The MiniMed™ 780G Glycemic Control and Quality of Life Study for the Treatment of Pediatric and Adult Subjects With Type 1 Diabetes in France (EQOL Study)
Conditions: Type 1 Diabetes
Sponsor: Medtronic MiniMed, Inc.

 
Study Title 
The MiniMed™ 780G Glycemic Control and 
Quality of Life study for the treatment of 
pediatric and adult subjects with Type 1 Diabetes 
in France. (EQOL Study) 
NCT Number 
NCT04308291 
Document Description 
Clinical Investigation Plan (Version 4.0) 
Document Date 
22-OCT-2020 
 

Signed By
Meaning of Signature
Date/Time (UTC)
APPROVALS
CONFIDENTIAL
  
DOCUMENT/RECORD   
 
This document/record is electronically controlled; printed copies are considered uncontrolled. 
System of Record: Regulatory Affairs Domain 
 
Document Name
RAD Version
Title
Clinical Study Manager (CSM)
Medical Writer
4.0
10/26/2020 09:01:06
EQOL Clinical investigation Plan V.4.0 22 Oct 2020
Document Author
10/26/2020 08:42:21
Monitor
10/26/2020 08:44:07
10/26/2020 08:42:22
10/26/2020 08:42:22
Therapy SME
EQOL Clinical Investigational Plan

 
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1. Investigator Statement 
 
Study product Name 
EQOL 
Sponsor 
Medtronic France 
Clinical Investigation Plan Identifier 
MDT19028328 
Version Number/Date 
Version 4.0 22Oct2020 
 
I have read the protocol, including all appendices, and I agree that 
it contains all necessary details 
for me and my staff to conduct this study as described. I will conduct this study as outlined herein 
and will make a reasonable effort to complete the study within the time designated. 
 
I agree to comply with the latest version of the Declaration of Helsinki, national and local laws, 
regulations, standards and requirements as specified in section 13.1 of the Clinical Investigation 
Plan. 
 
I agree to ensure that the confidential information contained in this document will not be used 
for any purpose other than the evaluation and conduct of the clinical investigation without the 
prior written consent of Medtronic. 
 
I will provide all study personnel under my supervision copies of the protocol and access to all
 
information provided by Medtronic. I will discuss this material with them to ensure that they are 
fully informed about the products and the study. 
Investigator’s Signature: 
 
Investigator’s Name: 
 
Institution: 
 
Date: 
 
 
 
 

 
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Table of Contents 
 
1. Investigator Statement 
...........................................................................................................2 
2. Glossary.. 
.................................................................................................................................6 
3. Synopsis. ........................................................................................................................... ……8 
4. Introduction 
..........................................................................................................................13 
4.1. Background 
.................................................................................................................13 
4.2. Purpose 
.......................................................................................................................16 
5. Objectives and Endpoints .....................................................................................................17 
5.1. Primary Objective and Endpoint ................................................................................17 
5.2. Secondary Objectives and Endpoints 
.........................................................................17 
6. Study Design .........................................................................................................................18 
6.1. Rationale 
.....................................................................................................................20 
7. Product Description 
..............................................................................................................22 
7.1. General 
.......................................................................................................................22 
7.1.1. 
MiniMed™ 780G Insulin Pump ........................................................................24 
7.1.2. 
GuardianTM Sensor (3) 
....................................................................................26 
7.1.3. 
One-Press Serter 
..............................................................................................26 
7.1.4. 
Guardian™ Link (3) Transmitter 
.......................................................................27 
7.1.5. 
Transmitter Charger 
.........................................................................................28 
7.1.6. 
Tester ...............................................................................................................28 
7.1.7. 
Accu-Chek® Guide Link Blood Glucose Meter - ROCHE Accu-Chek® 
...............28 
7.1.8. 
Medtronic CareLink™ Personal for Clinical Research Therapy Management 
Software for Diabetes 
......................................................................................29 
7.1.9. 
Other supplies Infusion sets, Reservoirs and Infusion Set Serter Devices ......30 
7.1.10. MiniMed Mobile App Patients 
.........................................................................31 
7.1.11. CareLink™ BLE USB [Blue Adaptor] 
..................................................................31 
7.2. Manufacturer .............................................................................................................31 
7.3. Packaging 
....................................................................................................................31 
7.4. Intended Population 
...................................................................................................31 

 
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7.5. Product Use 
................................................................................................................32 
7.6. Product Training Materials 
.........................................................................................32 
7.7. Product Storage 
..........................................................................................................32 
7.8. Product Accountability 
...............................................................................................32 
8. Study Site Requirements.......................................................................................................33 
8.1. Investigator/Investigation Site Selection ...................................................................33 
8.2. Study Site Activation ..................................................................................................33 
9. Selection of Subjects 
.............................................................................................................34 
9.1. Study Population ........................................................................................................34 
9.2. Subject Enrollment 
.....................................................................................................34 
9.3. Inclusion Criteria 
.........................................................................................................35 
9.4. Exclusion Criteria 
........................................................................................................35 
10. Study Procedures 
...............................................................................................................35 
10.1. Schedule of Events .....................................................................................................35 
10.2. Data Collection ...........................................................................................................37 
10.3. Enrollment/baseline visit ...........................................................................................37 
10.4. 6- and 12-month Follow-up Visits 
..............................................................................39 
10.5. Study Exit 
....................................................................................................................40 
10.6. Source Data ................................................................................................................40 
10.7. Data Release consent process 
....................................................................................40 
10.8. Assessment of Safety 
..................................................................................................41 
10.9. Recording Data 
...........................................................................................................41 
10.10. Deviation Handling 
.....................................................................................................42 
10.11. Subject Withdrawal or Discontinuation 
.....................................................................43 
11. Risks and Benefits 
..............................................................................................................44 
11.1. Potential Risks ............................................................................................................44 
11.2. Risk Minimization 
.......................................................................................................45 
11.3. Potential Benefits 
.......................................................................................................46 
11.4. Risk-Benefit Rationale ................................................................................................46 
12. Statistical Design and Methods .........................................................................................46 

 
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12.1. Sample size justification 
.............................................................................................46 
12.2. Sample size Calculations 
.............................................................................................47 
12.3. Data Analysis ..............................................................................................................47 
13. Ethics 49 
13.1. Statement(s) of Compliance 
.......................................................................................49 
14. Study Administration 
.........................................................................................................50 
14.1. Monitoring 
..................................................................................................................50 
14.2. Data Management 
......................................................................................................51 
14.3. Direct Access to Source Data/Documents .................................................................52 
14.4. Confidentiality 
............................................................................................................52 
14.5. Liability .......................................................................................................................53 
14.6. CIP Amendments 
........................................................................................................53 
14.7. Records and reports 
...................................................................................................54 
14.7.1. Investigator Records 
........................................................................................54 
14.7.2. Investigator reporting responsibilities 
.............................................................54 
14.7.3. Sponsor Records ..............................................................................................54 
14.7.4. Sponsor reporting requirements 
.....................................................................55 
14.7.5. Record Retention 
.............................................................................................56 
14.8. Publication and Use of Information 
...........................................................................56 
14.9. Suspension or Early Termination ...............................................................................57 
14.9.1. Early study suspension or termination 
............................................................57 
14.9.2. Early investigational site suspension or termination ......................................57 
14.9.3. Subject follow-up in case of termination.........................................................58 
15. References .........................................................................................................................59 
16. Version History 
...................................................................................................................61 
 
 
 
 
 
 

 
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2. Glossary 
 
Term 
Definition 
A1C 
Glycosylated or glycated hemoglobin 
AE 
 
Adverse Event 
 CGM 
Continuous Glucose Monitoring 
 CGMS 
Continuous Glucose Monitoring System 
CIP 
 Clinical Investigation Plan 
CL 
Closed Loop 
CRF 
 Case Report Form 
CSII 
Continuous Subcutaneous Insulin Infusion 
CTA 
 Clinical Trial Agreement 
CV 
Curriculum Vitae 
DM 
Diabetes Mellitus 
DoH 
 Declaration of Helsinki 
DRF 
Data Release Form 
DTL 
 Delegated Task List 
DTSQ 
Diabetes Treatment Satisfaction Questionnaire 
DQOL 
Diabetes Quality of life 
eCRF 
Electronic Case Report Form 
EC/IRB/HREB/Ethics Board/Head of Medical 
 Institution 
Ethics Committee 
FDA 
Food and Drug Administration 
HbA1c 
Glycosylated or glycated hemoglobin 
HCL 
Hybrid Closed Loop 
AHCL 
Advanced Hybrid Closed Loop 

 
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HCP 
Health Care Professional 
HFS 
Hypoglycemia Fear Survey 
IC  
Informed Consent 
IFU 
Instructions for Use 
LGS 
Low Glucose Suspend 
MDI 
Multiple Daily Injections 
OC-RDC 
Oracle Clinical Remote Data Capture 
PC 
Personal Computer 
PLGM 
Predictive Low-Glucose Management 
PRO 
Patient-reported outcome 
QOL 
Quality of Life 
RCT 
Randomized controlled trial 
RF 
Radio Frequency 
SAP 
Sensor Augmented Pump 
SG 
Sensor Glucose 
SMBG 
Self-Monitoring of Blood Glucose 
TIR 
Time in Range 
TLS 
Transport Layer Security 
T1D 
Type 1 Diabetes 
 
Humalog™* is a registered trademark of Eli Lilly and Company. 
NovoLog™* and NovoRapid® are a trademark of Novo Nordisk A/S. 
Carelink®, MiniMed®, Guardian™ are registered or unregistered trademarks of Medtronic. 
ACCU-CHEK® AND ACCU-CHEK® GUIDE LINK are registered trademarks of Roche Diabetes Care. 
 
 

 
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3. Synopsis 
 
Title 
The MiniMed™ 780G Glycemic Control and Quality of Life study for the 
treatment of pediatric and adult subjects with Type 1 Diabetes in France. 
(EQOL Study) 
Clinical Study Type 
Post-Market non-interventional, prospective, local, single-arm, multi-
center non-randomized study 
Product Name 
• MiniMed™ 780G Pump labelled as MiniMed™ Insulin Pump ( MMT-
1896WWA) - referred to as MiniMed™ 780G Pump throughout the 
protocol 
• Guardian™ Link (3) Transmitter Kit (MMT-7910W1)  
• Guardian™ Sensor (3) Glucose Sensor (MMT-7020D1, MMT-
7020C1), referred to as Guardian Sensor (3) throughout this 
protocol 
• One-Press Serter (MMT-7512W) -referred to as the Serter 
throughout the protocol 
• Accu-Chek® Guide Link Blood Glucose Meter - ROCHE Accu-Chek® 
(08116083016M)- referred to as the Study Meter throughout this 
protocol) 
• MiniMed Reservoir (MMT-332A; MMT-326A) 
• Infusion sets table list of compatible infusion sets is in table 2.  
• Activity Guard (ACC-1520) 
• MiniMed Mobile app (MMT-6101 for Android; MMT-6102 for iOS) 
• CareLink BLE USB [Blue Adaptor] (ACC-1003911B) 
• Medtronic CareLink™ Personal for Clinical Research Therapy 
Management Software (MMT-7338) 
Note: upload of MiniMed™ system data will be done via Medtronic 
CareLink™ Personal for Clinical Research Therapy Management Software 
until the mobile app is available. 
Medtronic may incorporate additional/updated devices, software and 
accessories into this clinical study as they receive appropriate license or 
regulatory approval and are released commercially by Medtronic. 
Sponsor/Local 
Sponsor 
Medtronic France SAS 
 
 
The sponsor will maintain a list of staff under a separate cover 

 
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Indication under 
investigation 
Subjects, 7 years of age and older, with Type 1 Diabetes mellitus (T1D) 
under Continuous Subcutaneous Insulin Infusion (CSII) therapy ≥6 
months with or without Continuous Glucose Monitoring (CGM). 
Investigation 
Purpose 
To evaluate the efficacy 
in glycemic control and the 
impact on the quality 
of life of patients using the MiniMed™ 780G System for the treatment of 
Type 1 diabetes, in real life settings in France. 
Product Status 
All products have obtained CE mark. 
Primary 
Objective(s) 
To evaluate if the MiniMed™ 780G system in Auto Mode increases the 
proportion of Time In Range (TIR) at 6 months compared to MiniMed™ 
780G system in Manual mode (with no SmartGuard™ functions) at 
baseline. TIR 
is defined as percentage of sensor glucose values within 70-
180mg/dL. 
Secondary 
Objective(s) 
Secondary Objective #1: To assess the change of the TIR at baseline and 
every three months until 12 months. 
Secondary Objective #2: To evaluate the change from baseline in 
satisfaction score based on the DTSQc evaluated at 6 months. 
Secondary Objective #3: To evaluate the change from baseline in quality 
of life based on the DQoL evaluated at 6 and 12 months. 
Secondary Objective #4: To evaluate the change from baseline in the 
fear of hypoglycemic events based on the HFS evaluated at 6 and 12 
months. 
Secondary Objective #5: To evaluate the change of glycemic parameters 
at baseline and every three months until 12 months and the change in 
HbA1c from baseline to 6 months and 12 months. 
Secondary Objective #6: To evaluate the treatment satisfaction score 
based on the DTSQs evaluated at baseline, 6 and 12 months 
Study Design 
Local, post-market, non-interventional, prospective, single-arm, multi-
center study of patients (Pediatric and adult). 
Sample Size 
Approximately 300 patients (children and adults) in approximately 32 
sites in France. 
Duration 
It is foreseen that the enrollment period will last for 
12 months. The 
follow up of the patients is of maximum 1-year post Auto Mode 
activation after baseline visit. Each subject will enter a run-in phase 
(baseline) in hospital outpatient setting of approximately 2 weeks as per 
standard clinical practice, followed by a study period of 12 months. 
Therefore, the maximum duration of subject participation in the study is 
approximately 12 months. The total study duration is expected to be 2 
years. 

