In-Home Study With MiniMed™ 780G Pump Automated Control in Type 2 - Evaluation of the AHCL System in Adults With Insulin-requiring Type 2 Diabetes
Phase: NA
Conditions: Type 2 Diabetes Treated With Insulin
Sponsor: Medtronic MiniMed, Inc.

 
Study Title 
IMPACT2: In-Home Study with MiniMedTM 
780G Pump Automated Control in Type 2 – 
Evaluation of the AHCL System in Adults with 
Insulin-requiring Type 2 Diabetes 
NCT Number 
NCT05238142 
Document Description 
Clinical Investigation Plan (Version F) 
Document Date 
08-APR-2024 
 

CIP341 Clinical Investigation Plan  
 
 
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Clinical Investigation Plan 
Clinical Investigation Plan 
(CIP) Study Title  
IMPACT2: In-Home Study with MiniMed™ 780G Pump Automated 
Control in Type 2 - Evaluation of the AHCL System in Adults with 
Insulin-requiring Type 2 Diabetes  
CIP Identifier 341 
Investigational Device 
Exemption (IDE) Number 
G210352 
Study Product Names & 
Model Numbers 
Investigational Product 
 
MiniMed™ 780G Insulin Pump (MMT-1884) - referred to as 
the study pump throughout this protocol 
 
MiniMed™ 780G BLE 2.0 Insulin Pump (MMT-1884) - referred 
to as the study pump throughout this protocol 
 
Guardian™ 4 Glucose Sensor (MMT-7040) - referred to as the 
study sensor throughout this protocol 
 
Guardian™ 4 Transmitter (MMT-7841) 
 
Disposable Sensor (MMT-5100) – labeled as DS5 referred to 
as study sensor throughout this protocol 
 
Non-Investigational Product 
 
Medtronic Extended infusion set (MMT-430, MMT-431, MMT-
432, MMT-433, MMT-440, MMT-441, MMT-442, MMT-433 
and MMT-443) or other approved Medtronic infusion sets 
 
Medtronic Extended Reservoir (MMT-342) or other approved 
Medtronic reservoirs 
 
One-Press Serter (MMT-7512) - referred to as the Serter 
throughout this protocol 
 
Transmitter Charger (MMT-7715) 
 
Tester (MMT-7736L) 
 
Medtronic CareLink™ Personal software (MMT-7333)  
 
Medtronic CareLink™ system software (MMT-7350)  
 
Roche Accu-Chek™ Guide Link Glucose Meter (08116083022, 
09651926001M, 09651942001M) -referred to as the Accu-
Chek Guide Link study meter throughout this protocol 
 
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)  

CIP341 Clinical Investigation Plan  
 
 
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 
Blue Bluetooth® Low Energy Adapter (ACC-1003911)- 
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) 
 
Sponsor-provided smartphone for subject and/or site use, 
upon request 
 
Sponsor-provided tablet for site use, upon request  
Description of CIP This study will confirm the safety and effectiveness of the MiniMed™ 
780G system in adults with insulin-requiring type 2 diabetes.  
Sponsor Medtronic MiniMed 
(“Medtronic”) 
18000 Devonshire St 
Northridge, CA 91325 
866.948.6633 
Document Version F (Equivalent to FDA Version F.1) 
Version Date 08-APR-2024 
Document Reference 
Number 
D00591227 
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. 
Admelog®  is a registered trademark of Sanofi-Aventis, U.S. LLC. 
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 a trademark of Nutrino Health Ltd. (“Nutrino”). 
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. 
© 2024 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. 
 

CIP341 Clinical Investigation Plan  
 
 
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Table of Contents 
Table of Contents ...................................................................................................................... 3 
1. 
Glossary .......................................................................................................................... 9 
2. 
Synopsis ........................................................................................................................ 11 
3. 
Introduction ................................................................................................................. 26 
3.1  Background ........................................................................................................................ 26 
3.2  Purpose .............................................................................................................................. 27 
4. 
Objectives and Endpoints ............................................................................................. 27 
4.1  Objective ............................................................................................................................ 27 
4.2  Endpoints ........................................................................................................................... 27 
4.2.1 
During Study Period ............................................................................................................ 27 
4.2.2 
During Run‐in Period ........................................................................................................... 29 
4.2.3 
Continued Access Period ..................................................................................................... 29 
4.2.4 
Simulation Data ................................................................................................................... 29 
5. 
Study Design ................................................................................................................. 30 
5.1  Duration ............................................................................................................................. 32 
5.2  Rationale ............................................................................................................................ 33 
6. 
Product Description ...................................................................................................... 33 
6.1  Intended Use ...................................................................................................................... 33 
6.2  General Overview of MiniMed 780G Insulin Pump System Components and Consumables .......... 33 
6.3  Investigational Product ........................................................................................................ 34 
6.3.1 
MiniMed 780G Insulin Pump .............................................................................................. 34 
6.3.2 
Guardian 4 Sensor ............................................................................................................... 36 
6.3.3 
Guardian 4 Transmitter ....................................................................................................... 36 
6.3.4 
Disposable Sensor (DS5) ..................................................................................................... 37 
6.4  Non-Investigational Product(s) ............................................................................................. 37 
6.4.1 
Medtronic Extended Infusion Set ....................................................................................... 37 
6.4.2 
Medtronic Extended Reservoir ........................................................................................... 38 
6.4.3 
One‐Press Serter ................................................................................................................. 38 
6.4.4 
Charger ................................................................................................................................ 39 
6.4.5 
Tester .................................................................................................................................. 39 

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6.4.6 
CareLink Personal Software ................................................................................................ 39 
6.4.7 
CareLink System Software................................................................................................... 39 
6.4.8 
Roche Accu‐Chek Guide Glucose Meter ............................................................................. 40 
6.4.9 
Accessory Applications – 780G system ............................................................................... 40 
6.4.10 
Blue Adapter ....................................................................................................................... 40 
6.4.11 
Ketone Meter ...................................................................................................................... 40 
6.5  Smartphone ........................................................................................................................ 40 
6.6  Consumable Devices ............................................................................................................ 41 
6.7  Insulin ................................................................................................................................ 41 
6.8  Anticipated Product Changes ................................................................................................ 41 
6.9  Product Accountability ......................................................................................................... 41 
6.9.1 
Receipt and Inventory of Study Devices by Investigational Center .................................... 42 
6.9.2 
Storage of Study Devices at Investigational Center ............................................................ 43 
6.9.3 
Dispensing of Study Devices ............................................................................................... 43 
6.9.4 
Return or Disposal of Study Devices ................................................................................... 43 
7. 
Study Site Requirements .............................................................................................. 44 
7.1  Investigator/Investigational Center Selection ......................................................................... 44 
7.2  Study Site Activation............................................................................................................ 44 
8. 
Selection of Subjects .................................................................................................... 45 
8.1  Study Population ................................................................................................................. 45 
8.2  Subject Enrollment .............................................................................................................. 45 
8.3  Inclusion Criteria ................................................................................................................. 45 
8.4  Exclusion Criteria................................................................................................................. 46 
9. 
Study Procedures .......................................................................................................... 47 
9.1  Schedule of Events .............................................................................................................. 47 
9.1.1 
Study Visit Schedule & Scheduled Follow‐Up Visit Windows ............................................. 50 
9.2  Data Collection .................................................................................................................... 60 
9.3  Subject Consent .................................................................................................................. 60 
9.4  Safety Monitoring/Risk Analysis ............................................................................................ 61 
9.4.1 
Glucose Monitoring Risk ..................................................................................................... 61 
9.4.2 
Hypoglycemic/Hyperglycemic Risk ..................................................................................... 61 

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9.4.3 
Calibration of CGM Risk ...................................................................................................... 61 
9.4.4 
Reuse Risk ........................................................................................................................... 61 
9.4.5 
Sterilization Risk .................................................................................................................. 61 
9.4.6 
Misuse Risk .......................................................................................................................... 61 
9.4.7 
Risk of Blood Sample Collection, Contamination from Sampling Techniques .................... 62 
9.4.8 
HbA1c Risk ........................................................................................................................... 62 
9.4.9 
Risks Associated with Rapid Weight Loss ............................................................................ 62 
9.4.10 
Transition of Subjects on MDI Therapy To/From Pump Therapy ....................................... 62 
9.4.11 
Risk Associated with Non‐Insulin Anti‐Diabetic Medications ............................................. 62 
9.4.12 
Risk Associated with SGLT Therapy ..................................................................................... 62 
9.5  Glucose and Glycemia Measurements .................................................................................... 62 
9.5.1 
Daily Blood Glucose ............................................................................................................ 63 
9.5.2 
Blood Ketone Values ........................................................................................................... 63 
9.5.3 
Sensor Glucose Values ........................................................................................................ 63 
9.5.4 
HbA1c .................................................................................................................................. 63 
9.6  Recording Data ................................................................................................................... 63 
9.7  Deviation Handling .............................................................................................................. 64 
9.7.1 
Documenting Requirements for Study Deviations ............................................................. 64 
9.7.2 
Reporting Requirements for Study Deviations ................................................................... 65 
9.7.3 
Analyzing Deviations ........................................................................................................... 65 
9.8  Subject Exit, Withdrawal or Discontinuation ........................................................................... 65 
9.8.1 
End of Subject Participation in Study/Completion of Study ............................................... 67 
9.8.2 
Lost to Follow‐Up ................................................................................................................ 67 
9.9  Study Stopping Rules ........................................................................................................... 67 
10. 
Risks and Benefits ........................................................................................................ 67 
10.1 Potential Risks .................................................................................................................... 67 
10.2 Risk Minimization ................................................................................................................ 73 
10.3 Potential Benefits ................................................................................................................ 74 
10.4 Risk-Benefit Rationale .......................................................................................................... 74 
10.5 Risk Determination .............................................................................................................. 74 
11. 
Adverse Events ............................................................................................................. 74 

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PI

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16.2.2 
Audits and Investigational Center Inspections ................................................................... 92 
16.2.3 
Investigational Center Disqualification ............................................................................... 93 
16.3 Data Management ............................................................................................................... 93 
16.3.1 
Electronic Case Report Forms (eCRFs) ................................................................................ 93 
16.3.2 
CareLink Personal/CareLink System Software .................................................................... 93 
16.3.3 
Subject Questionnaires ....................................................................................................... 94 
16.3.4 
Time Windows for Completion and Submission of Case Report Forms ............................. 94 
16.3.5 
Data Review and Processing ............................................................................................... 94 
16.4 Direct Access to Source Data/Documents .............................................................................. 94 
16.5 Confidentiality ..................................................................................................................... 94 
16.6 Liability and Subject Compensation ....................................................................................... 95 
16.7 CIP Amendments ................................................................................................................ 95 
16.8 Records and Reports ........................................................................................................... 95 
16.8.1 
Investigator Records ........................................................................................................... 95 
16.8.2 
Investigator Reporting Responsibilities .............................................................................. 96 
16.9 Record Retention ................................................................................................................ 96 
16.10 
Suspension or Early Termination ................................................................................... 97 
16.10.1  Early Investigational Center Suspension or Termination .................................................... 97 
16.10.2  Subject Follow‐Up In Case of Termination .......................................................................... 97 
16.11 
Study Close-Out ........................................................................................................... 97 
16.12 
Publication and Use of Information ................................................................................ 97 
17. 
References .................................................................................................................... 98 
18. 
Appendices ................................................................................................................... 99 
18.1 Appendix 1: Names and addresses ....................................................................................... 99 
18.1.1 
Investigational Centers and IRB .......................................................................................... 99 
18.1.2 
Monitor(s) Contact Information ......................................................................................... 99 
18.2 Appendix 2: Labeling of Devices ........................................................................................... 99 
18.3 Appendix 3: Sample Consent Materials .................................................................................. 99 
18.4 Appendix 4: Phase 1 – This phase has been completed ........................................................ 100 
18.4.1 
Study Design ...................................................................................................................... 100 
18.4.2 
Study Visit Schedule .......................................................................................................... 106 

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18.4.3 
Study Visit Details.............................................................................................................. 113 
19. 
Version History ........................................................................................................... 122 
 

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1. Glossary 
Abbreviations 
ADE 
Adverse Device Effect 
AID 
Automatic Insulin Delivery 
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 
CTA 
Clinical Trial Agreement 
CV 
Curriculum Vitae 
DD 
Device Deficiency 
DKA 
Diabetic Ketoacidosis 
DMC 
Data Monitoring Committee 
DoH 
Declaration of Helsinki 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
EOS 
End of Study 
ER 
Emergency Room 
FDA 
Food and Drug Administration 
GAD 
Glutamic Acid Decarboxylase 
GCP 
Good Clinical Practice 
HbA1c 
Glycosylated hemoglobin 
HIPAA 
Health Insurance Portability and Accountability Act 
HHS 
Hyperglycemic Hyperosmolar Syndrome 
ICF 
Informed Consent Form 
ID 
Identification 
IDE 
Investigational Device Exemption 
IEC 
Independent Ethic Committee 
IFU 
Instructions for Use 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
IV 
Intravenous 
MCRS 
Medtronic Clinical & Regulatory Solutions 
MDI 
Multiple Daily Injections 
NGSP 
National Glycohemoglobin Standardization Program 
PC 
Personal Computer 

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Abbreviations 
PI 
Principal Investigator 
PP 
Per Protocol 
QC 
Quality Control 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SAP 
Sensor Augmented Pump 
SG 
Sensor Glucose 
SGLT 
Sodium-glucose Linked Transporter 
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 
TS 
Technical Support 
TSH 
Thyroid-stimulating hormone 
UADE 
Unanticipated Adverse Device Effect 
 
 
 

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2. Synopsis 
Title 
IMPACT2: In-Home Study with MiniMed™ 780G Pump Automated Control in 
Type 2 – Evaluation of the AHCL System in Adults with Insulin-Requiring Type 2 
Diabetes  
Clinical Study 
Type 
Safety and Effectiveness Evaluation  
Sponsor 
Medtronic MiniMed, Inc. 
(“Medtronic”) 
18000 Devonshire St 
Northridge, CA 91325 
866.948.6633 
Indication 
Under 
Investigation 
Use of the MiniMed™ 780G system by adults with insulin-requiring type 2 diabetes. 
Study Product 
Names & Model 
Numbers 
Investigational Product 
 
MiniMed™ 780G Insulin Pump (MMT-1884) – referred to as the study pump 
throughout this protocol 
 
MiniMed™ 780G BLE 2.0 Insulin Pump (MMT-1884) – referred to as the 
study pump throughout this protocol 
 
Guardian™ 4 Glucose Sensor (MMT-7040) – referred to as the study sensor 
throughout this protocol 
 
Guardian™ 4 Transmitter (MMT-7841) 
 
Disposable Sensor (MMT-5100) – labeled as DS5 and referred to as study 
sensor throughout this protocol 
 
Non-Investigational Product 
 
Medtronic Extended infusion set (MMT-430, MMT-431, MMT-432, MMT-
433, MMT-440, MMT-441, MMT-442, and MMT-443) or other approved 
Medtronic infusion sets 
 
Medtronic Extended Reservoir (MMT-342) or other approved Medtronic 
reservoirs 
 
One-Press Serter (MMT-7512) – referred to as the Serter throughout this 
protocol 
 
Transmitter Charger (MMT-7715) 
 
Tester (MMT-7736L) 
 
Medtronic CareLink™ Personal software (MMT-7333) device  
 
Medtronic CareLink™ system software (MMT-7350) 
 
Roche Accu-Chek™ Guide Link Glucose Meter (08116083022, 
09651926001M, 09651942001M) – referred to as the Accu-Chek Guide Link 
study meter throughout this protocol 
 
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) 

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 
Blue Bluetooth® Low Energy Adapter (ACC-1003911)- 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) 
 
Sponsor-provided smartphone for subject and/or site use, upon request 
 
Sponsor-provided tablet for site use, upon request  
Purpose 
The purpose of this study is to confirm the safety and effectiveness of the 
MiniMed™ 780G system in adult patients with insulin-requiring type 2 diabetes in a 
home setting, which will support a future regulatory submission for labeling 
expansion. 
Objective(s) 
The objective of this study is to assess the safety and effectiveness of the MiniMed 
780G system when used by adults with insulin-requiring type 2 diabetes. 
Study Design 
This study is a multi-center, single arm study in adult subjects with insulin-requiring 
type 2 diabetes, conducted in 2 phases. Phase 1 has been completed. Subjects who 
participated in Phase 1 have been transitioned to Phase 2, if they consented to do 
so. New subjects will only participate in Phase 2. 
 
 
 
Phase 1: MiniMed™ 780G insulin pump with Guardian 4 Sensor 
Phase 1 studied the MiniMed™ 780G insulin pump with Guardian 4 Sensor. See 
Section 18.4.1 (Completed Study Design in Appendix 4: Phase 1) for the Study 
Design for Phase 1. This phase is now complete. 
 
Phase 2: MiniMed™ 780G BLE 2.0 insulin pump with Disposable Sensor 5 
(DS5) 
Phase 2 will study the MiniMed™ 780G BLE 2.0 insulin pump with the disposable 
sensor DS5. The combined run-in period and study period will be approximately 
135 days long.  
 
The period from Visit 1 (consent and screening) through Visit 8 should be 
completed within 45 days. 
 
Run-in Period (Visits 2-8): 
 
The run-in period begins at Visit 2 and ends once Visit 9 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, Humalog™ (insulin lispro 
injection), NovoLog®/NovoRapid® (insulin aspart solution for injection), or Admelog 
(insulin lispro injection). 
 
During the run-in period of the study, subjects will be using the study pump in 
Manual Mode, with only the Sensor Augmented Pump (SAP) function activated (i.e., 

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SmartGuard™ feature turned OFF). The “Suspend before Low” and “Suspend on 
Low” features may be used. 
 
Therapy at Screening 
Pump Setting During Run-in 
Period 
Continuous Subcutaneous Insulin 
Infusion (CSII) 
Manual Mode 
SAP (no closed loop) 
Manual Mode 
SAP with closed loop (i.e., Automatic 
Insulin Delivery (AID) in non-Medtronic 
pump 
Manual Mode 
SAP (with closed loop) in Medtronic 
pump as Auto Mode 
SmartGuard feature with Auto 
Correction OFF 
 
All subjects will be trained on diabetes management principles, such as the 
treatment of hyperglycemia and hypoglycemia. In addition, there will be training by 
investigational center staff regarding the need to have access to and how to use 
glucose and glucagon in case of hypoglycemia.   
 
