Safety and Effectiveness Evaluation of the MiniMed™ 780G System Used in Combination With the DS5 CGM
Phase: NA
Conditions: Type 1 Diabetes
Sponsor: Medtronic MiniMed, Inc.

 
Study Title Safety and Effectiveness Evaluation of the MiniMed™ 780G System Used in 
Combination with the DS5 CGM  
NCT Number NCT05714059 
Document Description CIP337 Clinical Investigation Plan (Version A) 
Document Date 
11-JAN-2023  
 
 

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 1 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
Clinical Investigation Plan
Clinical Investigation Plan
(CIP)/Study Title 
Safety and Effectiveness Evaluation of the MiniMed™ 780G System
Used in Combination with the DS5 CGM
CIP Identifier
337
Investigational Device 
Exemption (IDE) Number
G220306
Product Names & Model
Numbers
Investigational Products

MiniMed™ 780G Insulin Pump (MMT-1884) - referred to as 
the study pump throughout this CIP

Disposable Sensor (MMT-5100) – labeled as DS5 and 
referred to as DS5 throughout this CIP
Non-Investigational/Exempt Products

Medtronic Extended infusion set (MMT-430, MMT-431, MMT-
432, MMT-433, MMT-440, MMT-441, MMT-442, and MMT-
443)

Medtronic Extended Reservoir (MMT-342)

Medtronic CareLink™ Personal software (MMT-7333) 

Medtronic CareLink system software (MMT-7350)

Roche Accu-Chek™Guide Link Glucose Meter
(08116083022) -referred to as the Accu-Chek Guide Link
study meter throughout this CIP

MiniMed Clinical App (MMT-6103 Android™app; MMT-6104 
IOS™app)

CareLink Clinical App (MMT-6113 Android™ app; MMT-6114 
IOS™ app)

Blue Bluetooth® Low Energy Adapter (ACC-1003911)-
referred to as the Blue Adapter in this CIP

Abbott™ Precision Xtra™ Blood Glucose & Ketone 
Monitoring System or other approved ketone meter- to be 
used for blood ketone measurements only -referred to as 
the ketone meter throughout this CIP

Accu-Chek Guide test strips (07453736001)

Sponsor-provided smartphone, upon request

Over-the-counter (OTC) tape(s) if needed (e.g., Hypafix™ 
tape, etc.)
Description of CIP
This study will evaluate the safety and effectiveness of the MiniMed 
780G system used in combination with the DS5 CGM in type 1 adult 
and pediatric subjects in a home setting. 
Sponsor
Medtronic MiniMed, Inc.
(“Medtronic”)
18000 Devonshire St

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 2 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
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.
Precision Xtra™ is a registered trademark of Abbott™ Laboratories, Inc.
Humalog™ is a registered trademark of Eli Lilly and Company.
Hypafix™ is a registered trademark by BSN Medical Limited.
IOS™ is a trademark or registered trademark of Cisco.
NovoLog® is a registered trademark of Novo Nordisk A/S.
The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any 
use of such marks by Medtronic is under license. Other trademarks and trade names are those of their 
respective owners.
©2023 Medtronic. All rights reserved. Medtronic, Medtronic logo and Engineering the extraordinary are 
trademarks of Medtronic. ™Third-party brands are trademarks of their respective owners. All other 
brands are trademarks of a Medtronic company.
Northridge, CA 91325
866.948.6633
Document Version
A (Equivalent to A.4)
Version Date
11-JAN-2023
Document Reference 
Number
D00459337
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.

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 3 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
Table of Contents
Table of Contents ...................................................................................................................... 3
1.
Glossary.............................................................................................................................. 6
2.
Synopsis ............................................................................................................................. 8
3.
Introduction..................................................................................................................... 21
3.1 Background ......................................................................................................................21
3.2 Purpose............................................................................................................................21
4.
Objectives and Endpoints................................................................................................. 21
4.1 Objectives ........................................................................................................................21
4.2 Endpoints.........................................................................................................................21
5.
Study Design .................................................................................................................... 24
5.1 Duration...........................................................................................................................27
5.2 Rationale..........................................................................................................................27
6.
Product Description.......................................................................................................... 27
6.1 Intended Use....................................................................................................................27
6.2 General Overview of MiniMed 780G Insulin Pump System Components and Consumables..........28
6.3 Investigational Product ......................................................................................................28
6.4 Non-Investigational Product(s)............................................................................................30
6.5 Smartphone......................................................................................................................34
6.6 Consumable Devices..........................................................................................................34
6.7 Insulin .............................................................................................................................34
6.8 Anticipated Product Changes ..............................................................................................34
6.9 Product Accountability .......................................................................................................34
7.
Study Site Requirements ................................................................................................. 38
7.1 Investigator/Investigational Center Selection........................................................................38
7.2 Study Site Activation..........................................................................................................38
8.
Selection of Subjects........................................................................................................ 38
8.1 Study Population...............................................................................................................38
8.2 Subject Enrollment ............................................................................................................39
8.3 Inclusion Criteria...............................................................................................................39
8.4 Exclusion Criteria...............................................................................................................40
9.
Study Procedures ............................................................................................................. 41

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 4 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
9.1 Schedule of Events............................................................................................................41
9.2 Data Collection..................................................................................................................50
9.3 Subject Consent................................................................................................................50
9.4 Safety Monitoring/Risk Analysis...........................................................................................51
9.5 Glucose and Glycemia Measurements ..................................................................................52
9.6 Recording Data .................................................................................................................53
9.7 Deviation Handling ............................................................................................................54
9.8 Subject Exit, Withdrawal or Discontinuation..........................................................................55
9.9 Study Stopping Rules.........................................................................................................57
10. Risks and Benefits............................................................................................................ 57
10.1 Potential Risks ..................................................................................................................57
10.2 Risk Minimization...............................................................................................................63
10.3 Potential Benefits ..............................................................................................................63
10.4 Risk-Benefit Rationale........................................................................................................63
10.5 Risk Determination ............................................................................................................63
11. Adverse Events................................................................................................................. 63
11.1 Adverse Events .................................................................................................................63
11.2 Definitions and Classification of Adverse Events ....................................................................64
11.3 Recording of Adverse Events ..............................................................................................66
11.4 Notification of Adverse Events.............................................................................................67
11.5 Expedited Safety Reporting Requirements............................................................................67
11.6 Causality Assessment.........................................................................................................68
11.7 Anticipated or Unanticipated...............................................................................................70
12. Data Review Committees................................................................................................. 70
12.1 Clinical Events Committee .................................................................................................. 70
12.2 Data Monitoring Committee................................................................................................72
13. Device Deficiencies and Troubleshooting ........................................................................ 75
14. Statistical Design and Methods........................................................................................ 76
14.1 General Aspects of Analysis................................................................................................76
14.2 Subject Disposition............................................................................................................76
14.3 Subject Demographics and Baseline Characteristics...............................................................76
14.4 Endpoints and Hypotheses ................................................................................................. 76

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 5 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
14.5 Sample Size Considerations/Sample Size Justification ............................................................80
14.6 Final Report......................................................................................................................82
15. Ethics................................................................................................................................ 82
15.1 Statement(s) of Compliance ...............................................................................................82
15.2 IRB Approval ....................................................................................................................82
15.3 Role of the Sponsor’s Representatives .................................................................................83
15.4 Investigator’s Responsibilities .............................................................................................83
16. Study Administration ....................................................................................................... 86
16.1 Training of Clinical Staff .....................................................................................................86
16.2 Monitoring........................................................................................................................86
16.3 Data Management.............................................................................................................87
16.4 Direct Access to Source Data/Documents.............................................................................88
16.5 Confidentiality...................................................................................................................88
16.6 Liability and Subject Compensation .....................................................................................88
16.7 CIP Amendments ..............................................................................................................89
16.8 Records and Reports..........................................................................................................89
16.9 Record Retention ..............................................................................................................91
16.10
Suspension or Early Termination ..................................................................................91
16.11
Study Close-Out.........................................................................................................91
16.12
Publication and Use of Information...............................................................................91
17. References ....................................................................................................................... 92
18. Appendices....................................................................................................................... 92
18.1 Names and addresses........................................................................................................92
18.2 Labeling of Devices............................................................................................................92
18.3 Sample Consent Materials .................................................................................................. 93
19. Version History................................................................................................................. 93

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 6 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
1. Glossary
Abbreviations
ADE
Adverse Device Effect
AE
Adverse Event
AHCL
Advanced Hybrid Closed Loop
AUC
Area Under Curve
BG
Blood Glucose
BMI
Body Mass Index
CEC
Clinical Events Committee
CFR
Code of Federal Regulations
CGM
Continuous Glucose Monitoring
CIP
Clinical Investigation Plan
CRF
Case Report Form
CSII
Continuous Subcutaneous Insulin Infusion
CTA
Clinical Trial Agreement
CV
Curriculum Vitae
DD
Device Deficiency
DKA
Diabetic Ketoacidosis
DMC
Data Monitoring Committee
DoH
Declaration of Helsinki
eCRF
Electronic Case Report Form
EDC
Electronic Data Capture
EOS
End of Study
ER
Emergency Room
FDA
Food and Drug Administration
GCP
Good Clinical Practice
HbA1c
Glycosylated hemoglobin
HIPAA
Health Insurance Portability and Accountability Act
IB
Investigator’s Brochure
ICF
Informed Consent Form
ID
Identification
IDE
Investigational Device Exemption
IEC
Independent Ethics Committee
IRB
Institutional Review Board
ISO
International Organization for Standardization
IV
Intravenous
MC2
Medtronic Core Clinical Solutions
NGSP
National Glycohemoglobin Standardization Program
PC
Personal Computer
PI
Principal Investigator
QC
Quality Control
SADE
Serious Adverse Device Effect
SAE
Serious Adverse Event

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 7 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
Abbreviations
SAP
Sensor Augmented Pump
SAP
Statistical Analysis Plan
SG
Sensor Glucose
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

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 8 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
2. Synopsis
Title
Safety and Effectiveness Evaluation of the MiniMed™ 780G System
Used in Combination with the DS5 CGM
Clinical Study Type
Safety and Effectiveness Evaluation 
Sponsor
Medtronic MiniMed, Inc.
(“Medtronic”)
18000 Devonshire St
Northridge, CA 91325
866.948.6633
Indication Under 
Investigation

Type 1 diabetes

Labeling for the MiniMed 780G system used in combination 
with the DS5 CGM
Product Names & Model 
Numbers
Investigational Products

MiniMed™ 780G Insulin Pump (MMT-1884) - referred to as the 
study pump throughout this CIP

Disposable Sensor (MMT-5100) – labeled as DS5 and referred 
to as DS5 throughout this CIP
Non-Investigational/Exempt Products

Medtronic Extended infusion set (MMT-430, MMT-431, MMT-
432, MMT-433, MMT-440, MMT-441, MMT-442, and MMT-443)

Medtronic Extended Reservoir (MMT-342)

Medtronic CareLink™ Personal software (MMT-7333) 

Medtronic CareLink system software (MMT-7350)

Roche Accu-Chek™Guide Link Glucose Meter (08116083022) -
referred to as the Accu-Chek Guide Link study meter
throughout this CIP

MiniMed Clinical App (MMT-6103 Android™app; MMT-6104 
IOS™app)

CareLink Clinical App (MMT-6113 Android™ app; MMT-6114 
IOS™ app)

Blue Bluetooth® Low Energy Adapter (ACC-1003911)- referred 
to as the Blue Adapter in this CIP

Abbott™ Precision Xtra™ Blood Glucose & Ketone Monitoring 
System or other approved ketone meter- to be used for blood 
ketone measurements only -referred to as the ketone meter 
throughout this CIP

Accu-Chek Guide test strips (07453736001)

Sponsor-provided smartphone, upon request

Over-the-counter (OTC) tape(s) if needed (e.g., Hypafix™ 
tape, etc.)

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 9 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
Purpose
The purpose of this study is to confirm the safety and effectiveness of 
the MiniMed 780G insulin pump used in combination with the DS5
CGM in type 1 diabetes adult and pediatric subjects in a home setting.
Objective(s)
The objective of this study is to evaluate the safety and effectiveness
of the MiniMed 780G insulin pump used in combination with the DS5
CGM.
Study Design
This study is a multi-center, single arm study in insulin-requiring adult 
and pediatric subjects with type 1 diabetes on the MiniMed 780G 
system using DS5 as well as Medtronic Extended infusion set and 
reservoir. The run-in period and study period will be approximately 
120 days long. 
The period from Visit 1 (consent and screening) through Visit 6 must 
be completed in 30 days.
Run-in Period (Visits 2-6): 
The run-in period begins at Visit 2 and ends once Visit 7 occurs.
The intent of the run-in period will be to allow subjects to become 
familiar with new study devices while using their own insulin: 
Humalog™(insulin lispro injection), NovoLog® (insulin aspart solution 
for injection), or Admelog® (insulin lispro injection). During the run-in 
period, study subjects will be using the study pump with only the 
Sensor Augmented Pump (SAP) function activated (i.e., SmartGuard™
feature is turned OFF), DS5, Medtronic Extended infusion set and 
reservoir. 
SmartGuard (with Auto Correction OFF) during the run-in period will 
be permitted for study subjects who are using the Auto Mode feature 
in a Medtronic pump prior to screening. In the 780G study pump, the 
term “Auto Mode” has been replaced with “SmartGuard”. All others are 
to use the system in Manual Mode during the run-in period.
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) in 
non-Medtronic pump
Manual Mode
SAP (with closed loop) in 
Medtronic pump as Auto 
Mode
SmartGuard feature with 
Auto Correction OFF
During the run-in period and only for subjects with Auto Mode
experience through the use of a Medtronic insulin pump, a 120 mg/dL 
Auto Basal target should be set. It is recommended that Active Insulin 
Time is set to 4 hours.