 
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Inclusion/Exclusion 
Criteria 
 Inclusion 
Exclusion 
 
1. Subject is ≥7 years of age. 
2. Subject has a clinical 
diagnosis of type 1 diabetes 
for more than 1 year as 
determined via 
medical 
records  
or  
source 
documentation  
by  
an 
individual qualified to make a 
medical diagnosis. 
3. Subject has a glycosylated 
haemoglobin (HbA1c) value 
greater than 6.5% and less 
than 12% at time of 
enrolment visit. 
4. Subject is under Continuous 
Subcutaneous  
Insulin 
Infusion (CSII) therapy (with 
or 
without 
Continuous 
Glucose   Monitoring) for   6  
months or more before 
enrolment. 
5. Subject requires ≥8 units of 
insulin per day. 
6. Subjects  
and  
their 
parent(s)/guardian(s) 
must 
be able to speak and be 
literate in French as verified 
by the investigator. 
7. Subjects  
and  
their 
parent(s)/guardian(s)  
are 
willing to participate in the 
study and sign the DRF 
8. Subjects who are ≥18 years of 
age should be able to provide 
consent 
1. Subject has MiniMed™ 780G 
System IFU contraindication(s). 
2. Subject used Predictive Low- 
Glucose Management (PLGM) 
System (i.e. MiniMed™ 640G 
with SmartGuard™) in the last 
6 
months 
before the 
enrolment. 
3. Subject used Low Glucose 
suspend (LGS) feature (i.e. 
MiniMed™ Paradigm Veo Pump) 
in the last 6 months before the 
enrolment. 
4. Subject under Multiple Daily 
Injections (MDI) treatment in 
the 6 months before the 
enrolment. 
5. Subject has any unresolved 
adverse skin condition in the 
area of sensor placement (e.g., 
psoriasis, dermatitis 
herpetiformis, rash, hylococcus 
infection). 

 
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Study Procedures 
and Assessments 
Data will be collected as follow:  
 
Baseline 
Demographics at Baseline: age, gender. 
Medical history at Baseline: HbA1c, Previous treatment, Name of 
the last pump device, Date of the first pump treatment, Number of 
severe hypoglycemia events in the last year, years since diagnose of 
T1D; DTSQs; 
DQoL; 
HFS. 
Auto Mode Activation at Baseline: Auto Mode activation date 
At the end of the run-in period, the following data will be also 
collected:  
Mean TIR (70-180mg/dL); 
Mean Time spent of sensor glucose value below 70mg/dL and below 
54mg/dL; 
Mean Time spent of sensor glucose value above 180mg/dL and above 
250mg/dL; 
Number of bio-chemical hypoglycemic event per week. 
 
6M 
DTSQs and DTSQc;  
DQoL; 
HFS; 
Diabetes parameters via CareLink™ Personal for Clinical Research:  
TIR; 
Mean time spent of sensor glucose value below 70mg/dL and below 
54mg/dL; 
Mean time spent of sensor glucose value above 180mg/dL and above 
250mg/dL; 
Number of bio-chemical hypoglycemic event per week;  
HbA1c  
Number of severe hypoglycemia; 
Use of Auto Mode;  
Use of CGM; 
Number of Auto Mode outings. 
 
12M  
DTSQs;  
DQoL;  
HFS; 
Diabetes parameters via CareLink™ Personal for Clinical Research:  
TIR; 

 
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Mean time spent of sensor glucose value below 70mg/dL and below 
54mg/dL; 
Mean time spent of sensor glucose value above 180mg/dL and above 
250mg/dL; 
Number of bio-chemical hypoglycemic event per week;  
HbA1c  
Number of severe hypoglycemia; 
Use of Auto Mode;  
Use of CGM; 
Number of Auto Mode outings. 
 
Device data (insulin/CGM) will be collected throughout the 
study period and evaluated at every 3month. 
Safety 
Assessments 
Post-Market surveillance applies only. Adverse Events and Device 
Deficiencies are not collected. This is an efficacy and Quality of Life and 
treatment satisfaction non-interventional study. Complaint reporting will 
be done as per local requirements and Medtronic processes, including 
vigilance for commercially approved
 products. 
Statistics 
The sample size was determined using a one sample paired test assuming 
a one- sided type I error rate of 0.05 and power greater than 90%. The TIR 
at baseline is assumed to be around 60% and the TIR at 6 months follow 
up is assumed to be 63% with standard deviation as 16% and a correlation 
as 0.5. The sample size needed to demonstrate this hypothesis including 
20% of attrition rate 
is 306. 
Descriptive statistics will be used to summarize patient characteristics. For 
categorical variables, the description will consist in frequency and the 
percentage of each category. For continuous variables, the description will 
consist summary statistics as mean, standard deviation, standard error, 
minimum, median and maximum. 
The primary endpoint on efficacy defined as the change of TIR at 6 months 
from Auto Mode activation will be analyzed by means of paired (samples) 
t-test or Wilcoxon signed rank sum test according to the normal or non-
normal distribution. 
The primary outcome will include all patients as the ITT population. 
Sensitivity analysis will include the per protocol patients as defined by 
>70% Auto Mode usage. 
 
 
 

 
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4. Introduction 
 
4.1. 
Background 
The Medtronic MiniMed™ sensor augmented insulin pumps have been helping insulin requiring 
patients with diabetes mellitus all around the world for more than two decades. In order to address 
some of the unmet needs of these patients and to provide them the benefits of newer technologies, 
Medtronic Diabetes has developed a new Sensor Augmented Pump platform: the MiniMed™ 780G 
System, also referred as Advanced Hybrid Closed Loop system. 
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, including sensor-augmented pump therapy, 
experience improvements in glycemic control. Advanced features of sensor-augmented pump 
therapy are now being used 
in clinical practice; these 
include automatic suspension of 
insulin delivery 
when a pre-set glucose threshold is reached (suspend on low) or is predicted to be reached (suspend 
before low). Both approaches have shown that a significant reduction in the risk and burden of 
hypoglycemia can be achieved, especially in patients who are prone to experiencing hypoglycemia. 
Parallel to these approaches to mitigate the risk of hypoglycemia, more progressive advancements 
in technology can link insulin delivery directly to glucose levels. Closed-loop insulin delivery is 
different from conventional pump therapy and 
low glucose management technology, because 
it uses 
a control algorithm to automatically adjust insulin delivery based on subcutaneous sensor data to 
improve diabetes management. Manual meal-time announcement and prandial insulin boluses still 
need to be carried out by patients in order to overcome the delay in insulin action of currently 
available insulin analogues administered subcutaneously. The ‘hybrid’ closed-loop approach 
contrasts with a ‘fully’ closed-loop approach, in which user input to the control algorithm related to 
meals would no longer be required. 
Medtronic has conducted numerous studies to evaluate hybrid closed loop (HCL) technology, 
currently used in the MiniMed™ 670G System. 
The HCL System consists of an insulin pump that delivers insulin to the user, a continuous glucose 
monitor (CGM) including algorithm that measures the user's glucose levels for up to seven days, and 
a glucose meter used to calibrate the CGM. The MiniMed™ 670G System is able to decrease or stop 
insulin delivery when it detects the user's glucose is low or increase the insulin delivery when the 
system detects the user's glucose levels are high with no input from the user. 
After completing a variety of feasibility studies with the hybrid closed loop algorithm, two
 separate 
pivotal trials were initiated to show that the use of hybrid closed loop technology (MiniMed™ 670G 

 
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System) is safe in both adults and children over the age of 2. In the young adult/adult pivotal study, 
patients aged 14 to 75 years with type 1 diabetes were recruited from 10 centers (9 in the United 
States, 1 in Israel). The pediatric pivotal study was conducted as an at-home, multi-center study, 
which enrolled participants ages 2-13 years. Patients were recruited at 11 centers (10 in the United 
States, 1 in Israel). The study was identical in design to the young adult/adult pivotal study. 
Study results in the pediatric study mirrored data from the pivotal trial of the system in adults and 
adolescents (14 and above), showing patients spent more time 
in euglycemic range, experienced 
less 
glycemic variability, had less exposure to hypoglycemia and hyperglycemia and significantly reduced 
HbA1c compared to baseline data, where they used sensor-augmented pumps. No episodes of 
severe hypoglycemia or diabetic ketoacidosis and no serious device-related adverse events were 
reported. 
The Advanced Hybrid Closed Loop system (AHCL) 
is based on the MiniMed™ 670G hybrid closed loop 
system currently in commercial distribution in the United States, Canada and Europe. Relative to the 
MiniMed™ 670G system, AHCL includes enhancements intended to reduce the frequency of Auto 
Mode exits and decrease the time spent in hyperglycemia. Advancement such as automatic 
correction bolusing, sensor glucose based meal bolusing, automatic calibrations of Blood Glucose 
(BG) measurements transmitted to the pump and a variable target for automatic basal deliveries, all 
maximize the time spent in hybrid closed-loop operation, in order to further improve glucose control 
and overall user satisfaction.  
Patients using the AHCL system will not be required to confirm sensor glucose using SMBG (Self-
Monitoring of Blood Glucose) measurement before making therapy adjustments based on displayed 
sensor glucose values. 
The advanced algorithm receives continuous glucose monitoring (CGM) data every 5 minutes, and a 
“basal rate” insulin delivery is computed and adjusted every five minutes. Therefore, standard 
“basal” insulin that is pre-programmed in regular insulin pump therapy is replaced by the algorithm 
derived insulin delivery (given as a micro-bolus every 5 minutes).  
Meals will be announced, and sensor glucose based insulin bolus for a meal will be delivered 
according to the individualized patient carbohydrate ratio and insulin sensitivity factor. 
The MiniMed 780G system 
is 
intended for the continuous delivery of basal 
insulin at selectable rates, 
and the administration of insulin boluses at selectable amounts. The system is also intended to 
continuously monitor glucose values in the fluid under the skin. The MiniMed 780G system includes 
SmartGuard technology, which can be programmed to provide an automatic adjustment of insulin 
delivery based on continuous glucose monitoring (CGM) and can suspend the delivery of 
insulin when 
the SG value falls below, or is predicted to fall below, predefined threshold values. 
The MiniMed™ 780G system received CE (Conformité Européenne) Marking in June 2020. While in 
the United States, the MiniMed™780G system is for investigational use only, and not approved for
 

 
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sale or distribution.
 
Several clinical studies were conducted (Table 1) to demonstrate the safety and effectiveness of the 
MiniMed™ 670G and 780G Systems. However, data regarding the effect on glycemic control, quality 
of life and treatment satisfaction of MiniMed™ 780G System under the routine practice in France are 
highly recommended by the French National Authority for Health (HAS). 
 
Table 1: Clinical Program MiniMed™ HCL and AHCL Systems 
 
Study 
Sponsor 
Design 
Population System  
Manuscript 
Hybrid Closed 
Loop Pivotal 
Trial in Type 1 
Diabetes 
NCT02463097 
Medtronic Pivotal trial (US 
and Israel) 
Age 14-75 
HCL 
Published by Garg et 
al. “Glucose Outcomes 
with the In-Home Use 
of a Hybrid Closed-
Loop Insulin Delivery 
System in Adolescents 
and Adults with Type 1 
Diabetes” 
Diabetes Technol Ther. 
2017 Mar;19(3):155-
163. doi: 
10.1089/dia.2016.0421. 
Epub 2017 Jan 30. 
Safety 
Evaluation of the 
Hybrid Closed 
Loop (HCL) 
System in 
Pediatric 
Subjects with 
Type 1 Diabetes 
NCT02660827 
Medtronic 
Interventional, 
non- 
randomized, 
single-arm, 
multicenter trial 
(US and Israel) 
Age 2-13 
HCL 
Published by Forlenza et 
al. “Safety Evaluation of 
the MiniMed™ 670G 
System in Children 7-13 
Years of Age with Type 1 
Diabetes.” 
Diabetes Technol Ther. 
2019 Jan;21(1):11-19. 
doi: 
10.1089/dia.2018.0264.  
Epub 2018 Dec 26. 
Multi-center 
Trial in Adult and 
Pediatric 
Patients With 
Type 1 Diabetes 
Using Hybrid 
Closed Loop 
System and 
Control at Home 
NCT02748018 
Medtronic 
Interventional, 
randomized 
controlled trial 
(RCT) 
(US, Canada, 
Europe) 
Age 2-80 
HCL 
Ongoing recruitment 

 
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Safety 
Evaluation of the 
Advanced Hybrid 
Closed Loop 
(AHCL) System in 
Type 1 Adult and 
Pediatric 
Subjects 
G190075  
Medtronic 
Interventional, 
non-randomized, 
multi-center, 
single arm  
(US) 
Age 7-75   
AHCL 
Completed 2020 
ADAPT  
ADvanced 
Hybrid Closed 
Loop study in 
Adult Population 
with Type 1 
Diabetes:  
A Prospective, 
Open-label, 
Multi-center, 
Adaptive, 
Confirmatory 
and Randomized 
Controlled Study 
Medtronic 
Pre-market. 
Prospective, 
Open-label, 
Multi-center, 
Adaptive, 
Confirmatory 
and Randomized 
Controlled Study 
(EMEA) 
Age ≥ 18  
AHCL 
Ongoing recruitment 
 
 
4.2. 
Purpose 
Medtronic France SAS is sponsoring the CIP328 EQOL study, a Post-Market non-interventional, 
prospective, local, single-arm, multi-center non-randomized clinical study. The purpose of this study 
is to evaluate the impact on glycemic control and quality of life of patients using the MiniMed™ 780G 
System for the treatment of Type 1 diabetes, 
in real 
life settings 
in France to support reimbursement 
of the MiniMed™ 780G in France. This data will complete the available data from international 
pivotal studies, as it is highly recommended by the French authorities to provide local data on 
glycemic control, quality of life and treatment satisfaction in real life conditions. 
 
