device Effect  
Incidence of Severe Hypoglycemia    
Incidence of Severe Hyperglycemia    
Incidence of DKA 

 Device Deficiencies 
Descriptive summary will be used to characterize DDs: 
x 
All reports of device issues. 

 
 
 
 
 
 
 
PI
PI
PI
PI
PI
PI
PI

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 124 of 159 

 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
 

 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PI
PI
PI

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 125 of 159 

 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PI
PI
PI
PI

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 126 of 159 

 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Final Reports 
The study results will be summarized and presented in the final report.

 
15. Ethics 
 Statement(s) of Compliance 
This study will be conducted in compliance with international ethical and scientific quality standards, 
known as Good Clinical Practice (GCP). GCP includes review and approval by an independent EC/IRB 
before initiating a study, continuing review of an ongoing study by an EC/IRB, and obtaining and 
documenting the freely given informed consent of a subject before initiating the study. 
The CIP336 was designed to reflect the GCP principles outlined in ISO 14155:2020 and other 
international clinical requirements outlined below. These include the protection of the rights, safety and 
well-being of human subjects, controls to ensure the scientific conduct and credibility of the clinical 
investigation and the definition of responsibilities of the sponsor and investigators. In accordance with 
ISO 14155:2020, the sponsor shall avoid improper influence on, or inducement of, the subject, monitor, 
any investigator(s) or other parties participating in, or contributing to, the clinical investigation. All 
investigators shall avoid improper influence on or inducement of the subject, sponsor, monitor, other 
investigator(s) or other parties participating in or contributing to the clinical investigation. AE and DD 
handling in the CIP336 is ISO 14155:2020 compliant for all participating geographies.,  
The principles of the Declaration of Helsinki (DoH) have been implemented through the IC process, EC 
approval, study training, clinical trial registration, pre-clinical testing, risk-benefit assessment and 
publication policy.  
PI
PI

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 127 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Ultimately, all study sites in all geographies will follow and comply with: 
 
Principles of DoH 
 
21 CFR Part 11 (Electronic Records, Electronic Signatures) 
 
21 CFR Part 54 (Financial Disclosure by Clinical Investigators) 
 
The CTA 
 
The procedures described within this CIP 
 
Local EC Requirements 
 
In addition to the regulatory requirements outlined above, the study will be conducted according to 
federal, national and local laws, regulations, standards, and requirements of the countries/geographies 
where the study is being conducted. These include but are not limited to:  
 
In the United States, the study will be conducted under an FDA IDE in compliance with 
21 CFR Parts: 
 
50: Protection of Human Subjects 
 
54: Financial Disclosure by Clinical Investigators 
 
56: IRBs 
 
812: IDEs 
 
In Canada, SOR/98-282, Section 59-88 will be followed and Mandatory Problem 
Reporting 59(1), 59(2), 60 (1)). 
 
The study will be publicly registered prior to in accordance with the 2007 Food and Drug Administration 
Amendments Act (FDAAA) and DoH on http://clinicaltrials.gov (PL 110-85, section 810(a)). In addition, 
the study may be registered in local regulatory databases where required by local law.  
Approval of the CIP and CIP amendments is required from the following groups prior to any study 
procedures at a study site: 
 
Medtronic 
 
Geography-specific regulatory authorities (if regulatory approval is required) 
 
An independent medical EC or IRB. 
Similarly, approval of subsequent revisions to the CIP is required at each study site from the above 
mentioned groups prior to implementation of the revised CIP at the investigational center. 
 
 
 Role of the Sponsor’s Representatives 
Sponsor representatives may provide support as required for the study, such as technical support at 
investigational center. Sponsor representatives may provide technical support as required for the study 
under supervision of the PI, including: 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 128 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
1) Provide study training relevant and pertinent to the involvement of personnel conducting study 
activities and investigator responsibilities. 
2) Technical support will be provided during study period. 
3) Technical support will be under the supervision of a study investigator, but no data entry on the 
eCRF shall be performed by Medtronic personnel or their representatives at investigational 
centers. 
4) Technical support to conduct device interrogations.  
 
The sponsor shall avoid improper influence on, or inducement to, the subject, monitor, any 
investigator(s) or other parties participating in or contributing to this study. 
 
 Investigator’s Responsibilities 
Per 21 CFR 56.102, an investigator means “an individual who actually conducts a clinical investigation 
(i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, 
a subject) or, in the event of an investigation conducted by a team of individuals, is the responsible 
leader of that team.”  
Per ISO14155:2020, an investigator means “individual member of the investigation site team designated 
and supervised by the PI at an investigation site to perform critical clinical-investigation-related 
procedures or to make important clinical-investigation related decisions.” 
Each investigational center shall designate a primary investigator who will have overall responsibility for 
the conduct of the investigation at the investigational center. 
The primary investigators (and co-investigators if applicable) are responsible for conducting the study in 
accordance with this CIP, CTA, 21 CFR Part 812 that apply to significant risk (SR) device studies/ 
ISO14155:2020, applicable regulations, and any conditions of approval imposed by the reviewing EC/IRB 
or regulatory authority requirements. The investigator’s responsibilities include but are not limited to: 
 
Conduct of investigation in accordance to draft guidance from FDA, “Protecting the Rights, 
Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigators”/ 
International guidelines for clinical trials on medical devices ISO 14155:2020, to meet 
responsibilities with respect to protect human subjects and ensuring the integrity of the data 
from clinical investigations. This guidance is also intended to clarify FDA's/ regulatory 
authority’s expectations concerning the investigator's responsibility:  
1) to supervise a clinical study in which some study tasks are delegated to 
employees or colleagues of the investigator or other third parties, and  
2) to protect the rights, safety, and welfare of study subjects. 
 
Protecting the rights, safety, and welfare of subjects under the investigator’s care 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 129 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
o 
Providing reasonable medical care for study subjects for medical problems that arise 
during participation in the trial that are, or could be, related to the study intervention 
o 
Providing reasonable access to needed medical care, either by the investigator or by 
another identified, qualified individual (e.g., when the investigator is unavailable, when 
specialized care is needed) 
o 
Adhering to the CIP so that study subjects are not exposed to unreasonable risks 
 
Controlling devices under investigation  
 
Providing adequate supervision of those to whom tasks have been delegated. The 
investigator is accountable for regulatory violations resulting from failure to adequately 
supervise the conduct of a clinical study.  
 
Ensuring that the requirements for obtaining informed consent/assent are met in accordance 
with 21 CFR 50/ ISO 14155:2020 
 
Supervising the use of investigational device. An investigator shall permit an investigational 
device to be used only with subjects under the investigator’s supervision. An investigator 
shall not supply an investigational device to any person not authorized to receive it. 
 