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 10 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
Note: The Auto Basal target setting and Active Insulin Time should be 
set as recommended above, unless there is a documented safety 
reason that would not permit these settings to be used.
Subjects who do not have experience with Medtronic insulin pumps, as 
specified above, will use the system in Manual Mode.
All subjects and their parents/caregivers (if applicable) will be trained 
on diabetes management principles, such as the treatment of 
hyperglycemia and hypoglycemia. In addition, there will be training 
regarding the need to have access to and how to use glucose and 
glucagon in case of hypoglycemia.  
Parents/caregivers (if applicable) will be instructed that they should be 
with the subject in the same residence or building overnight.
If the MiniMed Clinical app and the CareLink Clinical app are being 
used, parents/caregivers (if applicable) will be instructed that subjects 
should be connected to CareLink via the appropriate Smartphone app 
for data uploading and push notifications for low or high blood sugar 
when they are apart, e.g., at school, other activities. Instructions on 
the appropriate operation of the apps will be provided.
For study purposes, subjects and parents/caregivers (if applicable) will 
be trained and/or instructed to perform self-monitoring of blood 
glucose (SMBG) if subjects are experiencing a severe hypoglycemic 
event, severe hyperglycemic event or diabetic ketoacidosis (DKA). 
Subjects and their parents/caregivers (if applicable) will also be 
instructed to check subject blood ketones using a Precision Xtra 
ketone meter or other approved ketone meter if the Accu-Chek Guide 
Link study meter reading is greater than 300 mg/dL.
As a precaution, subjects and their parents/caregivers (if applicable)
will be told that subjects should keep their own insulin pump supplies 
in a safe place and to have back up supplies on hand (such as insulin 
and syringe, or insulin pen) in the event they are asked to revert back 
to their own therapy during the study or experience study pump issues 
(i.e., infusion set occlusion with high glucose).  
Subjects and their parents/caregivers (if applicable) will be instructed 
to insert the DS5 into subjects only in the locations that are specified 
in the User Guide. Reminders will be given to subjects and their 
parents/caregivers (if applicable) at each office visit. Information 
about sensor insertions will be collected at each study visit on an 
electronic case report form (eCRF) in the study database, e.g.,
insertion location.
Subjects and their parents/caregivers (if applicable) will be trained on 
all parts of the device system. This will involve live training conducted 

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 11 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
by the investigational center staff. A training checklist for both subject
and parents/caregivers (if applicable) will be implemented and
completed. Parents/caregivers (if applicable) should be available for 
relevant parts or all of this training, either in person or virtually.
After completion of training on the study devices, subjects and their 
parents/caregivers (if applicable) may attend additional visits in the 
days immediately following the start of system use, as needed. 
Study Period (Visits 7-15):
All subjects will continue using the study pump with SmartGuard
feature enabled (including Auto Correction), Humalog/ NovoLog/ 
Admelog, DS5, infusion set and reservoir. During the study period, 
each subject will be encouraged to continue on the same brand of 
insulin with which they started. All SmartGuard™features will be 
activated and should be used for the duration of the study period. 
Subjects should use the system with the SmartGuard feature 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 the SmartGuard feature. During times when subjects are 
not able to use the SmartGuard feature, they should use the system in 
Manual Mode (e.g., with Suspend before low or Suspend on low
activated).
Therapy at Screening
Pump Setting During Study 
Period
Continuous Subcutaneous 
Insulin Infusion (CSII)
SmartGuard feature with Auto 
Correction ON
SAP (no closed loop)
SmartGuard feature with Auto 
Correction ON
SAP (with closed loop) in non-
Medtronic pump
SmartGuard feature with Auto 
Correction ON
SAP (with closed loop) in 
Medtronic pump as Auto Mode
SmartGuard feature with Auto 
Correction ON
During the first 3 weeks (between Visits 7 and 11) 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 or at the investigator’s discretion.
During the next 3 weeks (between Visits 11 and 13) of the study 
period, the Auto Basal target setting should be set to 100 mg/dL. 
Active Insulin Time is recommended to be set to 2-3 hours or at 
investigator’s discretion.
During the remaining weeks of the study (any time after Visit 13) of 
the study period, the Auto Basal target as well as Active Insulin Time 

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 12 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
should be set to what is best for the individual subject, at 
investigator’s discretion.
Note: The Auto Basal target setting and Active Insulin Time should be 
set as recommended above, unless there is a documented safety 
reason that would not permit these settings to be used.
After completion of live training on the SmartGuard function, subjects 
and their parents/caregivers (if applicable) may attend additional visits 
in the days immediately following the start of SmartGuard use, as 
needed. 
SMBG recommendations for 780G system:
Calibration is not required with the MiniMed 780G system using the 
DS5. 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 the
SmartGuard feature. Subjects will be instructed to perform SMBG if 
their symptoms do not match the sensor glucose (SG) value (i.e., they 
develop symptoms of hypoglycemia or hyperglycemia, but the SG
value does not correlate with their symptoms). 
Sample Size and 
Investigational Centers
A total of up to 250 subjects with insulin-requiring type 1 diabetes age 
7-80 will be enrolled at up to 25 investigational centers across the 
United States in order to have 200 subjects enter the study period. Up 
to 125 subjects will be enrolled in the pediatric age group (7-17 years 
of age), up to 125 in the adult age group (18 years or older):
Subject Age Group
Sub-groups
Enrollment Goal (N)
Pediatric
Age 7 – 17 years
Age 7 - 13 years
Minimum 20 Subjects
Age 14 - 17 years
Minimum 20 Subjects
Investigational centers will be encouraged to enroll a study population 
that represents a wide variety of backgrounds.  
Duration
The study is anticipated to last approximately 18 months from first 
investigational center initiation to study completion. Individual subject 
participation is expected to be approximately 120 days through the 
study period.
Inclusion Criteria
1.
Age 7 - 80 years at time of screening.
2.
Has a clinical diagnosis of type 1 diabetes:
a.
14 – 80 years of age: A clinical diagnosis of type 1 
diabetes for 2 years or more as determined via medical 
record or source documentation by an individual qualified 
to make a medical diagnosis.
b.
7 – 13 years of age: A clinical diagnosis of type 1 diabetes 
for 1 year or more as determined via medical record or 

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 13 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
source documentation by an individual qualified to make a 
medical diagnosis.
3.
Does not require a legally authorized representative to consent on 
their behalf due to mental or intellectual disability.
4.
Subject or parent/caregiver is literate and able to read the
language offered in the pump or pump materials.
5.
Subject and/or legally authorized representative is willing to 
provide informed consent for participation.
6.
Is willing to perform fingerstick blood glucose measurements as 
needed.
7.
Is willing to wear the system continuously throughout the study.
8.
Must have a minimum daily insulin requirement (Total Daily Dose) 
of greater than or equal to 8 units.
9.
Has a Glycosylated hemoglobin (HbA1c) less than 10% (as 
processed by Central Lab) at time of screening visit.
Note: All HbA1c blood specimens will be sent to and tested by 
a National Glycohemoglobin Standardization Program (NGSP)
certified Central Laboratory.  HbA1c testing must follow NGSP 
standards.  
10. Has thyroid-stimulating hormone (TSH) in the normal range OR if 
the TSH is out of normal reference range the Free T3 is below or 
within the lab’s reference range and Free T4 is within the normal 
reference range.  
11. Uses pump therapy for greater than 6 months prior to screening 
(with or without CGM experience).
12. Is willing to upload data from the study pump, must have Internet 
access, and a computer system, or compatible smartphone that 
meets the requirements for uploading the study pump.
13. Is willing to take one of the following insulins and can financially 
support the use of insulin preparations as required by the study: 
a.
Humalog (insulin lispro injection)
b.
NovoLog (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 DKA 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).

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 14 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
6.
Is female of child-bearing potential and result of pregnancy test is 
positive at screening.
7.
Is sexually active female of child-bearing potential and is not using 
a form of contraception deemed reliable by the investigator.
8.
Is female and plans to become pregnant during the course of the 
study.
9.
Is being treated for hyperthyroidism at time of screening.
10. Has diagnosis of adrenal insufficiency.
11. 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.
12. Is using hydroxyurea at time of screening or plans to use it during 
the study.
13. 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.
14. Has used a MiniMed 780G pump prior to screening.
15. Is currently abusing illicit drugs.
16. Is currently abusing marijuana.
17. Is currently abusing prescription drugs.
18. Is currently abusing alcohol.
19. Using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or 
other GLP-1 agonists), metformin, canagliflozin (Invokana or other 
SGLT2 inhibitors) at time of screening.
20. Has a history of visual impairment which would not allow subject 
to participate in the study and perform all study procedures safely, 
as determined by the investigator.
21. Has elective surgery planned that requires general anesthesia 
during the course of the study.
22. Has sickle cell disease, hemoglobinopathy; or has received red 
blood cell transfusion or erythropoietin within 3 months prior to 
time of screening.
23. Plans to receive red blood cell transfusion or erythropoietin over 
the course of study participation.
24. Is diagnosed with current eating disorder such as anorexia or 
bulimia.
25. Has been diagnosed with chronic kidney disease that results in 
chronic anemia.
26. Has a hematocrit that is below the normal reference range of lab 
used.  
27. Is on dialysis.
28. Has serum creatinine of >2 mg/dL.
29. Has celiac disease that is not adequately treated as determined by 
the investigator.
30. Has had any of the following cardiovascular events within 1 year 
of screening: myocardial infarction, unstable angina, coronary 
artery bypass surgery, coronary artery stenting, transient ischemic 
attack, cerebrovascular accident, angina, congestive heart failure, 
or ventricular rhythm disturbances.

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 15 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
31. Has had history of cardiovascular event 1 year or more from the 
time of screening without 
a.
a normal EKG and stress test within 6 months prior to 
screening or during screening or 
b.
clearance from a qualified physician prior to receiving the 
study devices if there is an abnormal EKG or stress test.
32. Has 3 or more cardiovascular risk factors listed below without a 
normal EKG within 6 months prior to screening or during screening 
or clearance from a qualified physician if there is an abnormal 
EKG:

Age >35 years

Type 1 diabetes of >15 years’ duration

Presence of any additional risk factor for coronary artery 
disease

Presence of microvascular disease (proliferative 
retinopathy or nephropathy, including microalbuminuria)

Presence of peripheral vascular disease

Presence of autonomic neuropathy
33. Is a member of the research staff involved with the study.
34. Is a Medtronic Diabetes employee or their immediate family 
member (excluding adult children and/or adult siblings).
Study Visit Schedule
Subjects may participate in up to 15 planned study visits, as presented 
below in Synopsis Figure 1, for approximately 120 days of device 
wear. A virtual office visit (audio visual) may be performed for certain 
office visits where an office visit is not possible. For detailed 
information, see Section 9.1.1.
Visit 1 to Visit 6 must be completed in 30 days.

Visit 1 (Office/Virtual Office): Consent and screening
o
Collect labs
Run-In: 

Visit 2 (Office/Virtual Office): Start Run-In
o
Eligibility has been confirmed 
o
Start study pump and CGM
o
Adjust pump settings as needed
o
Register and upload study pump in CareLink Personal
and CareLink system

Visit 3 (Phone): Day 1 after Visit 2 – Required for subjects 
without CGM or closed loop experience; as needed for all 
others
o
Ask subjects and their parents/caregivers (if 
applicable) if they require assistance, e.g., additional 
training
o
Ask subjects about adverse events and device 
performance
o
Review CareLink reports

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 16 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template

Visit 4 (Phone): Day 3 (±1 day) after Visit 2 – Required for 
subjects without CGM or closed loop experience; as needed 
for all others
o
Ask subjects and their parents/caregivers (if 
applicable) if they require assistance, e.g., additional 
training
o
Ask subjects about adverse events and device 
performance
o
Review CareLink reports

Visit 5 (Phone): Day 7 (±2 days) after Visit 2 
o
Ask subjects and their parents/caregivers (if 
applicable) if they require assistance, e.g., additional 
training
o
Ask subjects about adverse events and device 
performance
o
Review CareLink reports

Visit 6 (Office/Virtual Office): Day 14 (±3 days) after Visit 2
o
Ask subjects and their parents/caregivers (if 
applicable) if they require assistance, e.g., additional 
training
o
Ask subjects about adverse events and device 
performance
o
Review CareLink reports
o
Visit 6 and 7 may be combined
Study Period: 

Visit 7 (Office/Virtual Office): Start Study Period, 
Day 7 (-7 days) after Visit 6
o
Adjust pump settings as needed
o
Ask subjects about adverse events and device 
performance
o
Review CareLink reports
o
Start Auto Basal target at 120 mg/dL setpoint with 
Active Insulin Time set to 4 hours, titrate towards 2-3 
hours or at investigator’s discretion
o
Turn on SmartGuard with Auto Corrections “ON”

Visit 8 (Phone): Day 2 after Visit 7 – Required for subjects 
without CGM or closed loop experience; as needed for all 
others
o
Adjust pump settings as needed
o
Ask subjects and their parents/caregivers (if 
applicable) if they require assistance, e.g., additional 
training
o
Ask subjects about adverse events and device 
performance
o
Review CareLink reports

Visit 9 (Phone): Day 7 (±2 days) after Visit 7
o
Adjust pump settings as needed
o
Ask subjects about adverse events and device 
performance

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 17 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
o
Review CareLink reports

Visit 10 (Phone): Day 14 (±3 days) after Visit 7
o
Adjust pump settings as needed
o
Ask subjects about adverse events and device 
performance
o
Review CareLink reports

Visit 11 (Phone): Day 21 (±3 days) after Visit 7
o
Adjust pump settings as needed
o
Ask subjects about adverse events and device 
performance
o
Review CareLink reports
o
Change Auto Basal target to 100 mg/dL setpoint with 
Active Insulin Time set to 2-3 hours or at 
investigator’s discretion

Visit 12 (Office/Virtual Office): Day 28 (+7 days) after Visit 7
o
Adjust pump settings as needed
o
Ask subjects about adverse events and device 
performance
o
Review CareLink reports

Visit 13 (Phone): Day 44 (±3 days) after Visit 7
o
Adjust Auto Basal target with Active Insulin Time at 
investigator’s discretion
o
Ask subjects about adverse events and device 
performance
o
Review CareLink reports

Visit 14 (Office/Virtual Office): Day 60 (+7 days) after Visit 7
o
Ask subjects about adverse events and device 
performance
o
Review CareLink reports

Visit 15 (Office/Virtual Office): Day 90 (+7 days) after Visit 7
o
Collect HbA1C
o
Ask subjects about adverse events and device 
performance
o
Review CareLink reports
o
Return study devices
o
End of Study (EOS)

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 18 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
Synopsis Figure 1. Visit Schedule
Run-in Period
Office/Virtual 
Office 
Visit 1
Consent & 
Screening
Phone
Visit 3
Day 1 after 
Visit 2
Office/Virtual 
Office
Visit 2
Start Study 
Pump & CGM
Visit Schedule
Study Period
Visit 1 to Visit 6 must be completed in 30 days.
Office/Virtual Office 
Visit 6
Day 14 (±3 days) 
after Visit 2
Phone 
Visit 4
Day 3 (±1 
day) after 
Visit 2
Office/Virtual 
Office 
Visit 7
Day 7 (-7 days) 
after Visit 6
Phone
Visit 8
Day 2 after 
Visit 7
Phone 
Visit 10
Day 14
(±3 days) 
after Visit 7
Phone 
Visit 11
Day 21 
(±3 days) 
after Visit 7
Office/Virtual Office
Visit 12
Day 28
(+7 days) after Visit 
7
Phone 
Visit 13
Day 44 
(±3 days) after 
Visit 7
Office/Virtual Office 
Visit 15
Day 90
(+7 days) after Visit 7
EOS
Phone 
Visit 5
Day 7 (±2 
days) after 
Visit 2  
Phone
Visit 9
Day 7 (±2 
days) after 
Visit 7
Office/Virtual Office
Visit 14
Day 60
(+7 days) after Visit 7

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 19 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
Safety and 
Monitoring/Risk Analysis
Safety monitoring and risk analysis details are described in Section 
9.4.
Device Deficiencies 
Subject and investigational center reports of device deficiencies (DDs)
will be collected by subjects and/or investigational centers calling the 
24-Hour Technical Support (TS) for device troubleshooting and device 
complaints. For additional information, see Section 13.
Statistical Analysis for 
Endpoints and Hypothesis
Safety and effectiveness endpoints will be evaluated independently for
ages 18-80 and ages 7-17. 
Primary Safety Endpoint

Age 18-80: The overall mean change in HbA1c from baseline 
to end of 3-month study period. The goal is to show non-
inferiority with a margin of 0.4% comparing to a threshold of -
0.5% in reducing HbA1c from baseline to end of 3-month 
study period.

Age 7-17: The overall mean change in HbA1c from baseline to 
end of 3-month study period. The goal is to show non-
inferiority with a margin of 0.4% comparing to a threshold of -
0.38% in reducing HbA1c from baseline to end of 3-month 
study period.
Primary Effectiveness Endpoint

Age 18-80: The mean % of time in range (TIR 70-180 mg/dL) 
will be estimated and compared to a threshold of 73.7% by a 
non-inferiority test with a margin of 7.5% and a significance 
level of 0.025 (one-sided). 