Companions/care partners will be instructed that they should be with the subject in 
the same residence or building complex overnight. 
 
If the MiniMed Clinical/MiniMed Mobile app and the CareLink Clinical app are being 
used companions/care partners 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 work, 
other activities. Instructions on the appropriate operation of the apps will be 
provided. 
 
For study purposes, subjects will be instructed to perform self-monitoring of blood 
glucose (SMBG) if they are experiencing a severe hypoglycemic event, severe 
hyperglycemic event, hyperglycemic hyperosmolar syndrome (HHS) or diabetic 
ketoacidosis (DKA).  
 
 
Blood ketones will be measured by all subjects using a ketone meter when:  
o 
the subject is symptomatic for high blood glucose or 
o 
the sensor glucose is >300mg/dL, the BG should be checked by 
fingerstick and, if BG is >300mg/dL, blood ketones should be 
checked 
 
As a precaution, subjects 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 

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therapy during the study or experience study device issues (e.g., infusion set 
occlusion with high glucose).   
 
Subjects will be instructed to insert study sensors only in the locations that are 
specified in the User Guide. Subjects should be reminded about appropriate study 
sensor placement at each office visit. Information about predominant location of 
study sensor insertions will be collected on an electronic case report form (eCRF) at 
the end of a subject’s participation. 
 
Subjects will be trained on all parts of the device system. Companions/care 
partners should be trained on how to respond to high or low glucose events. This 
should involve training conducted by investigational center staff. A training 
checklist for each subject should be completed by investigational center-based 
trainers.  Companions/care partners should be available for relevant parts or, if 
desired, all of this training, either in person or virtually.  
 
After completion of training on the study devices, subjects will be asked to attend 
additional visits in the days immediately following the start of system use, as 
needed. They may also take advantage of having continued access to the digital 
learning content, provided it is available at study start. 
 
Study Period (Visits 9-18): 
The study period begins at Visit 9 and ends at the conclusion of Visit 18. 
 
Subjects will continue using the study pump and study sensor and will use the 
SmartGuard feature for approximately 90 days during the study period. Subjects 
should use the system with the SmartGuard feature (with Auto Correction ON) 
turned on at all times. When prompted by the pump, subjects should take 
appropriate measures and follow directions on the pump to remain in, or return to, 
SmartGuard. During times when subjects are not able to use SmartGuard, they 
should use the system in Manual Mode (e.g., using Suspend before low and 
Suspend on low settings). 
 
Pump Settings: 
During the first 3 weeks (between Visits 9 and 14) of the study period, a 120 
mg/dL 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 at the investigator’s 
discretion. 
 
During the next 3 weeks (between Visits 14 and 16) of the study period, a 100 
mg/dL Auto Basal Target should be set. Active Insulin time is recommended to be 
set to 2-3 hours or at investigator’s discretion. 
 

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During the remaining weeks (any time after Visit 16) 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 discretion.  
 
The Auto Basal target setting and Active Insulin Time should be set as shown 
above unless there is a documented safety reason that would not permit these 
settings to be used. 
 
After completion of training on SmartGuard functions, subjects 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 digital learning content, 
provided it is available at study start. 
 
SMBG recommendations for 780G BLE 2.0 system: 
With the 780G BLE 2.0 system and the study sensor, calibration is not required. 
However, a calibration is optional, and it will automatically 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 SmartGuard. 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). 
 
Companions: 
Subjects will be required to have a companion (may be care partner) who resides 
(or will live) in the same building (or home) during the study at night. Companions 
should be able to check SMBG, give glucose and/or administer glucagon.   
 
Sample Size and 
Investigational 
Centers 
A total of up to 575 subjects, with at least 300 subjects entering the study period 
of Phase 2, with insulin-requiring type 2 diabetes age 18-80 will be enrolled at up 
to 40 investigational centers across the United States. 
 
To widen the distribution of the type 2 diabetes population, investigational centers 
are encouraged to enroll a study population that represents a wide variety of races, 
ethnicities, BMI, TDD of insulin, and background diabetes medications.  
Duration 
The study is anticipated to last approximately 36 months from first investigational 
center initiation to study period completion. Individual subject participation is 
expected to be approximately 135 days through the study period of each phase. 
Inclusion 
Criteria 
1. Is age 18 – 80 years at time of screening. 
2. Has a clinical diagnosis of type 2 diabetes for 2 years or more as determined 
via medical record or source documentation by an individual qualified to make 
a medical diagnosis. 
3. Is on multiple daily injection (MDI) regimen (basal/bolus regimen with long-
acting insulin and rapid-acting analogs), defined as greater than or equal to 2 
injections per day for at least 3 months prior signing the informed consent, or 

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CSII pump therapy with or without CGM. The investigators will use their 
discretion to verify that insulin requirements have been stable for the last 3 
months prior to screening.   
4. Is able to comply with technology, according to Investigator’s judgment 
5. Does not require a legally authorized representative to consent on their behalf 
due to mental or intellectual disability. 
6. Is willing to perform fingerstick blood glucose measurements as needed. 
7. Is willing to wear the system continuously throughout the study.  
8. Has a Glycosylated hemoglobin (HbA1c) of 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. 
9. 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.   
10. 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. 
11. Is willing to take one of the following insulins and can financially support the 
use of insulin preparations as required by the study:  
a) Humalog (insulin lispro injection) 
b) NovoLog/NovoRapid (insulin aspart injection) 
c) Admelog (insulin lispro injection) 
Exclusion 
Criteria 
1. 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 
2. Has been hospitalized or has visited the ER in the 6 months prior to screening 
resulting in a primary diagnosis of uncontrolled diabetes.  
3. Has had diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar syndrome 
(HHS) in the last 6 months prior to screening visit.  
4. Will not tolerate tape adhesive in the area of sensor placement as assessed by 
a qualified individual. 
5. Has any unresolved adverse skin condition in the area of sensor placement 
(e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection) at 
time of screening. 
6. Has (Total Daily Dose) of less than 8 units or greater than 250 units at time of 
screening. 
7. Has positive GAD (Glutamic Acid Decarboxylase) Antibody test 
8. Is female of child-bearing potential and result of pregnancy test is positive at 
screening 

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9. Is sexually active female of child-bearing potential and is not using a form of 
contraception deemed reliable by the investigator. 
10. Is female and plans to become pregnant during the course of the study. 
11. Is being treated for hyperthyroidism at time of screening. 
12. Has diagnosis of adrenal insufficiency at time of screening. 
13. 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. 
Note: Intra-articular injections to treat pain (e.g., joint pain, bursitis, etc.) are 
permitted 
14. Is using hydroxyurea at time of screening or plans to use it during the study. 
15. 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 prior to screening (Note: Did 
not apply to subjects who transitioned from Phase 1 to Phase 2).  
16. Is currently abusing illicit drugs.  
17. Is currently abusing marijuana. 
18. Is currently abusing prescription drugs. 
19. Is currently abusing alcohol. 
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 greater than CKD2 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 any of the following cardiovascular events 1 year or more prior to 
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. 

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Subject may be enrolled if clearance from a board-certified cardiologist is 
provided prior to or at Screening.  
32. Is a member of the research staff involved with the study. 
33. Has used a MiniMed 780G pump prior to screening (Note: In Phase 2, this 
applies to new subjects only). 
Study Visit 
Schedule 
Subjects may participate in 2 phases: 
 
Phase 1 (Completed): Subjects participated in a minimum of 18 planned study 
visits, as presented in Section 18.4.3 , for approximately 135 days of device 
wear. Subjects were allowed to enter a continued access period, following the end 
of the study period. Phase 1 has been completed. For detailed information, see 
Section 18.4 Appendix 4: Phase 1.  
 
Phase 2: Subjects will participate in a minimum of 18 planned study visits, as 
presented below in Synopsis Figure 1, for approximately 135 days of device 
wear. 
 
Virtual office visit (audio visual) may be performed for office visits in cases where 
an office visit is not possible.  
 
Subjects who transitioned from Phase 1 to Phase 2: 
Phase 1 subjects were given the opportunity to transition into Phase 2 upon 
completion of the Phase 1 study period or at a subsequent continued access period 
visit. Transitioning subjects were expected to complete all required Visit 1 – Phase 
2 activities prior to entering Visit 9 – Phase 2 and did not need to complete Visit 2 
through Visit 8 of Phase 2.  
 
Phase 2: MiniMed™ 780G BLE 2.0 insulin pump with Disposable Sensor 5 
(DS5) 
 
Visit 1 to Visit 8 should be completed within 45 days. 
 
Visit 1 (Office): Consent and screening 
o 
Collect labs 
 
Run-In Period:  
 
Visit 2 (Office): Start Run-In 
o 
Eligibility has been confirmed  
o 
Start study pump and CGM in Manual Mode 
o 
Register and upload study pump in CareLink Personal and 
CareLink system 
o 
Ask subjects about adverse events and device performance   
 
Visit 3 (Phone): Day 1 after Visit 2  
o 
Ask subjects if they require assistance, e.g., additional training 
o 
Ask subjects about adverse events and device performance 

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o 
Review CareLink reports 
 
Visit 4 (Phone): Day 3 (-1 day) after Visit 2 
o 
Ask subjects 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 5 (-1 day) after Visit 2  
o 
Ask subjects if they require assistance, e.g., additional training 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
 
Visit 6 (Phone): Day 7 (-1 day, +2 days) after Visit 2  
o 
Ask subjects if they require assistance, e.g., additional training 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
 
Visit 7 (Phone): Day 14 (±2 days) after Visit 2  
o 
Ask subjects if they require assistance, e.g., additional training 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
 
Visit 8 (Office/Virtual Office): Day 21 (±3 days) after Visit 2 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
 
Study Period:  
 
Visit 9 (Office): Start Study Period, Day 7 (+7 days) after Visit 8  
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
o 
Start subjects on SmartGuard  
o 
Start auto basal target at 120 mg/dL setpoint 
 
Visit 10 (Phone): Day 2 (-1 day) after Visit 9 
o 
Adjust pump settings as needed 
o 
Ask subjects if they require assistance, e.g., additional training 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
 
Visit 11 (Phone): Day 4 (-1 day) after Visit 9 
o 
Adjust pump settings as needed 
o 
Ask subjects if they require assistance, e.g., additional training 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
 
Visit 12 (Phone): Day 7 (±2 days) after Visit 9  
o 
Adjust pump settings as needed 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
 
Visit 13 (Phone): Day 14 (±3 days) after Visit 9  
o 
Adjust pump settings as needed 
o 
Ask subjects about adverse events and device performance 

CIP341 Clinical Investigation Plan  
 
 
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056-F275 Rev F Clinical Investigation Plan Template 
o 
Review CareLink reports 
 
Visit 14 (Phone): Day 21 (±3 days) after Visit 9  
o 
Adjust pump settings as needed 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
o 
Change auto basal target at 100 mg/dL setpoint and  
 
Visit 15 (Office/Virtual Office): Day 30 (±3 days) after Visit 9  
o 
Adjust pump settings as needed 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
 
Visit 16 (Office/Virtual Office): Day 44 (±3 days) after Visit 9  
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 
 
Visit 17 (Office/Virtual Office): Day 60 (±7 days) after Visit 9  
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
 
Visit 18 (Office): Day 90 (±7 days) after Visit 9  
o 
Collect HbA1C 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
o 
Return study devices – unless subject decides to enter continued 
access period 
o 
End of Study (EOS) – unless subject decides to enter continued 
access period 

CIP341 Clinical Investigation Plan  
 
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056-F275 Rev F Clinical Investigation Plan Template 
Synopsis Figure 1. Phase 2 Visit Schedule 
Run-in Period 
Office 
Visit 1
Consent & 
Screening
Telephone 
Visit 3
Day 1 after 
Visit 2 
Office
Visit 2
Start Study 
Pump & CGM
Phase 2 - Visit Schedule
Study Period
Visit 1 to Visit 8 should be completed within 45 days.
Office/Virtual 
Office 
Visit 8
Day 21 (±3 days) 
after Visit 2
Telephone 
Visit 4
Day 3 (-1 
Day) after 
Visit 2 
Telephone 
Visit 6
Day 7 (-1 
Day, +2 days) 
after Visit 2 
Office 
Visit 9
Day 7 (+7 days) 
after Visit 8
Telephone 
Visit 10
Day 2 (-1 
Day) after 
Visit 9 
Telephone 
Visit 12
Day 7 (±2 
days) after 
Visit 9 
Telephone 
Visit 13
Day 14 (±3 
days) after 
Visit 9 
Telephone 
Visit 14
Day 21 (±3 
days) after 
Visit 9 
Office/Virtual 
Office 
Visit 15
Day 30 (±3 days) 
after Visit 9
Office/Virtual 
Office 
Visit 17
Day 60 (±7 days) 
after Visit 9
Office 
Visit 18
Day 90 (±7 days) after 
Visit 9
EOS
Telephone 
Visit 5
Day 5 (-1 
Day) after 
Visit 2 
Telephone 
Visit 7 (±2 
days)
Day 14 
after Visit 2 
Telephone 
Visit 11
Day 4 ( (-1 
Day) after 
Visit 9 
Office/Virtual 
Office 
Visit 16
Day 44 (±3 days) 
after Visit 9
 
Note:  Phase 1 subjects were given the opportunity to transition to Phase 2 upon completion of Phase 1 – Study Period  or at a subsequent continued access 
period visit. Phase 1 is now complete and the Phase 1 visit schedule is presented Section 18.4.2 for reference.

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CIP341 Clinical Investigation Plan  
 
 
D00591227 
Revision F 
 
Page 26 of 125 
 
Medtronic Business Restricted 
 
CONFIDENTIAL 
056-F275 Rev F Clinical Investigation Plan Template 
3. Introduction 
3.1 Background 
Type 2 diabetes mellitus, formerly known as non-insulin dependent diabetes and mature-onset 
diabetes, is characterized by a lack of insulin (reduced secretion that can reach an absolute lack) or 
insulin resistance (reduced insulin sensitivity of insulin receptors in cell membranes). In adults, type 2 
diabetes accounts for 90–95% of all diagnosed cases of diabetes.[1] The exact cause of type 2 
diabetes remains unknown, although both genetics (race/ethnicity, family history of diabetes, history 
of gestational diabetes, impaired glucose metabolism) and environmental factors (obesity and lack of 
exercise) appear to play roles. [2, 3] Type 2 diabetes usually begins as insulin resistance, a disorder in 
which the cells do not use insulin properly. The pancreas initially responds by increasing insulin 
production but over time this excess production cannot be maintained, leading to a decrease in 
insulin production and a lack of insulin.  
Algorithm driven closed-loop systems enable automated subcutaneous delivery of insulin in response 
to real-time continuous glucose sensor readings. Prior Medtronic studies to date have assessed the 
safety and effectiveness of closed-loop insulin delivery in patients with type 1 diabetes. For some 
patients with type 2 diabetes whose treatment consists of diet or non-insulin glucose-lowering 
medications, an episode of severe illness could result in elevated glucose levels that may make it 
necessary to provide insulin in order to improve and optimize glucose control. Other type 2 patients 
are using pumps, but do not yet have access to the benefits of closed loop control. Medtronic has 
conducted a study of pump systems in Type 2 patients, which found that Insulin Pump therapy has a 
sustained, durable, effect on glycemic control in uncontrolled type 2 diabetes.[4] 
The MiniMed 780G system is an advanced hybrid 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 Europe, Australia, and the 
United States. Previous clinical investigations involved the 670G Version 4.0 pump (contains the 780G 
AHCL (Advanced Hybrid Closed Loop) algorithm) used in combination with the Guardian Sensor (3) 
glucose sensor, Guardian Link (3) transmitter, and Humalog or NovoLog. The MiniMed 780G insulin 
pump has also been used in combination with Guardian 4 glucose sensor and Guardian 4 transmitter.  
This investigation is intended to confirm safety and effectiveness of the MiniMed 780G system in 
patients with type 2 diabetes. The study began with investigation of the MiniMed 780G system with 
the Guardian 4 Sensor/Transmitter in the type 2 diabetes population. The introduction of the 780G 
BLE 2.0 system with disposable sensor DS5 into the study is intended to confirm safety and 
effectiveness of the 780G insulin pump used in combination with the DS5; the DS5 combines the 
glucose sensor and transmitter into one disposable device. Additional details for non-clinical/clinical 
testing are provided in the report of prior investigations. 

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5. Study Design 
This study is a multi-center, single arm study in adult subjects with insulin-requiring type 2 diabetes, 
conducted in 2 phases. Phase 1 has been completed. Subjects who participated in Phase 1 have been 
transitioned to Phase 2, if they consented to do so. New subjects will only participate in Phase 2. 
 
 
Phase 1: MiniMed™ 780G insulin pump with Guardian 4 Sensor 
Phase 1 studied the MiniMed™ 780G insulin pump with Guardian 4 Sensor. See Section 18.4.1 
(Completed Study Design in Appendix 4: Phase 1) for the Study Design for Phase 1. This phase is 
now complete. 
 
Phase 2: MiniMed™ 780G BLE 2.0 insulin pump with DS5 
Phase 2 will study the MiniMed™ 780G BLE 2.0 insulin pump with the DS5. The combined run-in 
period and study period will be approximately 135 days long.  
 
The period from Visit 1 (consent and screening) through Visit 8 should be completed within 45 days. 
 
Run-in Period (Visits 2-8):  
 
The run-in period begins at Visit 2 and ends once Visit 9 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, Humalog (insulin lispro injection), NovoLog/NovoRapid (insulin aspart 
solution for injection), or Admelog (insulin lispro injection). 
 
During the run-in period of the study, subjects will be using the study pump in Manual Mode, with 
only the Sensor Augmented Pump (SAP) function activated (i.e., SmartGuard feature turned OFF). 
The “Suspend before Low” and “Suspend on Low” features may be used. 
 