 

 
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5. Objectives and Endpoints 
 
5.1. 
Primary Objective and Endpoint 
The primary objective 
is to evaluate 
if the treatment of T1D with MiniMed™ 780G System 
in pediatric 
and adult population increases the Time In Range (TIR) at 6 months compared to MiniMed™ 780G 
System in Manual Mode (with no SmartGuard™ functions) during the run-in period (expected to be 
approximately 2 weeks). TIR is defined as time spent of sensor glucose values within 70-180mg/dL. 
 
The primary endpoint 
is the change 
in (%) the time spent within range (TIR) defined as the proportion 
of sensor glucose concentration within the target range 70-180 mg/dL (3·9–10·0 mmol/L) between 
baseline and 6 months. 
 
5.2. 
Secondary Objectives and Endpoints 
Secondary objectives will aim at evaluating the difference in time in range, quality of life and 
treatment satisfaction. 
1) Secondary objective #1: To assess the change of the TIR collected at baseline and every three 
months until 12 months 
2) Secondary Objective #2: To evaluate the change from baseline in satisfaction score based on 
the DTSQc evaluated at 6 months. 
3) Secondary Objective #3: To evaluate the change from baseline in quality of life based on the 
DQoL evaluated at 6 and 12 months. 
4) Secondary Objective #4: To evaluate the change from baseline in the fear of hypoglycemic 
events based on the HFS evaluated at 6 and 12 months. 
5) Secondary Objective #5: To evaluate the change of glycemic parameters at baseline and every 
three months until 12 months and the change in HbA1c from baseline to 6 months and 12 
months. 
6) Secondary Objective #6: To evaluate the treatment satisfaction score based on the DTSQs 
evaluated at baseline, 6 and 12 months 
 
Secondary Endpoints: 
a) Secondary endpoint #1: The Time In Range (TIR) defined as the proportion of sensor glucose 
concentration within the target range of 70-180 mg/dL (3·9–10·0 mmol/L) every 3 months. 
b) Secondary Endpoint #2: The different DTSQc versions will be used to assess satisfaction in the 
following populations: 
a. DTSQc Adult (≥18 years old) 
b. DTSQc Teen (13-17 years old) 
c. DTSQc Parent (7-12 years old) 
c) Secondary Endpoint #3: the DQOL questionnaire will be used and the mean scores will be 
compared between baseline and 6 and 12 months. The different DQOL versions will be used 

 
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to assess quality of life in the following populations: 
a. DQOL Adult (≥18 years old) 
b. DQOL Adult with Adolescent-oriented items (13-17 years old) 
c. No DQOL version and therefore collection for patients 7-12 years old 
d) Secondary Endpoint #4: the HFS questionnaire will be used and the mean scores will be 
compared between baseline and 6 and 12 months. The different HFS versions will be used to 
assess the fear of hypoglycemic events in the following populations: 
a. HFS Adult (≥18 years old) 
b. HFS Teen (13-17 years old) 
c. HFS Parent (7-12 years old) 
e) Secondary Endpoint #5: The
 time of sensor glucose values below 70mg/dL and below 54mg/dL, 
time of sensor glucose values above 180mg/dL and above 250mg/dL at baseline and every 3 
months. The change in HbA1c from baseline to 6 and 12-month follow up. 
f) Secondary Endpoint #6: The different DTSQs versions will be used to assess satisfaction in the 
following populations: 
a. DTSQs Adult (≥18 years old) 
b. DTSQs Teen (13-17 years old) 
c. DTSQs Parent (7-12 years old) 
 
6. Study Design  
 
This study is a local, post-market, non-interventional, prospective, single-arm, multi-center, non-
randomized study assessing the glycemic control effect, treatment satisfaction and the quality of life 
of patients using MiniMed™ 780G System as per the standard care of practice. This study has a single-
arm design which will recruit a maximum of 300 subjects in up to 32 sites in France. At the time of 
Clinical Investigational Plan finalization, the list of participating sites was not finalized. The complete 
list, which includes the name, position, address and contact details of the investigators responsible 
for conducting the study for each investigational site, will be available under separate cover and 
provided to the sites. 
To avoid introduction of bias to the study results due to disproportionate enrollment, enrollment at 
any individual site should not exceed 10% (30 subjects) of the total sample size. It’s expected that 
sites enroll a minimum of 10 subjects per site. 
Enrollment will be competitive across study sites. The per-study site enrollment cap may be 
increased upon Sponsor approval. 
Subject enrolled in this study (or his/her parent/legal representative in case of DTSQ and HFS for 
patients 7-12 years old) will be asked to complete the questionnaires DTSQ, DQoL (if patient is ≥13 
years old) and HFS at baseline/enrollment visit and at 6- and 12- month follow-up visits. 
The following measures are taken to minimize potential sources of bias: 
 A multi-center design is used to ensure a representative sample of physicians providing the 

 
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treatment and to reach a reasonable enrollment period. 
 Site selection will be done per predefined selection criteria. 
 Only physicians that have adequate documented experience in diabetes management will 
participate. 
 Site training is performed according the training & education plan set up for the pump use in 
order to assure full understanding and engagement to comply with the pump best utilization. 
 Consecutive screening and enrollment will be encouraged and enforced as much as possible. 
 
Figure 1: Study design overview  
 
 
CareLink™ Personal for Clinical Research data uploads from the devices should be done via Bluetooth connectivity or via 
USB connection as per clinical practice, i.e. once a week. CareLink™ Data evaluation will be done every 3 months. 
 
Duration 
It is foreseen that the enrollment period will last for 12 months. The follow up of the patients i s of 
maximum 1 year post Auto Mode activation in baseline visit. Each subject will enter a run-in phase 
in hospital outpatient setting of approximately 2 weeks as per standard clinical practice, followed by 
a study period of 12 months. Therefore, the maximum duration of subject participation in the study 
is of approximately 12 months. The estimated study duration is 2 years. 

 
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6.1. 
Rationale 
The goal of diabetes treatment is the prevention of the onset and progression of micro- and 
macrovascular complications as well as the achievement of quality of life (QOL) and longevity 
equivalent to people without diabetes. Several studies have established the importance of glycemic 
control to prevent diabetic complications and based on this evidence, a glycated hemoglobin (HbA1c) 
level of <7% is currently recommended as the glycemic goal in most guidelines [1-4]. 
However, the outcome of diabetes treatments should not be evaluated only by glycemic control as 
the evaluation of the psychological aspects of patients, 
including treatment satisfaction, wellbeing and 
quality of life (QOL), is also important; they are referred to as patient-reported outcomes (PROs) [5–
6]. 
 
The improvement in the treatment satisfaction may result in improving patients’ self-efficacy and 
adherence to treatment. The improvement in treatment satisfaction may also reduce the risk of 
dropout from treatment. Therefore, improvement in treatment satisfaction may foster the 
achievement of long- term glycemic stability, eventually reducing the risk of developing diabetic 
complications (Figure 2). 
 
Figure 2: Factors associated with treatment satisfaction and expected effects from its improvement 
on clinical outcomes 
 
 
 
 

 
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The Diabetes Treatment Satisfaction Questionnaire (DTSQ) 
is a questionnaire used to assess patients’ 
satisfaction with their diabetes treatment [7]. The questionnaire has been developed to evaluate 
satisfaction with diabetes treatment regimens 
in patients with Type 1 and 2 diabetes. There are eight 
items each rated with a 7-point Likert scale. Six items relate to treatment satisfaction with scores 
ranging from 0 to 36, higher scores 
indicating greater satisfaction. Two other items assess perceived 
frequency of hyperglycemia and hypoglycemia with higher scores reflecting greater problems 
(Bradley & Lewis 1990). The original ‘status’ form (DTSQs) focuses on current satisfaction which is 
reflected in the response options: 6=very satisfied, 0= very dissatisfied. Ceiling effects have been 
reported and the developers modified the response options to improve precision. This ‘change’ 
version (DTSQc) items are equivalent to the DTSQs but response options changed to 3= more 
satisfied now, -3= less satisfied now with a midpoint of 0 reflecting no change. Responsiveness is 
reported for both versions but the DTSQc is described as more responsive than DTSQs version [8-9]. 
DTSQs and DTSQc are recommended by HAS, the French National Authority for Health. 
 
Although the improvement in treatment satisfaction assessed with DTSQ is expected to improve 
patients’ QOL, DTSQ does not assess QOL itself. Indeed, as QOL of patients with diabetes has been 
shown to be lower, a higher DTSQ score does not necessarily translate into higher QOL [5]. Thus, the 
use of questionnaires other than DTSQ, such as DQoL, is needed to evaluate QOL. DQoL has been 
widely used to measure quality of life among diabetes patients [10-11] and contains 46 items used to 
measure health- related quality of life among diabetes patients based on three main domains, 
namely, “satisfaction,” “impact,” and “worry.” 
The Hypoglycemia Fear Survey (HFS) originally was developed to measure behaviors and worries 
related to fear of hypoglycemia (FOH) in adults with type 1 diabetes. Both the original HFS (HFS-I) 
and the revised version (HFS-II) are composed of two subscales, the Behavior (HFS-B) and Worry 
(HFS-W). HFS-B items describe behaviors in which patients may engage to avoid hypoglycemic 
episodes and/or their negative consequences (e.g., keeping blood glucose [BG] levels above 150 
mg/dL, making sure other people are around, and limiting exercise or physical activity). HFS-W items 
describe specific concerns that patients may have about their hypoglycemic episodes (e.g., being 
alone, episodes occurring during sleep, or having an accident). Alternative versions of the HFS have 
been developed for use with pediatric patients with type 1 diabetes and their parents and will be 
used in the study (14–16). 
Following the objective to assess the new patient’s pathway and the benefits of MiniMed™ 780G 
system in real-life settings, the study design aims to follow routine practice, with before/after 
comparison of the data to show the benefit of the MiniMed™ 780G system on glycemic parameter, 
patient treatment satisfaction and quality of life. 
 
Due to the nature of the study, no data monitoring committee is needed. 
 

 
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7. Product Description 
 
7.1. 
General 
The Medtronic MiniMed™ 780G System is intended for continuous delivery of basal insulin (at user 
selectable rates) and administration of insulin boluses (in user selectable amounts) for the 
management of Type 1 diabetes mellitus in persons, seven years of age and older, requiring insulin, 
as well as for the continuous monitoring and trending of glucose levels via a sensor in the interstitial 
fluid under the skin. MiniMed™ 780G system with SmartGuard™ technology adjusts insulin delivery 
based on sensor glucose (SG) readings. The glucose sensor measures glucose values in the tissue 
fluid. The glucose values are wirelessly sent to the insulin pump, and displayed along with glucose 
trend information, alerts, and alarms on the pump screen. The insulin pump delivers a prescribed 
dosage of insulin through an infusion set. The insulin pump can automatically adjust the delivery of 
insulin using a mathematical equation, or algorithm that incorporates information from the CGM. 
The MiniMed 780G insulin pump operates 
in Manual mode when the SmartGuard feature is 
inactive. 
With the addition of smart device connectivity, the MiniMed™ 780G system will enable users and 
their care partners to see real-time glucose data and trends on compatible iOS and Android 
smartphones via apps via Bluetooth® connectivity. 
The MiniMed™ 780G System consists of the following devices: 
• MiniMed™ 780G Pump labeled as MiniMed™ Insulin Pump (MMT-1896WWA) - referred to as 
MiniMed™ 780G Pump throughout the protocol 
• Guardian™ Link (3) Transmitter Kit (MMT-7910W1)  
• Guardian™ Sensor (3) Glucose Sensor (MMT-7020D1, MMT-7020C1), referred to as Guardian 
Sensor (3) throughout this protocol 
• One-Press Serter (MMT-7512W) -referred to as the Serter throughout the protocol 
• Accu-Chek® Guide Link Blood Glucose Meter - ROCHE Accu-Chek® (08116083016M)- referred 
to as the Study Meter throughout this protocol) 
• MiniMed Reservoir (MMT-332A; MMT-326A) 
• Infusion sets table list of compatible infusion sets is Table 2.  
• Activity Guard (ACC-1520) 
• MiniMed Mobile app (MMT-6101 for Android; MMT-6102 for iOS) 
• CareLink™ BLE USB [Blue Adaptor] (ACC-1003911B) 
• Medtronic CareLink™ Personal for Clinical Research Therapy Management Software (MMT-
7338) 
Note: upload of MiniMed™ system data will be done via Medtronic CareLink™ Personal for Clinical 
Research Therapy Management Software until Mobile app is available. 