Age 7-17: The mean % of time in range (TIR 70-180 mg/dL) 
will be estimated and compared to a threshold of 65.3% by a 
non-inferiority test with a margin of 7.5% and a significance 
level of 0.025 (one-sided). 
Secondary Effectiveness Endpoints

Age 18-80: The mean % of time in hypoglycemia (< 54 
mg/dL) will be estimated and compared to a threshold of 
0.86% by a non-inferiority test with a margin of 2% and a 
significance level of 0.025 (one-sided).

Age 18-80: The mean % of time in range (TIR 70-180 mg/dL) 
will be estimated and compared to a threshold of 73.7% by a 
simple superiority test and a significance level of 0.025 (one-
sided).  

Age 7-17: The mean % of time in hypoglycemia (< 54 
mg/dL) will be estimated and compared to a threshold of 
0.71% by a non-inferiority test with a margin of 2% and a 
significance level of 0.025 (one-sided). 

Age 7-17: The mean % of time in range (TIR 70-180 mg/dL) 
will be estimated and compared to a threshold of 65.3% by a 
simple superiority test and a significance level of 0.025 (one-
sided).  

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 20 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
Descriptive Endpoints

Time spent in the SmartGuard feature versus time spent in 
Manual Mode 

Change in mean glucose value from baseline to EOS

Time in different ranges (% of SG): SG < 70 mg/dL, 70 
mg/dL ≤ SG ≤140 mg/dL, SG > 140 mg/dL, 180 mg/dL, 250 
mg/dL, and 350 mg/dL

Number of Events, Area Under Curve (AUC) and Time in the 
hyperglycemic range: SG > 140 mg/dL, 180 mg/dL, 250
mg/dL, and 350 mg/dL

Number of Events, AUC and Time in the hypoglycemic range: 
SG < 54 mg/dL and 70 mg/dL 

Change of Total Daily Dose (TDD) of insulin from baseline to 
EOS 

Change of weight from baseline to EOS 

Subgroup analysis will be performed for:
o
Setpoint
100 mg/dL
110 mg/dL
120 mg/dL
150 mg/dL (Temp Target Usage)
Safety Data Summarized

Serious Adverse Events (SAE) 

Serious Adverse Device Effects (SADE)

Unanticipated Adverse Device Effects 

Incidence of Severe Hypoglycemia   

Incidence of Severe Hyperglycemia   

Incidence of DKA
Device Deficiencies
Descriptive summary will be used to characterize DDs:

All reports of device issues.
Subject Feedback
Descriptive summary will be used to characterize study 
survey/questionnaire results. Refer to CIP337 Survey/Questionnaire 
Guide for administration details.
Simulation Data
Computer simulated data may be compared to study data.
Final Report
The study results will be summarized and presented in the final report.

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 21 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
3. Introduction
3.1
Background
In patients with insulin dependent diabetes mellitus, glycemic control is influenced by numerous factors 
such as insulin dosage, insulin absorption, timing, physiological/ lifestyle factors such as exercise, food 
intake, hormones and illness. These factors may contribute to significant variability in insulin 
requirements, which makes self-management of type 1 diabetes challenging.
Patients who are using continuous glucose monitoring (CGM), including sensor-augmented pump therapy, 
experience improvements in glycemic control. Advanced sensor-augmented insulin pumps are now being 
used in clinical practice including closed loop systems that automatically adjust the amount of insulin 
delivered to maintain glucose levels near the target value set by the user. 1
The MiniMed 780G system is a closed loop insulin system. In addition to automatically adjusting the 
amount of insulin delivered based on sensor glucose (SG) readings while operating with the SmartGuard 
feature activated, 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 and is under review by the United States Food and 
Drug Administration (FDA). Previous clinical investigations involved the 670G Version 4.0 pump (contains 
the 780G Advanced Hybrid Closed Loop [AHCL] algorithm) used in combination with the Guardian Sensor 
(3) glucose sensor, Guardian Link (3) transmitter, Humalog, and Novolog insulin. This investigation is 
intended to confirm safety and effectiveness of the 780G insulin pump used in combination with the DS5,
which 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.
3.2
Purpose
The purpose of this study is to confirm the safety and effectiveness of the MiniMed 780G insulin pump 
used in combination with the DS5 CGM in type 1 diabetes adult and pediatric subjects in a home setting.
4. Objectives and Endpoints
4.1
Objectives
The objective of this study is to evaluate the safety and effectiveness of the MiniMed 780G insulin pump 
used in combination with the DS5 CGM.
4.2
Endpoints
Safety and effectiveness endpoints will be evaluated independently for ages 18-80 and ages 7-17. 

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 22 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
4.2.1 Primary Safety Endpoint

Age 18-80: The overall mean change in HbA1c from baseline to end of 3-month study period. 
The goal is to show non-inferiority with a margin of 0.4% comparing to a threshold of -0.5% in 
reducing HbA1c from baseline to end of 3-month study period.

Age 7-17: The overall mean change in HbA1c from baseline to end of 3-month study period. The 
goal is to show non-inferiority with a margin of 0.4% comparing to a threshold of -0.38% in 
reducing HbA1c from baseline to end of 3-month study period.
4.2.2 Primary Effectiveness Endpoint

Age 18-80: The mean % of time in range (TIR 70-180 mg/dL) will be estimated and compared 
to a threshold of 73.7% by a non-inferiority test with a margin of 7.5% and a significance level 
of 0.025 (one-sided). 

Age 7-17: The mean % of time in range (TIR 70-180 mg/dL) will be estimated and compared to 
a threshold of 65.3% by a non-inferiority test with a margin of 7.5% and a significance level of 
0.025 (one-sided). 
4.2.3 Secondary Effectiveness Endpoint

Age 18-80: The mean % of time in hypoglycemia (< 54 mg/dL) will be estimated and compared 
to a threshold of 0.86% by a non-inferiority test with a margin of 2% and a significance level of 
0.025 (one-sided).

Age 18-80: The mean % of time in range (TIR 70-180 mg/dL) will be estimated and compared 
to a threshold of 73.7% by a simple superiority test and a significance level of 0.025 (one-
sided).  

Age 7-17: The mean % of time in hypoglycemia (< 54 mg/dL) will be estimated and compared 
to a threshold of 0.71% by a non-inferiority test with a margin of 2% and a significance level of 
0.025 (one-sided). 

Age 7-17: The mean % of time in range (TIR 70-180 mg/dL) will be estimated and compared to 
a threshold of 65.3% by a simple superiority test and a significance level of 0.025 (one-sided).  
4.2.4 Descriptive Endpoints

Time spent in the SmartGuard feature versus time spent in Manual Mode 

Change in mean glucose value from baseline to EOS

Time in different ranges (% of SG): SG < 70 mg/dL, 70 mg/dL ≤ SG ≤140 mg/dL, SG > 140
mg/dL, 180 mg/dL, 250 mg/dL, and 350 mg/dL

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 23 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template

Number of Events, Area Under Curve (AUC) and Time in the hyperglycemic range: SG > 140
mg/dL, 180 mg/dL, 250 mg/dL, and 350 mg/dL

Number of Events, AUC and Time in the hypoglycemic range: SG < 54 mg/dL and 70 mg/dL 

Change of Total Daily Dose (TDD) of insulin from baseline to EOS 

Change of weight from baseline to EOS 

Subgroup analysis will be performed for:
o
Setpoint
100 mg/dL
110 mg/dL
120 mg/dL
150 mg/dL (Temp Target Usage)
4.2.5
Safety Data Summarized

Serious Adverse Events (SAE) 

Serious Adverse Device Effects (SADE)

Unanticipated Adverse Device Effects 

Incidence of Severe Hypoglycemia   

Incidence of Severe Hyperglycemia   

Incidence of DKA

Serious Adverse Events (SAE) 

Serious Adverse Device Effects (SADE)

Unanticipated Adverse Device Effects 

Incidence of Severe Hypoglycemia   

Incidence of Severe Hyperglycemia   

Incidence of DKA

Serious Adverse Events (SAE) 

Serious Adverse Device Effects (SADE)

Unanticipated Adverse Device Effects 

Incidence of Severe Hypoglycemia   

Incidence of Severe Hyperglycemia   

Incidence of DKA

Serious Adverse Events (SAE) 

Serious Adverse Device Effects (SADE)

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 24 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template

Unanticipated Adverse Device Effects 

Incidence of Severe Hypoglycemia   

Incidence of Severe Hyperglycemia   

Incidence of DKA
4.2.6 Device Deficiencies
Descriptive summary will be used to characterize DDs:

All reports of device issues.
4.2.7 Subject Feedback
Descriptive summary will be used to characterize study survey/questionnaire results. Refer to CIP337
Survey/Questionnaire Guide for administration details.
4.2.8 Simulation Data
Computer simulated data may be compared to study data.
5. Study Design
This study is a multi-center, single arm study in insulin-requiring adult and pediatric subjects with type 1 
diabetes on the MiniMed 780G system using DS5 as well as Medtronic Extended infusion set and 
reservoir. The run-in period and study period will be approximately 120 days long. 
The period from Visit 1 (consent and screening) through Visit 6 must be completed in 30 days.
Run-in Period (Visits 2-6): 
The run-in period begins at Visit 2 and ends once Visit 7 occurs.
The intent of the run-in period will be to allow subjects to become familiar with new study devices while 
using their own insulin: Humalog™(insulin lispro injection), NovoLog® (insulin aspart solution for 
injection), or Admelog® (insulin lispro injection). During the run-in period, study subjects will be using the 
study pump with only the Sensor Augmented Pump (SAP) function activated (i.e., SmartGuard™feature 
is turned OFF), DS5, Medtronic Extended infusion set and reservoir. 

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 25 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
SmartGuard (with Auto Correction OFF) during the run-in period will be permitted for study subjects who 
are using the Auto Mode feature in a Medtronic pump prior to screening. In the 780G study pump, the 
term “Auto Mode” has been replaced with “SmartGuard”. All others are to use the system in Manual Mode 
during the run-in period.
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) in 
non-Medtronic pump
Manual Mode
SAP (with closed loop) in 
Medtronic pump as Auto 
Mode
SmartGuard feature with 
Auto Correction OFF
During the run-in period and only for subjects with Auto Mode experience through the use of a Medtronic 
insulin pump, a 120 mg/dL Auto Basal target should be set. It is recommended that Active Insulin Time is 
set to 4 hours.
Note: The Auto Basal target setting and Active Insulin Time should be set as recommended above, unless 
there is a documented safety reason that would not permit these settings to be used.
Subjects who do not have experience with Medtronic insulin pumps, as specified above, will use the 
system in Manual Mode.
All subjects and their parents/caregivers (if applicable) will be trained on diabetes management 
principles, such as the treatment of hyperglycemia and hypoglycemia. In addition, there will be training 
regarding the need to have access to and how to use glucose and glucagon in case of hypoglycemia.  
Parents/caregivers (if applicable) will be instructed that they should be with the subject in the same 
residence or building overnight.
If the MiniMed Clinical app and the CareLink Clinical app are being used, parents/caregivers (if applicable)
will be instructed that subjects should be connected to CareLink via the appropriate Smartphone app for 
data uploading and push notifications for low or high blood sugar when they are apart, e.g., at school, 
other activities. Instructions on the appropriate operation of the apps will be provided.
For study purposes, subjects and parents/caregivers (if applicable) will be trained and/or instructed to 
perform self-monitoring of blood glucose (SMBG) if subjects are experiencing a severe hypoglycemic 
event, severe hyperglycemic event or diabetic ketoacidosis (DKA). Subjects and their parents/caregivers
(if applicable) will also be instructed to check subject blood ketones using a Precision Xtra ketone meter 

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 26 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
or other approved ketone meter if the Accu-Chek Guide Link study meter reading is greater than 300
mg/dL.
As a precaution, subjects and their parents/caregivers (if applicable) will be told that subjects should 
keep their own insulin pump supplies in a safe place and to have back up supplies on hand (such as 
insulin and syringe, or insulin pen) in the event they are asked to revert back to their own therapy during 
the study or experience study pump issues (i.e., infusion set occlusion with high glucose).  
Subjects and their parents/caregivers (if applicable) will be instructed to insert the DS5 into subjects only 
in the locations that are specified in the User Guide. Reminders will be given to subjects and their 
parents/caregivers (if applicable) at each office visit. Information about sensor insertions will be collected 
at each study visit on an electronic case report form (eCRF) in the study database, e.g., insertion 
location.
Subjects and their parents/caregivers (if applicable) will be trained on all parts of the device system. This 
will involve live training conducted by the investigational center staff. A training checklist for both subject
and parents/caregivers (if applicable) will be implemented and completed. Parents/caregivers (if 
applicable) should be available for relevant parts or all of this training, either in person or virtually.
After completion of training on the study devices, subjects and their parents/caregivers (if applicable) 
may attend additional visits in the days immediately following the start of system use, as needed. 
Study Period (Visits 7-15):
All subjects will continue using the study pump with SmartGuard feature enabled (including Auto 
Correction), Humalog/ NovoLog/ Admelog, DS5, infusion set and reservoir. During the study period, each 
subject will be encouraged to continue on the same brand of insulin with which they started. All 
SmartGuard™features will be activated and should be used for the duration of the study period. 
Subjects should use the system with the SmartGuard feature 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 the SmartGuard feature. During times when subjects are not able to use the SmartGuard 
feature, they should use the system in Manual Mode (e.g., with Suspend before low or Suspend on low
activated).
Therapy at Screening
Pump Setting During Study Period
Continuous Subcutaneous Insulin Infusion (CSII)
SmartGuard feature with Auto Correction ON
SAP (no closed loop)
SmartGuard feature with Auto Correction ON
SAP (with closed loop) in non-Medtronic pump
SmartGuard feature with Auto Correction ON
SAP (with closed loop) in Medtronic pump as Auto 
Mode
SmartGuard feature with Auto Correction ON

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 27 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
During the first 3 weeks (between Visits 7 and 11) 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 or at the investigator’s discretion.
During the next 3 weeks (between Visits 11 and 13) of the study period, the Auto Basal target setting 
should be set to 100 mg/dL. Active Insulin Time is recommended to be set to 2-3 hours or at 
investigator’s discretion.
During the remaining weeks of the study (any time after Visit 13) of the study period, the Auto Basal 
target as well as Active Insulin Time should be set to what is best for the individual subject, at 
investigator’s discretion.
Note: The Auto Basal target setting and Active Insulin Time should be set as recommended above, unless 
there is a documented safety reason that would not permit these settings to be used.
After completion of live training on the SmartGuard function, subjects and their parents/caregivers (if 
applicable) may attend additional visits in the days immediately following the start of SmartGuard use, as 
needed. 
SMBG recommendations for 780G system:
Calibration is not required with the MiniMed 780G system using the DS5. 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 the SmartGuard feature. Subjects 
will be instructed to perform SMBG if their symptoms do not match the sensor glucose (SG) value (i.e.,
they develop symptoms of hypoglycemia or hyperglycemia, but the SG value does not correlate with their 
symptoms). 
5.1
Duration
The study is anticipated to last approximately 18 months from first investigational center initiation to 
study completion. Individual subject participation is expected to be approximately 120 days through the 
study period.
5.2
Rationale
The accuracy of the DS5 has been evaluated in previous clinical trials and has been confirmed to provide 
performance that meets the previously established requirements for glucose sensors used with the 
MiniMed 780G pump. This investigation is required to provide additional confirmation of the safety of the 
pump used in combination with the DS5.

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 28 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
6. Product Description
6.1
Intended Use
The MiniMed 780G system is intended for use by people seven years and older with type 1 diabetes who 
require at least 8 units of insulin per day.