Therapy at Screening 
Pump Setting During Run-in 
Period 
Continuous Subcutaneous Insulin 
Infusion (CSII) 
Manual Mode 
SAP (no closed loop) 
Manual Mode 
SAP (with closed loop [i.e., AID]) in 
non-Medtronic pump 
Manual Mode 
SAP (with closed loop) in Medtronic 
pump as Auto Mode 
SmartGuard feature with Auto 
Correction OFF 
 
All subjects will be trained on diabetes management principles, such as the treatment of 
hyperglycemia and hypoglycemia. In addition, there will be training by investigational center staff 
regarding the need to have access to and how to use glucose and glucagon in case of hypoglycemia.   
 

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Companions/care partners will be instructed that they should be with the subject in the same 
residence or building complex overnight. 
 
If the MiniMed Clinical/MiniMed Mobile app and the Carelink Clinical app are being used, 
companions/care partners 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 work, other activities. Instructions on the appropriate operation of the 
apps will be provided. 
 
For study purposes, subjects will be instructed to perform self-monitoring of blood glucose (SMBG) if 
they are experiencing a severe hypoglycemic event, severe hyperglycemic event, hyperglycemic 
hyperosmolar syndrome (HHS), or diabetic ketoacidosis (DKA). 
 
Blood ketones will be measured by all subjects using a ketone meter when:  
 
the subject is symptomatic for high blood glucose or 
 
the sensor glucose value is >300mg/dL, the BG is checked by fingerstick and, if BG is 
>300mg/dL, blood ketones should be checked 
 
As a precaution, subjects 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 device issues 
(e.g., infusion set occlusion with high glucose).   
 
Subjects will be instructed to insert study sensors only in the locations that are specified in the User 
Guide. Subjects should be reminded about appropriate study sensor placement at each office visit. 
Information about predominant location of study sensor insertions will be collected on an electronic 
case report form (eCRF) at the end of a subject’s participation. 
 
Subjects will be trained on all parts of the device system. Companions/care partners should be 
trained on how to respond to high or low glucose events. This should involve training conducted by 
investigational center staff. A training checklist for each subject should be completed by 
investigational center-based trainers. Companions/care partners should be available for relevant parts 
or, if desired, all of this training, either in person or virtually.  
 
After completion of training on the study devices, subjects will be asked to attend additional visits in 
the days immediately following the start of system use, as needed. They may also take advantage of 
having continued access to the digital learning content, provided it is available at study start. 
 
Study Period (Visits 9-18): 
The study period begins at Visit 9 and ends at the conclusion of Visit 18. 
 
Subjects will continue using the study pump and study sensor and will use the SmartGuard feature 
for approximately 90 days during the study period. Subjects should use the system with the 

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SmartGuard feature (with Auto Correction ON) turned on at all times. When prompted by the pump, 
subjects should take appropriate measures and follow directions on the pump to remain in, or return 
to, SmartGuard. During times when subjects are not able to use SmartGuard, they should use the 
system in Manual Mode (e.g., using Suspend before low and Suspend on low settings). 
 
Pump Settings: 
During the first 3 weeks (between Visits 9 and 14) of the study period, a 120 mg/dL Auto Basal 
Target should be used. It is recommended that Active Insulin Time is initially set to 4 hours and then 
titrated towards 2-3 hours at the investigator’s discretion. 
 
During the next 3 weeks (between Visits 14 and 16) of the study period, a 100 mg/dL Auto Basal 
Target setting should be used. Active Insulin time is recommended to be set to 2-3 hours or at 
investigator’s discretion. 
 
During the remaining weeks (any time after Visit 16) 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. 
The Auto Basal target setting and Active Insulin Time should be set as shown above unless there is a 
documented safety reason that would not permit these settings to be used. 
 
After completion of training on SmartGuard functions, subjects 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 digital learning content, provided it is available at study start. 
 
SMBG recommendations for 780G BLE 2.0 system: 
With the 780G BLE 2.0 system and the study sensor, calibration is not required. However, a 
calibration is optional, and it will automatically 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 
SmartGuard. 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). 
Companions: 
Subjects will be required to have a companion (may be care partner) who resides (or will live) in the 
same building (or home) during the study at night. Companions should be able to check SMBG, give 
glucose and/or administer glucagon.   
 
5.1 Duration 
The study is anticipated to last approximately 36 months from first investigational center initiation to 
study period completion. Individual subject participation is expected to be approximately 135 days 
through the study period of each phase.  

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5.2 Rationale 
Previous clinical investigations have confirmed the safety and clinical performance of the 780G insulin 
pump when used in a type 1 population in subjects 7 years of age or older. This investigation is 
intended to provide confirmation of the safety and clinical performance of the 780G system in a type 
2 population in subjects 18-80 years of age. 
6. Product Description 
6.1 Intended Use 
In this study, the MiniMed 780G system is intended for use by patients 18 years and older with type 
2 diabetes who require at least 8 units and up to 250 units of insulin per day. 
6.2 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 
Device Status 
MiniMed 780G Insulin Pump 
MMT-1884* 
Investigational 
MiniMed 780G BLE 2.0 Insulin Pump 
MMT-1884* 
Investigational 
Guardian 4 Sensor  
MMT-7040 
Investigational 
Guardian 4 Transmitter 
MMT-7841 
Investigational 
Disposable Sensor 5 (DS5) 
MMT-5100 
Investigational 
Medtronic Extended Reservoir  
MMT-342 
Non-Investigational 
Medtronic Extended Infusion Set 
MMT-433 and MMT-443 
Non-Investigational 
One-Press Serter 
MMT-7512 
Non-Investigational 
Charger  
MMT-7715 
Non-Investigational 
Tester  
MMT-7736L 
Non-Investigational 
Medtronic CareLink Personal software  
MMT-7333 
Non-Investigational 
Medtronic CareLink system software  
MMT-7350 
Non-Investigational 
Roche Accu-Chek Guide Link Glucose Meter 
08116083022, 09651926001M, 
09651942001M 
Non-Investigational 
MiniMed Clinical App 
MMT-6103 Android; MMT-6104 
IOS 
Non-Investigational 
CareLink Clinical App 
MMT-6113 Android; MMT-6114 
IOS 
Non-Investigational 
MiniMed Mobile App 
MMT-6101 Android; MMT-6102 
IOS 
Non-Investigational 
Blue Adapter 
ACC-1003911 
Non-Investigational 
Ketone Meter  
-- 
Non-Investigational 
*Note: Although the model numbers for the insulin pumps (780G and 780G BLE 2.0) are the same, each has a unique model 
number extension.  
 

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6.3 Investigational Product 
6.3.1 MiniMed 780G Insulin Pump 
The MiniMed 780G Insulin Pump 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 System components will interact as follows (MiniMed 780G 
System and components presented in Figure 2 [MiniMed 780G BLE 2.0 insulin pump with DS5]) and 
Figure 3 [MiniMed 780G insulin pump with Guardian 4 CGM]): 
 
 
Phase 1: The MiniMed 780G insulin pump receives the SG values and sensor integrity 
check from the Guardian 4 Transmitter, which is connected to the Guardian 4 sensor. 
 
Phase 2: The MiniMed 780G BLE 2.0 insulin pump receives the SG values and sensor 
integrity check from the DS5. 
 
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/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/MiniMed Mobile app. 

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Figure 2. 780G BLE 2.0 System with DS5 CGM 
 

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Figure 3. 780G System with Guardian 4 CGM 
 
6.3.2 
Guardian 4 Sensor 
The Guardian 4 sensor, referred to as the study 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. 
6.3.3 
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 
sensor integrity (SI) data from the sensor to compatible insulin pumps via a Bluetooth Low Energy 
wireless communication protocol. 

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6.3.4 
Disposable Sensor (DS5) 
The Disposable Sensor, referred to as study sensor in this CIP, is a disposable integrated sensor-
transmitter platform. The sensor is packaged into a single-use insertion device, called the inserter, 
resulting in an all-in-one device out of the box. The inserter is designed to simplify the insertion 
process. The sensor flex is inserted subcutaneously with an introducer needle, which is retracted by 
the inserter upon removal. The sensor wirelessly sends the collected sensor data to the MiniMed 
780G BLE 2.0 insulin pump or other compatible mobile device. 
 
 
 
6.4 Non-Investigational Product(s) 
6.4.1 Medtronic Extended Infusion Set  
Infusion sets are single-use by patients with diabetes mellitus requiring subcutaneously 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 
Extended 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 
 
Figure 4. DS5 

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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 5 illustrates 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).  
 
In this study, subjects may use the Medtronic Extended infusion set or other approved Medtronic 
infusion sets (see Section 6.6). 
Figure 5. Medtronic Extended Infusion Set 
 
6.4.2 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. In this study, subjects 
may use the Medtronic Extended Reservoir or other approved Medtronic reservoirs (see Section 
6.6). 
6.4.3 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 study 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.  

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6.4.4 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.  
6.4.5 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. 
6.4.6 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 uses 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. 
6.4.7 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 uses 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; 

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 
Application server to the database server. 
6.4.8 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.  
6.4.9 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/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/MiniMed Mobile app screen, for remote monitoring by a care partner (e.g., companion). 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.  
6.4.10 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/MiniMed Mobile app are 
not possible. 
6.4.11 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. 
6.5 Smartphone 
Sponsor may provide a smartphone and/or tablet, upon request. 

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6.6 Consumable Devices 
Glucose meter accessories, Medtronic infusion sets, Medtronic reservoirs, and other consumable 
materials will be provided to subjects for use in the study. 
6.7 Insulin  
Subjects will use their own rapid-acting analogue insulin (Novolog, Humalog, or Admelog) for this 
study. 
6.8 Anticipated Product Changes 
There are no changes anticipated for any of the products/devices during the course of the study. 
6.9 Product Accountability 
Good Clinical Practice (GCP) 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 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 2. 
Table 2. Product Accountability Requirements 
Device 
Record on 
Site 
Received 
eCRF 
Record 
Disbursement, 
Returned or Not 
Returned from 
Subject on Subject 
Device 
Identification eCRF 
Subject 
Return 
Device to 
Investigatio
nal Center  
Record 
Returned or 
Not Returned 
to Sponsor on 
Site Returned 
eCRF  
Investigatio
nal Center 
Return 
Device to 
Sponsor at 
Conclusion 
of Study 
MiniMed 780G 
Insulin Pump 
(MMT-1884) 
Yes 
Yes 
Yes 
Yes 
Yes 
MiniMed 780G 
BLE 2.0 Insulin 
Pump (MMT-
1884) 
Yes 
Yes 
Yes 
Yes 
Yes 
Guardian 4 Sensor 
(MMT-7040) 
Yes 
Yes 
Yes 
(Complaint 
and unused)
No* (Non-
Yes  
Yes (Unused) 
No* (Used) 

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Device 
Record on 
Site 
Received 
eCRF 
Record 
Disbursement, 
Returned or Not 
Returned from 
Subject on Subject 
Device 
Identification eCRF 
Subject 
Return 
Device to 
Investigatio
nal Center  
Record 
Returned or 
Not Returned 
to Sponsor on 
Site Returned 
eCRF  
Investigatio
nal Center 
Return 
Device to 
Sponsor at 
Conclusion 
of Study 
complain 
used) 
Guardian 4 
Transmitter 
(MMT-7841) 
Yes 
Yes 
Yes 
Yes 
Yes 
DS5 (MMT-5100) 
Yes 
Yes 
Yes 
(Complaint 
and unused)
No* (Non-
complaint 
used) 
Yes  
Yes (Complaint 
and unused) 
No* (Non-
complaint 
used) 
Roche Accu-Chek 
Guide Link Study 
Meter 
(08116083022, 
09651926001M, 
09651942001M) 
Yes 
Yes 
Yes 
 
Yes 
No* 
Ketone Meter 
Yes 
Yes 
Yes 
Yes 
No* 
Smartphone, as 
approved for 
distribution 
Yes 
Yes 
Yes 
Yes 
Yes 
Tablet, if 
distributed  
Yes 
N/A 
N/A 
Yes 
Yes 
*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.  
 
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.  
 
6.9.1 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  

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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 2. 
6.9.2 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. 
6.9.3 Dispensing of Study Devices 
Each time a study device 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) 
 
Device type 
 
Amount dispensed  
6.9.4 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 2 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 2. 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.  
 

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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.  
7. Study Site Requirements 
7.1 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. The principal 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. 
7.2 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:  
 
IRB approval (and voting list, as required by local law) of the current version of the Clinical 
Investigation Plan (CIP) and Informed Consent Form (ICF), and report of prior investigations 
 
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. 

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8. Selection of Subjects 
8.1 Study Population 
A total of up to 575 subjects, with at least 300 subjects entering the study period of Phase 2, with 
insulin-requiring type 2 diabetes age 18-80 will be enrolled at up to 40 investigational centers across 
the United States.  
To widen the distribution of the type 2 diabetes population, investigational centers are encouraged to 
enroll a study population that represents a wide variety of races, ethnicities, BMI, TDD of insulin, and 
background diabetes medications. 
8.2 Subject Enrollment 
Subjects will be considered enrolled in the study upon signing the ICF. 
A subject will be assigned a unique study subject ID via the eCRF, which is a 9-digit code 
(341XXXXXX).  The first three digits refer to the CIP number (341), the next three digits refer to the 
investigational center number, and the last 3 digits refer to the subject number assigned during Visit 
1 (e.g., 341002001 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. 
8.3 Inclusion Criteria 
1. Is age 18 – 80 years at time of screening. 
2. Has a clinical diagnosis of type 2 diabetes for 2 years or more as determined via medical record 
or source documentation by an individual qualified to make a medical diagnosis. 
3. Is on MDI regimen (basal/bolus regimen with long-acting insulin and rapid-acting analogs), 
defined as greater than or equal to 2 injections per day for at least 3 months prior signing the 
informed consent, or CSII pump therapy with or without CGM. The investigator will use their 
discretion to verify that insulin requirements have been stable for the last 3 months prior to 
screening. 
4. Is able to comply with technology, according to Investigator’s judgment 
5. Does not require a legally authorized representative to consent on their behalf due to mental or 
intellectual disability. 
6. Is willing to perform fingerstick blood glucose measurements as needed. 
7. Is willing to wear the system continuously throughout the study.  
8. Has a Glycosylated hemoglobin (HbA1c) of 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. 
9. 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.   

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10. 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. 
11. Is willing to take one of the following insulins and can financially support the use of insulin 
preparations as required by the study:  
a) Humalog (insulin lispro injection) 
b) NovoLog/NovoRapid (insulin aspart injection) 
c) Admelog (insulin lispro injection) 
8.4 Exclusion Criteria 
1. 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 
2. Has been hospitalized or has visited the ER in the 6 months prior to screening resulting in a 
primary diagnosis of uncontrolled diabetes.  
3. Has had diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar syndrome (HHS) in the last 6 
months prior to screening visit.  
4. Will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified 
individual. 
5. Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, 
dermatitis herpetiformis, rash, Staphylococcus infection) at time of screening. 
6. Has (Total Daily Dose) of less than 8 units or greater than 250 units at time of screening. 
7. Has positive GAD (Glutamic Acid Decarboxylase) Antibody test 
8. Is female of child-bearing potential and result of pregnancy test is positive at screening 
9. Is sexually active female of child-bearing potential and is not using a form of contraception 
deemed reliable by the investigator. 
10. Is female and plans to become pregnant during the course of the study. 
11. Is being treated for hyperthyroidism at time of screening. 
12. Has diagnosis of adrenal insufficiency at time of screening. 
13. 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. 
Note: Intra-articular injections to treat pain (e.g., joint pain, bursitis, etc.) are permitted 
14. Is using hydroxyurea at time of screening or plans to use it during the study. 
15. 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 
prior to screening. (Note: Did not apply to subjects who transitioned from Phase 1 to Phase 2). 
16. Is currently abusing illicit drugs.  
17. Is currently abusing marijuana. 
18. Is currently abusing prescription drugs. 
19. Is currently abusing alcohol. 
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. 

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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 greater than CKD2 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 prior to 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. Subject may be enrolled if clearance from a board-certified cardiologist is provided 
prior to or at Screening.  
32. Is a member of the research staff involved with the study. 
33. Has used a MiniMed 780G pump prior to screening (Note: In Phase 2, this applies to new 
subjects only). 
9. Study Procedures 
9.1 Schedule of Events 
Subjects may participate in 2 phases. 
Phase 1 (Completed): Subjects participated in a minimum of 18 planned study visits, as presented 
in Section 18.4.3, for approximately 135 days of device wear. Subjects were allowed to enter a 
continued access period, following the end of the study period. Phase 1 has been completed. For 
detailed information, see Section 18.4 Appendix 4: Phase 1.  
Phase 2: Subjects will participate in a minimum of 18 planned study visits, as presented below in 
Figure 6, for approximately 135 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. 

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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 9. Refer to CIP341 
Questionnaire Guide for collection of early exit survey/questionnaire requirements.  
The Exit eCRF and all associated activities should be completed for all subjects who have withdrawn, 
discontinued, or completed the study. 
 
Subjects who transitioned from Phase 1 to Phase 2: 
Phase 1 subjects were given the opportunity to transition into Phase 2 upon completion of the Phase 
1 study period or at a subsequent continued access period visit. Transitioning subjects were expected 
to complete all required Visit 1 – Phase 2 activities prior to entering Visit 9 – Phase did not need to 
complete Visit 2 through Visit 8 of Phase 2.  
Refer to Section 9.1.1, Table 3 for the Visit Details. 