 
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Medtronic may 
incorporate updated devices, software and accessories 
into this clinical study as they 
receive appropriate license or regulatory approval and are released commercially by Medtronic. EC 
will be notified of the integrated updates.   
Details on the MiniMed™ 780G System Components and consumable materials used in this study are 
reported 
in Table 2. CE marked devices will be used within 
intended use as described 
in the approved 
IFU for which CE mark has been obtained. All materials that will or may be in contact with tissues 
and/or body fluids are presented in the approved IFU. 
 
System data can be uploaded via Medtronic CareLink™ Personal for Clinical Research software or via 
Mobile app. 
 
Table 2. MiniMed™780G System Components and consumable materials 
 
Device name 
MDT Model number/ 
part number* 
Europe 
MiniMed™ 780G Pump 
MMT-1896WWA  
CE Marked 
Accu-Chek® Guide Link Blood Glucose Meter - ROCHE 
Accu-Chek® 
08116083016M 
CE Marked 
CareLink™ BLE USB [Blue Adaptor] 
ACC-1003911B 
CE Marked 
Guardian™ Link (3) Transmitter Kit 
MMT-7910W1 
CE Marked 
Guardian™ Link (3) Transmitter 
MMT-7911 
CE Marked 
Guardian™ Sensor (3) Glucose Sensor 
MMT-7020C1 
CE Marked 
Guardian™ Sensor (3) Glucose Sensor 
MMT-7020D1 
CE Marked 
One-Press Serter 
MMT-7512W 
CE Marked 
Activity Guard (clip protecteur) 
ACC-1520 
CE Marked 
MiniMed Mobile App Android Patients 
MMT-6101 
CE Marked 
MiniMed Mobile App iOS Patients 
MMT-6102 
CE Marked 
Medtronic CareLink™ Personal for Clinical Research 
Therapy Management Software 
MMT-7338  
CE Marked 
MiniMed Reservoir 3 ml 
MMT-332A 
CE Marked 
MiniMed Reservoir 1,8ml 
MMT-326A 
CE Marked 
MiniMed™ Mio™ Advance 
MMT-242A 
CE Marked 
MiniMed™ Mio™ Advance 
MMT-213A 
CE Marked 
MiniMed™ Mio™ Advance 
MMT-243A 
CE Marked 
MiniMed™ Mio™ Advance 
MMT-244A 
CE Marked 
Microperfuseur Quick-set™ 
MMT-397A 
CE Marked 
Microperfuseur Quick-set™ 
MMT-399A 
CE Marked 
Microperfuseur Quick-set™ 
MMT-394A 
CE Marked 
Microperfuseur Quick-set™ 
MMT-396A 
CE Marked 
Microperfuseur Quick-set™ 
MMT-398A 
CE Marked 

 
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Quick-serter™ : dispositif d'insertion pour Quick-set™  
MMT-305QS 
CE Marked 
Microperfuseur SureT ™ 
MMT-866A 
CE Marked 
Microperfuseur SureT ™ 
MMT-876A 
CE Marked 
Microperfuseur Silhouette™ 
MMT-378A 
CE Marked 
Microperfuseur Silhouette™ 
MMT-381A 
CE Marked 
Microperfuseur Silhouette™ 
MMT-382A 
CE Marked 
Microperfuseur Silhouette™ 
MMT-377A 
CE Marked 
Sil-serter™ : dispositif d'insertion pour Silhouette™  
MMT-385 
CE Marked 
Microperfuseur Mio™ 
MMT-975A 
CE Marked 
Microperfuseur Mio™ 
MMT-965A 
CE Marked 
Microperfuseur Mio™ 
MMT-943A 
CE Marked 
Microperfuseur Mio™ 
MMT-923A 
CE Marked 
Microperfuseur Mio™30 
MMT-905A 
CE Marked 
Microperfuseur Mio™30 
MMT-906A 
CE Marked 
*MMT numbers may change if other compatible infusion sets become available 
 
7.1.1. 
MiniMed™ 780G Insulin Pump 
The MiniMed™ 780G Insulin Pump (Figure 3) is intended for continuous insulin delivery, at set and 
variable rates, and administration of 
insulin boluses, 
in user selectable amounts, for the management 
of diabetes mellitus in persons requiring insulin. When used with the CGM components (Guardian™ 
Sensor (3), Guardian™ Link (3) Transmitter), the pump system is capable of continuous or periodic 
monitoring of glucose levels in the interstitial fluid under the skin and detection of possible low or 
high blood glucose episodes. The pump also displays continuous glucose values, storing this data so 
that it can be retrospectively analyzed to track patterns and improve diabetes management. 
The MiniMed™ 780G 
Insulin Pump also 
includes the closed 
loop algorithm as part of the SmartGuard™ 
collection of features that may be enabled by the user. SmartGuard™ is comprised of Manual Mode 
Low Management, which includes the suspend on low feature (suspends 
insulin delivery when a pre-
set low Sensor Glucose (SG) threshold is reached), the suspend before 
low feature (enables 
insulin to 
suspend 30 minutes before a pre-set low SG threshold 
is reached), and Auto Mode (Advanced hybrid 
closed loop (AHCL)) feature. The Auto Mode and Manual Mode Low Management features will not 
be active at the same 
time. 
The pump may also be used as a simple pump without CGM or as a sensor augmented pump without 
the SmartGuard™ features. 
The system has two modes: Manual Mode and Auto Mode. In Manual Mode, the system can be 
programmed by the user to deliver basal insulin at a pre-programmed constant rate. The system can 
automatically suspend delivery of insulin if the sensor glucose value falls below or is predicted to fall 

 
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below a predetermined threshold. The system will then also automatically resume delivery of insulin 
once sensor glucose values rise above or are predicted to rise above a predetermined threshold. In 
Auto Mode, the system can automatically adjust basal 
insulin by continuously 
increasing, decreasing, 
or suspending delivery of 
insulin based on CGM values. Although Auto Mode can automatically adjust 
basal insulin delivery without input from the user, the user must still manually deliver insulin therapy 
during meals. 
When Auto Mode is enabled on the MiniMed™ 780G insulin pump, the sensor glucose values (SGVs) 
received from the Guardian™ Link (3) Transmitter by the insulin pump will be used to automatically 
calculate the basal insulin dose. It will then deliver insulin to the patient, at five-minute intervals, to 
achieve glycemic control. 
With the AHCL system, subjects must still deliver bolus insulin for meals as calculated by the insulin 
to carbohydrate ratio. This ratio is determined by the Health Care Professional (HCP)/patient. In 
addition, the setting for active insulin must be programmed at the time Auto Mode is enabled. 
 Basal 
rates are set for period of open loop therapy, exit from Auto Mode. 
When Auto Mode is not enabled, the user may enable the Manual Mode, Smart Guard™ Low 
Management feature. Here, basal rate delivery will be suspended either when the SGV reached a 
programmed low threshold (Suspend on Low) or before the SGV has reached the programmed low 
threshold (Suspend before Low). If the Low Management features were programmed at the time 
Auto Mode was enabled, they will be automatically available in the event of an exit from Auto Mode. 
Compared to the MiniMed 670G system, the AHCL MiniMed 780G system includes the following 
advanced features:  
• Automatic Correction Bolus: Automatic correction boluses that can be based on SG values and 
a lowered correction target from 150 to 120 mg/dL (8.3 to 6.7 mmol/L) to increase Time in 
Range (TIR). 
• Safe Meal Bolus algorithm: Reduction of the amount of a meal bolus, if it is predicted to 
increase the risk of post-prandial hypoglycemia to increase TIR. 
• SG Based meal bolus: Patients have the option to use a sensor glucose value to bolus for meals 
• Auto-Basal Control: Optional lower basal rate target in Auto Mode, either 120mg/dL (6.7 
mmol/L) or 110 mg/dL (6.1 mmol/L) or 100 mg/dL (5.6 mmol/L) 
• Confirmed Calibrations: Each Blood Glucose Measurement is used as a calibration resulting in 
less unnecessary Auto Mode exits and missed calibrations, and consequently in less alarms to 
increase TIR and user satisfaction. 
 
 
 
 
 

 
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Figure 3. MiniMed™780G Insulin Pump 
 
 
7.1.2. 
GuardianTM Sensor (3) 
The Guardian™ Sensor (3), referred to as Guardian™ Sensor (3) in this protocol, is a subcutaneous 
sensor that contains a microelectrode with a thin coating of glucose oxidase beneath several layers 
of biocompatible membrane. It is intended to penetrate the skin at a 90-degree angle and is shorter 
and thinner than the previous generation of MiniMed™ sensors. An 
introducer needle penetrates the 
skin surface and provides support for the sensor microelectrode during insertion. The electrode 
tubing maintains the electrode structure by providing support during and after subcutaneous 
insertion. The sensor continuously converts small amounts of glucose from the subject’s interstitial 
fluid into an electronic signal that is received by a transmitter or recorder, the strength of which is 
proportional to the amount of glucose present in the blood. The electrode is composed of 
embedding, signal-conducting and insulating 
layers. 
 
Figure 4: Guardian™ Sensor 3 
 
 
7.1.3. 
One-Press Serter 
The One-Press Serter, referred to as the Serter (Figure 5) 
in this protocol, 
is an 
insertion device that is 
used to ensure correct placement of the Guardian™ Sensor (3) into the user’s subcutaneous tissue. 
Insertion is triggered when the two spring loaded buttons on the sides of the Serter are pressed 
simultaneously. The Serter is intended as a non-sterile and multi-use device. It is indicated for single-
patient use and is not intended for multiple patient use. 

 
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Figure 5. One-Press Serter 
 
 
7.1.4. 
Guardian™ Link (3) Transmitter 
The Guardian™ Link (3) transmitter with Bluetooth™* wireless technology is a rechargeable device 
and powers the glucose sensor, collects and calculates the sensor data, and sends the data to a 
compatible MiniMed™ insulin pump system with smart device connectivity for the management of 
diabetes mellitus.  
The Guardian™ Link (3) Transmitter reads the electronic signal generated by the sensor. In addition, 
the transmitter contains a custom Application Specific Integrated Circuit (ASIC), which enables 
Electrochemical Impedance Spectroscopy (EIS). The EIS measurements are used as diagnostics for 
the sensor, which are incorporated into the sensor calibration logic. 
In addition, the transmitter also contains the sensor calibration algorithm which converts the sensor 
signal to a SG value using calibration blood glucose (BG)
 values from a meter relayed to the transmitter 
through the pump. The transmitter transmits the calculated glucose data to the pump via 2.4GHz RF 
technology (Tel-D communication protocol) and Bluetooth™ wireless technology. The new algorithm 
is designed to 
improve and optimize performance when paired with the Guardian™ Sensor (3). Some 
elements of the new calibration logic include prompting the user to calibrate when needed, referred 
to as “Smart Cal,” instead of strictly scheduled time-based calibration requirements. 
The transmitter is attached to the sensor via a connector and a tape is applied on top of the sensor. 
 
Figure 6: Guardian™ Link (3) Transmitter 
 
                 
 
    Transmitter 
Transmitter + Sensor 

 
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7.1.5. 
Transmitter Charger 
The Transmitter Charger (Figure 7) 
is used to recharge the Guardian™ Link (3) Transmitter as needed. 
The transmitter contains a non-replaceable, rechargeable battery. A fully charged battery provides 
up to 7 days of Guardian™ Link (3) Transmitter use. The system includes a battery charger that will 
recharge the device according to the user guide. 
 
Figure 7.  Transmitter Charger 
 
 
 
7.1.6. 
Tester 
The Tester operates as a sensor simulator creating signal current at a level that is within the range of 
an in-vivo sensor during normal operation. 
 
7.1.7. 
Accu-Chek® Guide Link Blood Glucose Meter - 
ROCHE Accu-Chek® 
Accu-Chek® Guide Link Blood Glucose Meter by Roche, referred to as the Study Meter throughout 
protocol, will be provided to study participants for use with the MiniMed™ 780G Insulin Pump. The 
meter measures a subject’s capillary blood glucose level using the Accu-Chek® Guide Linkby Roche, 
which is then used to calibrate the pump.  
Accu-Chek® Guide Link meter Blood Glucose Monitoring System sends BG meter readings directly to 
the pump. When an Accu-Chek® Guide Link meter is used, the reading appears on the Home screen 
when the Sensor feature is off. The MiniMed 780G insulin pump with smart device connectivity can 
pair only with an Accu-Chek® Guide Link meter to automatically receive BG readings. If the Accu-
Chek® Guide Link meter is not paired with the pump, enter BG readings manually. 
Accu-Chek® Guide Link with the newest Bluetooth Low Energy (BLE) technology. The BLE allows for 
low-energy connectivity to the associated Accu-Chek® Connect diabetes management app.  
The MiniMed™780G Insulin Pump uses the calibration point in the real- time algorithm which 
calculates the SGVs that are displayed to the subject. The result of the finger stick (capillary Self-
Monitoring of Blood Glucose (SMBG)) reading performed is entered into the AHCL MiniMed™780G 
Insulin Pump and can be stored in its memory as a glucose point. The MiniMed™780G Insulin Pump 

 
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asks the user every time a calibration is needed, if the user wants to use the linked meter Blood 
Glucose for calibration. If yes is selected, the glucose value will be stored in memory as a calibration 
point.  
Figure 8: Accu-Chek® Guide Link Blood Glucose Meter - ROCHE Accu-Chek® 
 
 
 
7.1.8. 
Medtronic CareLink™ Personal for Clinical 
Research Therapy Management Software for 
Diabetes  
Medtronic CareLink™ Personal Therapy Management Software for Diabetes is a web-based system 
that allows the device data to be viewed and easily evaluated by the physician. A personal computer 
(PC) 
links to the Medtronic CareLink™ Personal system via the Internet and allows for upload of data 
from MiniMed™ insulin pump and third-party blood glucose meters. For the purposes of this study, 
uploads are performed both by the Investigational Center staff and subjects. 
The data contained in CareLink™ Personal is accessible to users using a standard browser, e.g., 
Microsoft® Internet Explorer on an Internet enabled PC and a unique username (XXX-XXX-XXX) and 
password created for each patient, per standard of care. 
 