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 29 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
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 Regulatory 
Status
MiniMed 780G Insulin Pump
MMT-1884
Investigational
DS5
MMT-5100
Investigational
Medtronic Extended infusion 
set 
MMT-430, MMT-431, MMT-432, MMT-433, 
MMT-440, MMT-441, MMT-442, and MMT-
443
Non-Investigational
Medtronic Extended Reservoir 
MMT-342
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
Non-Investigational
MiniMed Clinical App
MMT-6103 Android; MMT-6104 IOS
Non-Investigational**
CareLink Clinical App
MMT-6113 Android; MMT-6114 IOS
Non-Investigational**
Blue Adapter
ACC-1003911
Non-Investigational
Precision Xtra Ketone Meter or 
other approved ketone meter
N/A
Non-Investigational
*Class I exempt
**Class II exempt
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 will be used in combination with the following devices (MiniMed 
780G System and components presented in Figure 1):

The MiniMed 780G 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 app, to provide a secondary display for passive monitoring of CGM and pump 
data for the user.

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 30 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template

The MiniMed 780G Pump also transmits data to CareLink Personal/CareLink system software 
through the Blue Adapter/ MiniMed Clinical app.
Figure 1. 780G System and Components
6.3.2
Disposable Sensor (DS5)
The Disposable Sensor, referred to as DS5 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. 

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 31 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
Figure 2. DS5
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
The cannula, connected to the catheter hub, is introduced into subcutaneous tissue (i.e., infusion site).  
The tubing connects the catheter hub and the tubing connector to provide the fluid from the medication 
reservoir housed within the insulin pump.
The device utilizes a new high-performance tubing connector (H-Cap) to replace the current proprietary 
Paradigm connector (P-Cap), an extended wear tubing to replace the current tubing, and an extended 
wear adhesive patch. Figure 2 and Figure 3 illustrate the device and the tubing connectors.

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 32 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
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). 
Figure 3. Medtronic Extended infusion set
Figure 4. Connector, P-Cap (Left); High-Performance Connector, H-Cap (Right)

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 33 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
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.
6.4.3 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.
6.4.4 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:

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 34 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template

The internet to the web server;

Web server to the application server;

Application server to the database server.
6.4.5 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. 
6.4.6
Accessory Applications – MiniMed 780G system
The MiniMed Clinical app is an optional accessory, which receives pump data via Bluetooth Low Energy 
wireless communication from the pump. The MiniMed Clinical 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 app is not designed to control or monitor the 
performance of the insulin pump nor for direct monitoring of pump data. As a mirroring display, the app 
can provide alerts to the subject via the user interface. All alerts must be addressed on the insulin pump. 
The CareLink Clinical app is an optional accessory which receives pump data wirelessly from the CareLink
server. The CareLink Clinical app provides a mirroring display of the MiniMed Clinical app screen, for 
remote monitoring by a care partner (e.g., caregiver). The CareLink Clinical app is not designed to 
monitor the performance of the insulin pump nor for direct monitoring of pump data. As a mirroring 
display, the app can provide notifications to the care partner via the user interface. 
6.4.7
Blue Adapter
The Blue Adapter is an optional accessory with Bluetooth technology that facilitates the communication 
between a PC and the insulin pump, via a Bluetooth Low Energy wireless communication protocol. The 
Blue Adapter is an off-the-shelf non-medical device intended to transfer data to CareLink server. The Blue 
Adapter does not have any computation, diagnostic, monitoring or therapeutic function/benefit. 
Medtronic will provide the Blue Adapter as a convenience to subjects as an alternative for subjects when 
automatic uploads via the MiniMed Clinical app are not possible.
6.4.8
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 

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 35 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
Investigator/Coordinator binder for details) and as described in the body of this study CIP. 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, upon request.
6.6
Consumable Devices
Glucose meter accessories (e.g., Accu-Chek Guide test strips), 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.

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 36 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
Table 2. Device 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 Investigational 
Center
Record 
Returned or 
Not Returned 
to Sponsor on 
Site Returned 
eCRF
Investigational Center 
Return Device to Sponsor 
at Conclusion of Study
MiniMed 780G Insulin 
Pump 
(MMT-1884)
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)
Medtronic Extended 
infusion set 
(MMT-430, MMT-431, 
MMT-432, MMT-433, 
MMT-440, MMT-441, 
MMT-442, and MMT-
443)
Yes
Yes
Yes (Complaint)
No* (Non-complaint used 
and unused)
Yes
Yes (Complaint)
No* (Non-complaint used 
and unused)
Medtronic Extended 
Reservoir 
(MMT-342)
Yes
Yes
Yes (Complaint)
No* (Non-complaint used
and unused)
Yes
Yes (Complaint)
No* (Non-complaint used 
and unused)

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 37 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
Device
Record on 
Site Received 
eCRF
Record 
Disbursement, 
Returned or Not 
Returned from 
Subject on Subject 
Device Identification 
eCRF
Subject Return Device 
to Investigational 
Center
Record 
Returned or 
Not Returned 
to Sponsor on 
Site Returned 
eCRF
Investigational Center 
Return Device to Sponsor 
at Conclusion of Study
Roche Accu-Chek 
Guide Link Study 
Meter**
(08116083022)
Yes
Yes
Yes
Yes
No*
Ketone meter
Yes
Yes
Yes
Yes
No*
Smartphone, as 
approved for 
distribution 
Yes
Yes
Yes
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.
**Devices may be combined and distributed in kits. 

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 38 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
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 
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 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.  

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 39 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
Other consumable devices (e.g., alcohol wipes, study meter supplies, and tape), and accessories shipped 
in kits, supplies or materials may be returned to the sponsor, they may be retained by investigational 
centers for educational purposes only, or they may be disposed of appropriately by the investigational 
center staff.  
Disposable and consumable devices that have been used by a subject will be disposed of appropriately
by the subject or the investigational center staff during the conduct of the study. 
All study devices that are required to be entered into the study database and/or source document must 
be accounted for as described above before they are returned to the sponsor. 
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.
8. Selection of Subjects
8.1
Study Population
A total of up to 250 subjects with insulin-requiring type 1 diabetes age 7-80 will be enrolled at up to 25
investigational centers across the United States in order to have 200 subjects enter the study period. Up 
to 125 subjects will be enrolled in the pediatric age group (7-17 years of age), up to 125 in the adult age 
group (18 years or older):
Subject Age Group
Sub-groups
Enrollment Goal (N)
Pediatric
Age 7 – 17 years
Age 7 - 13 years
Minimum 20 Subjects
Age 14 - 17 years
Minimum 20 Subjects

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 40 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
Investigational centers will be encouraged to enroll a study population that represents a wide variety of 
backgrounds.  
8.2
Subject Enrollment
Subjects will be considered enrolled in the study upon signing the ICF and assent form (if applicable).
A subject will be assigned a unique study subject ID via the eCRF, which is a 9-digit code (337XXXXXX).  
The first three digits refer to the CIP number (337), 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., 337002001
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.
Age 7 - 80 years at time of screening.
2.
Has a clinical diagnosis of type 1 diabetes:
a.
14 – 80 years of age: A clinical diagnosis of type 1 diabetes for 2 years or more as 
determined via medical record or source documentation by an individual qualified to 
make a medical diagnosis.
b.
7 – 13 years of age: A clinical diagnosis of type 1 diabetes for 1 year or more as 
determined via medical record or source documentation by an individual qualified to 
make a medical diagnosis.
3.
Does not require a legally authorized representative to consent on their behalf due to mental or 
intellectual disability.
4.
Subject or parent/caregiver is literate and able to read the language offered in the pump or pump 
materials.
5.
Subject and/or legally authorized representative is willing to provide informed consent for 
participation.
6.
Is willing to perform fingerstick blood glucose measurements as needed.
7.
Is willing to wear the system continuously throughout the study.
8.
Must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units.
9.
Has a Glycosylated hemoglobin (HbA1c) less than 10% (as processed by Central Lab) at time of 
screening visit.
Note: All HbA1c blood specimens will be sent to and tested by a National Glycohemoglobin 
Standardization Program (NGSP) certified Central Laboratory.  HbA1c testing must follow NGSP 
standards.  
10. Has thyroid-stimulating hormone (TSH) in the normal range OR if the TSH is out of normal reference 
range the Free T3 is below or within the lab’s reference range and Free T4 is within the normal 
reference range.  
11. Uses pump therapy for greater than 6 months prior to screening (with or without CGM experience).
12. Is willing to upload data from the study pump, must have Internet access, and a computer system,
or compatible smartphone that meets the requirements for uploading the study pump.
13. Is willing to take one of the following insulins and can financially support the use of insulin 
preparations as required by the study: 
a.
Humalog (insulin lispro injection)
b.
NovoLog (insulin aspart injection)
c.
Admelog (insulin lispro injection)

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 41 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
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 DKA 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).
6.
Is female of child-bearing potential and result of pregnancy test is positive at screening.
7.
Is sexually active female of child-bearing potential and is not using a form of contraception deemed 
reliable by the investigator.
8.
Is female and plans to become pregnant during the course of the study.
9.
Is being treated for hyperthyroidism at time of screening.
10. Has diagnosis of adrenal insufficiency.
11. 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.
12. Is using hydroxyurea at time of screening or plans to use it during the study.
13. 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.
14. Has used a MiniMed 780G pump prior to screening.
15. Is currently abusing illicit drugs.
16. Is currently abusing marijuana.
17. Is currently abusing prescription drugs.
18. Is currently abusing alcohol.
19. Using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, 
canagliflozin (Invokana or other SGLT2 inhibitors) at time of screening.
20. Has a history of visual impairment which would not allow subject to participate in the study and 
perform all study procedures safely, as determined by the investigator.
21. Has elective surgery planned that requires general anesthesia during the course of the study.
22. Has sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin 
within 3 months prior to time of screening.
23. Plans to receive red blood cell transfusion or erythropoietin over the course of study participation.

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 42 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
24. Is diagnosed with current eating disorder such as anorexia or bulimia.
25. Has been diagnosed with chronic kidney disease that results in chronic anemia.
26. Has a hematocrit that is below the normal reference range of lab used.  
27. Is on dialysis.
28. Has serum creatinine of >2 mg/dL.
29. Has celiac disease that is not adequately treated as determined by the investigator.
30. Has had any of the following cardiovascular events within 1 year of screening: myocardial infarction, 
unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, 
cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances.
31. Has had history of cardiovascular event 1 year or more from the time of screening without 
a.
a normal EKG and stress test within 6 months prior to screening or during screening or 
b.
clearance from a qualified physician prior to receiving the study devices if there is an 
abnormal EKG or stress test.
32. Has 3 or more cardiovascular risk factors listed below without a normal EKG within 6 months prior to 
screening or during screening or clearance from a qualified physician if there is an abnormal EKG:

Age >35 years

Type 1 diabetes of >15 years’ duration

Presence of any additional risk factor for coronary artery disease

Presence of microvascular disease (proliferative retinopathy or nephropathy, including 
microalbuminuria)

Presence of peripheral vascular disease

Presence of autonomic neuropathy
33. Is a member of the research staff involved with the study.
34. Is a Medtronic Diabetes employee or their immediate family member (excluding adult children and/or 
adult siblings).
9. Study Procedures
9.1
Schedule of Events
Subjects may participate in up to 15 planned study visits, as presented in Figure 5 (Section 9.1.1) for 
approximately 120 days of device wear. A virtual office visit (audio visual) may be performed for certain 
office visits where an office visit is not possible. The exit visit should occur at the office, unless an 
emergent situation occurs.
If the subject visits the investigational center outside of the scheduled study visits, a Visit eCRF will be 
completed to document the reason for the unscheduled visit.
Refer to Section 9.1.1, Table 3 for the Visit Details.
If subject exits the study early (i.e., before their last scheduled visit), HbA1c requirements that apply to 
the final visit will be completed for subjects who have completed Visit 7. Refer to CIP337 
Survey/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.

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 43 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
9.1.1 Study Visit Schedule & Scheduled Follow-Up Visit Windows
Visit 1 to Visit 6 must be completed in 30 days.

Visit 1 (Office/Virtual Office): Consent and screening
o
Collect labs
Run-In: 

Visit 2 (Office/Virtual Office): Start Run-In
o
Eligibility has been confirmed 
o
Start study pump and CGM
o
Adjust pump settings as needed
o
Register and upload study pump in CareLink Personal and CareLink system

Visit 3 (Phone): Day 1 after Visit 2 – Required for subjects without CGM or closed loop 
experience; as needed for all others
o
Ask subjects and their parents/caregivers (if applicable) 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 – Required for subjects without CGM or closed loop 
experience; as needed for all others
o
Ask subjects and their parents/caregivers (if applicable) if they require assistance, e.g., 
additional training
o
Ask subjects about adverse events and device performance
o
Review CareLink reports

Visit 5 (Phone): Day 7 (±2 days) after Visit 2 
o
Ask subjects and their parents/caregivers (if applicable) if they require assistance, e.g., 
additional training
o
Ask subjects about adverse events and device performance
o
Review CareLink reports

Visit 6 (Office/Virtual Office): Day 14 (±3 days) after Visit 2
o
Ask subjects and their parents/caregivers (if applicable) if they require assistance, e.g., 
additional training
o
Ask subjects about adverse events and device performance
o
Review CareLink reports
o
Visit 6 and 7 may be combined
Study Period: 

Visit 7 (Office/Virtual Office): Start Study Period, 
Day 7 (-7 days) after Visit 6

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 44 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
o
Adjust pump settings as needed
o
Ask subjects about adverse events and device performance
o
Review CareLink reports
o
Start Auto Basal target at 120 mg/dL setpoint with Active Insulin Time set to 4 hours, 
titrate towards 2-3 hours or at investigator’s discretion
o
Turn on SmartGuard with Auto Corrections “ON”

Visit 8 (Phone): Day 2 after Visit 7 – Required for subjects without CGM or closed loop 
experience; as needed for all others
o
Adjust pump settings as needed
o
Ask subjects and their parents/caregivers (if applicable) if they require assistance, e.g., 
additional training
o
Ask subjects about adverse events and device performance
o
Review CareLink reports

Visit 9 (Phone): Day 7 (±2 days) after Visit 7
o
Adjust pump settings as needed
o
Ask subjects about adverse events and device performance
o
Review CareLink reports

Visit 10 (Phone): Day 14 (±3 days) after Visit 7
o
Adjust pump settings as needed
o
Ask subjects about adverse events and device performance
o
Review CareLink reports

Visit 11 (Phone): Day 21 (±3 days) after Visit 7
o
Adjust pump settings as needed
o
Ask subjects about adverse events and device performance
o
Review CareLink reports
o
Change Auto Basal target to 100 mg/dL setpoint with Active Insulin Time set to 2-3 
hours or at investigator’s discretion

Visit 12 (Office/Virtual Office): Day 28 (+7 days) after Visit 7
o
Adjust pump settings as needed
o
Ask subjects about adverse events and device performance
o
Review CareLink reports

Visit 13 (Phone): Day 44 (±3 days) after Visit 7
o
Adjust Auto Basal target with Active Insulin Time at investigator’s discretion
o
Ask subjects about adverse events and device performance
o
Review CareLink reports

Visit 14 (Office/Virtual Office): Day 60 (+7 days) after Visit 7
o
Ask subjects about adverse events and device performance
o
Review CareLink reports

Visit 15 (Office/Virtual Office): Day 90 (+7 days) after Visit 7
o
Collect HbA1C
o
Ask subjects about adverse events and device performance
o
Review CareLink reports
o
Return study devices
o
End of Study (EOS)