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Figure 6. Phase 2 Visit Schedule 
Run-in Period 
Office 
Visit 1
Consent & 
Screening
Telephone 
Visit 3
Day 1 after 
Visit 2 
Office
Visit 2
Start Study 
Pump & CGM
Phase 2 - Visit Schedule
Study Period
Visit 1 to Visit 8 should be completed within 45 days.
Office/Virtual 
Office 
Visit 8
Day 21 (±3 days) 
after Visit 2
Telephone 
Visit 4
Day 3 (-1 
Day) after 
Visit 2 
Telephone 
Visit 6
Day 7 (-1 
Day, +2 days) 
after Visit 2 
Office 
Visit 9
Day 7 (+7 days) 
after Visit 8
Telephone 
Visit 10
Day 2 (-1 
Day) after 
Visit 9 
Telephone 
Visit 12
Day 7 (±2 
days) after 
Visit 9 
Telephone 
Visit 13
Day 14 (±3 
days) after 
Visit 9 
Telephone 
Visit 14
Day 21 (±3 
days) after 
Visit 9 
Office/Virtual 
Office 
Visit 15
Day 30 (±3 days) 
after Visit 9
Office/Virtual 
Office 
Visit 17
Day 60 (±7 days) 
after Visit 9
Office 
Visit 18
Day 90 (±7 days) after 
Visit 9
EOS
Telephone 
Visit 5
Day 5 (-1 
Day) after 
Visit 2 
Telephone 
Visit 7 (±2 
days)
Day 14 
after Visit 2 
Telephone 
Visit 11
Day 4 ( (-1 
Day) after 
Visit 9 
Office/Virtual 
Office 
Visit 16
Day 44 (±3 days) 
after Visit 9
 
Note:  Phase 1 subjects were given the opportunity to transition into Phase 2 upon completion of Phase 1 – Study Period or at a subsequent continued access 
period visit. Phase 1 is now complete and the Phase 1 visit schedule is presented in Section 18.4.2 for reference.

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9.1.1 Study Visit Schedule & Scheduled Follow-Up Visit Windows 
 
Visit 1 to Visit 8 should be completed within 45 days. 
 
Visit 1 (Office): Consent and screening 
o 
Collect labs 
 
Run-In Period:  
 
Visit 2 (Office): Start Run-In 
o 
Eligibility has been confirmed  
o 
Start study pump and CGM in Manual Mode 
o 
Register and upload study pump in CareLink Personal and CareLink system   
o 
Ask subjects about adverse events and device performance 
 
 
Visit 3 (Phone): Day 1 after Visit 2 
o 
Ask subjects 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 (-1 day) after Visit 2 
o 
Ask subjects 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 5 (-1 day) after Visit 2  
o 
Ask subjects if they require assistance, e.g., additional training 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
 
Visit 6 (Phone): Day 7 (-1, +2 days) after Visit 2  
o 
Ask subjects if they require assistance, e.g., additional training 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
 
Visit 7 (Phone): Day 14 (±2 days) after Visit 2  
o 
Ask subjects if they required assistance, e.g., additional training 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
 
 
Visit 8 (Office/Virtual Office): Day 21 (±3 days) after Visit 2 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
 
 
Study Period:  
 
Visit 9 (Office): Start Study Period, Day 7 (+7) after Visit 8 

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o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
o 
Start subjects on SmartGuard 
o 
Start auto basal target at 120 mg/dL  
 
Visit 10 (Phone): Day 2 (-1 day) after Visit 9 
o 
Adjust pump settings as needed 
o 
Ask subjects if they require assistance, e.g., additional training 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
 
 
Visit 11 (Phone): Day 4 (-1 day) after Visit 9  
o 
Adjust pump settings as needed 
o 
Ask subjects if they require assistance, e.g., additional training 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
 
Visit 12 (Phone): Day 7 (±2 days) after Visit 9  
o 
Adjust pump settings as needed 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
 
 
Visit 13 (Phone): Day 14 (±3 days) after Visit 9  
o 
Adjust pump settings as needed 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
 
 
Visit 14 (Phone): Day 21 (±3 days) after Visit 9  
o 
Adjust pump settings as needed 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
o 
Change auto basal target at 100 mg/dL setpoint  
 
Visit 15 (Office/Virtual Office): Day 30 (±3 days) after Visit 9 
o 
Adjust pump settings as needed 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
 
 
Visit 16 (Office/Virtual Office): Day 44 (±3 days) after Visit 9  
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 
 

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 
Visit 17 (Office/Virtual Office): Day 60 (±7 days) after Visit 9 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
 
 
Visit 18 (Office): Day 90 (±7 days) after Visit 9  
o 
Collect HbA1C 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
o 
Return study devices  
o 
End of Study (EOS)  
 

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Table 3. Phase 2 Study Visit Details 
 
 
Run-In Period 
Study Period 
 
Visit 1 
(Office) 
Visit 2 
(Office) 
Visit  
3, 4 & 5 
(Phone) 
Visit 6 
(Phone) 
Visit 7 
(Phone) 
Visit 8 
(Office/Virtual 
Office) 
Visit 9 
(Office) 
Visit  
10 & 11  
(Phone) 
Visit  
12, 13 & 14 
(Phone) 
Visit  
15 & 16 
(Office/ 
Virtual 
Office) 
Visit 17 
(Office/Virtual 
Office) 
Visit 18* 
(Office) 
Visit Window 
Enrollment 
 
Day 1, 3 (-1 
day), and 5 
(-1 day) 
after Visit 2  
Day 7 (-1 
day, +2 
days) after 
Visit 2  
Day 14 
(±2 days) 
after Visit 
2  
Day 21 (±3 
days) after 
Visit 2  
Day 7  
(+7 days) 
after Visit 
8 
Day 2  (-1 
day) and 4  
(-1 day) 
after Visit 9 
Day 7 (±2 
days), 14 (±3 
days), and 21 
(±3 days) after 
Visit 9 
Day 30 (±3 
days) and 44  
(±3 days) 
after Visit 9 
Day 60 (±7 
days) after 
Visit 9 
Day 90 
(±7 days) 
after Visit 
9 
End of 
Study 
Collect consent forms, e.g., ICF, 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. All collected blood specimens will 
be sent to and tested by a NGSP certified Central Laboratory. 
Testing must follow NGSP standards. 
Note: If the visit must be conducted via Virtual Office, the blood 
tests may be collected via mobile phlebotomy service. 
X 
 
 
 
 
 
 
 
 
 
 
X 
Collect specimens for required local lab testing: Hematocrit, 
Creatinine, TSH, GAD, c-peptide (Note: c-peptide is not part of 
inclusion/exclusion criteria) – 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 
(including the type of insulin being used). The only insulins 
permitted for use in the study are Humalog, Novolog/NovoRapid, 
and Admelog. 
 
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) 

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Run-In Period 
Study Period 
 
Visit 1 
(Office) 
Visit 2 
(Office) 
Visit  
3, 4 & 5 
(Phone) 
Visit 6 
(Phone) 
Visit 7 
(Phone) 
Visit 8 
(Office/Virtual 
Office) 
Visit 9 
(Office) 
Visit  
10 & 11  
(Phone) 
Visit  
12, 13 & 14 
(Phone) 
Visit  
15 & 16 
(Office/ 
Virtual 
Office) 
Visit 17 
(Office/Virtual 
Office) 
Visit 18* 
(Office) 
Visit Window 
Enrollment 
 
Day 1, 3 (-1 
day), and 5 
(-1 day) 
after Visit 2  
Day 7 (-1 
day, +2 
days) after 
Visit 2  
Day 14 
(±2 days) 
after Visit 
2  
Day 21 (±3 
days) after 
Visit 2  
Day 7  
(+7 days) 
after Visit 
8 
Day 2  (-1 
day) and 4  
(-1 day) 
after Visit 9 
Day 7 (±2 
days), 14 (±3 
days), and 21 
(±3 days) after 
Visit 9 
Day 30 (±3 
days) and 44  
(±3 days) 
after Visit 9 
Day 60 (±7 
days) after 
Visit 9 
Day 90 
(±7 days) 
after Visit 
9 
End of 
Study 
Confirm subject eligibility results, including labs, prior to moving 
forward with any study procedures 
 
X 
 
 
 
 
 
 
 
 
 
 
Assist with Questionnaires – Refer to CIP341 Questionnaire Guide 
for administration details. 
 
X 
 
 
 
 
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 
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 
Train subjects on the use of the Accu-Chek Guide Link study 
meter and ketone meter, refer to user guides 
 
X 
 
 
 
 
 
 
 
 
 
 
Train subjects on the use of the 780G BLE 2.0 insulin pump with 
DS5 
 
X 
 
 
 
 
 
 
 
 
 
 
Start study subjects on the 780G BLE 2.0 insulin pump system 
(Manual Mode)  
 
X 
 
 
 
 
 
 
 
 
 
 
Provide study subjects the Medtronic infusion sets, reservoirs, 
sensors and transmitter 
 
X 
 
 
 
As needed 
As needed 
 
 
As needed 
As needed 
As needed 
Train subjects on the Medtronic infusion sets, reservoirs, sensors 
and transmitter 
 
X 
 
 
 
 
 
 
 
 
 
 
Start study subjects on CGM (transmitter and sensor) and 
accessories 
 
X 
 
 
 
 
 
 
 
 
 
 
Instruct subjects 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 
If applicable 
Train study subjects on the 780G BLE 2.0 SmartGuard features.  
 
 
 
 
 
 
X 
 
 
 
 
 
Instruct subjects on the SmartGuard feature of the pump as well 
as specific considerations regarding SmartGuard: 
 
Ensure that the Auto Correction feature is turned ON and 
remains ON throughout the course of the study. 
 
Instruct subjects to switch from pump therapy to manual 
injections until issue is resolved if: 
 
 
 
 
 
 
X  
 
 
 
 
 

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Run-In Period 
Study Period 
 
Visit 1 
(Office) 
Visit 2 
(Office) 
Visit  
3, 4 & 5 
(Phone) 
Visit 6 
(Phone) 
Visit 7 
(Phone) 
Visit 8 
(Office/Virtual 
Office) 
Visit 9 
(Office) 
Visit  
10 & 11  
(Phone) 
Visit  
12, 13 & 14 
(Phone) 
Visit  
15 & 16 
(Office/ 
Virtual 
Office) 
Visit 17 
(Office/Virtual 
Office) 
Visit 18* 
(Office) 
Visit Window 
Enrollment 
 
Day 1, 3 (-1 
day), and 5 
(-1 day) 
after Visit 2  
Day 7 (-1 
day, +2 
days) after 
Visit 2  
Day 14 
(±2 days) 
after Visit 
2  
Day 21 (±3 
days) after 
Visit 2  
Day 7  
(+7 days) 
after Visit 
8 
Day 2  (-1 
day) and 4  
(-1 day) 
after Visit 9 
Day 7 (±2 
days), 14 (±3 
days), and 21 
(±3 days) after 
Visit 9 
Day 30 (±3 
days) and 44  
(±3 days) 
after Visit 9 
Day 60 (±7 
days) after 
Visit 9 
Day 90 
(±7 days) 
after Visit 
9 
End of 
Study 
 
Hospital admission is needed for any reason 
 
Glucose is persistently elevated (i.e., above 300 mg/dL) 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 
 
X 
As needed 
As needed 
As needed 
As needed 
X 
As needed 
As needed 
As needed 
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 
 
 
 
 
 
 
 
 
 
 
Train subjects on the use of CareLink Personal–provide relevant 
set of written instructions 
 
X 
 
 
 
 
 
 
 
 
 
 
Set up 780G BLE 2.0 system apps, if applicable: 
 
MiniMed Clinical/MiniMed Mobile app 
 
CareLink Clinical app 
 
X  
 
 
 
 
 
 
 
 
 
 
 
If applicable: 
Train subjects and companions/care partners on the use of the 
780G BLE 2.0 system apps: MiniMed Clinical/MiniMed Mobile app 
and CareLink Clinical app 
 
X  
(if applicable) 
 
X 
(if applicable) 
 
X  
(if needed) 
 
 
 
 
 
 
If applicable: 
For subjects who are currently using SGLT inhibitors, the 
investigational center will provide training as well as a wallet card-
formatted STICH protocol. 
 
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) 
Start Auto Basal Target = 120 mg/dL with Active Insulin Time = 4 
hours-titrated towards 2-3 hours at investigator’s discretion at 
Visit 9 
 
 
 
 
 
 
X 
 
 
 
 
 

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Run-In Period 
Study Period 
 
Visit 1 
(Office) 
Visit 2 
(Office) 
Visit  
3, 4 & 5 
(Phone) 
Visit 6 
(Phone) 
Visit 7 
(Phone) 
Visit 8 
(Office/Virtual 
Office) 
Visit 9 
(Office) 
Visit  
10 & 11  
(Phone) 
Visit  
12, 13 & 14 
(Phone) 
Visit  
15 & 16 
(Office/ 
Virtual 
Office) 
Visit 17 
(Office/Virtual 
Office) 
Visit 18* 
(Office) 
Visit Window 
Enrollment 
 
Day 1, 3 (-1 
day), and 5 
(-1 day) 
after Visit 2  
Day 7 (-1 
day, +2 
days) after 
Visit 2  
Day 14 
(±2 days) 
after Visit 
2  
Day 21 (±3 
days) after 
Visit 2  
Day 7  
(+7 days) 
after Visit 
8 
Day 2  (-1 
day) and 4  
(-1 day) 
after Visit 9 
Day 7 (±2 
days), 14 (±3 
days), and 21 
(±3 days) after 
Visit 9 
Day 30 (±3 
days) and 44  
(±3 days) 
after Visit 9 
Day 60 (±7 
days) after 
Visit 9 
Day 90 
(±7 days) 
after Visit 
9 
End of 
Study 
Start Auto Basal Target = 100 mg/dL with Active Insulin Time = 
2-3 hours or at investigator’s discretion at Visit 14 
 
 
 
 
 
 
 
 
X 
(Visit 14) 
 
 
 
Dispense study materials (e.g., smartphone [upon request and 
approval], reference guides, subject training materials, etc.) 
 
X 
 
 
 
 
X 
X 
X 
 
 
 
Dispense other study supplies as needed (e.g., alcohol swabs, 
adhesive remover, etc.) 
 
X 
 
 
 
As needed 
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 
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 
Review CareLink system reports 
 
 
X 
 
 
X 
X 
X 
 
X 
X 
If applicable 
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 
 
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 
If applicable 
Collect study devices at study end (see device disposition Table 2 
for details). 
Note: If the visit must be conducted via Virtual Office, the blood 
tests may be collected via mobile phlebotomy service. Subjects 
should send devices back to the investigational center.  
 
 
 
 
 
 
 
 
 
 
 
X 
Ask if subjects 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 

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Run-In Period 
Study Period 
 
Visit 1 
(Office) 
Visit 2 
(Office) 
Visit  
3, 4 & 5 
(Phone) 
Visit 6 
(Phone) 
Visit 7 
(Phone) 
Visit 8 
(Office/Virtual 
Office) 
Visit 9 
(Office) 
Visit  
10 & 11  
(Phone) 
Visit  
12, 13 & 14 
(Phone) 
Visit  
15 & 16 
(Office/ 
Virtual 
Office) 
Visit 17 
(Office/Virtual 
Office) 
Visit 18* 
(Office) 
Visit Window 
Enrollment 
 
Day 1, 3 (-1 
day), and 5 
(-1 day) 
after Visit 2  
Day 7 (-1 
day, +2 
days) after 
Visit 2  
Day 14 
(±2 days) 
after Visit 
2  
Day 21 (±3 
days) after 
Visit 2  
Day 7  
(+7 days) 
after Visit 
8 
Day 2  (-1 
day) and 4  
(-1 day) 
after Visit 9 
Day 7 (±2 
days), 14 (±3 
days), and 21 
(±3 days) after 
Visit 9 
Day 30 (±3 
days) and 44  
(±3 days) 
after Visit 9 
Day 60 (±7 
days) after 
Visit 9 
Day 90 
(±7 days) 
after Visit 
9 
End of 
Study 
Ask subjects about device performance issues and if they called 
the Medtronic 24 -Hour Technical Support (TS) line to report 
them. 
Instruct/Remind subjects to contact the Medtronic 24-Hour TS in 
the event they experience problems with their study devices. 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Ask subjects if they require assistance, e.g., additional training 
 
 
X 
X 
X 
X 
 
X 
 
 
 
 
Ask subjects about the use of SGLT inhibitors during the 
Continued Access Period 
 
 
 
 
 
 
 
 
 
 
 
 
Remind subjects that the use and wear of study devices 
throughout the study is a requirement 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
If applicable 
Instruct/Remind subjects regarding the content of the Home 
Reference Guide 
 
X 
 
 
 
 
 
 
 
 
 
 
Instruct subjects on carbohydrate (CHO) counting as needed 
(Investigator discretion) 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
If applicable 
Instruct subjects on diabetes self-management principles 
including response to glycemic events, e.g., use of oral 
glucose/glucagon in case of severe hypoglycemia or checking for 
ketones in case of severe hyperglycemia 
Note: Companions/care partners should be trained on how to 
respond to high or low glucose events. 
 
X 
 
 
 
 
 
 
 
 
 
 
Instruct subjects and companions/care partners that blood ketone 
testing is required every time BG is greater than 300 mg/dL, as 
measured by the Accu-Chek Guide Link study meter. 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
If applicable 
Instruct subjects 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 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
If applicable 

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Run-In Period 
Study Period 
 
Visit 1 
(Office) 
Visit 2 
(Office) 
Visit  
3, 4 & 5 
(Phone) 
Visit 6 
(Phone) 
Visit 7 
(Phone) 
Visit 8 
(Office/Virtual 
Office) 
Visit 9 
(Office) 
Visit  
10 & 11  
(Phone) 
Visit  
12, 13 & 14 
(Phone) 
Visit  
15 & 16 
(Office/ 
Virtual 
Office) 
Visit 17 
(Office/Virtual 
Office) 
Visit 18* 
(Office) 
Visit Window 
Enrollment 
 
Day 1, 3 (-1 
day), and 5 
(-1 day) 
after Visit 2  
Day 7 (-1 
day, +2 
days) after 
Visit 2  
Day 14 
(±2 days) 
after Visit 
2  
Day 21 (±3 
days) after 
Visit 2  
Day 7  
(+7 days) 
after Visit 
8 
Day 2  (-1 
day) and 4  
(-1 day) 
after Visit 9 
Day 7 (±2 
days), 14 (±3 
days), and 21 
(±3 days) after 
Visit 9 
Day 30 (±3 
days) and 44  
(±3 days) 
after Visit 9 
Day 60 (±7 
days) after 
Visit 9 
Day 90 
(±7 days) 
after Visit 
9 
End of 
Study 
 
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 target feature can be used 
repeatedly and in succession 
Remind subject to bring in both Accu-Chek Guide Link study 
meter and ketone meter at each required office visit.  
 