Disposing of device properly. Upon completion or termination of a clinical investigation or the 
investigator’s part of an investigation, or at the sponsor’s request, an investigator shall return 
to the sponsor any remaining supply of the device or otherwise dispose of the device as the 
sponsor directs.  
 
Allowing study devices to be used only with subjects under the investigator’s supervision and 
to supply study devices only to persons authorized to receive it 
 
Ensuring that investigational center staff are adequately trained to perform their assigned 
duties 
 
Maintenance of accurate, complete, and current records relating to the investigator’s part of 
an investigation, to include: 
o 
attribution, legibility, and timeliness of source data 
o 
all relevant correspondence with another investigator, an EC/IRB, the sponsor, a monitor, 
or FDA/regulatory authority, including required reports 
o 
records of receipt, use or disposition of study devices 
o 
records of each subject’s case history and exposure to the device, including information 
reported in the eCRFs and in all other required reports 
o 
the CIP, with documents showing the dates of and reasons for each deviation from the 
CIP 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 130 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
any other records the FDA/ regulatory authority requires to be maintained by regulations 
or by specific requirement for a category of investigations or a particular investigation 
 
Preparation and submission to Medtronic and, when required, FDA/ regulatory authority and 
the reviewing EC/IRB, the following complete, accurate, and timely reports: 
o 
any reportable AEs (see Section 11) occurring during an investigation 
o 
progress reports on the investigation as required by the FDA/ regulatory authority and 
EC/IRB 
o 
any deviation from the CIP made to protect the life or physical well-being of a subject in 
an emergency 
o 
any use of the device without obtaining informed consent/assent 
o 
any further information requested by the FDA/ regulatory authority and EC/IRB about 
any aspect of the investigation 
 
Permitting FDA or other regulatory authorities to inspect and copy any records pertaining to 
the investigation including, in certain situations, those which identify subjects  
 
Meeting with the monitor to discuss study progress and findings 
 
Ensuring that investigational center resources are adequate to fulfill the obligations of the 
study 
 
Ensuring completion of eCRF to include entry and addressing discrepancies in a timely 
fashion and approving selected eCRFs.  
 
Only authorized study personnel as listed on the Delegation of Authority Log are permitted to consent 
subjects, receive, dispense, dispose of and return investigational products, conduct subject visits, insert 
devices, and enter data on eCRFs. These tasks may be delegated by the investigator. However, the 
investigator is ultimately responsible to ensure investigational center-staff are qualified and perform the 
tasks that have been delegated to them correctly. In addition, the investigator is responsible for the 
conduct of investigational center in the execution of the clinical trial. 
16. Study Administration 
 Training of Clinical Staff 
Training of the investigational center staff on the conduct of the study and system being studied will be 
initiated before the CIP is implemented.  All participating physicians and coordinators will be familiarized 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 131 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
with the system. Other members of the investigational center staff may require training depending on 
their role listing on the Delegation of Authority Log. Training may contain both lecture and hands-on 
experience. 
The PI is responsible for ensuring that investigational center staff are trained to perform their assigned 
duties per Delegation of Authority Log. Individual investigational center staff must be appropriately 
trained prior to performing study related tasks.  
 Monitoring 
Monitoring visits may be conducted at the start, during and at the closure of the clinical study in 
accordance with Medtronic SOPs and the Monitoring Plan. At minimum, it will be verified whether signed 
and dated ICF/assent form have been obtained from each subject at the point of enrollment and that AEs 
discussed in Section 11 were reported via completion of the AE eCRFs. More details regarding the 
monitoring activities (frequency of monitoring visits, planned extent of source data verification) are 
described in the Monitoring Plan. 
 Accessibility of Investigational Center Staff and Study Materials 
The PI(s), his/her delegate(s) and the study coordinator(s) shall be accessible to Medtronic field 
personnel, monitor, regulatory authority personnel, and the Clinical Study Manager. This accessibility is of 
particular importance for reviewing data in the eCRF. Access to subject’s medical files for source data 
verification will need to be granted prior to any monitoring visits.  
 
 Audits and Investigational Center Inspections 
In addition to regular monitoring visits, the sponsor may conduct audits at participating investigational 
centers. The purpose of an audit is to verify the adequate performance of the clinical study related 
activities independent of the employees involved in the clinical study. Regulatory authorities may also 
perform inspections at participating investigational centers. Any regulatory authority inspection 
announcements shall be forwarded immediately to the Clinical Study Manager. 
The investigator and/or institution shall permit sponsor and regulatory authorities direct access to source 
data and documents, taking into account any restrictions due to local law, to perform clinical study-
related monitoring, audits, EC/IRB review, and regulatory inspections. 
 Investigational Center Disqualification 
Sponsor and/or the EC/IRB retain the right to disqualify an investigational center and remove all study 
materials at any time. Specific instances that may precipitate investigational center disqualification 
include but are not limited to: 
 
Unsatisfactory subject enrollment with regards to quantity. 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 132 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
Persistent non-compliance to protocol procedures on the part of an 
investigator/investigational center  
 
Inaccurate, incomplete, and/or untimely data recording on a recurrent basis. 
 
The incidence and/or severity of adverse experiences in this or other studies indicating a 
potential health hazard caused by the device. 
 
Unsatisfactory accountability of investigational devices. 
A written statement fully documenting the reasons for such a termination will be provided to sponsor, the 
EC/IRB, investigational center(s) and other regulatory authorities, as required. 
 
 
 Data Management 
 Electronic Case Report Forms (eCRFs) 
The investigator must ensure accuracy, completeness and timeliness of the data reported in the eCRFs 
and in all other required reports. Data reported on the eCRFs, which are derived from source documents, 
such as subject medical records, must be consistent with the source documents and the discrepancies 
need to be justified in a documented rationale. 
Only authorized persons can complete eCRFs. eCRFs shall be signed by investigational center staff as 
specified on the Delegation of Authority Log included in the Investigator Site File. The EDC system 
maintains an audit trail on entries, changes, and corrections in the eCRFs.  
A copy of the eCRFs to be used in this clinical study is available under a separate cover upon request to 
the sponsor and in the Investigator Site File.  
Investigational centers will be trained to the use of the eCRFs. Access to final eCRFs for study conduct 
will be granted after training is performed and prior to patient’s enrollment.  
 