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 45 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
Figure 5. Visit Schedule
Run-in Period
Office/Virtual 
Office 
Visit 1
Consent & 
Screening
Phone
Visit 3
Day 1 after 
Visit 2
Office/Virtual 
Office
Visit 2
Start Study 
Pump & CGM
Visit Schedule
Study Period
Visit 1 to Visit 6 must be completed in 30 days.
Office/Virtual Office 
Visit 6
Day 14 (±3 days) 
after Visit 2
Phone 
Visit 4
Day 3 (±1 
day) after 
Visit 2
Office/Virtual 
Office 
Visit 7
Day 7 (-7 days) 
after Visit 6
Phone
Visit 8
Day 2 after 
Visit 7
Phone 
Visit 10
Day 14
(±3 days) 
after Visit 7
Phone 
Visit 11
Day 21 
(±3 days) 
after Visit 7
Office/Virtual Office
Visit 12
Day 28
(+7 days) after Visit 
7
Phone 
Visit 13
Day 44 
(±3 days) after 
Visit 7
Office/Virtual Office 
Visit 15
Day 90
(+7 days) after Visit 7
EOS
Phone 
Visit 5
Day 7 (±2 
days) after 
Visit 2  
Phone
Visit 9
Day 7 (±2 
days) after 
Visit 7
Office/Virtual Office
Visit 14
Day 60
(+7 days) after Visit 7

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 46 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
Table 3. Visit Details
Run-In Period
Study Period
Visit 1
(Office or Virtual 
Office)
Visit 2
(Office or 
Virtual Office)
Visit 3* and 
4*
(Phone)
Visit 5
(Phone)
Visit 6
(Office or 
Virtual Office)
Visit 7
(Office or 
Virtual Office)
Visit 8*
(Phone)
Visit 9, 10 & 11
(Phone)
Visit 12
(Office or 
Virtual Office)
Visit 13
(Phone)
Visit 14
(Office or 
Virtual Office)
Visit 15**
(Office or 
Virtual 
Office)
Visit Window
Enrollment
Day 1 and Day 
3 (±1 day)
after Visit 2
Day 7 (±2 
days) after 
Visit 2 
Day 14 (±3 
days) after 
Visit 2 
Day 7 
(-7 days) 
after Visit 6
Day 2 after Visit 
7
Day 7 (±2 days)
after Visit 7), 
Day 14 and Day 
21 (±3 days)
after Visit 7
Day 28 (+7 
days) after 
Visit 7
Day 44 
(±3 days)
after Visit 7
Day 60 (+7 
days) after 
Visit 7
Day 90
(+7 days)
after Visit 7
EOS
Visit Activities and Data Collection
Collect consent forms, e.g., ICF, Assent form (if applicable), California 
Experimental Subject’s Bill of Rights (if applicable), HIPAA form and forms 
required by local regulation
X
Assess subject eligibility to participate in the study 
X
Measure subject height and weight 
Note: Body mass index (BMI) will be calculated automatically in the study 
database, based on height and weight measurements entered.
X
X
Collect demographic and other baseline characteristics according to eCRF 
questions
X
Collect urine test for pregnancy from female subjects of child-bearing age or 
capability (Point of Care or local lab)
X
Collect blood sample for HbA1c testing. 
All collected blood specimens will be sent to and tested by a NGSP certified 
Central Laboratory. HbA1c testing must follow NGSP standards.
X
X
Collect specimens for required lab testing: Hematocrit, Creatinine, TSH (see 
lab instructions for additional information)
X
Collect information about medical history
X
Collect information about concomitant medications
X
Collect any changes to diabetes medications during the study (including the 
type of insulin being used).
The only insulins permitted for use in the study are Humalog, Novolog, and 
Admelog.
During the study period, each subject will be encouraged to continue 
on the same brand of insulin with which they started.
X 
(if applicable)
X 
(if applicable)
X 
(if applicable)
X 
(if applicable)
X 
(if applicable)
X 
(if applicable)
X 
(if applicable)
X 
(if applicable)
X 
(if applicable)
X 
(if applicable)
X 
(if applicable)
Confirm subject eligibility results, including labs, prior to moving forward with 
any study procedures
X
Assist with Surveys/Questionnaires - Refer to CIP337 Surveys/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
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
Train subjects and their parents/caregivers (if applicable) on the use of the
Accu-Chek Guide Link study meter and ketone meter, refer to user guides
X

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 47 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
Run-In Period
Study Period
Visit 1
(Office or Virtual 
Office)
Visit 2
(Office or 
Virtual Office)
Visit 3* and 
4*
(Phone)
Visit 5
(Phone)
Visit 6
(Office or 
Virtual Office)
Visit 7
(Office or 
Virtual Office)
Visit 8*
(Phone)
Visit 9, 10 & 11
(Phone)
Visit 12
(Office or 
Virtual Office)
Visit 13
(Phone)
Visit 14
(Office or 
Virtual Office)
Visit 15**
(Office or 
Virtual 
Office)
Visit Window
Enrollment
Day 1 and Day 
3 (±1 day)
after Visit 2
Day 7 (±2 
days) after 
Visit 2 
Day 14 (±3 
days) after 
Visit 2 
Day 7 
(-7 days) 
after Visit 6
Day 2 after Visit 
7
Day 7 (±2 days)
after Visit 7), 
Day 14 and Day 
21 (±3 days)
after Visit 7
Day 28 (+7 
days) after 
Visit 7
Day 44 
(±3 days)
after Visit 7
Day 60 (+7 
days) after 
Visit 7
Day 90
(+7 days)
after Visit 7
EOS
Train subjects and their parents/caregivers (if applicable) on the use of the 
780G pump
X
Start study subjects on the 780G insulin pump system accordingly:
SmartGuard (with Auto Correction OFF) during the run-in period will be 
permitted for study subjects who are using the Auto Mode feature in a 
Medtronic pump prior to screening. In the 780G study pump, the term “Auto 
Mode” has been replaced with “SmartGuard”. All others are to use the system 
in Manual Mode during the run-in period.
X
Provide study subjects the Medtronic Extended infusion sets, reservoirs, and 
DS5
X
As needed
As needed
As needed
As needed
As needed
As needed
As needed
Train subjects and their parents/caregivers (if applicable) on the Medtronic 
Extended infusion sets, reservoirs, and DS5. 
X
Start study subjects on CGM(DS5) and accessories
X
Instruct subjects and their parents/caregivers (if applicable) to place the DS5 
in a location that is approved for placement per the User guide and study 
directions and also report the sensor insertion information, as applicable:

Ages 7-17 years: Back of upper arm and upper buttock

Ages 18 years and older: Back of upper arm
X
X
X
X
X
X
X
X
X
X
X 
Train study subjects and their parents/caregivers (if applicable) on the 780G 
SmartGuard features
X
X
Start study subjects on 780G SmartGuard with Auto Correction ON.
X 
Instruct subjects and their parents/caregivers (if applicable) 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 [16.7 
mmol/L]) and not responding to correction boluses and/or 
infusion set change(s).

There is an occlusion alarm with elevated glucose, where the 
study subject is not able to address the occlusion by changing 
the infusion set
X 
X 
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 and their parents/caregivers (if applicable) 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)
If applicable:

Train subjects and their parents/caregivers on the use of the 
780G system apps: MiniMed Clinical app and CareLink Clinical 
app
X (if applicable)
Adjust pump settings
As needed
As needed
As needed
As needed
As needed

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 48 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
Run-In Period
Study Period
Visit 1
(Office or Virtual 
Office)
Visit 2
(Office or 
Virtual Office)
Visit 3* and 
4*
(Phone)
Visit 5
(Phone)
Visit 6
(Office or 
Virtual Office)
Visit 7
(Office or 
Virtual Office)
Visit 8*
(Phone)
Visit 9, 10 & 11
(Phone)
Visit 12
(Office or 
Virtual Office)
Visit 13
(Phone)
Visit 14
(Office or 
Virtual Office)
Visit 15**
(Office or 
Virtual 
Office)
Visit Window
Enrollment
Day 1 and Day 
3 (±1 day)
after Visit 2
Day 7 (±2 
days) after 
Visit 2 
Day 14 (±3 
days) after 
Visit 2 
Day 7 
(-7 days) 
after Visit 6
Day 2 after Visit 
7
Day 7 (±2 days)
after Visit 7), 
Day 14 and Day 
21 (±3 days)
after Visit 7
Day 28 (+7 
days) after 
Visit 7
Day 44 
(±3 days)
after Visit 7
Day 60 (+7 
days) after 
Visit 7
Day 90
(+7 days)
after Visit 7
EOS
During the run-in period and only for subjects with Auto Mode experience
through the use of a Medtronic insulin pump, a 120 mg/dL Auto Basal target 
should be set. It is recommended that Active Insulin Time is set to 4 hours.
Note: The Auto Basal target setting and Active Insulin Time should be set as
recommended above, unless there is a documented safety reason that would 
not permit these settings to be used.
Subjects who do not have experience with Medtronic insulin pumps, as 
specified above, will use the system in Manual Mode.
X
X
X
X
Start Auto Basal target at 120 mg/dL setpoint with Active Insulin Time set to 4 
hours, titrate towards 2-3 hours or at investigator’s discretion.
Turn on SmartGuard with Auto Corrections “ON”.   
Note: The Auto Basal target setting and Active Insulin Time should be set as 
recommended above, unless there is a documented safety reason that would 
not permit these settings to be used.
X
Change Auto Basal target to 100 mg/dL setpoint with Active Insulin Time set 
to 2-3 hours or at investigator’s discretion.
Note: The Auto Basal target setting and Active Insulin Time should be set as 
recommended above, unless there is a documented safety reason that would 
not permit these settings to be used.
X
(Visit 11)
Adjust the Auto Basal target as well as Active Insulin Time to what is best for 
the individual subject, at investigator’s discretion.
Note: The Auto Basal target setting and Active Insulin Time should be set as 
recommended above, unless there is a documented safety reason that would 
not permit these settings to be used.
X
Dispense study materials (e.g., smartphone [upon request and approval], 
reference guides, subject training materials, etc.)
X
Dispense other study supplies as needed (e.g., alcohol swabs, adhesive 
remover, etc.)
X
As needed
As needed
As needed
As needed
At all visits and/or between visits (if the investigational center is contacted), 
adjust insulin settings and insulin dose as needed
X
As needed
As needed
As needed
As needed
As needed
As needed
As needed
As needed
As needed
Confirm the study pump upload data is available in CareLink system software 
(at office visit or day prior if phone or virtual office visit)
X
X
X
X
X
X
X
X
X
X
Print and review CareLink system reports
X
X
X
X
X
X
X
X
X
X

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 49 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
Run-In Period
Study Period
Visit 1
(Office or Virtual 
Office)
Visit 2
(Office or 
Virtual Office)
Visit 3* and 
4*
(Phone)
Visit 5
(Phone)
Visit 6
(Office or 
Virtual Office)
Visit 7
(Office or 
Virtual Office)
Visit 8*
(Phone)
Visit 9, 10 & 11
(Phone)
Visit 12
(Office or 
Virtual Office)
Visit 13
(Phone)
Visit 14
(Office or 
Virtual Office)
Visit 15**
(Office or 
Virtual 
Office)
Visit Window
Enrollment
Day 1 and Day 
3 (±1 day)
after Visit 2
Day 7 (±2 
days) after 
Visit 2 
Day 14 (±3 
days) after 
Visit 2 
Day 7 
(-7 days) 
after Visit 6
Day 2 after Visit 
7
Day 7 (±2 days)
after Visit 7), 
Day 14 and Day 
21 (±3 days)
after Visit 7
Day 28 (+7 
days) after 
Visit 7
Day 44 
(±3 days)
after Visit 7
Day 60 (+7 
days) after 
Visit 7
Day 90
(+7 days)
after Visit 7
EOS
Review surveillance report in Medtronic’s secure upload application and review 
with subjects as necessary
As needed
As needed
As needed
As needed
As needed
As needed
As needed
As needed
As needed
As needed
Enter data into eCRFs as required
X
X
X
X
X
X
X
X
X
X
X
X
Schedule next visit day and time
X
X
X
X
X
X
X
X
X
X
X
Collect 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
Questions To Ask at Study Visits
Ask if subjects and their parents/caregivers (if applicable) 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
XWe 
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 and their parents/caregivers( if applicable) if they require 
assistance, e.g., additional training
X
X
X
X
Study Subject General Training and Instructions
Remind subjects and their parents/caregivers (if applicable) that the use and 
wear of study devices throughout the study is a requirement
X
X
X
X
X
X
X
X
X
X
Instruct/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
Instruct subjects and their parents/caregivers (if applicable) on diabetes self-
management principles, including response to glycemic events, e.g., use of 
oral glucose and glucagon in case of hypoglycemia or checking ketones in 
case of severe hyperglycemia.  
X
Instruct subjects and their parents/caregivers (if applicable) that subject blood 
ketone testing is required every time BG is greater than 300 mg/dL (16.7 
mmol/L), as measured by the Accu-Chek Guide Link study meter.
X
X
X
X
X
X
X
X
X
X
Instruct subjects and their parents/caregivers (if applicable) 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

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 50 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
Run-In Period
Study Period
Visit 1
(Office or Virtual 
Office)
Visit 2
(Office or 
Virtual Office)
Visit 3* and 
4*
(Phone)
Visit 5
(Phone)
Visit 6
(Office or 
Virtual Office)
Visit 7
(Office or 
Virtual Office)
Visit 8*
(Phone)
Visit 9, 10 & 11
(Phone)
Visit 12
(Office or 
Virtual Office)
Visit 13
(Phone)
Visit 14
(Office or 
Virtual Office)
Visit 15**
(Office or 
Virtual 
Office)
Visit Window
Enrollment
Day 1 and Day 
3 (±1 day)
after Visit 2
Day 7 (±2 
days) after 
Visit 2 
Day 14 (±3 
days) after 
Visit 2 
Day 7 
(-7 days) 
after Visit 6
Day 2 after Visit 
7
Day 7 (±2 days)
after Visit 7), 
Day 14 and Day 
21 (±3 days)
after Visit 7
Day 28 (+7 
days) after 
Visit 7
Day 44 
(±3 days)
after Visit 7
Day 60 (+7 
days) after 
Visit 7
Day 90
(+7 days)
after Visit 7
EOS

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 and their parents/caregivers (if applicable) to bring in both 
Accu-Chek Guide Link study meter and ketone meter at each required office 
visit.
X
X
X
X
X
X
X
Remind subject and their parents/caregivers (if applicable) to keep their
devices charged, as applicable
X
X
X
X
X
X
X
X
X
X
Instruct subjects and their parents/caregivers (if applicable) 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
X
X
X
Instruct subjects their parents/caregivers (if applicable) to refer primary 
healthcare providers to the investigational center staff if they have any 
questions about study devices and their functions
X
X
X
X
X
X
X
X
X
X
X
Instruct subjects and their parents/caregivers (if applicable) that they should 
not assume that SmartGuard is able to prevent all hypoglycemia or all 
hyperglycemia, including diabetic ketoacidosis
X
X
Instruct study subjects and their parents/caregivers (if applicable) 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
Instruct/Remind subjects and their parents/caregivers (if applicable) to give 
subjects meal bolus of insulin 15-20 minutes before meals during the study
X
X
X
X
X
X
X
X
X
X
*Required for subjects without CGM or closed loop experience; as needed for all others.
**When subjects exit the study early, all requirements that are listed for the final visit apply.