The system uses standard Transport Layer Security (TLS) technology. TSL 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: 
1. The internet to the web server; 
2. Web server to the application server; 
3. Application server to the database server. 
 

 
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7.1.9. 
Other supplies Infusion sets, Reservoirs and 
Infusion Set Serter Devices 
All consumables for pump therapy will be provided, including: 
 
7.1.9.1. Infusion Sets 
Available infusion sets are the following: 
 Quick Set Infusion sets 
 Silhouette Infusion sets 
 Sure-T Infusion sets 
 Mio Infusion sets 
 Mio 30 Infusion sets 
 Mio Advance Infusion sets 
 
Note: Medtronic may incorporate additional infusion sets into this clinical study as they become 
commercially available. Instructions for the infusion sets used in this study are provided in their 
respective manuals. All infusion sets provided to subjects must be approved for use with MiniMed™ 
780G for rapid- acting analogue insulin Humalog, Novorapid and Novolog. 
 
7.1.9.2. Infusion Set Serter Devices 
Available infusion set serter devices are: 
 Quick-Serter 
 
 Sil-Serter 
 
 
The devices are indicated for single patient multi use, i.e. a patient uses the same serter every 2 to 3 
days to insert a new infusion set as described in the IFU. All infusion set serter devices provided to 
subjects must be approved for use with MiniMed™ 780G System for rapid-acting analogue insulin 
Humalog, Novorapid and Novolog. 
 
7.1.9.3. Reservoirs 
Patients are instructed to change their reservoir every 2 to 3 days. All reservoirs provided to subjects 
must be approved for use with MiniMed™ 780G System for rapid-acting analogue insulin Humalog, 
Novorapid and Novolog. The reservoir stores insulin for delivery and is inserted into the pump 
reservoir compartment. 
 
 

 
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7.1.10. MiniMed Mobile App Patients 
The Mobile app provides a secondary display of insulin pump data and CGM, and uploads system 
data to CareLink™ software. The glucose levels can be viewed on the smartphone, allowing an easily 
glucose trend monitoring, and the Mobile app provides notifications if there are high or low blood 
glucose level. It is available to download at no cost for most iOS and Android smartphones. 
 
7.1.11. CareLink™ BLE USB [Blue Adaptor] 
Blue Adapter uploads system data from the MiniMed 780G pump to the CareLink™ software through 
a USB port on a computer. 
Figure 9: CareLink™ BLE USB [Blue Adaptor] 
 
7.2. 
Manufacturer 
Except for the Accu-Chek® Guide Link Blood Glucose Meter - that is produced and distributed by 
ROCHE, all other components of the MiniMed™ 780G System are produced and distributed by 
Medtronic. 
The manufacturer is listed below: 
 Medtronic MiniMed™ 18000 Devonshire Street 
 Northridge CA, 91325 USA 
 Unomedical a/sAaholmvej 1-3, Osted4320 Lejre Denmark 
 
7.3. 
Packaging 
All devices will be labelled in accordance with local language requirements. 
Study pump, study meters and sensors are supplied with additional commercially available materials 
(i.e., alcohol wipes, tape, etc.) free of charge. 
 
7.4. 
Intended Population 
The study will be proposed to patients with type 1 diabetes mellitus. The intended population must 
comply with the therapeutic indication of the MiniMed™ 780G System as described in the approved 
IFU for which CE mark has been obtained. 
 

 
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7.5. 
Product Use 
Devices should be used within the intended use described 
in the approved IFU for which CE mark has 
been obtained for subjects who meet the eligibility criteria for the study. 
 
There will be no specific procedure within this study for the management of MiniMed™ 780G System 
since it is a non-interventional study conducted according to routine practice and on CE marked 
devices. Additional device traceability is not applicable for this registry. There will be no device log in 
the Investigator Site File. 
 
7.6. 
Product Training Materials 
Training of the center staff on the conduct of the study will be initiated before the protocol is 
implemented. All participating physicians and other stakeholders will be familiarized with the system 
as per standard practice.  Training contains both lecture and hands-on experience. 
 
People in charge to follow the subjects may be present for the training and study follow-up visits to 
provide technical support. 
 
7.7. 
Product Storage 
It is the responsibility of the investigator to correctly handle and store market released product. 
These products will be used according to their labeling.  
 
7.8. 
Product Accountability 
All products used in this study will be market released in the geographies they are used. Device 
Traceability may be required per 
local 
laws and regulations. If there are additional 
local requirements 
related to the system beyond what is collected by Medtronic on the eCRF, this is the Investigator’s 
responsibility and should be recorded in the subject’s medical records, but will not be collected by 
Medtronic (e.g., national registration card number, identification code linked to names and contact 
information, log of all subjects enrolled in the study, lot or batch number). 
 
 

 
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8. Study Site Requirements 
 
8.1. 
Investigator/Investigation Site Selection 
All investigators managing the subject must be qualified practitioners and experienced in the 
diagnosis and treatment of subjects with Type 1 Diabetes. All physicians must be experienced and/or 
trained in the handling of MiniMed 780G system. 
The role of the principal investigator is to implement and manage the day-to-day conduct of the 
clinical investigation as well as ensure data integrity and the rights, safety and well-being of the 
subjects involved in the clinical investigation. 
The principal investigator shall: 
• Be qualified by education, training, and experience to assume responsibility for the proper 
conduct of the clinical investigation 
•  Be experienced in the field of application and training in the use of MIniMed 780G system 
• Investigator is not debarred, disqualified, or working under sanctions in applicable regions 
•  Be able to demonstrate that the proposed investigational study site: 
o Has the required number of eligible subjects needed within the recruitment period 
o Has one or more qualified investigators, a qualified investigational study site team and 
adequate facilities for the foreseen duration of the clinical investigation 
Study site personnel training will be completed and documented prior to participation in this study. 
An 
investigator/investigation site may be 
included 
in the 
investigation 
if the 
investigator/investigation 
site complies with the following requirements: 
 Site is using Medtronic MiniMed™ Pumps as part of their standard of care. 
 Site has sufficient resources to conduct the study 
 
8.2. 
 Study Site Activation 
During the activation process (prior to subject enrollment), Medtronic will train study site personnel 
on the clinical investigation plan, informed consent, and on data collection and reporting tools. If 
new members join the study site team, they will receive training on the applicable study 
requirements relevant to their role before contributing to the study. 
Prior to performing study related activities, all regulatory requirements shall be fulfilled, including, 
but not limited to the following: 
 EC approval (and voting list, as required by local law) of the current version of the 
CIP and IC. 
 Fully 
executed 
CTA.  
Medtronic contracts 
with 
participating 
institutions/investigators through a Clinical Trial Agreement that defines the scope 
and responsibilities and associated compensation related to carrying out the 
obligations under a clinical study sponsored by Medtronic. A Clinical Investigation 
Agreement shall be entered into by the participating investigation site and/or the 

 
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principal clinical investigator at each investigation site as per the local legal 
requirements and returned to Medtronic prior to the commencement of any study 
activities. Whenever possible, the investigator is indicating approval of the Clinical 
Investigation Plan and subsequent amendments, by signing and dating the 
agreement. 
 Current CV of investigators of the investigation study site team (as required), . A 
recent signed and dated Curriculum Vitae should be collected from each principal 
investigator and co- investigators participating in this study, evidencing the 
required qualifications per local law, including the year and, possibly, where 
obtained, and shall include their current position at the investigation site. 
  Documentation of delegated tasks 
  Documentation of study training. 
  Additional requirements imposed by local regulations and EC shall be followed, if 
appropriate. 
In addition, all participating study site 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 
principal investigator to perform study related activities. 
Medtronic will provide each study site with documentation of study site/investigator readiness; this 
letter must be received prior to performing study related activities. 
 
9. Selection of Subjects 
 
9.1. 
Study Population 
Subjects 7 years of age or older with T1D and under Continuous Subcutaneous Insulin Infusion (CSII) 
therapy (with or without CGM) may be considered for this study if they meet all of the inclusion and 
none of the exclusion criteria outlined in this clinical investigation plan. 
 
9.2. 
Subject Enrollment 
The point of enrollment is defined as the time at which the in- and exclusion criteria have been 
checked and fulfilled and at which the subject (or his/her parent/legal representative) and the 
principal 
investigator or authorized designee, as required, have personally signed and dated the Data 
Release Form (DRF). At that point, the subject is considered enrolled in the study. A study subjects 
ID number will be assigned, and the subject must be followed until study closure or study exit, 
whichever occurs first. The investigator will record on the medical file of the subject that he/she 
participates in this study. 

 
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9.3. 
Inclusion Criteria 
 Subject is ≥7 years of age. 
 Subject has a clinical diagnosis of type 1 diabetes for more than 1 year as determined via 
medical records or source documentation by an individual qualified to make a medical 
diagnosis. 
 Subject has a glycosylated haemoglobin (HbA1c) value greater than 6.5% and less than 12% at 
time of enrolment visit. 
 Subject is under Continuous Subcutaneous Insulin Infusion (CSII) therapy (with or without 
Continuous Glucose Monitoring) for 6 months or more before enrolment. 
 Subject requires ≥8 units of insulin per day. 
 Subjects and their parent(s)/guardian(s) must be able to speak and be literate in French as 
verified by the investigator. 
 Subjects and their parent(s)/guardian(s) are willing to participate in the study and sign the DRF. 
 Subjects who are ≥18 years of age should be able to provide consent. 
 
9.4. 
Exclusion Criteria 
 Subject has MiniMed™ 780G System IFU contraindication(s). 
 Subject used Predictive Low-Glucose Management (PLGM) System (i.e. MiniMed™ 640G with 
SmartGuard) in the 6 months before the enrolment. 
 
 Subject used Low Glucose suspend (LGS) feature (i.e. MiniMed™ Paradigm Veo Pump) in the 6 
months before the enrolment. 
 Subject under Multiple-Daily Injections (MDI) treatment in the 6 months before the enrolment. 
 Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., 
psoriasis, dermatitis herpetiformis, rash, Staphylococcus 
infection). 
 
10. Study Procedures  
 
10.1. Schedule of Events 
The study is conducted according to the same schedule as the routine follow-up of patients. Every 
attempt to minimize missed follow-ups should be made. 
The study does not require any specific exam or procedure that falls outside routine practice.  
An overview of data collection is given in Table 3 below. 
 
 
 
 

 
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Table 3: Schedule of Assessments 
 
Data collection 
Enrollment 
/Baseline 
6-month 
Follow-up 
(±45 days) 
12-month 
Follow-up (±45 
days) 
Data Release Form 
√ 
 
 
Inclusion and exclusion criteria 
√ 
 
 
Demographics 
√ 
 
 
Medical history 
√ 
 
 
HbA1c1 
√ 
√ 
√ 
Auto Mode Activation Date 
√ 
 
 
Ensure that CareLink™ Personal 
upload was done2 
√4 
√ 
√ 
CGM data 
√ 
√ 
√ 
Study Exit 
 
 
√ 
Study Deviation 
Upon occurrence 
QUESTIONNAIRES : 
 
 
 
DTSQs 
√ 
√ 
√ 
DTSQc 
 
√ 
 
DQoL3 
√ 
√ 
√ 
HFS 
√ 
√ 
√ 
1. 
Available HbA1c value collected up to 30 days before enrollment and more or less 30 days from 6-month and 12-
month follow up visits can be used. 
2. 
CareLink™ data should be uploaded via Bluetooth connectivity from the devices or via USB connection as per 
clinical practice, i.e. once a week. CareLink™ Data evaluation will be done every 3 months for secondary objectives. 
3. 
DQoL will not be administered in case patient is between 7 and 12 years old. 
4. 
Baseline CGM data will be collected before Auto Mode activation at the end of the run-in phase 
Data Release Form will be obtained prior to subject enrollment and/or before any study-specific 
procedures are initiated. The principal investigator or his/her authorized designee will conduct the 
Data Release Form process in accordance with local law and regulations. 
 