 CareLink Personal/CareLink System Software 
During the course of the study, subject’s BG values may be assessed from the Accu-Chek Guide Link 
study meter. The SG values may be assessed from the study pump. The study pump will be uploaded in 
CareLink Personal/CareLink system software by the investigator or designated investigational center staff 
and subjects at home. The system uses TLS technology, which encrypts all data it stores (21 CFR Part 11 
compliant). The data in the different databases are linked to each other via the subject’s ID. 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 133 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 Patient Questionnaires 
The questionnaires will be provided in local language in the countries. Subjects will be provided a link to 
complete the questionnaires online. Refer to CIP336 Questionnaire Guide. If the online link cannot be 
accessed due to technical problems, subjects will complete the questionnaire using a paper format. The 
investigator, or designated investigational center staff, will then enter the subject’s responses from the 
paper questionnaires to online once it becomes available. If paper format is used, the investigator or 
designated investigational center staff should maintain the original paper source in the subject’s source 
file. 
 
 Time Windows for Completion and Submission of Case Report Forms 
It is expected that eCRFs are completed in a timely manner with the exception of the reportable AEs (see 
Section 11). After data entry, eCRFs should be submitted (i.e., saved) so that monitors can proceed 
with data verification without delay. 
 
 Data Review and Processing 
Data management will be done according to sponsor SOPs and the Data Management Plan for this clinical 
study.  
 
Collected data will be reviewed for completeness, correctness, and consistency, as per the monitoring 
plan. In case of issues, queries will be entered on the respective eCRF for the investigator to complete, 
correct, or comment on the data.  
 
 
 Direct Access to Source Data/Documents 
The subject’s clinic file, CareLink Personal/CareLink system software data, laboratory reports, 
questionnaires and source documents are handled as source data.  
Medtronic clinical representatives or delegates will be granted access by the investigational center to all 
source documents including electronic source documents or copies of electronic source documents, if 
applicable, for the purposes of monitoring, audit, or inspection.  
 Confidentiality 
The investigator will ensure that the subject’s anonymity is maintained. Subjects will not be identified in 
any publicly released reports of this study. All records will be kept confidential to the extent provided by 
federal, state and local law. The study monitors and other authorized representatives of the sponsor may 
inspect all documents and records required to be maintained by the investigator, including but not limited 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 134 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
to, medical records. The investigator will inform the subjects that the above-named representatives will 
review their study-related records without violating the confidentiality of the subjects. All laboratory 
specimens, evaluation forms, reports, and other records that leave the investigational center will be 
identified only by the subject ID code in order to maintain subject confidentiality. All records will be kept 
locked and all computer entry and networking programs will be done with coded numbers only.   
 Liability and Subject Compensation 
 
The subjects may receive compensation for participation in this study. Travel fees to the site may be 
reimbursed for study specific visits if required by local regulations. Refer to the ICF for details of the 
subject’s compensation, if applicable. 
 
 Insurance (Canada) 
Medtronic Canada ULC is a wholly owned subsidiary of Medtronic, which as the parent company of such 
entity maintains appropriate general liability insurance coverage as required under applicable laws and 
regulations and will comply with applicable local law and custom concerning specific insurance coverage. 
If required, a General Liability insurance statement/certificate will be provided to the EC. 
 
 
 CIP Amendments 
An investigator or study team member can propose any appropriate modification(s) of the CIP or study 
device/product or study device/product use. Medtronic will review this proposal and decide whether the 
modification(s) will be implemented.  
Sponsor can decide to review the CIP based on new information, or for other reasons,  and will submit 
any significant amendment to the CIP, including a justification for this amendment, to the appropriate 
regulatory authority (if applicable) for their approval and to the investigators to obtain approval from 
their EC/IRB. The investigator will only implement the amendment after the sponsor has obtained 
regulatory authority (if applicable) approval and the amendment has been approved by the EC/IRB. 
Administrative amendments to the CIP will be submitted to the EC/IRB for notification. 
 
 Investigational Center Compensation 
Medtronic contracts with participating institutions/investigators through a CTA that defines the scope and 
responsibilities and associated compensation related to carrying out the obligations under a clinical study 
sponsored by Medtronic. 
 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 135 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 Records and Reports 
 Investigator Records 
At a minimum, the following records must be kept by the investigator: 
 
All essential study documents and correspondence that pertains to the clinical study 
 
CIP and, if applicable, any amendments 
 
IB/report of prior investigations and/or user guide 
 
Medtronic and EC/IRB-approved Subject ICF/assent form 
 
EC/IRB and regulatory authority approval or notification 
 
Fully signed clinical study agreements (i.e., including Investigator Statement and Signature 
Page, Clinical Trial Agreement and Confidential Disclosure Agreement) 
 
Completed Delegation of Authority Log  
 
Training documentation of all investigational center staff 
 
Subject Screening log and/or subject ID log  
 
Signed, dated and fully executed Subject ICF/assent form  
 
Source documentation 
 
Fully executed eCRFs and corrections  
 
Report of AEs and DDs 
 
Device accountability records 
 
CIP Deviation/ CIP Non-Compliance, if any 
 
Clinical Bulletins (if applicable)- A brief official update or summary of current study news on a 
matter of immediate interest and high importance to investigational center surrounding the 
CIP. 
 
Current signed and dated CV of PI (and key study team members if required per local 
requirements) 
 
Study reports 
 
 
 
 Investigator Reporting Responsibilities  
 
Table 9. Investigator Reporting Requirements Applicable to the US  
Report 
Submit to 
Description/Constraints 
AEs and DDs 
Sponsor, IRB, and 
regulatory 
authority, where 
applicable 
Refer to Section 11 and 13 for reporting requirements. 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 136 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Report 
Submit to 
Description/Constraints 
Withdrawal of IRB 
approval (either 
suspension or 
termination) 
Sponsor 
An investigator shall report to the sponsor, within 5 working 
days, a withdrawal of approval by the reviewing IRB of the 
investigator's part of an investigation. 
Progress report 
Sponsor and 
IRB 
The investigator must submit this report to the sponsor and 
IRB at regular intervals but in no event less than yearly. 
Study deviations 
Sponsor and 
IRB 
Notice of deviations from the CIP to protect the life or 
physical wellbeing of a subject in an emergency shall be 
given as soon as possible but no later than 5 working days 
after the emergency occurred. 
Failure to obtain 
informed 
consent/assent prior 
to investigational 
device use 
Sponsor and 
IRBs 
If an investigator uses a device without obtaining informed 
consent/assent the investigator shall report such use within 5 
working days after device use. 
Final report 
Sponsor 
IRBs 
Relevant 
Authorities 
This report must be submitted within 3 months of study 
completion or termination of the investigation or the 
investigator’s part of the investigation. 
Other 
Sponsor, IRB and 
FDA 
An investigator shall, upon request by a reviewing IRB, FDA 
or any other regulatory authority, provide accurate, 
complete, and current information about any aspect of the 
investigation. 
 