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 51 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
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 and assent (if applicable) 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 
assent form (if applicable) 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
and their parent, guardian, or legally authorized representative (as applicable) will be given ample time 
and offered the opportunity to review these documents away from the investigational center.
If the subject is below 18 years of age, he/she should be informed about the study to the extent 
compatible with the subject’s understanding. Per IRB, if the subject could give consent to decisions about 
participation in research, the investigator must obtain that consent in addition to the consent of their 
legally authorized representative or guardian. Consent by a legal guardian or authorized representative is 
only allowed for subjects who are younger than legal age according to their state requirements.
The following will be provided to or explained to the subject and their parent, guardian, or legally 
authorized representative by the investigator or designee: the purpose and duration of the study, the 
requirements expected to be adhered to by the subject during the study and the potential risks /potential 
benefits associated with participation in the study. Every attempt will be made to answer the subject’s 
and their parent’s, guardian’s, or legally authorized representative’s questions during the informed 
consent and assent process. The language used shall be as non-technical as possible and must be 
understandable to the subject or their parent, guardian, or legally authorized representative.
Neither the investigator, nor the investigational center staff shall coerce or unduly influence a subject or 
their parent, guardian, or legally authorized representative to participate or to continue to participate in 
the clinical study. The informed consent/assent process shall not waive or appear to waive the subject’s 
rights. The assent, if required, should be administered according to the investigational center’s Standard 
Operating Procedures (SOPs) and the IRB instructions, as applicable.
Subjects will complete California Experimental Subject’s Bill of Rights (if applicable), the HIPAA Form, and 
the ICF/assent form. The consenting process must be documented in the subject’s source documents. 
The subject and their parent, guardian, or legally authorized representative will receive copies of the fully 
executed documents. A subject’s participation in study procedures cannot begin before the consent 
process has been properly executed. When the subject decides to participate in the 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 

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 52 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
should inform the subject and their parent, guardian, or legally authorized representative in a timely 
manner. 
Medtronic will revise the written ICF/assent form whenever new information becomes available that may 
be relevant to the subject’s confirmed participation in the clinical study. The revised information will be 
sent to the investigator for approval by the IRB. After approval by the IRB, a copy of this information 
must be provided to the participating subjects, and the informed consent/assent process as described 
above needs to be repeated.
If the ICF/assent form is amended during the course of the study, the IRB will determine:

Whether or not active subjects and their parent, guardian, or legally authorized representative
should be re-consented at their next visit and 

Whether or not subjects who have completed the study at the time of the amendment should be 
re-consented. 
Subjects and their parent, guardian, or legally authorized representative will be informed that qualified 
personnel from the investigational center, the sponsor (Medtronic), regulatory authorities such as the 
FDA 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/assent violations to their IRB and 
sponsor:

Failure to obtain informed consent/assent from subject and their parent, guardian, or legally 
authorized representative.

Failure to obtain informed consent/assent prior to performing one or more study procedures.

Failure to maintain ICFs/assent forms on file for all subjects who have provided informed 
consent.

Use of an ICF/assent form that has not received approval from the IRB.

Use of an incorrect version of the ICF/assent 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.  

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 53 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
9.4.2 Hypoglycemic/Hyperglycemic Risk
Intervention and treatment for hypoglycemia and hyperglycemia is addressed in Section 10.1.
9.4.3 Calibration of CGM Risk
When an erroneous blood glucose value is used to calibrate a CGM, this can result in inaccurate SG 
values. Subjects will be trained on appropriate calibration.
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

DS5
9.4.6 Misuse Risk
Comprehensive training will take place at the initiation visit for investigational center staff regarding the 
operation of the MiniMed 780G system, to include all of its functional components and all other study 
devices to be used during the study at the investigational center.
9.4.7 Risk of Blood Sample Collection, Contamination from Sampling Techniques
Detailed mitigations to blood sampling risk are provided in Section 10.1.
9.4.8 HbA1c Risk
A Central laboratory will be used for HbA1c testing.
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.
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.  

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 54 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
9.5.2
Blood Ketone Values
Subject’s blood ketones will be measured by all subjects and parents/caregivers (if applicable) using the 
ketone meter when certain conditions are met:

When a subject is symptomatic for high blood glucose

When sensor glucose displays a glucose value >300mg/dL, BG should be checked by fingerstick 
and, if BG is >300mg/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 7 
and exit early, a HbA1c will be collected.
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 app and the CareLink Clinical app.
The investigator will ensure that all eCRFs are completed promptly, completely, and accurately. Medtronic 
will provide detailed instructions to assist with eCRF completion. In the event of data discrepancies, 
investigational centers will be asked to resolve queries electronically in the EDC system; otherwise, 
irresolvable data-related issues will be routed to the sponsor for review and final disposition. An audit trail 
is maintained in the EDC system to capture any corrections or changes of the eCRFs. System backups for 
data stored in the EDC system will be consistent with Medtronic SOPs.
Medtronic will only consider eCRFs to be complete when all discrepancies between source data and eCRF 
have been resolved. eCRF content will be reviewed by a study monitor, as described in the Monitoring 
Plan. In addition, specific eCRFs must also be reviewed and electronically signed by the investigator, 
indicating his/her agreement with the accuracy of all recorded data. It is expected that the investigator 
and his/her staff will cooperate with the monitoring team and provide any missing data in a timely 
manner.

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 55 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
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 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 6 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).
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.: 

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 56 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template

Failure to obtain informed consent/assent, i.e., there is no documentation of consenting

Informed consent/assent obtained after initiation of study procedures

Continuation of a subject who did not meet all inclusion/exclusion criteria

Performing study procedure not approved by the IRB

Failure to inform IRB and sponsor of reportable AEs (see Section 11)

Investigational study device dispensed without obtaining informed consent/assent
In the event the deviation involves a failure to obtain a subject’s consent, or is made to protect the life or 
physical well-being of a subject in an emergency, the deviation must be reported to 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 6, 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 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:

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 57 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template

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, 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 begins using pramlintide (Symlin), DPP-4 inhibitors, 
liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 
inhibitors).

During the course of the study, subject receives red blood cell transfusion or erythropoietin.

During the course of the study, the subject demonstrates that he/she is not able to comprehend 
instructions for study procedures, as evaluated by the appropriate research staff. 

During the 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 

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, 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.
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.

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 58 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
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 investigational 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, 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.

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 59 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
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

Hyperglycemia secondary to site falling off including 
DKA

Anxiety associated with insertion
Prevention and mitigation include:

Follow the provided user guides for 
insertions and care of infusion sets.

If an infusion site becomes irritated or 
inflamed, the infusion set will be 
removed and another 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 

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
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. 

Parent(s)/guardian(s), if applicable,
should be present at night with subjects 
and will be trained on study device and 
diabetes management principles and 
instructed to call investigator with 
problems. 

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 60 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template

Insulin deterioration leading to hyperglycemia

Incomplete priming; fails to prime tubing and/or 
cannula, leading to hyperglycemia

Remove a reservoir, without suspending and 
reconnecting after a while resulting in a 
hypoglycemia

Patient not filling pump reservoir when needed 
leading to hyperglycemia

Magnetic resonance imaging resulting in pump 
transmitter malfunction

Inaccurate insulin delivery due to sudden altitude 
changes.

Hypoglycemia or hyperglycemia from manual bolus

Hypoglycemia or hyperglycemia from the use of the 
SmartGuard feature where SG values may be used 
to calculate insulin bolus amounts 

Hypoglycemia or hyperglycemia from computer 
hacking 
Risks with hyperglycemia may include 

Diabetic ketoacidosis

Symptomatic ketosis

Cardiovascular event 

Dehydration 

Potassium and sodium imbalance

Shock

Altered mental status 

Coma 

Acidosis
Prevention and mitigation include:

Follow the provided user guides for 
insulin pump management.  

Parent(s)/guardian(s), if applicable,
should be present at night with subjects 
and will be trained on study device and 
diabetes management principles and 
instructed to call investigator with 
problems. 

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).

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 61 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
Risks with hypoglycemia may include:

Seizure 

Coma 

Altered mental status 

Loss of consciousness 

Cardiovascular event 

Death 

Risk of rebound hyperglycemia with ketosis
Prevention and mitigation include:

Follow the provided user guides for 
insulin pump management.  

Parent(s)/guardian(s), if applicable,
should be present at night with subjects 
and will be trained on study device and 
diabetes management principles and 
instructed to call investigator with 
problems

Train prior to study device use on 
appropriate device use and diabetes 
management principles and instruct to 
call investigator with problems.

Instruct to check their meter glucose if 
their low symptoms do not match their 
sensor alerts or SG readings in order to 
make diabetes treatment decisions. 

Instruct to check their meter glucose if 
there are any concerns that the SG
value is not accurate).

Instruct to have glucose and glucagon
on hand for hypoglycemia.
Risk with Sensors 
Prevention and Mitigation
Risks with sensors may include:

Skin irritation or reaction to adhesives

Bruising

Discomfort

Redness

Bleeding

Pain

Rash

Infection

Irritation from tapes used with glucose-sensing 
products

Raised bump

Appearance of a small “freckle-like” dot where 
needle was inserted

Allergic reaction

Syncopal episode secondary to needle insertion

Soreness or tenderness

Swelling at insertion site

Sensor fracture, breakage or damage

Minimal blood splatter associated with sensor needle 
removal

Residual redness associated with adhesive and/ or 
tapes

Scarring

Scab

Blister

Itchiness

Inflammation

Anxiety

Incorrect SG reading results in incorrect diabetes
management
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. 

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 62 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template

Subject over-treating secondary to alarms which can 
result in hyperglycemia or hypoglycemia
Risks with Inserter
Prevention and Mitigation
Risks with inserters 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 inserter 
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: 

Hypoglycemia

Severe hypoglycemia

Hyperglycemia

Diabetic ketoacidosis

User entry error
o
Patient administering boluses by entering false 
carb doses leading to hypoglycemia or
hyperglycemia
o
Patient entering false glucose values for any 
reason leading to hypoglycemia and 
hyperglycemia 
o
Patient entering false BG values for calibration 
leading to hypoglycemia or hyperglycemia

Sensor failure resulting from patient failure to 
calibrate leading to hypoglycemia or hyperglycemia

Sensor over-reading resulting in hypoglycemia 

Sensor under-reading resulting in hyperglycemia

Sensor missed transmission, or any other fault 
resulting in no SG value, leading to hyperglycemia 
or hypoglycemia 

Voluntary insulin delivery (with the pump or with a 
syringe) immediately prior to entering SmartGuard
may result in severe hypoglycemia despite shutting 
down insulin delivery by the algorithm

Hypoglycemia related to patient taking insulin via 
injection while in Closed Loop (SmartGuard)

Hypoglycemia or hyperglycemia related to entering 
or exiting Closed Loop (SmartGuard)

Insulin over-delivery due to potential interference 
from acetaminophen

Cyber security hacking into pump
Prevention and mitigation include: 

Follow the provided user guides for 
insulin pump management.  

Train prior to study device use on 
appropriate device use and diabetes 
management principles and instruct to 
call investigator with problems. 

Instruct to check their meter glucose if 
their high or low symptoms do not 
match their sensor alerts or SG readings 
in order to make diabetes treatment 
decisions. 

Instruct to check their meter glucose if 
there are any concerns that the SG
value is not accurate. 

Instruct if there are no sensor values, 
no treatments decision will be made 
until a BG is confirmed. 

Instruct to have glucose and glucagon
on hand for hypoglycemia.

Instruct to avoid the use of products 
containing acetaminophen.

If acetaminophen is taken, subjects will 
be instructed to use additional BG meter 
readings to verify their glucose levels. 

If acetaminophen is taken, while the 
SmartGuard feature is active, subjects 
will be instructed to use the temp target 
feature (when used, Auto Correction is 
not available).

Instruct subjects that in case of 
prolonged use of acetaminophen, the 

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 63 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
temp target feature can be used 
repeatedly and in succession.

Pump has cybersecurity encryptions to 
prevent hacking. 
Risks with hyperglycemia may include 

Diabetic ketoacidosis

Symptomatic ketosis

Cardiovascular event 

Dehydration 

Potassium and sodium imbalance

Shock

Altered mental status 

Coma 

Acidosis
Prevention and mitigation include:

Follow the provided user guides for 
insulin pump management.  

Train prior to study device use on 
appropriate device use and diabetes 
management principles and instruct to 
call investigator with problems. 

Instruct to check their meter glucose if 
their high symptoms do not match their 
sensor alerts or SG readings in order to 
make diabetes treatment decisions. 

Instruct to check their meter glucose if 
there are any concerns that the SG
value is not accurate.

Instruct if there are no sensor values, 
no treatments decision will be made 
until a BG is confirmed.
Risks with hypoglycemia may include:

Seizure

Coma

Altered mental status

Loss of consciousness

Cardiovascular event 

Death  

Risk of rebound hyperglycemia with ketosis
Prevention and mitigation include:

Follow the provided user guides for 
insulin pump management.  

Train prior to study device use on 
appropriate device use and diabetes 
management principles and instruct to 
call investigator with problems. 

Instruct to check their meter glucose if 
their low symptoms do not match their 
sensor alerts or SG readings in order to 
make diabetes treatment decisions. 

Instruct to check their meter glucose if 
there are any concerns that the SG
value is not accurate.

Instruct if there are no sensor values, 
no treatment decisions will be made 
until a BG is confirmed.

Instruct to have glucose and glucagon
on hand for hypoglycemia.
Risk with Acetaminophen Use
Prevention and Mitigation
Potential risks with acetaminophen may include:

False elevation of SG readings potentially resulting in 
an over-delivery of insulin which may cause 
hypoglycemia. The level of inaccuracy depends on 
the amount of acetaminophen active in subject’s 
body and may be different for each subject
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.

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 64 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template

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) 

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.
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 DS5 and a variety of safety checks that are an integral part of the MiniMed 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 

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 65 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
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.
This means that the subject was impaired cognitively to the point that he/she was unable to treat himself 
or herself, was unable to verbalize his or her needs, and was incoherent, disoriented and/or combative.
These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma 
glucose measurements may not be available during such an event, but neurological recovery attributable 
to the restoration of plasma glucose to normal is considered sufficient evidence that the event was 
induced by a low plasma glucose concentration. 2
Severe Hyperglycemia is defined as hyperglycemia (BG greater than [>] 300 mg/dL or 16.7 mmol/L)
with BG ketones greater than (>) 1.5 mmol/L, and/or accompanied by symptoms of nausea, vomiting or 
abdominal pain.
The meter and ketone test strips are supplied for the evaluation of ketone monitoring. Only blood 
ketones will be recognized (not urine ketones) for assisting in diagnosis of severe hyperglycemia. The 
monitors/test strips are quality controlled prior to dispensing to subjects. Blood ketones provide 
contemporaneous understanding of ketone levels associated with elevations in glucose.
Diabetic Ketoacidosis/DKA diagnostic criteria: BG greater than (>) 250 mg/dL or greater than (>)
13.9 mmol/L, arterial pH less than (<) 7.3, bicarbonate less than (<) 15 mEq/L, moderate ketonuria or 
ketonemia and requiring treatment within a health care facility. 3
Hyperglycemic events will be recorded as DKA if the event includes the presence of all of the following:

Arterial blood pH less than (<) 7.30 or serum bicarbonate less than (<) 15 mEq/L

Blood glucose greater than (>) 250 mg/dL or greater than (>) 13.9 mmol/L

Serum ketones or large/moderate urine ketones

Symptoms such as polyuria, polydipsia, nausea, or vomiting

Treatment provided in a health care facility

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 66 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
Adverse Event (AE) (ISO 14155:2020)
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including 
abnormal laboratory findings) in subjects, users or other persons, whether or not related to the 
investigational medical device and whether anticipated or unanticipated.
Note 1 to entry:
This definition includes events related to the investigational medical device or the 
comparator.
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

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 67 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
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, 
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 Recording 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 device (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 CIP
definition of severe hypoglycemia, severe hyperglycemia or DKA is considered an untoward event and a 
worsening from the subject’s baseline and would be reported to sponsor on an AE eCRF. 