 

 
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10.2. Data Collection 
 
Data collection requirements are summarized in Table 4 below. 
Table 4: Data collection and study procedure requirements at subject visits. Minimum number of 
CRF planned at each visit per subject 
 
 
Baseline 6M FU 12M FU Exit Deviation Unplanned 
CRF Long Name  
eCRF 
 
 
 
 
 
 
Data Release and 
Eligibility 
A_CONSENT 
1 
 
 
 
 
 
Baseline  
A_Base 
2 
 
 
 
 
 
Follow Up 
A_FU 
 
1  
1 
 
 
 
DTSQs Parent  
A_DTSQsP 
3  
2  
2 
 
 
 
DTSQs Teen 
A_DTSQsT 
4  
3  
3 
 
 
 
DTSQs Adult 
A_DTSQsA 
5  
4  
4 
 
 
 
DTSQ change Parent  
A_DTSQcP 
 
5 
 
 
 
 
DTSQ change Teen  
A_DTSQcT 
 
6 
 
 
 
 
DTSQ change Adult  
A_DTSQcA 
 
7 
 
 
 
 
DQOL 
A_DQOL 
6  
8  
5 
 
 
 
HFS Parent 
A_HFS_P 
7  
9  
6 
 
 
 
HFS Teen 
A_HFS_T 
8  
10  
7 
 
 
 
HFS Adult 
A_HFS_A 
9  
11  
8 
 
 
 
Auto Mode Activation  A_AUTOMOD 
10 
 
 
 
 
 
Study Exit 
A_EXIT 
 
 
 
1 
 
 
Protocol Deviation  
A_PROT_DEV 
 
 
 
 
1  
x 
 
10.3.   
Enrollment/baseline visit 
The investigational center will not initiate any subject activities until EC approval (and all necessary 
approvals) has been granted. The investigator will check the study eligibility based on a patient 
meeting, all the study inclusion criteria and none of the exclusion criteria. Investigator will inform the 
patient about the study and will provide him/her the EC approved Data Release Form. After subjects 
having given their written Date Release consent, they are considered enrolled in the study and the 
following information will be collected: 
 
Baseline: 
▪ Demographics 
o Age, sex 
▪ Medical history 
o HBA1c (available value collected up to 30 days before enrollment can be used) 
o Previous treatment 
o Name of the last pump device 

 
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o Date of the first pump treatment 
o Years since diagnose of T1D 
o Number of severe hypoglycemia in the last year 
 
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 his or 
herself, was unable to verbalize his or her needs, and was incoherent, disoriented and/or combative. 
▪ Questionnaires 
o DTSQs 
o DQoL (except for patients between 7 and 12 years old) 
o HFS 
The questionnaires will be completed following the specific, standardized instructions in the waiting 
room and returned the same day. Paper versions of the questionnaires will be made available for 
this purpose. 
 
To minimize any bias, subjects will fill out the questionnaire before they get equipped by the 
MiniMed™ 780G 
insulin pump, before clinician assessments and discussion of their clinical condition, 
and any other related topics that could influence patient’s perception and feelings prior to 
responding to the questions. 
 
Once eligibility has been confirmed, subject will start a run-in phase in a hospital outpatient setting, 
as per standard practice of the site. 
The objective of the run-in phase is to train the subjects on the MiniMed™ 780G 
insulin pump, assess 
subjects’ compliance and ability to comprehend the study procedures and tolerance of wearing the 
sensor and transmitter continuously. It is expected that during the run-in phase the MiniMed™ 780G 
insulin pump will be set in Manual mode and all the algorithms are switched off, and baseline CGM 
data will be collected. Data from the MiniMed™ 780G 
insulin pump will be uploaded 
in the CareLink™ 
Personnel for Clinical Research as per standard practice before Auto Mode activation.  
Baseline CGM data are listed below: 
 Mean TIR (70-180mg/dL) 
 Mean Time spent of sensor glucose value below 70mg/dL and below 54mg/dL 
 Mean Time spent of sensor glucose value above 180mg/dL and above 250mg/dL 
 Number of bio-chemical hypoglycemic event per week 
 
Bio-chemical hypoglycemic events are defined as events with sensor glucose values lower than 54 
mg/dL for more than 15 min consecutively. 
 
The expected duration of the run-in phase is approximately 2 weeks. At the end of the run-in phase 
the MiniMed™ 780G insulin pump will be set in Auto Mode and the date of activation will be 
collected. and identified as a start of the study phase. 

 
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10.5. Study Exit 
A study exit form will be completed for all included subjects. Per normal study completion, the date 
of the last follow up visit, the 12-month Follow-up visit, will correspond to the study exit date. At the 
end of the study, the subjects will continue to be treated following the routine practice of each center 
and physician’s discretion. 
 
10.6. Source Data 
The investigator will indicate in the clinical records that the subject is enrolled in this clinical 
investigation. 
 
Subject’s medical records, CareLink™ Personal For Clinical Research software data, and questionnaires 
will be used as source documents. Worksheets can be used as source documentation. The 
investigator must ensure accuracy, completeness and timeliness of the data reported in the eCRFs. 
The data in the eCRF should be consistent with the source documentation (including subject medical 
records, questionnaires and worksheets). Sponsor study personnel will review all eCRFs and create 
data queries for missing data that impacts data analysis. 
 
The investigator(s) and study personnel must be accessible to the Medtronic clinical study team or 
any person mandated by Medtronic. This accessibility is of particular importance for the completion 
and clarification of the data on the eCRF. Access to the subject records and other source data must be 
provided to study monitors, auditors and/or inspectors. All persons involved within this study are 
working under medical or professional secret policy. 
 
Where copies of the original source document as well as printouts of original electronic source 
documents are retained, these shall be signed and dated by a member of the investigation site team. 
 
10.7. Data Release consent process 
In advance of the consent discussion, the subject (and his/her parent/legal representative) should 
receive the Ethic Committee (EC) approved Data Release Form. During the consent discussion, the 
investigator or his/her authorized designee must fully inform the subject (and his/her parent/legal 
representative) of all aspects of the clinical study that are relevant to the subject’s (and his/her 
parent/legal representative) decision to participate in the clinical study. All items addressed in the 
Data Release Form must be explained. The language used shall be native and as non-technical as 
possible and must be understandable to the subject (and his/her parent/legal representative). 
The subject (and his/her parent/legal representative) must have ample time and opportunity to read 
and understand the Data Release Form, to inquire about details of the clinical study, and to decide 
whether or not to participate in the clinical study. All questions about the clinical study should be 

 
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answered to the satisfaction of the subject (and his/her parent/legal representative). Neither the 
investigator, nor the investigation site staff shall coerce or unduly 
influence a patient to participate or 
to continue to participate in the clinical study. The Data Release Form process shall not waive or 
appear to waive the patient’s subject’s rights. 
When the subject (and his/her parent/legal representative) decides to participate 
in the clinical study, 
the Data Release Form must be signed and personally dated by the subject or parent/legal 
representative and investigator or authorized designees. Subjects who are 7-17 years old are not 
required to sign a DRF, their parent/legal representative will sign a DRF on their behalf. 
After all persons have signed and dated the Data Release Form, the investigator must provide the 
subject or parent/ legal representative with a copy of the dated Data Release Form. The original Data 
Release Form will be kept on-site as part of Investigator Site File (ISF) and the Investigator must 
document the Data Release Consent process. 
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 designees should inform the subject (or his/her parent/legal representative) in a timely 
manner. 
Medtronic will revise the written Data Release Form whenever new information becomes available 
that may be relevant to the subject’s confirmed participation in the clinical study. After approval by 
the EC, a copy of this information must be provided to the participating subjects (or his/her 
parent/legal representative), and the Data Release Form process as described above needs to be 
repeated if the new information is relevant to the subject (and his/her parent/legal representative). 
 
A copy of the Data Release Form will be provided under a separate cover. 
 
10.8. Assessment of Safety 
This is a non-interventional study assessing the glycemic control and Quality of Life of subjects with 
T1D. No Adverse Events or Device Deficiencies are collected, and there are no specific safety 
parameters to be assessed as part of the study. Complaint reporting will be done as per local 
requirements and Medtronic processes, including v
ig
i
lance
 reporting
 for commercially approved
 
products.
 
 
10.9. Recording Data 
This study will utilize a Clinical Remote Data Capture (RDC) system that is the property of Medtronic. 
Each enrolled subject will be assigned a unique study ID number, which is pre-configured in the RDC 
system. Records of the subject/subject ID relationship will be maintained by the study site. Individual 
subject medical information obtained for this study will be considered confidential. The subject’s 

 
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medical charts must be clearly marked to indicate that subjects are enrolled into the study, per the 
site’s SOPs. 
 
Required data will be recorded on electronic Case Report Forms (CRFs) by authorized site personnel 
as indicated on the Delegated Task List (DTL), which can be found in the Investigator Site File (ISF). 
Study personnel delegated for CRF completion will be trained on the use of the RDC system and 
thereafter provided with a username and password to access the system. The CRFs must be 
completed and/or updated to reflect the latest observations on the subjects participating in the 
study. The investigator (or delegated co-investigator) will electronically sign the appropriate pages 
of each CRF. 
 
The RDC system maintains an audit trail of entries, changes, and corrections in CRFs. If a person only 
authorized to complete CRFs makes changes to an already signed CRF, the investigator shall re-
approve that CRF. 
 
The 
investigator must ensure accuracy, completeness, 
legibility and timeliness of the data reported 
in 
the CRFs and in all other required reports. Data reported on the CRFs which are derived from source
 
documents must be consistent with the source documents or the discrepancies need to be justified 
in a documented rationale, signed and dated by an Investigator and filed in the subject’s research 
records at the site. 
 
10.10. Deviation Handling 
A CIP and/or study deviation is an event where the investigator or site personnel did not conduct the 
clinical study according to the Clinical Investigational Plan or Clinical Investigation Agreement. 
 
Example of deviations may include but are not limited to: 
 
 Failure to obtain Data Release Form prior to participation in the study; 
 Incorrect version of Data Release form provided to subject; 
 Failure to obtain EC approval before the start of the study; 
 Subject did not meet enrollment criteria and was enrolled; 
 Subject failure to attend a follow-up visit; 
 Required assessment/data collection during visit not done; 
 Source data permanently 
lost. 
 
Investigators may not deviate from the CIP, unless the deviation is necessary to protect the rights, 
safety and wellbeing of the subject in an emergency situation. Deviations should be reported to 
Medtronic regardless of whether medically justifiable, pre-approved by Medtronic, or taken to 
protect the subject in emergency. Study deviations should be reported to Medtronic via the study 

 
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deviation CRF in a timely manner. 
 
Investigators are also required to adhere to 
local EC requirements and procedures for reporting study 
deviations. Reporting of all other study deviations should comply with EC policies and/or local laws 
and must be reported to Medtronic as soon as possible upon the study site becoming aware of the 
deviation. 
Medtronic is responsible for analyzing deviations, assessing their significance, and identifying any 
corrective and/or preventive actions that may be warranted. Repetitive or serious investigator 
compliance issues may represent a need to initiate a corrective action plan, which may include 
suspension of enrollment or termination of the investigator or site participation in the study. 
 
10.11. Subject Withdrawal or Discontinuation 
Participation in this study 
is voluntary and the study subject has the right to discontinue participation 
at any time without penalty or 
loss of benefits to which the subject 
is otherwise entitled. A withdrawn 
subject will be treated according to standard of medical care and will not be replaced. Subjects will 
be included in the analyses up to the time that consent was withdrawn. 
 
Subjects may also be withdrawn from the study at the discretion of the Investigator if the patient’s 
well- being is jeopardized by continuation of the study. 
 
If a subject chooses to end his or her study participation or if a subject is removed from the study at 
the Investigator’s discretion, the date, circumstances and the reason for termination must be 
documented both in source documents and on the appropriate eCRF. No data obtained after 
withdrawal of consent will be recorded on eCRF. 
 
The study site will make every effort to have all subjects complete the follow-up visit schedule. A 
subject will not be considered lost to follow-up unless all efforts to obtain compliance are 
unsuccessful. At a minimum, the effort to obtain follow-up information must include 3 attempts to 
make contact via telephone and if contact via phone is not successful, a traceable letter from the 
investigator should be sent to the subject’s 
last known address, a copy of which should be maintained 
in the subject’s study record. If both telephone and mail contact efforts are unsuccessful, the 
subject’s personal physician (if subject confirmed agreement in consent) should be contacted to 
verify the subject’s safety information and vital status (alive or deceased). Subject will then be 
deemed 
lost to follow up. All contact efforts to obtain follow-up must be documented 
in the subject’s 
medical records. 
 
If a subject discontinues the study at any time or is withdrawn from the study early, they should 
continue to be followed as per standard care. 

 
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11. Risks and Benefits 
 
11.1. Potential Risks 
The study aims to evaluate the effect on glycemic control, treatment satisfaction and the impact on 
the quality of 
life of patients using the MiniMed™ 780G System following the standard care 
in France. 
There are no expected additional risks relative to participation in this study as devices used are 
commercially available and used in accordance with approved labelling. 
 
Furthermore, the study is non-interventional, subjects are treated according to standard clinical 
practice, therefore there are no additional risks associated with study participation. 
 
Potential risks associated with the use of MiniMed™ 780G System include, but are not limited to the 
following list: 
 
 Hypoglycemia 
 Hyperglycemia 
 Diabetic Ketoacidosis 
 Seizure 
 Coma 
 Death 
 
General risks related to insulin pump infusion set may include: 
 Localized infection 
 Skin irritation or redness 
 Bruising 
 Discomfort or pain 
 Bleeding 
 Irritation 
 Rash 
 Occlusions that can interrupt insulin delivery and lead to hyperglycemia or Diabetic 
Ketoacidosis  
 
General risks related to sensor use may 
include: 
 Skin irritation or other reactions 
 Bruising 
 Discomfort 
 Redness 
 Bleeding 
 Pain 
 Rash 

 
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 Infection 
 Raised bump 
 Appearance of a small "freckle-like" dot where needle was 
inserted 
 Allergic reaction 
 Fainting secondary to anxiety or fear of 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, tape, or both 
 Scarring 
 
Specific risks related to sensor use: 
Use of medications with paracetamol, including, but not limited to fever reducers or cold medicine, 
while wearing the sensor may falsely raise sensor glucose readings and result in an over-delivery of 
insulin. The level of inaccuracy depends on the amount of paracetamol active in the body and may 
be different for each person. 
  