 
Table 10. Investigator Reporting Requirements Applicable to Canada  
Report 
Submit to 
Description/Constraints 
AEs and DDs 
Sponsor, EC, and 
regulatory 
authority, where 
applicable 
Refer to Section 11 and 13 for reporting requirements. 
Incident(s) as 
described in Section 
59 of SOR/98-282 
EC 
Sponsor, 
manufacturer and 
importer of the 
device 
The investigator must report the incident(s) as described in 
Section 59 of SOR/98-282 and the circumstances 
surrounding it within 72 hours after it comes to his/her 
attention, per Section 81(k)(v). 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 137 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Report 
Submit to 
Description/Constraints 
Withdrawal of EC 
approval 
Sponsor and 
Relevant 
Authorities 
The investigator must report a withdrawal of approval by the 
reviewing EC of the investigator’s part of the investigation 
within 5 working days. 
Study Deviations  
Sponsor and 
EC 
Notice of deviations from the CIP to protect the life or 
physical well-being of a subject in an emergency shall be 
given as soon as possible, but no later than 5 working days 
after the emergency occurred.  
Final Report 
IRBs/ECs and  
Relevant 
Authorities 
This report must be submitted within 3 months of study 
completion or termination. 
 
 
 
Record Retention 
The sponsor and investigator will retain all records and documents pertaining to this study. They will be 
available for inspection by the appropriate regulatory authorities. In addition, the investigator will retain 
the source documents from which the information entered on the eCRF was derived. These records are to 
be retained in a secure storage facility maintained by the investigational center until 2 years (or longer if 
local laws require) after approval of the above-listed study devices or termination of the study, whichever 
is longer. The investigator should not dispose of these records without the approval of the sponsor. 
 
Suspension or Early Termination 
Sponsor or a regulatory authority may decide to suspend or prematurely terminate the clinical study 
(e.g., if information becomes available that the risk to study subject is higher than initially indicated, lack 
of enrollment or because of a business decision). If the clinical study is terminated prematurely or 
suspended, sponsor shall promptly inform the investigators and regulatory authorities (if applicable) of 
the termination or suspension and the reason(s) for this. The investigator shall then promptly inform the 
reviewing EC/IRB and the study subjects.  
 
 
 Early Investigational Center Suspension or Termination 
Sponsor, EC/IRB or a regulatory authority may decide to suspend or prematurely terminate an 
investigational center (e.g., in case of expiring approval of the reviewing EC/IRB, non-compliance to the 
CIP, or lack of enrollment). Suspended clinical studies cannot be resumed without permission from 
EC/IRB and regulatory authority (if applicable). If an investigational center is suspended or prematurely 
terminated, sponsor shall promptly inform the investigator(s) of the termination or suspension and the 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 138 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
reason(s) for this. The investigator shall then promptly inform the reviewing EC/IRB and the study 
subjects.  
When the risks are found to outweigh the potential benefits or when there is conclusive proof of definite 
outcomes, investigators must assess whether to continue, modify, or immediately stop the clinical study 
in the respective investigational center and immediately inform the sponsor and EC/IRB, if applicable. 
 
 
Subject Follow-Up In Case of Termination 
In case of early investigational center suspension or termination, all subjects should be contacted to plan 
an early termination visit at the investigational center. All efforts will be made to complete and report all 
study observations at the time of termination. The subject will return the study devices to the 
investigational center. Following suspension or early termination, subjects will receive standard medical 
care from their own providers. 
 
 
Study Close-Out 
At the time of a study close-out, the investigators will be notified by sponsor. Appropriate 
notification/report to EC/IRB and regulatory authority will be provided if required per local laws and 
regulations. 
 
 
Publication and Use of Information 
Publications from this CIP will be handled according to SOPs and as indicated in the CTA. A separate 
Publication Plan will describe the publication strategy and processes for publications of the study. Clinical 
trials data will be shared by Medtronic with its manufacturer (Novo Nordisk) of the insulin used in the 
study. 
Publications will adhere to authorship criteria defined by the International Committee of Medical Journal 
Editors (ICMJE, Uniform requirements for manuscripts submitted to biomedical journals, www.icmje.org).  
Individual authorship criteria defined by the target journal or conference will be followed when it differs 
from ICMJE criteria. 
Authors, including Medtronic personnel, must at a minimum meet all of the conditions below: 
 
Substantial contributions to conception and design of the work, or the acquisition, 
analysis, or interpretation of data for the work; AND 
 
Drafting the work or revising it critically for important intellectual content; AND 
 
Final approval of the version to be published; AND 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 139 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
Agreement to be accountable for all aspects of the work in ensuring that questions 
related to the accuracy or integrity of any part of the work are appropriately investigated 
and resolved.  
Decisions regarding authorship and contributor-ship will be made by a publication planning committee. 
The selected authors will be responsible for drafting the publication. All selected authors must fulfill the 
authorship conditions stated above to be listed as authors, and all contributors who fulfill the conditions 
must be listed as authors. 
All investigators not listed as co-authors will be acknowledged as the “Medtronic CIP336 Study 
Investigators” and will be individually listed according to the guidelines of the applicable scientific journal 
when possible and affiliation. Any other contributors will be acknowledged by name with their specific 
contribution indicated. 
Publications from the study will be handled according to Medtronic Global Standard Operating Procedures 
and as indicated in the Clinical Trial Agreement. The identity of the subjects may not be disclosed, unless 
required by law, to any persons not immediately involved in the study or the study procedures. The study 
will be publicly registered on http://www.clinicaltrials.gov prior to subject enrollment. Study results, when 
available, will be posted in this database. 
 
17. References 
1. 
Beato-Víbora PI, Gallego-Gamero F, Lázaro-Martín L, Romero-Pérez MDM, Arroyo-Díez FJ. 
Prospective Analysis of the Impact of Commercialized Hybrid Closed-Loop System on Glycemic 
Control, Glycemic Variability, and Patient-Related Outcomes in Children and Adults: A Focus on 
Superiority over Predictive Low-Glucose Suspend Technology. Diabetes Technology and 
Therapeutics. 2020;22(12):912-919. 
2. 
Cryer PE. Defining and reporting hypoglycemia in diabetes: A report from the American diabetes 
association workgroup on hypoglycemia. Diabetes Care. 2005;28(5):1245-1249. 
3. 
Hyperglycemic Crises in Diabetes. Diabetes Care. 2004;27(SUPPL. 1):S94-S102. 
 