X 
 
 
X 
X 
 
 
X 
X 
X 
If applicable 
Remind subject to keep their devices charged, as applicable 
 
X 
X 
 
 
X 
X 
X 
 
X 
X 
If applicable 
Instruct subjects 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 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  
 
X 
X 
 
 
X 
X 
X 
 
X 
X 
If applicable 
Instruct subjects 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 that they should not assume that SmartGuard is 
able to prevent all hypoglycemia or all hyperglycemia including 
diabetic ketoacidosis and HHS 
 
X 
 
 
 
 
X 
 
 
X 
X 
If applicable 

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Run-In Period 
Study Period 
 
Visit 1 
(Office) 
Visit 2 
(Office) 
Visit  
3, 4 & 5 
(Phone) 
Visit 6 
(Phone) 
Visit 7 
(Phone) 
Visit 8 
(Office/Virtual 
Office) 
Visit 9 
(Office) 
Visit  
10 & 11  
(Phone) 
Visit  
12, 13 & 14 
(Phone) 
Visit  
15 & 16 
(Office/ 
Virtual 
Office) 
Visit 17 
(Office/Virtual 
Office) 
Visit 18* 
(Office) 
Visit Window 
Enrollment 
 
Day 1, 3 (-1 
day), and 5 
(-1 day) 
after Visit 2  
Day 7 (-1 
day, +2 
days) after 
Visit 2  
Day 14 
(±2 days) 
after Visit 
2  
Day 21 (±3 
days) after 
Visit 2  
Day 7  
(+7 days) 
after Visit 
8 
Day 2  (-1 
day) and 4  
(-1 day) 
after Visit 9 
Day 7 (±2 
days), 14 (±3 
days), and 21 
(±3 days) after 
Visit 9 
Day 30 (±3 
days) and 44  
(±3 days) 
after Visit 9 
Day 60 (±7 
days) after 
Visit 9 
Day 90 
(±7 days) 
after Visit 
9 
End of 
Study 
Instruct study subjects that regular weekly uploads of the study 
pump is required. With Bluetooth connection and the MiniMed 
Clinical/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. 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
If applicable 
Instruct subjects to give meal bolus of insulin 15-20 minutes 
before meals during the run-in period and study period  
 
X 
X 
X 
X 
X 
 
 
 
 
 
 
*Note: When subjects exit the study early during the study period, all requirements that are listed for Visit 18 apply. 
**Note: Office visits should be completed unless there are circumstances that may put patients at risk or where in person visits may not be allowed. 

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9.2 Data Collection 
All data collection and study procedure requirements are described at the subject visits in Section 
9.1.  
9.3 Subject Consent 
Informed Consent will be obtained in accordance with the Code of Federal Regulations (CFR) Title 21, 
Part 50. Prior to entry into the study, the California Experimental Subject’s Bill of Rights (if 
applicable), the Institutional Review Board (IRB) and Medtronic approved ICF form and an 
Authorization Form required by the Health Insurance Portability and Accountability Act (HIPAA) will 
be presented to each subject to review and sign as applicable. The subject will be given ample time 
and offered the opportunity to review these documents away from the investigational center.  
 
The following will be provided to or explained to the subject 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 questions during the informed consent process. The 
language used shall be as non-technical as possible and must be understandable to the subject. 
 
Neither the investigator, nor the investigation center staff shall coerce or unduly influence a subject 
to participate or to continue to participate in the clinical study. The informed consent process shall 
not waive or appear to waive the subject’s rights.  
 
Subjects will complete California Experimental Subject’s Bill of Rights (if applicable), the HIPAA Form, 
and the ICF. The consenting process must be documented in the subject’s source documents. The 
subject 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 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 a in a timely manner.  
 
Medtronic will revise the written ICF 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 IRB. After approval by the IRB, a copy of this information 
must be provided to the participating subjects, and the informed consent process as described above 
needs to be repeated. 
 
If the ICF is amended during the course of the study, the IRB will determine: 
 
Whether or not active subjects should be re-consented at their next visit and  

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 
Whether or not subjects who have completed the study at the time of the amendment should 
be re-consented.  
 
Subjects will be informed that qualified personnel from the investigational center, the sponsor 
(Medtronic), regulatory authorities such as the FDA and/or the 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 violations to their IRB and 
sponsor: 
 
Failure to obtain informed consent from subject. 
 
Failure to obtain informed consent prior to performing one or more study procedures. 
 
Failure to maintain ICFs forms on file for all subjects who have provided informed consent. 
 
Use of an ICF form that has not received approval from the IRB. 
 
Use of an incorrect version of the ICF form. 
9.4 Safety Monitoring/Risk Analysis 
9.4.1 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.   
9.4.2 Hypoglycemic/Hyperglycemic Risk 
Intervention and treatment for hypoglycemia and hyperglycemia is addressed in Section 10. 
9.4.3 Calibration of CGM Risk 
When an erroneous blood glucose value is entered, which then calibrates the CGM, it can result in an 
inaccurate SG value. Subjects will be trained accordingly. 
9.4.4 Reuse Risk 
All study devices will be single patient use.  
9.4.5 Sterilization Risk 
The following devices will be supplied sterilized: 
 
Infusion sets 
 
Insulin reservoirs 
 
Sensors 
9.4.6 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. 

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9.4.7 Risk of Blood Sample Collection, Contamination from Sampling Techniques 
Detailed mitigations to blood sampling risk are provided in Section 10. 
9.4.8 HbA1c Risk 
A Central laboratory will be used for HbA1c testing. 
9.4.9 Risks Associated with Rapid Weight Loss 
Subjects who undergo a weight loss regimen that includes GLP-1 and other drugs may be subject to 
glycemic variability. Investigators should use their discretion to make sure that any such regimen is 
stable and does not cause additional risk to study subjects. 
9.4.10 Transition of Subjects on MDI Therapy To/From Pump Therapy 
To assist subjects who enter the study on MDI therapy, investigators and their staff will be instructed 
on best practices regarding the safe transition from MDI therapy to pump use at the start of the 
study and a safe transition back to MDI therapy at the end of the study. 
For subjects transitioning from MDI to Pump: 
 
Consider reducing MDI total daily dose by 25% to calculate pump total daily dose before 
calculating pump settings 
 
Consider instructing subjects not to administer their long-acting insulin dose the night 
before/morning of the scheduled pump start. 
o 
If pump therapy is initiated within 24-36 hours of the last long-acting insulin injection 
(depending on the duration of action of the brand administered), consider setting a 
temporary basal rate of 0% to run until that time has passed 
For subjects transitioning back to MDI therapy after study participation ends: 
 
Consider recalculating injection doses based on pump settings, or returning to that subject’s 
previous MDI dose schedule and adjust as needed 
9.4.11 Risk Associated with Non-Insulin Anti-Diabetic Medications 
If, during the study period with AHCL therapy, the time below 70 mg/dL exceeds 4% for individual 
study subjects, investigator should use their clinical discretion and also consider changing pump 
settings. In addition to changing pump settings, investigators might also consider dose reductions or 
stopping the use of one or both of these two classes of medications (sulfonylureas &/or meglitinides) 
for individual subjects. 
9.4.12 Risk Associated with SGLT Therapy 
For subjects who are currently using SGLT inhibitors, the investigational center will provide training 
as well as a wallet card-formatted STICH protocol. The STICH protocol warns patients who are taking 
SGLT inhibitors about the risks associated with this therapy relative to the occurrence of ketosis and 
DKA. 
9.5 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. 

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9.5.1 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.   
9.5.2 Blood Ketone Values 
Blood ketones will be measured by all subjects using a ketone meter when:  
 
the subject is symptomatic for high blood glucose or 
 
the sensor glucose is >300 mg/dL, the BG should be checked by fingerstick, if BG is >300 
mg/dL, 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.  
9.5.3 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.  
9.5.4 HbA1c 
HbA1c is collected at baseline and the end of subjects’ participation; if subjects have completed Visit 
9 and exit early, labs will be collected. In the continued access period, HbA1c were collected every 90 
days.  
9.6 Recording Data 
Data, except questionnaires, 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/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 

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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. 
9.7 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/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 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. 
If there is a documented safety reason that would not permit the use of CIP defined Auto Basal 
target setting and Active Insulin Time settings, then use of the alternative settings will not be 
considered a deviation. 
9.7.1 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 5 for reporting 
timelines for emergency deviations.   
CIP deviations should be reported as follows: 
a) To the IRB for notification/acknowledgement; 
b) To the sponsor and, if required; 
c) To the applicable regulatory authority (reported by sponsor). 

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9.7.2 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 (21 CFR 812.140 Records).   
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, i.e., there is no documentation of consenting 
 
Informed consent 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 IRB 
 
Failure to inform IRB and sponsor of reportable AEs (see Section 11) 
 
Investigational study device dispensed without obtaining informed consent 
 
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 the IRB as 
well as Medtronic within five (5) working days. 
 
Reporting of all other study deviations should comply with: 
 
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 5, for specific deviation reporting requirements and 
timeframes for reporting to Medtronic, IRB, and regulatory authority (if applicable). 
9.7.3 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.  
 
9.8 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 

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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. 
 
During the course of the study, subject uses insulin that is not allowed to be used in the 
study. The only permitted insulins are Humalog, Novolog/NovoRapid and Admelog. 
 
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 
repeatedly 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 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 run-in period, 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. (Note: 
Intra-articular injections to treat pain (e.g., joint pain, bursitis, etc.) are permitted.) 
o 
Exception: During the continued access period in Phase 1 of the study, subjects will be 
allowed to receive orally administered steroid treatments for a maximum of 2 weeks. 
Intra-articular injections to treat pain (e.g., joint pain, bursitis, etc.) continue to be 
permitted. Duration of use as well as type of steroid used must be documented on the 
Concomitant Medications CRF. 
 
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 MiniMed 780G system SmartGuard feature.  
 
During the study, the subject experiences one episode of DKA or HHS, if it is related to the 
use of MiniMed 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. 

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9.8.1 End of Subject Participation in Study/Completion of Study  
After the study has been completed (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. 
9.8.2 Lost to Follow-Up 
If a subject does not return to the investigational center for required follow-up visit(s) and cannot be 
reached, the investigational center staff 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 investigational center, subject will be considered “lost to 
follow up” and this needs to be documented in the Study Exit eCRF. All efforts will be made by 
investigation center staff to collect all study devices and supplies back from subject, if applicable. 
9.9 Study Stopping Rules 
The study may be stopped if the Data Monitoring Committee (DMC) determines that there are 
significant safety issues, including the occurrence of certain types of individual adverse events (i.e. 
UADE, device related DKA, device related HHS and device related Severe Hypoglycemia) that have 
undergone expedited adjudication by the Clinical Events Committee (CEC). See CEC Section 12.1 
and DMC Section 12.2 for more details regarding the expedited review responsibilities of both 
committees. 
10. Risks and Benefits 
10.1 Potential Risks 
The potential residual risks and mitigations associated with the devices used during this study are 
listed in Table 4. 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. 
 
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. 

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Table 4. Risks, Prevention and Mitigation 
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 or HHS 
 
Hyperglycemia secondary to site falling off 
including DKA or HHS 
 
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 set 
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 
administration of too much or too little insulin which 
can lead to the following clinical consequences: 
 
 
Hypoglycemia 
 
Hyperglycemia 
 
Diabetic ketoacidosis or HHS 
 
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 
 
Insulin deterioration leading to 
hyperglycemia 
 
Incomplete priming; fails to prime tubing 
and/or cannula, leading to hyperglycemia 
Prevention and mitigation include: 
 
 
Follow the provided user guides & instructions 
for insulin and 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.  
 
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.  
 

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 
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 or HHS 
 
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.  
 
Alternative method of managing glucose levels 
will be available (insulin and syringe for 
example). 
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 to have glucose and glucagon on hand 
for hypoglycemia. 
Risk with Sensors  
Prevention and Mitigation 

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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 
 
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 
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 sensor 
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.  
 
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 
Prevention and mitigation include: 
 
 
Follow the provided user guides.  
 
Train on the proper use of the transmitters.  

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 
Allergic reaction 
 
Soreness or tenderness 
 
Residual redness associated with adhesive 
and/ or tapes 
 
Scarring 
 
Scab 
 
Blister 
 
Itchiness 
 
Inflammation 
Risks with Serter 
Prevention and Mitigation 
Risks with serters may include: 
 
 
Improper insertion may lead to device 
performance issue  
Prevention and mitigation include: 
 
 
Follow the provided user guides for insertions 
and care of device. 
 
Train on the proper use of the serter and skin 
preparation prior to insertion. 
Risks with Fingersticks and Blood Draws 
Prevention and Mitigation 
Risks with frequent fingerstick testing and blood 
draws 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 
 
Potential risks associated with drawing 
blood include discomfort, bruising and 
hematoma 
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. 
 
Blood draws will be performed by a trained 
healthcare professional 
 
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. 

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 
Hypoglycemia 
 
Severe hypoglycemia 
 
Hyperglycemia 
 
Diabetic ketoacidosis or HHS 
 
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 
 
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.  
 
 
Risks with hyperglycemia may include  
 
 
Diabetic ketoacidosis or HHS 
 
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.  

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 
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  
 
Allergic reactions including those which are 
serious and potentially fatal can occur 
 
Kidney disease 
 
Lowered blood counts (red cells, and white 
cells)  
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. 
 
 
10.2 Risk Minimization 
Refer to “Prevention and Mitigation” column in the table under Section 10.1. 

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10.3 Potential Benefits 
The main benefit of this study is that subjects may experience improved glucose control. They may 
gain increased awareness of emerging technologies for diabetes management as a result of their 
participation.  
10.4 Risk-Benefit Rationale 
The main benefit of this study is that subjects may experience improved glucose control. With all 
closed loop insulin pumps, there is a risk that the pump will deliver too much or not enough insulin, 
resulting in hypoglycemia or hyperglycemia. These risks have been minimized through previous 
characterization of the performance of the 780G system and a variety of safety checks that are an 
integral part of the 780G closed loop algorithm. 
10.5 Risk Determination 
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 
11.1 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. 
11.2 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.[5] 

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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. [5] 
 
Severe Hyperglycemia is defined as hyperglycemia (BG greater than [>] 300 mg/dL) 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, arterial pH less 
than (<) 7.3, bicarbonate less than (<) 15 mEq/L, moderate ketonuria or ketonemia and requiring 
treatment within a health care facility.[6]  
 
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  
 
Serum ketones or large/moderate urine ketones 
 
Symptoms such as polyuria, polydipsia, nausea, or vomiting 
 
Treatment provided in a health care facility 
 
Hyperosmolar Hyperglycemic State/HHS diagnostic criteria:  BG greater than (>) 600 mg/dl, 
arterial pH greater than (>) 7.3, bicarbonate greater than (>) 15 mEq/l, minimal ketonuria and 
ketonemia and requiring treatment within a health care facility.[6] 
 
Hyperglycemic events will be recorded as HHS if the event includes the presence of all of the 
following: 
 
Arterial blood pH greater than (>) 7.3 or serum bicarbonate greater than (>) 15 
mEq/L 
 
Blood glucose greater than (>) 600 mg/dL 
 
Negative/mild ketones 
 
Treatment provided in a health care facility 
 
 
Adverse Event (AE) (ISO 14155:2020) 

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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. 
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. 
 
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, 

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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. 
 
11.3 Reporting of Adverse Events 
The investigator or designee will record ALL AEs while the subject is enrolled in the clinical study.  
Each AE needs to be assessed for its device or procedure relatedness. A device related AE is 
associated with the use of the study devices (e.g., infection of sensor site or infusion set occlusion 
resulting in DKA). 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, HHS, 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. 
 
11.4 Notification of Adverse Events 
Sponsor Notification: 

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The investigational center staff must report all AEs to Medtronic in a timely manner. All severe 
hypoglycemia, DKA, HHS, SAE, SADE, and UADE 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. 
 
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 upon request 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. 
11.5 Expedited Safety Reporting Requirements 
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)). See Section 12.20 for expedited reporting requirements 
for UADE.   
 
The sponsor will notify the investigator and IRB of any event that results in a safety report per 
regulations to the FDA. Documentation of 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 IRB reporting requirements. 
 
11.6 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: 

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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; 
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); 

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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. 
 
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 
 
11.7 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 or user guide. 
 
Unanticipated: the event has not been previously identified in the CIP; labeling; report of 
priors or user guide. 
12. Data Review Committees 
12.1 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 
 
Severe hypoglycemia 
 
Diabetic ketoacidosis 
 
Diabetic hyperglycemic hyperosmolar syndrome 
 
Severe hyperglycemia 
 
CEC is to review and adjudicate unanticipated adverse device effects (UADE), device related DKA, 
device related HHS, and device related severe hypoglycemia within 10 business days from the time 
that the sponsor is notified. Adjudication will occur once all applicable documentation has been 

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received and reviewed by the CEC. 
 
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 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:  
 
1. Was the severe hypoglycemia, HHS 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 HHS or 
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, 
HHS 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.  
 
 

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3. Severe hypoglycemia, severe hyperglycemia, HHS 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, HHS 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. 
 
12.2 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 HHS 
 
Event rate of device related AEs  
 
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:  
 
UADE 

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 
Device related DKA 
 
Device related HHS 
 
Device related Severe Hypoglycemia 
 
1. Investigational center staff will notify the sponsor within approximately 24 hours of investigator 
or study coordinator awareness of events described above. 
2. Sponsor will notify the FDA within approximately 3 business days of awareness of the event and 
provide updates to the agency as information becomes available. 
3. DMC is to meet within 10 business days from CEC adjudication of the event. The investigator 
should be available to answer questions from DMC, as needed. 
4. Based on their review, DMC will recommend that the sponsor make a decision regarding the 
following: 
a) Whether or not subject enrollment may continue 
b) Whether or not new subject enrollment should be suspended, with enrolled subjects 
continuing in the study. 
c) Whether or not the entire study should be stopped, including those subjects who have 
already received study devices. 
 
5. DMC and/or IRB will recommend whether or not the study should be stopped based on the 
number of events that have occurred during the study, weighed against the potential benefits of 
continuing the study. 
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 provide a recommendation to proceed with the following staged enrollment: 
 
After 10 subjects with a TDD at or below 125 units have completed 6 weeks of the study period, the DMC 
will assess if it is safe to proceed with subjects using SmartGuard who have a TDD of greater than 125 
units.  
 