Risks related to meter use: 
 See the user guide that came with the device for the most current risks. 
 
General risks related to serter use may include: 
 The serter contains small parts and may pose a choking hazard that can result in serious 
injury or death. 
 Side effects include discomfort and skin irritation at the insertion site. 
 
11.2. Risk Minimization 
The potential risks associated with the MIniMed 780G system were identified and have been 
successfully mitigated and are addressed in the user guide. There are no expected additional risks 
relative to participation in this study as devices used are commercially available and used in 
accordance with approved labelling. Any potential risks associated with this study are further 
minimized by selecting qualified investigators and training study personnel on the CIP. 
Specific risks minimizations related to sensor use include, but are not limited to: 
 Use of medications with paracetamol: if paracetamol is taken, stop the use of the 
medication before using SG readings to make treatment decisions. Use additional BG 
meter readings to verify glucose levels, turn off the Auto correction feature, and consider 
turning off the SmartGuard feature. Check the label of any medication to confirm whether 
paracetamol is an active ingredient.  
 Do not use SG values to make therapy treatment decisions while the pump is in Manual 

 
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mode. SG values can only be used to make therapy treatment decisions while the 
SmartGuard feature 
is active. SG and BG values may differ. If the SG reading 
is 
low or high, 
or there are symptoms of low or high glucose, confirm the SG reading with a BG meter 
prior to making therapy decisions to avoid hypoglycemia or hyperglycemia. 
 For persons seven to thirteen years of age, sensor insertion is approved for in the 
abdomen and buttocks. Do not insert the sensor into any other location. 
 For persons fourteen years and older, sensor insertion is approved for the abdomen and 
back of the upper arm. Do not insert the sensor into any other location. 
 
11.3. Potential Benefits 
Subjects’ participation 
in this study may offer no additional benefits 
in respect to the same treatment 
provided outside of the trial. Participation in this study will help in contributing to evidence-based 
medicine and in releasing data to support product reimbursement and utilization in France. 
 
11.4. Risk-Benefit Rationale 
Subjects are not put at any additional risk for participating 
in the study, as compared having the 
MiniMed™ 780G System treatment as part of their routine care. 
The probable benefits of the device are based on data collected in several clinical research studies 
as described 
in section 4.1 Background. These data are and were used to support regulatory approval 
of the MiniMed™ 780G System in the United States and in Europe. 
Participation in this study will help in contributing to evidence-based medicine and in releasing data 
to support product reimbursement and utilization in France. 
 
 
12. Statistical Design and Methods 
 
12.1. Sample size justification 
The primary endpoint is to evaluate if the MiniMed™ 780G therapy in Auto Mode increases the 
proportion of Time In Range (TIR) at 6 months compared to the MiniMed™ 780G therapy in manual 
mode at baseline. The endpoint 
is the Time 
In Range (TIR) defined as the proportion of sensor glucose 
concentration within the target range 70-180 mg/dL (3·9–10·0 mmol/L). 
 
The Pivotal study [12, 13] enrolled adolescents (ages 14–21 years) and adults (ages 22–75 years) with 
type 1 diabetes 
in a multicenter pivotal trial. The Medtronic MiniMed™ 670G system was used during 
a 2- week run-in phase without HCL control, or Auto Mode, enabled (Manual Mode) and, thereafter, 
with Auto Mode enabled during a 3-month study phase. The study has shown a significant 

 
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improvement on TIR of 60.4% (10.9%) to 67.2% (8.2%) in adolescents and from 68.8% (11.9%) to 
73.8% (8.4%) in adults. Using this information and considering that this study is expected to include 
around 32 sites and including also patients aged >7 years old, a lower increase of TIR and higher 
variability are expected. The following assumptions were made: 
 Improvement in TIR of at least 3% points at 6 months compared to the baseline. 
 Standard deviation as 16% due to the mixed population and multiple sites expected for this 
study. 
 
12.2. Sample size Calculations 
The sample size was determined using a one sample paired test assuming a one-sided type I error 
rate of 0.05 and a power greater than 90%. The TIR at baseline is assumed to be 60% and the TIR at 6 
months follow up (TIR calculated using overall 6 months CGM data) is assumed to be 63% with same 
standard deviation as 16% and a correlation as 0.5. Thus, the hypothesis to be tested 
is: 
 
H0: µTIR6m – µTIR baseline = d0 
 
HA: µTIR6m – µTIR baseline > d0 
 
where d0 = 3 is the expected increase of TIR at 6 months. The sample size needed to demonstrate 
this hypothesis is 245 paired assessments per subject. The calculation is adjusted for loss-to-follow-
up and protocol failures, including potential subjects with less than 70% of the time in Auto Mode 
with an assumption considering an attrition rate of 20%. The total number of subjects to be enrolled 
is 306. 
 
12.3. Data Analysis 
A detailed description of the statistical methods will be contained in the Statistical Analysis Plan 
(SAP). Any change to the data analysis methods described in this section and/or the SAP will require 
an amendment only if it changes a principal feature of the study description. Any other changes to 
the data analysis methods will be described and justified in the Final Report or publications. 
 
Descriptive statistics will be used to summarize patient characteristics. For categorical variables, the 
description will consist at least of the sample size, numbers of missing data and valid data, the 
frequency and the percentage of each category. Denominators for calculation of percentages will be 
taken as the number of subjects with available (not missing or unknown) observations in the 
specified patients sets and groups unless otherwise stated. Percentages will be presented with no 
decimal. For continuous variables, the description will consist at least of the sample size (N), number 
of subjects with non-missing observation (n), mean, standard deviation, standard error, minimum, 

 
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median and maximum. For n<3, only mean, minimum and maximum will be displayed. In general, 
minimums and maximums will be presented to the same level of accuracy as the raw data; means 
and medians will be presented to 1 further decimal place; if appropriate, standard deviation and 
standard error will be presented to 2 further decimal places. 
 
Since the impact of missing data is expected to be small no multiple imputation method for missing 
data is planned. However, should the issue of missing data arise, the choice of the imputation 
method for missing data will depend on the pattern of missing data and the type of the imputed 
variable. 
 
The study is a multicenter trial and a multicenter impact on primary outcomes will be investigated. 
A description by means summary statistics on primary outcomes by sites will be provided. 
 
Outliers and influential observations will be identified via graphical plots. Once outliers or influential 
observations are identified, the study team will be informed and according to their decision the 
analysis for primary endpoint may be repeated excluding the outliers. Additional exploratory 
analyses will be conducted as deemed appropriate. 
 
The primary analysis will be performed on the Intention To Treat (ITT) set and a sensitivity analysis 
will be performed using the Per Protocol set including all subjects that were compliant with the 
protocol. 
 
The ITT includes all patients enrolled in the study those sign Data Release Form, fulfill the inclusion 
and exclusion criteria. The ITT will be used for all endpoints and safety evaluation. For patients who 
dropout the analyses will include all data up to the point of their last data collection. 
 
The PP includes all patients enrolled in the study those sign Data Release Form, fulfill the inclusion 
and exclusion criteria and having at least 70% of time using the Auto Mode. The PP set will be used 
for all endpoints. 
 
The primary endpoint on efficacy defined as the change of TIR at 6 months from Auto Mode activation 
at baseline will be analyzed by means of paired (samples) t-test or Wilcoxon signed rank sum test 
according to the normal or non-normal distribution. The mean change will be displayed together 
with their 95% confidence interval (95%CI). Additional exploratory analysis on the TIR change over 
time (baseline, 3, 6 and 12 months follow-up) will be analyzed by means of mixed models for 
repeated measures. The dependent variable will be pre-log transformed depending on normal or 
non-normal distribution. The model will have the clinical outcomes as dependent variables and 
baseline values and visits as explanatory variables. All assumptions for regression models will be 
performed by assessment of plots of the residual values. Difference between visits means will be 
tested by applying contrast on the estimated model. The plot for the mean change over time will be 

 
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reported. 
 
The secondary endpoint on satisfaction defined by the DTSQc will be analyzed by means of one 
sample Z- score test. The DTSQc has six items related to treatment satisfaction and two other items 
assess perceived frequency of hyperglycemia and hypoglycemia. Each item has a maximum of 3 
(more satisfied now) and a minimum of -3 (less satisfied now) with a midpoint of 0 reflecting no 
change. The scale total is computed by adding 6 items (1,4,5,6,7,8) and the 2 items on 
hypo/hyperglycemia will be analyzed separately. Previous studies on patients treated with 
MiniMed™ 640G pump have shown a good satisfaction using the DTSQc questionnaire. The sample 
size estimated would also allow us to demonstrate a positive DTSQc satisfaction score.  
Other secondary endpoints on quality of life defined as the change from baseline will be analyzed by 
means of paired (samples) t-test or Wilcoxon signed rank sum test according to the normal or non-
normal distribution. The mean change will be displayed together with their 95% confidence interval 
(95%CI). 
The secondary endpoint on HbA1c change over time (baseline, 6- and 12-months follow-up) will be 
analyzed by means of mixed models for repeated measures. The dependent variable will be pre-log 
transformed depending on normal or non-normal distribution. The model will have the clinical 
outcomes as dependent variables and baseline values and visits as explanatory variables. All 
assumptions for regression models will be performed by assessment of plots of the residual values. 
Difference between visits means will be tested by applying contrast on the estimated model. The 
plot for the mean change over time will be reported. 
 
It is anticipated that SAS (SAS Institute Inc., Cary, NC, USA) will be used to perform all statistical 
analyses. Statistical tests will be based on a one-sided significance level of 0.05, and possible 
interaction effects will be evaluated at a significance level of 0.10. No adjustments for multiple 
comparisons will be performed. Additional exploratory analyses will be conducted as deemed 
appropriate. 
 
Procedures for reporting any deviation(s) from the original statistical plan including that justification 
will be documented. 
 
13. Ethics 
 
13.1. Statement(s) of Compliance 
The study is designed to reflect the Good Clinical Practice (GCP) principles such as the protection of 
the rights, safety and well-being of human subjects, controls to ensure the scientific conduct and 
credibility of the clinical investigation and the definition of responsibilities of Medtronic and 
investigators. 

 
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The study will be conducted according to national and local laws, regulations, standards and 
requirements of the country in which the clinical study is conducted, including data protection laws, 
and according to the Clinical Investigation Agreement and the Clinical Investigation Plan. 
 
The study will also be conducted in compliance with the latest version of the Declaration of Helsinki. 
The principles of the Declaration of Helsinki are implemented in this study by means of the patient 
Data Release Form (DRF) process, Ethics Committee approval, study training, clinical trial registration 
and publication policy. 
 
Where applicable, regulatory authority notification will be done. Investigational sites will not be 
activated, nor begin enrolling subjects, until the required approval/favorable opinion from the 
respective Ethics Committee has been obtained (as appropriate). 
 
Additionally, any requirements imposed by the regulatory agency or Ethics Committee shall be 
followed, as appropriate. Medtronic will be informed by the Ethics Committee and/or the 
investigator in case any action is taken by an Ethics Committee with respect to this investigation. 
 
14. Study Administration 
 
14.1. Monitoring 
Monitoring and monitoring oversight will be provided by Medtronic and detailed in a study-specific 
Monitoring Plan separate from this CIP. The list of monitors involved in the study will be maintained 
under a separate cover. 
 
Site qualification will be conducted by Medtronic personnel remotely to verify site interest and 
capability to perform the study. Prior to first enrollment Medtronic will conduct training to prepare 
the site to conduct the study, as outlined in the Monitoring Plan. In addition, monitoring visits will 
be conducted during the course of the study in accordance with Medtronic Standard Operating 
Procedures (SOPs) and the Monitoring Plan. 
Regulatory documents (e.g. EC approval letter and Clinical Trial Agreement) will be reviewed, a 
complete list of documents that will be reviewed is maintained in the Monitoring Plan. Subject data 
will be monitored against source documentation (e.g. clinic and hospital charts) as specified in the 
Monitoring Plan. Extent of source data verification will also be detailed in the Monitoring Plan and 
performed accordingly. Center study progress, investigator’s adherence to the CIP and maintenance 
of records and reports will be checked. 
 
The principal investigator(s) or his/her delegate(s) shall be accessible to Medtronic study team. This 

 
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accessibility is of particular importance for reviewing data in the eCRF. 
 
Direct access to patient medical files for source data verification should be granted and prepared 
prior to any monitoring visits. If electronic source documentation is used at the site, the site must 
provide to the monitor: 
 
o Direct access to the electronic medical record(s), or 
o Direct access to the electronic medical record(s) by reviewing alongside appropriate study 
staff. 
Findings from each monitoring visit will be provided in writing to the clinical study personnel at the 
site. Corrective action will be taken to resolve any issues of noncompliance. 
 