18. Appendices 
 Names and addresses 
 
 Investigational Centers and EC/IRB 
The names and addresses of investigators and participating investigational centers will be kept under 
separate cover.  
 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 140 of 159 

 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
 Monitor(s) Contact Information 
The study will be monitored by the Medtronic Clinical& Regulatory Solutions (MCRS) Global Monitoring 
and monitoring duties to be entrusted under: 
 
 
 
Medtronic 
710 Medtronic Parkway  
Minneapolis, MN 55432 
 
The names and addresses of monitors will be kept under separate cover. 
 
 
 Clinical Laboratory(ies) Contact Information 
The names and addresses of clinical laboratory(ies) will be kept under separate cover. The most current 
list of the contact persons is available upon request.  
 
 
 Labeling of Devices 
The current labels for investigational devices and IFUs for all devices will be provided to the investigators 
under separate cover. 
 
 Sample Consent Materials 
Samples of the following consent forms/materials will be provided in a separate cover which includes the 
California Experimental Subject’s Bill of Rights (if applicable), ICF, assent form, and the HIPAA 
Authorization. 


 Questionnaires 
The questionnaires are available in local language and will be provided under a separate cover upon 
request to the sponsor.   
 
PI

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 141 of 159 

 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
19. Version History 
Version 
Summary of changes 
Justification 
of changes 
Potential 
impact of the 
change on 
performance, 
effectiveness, 
or safety or 
other 
endpoints 
Identification of 
the affected study 
documents 
Author(s)/Title 
A.1 
Not Applicable, New Document 
Not 
Applicable, 
New 
Document 
Not Applicable, 
New Document 
Not Applicable, New 
Document 
 
 
 
A.2 
x 
See “Attachment 1: CIP336 Description of 
Protocol Changes Version A.1 to A.2” for 
details on changes 
x 
Updated Medtronic Extended infusion set 
model number for Canada; harmonized 
throughout CIP, as applicable in title page, 
synopsis, device regulatory status table, and 
DA Table  
x 
Updated Study Design section 
x 
Updated Background section 
x 
Updated Table 1 – Canada Device 
Regulatory Status on the Medtronic 
Extended infusion sets 
x 
Updated Table 4- Canada DA Requirements 
for Medtronic infusion set 
x 
Updated Study Site Activation section 
x 
Updated Schedule of Events section 
x 
Updated Table 6, Visit Details  
x 
Updated End of Subject Participation in 
Study section 
See “Attachment 1: CIP336 
Description of Protocol 
Changes Version A.1 to A.2” 
for details  
 
ICFs, CRFs, and PFF 
 
 
 
PI
PI

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 142 of 159 

 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Version 
Summary of changes 
Justification 
of changes 
Potential 
impact of the 
change on 
performance, 
effectiveness, 
or safety or 
other 
endpoints 
Identification of 
the affected study 
documents 
Author(s)/Title 
x 
Updated Definitions and Classification of 
Adverse Events section 
x 
Updated Insurance sections for Canada and 
Europe 
A.3 
x 
See “Attachment 1: CIP336 Description of 
Protocol Changes Version A.2 to A.3” for 
details on changes 
x 
Added new simulation data analysis 
x 
Updated Table 1 – Europe Device Regulatory 
Status on the apps and Blue Adapter 
x 
Updated Table 6, Visit Details 
o 
Conversion for mmol/L added for 
100 mg/dL Auto Basal target 
settings 
o 
Added “x” mark at Visit 6,7, and 8 
for “Print and review CareLink 
Reports”  
o 
Removed  investigational center 
staff to “collect” questionnaires as 
this will be direct entry 
x 
Updated Recording Data section 
x 
Updated Patient Questionnaires section 
See “Attachment 1: CIP336 
Description of Protocol 
Changes Version A.2 to A.3” 
for details  
 
None 
 
 
 
A.4 
x 
See “Attachment 1: CIP336 Description of 
Protocol Changes Version A.3 to A.4” for 
details on changes 
x 
Updated Glossary 
See “Attachment 1: CIP336 
Description of Protocol 
Changes Version A.3 to A.4” 
for details  
ICFs, CRFs, and PFF 
 
 
  
PI
PI

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 143 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Version 
Summary of changes 
Justification 
of changes 
Potential 
impact of the 
change on 
performance, 
effectiveness, 
or safety or 
other 
endpoints 
Identification of 
the affected study 
documents 
Author(s)/Title 
 
Updated List of Trademarks 
 
Removed Precision Xtra ketone meter and 
updated to generic term, ketone meter  
 
Updated Background section 
 
Updated Study Design section 
o 
Removed statement about 
enrollment of 2-6 years old not 
taking place in Europe. 
o 
Added instructions for 
parents/caregivers/companions 
should be in same residence or 
building overnight as their child 
o 
Added use of push notifications for 
hypoglycemia alarms when pediatric 
subjects are away from 
parents/caregivers 
o 
Modified to ensure use of the 120 
mg/dL (6.7 mmol/L) setpoint during 
the run-in period Setpoints have 
been arranged to allow for titration 
during the first part of the study 
period. Meal and exercise challenges 
will take place during weeks 2 and 4 
of the study period, at each setpoint. 
o 
Added a checklist to document 
subject/parent/caregiver training 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 144 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Version 
Summary of changes 
Justification 
of changes 
Potential 
impact of the 
change on 
performance, 
effectiveness, 
or safety or 
other 
endpoints 
Identification of 
the affected study 
documents 
Author(s)/Title 
and materials will be provided to 
them on important information to be 
used during the study.  
o 
Added meal and stress challenges to 
evaluate system with insulin under 
investigation at different Auto Basal 
target setpoints.  
o 
Added an additional enrollment 
stage to monitor different age 
groups as they use the system with 
a new insulin. All meal and exercise 
challenges are taking place during 
the first 28 days of the study period.  
 