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. 

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13. Device Deficiencies and Troubleshooting 
The Medtronic 24-Hour Technical Support (TS) will be consulted for device troubleshooting (e.g., 
assistance is needed by subject to operate their device[s]). When subjects call the TS, they are 
instructed to notify the TS operator that they are currently participating in a clinical research study. 
All device deficiencies that are reported to the TS will be documented by the TS staff. 
 
The investigational center will be provided with a copy of all TS calls for their subjects. The TS call 
reports should be reviewed for investigational center staff awareness and assessment for the 
possibility of an AE. If an AE is detected the investigational center staff will complete the appropriate 
eCRF(s). 
 
All device deficiencies reported directly to the investigational center staff by a subject should either 
be reported to the TS by the subject or investigational center staff. Any device deficiency the 
investigational center may have should be reported to the TS.  
 
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.  
 
To return a study device as part of a device deficiency, the investigational center staff and/ or 
subject are required to call the 24-Hour TS. Following the call to TS, the investigational center staff 
should then follow the study procedures for returning products with device deficiencies. 
 
It is the responsibility of the investigator to follow their IRB reporting requirements. 
14. Statistical Design and Methods 
14.1 General Aspects of Analysis 
For each phase, 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. For 
each phase, data and analyses 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. 
14.2 Subject Disposition 
For each phase, 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 by period. 

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14.3 Subject Demographics and Baseline Characteristics 
For each phase, 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. 
14.4 Endpoints and Hypotheses 
The following endpoints will be evaluated for each of the phases, separately.  
 
Phase 1: MiniMed™ 780G insulin pump with Guardian 4 Sensor 
Phase 2: MiniMed™ 780G BLE 2.0 insulin pump with DS5 
 
14.4.1 Study Period 
14.4.1.1 Primary Safety Endpoint  
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% with a margin of 0.4%. A 
significance level of 0.025 (one-sided) will be used. 
The hypothesis of non-inferiority is mathematically expressed as: 
H0: ∆µ780G ≥ 0% + 0.4%  
Ha: ∆µ780G < 0% + 0.4%  
Note: Phase 1 subjects transitioned into Phase 2 will not be included in this analysis for Phase 2. 
14.4.1.2  Primary Effectiveness Endpoint  
The mean % of time in range (TIR 70-180 mg/dL), µ780G, will be estimated and compared by a non-
inferiority test to the threshold of 70% with a margin of 7.5%. A significance level of 0.025 (one-
sided) will be used.  
 
The hypothesis of non-inferiority is mathematically expressed as: 
 
H0: µ780G ≤ 70% – 7.5%  
Ha: µ780G > 70% – 7.5% 
14.4.1.3  Secondary Effectiveness Endpoint 
The mean % of time in range (TIR 70-180 mg/dL), µ780G, will be estimated and compared by a 
simple superiority test with a significance level of 0.025 (one-sided).  
 
The hypothesis of superiority is mathematically expressed as: 
 
H0: µ780G ≤ 70%  

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14.6.1 Phase 1 
A study report will be generated once the subjects have completed the continued access period. 
Primary, secondary, and descriptive endpoints, subject feedback, and safety data for subjects will be 
summarized and presented in the report. 
14.6.2 Phase 2 
A study report will be generated once the subjects have completed the study period. Primary, 
secondary, and descriptive endpoints, subject feedback, and safety data for subjects will be 
summarized and presented in the report. 
15. Ethics 
15.1 Statement(s) of Compliance 
This clinical study will be conducted in compliance with the CIP, Clinical Investigation Agreement; US 
CFR Title 21 Part 11 (Electronic Records; Electronic Signatures), Part 50 (Informed consents), Part 
54 (Financial Disclosure by Clinical Investigators), Part 56 (IRBs), Part 812 (Investigational Device 
Exemptions), and all other applicable federal and local regulatory requirements. 
The study will also be conducted in compliance with the principles of good clinical practice (GCP) 
meaning that the study design, conduct, performance, monitoring, auditing, recording, analysis and 
reporting will assure that the data and results are credible and accurate and that the rights, safety 
and well-being of subjects are protected. GCP includes review and approval by an independent ethic 
committee (IEC)/ IRB before initiating the investigation, ongoing review of the investigation by an 
IEC/IRB and obtaining and documenting the freely given informed consent of the subject before 
their participation in the investigation. 
The ethical principles that have their origin in the Declaration of Helsinki (DoH) have been 
implemented in this clinical study by means of the informed consent process, IRB approval, study 
training, clinical trial registration, pre-clinical testing, risk-benefit assessment, publication policy, etc. 
15.2 IRB Approval 
This CIP, any subsequent amendments to this CIP, the ICF form, subject materials, and any form of 
subject recruitment information (e.g., advertisements) relating to this study will be approved by the 
responsible IRB in accordance with 21 CFR Part 56.  
The investigational center will not initiate any subject activities until IRB approval has been granted, 
the sponsor has cleared the investigational center to begin the study, and the investigational center 
staff has been appropriately trained to conduct the study.  
15.3 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.” Each investigational center shall designate a primary 

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investigator who will have overall responsibility for the conduct of the investigation at the 
investigational center. 
The principal investigators (and co-investigators if applicable) are responsible for conducting the 
study in accordance with this CIP, CTA, and 21 CFR Part 812 that apply to significant risk (SR) 
device studies. 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”, 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 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 
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 (21 CFR 812.100) 
 
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 are met in accordance 
with 21 CFR 50 
 
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 
under 21 CFR Part 812 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.  

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 
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 (21 CFR 812.140), to include: 
o 
attribution, legibility, and timeliness of source data 
o 
all relevant correspondence with another investigator, an IRB, the sponsor, a 
monitor, or FDA, 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 
o 
any other records the FDA 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 and the reviewing 
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 and 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 
o 
any further information requested by the FDA and 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 (21 CFR 812.145) 
 
Meeting with the monitor to discuss study progress and findings 
 
Ensuring that investigational center resources are adequate to fulfill the obligations of 
the study 

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 
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 
16.1 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 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.  
16.2 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 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. 
16.2.1 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.  
16.2.2 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. 

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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, IRB review, and regulatory inspections. 
16.2.3 Investigational Center Disqualification 
Sponsor and/or the 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. 
 
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 IRB, investigational center(s) and other regulatory authorities, as required. 
 
16.3 Data Management 
16.3.1 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 subject’s enrollment.  
16.3.2 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 

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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. 
16.3.3 Subject Questionnaires 
In this study, we are collecting subject feedback regarding user experience and quality of life 
through questionnaires. Subjects will be provided a link to complete the questionnaires that will be 
kept online. Refer to CIP341 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. 
16.3.4 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. 
16.3.5 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.  
16.4 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.  
16.5 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 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 

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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.   
16.6 Liability and Subject Compensation 
Subjects will be paid for participation. Refer to the ICF on the details of the subject’s compensation. 
 
16.7 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 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 
IRB. Administrative amendments to the CIP will be submitted to the IRB for notification. 
16.8 Records and Reports 
16.8.1 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 
 
Report of prior investigations and/or user guide 
 
Medtronic and IRB-approved Subject ICF form 
 
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 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) 

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 
Study reports 
 
16.8.2 Investigator Reporting Responsibilities  
Table 5. Investigator Reporting Requirements 
Report 
Submit to 
Description/Constraints 
AEs and DDs 
Sponsor, IRB, and 
regulatory authority, 
where applicable 
Refer to Section 11 and 13 for reporting 
requirements. 
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 prior to 
investigational device use 
Sponsor and 
IRBs 
If an investigator uses a device without obtaining 
informed consent 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. 
 
16.9 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 

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of the study, whichever is longer. The investigator should not dispose of these records without the 
approval of the sponsor. 
16.10 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 authority of the 
termination or suspension and the reason(s) for this. The investigator shall then promptly inform the 
reviewing IRB and the study subjects.  
16.10.1  Early Investigational Center Suspension or Termination 
Sponsor, 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 IRB, non-compliance to the 
CIP, or lack of enrollment). Suspended clinical studies cannot be resumed without permission from 
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 reason(s) for this. The investigator shall then promptly inform the reviewing 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 IRB, if 
applicable. 
16.10.2 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. 
16.11 Study Close-Out 
At the time of a study close-out, the investigators will be notified by sponsor. Appropriate 
notification/report to IRB and regulatory authority will be provided if required per local laws and 
regulations. 
16.12 Publication and Use of Information 
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. 

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17. References 
1. 
Inzucchi, S.E. and R.S. Sherwin, The prevention of type 2 diabetes mellitus. Endocrinol Metab Clin 
North Am, 2005. 34(1): p. 199‐219, viii. 
2. 
Jack, L., Jr., L. Boseman, and F. Vinicor, Aging Americans and diabetes. A public health and 
clinical response. Geriatrics, 2004. 59(4): p. 14‐7. 
3. 
Centers for Disease, C. and Prevention, Prevalence of overweight and obesity among adults with 
diagnosed diabetes‐‐United States, 1988‐1994 and 1999‐2002. MMWR Morb Mortal Wkly Rep, 
2004. 53(45): p. 1066‐8. 
4. 
Reznik, Y., et al., Insulin pump treatment compared with multiple daily injections for treatment 
of type 2 diabetes (OpT2mise): a randomised open‐label controlled trial. Lancet, 2014. 
384(9950): p. 1265‐72. 
5. 
Cryer, P.E., Defining and reporting hypoglycemia in diabetes: A report from the American 
diabetes association workgroup on hypoglycemia. Diabetes Care, 2005. 28(5): p. 1245‐1249. 
6. 
Hyperglycemic Crises in Diabetes. Diabetes Care, 2004. 27(SUPPL. 1): p. S94‐S102. 
 
 

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18.4 
Appendix 4: Phase 1 – This phase has been completed 
Phase 1 has been completed and subjects are no longer being enrolled in or participating in this 
phase of the study. 
18.4.1 Study Design 
Phase 1 will study the MiniMed™ 780G insulin pump with Guardian 4 Sensor. The period from Visit 1 
(consent and screening) through Visit 8 should be completed within 45 days. 
 
Run-in Period (Visits 2-8):  
 
The run-in period begins at Visit 2 and ends once Visit 9 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, Humalog (insulin lispro injection), NovoLog/NovoRapid (insulin aspart 
solution for injection), or Admelog (insulin lispro injection). 
 
During the run-in period of the study, subjects will be using the study pump in Manual Mode, with 
only the Sensor Augmented Pump (SAP) function activated (i.e., SmartGuard feature turned OFF). 
The “Suspend before Low” and “Suspend on Low” features may be used. 
 
Therapy at Screening 
Pump Setting During Run-in 
Period 
Continuous Subcutaneous Insulin 
Infusion (CSII) 
Manual Mode 
SAP (no closed loop) 
Manual Mode 
SAP (with closed loop [i.e., AID]) in 
non-Medtronic pump 
Manual Mode 
SAP (with closed loop) in Medtronic 
pump as Auto Mode 
SmartGuard feature with Auto 
Correction OFF 
 
All subjects will be trained on diabetes management principles, such as the treatment of 
hyperglycemia and hypoglycemia. In addition, there will be training by investigational center staff 
regarding the need to have access to and how to use glucose and glucagon in case of hypoglycemia.   
 
Companions/care partners will be instructed that they should be with the subject in the same 
residence or building complex overnight. 
 
If the MiniMed Clinical app and the Carelink Clinical app are being used, companions/care partners 
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 
work, other activities. Instructions on the appropriate operation of the apps will be provided. 
 

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For study purposes, subjects will be instructed to perform self-monitoring of blood glucose (SMBG) if 
they are experiencing a severe hypoglycemic event, severe hyperglycemic event, hyperglycemic 
hyperosmolar syndrome (HHS), or diabetic ketoacidosis (DKA). 
 
Blood ketones will be measured by all subjects using a ketone meter when:  
 
the subject is symptomatic for high blood glucose or 
 
the sensor glucose value is >300mg/dL, the BG is checked by fingerstick and, if BG 
is >300mg/dL, blood ketones should be checked 
 
As a precaution, subjects 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 device 
issues (e.g., infusion set occlusion with high glucose).   
 
Subjects will be instructed to insert study sensors only in the locations that are specified in the User 
Guide. Subjects should be reminded about appropriate study sensor placement at each office visit. 
Information about predominant location of study sensor insertions will be collected on an electronic 
case report form (eCRF) at the end of a subject’s participation. 
 
Subjects will be trained on all parts of the device system. Companions/care partners should be 
trained on how to respond to high or low glucose events. This should involve training conducted by 
investigational center staff. A training checklist for each subject should be completed by 
investigational center-based trainers. Companions/care partners should be available for relevant 
parts or, if desired, all of this training, either in person or virtually.  
 
After completion of training on the study devices, subjects will be asked to attend additional visits in 
the days immediately following the start of system use, as needed. They may also take advantage of 
having continued access to the digital learning content, provided it is available at study start. 
 
Study Period (Visits 9-18): 
The study period begins at Visit 9 and ends at the conclusion of Visit 18. 
 
Subjects will continue using the study pump and study sensor and will use the SmartGuard feature 
for approximately 90 days during the study period. Subjects should use the system with the 
SmartGuard feature (with Auto Correction ON) turned on at all times. When prompted by the pump, 
subjects should take appropriate measures and follow directions on the pump to remain in, or return 
to, SmartGuard. During times when subjects are not able to use SmartGuard, they should use the 
system in Manual Mode (e.g., using Suspend before low and Suspend on low settings). 
 
Pump Settings: 
During the first 3 weeks (between Visits 9 and 14) of the study period, a 120 mg/dL 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 at the investigator’s discretion. 

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During the next 3 weeks (between Visits 14 and 16) of the study period, a 100 mg/dL Auto Basal 
Target should be set. Active Insulin time is recommended to be set to 2-3 hours or at investigator’s 
discretion. 
 
During the remaining weeks (any time after Visit 16) 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 
discretion.  
The Auto Basal target setting and Active Insulin Time should be set as shown above unless there is 
a documented safety reason that would not permit these settings to be used. 
 
After completion of training on SmartGuard functions, subjects 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 digital learning content, provided it is available at study start. 
 
SMBG recommendations for 780G system: 
With the 780G system and the study sensor, calibration is not required. However, a calibration is 
optional, and it will automatically 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 SmartGuard. 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 
periods.  
 
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. 
 
It is important for subjects to avoid additional meal/snack or exercise up to 4 hours after the start of 
each challenge. If additional meal/snack is consumed or exercise is done within 4 hours after the 
start of the challenge, the subject will acknowledge this on the challenge log. Subjects will be asked 
to check BG at the start of the meal/exercise, as well as 2 hours and 4 hours after the meal/exercise 
and take bolus correction as necessary. Content and timing of the meal and exercise, along with 
answers to challenge questions, will be recorded on a log provided by the study team. 
 
 
 

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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 (between visits 7 and 9) with subjects using 
the system in Manual Mode (SmartGuard must be turned off at least 6 hours prior to the 
meal challenge for subjects using it during the run-in period) 
o 
One Regular sized meal with missed meal bolus at lunch 
o 
One Large sized meal at breakfast, lunch or dinner 
 
 
Two meal challenges during the study period (between Visits 12 and 14) with subjects using 
the system in SmartGuard, Auto Basal target set at 120 mg/dL 
o 
One Regular sized meal with missed meal bolus at lunch 
o 
One Large sized meal at breakfast, lunch or dinner 
 
 
Two meal challenges during the study period (between Visits 15 and 16) with subjects using 
the system in SmartGuard, Auto Basal target set at 100 mg/dL 
o 
One Regular sized meal with missed meal bolus at lunch 
o 
One 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 investigator’s discretion – at any time after Visit 16 
o 
One Large sized meal at breakfast, lunch or dinner 
 
Meal challenges should only start if the following conditions are met:  
 
SMBG at start of meal is < 200 mg/dL 
 
Sensor glucose is available.  
 