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 68 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
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:
The investigational center staff must report all AEs to Medtronic in a timely manner. All severe 
hypoglycemia, DKA, 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 and 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 12.2 for expedited reporting requirements for UADE.  

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 69 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
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:
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 

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 70 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
another device, drug or treatment). Cases where relatedness cannot be assessed, or no 
information has been obtained should also be classified as possible.

Probable: the relationship with the use of the investigational device, comparator, or the 
relationship with procedures, seems relevant and/or the event cannot reasonably be explained by 
another cause.

Causal relationship: the event is associated with the investigational device, comparator, or 
with procedures beyond reasonable doubt when:
o
the event is a known side effect of the product category the device belongs to or of 
similar devices and procedures;
o
the event has a temporal relationship with investigational device use/application or 
procedures;
o
the event involves a body-site or organ that

the investigational device or procedures are applied to;

the investigational device or procedures have an effect on;
o
the event follows a known response pattern to the medical device (if the response 
pattern is previously known);
o
the discontinuation of medical device application (or reduction of the level of 
activation/exposure) and reintroduction of its use (or increase of the level of 
activation/exposure), impact on the event (when clinically feasible);
o
other possible causes (e.g., an underlying or concurrent illness/clinical condition or/and 
an effect of another device, drug or treatment) have been adequately ruled out;
o
harm to the subject is due to error in use;
o
the event depends on a false result given by the investigational device used for 
diagnosis, when applicable;
In order to establish the relatedness, not all the criteria listed above might be met at the same 
time, depending on the type of device/procedures and the event.
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

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 71 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
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/ Investigator’s Brochure 
(IB) or user guide.

Unanticipated: the event has not been previously identified in the CIP; labeling; report of 
priors/IB or user guide.
12.
Data Review Committees
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 CIP, which include reports of:

Serious adverse event

Serious adverse device effect

Unanticipated adverse device effect

Severe hypoglycemia

Diabetic ketoacidosis

Severe hyperglycemia
During the study, the following steps will be taken for: 

Unanticipated adverse device effects (UADE)

Device related DKA 

Device related severe hypoglycemia 
CEC is to review and adjudicate the event within 10 business days from the time that the sponsor is 
notified. Adjudication will occur once all applicable documentation has been 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.

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 72 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
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 or DKA related to the AHCL algorithm, or was it related to a known 
insulin pump risk? For example, a question that may be considered in DKA would be whether the 
event was related to an infusion set issue or caused by the AHCL algorithm. 
2.
Another important consideration would be if the severe hypoglycemia, severe hyperglycemia or 
DKA event was related to a device malfunction versus patient non-compliance. For example, if a 
software anomaly leading to an under-delivery of insulin is discovered versus the subject 
repeatedly ignoring alarms prompting the subject to take action.  
3.
Severe hypoglycemia, severe hyperglycemia or DKA caused directly by an infusion set issue when 
the study pump is functioning as intended would likely result in acceptance to proceed with the 
study versus severe hypoglycemia or DKA that are directly caused by the AHCL algorithm or a 
device malfunction might stop study enrollment or entire study altogether.
4.
It should be noted that the final determination of causality related to 780G system that is made 
by the CEC may include additional factors which the members consider to be clinically relevant 
and important.

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 73 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
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 3 main functions: 
First: DMC will track and trend the overall safety of the study.    
Event rate, defined as number of events per 100 patient years will be reviewed by the DMC with 
respect to the following:

Event rate of all SAEs  

Event rate of severe hypoglycemia

Event rate of severe hyperglycemia

Event rate of DKA

Event rate of device related AEs  
Second: Based on their meetings, DMC will recommend a decision to the sponsor regarding the 
following: 

Whether or not enrollment should be halted.

Whether or not the entire study will need to be stopped including for those subjects who have 
received study devices already. 
Note: If it is decided to withdraw subjects from participation in the study or if the study is stopped, 
subjects will be followed-up in accordance with standard practice by their own providers.
Third:
During the study, the following steps will be taken for:

Unanticipated adverse device effects (UADE)

Device related DKA 

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.

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 74 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
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.
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.
In their recommendation to the sponsor, the DMC may take into account the thresholds listed below for 
the number of subjects experiencing hypoglycemia requiring assistance from another person or DKA to 
identify when the number of subjects experiencing these events exceeds the number that would be 
anticipated for the study population over the duration of this study. These thresholds should be 
interpreted with caution due to potential differences in study populations and study design.
a.
Rates taken from type 1 exchange (Cengiz et. Al, and Weinstock et. Al), are higher than 
the clinical studies STAR 3, 530G adult in-home study (CEP266) and 530G Pediatric in-
home study (CEP287).  
b.
Reasons for lower rates of severe hypoglycemia and DKA in the clinical studies 
mentioned could be related to several factors including but not limited to the exclusion of 
those with DKA or severe hypoglycemia, additional attention secondary to mandatory 
study visits, selection bias of motivated patients willing to perform study procedures and 
access to free study devices during the course of the study.
c.
The DMC should consider stopping study if rates of severe hypoglycemia and DKA are 
significantly worse (e.g., higher) in AHCL than rates provided by clinical trials mentioned 
in Table 5.  
d.
Age consideration may also be factored in by the DMC.  For example, severe 
hypoglycemia rates in those >25 years may be higher than those 25 years and below.      

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 75 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
e.
Should DKA and/or severe hypoglycemia occur early in the study, the DMC should 
consider that the higher event rate may not necessarily represent a significant safety 
concern.  
Table 5. Hypoglycemia/ Hyperglycemia/ DKA Threshold
Adverse Event
Reference
Reference 
Rate > 25 
years old
Reference 
Rate
15-25 years 
old
Reference 
Rate <15 
years old
Severe 
Hyperglycemia 
events per 100 
patient years
CER 302
NA
NA
71.64
DKA events per 
100 patient 
years
STAR 3
Bergenstal et. al 
SAP arm: 
0.68
Control arm: 
0
SAP arm:  
2.7
Control arm: 
3.6
SAP arm: 
2.2
Control arm: 
0
530G Adult in-home study 
CEP 266
(MDT on file)
1.27
3.4
N/A
Pediatric in-home study CEP 
287
(MDT on file)
N/A
N/A
0
Type 1 exchange Weinstock 
et. al
4.8
N/A
N/A
Type 1 exchange Cengiz et. 
al
N/A
9.9
9.9
Severe 
hypoglycemia 
per 100 patient 
years
STAR 3
Bergenstal et. al 
SAP arm: 
16.5
Control arm: 
20.9
SAP arm:  
5.4
Control arm: 
3.9
SAP arm:  
10.2
Control arm: 
3.6
530G Adult in-home study 
CEP 266
(MDT on file)
0.85
0
N/A
530G Pediatric in-home study 
CEP 287
(MDT on file)
N/A
N/A
1.42
Type 1 exchange Weinstock 
et. al
11.8
N/A
N/A
Type 1 exchange Cengiz et. 
al
N/A
6.2
6.2

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 76 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
Severe hypoglycemia and DKA event rates were taken from the following:
1.
Richard Bergenstal et.al: Effectiveness of Sensor-Augmented Insulin-Pump Therapy in Type 1
Diabetes. New England Journal of Medicine, 2010; 363:311-20
2.
Weinstock et. al: Severe hypoglycemia and diabetic ketoacidosis in adults with type 1 diabetes: 
results from the T1D Exchange clinic registry. J Clin Endocrinol Metab. 2013 Aug;98(8):3411-9.
3.
Cengiz et. al: Severe hypoglycemia and diabetic ketoacidosis among youth with type 1 diabetes 
in the T1D Exchange clinic registry. Pediatr Diabetes. 2013 Sep;14(6):447-54.
4.
MDT on file: Statistical Analysis Plan (SAP) for CEP304, 056-F286
13.
Device Deficiencies and Troubleshooting
The 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 DDs 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 DDs 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 DD 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 DD, 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 DDs.
It is the responsibility of the investigator to follow their IRB reporting requirements.

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 77 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
14.
Statistical Design and Methods
14.1 General Aspects of Analysis
All data collected from the time of screening until the end of the study will be collected on eCRFs, subject 
surveys/questionnaires, and electronically by uploading the various devices. Data and analysis will be 
summarized in a Clinical Study Report. Any deviations from original statistical plan and the rationale will 
be described in the Clinical Study Report.
14.2 Subject Disposition
The number of subjects enrolled, completed, and early terminated in the study will be presented.  The 
reasons for discontinuing prior to study completion will be summarized.
14.3 Subject Demographics and Baseline Characteristics
Subject characteristics, including age, gender, race, ethnicity, medical diagnosis, height, weight, BMI, and 
baseline HbA1c will be summarized by descriptive statistics (mean, standard deviation, minimum, median, 
and maximum) for continuous variables and by counts and percentages for categorical variables.
14.4 Endpoints and Hypotheses
Safety and effectiveness endpoints will be evaluated independently for ages 18-80 and ages 7-17. 
14.4.1Primary Safety Endpoint
Age 18-80:

The overall mean change in HbA1c, ∆µ780G, from baseline to end of 3-month study period will be 
estimated and compared by a non-inferiority test to the threshold of -0.50% with a margin of 
0.4%. A significance level of 0.025 (one-sided) will be used.
The hypothesis of non-inferiority is mathematically expressed as:
H0: ∆µ780G ≥-0.50% + 0.4% 
Ha: ∆µ780G < -0.50% + 0.4% 
Age 7-17:

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 78 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template

The overall mean change in HbA1c, ∆µ780G, from baseline to end of 3-month study period will be 
estimated and compared by a non-inferiority test to the threshold of -0.38% with a margin of 
0.4%. A significance level of 0.025 (one-sided) will be used.
The hypothesis of non-inferiority is mathematically expressed as:
H0: ∆µ780G ≥-0.38% + 0.4% 
Ha: ∆µ780G < -0.38% + 0.4% 
14.4.2Analysis of Effectiveness Endpoint
14.4.2.1
Primary Effectiveness Endpoint
Age 18-80:

The mean % of time, µ780G, in range (TIR 70-180 mg/dL) will be estimated and compared by a 
non-inferiority test to the threshold of 73.7% with a margin of 7.5%. A significance level of
0.025 (one-sided) will be used.
The hypothesis of non-inferiority is mathematically expressed as:
H0: µ780G ≤ 73.7% – 7.5% 
Ha: µ780G > 73.7% – 7.5%
Age 7-17:

The mean % of time, µ780G, in range (TIR 70-180 mg/dL) will be estimated and compared by a 
non-inferiority test to the threshold of 65.3% with a margin of 7.5%. A significance level of 
0.025 (one-sided) will be used. 
The hypothesis of non-inferiority is mathematically expressed as:
H0: µ780G ≤ 65.3% – 7.5% 
Ha: µ780G > 65.3% – 7.5%
14.4.2.2
Analysis of Secondary Effectiveness Endpoints
Age 18-80:

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 79 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template

Secondary Effectiveness Endpoint: The mean % time, µ780G, in hypoglycemia (< 54 mg/dL) will 
be estimated and compared by a non-inferiority test to the threshold of 0.86% with a margin of 
2%. A significance level of 0.025 (one-sided) will be used. 
The hypothesis of non-inferiority is mathematically expressed as:
H0: µ780G ≥ 0.86% + 2% 
Ha: µ780G < 0.86% + 2%

Secondary Effectiveness Endpoint: The mean % of time, µ780G, in range (TIR 70-180 mg/dL) 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 ≤73.7% 
Ha: µ780G > 73.7%
Age 7-17:

Secondary Effectiveness Endpoint: The mean % time, µ780G, in hypoglycemia (< 54 mg/dL) will 
be estimated and compared by a non-inferiority test to the threshold of 0.71% with a margin of 
2%. A significance level of 0.025 (one-sided) will be used.
The hypothesis of non-inferiority is mathematically expressed as:
H0: µ780G ≥ 0.71% + 2% 
Ha: µ780G < 0.71% + 2%

Secondary Effectiveness Endpoint: The mean % of time, µ780G, in range (TIR 70-180 mg/dL) 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 ≤65.3% 
Ha: µ780G > 65.3%
14.4.3Descriptive Endpoints

Time spent in the SmartGuard feature versus time spent in Manual Mode 

Change in mean glucose value from baseline to EOS

Time in different ranges (% of SG): SG < 70 mg/dL, 70 mg/dL ≤ SG ≤140 mg/dL, SG > 140
mg/dL, 180 mg/dL, 250 mg/dL, and 350 mg/dL

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 80 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template

Number of Events, Area Under Curve (AUC) and Time in the hyperglycemic range: SG > 140
mg/dL, 180 mg/dL, 250 mg/dL, and 350 mg/dL

Number of Events, AUC and Time in the hypoglycemic range: SG < 54 mg/dL and 70 mg/dL 

Change of Total Daily Dose (TDD) of insulin from baseline to EOS 

Change of weight from baseline to EOS 

Subgroup analysis will be performed for:
o
Setpoint
100 mg/dL
110 mg/dL
120 mg/dL
150 mg/dL (Temp Target Usage)
14.4.4 Safety Data Summarized

Serious Adverse Events (SAE) 

Serious Adverse Device Effects (SADE)

Unanticipated Adverse Device Effects 

Incidence of Severe Hypoglycemia   

Incidence of Severe Hyperglycemia   

Incidence of DKA

Serious Adverse Events (SAE) 

Serious Adverse Device Effects (SADE)

Unanticipated Adverse Device Effects 

Incidence of Severe Hypoglycemia   

Incidence of Severe Hyperglycemia   

Incidence of DKA
14.4.5Device Deficiencies
Descriptive summary will be used to characterize DDs:

All reports of device issues.
14.4.6Subject Feedback
Descriptive summary will be used to characterize study survey/questionnaire results. Refer to CIP337
Survey/Questionnaire Guide for administration details.

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 81 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
14.4.7Simulation Data
Computer simulated data may be compared to study data.

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 82 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
14.5 Sample Size Considerations/Sample Size Justification
14.5.1Age 18-80

Sample size for the primary safety endpoint: the overall mean change in HbA1c from baseline to 
end of 3-month study period, non-inferiority test
The overall mean change in HbA1c from baseline to end of 3-month study period from 670G 
(CEP294 HCL age 18 to 75, N = 101) study was -0.50%. Assuming the mean change in HbA1c
from baseline to end of 3-month study period from 780G is the same as 670G, with a standard 
deviation of 0.7%, SAS power and sample size calculator with one sample T test shows that a 
total of 80 subjects will provide > 80% power to detect the non-inferiority (with a margin of 
0.4%) with a significance level of 0.025 (one-sided).

Sample size for the primary effectiveness endpoint: the mean % of time in range (TIR 70-180 
mg/dL), non-inferiority test
The mean % of time in target from 670G (CEP294 HCL age 18 to 75, N = 104) study was 
73.7%. Assuming the mean time in target (%) from 780G is the same as 670G, with a standard 
deviation of 8.8%, SAS power and sample size calculator with one sample T test shows that a 
total of 80 subjects will provide > 80% power to detect the non-inferiority (with a margin of 
7.5%) with a significance level of 0.025 (one-sided).