Harmonized term used across CIP 
“caretaker” to “caregiver” 
 
Clarified that subjects and 
parents/caregivers on how to use glucose 
and glucagon, in addition to having glucose 
and glucagon on hand for hypoglycemia 
(Updated in Study Design and Visit Details 
Table) 
 
Separated pediatric groups by enrollment 
target 
 
Inclusion criteria 
o 
#2c- Updated for 2-6 years of age 
from “a clinical diagnosis of type 1 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 145 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Version 
Summary of changes 
Justification 
of changes 
Potential 
impact of the 
change on 
performance, 
effectiveness, 
or safety or 
other 
endpoints 
Identification of 
the affected study 
documents 
Author(s)/Title 
diabetes for 3 months or more” to “a 
clinical diagnosis of type 1 diabetes 
for 6 months or more” 
o 
#4- harmonized term of caretaker to 
parent/caregiver 
o 
#6,7,12 and #13- administrative 
updates 
o 
New inclusion criteria #14- add 
subjects must be willing take Fiasp 
insulin in study period 
 
Updated Study Visit Schedule, Figure, and 
Visit Details-Updated to 14 study visits. The 
visits were updated to account for subject 
training needs after starting on the 780G 
system. 
 
Corrected conversion of mg/dL to mmol/L, 
as applicable 
 
Updated title of Table 2 
 
Descriptive endpoints added to capture the 
inclusion of meal and exercise challenges  
 
Canada Device Regulatory Status for 
Extended infusion set updated to 
investigational  
 
Europe Device Regulatory Status for 
Guardian 4 Sensor and Guardian 4 
Transmitter updated   

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 146 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Version 
Summary of changes 
Justification 
of changes 
Potential 
impact of the 
change on 
performance, 
effectiveness, 
or safety or 
other 
endpoints 
Identification of 
the affected study 
documents 
Author(s)/Title 
 
Extended infusion set for Device 
Accountability Requirements Table updated 
for Canada  
 
Updated Blue Adapter description section 
 
Updated Schedule of Events section 
 
Updated Investigator/Investigational Center 
Selection and Medical Staff section  
 
Updated Table 6, Visit Details 
o 
Additional study procedures to align 
with new study requirements 
o 
Added “Adjust pump settings” 
o 
Added “Ask subjects if they require 
assistance, e.g., additional training” 
o 
Added “Instruct subjects and their 
parents/caregivers on diabetes self-
management principles, including 
the use of glucose and glucagon in 
the event of severe hypoglycemia”  ” 
o 
Added “Instruct/Remind subjects 
about the requirement to perform a 
meal challenge during the run-in 
period. SmartGuard should not be 
activated” 
o 
Added “Instruct/Remind subjects 
about the requirement to perform 
meal and exercise challenges during 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 147 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Version 
Summary of changes 
Justification 
of changes 
Potential 
impact of the 
change on 
performance, 
effectiveness, 
or safety or 
other 
endpoints 
Identification of 
the affected study 
documents 
Author(s)/Title 
the study period” 
 
Updated Box to “secure upload application” 
throughout CIP 
 
Updated Subject Consent section 
 
Updated Calibration of CGM Risk section 
 
Updated Recording Data and Patient 
questions section to address back up plan in 
case the link to a panned electronic 
questionnaire is not available 
 
Updated End of Subject Participation in 
Study/ Completion of Study section 
 
Updated Table 12 on reporting of Study 
Deviations  
 
Updated prevention and mitigation for Risks 
with Insulin Administration and Pumps 
 
Updated Severe Hyperglycemia and SAE 
definition 
 
Updated Notification of Adverse Events 
section 
 
Updated Expedited Safety Reporting 
Requirements section 
 
Updated DMC section to align with staged 
enrollment 
 
Updated Statement(s) of Compliance section 
 
Updated Publication and Use of Information 
section 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 148 of 159 

 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Version 
Summary of changes 
Justification 
of changes 
Potential 
impact of the 
change on 
performance, 
effectiveness, 
or safety or 
other 
endpoints 
Identification of 
the affected study 
documents 
Author(s)/Title 
x 
Updated References section 
A.5 
x 
Updated IDE number 
x 
Added “standard of care in Europe” for 
ketone meter description 
x 
Updated Study Design section 
x 
Updated staged enrollment for both Stage 1 
and Stage 2- 28 days completion to 30 days 
x 
Updated number of subject enrollment 
(numbers in pediatric and adult age group 
revised) and  number of subject entering 
study period  
x 
Updated Study Visit Schedule and Figure for 
Visit 3, 4, and 8 
x 
Updated Visit Details Table (column title)- 
For Visit 3,4, and 8- added asterisk 
“Required for subjects without CGM or 
closed loop experience; as needed for all 
others.”  
x 
Added parents/caregivers/companions, 
where applicable throughout CIP 
x 
Updated Blood Ketone Values section 
x 
Updated Table 7- Added that 
parent(s)/guardian(s)/companion(s) “should 
be present at night with subjects” to align 
with updated study design  
x 
Updated Sample Size Considerations/Sample 
See “Attachment 1: CIP336 
Description of Protocol 
Changes Version A.4 to A.5” 
for details  
 
ICFs, CRFs, Home 
Reference Guide, 
and  CIP336 
Questionnaire Guide 
 
 
  
PI

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 149 of 159 

 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Version 
Summary of changes 
Justification 
of changes 
Potential 
impact of the 
change on 
performance, 
effectiveness, 
or safety or 
other 
endpoints 
Identification of 
the affected study 
documents 
Author(s)/Title 
Size Justification section 
x 
Updated Expected Drop-out Rates 
A.6 
x 
Added Guardian 4 Sensor model number for 
Canada (MMT-7040C4) 
x 
Updated Statistical Analysis for Endpoints 
and Hypothesis 
x 
Updated Analysis Populations and Handling 
of Missing Data, Error section 
x 
Updated Pass/Fail Criteria 
See “Attachment 1: CIP336 
Description of Protocol 
Changes Version A.5 to A.6” 
for details  
 
PFF  
 
 
 
A 
(Equivalent 
to FDA 
Version 
A.7) 
x 
Updated to train “companions” on diabetes 
management principles, check blood 
ketones, check SMBG, and all parts of device 
system. A checklist will be implemented and 
completed for the companions as well. The 
changes are reflected throughout CIP, as 
applicable, and under the following sections: 
o 
Study Design 
o 
Study Visit Schedule 
o 
Visit Details Table 
x 
Updated prevention and mitigation for Risks 
with Insulin Administration and Pumps- 
added parent/caregivers and companions 
should be present during meal and exercise 
challenges 
See “Attachment 1: CIP336 
Description of Protocol 
Changes Version A.6 to A.7” 
for details  
 
ICFs 
 
 
 
B 
(Equivalent 
x 
See “Attachment 1: CIP336 Description of 
Protocol Changes Version A to B.1” for 
See “Attachment 1: CIP336 
Description of Protocol 
IB and Product 
Management 
 