Timing 
Settings/Conditions 
Meal Size 
Meal Type 
Notes 
Run-in Period 
between visits 
7 and 9 
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 
7 and 9 
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 
12 and 14  
SmartGuard  
(120 mg/dL 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 setpoint 

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Study Period 
between Visits 
12 and 14 
SmartGuard  
(120 mg/dL 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 and run-in 
period meal   
Study Period 
between Visits 
15 and 16 
SmartGuard  
(100 mg/dL 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. 
Study Period 
between Visits 
15 and 16 
SmartGuard  
(100 mg/dL 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 and run-in 
period large sized meal     
Study Period 
Any time after 
Visit 16 
SmartGuard  
(Auto Basal target 
setpoint at 
investigator’s discretion) 
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 
/100mg/dL and run-in period large 
sized meals 
 
Details about Regular Meal Challenges 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 patients would normally eat at this mealtime. Subjects will be asked to 
check BG at the start of the meal, as well as 2 hours and 4 hours after the meal and provide 
correction as necessary. Content and timing of the meal, along with BG values, will be recorded on a 
log provided by the study team.  
During the study period, once at each Auto Basal setpoint (i.e. 120 mg/dL and 100 md/dL), 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. Subjects will be asked to check BG at the 
start of the meal, as well as 2 hours and 4 hours after the start of the meal and provide correction 
as necessary. Details should be recorded, along with BG values, on the log. 
Details about Large sized Meal Challenges:   
On large sized meal challenge days, subjects will be instructed to eat one 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.  A log  will be used to collect 
information about the food that was eaten, the name of the restaurant (if applicable), and 
confirmation that meal size was at least 50% more in terms of calories, carbohydrates and fat. The 
log will also be used to record the time and date of the meal and  check box confirmation that a BG 
was taken at the start of the meal, 2 hours after the start of the meal and 4 hours after the start of 
the meal. The timing of the meal challenges will be at the investigator’s discretion. The subject’s 

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companion/care partner 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). They must be 
able to check SMBG (in case it is needed) and give glucose/administer glucagon if required. 
Exercise Challenge for all subjects (during Study Period only):   
The following exercise challenges are required during the study period: 
 
2 exercise challenges at setpoint of 120 mg/dL, between Visits 12 and 14 
 
2 exercise challenges at setpoint of 100 mg/dL, between Visits 15 and 16 
 
1 exercise challenge at investigator’s discretion, at any time after Visit 16 
 
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 12 
and 14 
SmartGuard  
(120 mg/dL setpoint) 
Min 30 minutes, 
up to 1.5 hours 
Challenge must take place 
on days without meal 
challenge 
Study Period 
between Visits 12 
and 14 
SmartGuard  
(120 mg/dL setpoint) 
Min 30 minutes, 
up to 1.5 hours 
Challenge must take place 
on days without meal 
challenge 
Study Period 
between Visits 15 
and 16 
SmartGuard  
(100 mg/dL setpoint) 
Min 30 minutes, 
up to 1.5 hours 
Challenge must take place 
on days without meal 
challenge 
Study Period 
between Visits 15 
and 16 
SmartGuard  
(100 mg/dL setpoint) 
Min 30 minutes, 
up to 1.5 hours 
Challenge must take place 
on days without meal 
challenge 
Study Period 
Any time after Visit 
16 
SmartGuard  
(Auto Basal target setpoint at 
investigator’s discretion) 
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 or 120 mg/dL, depending on what is required at that time of the study period, unless a 
subject prefers to use the 150 mg/dL temp target before, during and immediately after the exercise 
challenges. A log will be used to collect information about exercise type, date, time (start and finish 
of exercise) and duration. The log should also ask a confirmation that SMBG was done at the 

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beginning of exercise, as well as 2 and 4 hours after the start of the exercise. 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. The subject’s companion/care 
partner 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. 
Subjects should have carbohydrates available during and after exercise, if needed for safety reasons. 
If, during exercise, subjects experience any physical discomfort (e.g., chest pain, palpitations, 
shortness of breath, dizziness), exercise should be stopped immediately and subject should seek 
medical attention, if required. Subjects should contact the investigational center to report incidences 
of discomfort that lead to the cessation of exercise. 
Examples of types of exercise include, but are not limited to: 
 
Running 
 
Cycling 
 
Swimming 
 
Hiking 
 
Walking 
 
Games (e.g., Wii interactive video games) 
 
Yoga/stretching 
 
Any sport activity that involves ongoing physical movement (e.g., tennis, golf, basketball, 
volleyball, soccer)  
 
Dancing  
 
Zumba  
 
Aerobics 
 
Spinning 
 
Companions: 
Subjects will be required to have a companion (may be care partner) 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 (Phase 1). 
Companions should be able to check SMBG, give glucose and/or administer glucagon.   
 
Continued Access Period (from the end of Visit 18): 
Phase 1 subjects will have the opportunity to transition into Phase 2 upon completion of Phase 1 – 
Study Period or at their next continued access period visit. The continued access period for Phase 1 
of the study will end as soon as subjects transition to Phase 2 or exit the study.  
 
18.4.2 Study Visit Schedule 
Subjects will participate in a minimum of 18 planned study visits, as presented below in 

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Figure 7, for approximately 135 days of device wear. Subjects may enter a continued access period, 
following the end of the study period. 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. 
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 9. Refer to CIP341 
Questionnaire Guide for collection of early exit survey/questionnaire requirements.  
The Exit eCRF and all associated activities should be completed for all subjects who have withdrawn, 
discontinued, or completed the study. 
 

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Figure 7. Phase 1 Visit Schedule – This phase has been completed 
Run-in Period
Office 
Visit 1
Consent & 
Screening
Telephone 
Visit 3
Day 1 after 
Visit 2 
Office
Visit 2
Start Study 
Pump & CGM
Phase 1 - Visit Schedule
Study Period
Visit 1 to Visit 8 should be completed within 45 days.
Office/Virtual 
Office 
Visit 8
Day 21 (±3 days) 
after Visit 2
Telephone 
Visit 4
Day 3 (-1 
Day) after 
Visit 2 
Telephone 
Visit 6
Day 7 (-1 
Day, +2 days) 
after Visit 2 
Office 
Visit 9
Day 7 (+7 days) 
after Visit 8
Telephone 
Visit 10
Day 2 (-1 
Day) after 
Visit 9 
Telephone 
Visit 12
Day 7 (±2 
days) after 
Visit 9 
Telephone 
Visit 13
Day 14 (±3 
days) after 
Visit 9 
Telephone 
Visit 14
Day 21 (±3 
days) after 
Visit 9 
Office/Virtual 
Office 
Visit 15
Day 30 (±3 days) 
after Visit 9
Office/Virtual 
Office 
Visit 17
Day 60 (±7 days) 
after Visit 9
Office 
Visit 18
Day 90 (±7 days) after 
Visit 9
EOS (if not participating in CA)
Telephone 
Visit 5
Day 5 (-1 
Day) after 
Visit 2 
Telephone 
Visit 7 (±2 
days)
Day 14 
after Visit 2 
Telephone 
Visit 11
Day 4 ( (-1 
Day) after 
Visit 9 
Continued Access Period 
(until subject transitions into Phase 2 or exits the study)
Office 
Visit 19
Combined with 
Visit 18
Office
Visit 20
Day 30 (±7 days) 
after Visit 19
Office
Visit 21
Day 90 (±7 days) 
after Visit 19
Office 
Visit 22, 23, etc.
90 Days (±7 days) after 
each prior visit until EOS 
or transition into Phase 2
Office/Virtual 
Office 
Visit 16
Day 44 (±3 days) 
after Visit 9

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Visit 1 to Visit 8 should be completed within 45 days. 
 
Visit 1 (Office): Consent and screening 
o 
Collect labs 
 
Run-In Period:  
 
Visit 2 (Office): Start Run-In 
o 
Eligibility has been confirmed  
o 
Start study pump and CGM in Manual Mode 
o 
Register and upload study pump in CareLink Personal and CareLink system   
o 
Ask subjects about adverse events and device performance 
 
 
Visit 3 (Phone): Day 1 after Visit 2 
o 
Ask subjects 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 (-1 day) after Visit 2 
o 
Ask subjects 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 5 (-1 day) after Visit 2  
o 
Ask subjects if they require assistance, e.g., additional training 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
 
Visit 6 (Phone): Day 7 (-1, +2 days) after Visit 2  
o 
Ask subjects if they require assistance, e.g., additional training 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
 
Visit 7 (Phone): Day 14 (±2 days) after Visit 2  
o 
Ask subjects if they required 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 8 (Office/Virtual Office): Day 21 (±3 days) after Visit 2 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
 
 
 
Study Period:  

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 
Visit 9 (Office): Start Study Period, Day 7 (+7) after Visit 8 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
o 
Start subjects on SmartGuard 
o 
Start auto basal target at 120 mg/dL  
o 
Instruct subjects about the required meal and exercise challenges for the 120 
mg/dL and 100 mg/dL setpoint during the study period  
 
Visit 10 (Phone): Day 2 (-1 day) after Visit 9 
o 
Adjust pump settings as needed 
o 
Ask subjects 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 setpoint  
 
 
Visit 11 (Phone): Day 4 (-1 day) after Visit 9  
o 
Adjust pump settings as needed 
o 
Ask subjects 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 setpoint  
 
 
Visit 12 (Phone): Day 7 (±2 days) after Visit 9  
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 setpoint  
 
 
Visit 13 (Phone): Day 14 (±3 days) after Visit 9  
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 setpoint  
 
 
Visit 14 (Phone): Day 21 (±3 days) after Visit 9  
o 
Adjust pump settings as needed 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
o 
Change auto basal target at 100 mg/dL setpoint  
o 
Remind subjects about meal/exercise challenges for 100 mg/dL setpoint  
 
Visit 15 (Office/Virtual Office): Day 30 (±3 days) after Visit 9 
o 
Adjust pump settings as needed 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 

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o 
Remind subjects about meal/exercise challenges for 100 mg/dL setpoint 
 
 
Visit 16 (Office/Virtual Office): Day 44 (±3 days) after Visit 9  
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 17 (Office/Virtual Office): Day 60 (±7 days) after Visit 9 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
o 
Remind subjects about meal/exercise challenges 
 
 
Visit 18 (Office): Day 90 (±7 days) after Visit 9  
o 
Collect HbA1C 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
o 
Return study devices – unless subject decides to enter continued access period 
o 
End of Study (EOS) – unless subject decides to enter continued access period 
o 
Will be combined with Visit 19 if subject decides to enter continued access 
period 
Continued Access Period:  Phase 1 subjects will have the opportunity to transition into Phase 
2 upon completion of Phase 1 – Study Period or at their next continued access period visit. The 
continued access period for Phase 1 of the study will end as soon as subjects transition to Phase 
2 or exit the study. 
 
Visit 19 (Office): Combined with Visit 18 
o 
Subjects are instructed to continue uploading study device data at least weekly 
o 
Instruct subjects about the use of SGLT inhibitors 
 
 
Visit 20 (Office): Day 30 (±7 days) after Visit 19 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
o 
Remind subjects about the use of SGLT inhibitors 
 
 
Visit 21 (Office): Day 90 (±7 days) after Visit 19 
o 
Ask subjects about adverse events and device performance 
o 
Review CareLink reports 
o 
Collect HbA1c 
o 
Remind subjects about the use of SGLT inhibitors 
 
Subsequent visits (Visit 22, 23, etc.) will take place at 90-day intervals (±7 days) from 
Visit 21 (with the same questions asked and collection of HbA1c as during Visit 21), 
until the Sponsor announces the end of the study. The continued access visits should 
be Office visits, barring circumstances that put patient safety at risk (e.g., events 

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related to COVID-19), or where in person visits may not be allowed. HbA1c should be 
collected every 90 days. If a subject elects to leave the study at any point during the 
continued access period, devices will be collected at that time and study exit 
procedures will be followed. 

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18.4.3 Study Visit Details 
 
 
 
Run-In Period 
Study Period 
Continued Access Period 
 
Visit 1 
(Office) 
Visit 2 
(Office) 
Visit  
3, 4 & 5 
(Phone) 
Visit 6 
(Phone) 
Visit 7 
(Phone) 
Visit 8 
(Office/
Virtual 
Office) 
Visit 9 
(Office) 
Visit  
10 & 11  
(Phone) 
Visit  
12, 13 & 14 
(Phone) 
Visit  
15 & 16 
(Office/ 
Virtual 
Office) 
Visit 17 
(Office/
Virtual 
Office) 
Visit 
18* 
(Office) 
Visit 19 
(Office) 
Visit 20 
(Office 
**) 
Visit 21 
(Office 
**) 
Visits 
22, 23, 
etc. 
(Office  
**) 
Visit Window 
Enrollment 
 
Day 1, 3 
(-1 day), 
and 5 (-1 
day) 
after Visit 
2  
Day 7 (-1 
day, +2 
days) 
after 
Visit 2  
Day 14 
(±2 
days) 
after 
Visit 2  
Day 21 
(±3 
days) 
after 
Visit 2  
Day 7 
(+7 
days) 
after 
Visit 8 
Day 2  (-
1 day) 
and 4  
(-1 day) 
after 
Visit 9 
Day 7 (±2 
days), 14 
(±3 days), 
and 21 (±3 
days) after 
Visit 9 
Day 30 
(±3 days) 
and 44  
(±3 days) 
after Visit 
9 
Day 60 
(±7 
days) 
after 
Visit 9 
Day 90 
(±7 
days) 
after 
Visit 9 
EOS 
Period 
Combined 
with Visit 
18 
Day 30 
(±7 
days) 
after 
Visit 19 
Day 90 
(±7 
days) 
after 
Visit 19 
90 
Days 
(±7 
days) 
after 
each 
prior 
visit 
Visit Activities and Data Collection 
Collect consent forms, e.g., ICF, 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. All collected blood 
specimens will be sent to and tested by a NGSP 
certified Central Laboratory. Testing must follow 
NGSP standards. 
Note: If the visit must be conducted via Virtual 
Office, the blood tests may be collected via mobile 
phlebotomy service. 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
 
X  
(if 
applicable) 
X  
(if 
applicabl
e) 
Collect specimens for required local lab testing: 
Hematocrit, Creatinine, TSH, GAD, c-peptide (Note: 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Run-In Period 
Study Period 
Continued Access Period 
 
Visit 1 
(Office) 
Visit 2 
(Office) 
Visit  
3, 4 & 5 
(Phone) 
Visit 6 
(Phone) 
Visit 7 
(Phone) 
Visit 8 
(Office/
Virtual 
Office) 
Visit 9 
(Office) 
Visit  
10 & 11  
(Phone) 
Visit  
12, 13 & 14 
(Phone) 
Visit  
15 & 16 
(Office/ 
Virtual 
Office) 
Visit 17 
(Office/
Virtual 
Office) 
Visit 
18* 
(Office) 
Visit 19 
(Office) 
Visit 20 
(Office 
**) 
Visit 21 
(Office 
**) 
Visits 
22, 23, 
etc. 
(Office  
**) 
Visit Window 
Enrollment 
 
Day 1, 3 
(-1 day), 
and 5 (-1 
day) 
after Visit 
2  
Day 7 (-1 
day, +2 
days) 
after 
Visit 2  
Day 14 
(±2 
days) 
after 
Visit 2  
Day 21 
(±3 
days) 
after 
Visit 2  
Day 7 
(+7 
days) 
after 
Visit 8 
Day 2  (-
1 day) 
and 4  
(-1 day) 
after 
Visit 9 
Day 7 (±2 
days), 14 
(±3 days), 
and 21 (±3 
days) after 
Visit 9 
Day 30 
(±3 days) 
and 44  
(±3 days) 
after Visit 
9 
Day 60 
(±7 
days) 
after 
Visit 9 
Day 90 
(±7 
days) 
after 
Visit 9 
EOS 
Period 
Combined 
with Visit 
18 
Day 30 
(±7 
days) 
after 
Visit 19 
Day 90 
(±7 
days) 
after 
Visit 19 
90 
Days 
(±7 
days) 
after 
each 
prior 
visit 
c-peptide is not part of inclusion/exclusion criteria) – 
see lab instructions for additional information 
Collect information about medical history 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Collect information about concomitant medications  
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Collect any changes to diabetes medications during 
the study (including the type of insulin being used). 
The only insulins permitted for use in the study are 
Humalog, Novolog/NovoRapid, and Admelog. 
 
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) 
X  
(if applicable) 
X  
(if 
applicable) 
X  
(if 
applicable) 
X  
(if 
applicabl
e) 
Confirm subject eligibility results, including labs, 
prior to moving forward with any study procedures 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Assist with Questionnaires – Refer to CIP341 
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 
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 
As needed 
As 
needed 
Train subjects on the use of the Accu-Chek Guide 
Link study meter and ketone meter, refer to user 
guides 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Train subjects on the use of the 780G pump with 
Guardian 4 sensor 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Start study subjects on the 780G insulin pump 
system (Manual Mode)  
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Provide study subjects the Medtronic infusion sets, 
reservoirs, sensors and transmitter 
 
X 
 
 
 
As 
needed 
As 
needed 
 
 
As needed 
As 
needed 
As 
needed 
As needed 
As needed 
As needed 
As 
needed 
Train subjects on the Medtronic infusion sets, 
reservoirs, sensors and transmitter 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

CIP341 Clinical Investigation Plan  
 
 
D00591227 
Revision F 
 
Page 115 of 125 
 
Medtronic Business Restricted 
 
CONFIDENTIAL 
056-F275 Rev F Clinical Investigation Plan Template 
 
 
Run-In Period 
Study Period 
Continued Access Period 
 
Visit 1 
(Office) 
Visit 2 
(Office) 
Visit  
3, 4 & 5 
(Phone) 
Visit 6 
(Phone) 
Visit 7 
(Phone) 
Visit 8 
(Office/
Virtual 
Office) 
Visit 9 
(Office) 
Visit  
10 & 11  
(Phone) 
Visit  
12, 13 & 14 
(Phone) 
Visit  
15 & 16 
(Office/ 
Virtual 
Office) 
Visit 17 
(Office/
Virtual 
Office) 
Visit 
18* 
(Office) 
Visit 19 
(Office) 
Visit 20 
(Office 
**) 
Visit 21 
(Office 
**) 
Visits 
22, 23, 
etc. 
(Office  
**) 
Visit Window 
Enrollment 
 
Day 1, 3 
(-1 day), 
and 5 (-1 
day) 
after Visit 
2  
Day 7 (-1 
day, +2 
days) 
after 
Visit 2  
Day 14 
(±2 
days) 
after 
Visit 2  
Day 21 
(±3 
days) 
after 
Visit 2  
Day 7 
(+7 
days) 
after 
Visit 8 
Day 2  (-
1 day) 
and 4  
(-1 day) 
after 
Visit 9 
Day 7 (±2 
days), 14 
(±3 days), 
and 21 (±3 
days) after 
Visit 9 
Day 30 
(±3 days) 
and 44  
(±3 days) 
after Visit 
9 
Day 60 
(±7 
days) 
after 
Visit 9 
Day 90 
(±7 
days) 
after 
Visit 9 
EOS 
Period 
Combined 
with Visit 
18 
Day 30 
(±7 
days) 
after 
Visit 19 
Day 90 
(±7 
days) 
after 
Visit 19 
90 
Days 
(±7 
days) 
after 
each 
prior 
visit 
Start study subjects on CGM (transmitter and 
sensor) and accessories 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Instruct subjects 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 
If 
applicable 
X 
X 
X 
X 
Train study subjects on the 780G SmartGuard 
features.  
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
Instruct subjects on the SmartGuard feature of the 
pump as well as specific considerations regarding 
SmartGuard: 
 
Ensure that the Auto Correction feature is 
turned ON and remains ON throughout the 
course of the study. 
 