Sample size for the secondary effectiveness endpoint: the mean % of time below range (< 54 
mg/dL), non-inferiority test
The mean % of time below range (< 54 mg/dL) from 670G (CEP294 HCL age 18 to 75, N = 104) 
study was 0.86%. Assuming the mean time below target (%) from 780G is the same as 670G, 
with a standard deviation of 0.79%, SAS power and sample size calculator with one sample T 
test shows that a total of 80 subjects will provide > 80% power to detect the non-inferiority (with 
a margin of 2%) with a significance level of 0.025 (one-sided).

Sample size for the secondary effectiveness endpoint: the mean % of time in range (TIR 70-180 
mg/dL), simple superiority test
The mean % of time in target from 670G (CEP294 HCL age 18 to 75, N = 104) study was 
73.7%. Assuming the mean time in target (%) from 780G is 76%, with a standard deviation of 

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 83 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
7.2%, SAS power and sample size calculator with one sample T test shows that a total of 80 
subjects will provide > 80% power to detect the simple superiority with a significance level of 
0.025 (one-sided).
14.5.2Age 7-17

Sample size for the primary safety endpoint: the overall mean change in HbA1c from baseline to 
end of 3-month study period, non-inferiority test
The overall mean change in HbA1c from baseline to end of 3-month study period from 670G 
(CEP294 and CEP302 HCL age 7 to 17, N = 125) study was -0.38%. Assuming the mean change
in HbA1c from baseline to end of 3-month study period from 780G is the same as 670G, with a 
standard deviation of 0.7%, SAS power and sample size calculator with one sample T test shows 
that a total of 80 subjects will provide > 80% power to detect the non-inferiority (with a margin 
of 0.4%) with a significance level of 0.025 (one-sided).

Sample size for the primary effectiveness endpoint: the mean % of time in range (TIR 70-180 
mg/dL), non-inferiority test
The mean % of time in target from 670G (CEP294 and CEP302 HCL age 7 to 17, N = 125) study 
was 65.3%. Assuming the mean time in target (%) from 780G is the same as 670G, with a 
standard deviation of 8%, SAS power and sample size calculator with one sample T test shows 
that a total of 80 subjects will provide > 80% power to detect the non-inferiority (with a margin 
of 7.5%) with a significance level of 0.025 (one-sided).

Sample size for the secondary effectiveness endpoint: the mean % of time below range (< 54 
mg/dL), non-inferiority test
The mean % of time below range (< 54 mg/dL) from 670G (CEP294 and CEP302 HCL age 7 to 
17, N = 125) study was 0.71%. Assuming the mean time below target (%) from 780G is the 
same as 670G, with a standard deviation of 0.60%, SAS power and sample size calculator with 
one sample T test shows that a total of 80 subjects will provide > 80% power to detect the non-
inferiority (with a margin of 2%) with a significance level of 0.025 (one-sided).

Sample size for the secondary effectiveness endpoint: the mean % of time in range (TIR 70-180 
mg/dL), simple superiority test
The mean % of time in target from 670G (CEP294 and CEP302 HCL age 7 to 17, N = 125) study 
was 65.3%. Assuming the mean time in target (%) from 780G is 67.6% , with a standard 

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 84 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
deviation of 7%, SAS power and sample size calculator with one sample T test shows that a total 
of 80 subjects will provide > 80% power to detect the simple superiority with a significance level 
of 0.025 (one-sided).
14.5.3Expected Drop-out Rates
Incorporating the expected drop-out rates, a total of up to 250 subjects will be enrolled, in order to have
200 subjects enter the study period .
14.6 Final Report
The study results will be summarized and presented in the final 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 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 (or the subject’s legally authorized representative) 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/assent 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/assent form, subject materials, and any form

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 85 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
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 Role of the Sponsor’s Representatives
Sponsor representatives may provide support as required for the study, such as technical support at 
investigational center. Sponsor representatives may provide technical support as required for the study 
under supervision of the PI, including:
1)
Provide study training relevant and pertinent to the involvement of personnel conducting study 
activities and investigator responsibilities.
2)
Technical support will be provided during study period.
3)
Technical support will be under the supervision of a study investigator, but no data entry on the 
eCRF shall be performed by Medtronic personnel or their representatives at investigational 
centers.
4)
Technical support to conduct device interrogations. 
The sponsor shall avoid improper influence on, or inducement to, the subject, monitor, any 
investigator(s) or other parties participating in or contributing to this study.
15.4 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 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: 

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 86 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
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/assent 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. 

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

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 87 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
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

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/assent
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

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.

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 88 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
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/assent form have been obtained from each subject at the point of enrollment and that AEs 
discussed in Section 11 were reported via completion of the AE eCRFs. More details regarding the 
monitoring activities (frequency of monitoring visits, planned extent of source data verification) are 
described in the Monitoring Plan.
16.2.1Accessibility 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. 
16.2.2Audits and Investigational Center Inspections
In addition to regular monitoring visits, the sponsor may conduct audits at participating investigational 
centers. The purpose of an audit is to verify the adequate performance of the clinical study related 
activities independent of the employees involved in the clinical study. Regulatory authorities may also 
perform inspections at participating investigational centers. Any regulatory authority inspection 
announcements shall be forwarded immediately to the Clinical Study Manager.
The investigator and/or institution shall permit sponsor and regulatory authorities direct access to source 
data and documents, taking into account any restrictions due to local law, to perform clinical study-
related monitoring, audits, IRB review, and regulatory inspections.
16.2.3Investigational 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.

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 89 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template

Persistent non-compliance to CIP 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
16.3.1Electronic 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. 
16.3.2CareLink Personal/CareLink System Software
During the course of the study, subject’s BG values may be assessed from the Accu-Chek Guide Link 
study meter.  The SG values may be assessed from the study pump. The study pump will be uploaded in 
CareLink Personal/CareLink system software by the investigator or designated investigational center staff 
and subjects at home. The system uses TLS technology, which encrypts all data it stores (21 CFR Part 11 
compliant). The data in the different databases are linked to each other via the subject’s ID.
16.3.3Subject Surveys/Questionnaires
Subjects will be provided a link to complete the questionnaires that will be kept online. Refer to CIP337
Questionnaire Guide. If the online link cannot be accessed due to technical issues, 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.

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 90 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
16.3.4Time 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.
16.3.5Data 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, 
surveys/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 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 for details of the subject’s compensation.

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 91 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
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
16.8.1Investigator 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/assent 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/assent form 

Source documentation

Fully executed eCRFs and corrections 

Report of AEs and DDs

Device accountability records

CIP Deviation/ CIP Non-Compliance, if any

Clinical Bulletins (if applicable)- A brief official update or summary of current study news on a 
matter of immediate interest and high importance to investigational center surrounding the 
CIP.

Current signed and dated CV of PI (and key study team members if required per local 
requirements)

Study reports

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 92 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
16.8.2Investigator Reporting Responsibilities 
Table 6. 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/assent prior 
to investigational 
device use
Sponsor and
IRBs
If an investigator uses a device without obtaining informed 
consent/assent the investigator shall report such use within 5 
working days after device use.
Final report
Sponsor
IRBs
Relevant 
Authorities
This report must be submitted within 3 months of study 
completion or termination of the investigation or the 
investigator’s part of the investigation.
Other
Sponsor, IRB and 
FDA
An investigator shall, upon request by a reviewing IRB, FDA 
or any other regulatory authority, provide accurate, 
complete, and current information about any aspect of the 
investigation.

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 93 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
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 of the study, whichever
is longer. The investigator should not dispose of these records without the approval of the sponsor.
16.10Suspension 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.
16.11Study 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.
16.12Publication 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.

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 94 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
The identity of the subjects may not be disclosed, unless required by law, to any persons not immediately 
involved in the study or the study procedures. The study will be publicly registered on 
http://www.clinicaltrials.gov prior to subject enrollment. Study results, when available, will be posted in 
this database.
17.
References
1.
Beato-Víbora PI, Gallego-Gamero F, Lázaro-Martín L, Romero-Pérez MDM, Arroyo-Díez FJ. Prospective 
Analysis of the Impact of Commercialized Hybrid Closed-Loop System on Glycemic Control, Glycemic 
Variability, and Patient-Related Outcomes in Children and Adults: A Focus on Superiority over Predictive 
Low-Glucose Suspend Technology. Diabetes Technology and Therapeutics. 2020;22(12):912-919.
2.
Cryer PE. Defining and reporting hypoglycemia in diabetes: A report from the American diabetes association 
workgroup on hypoglycemia. Diabetes Care. 2005;28(5):1245-1249.
3.
Hyperglycemic Crises in Diabetes. Diabetes Care. 2004;27(SUPPL. 1):S94-S102.
18.
Appendices
18.1 Names and addresses
18.1.1Investigational Centers and IRB
At the time this CIP was finalized, the investigational centers at which the study will be conducted had 
not been identified nor had any IRBs reviewed the investigational plan. The names and addresses of 
investigators, and participating investigational centers will be kept under separate cover.
18.1.2Monitor(s) Contact Information
The study will be monitored by the Medtronic Core Clinical Solutions (MC2) Global Monitoring and 
monitoring duties to be entrusted under:
Clinical Monitoring Manager, MC2 Global Monitoring
Medtronic
710 Medtronic Parkway 
Minneapolis, MN 55432
The names and addresses of monitors will be kept under separate cover. 
18.2 Labeling of Devices
The current labels and user guides for the investigational devices will be provided to the investigators in a 
separate cover.

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 95 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
18.3 Sample Consent Materials
Samples of the following consent forms/materials will be provided in a separate cover which includes the 
California Experimental Subject’s Bill of Rights (if applicable), ICF, assent form, and the HIPAA 
Authorization.
19.
Version History
Version
Summary of changes
Author(s)/Title
A.1
Not Applicable, New Document
A.2

See “Attachment 1: CIP337
Description of CIP Changes Version 
A.1 to A.2” for details on changes

Added Admelog to list of 
trademarks

Updated attribution statement and 
year in copyright statement

Transferred CIP to the revised 
Enterprise Clinical QMS CIP 
template (056-F275, Version E)

Updated Glossary section

Replaced the term “IFU” with “user 
guide” throughout CIP 

Harmonized the header name for 
products under the title page and 
synopsis table  

Updated word “protocol” to “CIP” 
to maintain consistent term used
throughout the document

Updated Title page, Synopsis 
(Clinical Study Type), Purpose, 
Objective, and Background 
section: Harmonized term 
“efficacy” to “effectiveness”

Updated Medtronic Extended 
infusion set model numbers and 
harmonized throughout CIP, as 
applicable in title page, synopsis, 
device system Table 1, and DA 
Requirements Table

Updated Medtronic Extended 
Reservoir device regulatory status 

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 96 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
to non-investigational. Harmonized 
throughout CIP, as applicable in 
title page, synopsis, device system 
Table 1, product description moved 
from “Investigational Product” 
section to “Non-Investigational 
Product” section, and DA 
Requirements Table

Clarified the use of SmartGuard 
during Run-in Period and Study 
Period for both subjects with Auto 
Mode and without Auto Mode 
experience. The changes are 
reflected under the following 
sections:
o
Study Design
o
Visit Details Table

Updated Study Design & Visit 
Details section:
o
Updated Auto Basal target 
settings and Active Insulin 
Time settings during run-in 
period and study period
o
Changed setting 
requirements for more 
flexibility per investigator’s 
discretion 
o
Added language during the 
study period to encourage 
subjects to continue on the 
same brand of insulin with 
which they started 

Added new visit 13 under Study 
Period –Day 44 (±3 days) after 
Visit 7. The changes are reflected 
under the following sections:
o
Study Design
o
Schedule of Events
o
Study Visit Schedule
o
Visit Schedule figure
o
Visit Details Table

Added “Adjust pump settings” in 
Study Visit Schedule and Visit 
Details Table

Updated Visit Details Table:
o
Added “Instruct/Remind 
subjects regarding the 
content of the Home 
Reference Guide”

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 97 of 97
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
o
Updated to “(including the 
type of insulin being used). 
The only insulins permitted 
for use in the study are 
Humalog, Novolog, and 
Admelog.”
o
Added instructions for
subjects and their 
parents/caregivers (if 
applicable) to report the 
Medtronic Extended 
infusion set and reservoir 
changes and reason for 
the changes, as applicable.
o
Added insertion locations 
and instructions for 
subjects and their 
parents/caregivers( if 
applicable) to report the 
sensor insertion 
information as specified for 
the applicable age group 
according to the User 
guide 

Updated the following Study Visit 
Schedule – Visit 1, Visit 4 windows, 
and Visit 15

Updated number of investigational 
centers 

Added use of Admelog. The 
changes are reflected under the 
following sections:
o
Study Design
o
Inclusion Criteria (#13)
o
Insulin
o
Visit Details Table
o
Subject Exit, Withdrawal or 
Discontinuation

Updated Exclusion Criteria #11

Added Exclusion Criteria for 780G 
users

Updated Consumable Devices 
section

Updated Product Accountability 
section: Table 2. DA Requirements

Updated Return or Disposal of 
Study Devices section

Updated Deviation Handling
section

Updated End of Subject 

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 98 of 98
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
Participation in Study/ Completion 
of Study section

Updated Subject Exit, Withdrawal 
or Discontinuation section

Updated Study Stopping Rules 
section

Updated Section 11.3: updated 
section title from “Reporting of 
Adverse Events” to “Recording of 
Adverse Events”

Updated Notification of Adverse 
Events section

Updated Expedited Safety 
Reporting Requirements section

Updated prevention and mitigation 
for the following (added “and 
glucagon”): Risks with Insulin 
Administration and Pumps and Risk 
with Closed Loop Therapy

Updated Clinical Events Committee 
section

Updated Data Monitoring 
Committee section

Updated Monitor(s) Contact 
Information section

Updated Labeling of Devices 
section
A.3 (FDA Approved)

See “Attachment 1: CIP337
Description of CIP Changes Version 
A.2 to A.3” for details on changes

Added Exclusion Criteria for 
Medtronic Diabetes employee or 
their immediate family member
(excluding adult children and/or 
adult siblings)

Updated Study Visit Schedule Fig.

Updated Visit Details Table:
o
Harmonized start of 780G 
pump during run-in period 
and study period with 
study design
o
Removed instructions for 
subjects and their 
parents/caregivers (if 
applicable) to report the 
Medtronic Extended 
infusion set and reservoir 
changes and reason for 
the changes, as applicable

CIP337 Clinical Investigation Plan
Form
D00459337
Version A
Page 99 of 99
Medtronic Business Restricted
CONFIDENTIAL
056-F275, Rev E Clinical Investigation Plan Template
A (Equivalent to 
A.4)

See “Attachment 1: CIP337 
Description of CIP Changes Version 
A.3 to A.4 ” for details on changes

Updated IDE number

Updated year in copyright 
statement

Updated Schedule of Events 
Section- removed Telemedicine 
since we are allowing virtual office 
visits where office visit occurs (this 
includes blood draws and device 
related assistance)

Added option for Virtual Office 
under Visit 1 and Visit 2 for the 
following:
o
Study Visit Schedule
section
o
Visit Schedule Figure
o
Visit Details Table

Harmonized start of Auto Basal 
target at 120 mg/dL, 100 mg/dL, 
and investigator’s discretion as 
specified under Study Design for 
the following:
o
Study Visit Schedule
section
o
Visit Details Table 

Updated Table 1: For Precision 
Xtra Ketone Meter or other 
approved ketone meter, added 
“N/A” under “MDT Model number/ 
part number” column

Updated Publication and Use of 
Information section