 
PI
PI
PI

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 150 of 159 

 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Version 
Summary of changes 
Justification 
of changes 
Potential 
impact of the 
change on 
performance, 
effectiveness, 
or safety or 
other 
endpoints 
Identification of 
the affected study 
documents 
Author(s)/Title 
to FDA 
Version 
B.1) 
details on changes 
x 
Updated year in copyright statement 
x 
Updated Medtronic Extended infusion set 
model numbers for all regions and 
harmonized throughout CIP, as applicable in 
title page, synopsis, device regulatory status 
table, and DA Table  
x 
Updated Study Design section 
x 
Updated Exclusion Criteria #12 
x 
Updated Fiasp insulin accountability at 
subject level (DA Requirements Table for all 
regions) 
x 
Updated Return or Disposal of Study Devices 
section 
x 
Updated Schedule of Events and HbA1c 
section- typo corrected from Visit 5 to Visit 
7.  
x 
Updated Study Stopping Rules section 
x 
Updated prevention and mitigation for the 
following (added “and glucagon”): Risks with 
Insulin Administration and Pumps and Risk 
with Closed Loop Therapy 
x 
Updated Clinical Events Committee section 
x 
Updated Data Monitoring Committee section 
Changes Version A to B.1” for 
details  
 
Assessment Form 
 
C.1  
x 
See “Attachment 1: CIP336 Description of 
Protocol Changes Version B to C.1” for details 
See “Attachment 1: CIP336 
Description of Protocol 
ICF, CIP Training 
PPT, Device Training 
 
 
PI
PI

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 151 of 159 

 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Version 
Summary of changes 
Justification 
of changes 
Potential 
impact of the 
change on 
performance, 
effectiveness, 
or safety or 
other 
endpoints 
Identification of 
the affected study 
documents 
Author(s)/Title 
on changes 
x 
Transferred protocol to the revised Enterprise 
Clinical QMS CIP template (056-F275, Version 
D) 
x 
Added Health Canada ITA number 
x 
Added FootPrint™ to list of trademarks 
x 
Updated Glossary section 
x 
Clarified kit numbers and added pump numbers 
for Europe 
x 
Clarified kit number and added meter number 
for Canada 
x 
Updated Synopsis (Clinical Study Type), 
Objective, and Background section: 
Harmonized term “efficacy” to “effectiveness” 
x 
Clarified the use of SmartGuard during Run-in 
Period and Study Period for both subjects with 
Auto Mode and without Auto Mode experience. 
The changes are reflected under the following 
sections: 
o 
Study Design 
o 
Visit Details Table 
x 
Updated Study Design & Visit Details Table-
changed setting requirements for more 
flexibility per investigator’s discretion  
x 
Updated Study Design section- clarified the role 
of the FoodPrint™ phone app in the collection 
Changes Version B to C.1” for 
details  
 
PPT, CRF 
Requirements, CCGs, 
Product 
Management 
Assessment Form, 
Pump Training 
Checklist, 
Instructions for Site, 
Device Tasks by 
Visit, Questionnaire 
Guide, Questionnaire 
Flow Chart, Visit 
Calculator, and 
Source Worksheets 
 
 
PI

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 152 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Version 
Summary of changes 
Justification 
of changes 
Potential 
impact of the 
change on 
performance, 
effectiveness, 
or safety or 
other 
endpoints 
Identification of 
the affected study 
documents 
Author(s)/Title 
of data during meal and exercise challenges 
 
Removed enrollment of subjects 2-6 years of 
age. The changes are reflected under the 
following sections: 
o 
Study Design 
o 
Sample Size/Study Population  
o 
Inclusion Criteria 
o 
Rationale 
o 
Data Monitoring Committee 
o 
Synopsis and Endpoints for following 
subheader sections: Primary Safety 
Endpoint, Primary Effectiveness Endpoint, 
and Secondary Effectiveness Endpoints 
o 
Endpoints and Hypotheses  
o 
Primary Safety Endpoint, Primary 
Effectiveness Endpoint, and Secondary 
Effectiveness Endpoints 
o 
Sample Size Considerations/Sample Size 
Justification 
 
Removed device training requirements for 
companions. The changes are reflected under 
the following sections: 
o 
Study Design 
o 
Study Visit Schedule 
o 
Visit Details Table 
o 
Potential Risks 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 153 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Version 
Summary of changes 
Justification 
of changes 
Potential 
impact of the 
change on 
performance, 
effectiveness, 
or safety or 
other 
endpoints 
Identification of 
the affected study 
documents 
Author(s)/Title 
 
Updated inclusion criteria #8- expanded criteria 
to specify that subjects have a maximum total 
daily dose of 250 units or less 
 
Added new visit under Study Period – Day 44 
(±3 days) after Visit 7. The changes are 
reflected under the following sections: 
o 
Study Design 
o 
Study Visit Schedule 
o 
Visit Schedule figure 
o 
Visit Details Table 
 
Typo for setpoint at Visit 10 corrected in Study 
Visit Schedule 
 
Table 1- Updated the following device 
regulatory status for: 
o 
EU on pump, sensor, and transmitter  
o 
Canada on Medtronic Extended Reservoir 
 
Table 2- estimated numbers of Medtronic 
Extended Infusion set updated (updated both 
item description and units per subject) 
 
Updated MiniMed 780G Insulin Pump section 
 
Table 3- Updated US DA Requirements for 
Smartphone 
 
Table 4- Updated Canada DA Requirements for  
Smartphone  
 
Table 5- Added asterisk next to study pump to 
denote kit distribution 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 154 of 159 

 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Version 
Summary of changes 
Justification 
of changes 
Potential 
impact of the 
change on 
performance, 
effectiveness, 
or safety or 
other 
endpoints 
Identification of 
the affected study 
documents 
Author(s)/Title 
x 
DA requirements table for all regions - Added 
asterisk next to study meter to denote kit 
distribution 
x 
Updated Subject Enrollment section 
x 
Updated prevention and mitigation for the 
Risks with Insulin Administration and Pumps, 
associated with hypoglycemia- added “and 
glucagon”  
x 
Updated Data Monitoring Committee section 
x 
Updated Descriptive Endpoints section 
x 
Updated Analysis Populations and Handling of 
Missing Data, Error section for PP population 
x 
Updated Investigational Centers and EC/IRB 
section 
C 
(Equivalent 
to Version 
C.2) 
x 
See “Attachment 1: CIP336 Description of 
Protocol Changes Version C.1 to C.2” for details 
on changes 
x 
Corrected trademark for FootPrint™  
x 
Updated attribution statement in copyright 
statement 
x 
Transferred protocol to the revised Enterprise 
Clinical QMS CIP template (056-F275, Version 
E) 
x 
Updated Study Design section- Active Insulin 
Time settings updated during the run-in period 
and the first 3 weeks of study period  
See “Attachment 1: CIP336 
Description of Protocol 
Changes Version C.1 to C.2” 
for details  
 