Instruct subjects to switch from pump 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) 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 
 
 
 
 
 
 
X  
 
 
 
 
 
 
 
 
 
Adjust pump settings 
 
X 
As needed 
As needed 
As needed 
As needed 
X 
As needed 
As needed 
As needed 
As needed 
As needed 
As needed 
As needed 
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 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

CIP341 Clinical Investigation Plan  
 
 
D00591227 
Revision F 
 
Page 116 of 125 
 
Medtronic Business Restricted 
 
CONFIDENTIAL 
056-F275 Rev F Clinical Investigation Plan Template 
 
 
Run-In Period 
Study Period 
Continued Access Period 
 
Visit 1 
(Office) 
Visit 2 
(Office) 
Visit  
3, 4 & 5 
(Phone) 
Visit 6 
(Phone) 
Visit 7 
(Phone) 
Visit 8 
(Office/
Virtual 
Office) 
Visit 9 
(Office) 
Visit  
10 & 11  
(Phone) 
Visit  
12, 13 & 14 
(Phone) 
Visit  
15 & 16 
(Office/ 
Virtual 
Office) 
Visit 17 
(Office/
Virtual 
Office) 
Visit 
18* 
(Office) 
Visit 19 
(Office) 
Visit 20 
(Office 
**) 
Visit 21 
(Office 
**) 
Visits 
22, 23, 
etc. 
(Office  
**) 
Visit Window 
Enrollment 
 
Day 1, 3 
(-1 day), 
and 5 (-1 
day) 
after Visit 
2  
Day 7 (-1 
day, +2 
days) 
after 
Visit 2  
Day 14 
(±2 
days) 
after 
Visit 2  
Day 21 
(±3 
days) 
after 
Visit 2  
Day 7 
(+7 
days) 
after 
Visit 8 
Day 2  (-
1 day) 
and 4  
(-1 day) 
after 
Visit 9 
Day 7 (±2 
days), 14 
(±3 days), 
and 21 (±3 
days) after 
Visit 9 
Day 30 
(±3 days) 
and 44  
(±3 days) 
after Visit 
9 
Day 60 
(±7 
days) 
after 
Visit 9 
Day 90 
(±7 
days) 
after 
Visit 9 
EOS 
Period 
Combined 
with Visit 
18 
Day 30 
(±7 
days) 
after 
Visit 19 
Day 90 
(±7 
days) 
after 
Visit 19 
90 
Days 
(±7 
days) 
after 
each 
prior 
visit 
Link the study subjects account to the investigational 
center account 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Train subjects on the use of CareLink Personal–
provide relevant set of written instructions 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Set up 780G system apps, if applicable: 
 
MiniMed Clinical app 
 
CareLink Clinical app 
 
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
If applicable: 
Train subjects and companions/care partners on the 
use of the 780G system apps: MiniMed Clinical app 
and CareLink Clinical app 
 
X  
(if 
applicable) 
 
X 
(if 
applicable) 
 
X  
(if needed) 
 
 
 
 
 
 
 
 
 
 
If applicable: 
For subjects who are currently using SGLT inhibitors, 
the investigational center will provide training as well 
as a wallet card-formatted STICH protocol. 
 
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) 
X  
(if applicable) 
X  
(if 
applicable) 
X  
(if 
applicable) 
X  
(if 
applicabl
e) 
Instruct/Remind subjects and their companions/care 
partners about the requirement to perform meal 
challenges during the run-in period 
SmartGuard should not be activated. 
Instruct subjects about the Smartphone app to 
collect meal data. 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Instruct/Remind subjects about the requirement to 
perform meal and exercise challenges during the 
study period: 
 
At 120 mg/dL Auto Basal Setpoint Week 2-3 
of the study period 
 
At 100 mg/dL Auto Basal Setpoint during 
Week 5 -6 of the study period 
 
At current Auto Basal Setpoint anytime after 
Week 6 of the study period 
 
 
 
 
 
 
X 
X 
X 
X 
 
 
 
 
 
 

CIP341 Clinical Investigation Plan  
 
 
D00591227 
Revision F 
 
Page 117 of 125 
 
Medtronic Business Restricted 
 
CONFIDENTIAL 
056-F275 Rev F Clinical Investigation Plan Template 
 
 
Run-In Period 
Study Period 
Continued Access Period 
 
Visit 1 
(Office) 
Visit 2 
(Office) 
Visit  
3, 4 & 5 
(Phone) 
Visit 6 
(Phone) 
Visit 7 
(Phone) 
Visit 8 
(Office/
Virtual 
Office) 
Visit 9 
(Office) 
Visit  
10 & 11  
(Phone) 
Visit  
12, 13 & 14 
(Phone) 
Visit  
15 & 16 
(Office/ 
Virtual 
Office) 
Visit 17 
(Office/
Virtual 
Office) 
Visit 
18* 
(Office) 
Visit 19 
(Office) 
Visit 20 
(Office 
**) 
Visit 21 
(Office 
**) 
Visits 
22, 23, 
etc. 
(Office  
**) 
Visit Window 
Enrollment 
 
Day 1, 3 
(-1 day), 
and 5 (-1 
day) 
after Visit 
2  
Day 7 (-1 
day, +2 
days) 
after 
Visit 2  
Day 14 
(±2 
days) 
after 
Visit 2  
Day 21 
(±3 
days) 
after 
Visit 2  
Day 7 
(+7 
days) 
after 
Visit 8 
Day 2  (-
1 day) 
and 4  
(-1 day) 
after 
Visit 9 
Day 7 (±2 
days), 14 
(±3 days), 
and 21 (±3 
days) after 
Visit 9 
Day 30 
(±3 days) 
and 44  
(±3 days) 
after Visit 
9 
Day 60 
(±7 
days) 
after 
Visit 9 
Day 90 
(±7 
days) 
after 
Visit 9 
EOS 
Period 
Combined 
with Visit 
18 
Day 30 
(±7 
days) 
after 
Visit 19 
Day 90 
(±7 
days) 
after 
Visit 19 
90 
Days 
(±7 
days) 
after 
each 
prior 
visit 
Advise subjects that they should contact the 
investigational center staff if they develop symptoms 
during the exercise that prompt them to stop, e.g., 
chest pain, palpitations, shortness of breath, 
dizziness 
Instruct subjects about the Smartphone app to 
collect meal and exercise data. 
Start Auto Basal Target = 120 mg/dL with Active 
Insulin Time = 4 hours-titrated towards 2-3 hours at 
investigator’s discretion at Visit 9 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
Start Auto Basal Target = 100 mg/dL with Active 
Insulin Time = 2-3 hours or at investigator’s 
discretion at Visit 14 
 
 
 
 
 
 
 
 
X 
(Visit 14) 
 
 
 
 
 
 
 
Dispense study materials (e.g., smartphone [upon 
request and approval], reference guides, subject 
training materials, etc.) 
 
X 
 
 
 
 
X 
X 
X 
 
 
 
 
 
 
 
Dispense other study supplies as needed (e.g., 
alcohol swabs, adhesive remover, etc.) 
 
X 
 
 
 
As needed 
As needed 
 
 
As needed 
As needed 
As needed 
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 
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 
X 
X 
Review CareLink system reports 
 
 
X 
 
 
X 
X 
X 
 
X 
X 
If 
applicable 
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 
As needed 
As needed 
As 
needed 
Enter data into eCRFs as required 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 

CIP341 Clinical Investigation Plan  
 
 
D00591227 
Revision F 
 
Page 118 of 125 
 
Medtronic Business Restricted 
 
CONFIDENTIAL 
056-F275 Rev F Clinical Investigation Plan Template 
 
 
Run-In Period 
Study Period 
Continued Access Period 
 
Visit 1 
(Office) 
Visit 2 
(Office) 
Visit  
3, 4 & 5 
(Phone) 
Visit 6 
(Phone) 
Visit 7 
(Phone) 
Visit 8 
(Office/
Virtual 
Office) 
Visit 9 
(Office) 
Visit  
10 & 11  
(Phone) 
Visit  
12, 13 & 14 
(Phone) 
Visit  
15 & 16 
(Office/ 
Virtual 
Office) 
Visit 17 
(Office/
Virtual 
Office) 
Visit 
18* 
(Office) 
Visit 19 
(Office) 
Visit 20 
(Office 
**) 
Visit 21 
(Office 
**) 
Visits 
22, 23, 
etc. 
(Office  
**) 
Visit Window 
Enrollment 
 
Day 1, 3 
(-1 day), 
and 5 (-1 
day) 
after Visit 
2  
Day 7 (-1 
day, +2 
days) 
after 
Visit 2  
Day 14 
(±2 
days) 
after 
Visit 2  
Day 21 
(±3 
days) 
after 
Visit 2  
Day 7 
(+7 
days) 
after 
Visit 8 
Day 2  (-
1 day) 
and 4  
(-1 day) 
after 
Visit 9 
Day 7 (±2 
days), 14 
(±3 days), 
and 21 (±3 
days) after 
Visit 9 
Day 30 
(±3 days) 
and 44  
(±3 days) 
after Visit 
9 
Day 60 
(±7 
days) 
after 
Visit 9 
Day 90 
(±7 
days) 
after 
Visit 9 
EOS 
Period 
Combined 
with Visit 
18 
Day 30 
(±7 
days) 
after 
Visit 19 
Day 90 
(±7 
days) 
after 
Visit 19 
90 
Days 
(±7 
days) 
after 
each 
prior 
visit 
Schedule next visit day and time 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
If 
applicable 
 
 
 
 
Collect study devices at study end (see device 
disposition Table 2 for details). 
Note: If the visit must be conducted via Virtual 
Office, the blood tests may be collected via mobile 
phlebotomy service. Subjects should send devices 
back to the investigational center.  
 
 
 
 
 
 
 
 
 
 
 
If EOS 
 
 
 
When 
subject 
exits or 
sponsor 
conclude
s study 
Questions To Ask at Study Visits 
Ask if subjects have general study-related questions 
and concerns 
X 
X 
X 
X 
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 
X 
X 
X 
X 
Ask subjects about device performance issues and if 
they called the Medtronic 24 -Hour Technical 
Support (TS) line to report them. 
Instruct/Remind subjects to contact the Medtronic 
24-Hour TS in the event they experience problems 
with their study devices. 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Ask subjects if they require assistance, e.g., 
additional training 
 
 
X 
X 
X 
X 
 
X 
 
 
 
 
 
 
 
 

CIP341 Clinical Investigation Plan  
 
 
D00591227 
Revision F 
 
Page 119 of 125 
 
Medtronic Business Restricted 
 
CONFIDENTIAL 
056-F275 Rev F Clinical Investigation Plan Template 
 
 
Run-In Period 
Study Period 
Continued Access Period 
 
Visit 1 
(Office) 
Visit 2 
(Office) 
Visit  
3, 4 & 5 
(Phone) 
Visit 6 
(Phone) 
Visit 7 
(Phone) 
Visit 8 
(Office/
Virtual 
Office) 
Visit 9 
(Office) 
Visit  
10 & 11  
(Phone) 
Visit  
12, 13 & 14 
(Phone) 
Visit  
15 & 16 
(Office/ 
Virtual 
Office) 
Visit 17 
(Office/
Virtual 
Office) 
Visit 
18* 
(Office) 
Visit 19 
(Office) 
Visit 20 
(Office 
**) 
Visit 21 
(Office 
**) 
Visits 
22, 23, 
etc. 
(Office  
**) 
Visit Window 
Enrollment 
 
Day 1, 3 
(-1 day), 
and 5 (-1 
day) 
after Visit 
2  
Day 7 (-1 
day, +2 
days) 
after 
Visit 2  
Day 14 
(±2 
days) 
after 
Visit 2  
Day 21 
(±3 
days) 
after 
Visit 2  
Day 7 
(+7 
days) 
after 
Visit 8 
Day 2  (-
1 day) 
and 4  
(-1 day) 
after 
Visit 9 
Day 7 (±2 
days), 14 
(±3 days), 
and 21 (±3 
days) after 
Visit 9 
Day 30 
(±3 days) 
and 44  
(±3 days) 
after Visit 
9 
Day 60 
(±7 
days) 
after 
Visit 9 
Day 90 
(±7 
days) 
after 
Visit 9 
EOS 
Period 
Combined 
with Visit 
18 
Day 30 
(±7 
days) 
after 
Visit 19 
Day 90 
(±7 
days) 
after 
Visit 19 
90 
Days 
(±7 
days) 
after 
each 
prior 
visit 
Ask subjects about the use of SGLT inhibitors during 
the Continued Access Period 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
Study Subject General Training and Instructions 
Remind subjects that the use and wear of study 
devices throughout the study is a requirement 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
If 
applicable 
X 
X 
X 
X 
Instruct/Remind subjects regarding the content of 
the Home Reference Guide 
 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
Instruct subjects on carbohydrate (CHO) counting as 
needed (Investigator discretion) 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
If 
applicable 
X 
X 
X 
 
Instruct subjects on diabetes self-management 
principles including response to glycemic events, 
e.g., use of oral glucose/glucagon in case of severe 
hypoglycemia or checking for ketones in case of 
severe hyperglycemia 
Note: Companions/care partners should be trained 
on how to respond to high or low glucose events. 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Instruct subjects and companions/care partners that 
blood ketone testing is required every time BG is 
greater than 300 mg/dL, as measured by the Accu-
Chek Guide Link study meter. 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
If 
applicable 
X 
X 
X 
X 
Instruct subjects 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 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
If 
applicable 
X 
X 
X 
X 

CIP341 Clinical Investigation Plan  
 
 
D00591227 
Revision F 
 
Page 120 of 125 
 
Medtronic Business Restricted 
 
CONFIDENTIAL 
056-F275 Rev F Clinical Investigation Plan Template 
 
 
Run-In Period 
Study Period 
Continued Access Period 
 
Visit 1 
(Office) 
Visit 2 
(Office) 
Visit  
3, 4 & 5 
(Phone) 
Visit 6 
(Phone) 
Visit 7 
(Phone) 
Visit 8 
(Office/
Virtual 
Office) 
Visit 9 
(Office) 
Visit  
10 & 11  
(Phone) 
Visit  
12, 13 & 14 
(Phone) 
Visit  
15 & 16 
(Office/ 
Virtual 
Office) 
Visit 17 
(Office/
Virtual 
Office) 
Visit 
18* 
(Office) 
Visit 19 
(Office) 
Visit 20 
(Office 
**) 
Visit 21 
(Office 
**) 
Visits 
22, 23, 
etc. 
(Office  
**) 
Visit Window 
Enrollment 
 
Day 1, 3 
(-1 day), 
and 5 (-1 
day) 
after Visit 
2  
Day 7 (-1 
day, +2 
days) 
after 
Visit 2  
Day 14 
(±2 
days) 
after 
Visit 2  
Day 21 
(±3 
days) 
after 
Visit 2  
Day 7 
(+7 
days) 
after 
Visit 8 
Day 2  (-
1 day) 
and 4  
(-1 day) 
after 
Visit 9 
Day 7 (±2 
days), 14 
(±3 days), 
and 21 (±3 
days) after 
Visit 9 
Day 30 
(±3 days) 
and 44  
(±3 days) 
after Visit 
9 
Day 60 
(±7 
days) 
after 
Visit 9 
Day 90 
(±7 
days) 
after 
Visit 9 
EOS 
Period 
Combined 
with Visit 
18 
Day 30 
(±7 
days) 
after 
Visit 19 
Day 90 
(±7 
days) 
after 
Visit 19 
90 
Days 
(±7 
days) 
after 
each 
prior 
visit 
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 
Remind subject to bring in both Accu-Chek Guide 
Link study meter and ketone meter at each required 
office visit.  
 
X 
 
 
X 
X 
 
 
X 
X 
X 
If 
applicable 
X 
X 
X 
X 
Remind subject to keep their devices charged, as 
applicable 
 
X 
X 
 
 
X 
X 
X 
 
X 
X 
If 
applicable 
X 
X 
X 
X 
Instruct subjects 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 
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  
 
X 
X 
 
 
X 
X 
X 
 
X 
X 
If 
applicable 
X 
X 
X 
X 
Instruct subjects 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 
X 
X 
X 
X 
Instruct subjects that they should not assume that 
SmartGuard is able to prevent all hypoglycemia or all 
 
X 
 
 
 
 
X 
 
 
X 
X 
If 
applicable 
X 
X 
X 
X 

CIP341 Clinical Investigation Plan  
 
 
D00591227 
Revision F 
 
Page 121 of 125 
 
Medtronic Business Restricted 
 
CONFIDENTIAL 
056-F275 Rev F Clinical Investigation Plan Template 
 
 
Run-In Period 
Study Period 
Continued Access Period 
 
Visit 1 
(Office) 
Visit 2 
(Office) 
Visit  
3, 4 & 5 
(Phone) 
Visit 6 
(Phone) 
Visit 7 
(Phone) 
Visit 8 
(Office/
Virtual 
Office) 
Visit 9 
(Office) 
Visit  
10 & 11  
(Phone) 
Visit  
12, 13 & 14 
(Phone) 
Visit  
15 & 16 
(Office/ 
Virtual 
Office) 
Visit 17 
(Office/
Virtual 
Office) 
Visit 
18* 
(Office) 
Visit 19 
(Office) 
Visit 20 
(Office 
**) 
Visit 21 
(Office 
**) 
Visits 
22, 23, 
etc. 
(Office  
**) 
Visit Window 
Enrollment 
 
Day 1, 3 
(-1 day), 
and 5 (-1 
day) 
after Visit 
2  
Day 7 (-1 
day, +2 
days) 
after 
Visit 2  
Day 14 
(±2 
days) 
after 
Visit 2  
Day 21 
(±3 
days) 
after 
Visit 2  
Day 7 
(+7 
days) 
after 
Visit 8 
Day 2  (-
1 day) 
and 4  
(-1 day) 
after 
Visit 9 
Day 7 (±2 
days), 14 
(±3 days), 
and 21 (±3 
days) after 
Visit 9 
Day 30 
(±3 days) 
and 44  
(±3 days) 
after Visit 
9 
Day 60 
(±7 
days) 
after 
Visit 9 
Day 90 
(±7 
days) 
after 
Visit 9 
EOS 
Period 
Combined 
with Visit 
18 
Day 30 
(±7 
days) 
after 
Visit 19 
Day 90 
(±7 
days) 
after 
Visit 19 
90 
Days 
(±7 
days) 
after 
each 
prior 
visit 
hyperglycemia including diabetic ketoacidosis and 
HHS 
Instruct study subjects that regular weekly uploads 
of the study pump is required. With Bluetooth 
connection and the MiniMed Clinical 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. 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
If 
applicable 
X 
X 
X 
X 
Instruct subjects to give meal bolus of insulin 15-20 
minutes before meals during the run-in period and 
study period  
 
X 
X 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 

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
 
D00591227 
Revision F 
 
Page 122 of 125 
 

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