Pump Training 
Checklist 
 
 
 
PI

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 155 of 159 

 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Version 
Summary of changes 
Justification 
of changes 
Potential 
impact of the 
change on 
performance, 
effectiveness, 
or safety or 
other 
endpoints 
Identification of 
the affected study 
documents 
Author(s)/Title 
D.1 
x 
See “Attachment 1: CIP336 Description of 
CIP Changes Version C to D.1 ” for details on 
changes 
x 
Updated year in copyright statement 
x 
Added Australia as local sponsor 
x 
Removed all Europe information, associated 
study and regulatory requirements related to 
Europe as reflected under the following: 
o 
Title page 
o 
Glossary section 
o 
Synopsis section 
o 
Study Design section 
o 
Background section 
o 
Table 1 
o 
Table 2 
o 
Product Accountability section 
o 
Study Population section 
o 
Visit Details Table 
o 
Subject Consent section 
o 
Unplanned CIP Deviations section 
o 
Reporting Requirements for Study 
Deviations section 
o 
Table 6 
o 
Reporting of Adverse Events section 
o 
Expedited Safety Reporting 
Requirements section 
See “Attachment 1: CIP336 
Description of CIP Changes 
Version C to D.1 ” for details  
ICF, CIP Training 
PPT, Device Training 
PPT, CRF 
Requirements, CCGs, 
DRGs, Site materials, 
and Subject facing 
materials  
 
 
 
 
PI

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 156 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Version 
Summary of changes 
Justification 
of changes 
Potential 
impact of the 
change on 
performance, 
effectiveness, 
or safety or 
other 
endpoints 
Identification of 
the affected study 
documents 
Author(s)/Title 
o 
Adverse Event and Device Deficiency 
Classification section 
o 
Clinical Events Committee section 
o 
Statement(s) of Compliance section 
o 
Insurance (Europe) section 
o 
Table 12 (removed) 
o 
Investigational Centers and EC/IRB 
section 
 
Updated the following details under Study 
Design section: 
o 
regular sized meal challenge with 
missed meal bolus 
o 
subjects to avoid additional 
meal/snack or exercise up to four 
hours after the start of the challenge 
o 
removed the word “live” training 
 
Updated “weeks” with associated study visit 
 
Harmonized start of Auto Basal target at 120 
mg/dL, 100 mg/dL, and investigator’s 
discretion as specified under Study Design 
for the following: 
o 
Study Visit Schedule section 
o 
Visit Details Table  
 
Increased study duration and number of 
investigational centers 
 
Added Exclusion Criteria for 780G users and 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 157 of 159 

 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Version 
Summary of changes 
Justification 
of changes 
Potential 
impact of the 
change on 
performance, 
effectiveness, 
or safety or 
other 
endpoints 
Identification of 
the affected study 
documents 
Author(s)/Title 
harmonized updates to Study Design section 
and Visit Details Table 
x 
Updated Schedule of Events Section- 
removed exceptions for Telemedicine  
x 
Updated Table 1:  
o 
US regulatory classification for 
Medtronic Extended reservoir 
updated to non-investigational 
o 
Forketone meter and Fiasp, added 
“N/A” under “MDT Model number/ 
part number” column  
x 
Visit Details table- additional “As needed” 
updated for “Dispense Fiasp” on subsequent 
office visits 
x 
Updated Publication and Use of Information 
section 
x 
Updated Monitor(s) Contact Information 
section 
D 
(Equivalent 
to Version 
D.2) 
x 
See “Attachment 1: CIP336 Description of CIP 
Changes Version D.1 to D.2 ” for details on 
changes 
x 
Updated Study Design section 
See “Attachment 1: CIP336 
Description of CIP Changes 
Version D.1 to D.2” for details 
ICF, Training 
materials, Site 
materials, and 
Subject facing 
materials  
 
 
 
 
E 
(Equivalent 
to Version 
x 
See “Attachment 1: CIP336 Description of CIP 
Changes Version D to E” for details on changes 
x 
Updated Glossary section 
See “Attachment 1: CIP336 
Description of CIP Changes 
Version D to E” for details 
Product 
Management 
Assessment Form, 
 
 
 
PI
PI

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 158 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Version 
Summary of changes 
Justification 
of changes 
Potential 
impact of the 
change on 
performance, 
effectiveness, 
or safety or 
other 
endpoints 
Identification of 
the affected study 
documents 
Author(s)/Title 
E.1) 
 
Updated Canada model numbers and device 
regulatory status for Medtronic Extended 
infusion set under the following: 
o 
Title page 
o 
Synopsis section 
o 
Table 1 with footnote for commercial 
stock disbursement after depletion 
of investigational Extended infusion 
sets stock products 
o 
Table 4 
 
Updated Table 1: 
o 
Updated US Device Regulatory 
Status for Guardian 4 Sensor (MMT-
7040) and Guardian 4 Transmitter 
(MMT-7841)  
o 
Added footnote for commercial stock 
disbursement after depletion of 
sensor and transmitter 
investigational stock products. 
o 
Updated Canada Regulatory Status 
for the following: 
 
Medtronic CareLink Personal 
software 
 
Medtronic CareLink system 
software 
 
MiniMed Clinical App 
ICFs, Training 
materials, Site 
materials, and 
Subject facing 
materials 
 

CIP336 Clinical Investigation Plan 
 
Form 
D00459338 
Version E 
Page 159 of 159 
 
 Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Version 
Summary of changes 
Justification 
of changes 
Potential 
impact of the 
change on 
performance, 
effectiveness, 
or safety or 
other 
endpoints 
Identification of 
the affected study 
documents 
Author(s)/Title 
 
CareLink Clinical App 
 
Updated Background section 
 
Added the MiniMed Mobile App under as 
reflected under the following: 
o 
Title page 
o 
Synopsis section 
o 
Study Design section 
o 
Table 1 
o 
MiniMed 780G Insulin Pump section 
o 
Figure 1 
o 
Accessory Applications – 780G 
system section 
o 
Blue Adapter section 
o 
Table 5 
o 
Recording Data section 
 
Updated use of SmartGuard is not allowed 
during challenges in the run-in period as 
reflected under the following:  
o 
Synopsis section 
o 
Study Design section 
o 
Table 5 
 
Updated name of MC2 to MCRS 
 
Updated Labeling of Devices section