14.2. Data Management 
Data will be collected using an electronic data management system for studies.  CRF data will be 
stored in a secure, password-protected database which will be backed up nightly.  Data will be 
reviewed using programmed and manual data checks.  Data queries will be made available to study 
sites for resolution. Study management reports may be generated to monitor data quality and study 
progress. At the end of the study, the data will be frozen and will be retained indefinitely by 
Medtronic. 
All records and other information about subjects participating in this study will be treated as 
confidential. Data will be transferred and processed by Medtronic or a third party designated by 
Medtronic in a key coded form, unless it’s impossible to pseudonymize for instance. 
Procedures in the CIP require source documentation. Source documentation will be maintained at 
the study site. Source documents, which may include worksheets, subject medical records, 
programmer printouts, and interrogation files, must be created and maintained by the 
investigational study site team. 
The investigator must ensure accuracy, completeness and timeliness of the data reported in the 
eCRFs and in all other required reports, if any. Electronic device data will be collected from the study 
pump using CareLink™ Personal For Clinical Research software. The system uses TLS technology, 
which encrypts all data it stores. 
 
Only authorized persons can complete eCRFs. eCRFs shall be signed by 
investigators (physicians only) 
as specified on the Delegated Tasks List included in the Investigator Site File. If a person is only 
authorized to complete eCRFs or make changes to an already signed eCRF, the investigator shall re-
sign this eCRF. 
 

 
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The RDC system maintains an audit trail on entries, changes or corrections in the eCRFs. The study 
database will employ validation programs (e.g. range and logic checks) on entered data to identify 
possible data entry errors and to facilitate data validation. 
 
A copy of the electronic Case Report Forms will be provided under a separate cover. 
 
It is expected that eCRF will be completed within 10 working days from the performed visit or as 
soon as source documents are available. A delayed completion of the eCRF will not be considered a 
Protocol Deviation. 
Data management will be done according to Medtronic SOPs and the Data Management Plan for this 
study. These documents will be made available upon request. 
 
Data will be reviewed for completeness, correctness and consistency. In case of issues, queries will 
be sent to the investigator to complete, correct or comment the data. 
 
14.3. Direct Access to Source Data/Documents 
The PI and the study team must ensure availability and accessibility of source documents from which 
the 
information on the eCRF was derived to Medtronic personnel, monitoring team and clinical study 
manager. This accessibility is of particular importance for reviewing data in the CRF. 
In addition to monitoring visits, Medtronic may conduct audits at participating investigational sites. 
The purpose of an audit is to verify the adequate performance of the clinical study related activities. 
Regulatory authorities may also perform inspections at participating investigational sites. 
 
The investigator and/or institution shall permit Medtronic and regulatory bodies direct access to 
source data and documents, taking 
into account any restrictions due to local law, to perform clinical 
study-related monitoring, audits, EC review, and regulatory 
inspections. 
 
Any regulatory authority inspection announcements shall be forwarded immediately to the Clinical 
Study Team. 
 
14.4. Confidentiality 
All information and data sent to parties involved in study conduct concerning subjects or their 
participation in this study will be considered confidential. Each enrolled subject will be assigned to a 
unique subject ID number (SID), which is pre-configured in EDC system. Records of the subject/SID 
relationship will be maintained by the study site. The SID is to be recorded on all study documents to 
link them to the subject’s medical records at the site. To maintain confidentiality, the subjects’ name 
or any other personal identifiers should not be recorded on any study document other than the 

 
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subject’s DRF. In the event a subject’s name 
is included for any reason, it will be immediately blinded 
as applicable. 
 
Confidentiality of data will be observed by all parties involved at all times throughout the clinical 
study. All data shall be secured against unauthorized access. The privacy of each subject and 
confidentiality of his/her information shall be preserved in reports and when publishing any data. 
 
Sites will maintain subject privacy according to local and national regulations and institutional 
requirements. 
 
In general Sponsor’s representatives, EC members, European or other 
international public regulatory 
authorities may have access to subject confidential information. 
 
14.5. Liability 
Due to the study type, no insurance is needed in accordance with local law. However, Medtronic 
maintains a General Liability Insurance Coverage, including products. If required, a General Liability 
Insurance statement could be provided. Warranty information is provided in the product packaging 
for the commercially released MIniMed 780G system and additional copies are available upon 
request. 
 
Medtronic France SAS is wholly owned subsidiary of Medtronic Inc., which as the parent company of 
such entity maintains appropriate clinical study liability insurance coverage as required under 
applicable laws and regulations and will comply with applicable law and custom concerning specific 
insurance coverage. If required, a Clinical Trial Insurance statement/certificate will be provided to 
the EC. 
 
14.6. CIP Amendments 
In case the investigator proposes any appropriate modification(s) of the CIP or product use, 
Medtronic will review this proposal and decide whether the modification(s) will be implemented. 
 
Medtronic will submit any significant amendment to the CIP, including a justification for this 
amendment, to the appropriate EC and to the 
investigators. The 
investigator will only 
implement the 
amendment after approval of the EC and sponsor. Furthermore, 
investigators shall sign any approved 
amendment for agreement. 
 
 

 
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14.7. Records and reports 
 
14.7.1. Investigator Records 
The investigator is responsible for the retention of the records listed below. The Investigator Site File 
or appropriate Patient Study Binders shall include at a minimum the following records: 
 
 Clinical Investigation Plan and, if applicable, any amendment 
 Signed and dated Clinical Investigation Agreement 
 Instructions For Use 
 Completed Subject Identification log for all enrolled patients 
 Blank Patient Data Release Form 
 Delegated Tasks List 
 Training documentation of study site personnel 
 Dated current CV of the study site personnel 
 Study-related correspondence between center and sponsor 
 Patient questionnaires 
 Signed Patient Data Release Form 
 
14.7.2. Investigator reporting responsibilities 
The investigator is responsible for completing and signing off all electronic case report forms, for 
study deviation reporting through the electronic Case Report Forms.  If any action is taken by an EC 
with respect to this study, copies of all pertinent documentation must be forwarded to Medtronic in 
a timely manner. 
 
14.7.3. Sponsor Records 
The sponsor is responsible for the retention of the records listed below. The Trial Master File shall 
include at a minimum the following records: 
 
 All documents and correspondence which pertains to the trial 
 Clinical Investigation Plan and, if applicable, any amendments 
 List of participating centers 
 Relevant correspondance with the Haute Autorité de Santé (HAS), if any 
 Names/contact addresses of study monitors 
 Statistical analyses and underlying supporting data 
 Final report of the clinical 
investigation 
 Signed and dated Clinical Investigation Agreements for all centers 
 Instructions For Use 
 Blank Patient Data Release Form 
 Training documentation of site personnel involved in the study 

 
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14.7.5. Record Retention 
Medtronic records and reports will be stored at Medtronic during the course of the study. After the 
closure of the study, all records and reports will be archived per Medtronic standards. 
 
The investigator must be willing to give access to study monitors, auditors, EC members and 
inspectors, and have appropriate facilities to retain relevant study documents. The 
investigator must 
retain the Investigator Site File, patient source documents and CRFs for a minimum of 15 years after 
study closure or longer if required by local law, regulations or institution. 
 
The investigator and sponsor must take measures to prevent accidental or early destruction of the 
study related materials. No study document or image will be destroyed without prior written 
agreement between Medtronic and the investigator. Should the investigator wish to assign the study 
records to another party or move them to another location, advance written notice must be given to 
Medtronic. 
 
14.8. Publication and Use of Information 
The study will be registered in a public database. 
Publications and presentations referring to this clinical study will be coordinated by Medtronic to 
allow the use of all available data. 
 
All participating investigational sites will have to adhere to the following Publication Policy: 
 
 Medtronic may use the study data for regulatory authority submission, may publish the 
results in peer reviewed scientific journal(s) and present the data at major congresses. 
 Authorship on any publication(s) resulting from this clinical study will be assigned according 
to substantial contributions to conception and design, acquisition of data, or analysis and 
interpretation of data, drafting the article or revising it critically for important intellectual 
content, and final approval of the version to be published. This is in accordance with the 
Vancouver principles (The Uniform Requirements for Manuscripts Submitted to Biomedical 
Journals: Writing and Editing for Biomedical Publication, ICMJE, October 2008), as agreed 
upon by the editors of all major medical journals. 
 The number of authors will be dependent on the regulations of the concerning journal. 
Names of all participating investigators will appear in the Acknowledgment of the paper, if 
allowed by the journal. 
 Based on the principle that Medtronic owns the data of this clinical study, a single 
investigational site may access and use the data provided by 
itself for scientific publications 
following prior approval by Medtronic. 
 Pooling data from several investigational sites for publication purposes, national 
projects and international projects all require prior approval from Medtronic. 

 
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 Medtronic as the owner of the data can use the data and/or any results derived from the 
data or publications based on that data for marketing purposes, further research and 
development of devices or educational use. 
 
The study sponsor will collect data 
in such way that no subject can be 
identified. Participating subjects 
will not be identified by name in any published reports about the clinical study. 
 
14.9. Suspension or Early Termination 
 
14.9.1. Early study suspension or termination 
Early Termination is the closure of a study that occurs prior to meeting defined endpoints. This is 
possible for the whole study or a single study site Suspension is a temporary postponement of study 
activities related to enrollment and distribution of the product Medtronic may decide to suspend or 
prematurely terminate the study (e.g. if information becomes available that the risk to study subject 
is higher than initially indicated). If the study is terminated prematurely or suspended, Medtronic 
shall promptly 
inform the clinical 
investigators and the reviewing EC of the termination or suspension 
and the reason(s) for this. The 
investigator shall then promptly 
inform the study subjects. The clinical 
research agreement will be amended or terminated. 
Possible reasons for considering study-wide suspension or termination of the study include but are 
not limited to: 
 New findings associated with the system or product under investigation which might be 
related to the safety or welfare of the subject 
 Observed/suspected performance different from the product’s design intent 
 Decision by Medtronic  
 Technical issues during the manufacturing process  
 
14.9.2. Early investigational site suspension or 
termination 
Medtronic or EC may decide to suspend or prematurely terminate an investigational site. If an 
investigational site is suspended or prematurely terminated, Medtronic shall promptly inform the 
investigator(s) and the reviewing EC of the termination or suspension and the reason(s) for this. The 
investigator shall then promptly inform 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 site and immediately inform the sponsor and EC, if 
applicable. 

 
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Possible reasons for clinical investigator or center termination or suspension include but are not 
limited to: 
 Consistent non-compliance to the CIP (e.g. failure to adhere to inclusion/exclusion criteria, 
failure to follow subjects per scheduled follow-ups, etc.) 
 Lack of enrollment 
 Noncompliance to regulations and the terms of the Clinical Study Agreement (e.g. failure to 
submit data in a timely manner, failure to follow-up on data queries and monitoring findings 
in a timely manner, etc.) 
 Ethics Committee suspension of the center 
 Fraud or fraudulent misconduct (as defined by local law and regulations) 
 Investigator request (e.g. no longer able to support the study) 
 
14.9.3. Subject follow-up in case of termination 
In case of early termination and at study exit, all subjects should continue to be followed by their 
physicians per standard care and no further patient data will be collected under this clinical 
investigation plan. 
 
 

 
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15. References 
 
1. Holman, R.R.; Paul, S.K.; Bethel, M.A.; Matthews, D.R.; Neil, H.A. 10-year follow-up of intensive 
glucose control in type 2 diabetes. N. Engl. J. Med. 2008, 359, 1577–1589. 
2. Nathan, D.M.; Cleary, P.A.; Backlund, J.Y.; Genuth, S.M.; Lachin, J.M.; Orchard, T.J.; Raskin, P.; 
Zinman, B. Intensive diabetes treatment and cardiovascular disease in patients with type 1 
diabetes. N. Engl. J. Med. 2005, 353, 2643–2653. 
3. Shichiri, M.; Kishikawa, H.; Ohkubo, Y.; Wake, N. Long-term results of the Kumamoto Study on 
optimal diabetes control in type 2 diabetic patients. Diabetes Care 2000, 23, B21–B29. 
4. American Diabetes Association. Glycemic Targets: Standards of Medical Care in Diabetes—2018. 
Diabetes Care 2018, 41, S55–S64. 5. International Diabetes Federation Guideline Development 
Group. Global Guideline for Type 2 Diabetes. Diabetes Res. Clin. Pract. 2014, 104, 1–52 
5. Bradley, C.; Speight, J. Patient perceptions of diabetes and diabetes therapy: Assessing quality of 
life. Diabetes Metab. Res. Rev. 2002, 18, S64–S69 
6. Roborel de Climens, A.; Tunceli, K.; Arnould, B.; Germain, N.; Iglay, K.; Norquist, J.; Brodovicz, 
K.G. Review of patient-reported outcome instruments measuring health-related quality of life 
and satisfaction in patients with type 2 diabetes treated with oral therapy. Curr. Med. Res. Opin. 
2015, 31, 643–665. 
7. Bradley, C.; Gamsu, D.S. Guidelines for encouraging psychological well-being: Report of a 
Working Group of the World Health Organization Regional Office for Europe and International 
Diabetes Federation European Region St Vincent Declaration Action Programme for Diabetes. 
Diabet. Med. 1994, 11, 510–516 
8. Moon RJ, Bascombe LA, Holt RI. The addition of metformin in type 1 diabetes improves insulin 
sensitivity, diabetic control, body composition and patient well-being. Diabetes Obes Metab. 
2007 Jan;9(1):143-5. 
9. Ashwell SG, Bradley C, Stephens JW, Witthaus E, Home PD. Treatment satisfaction and quality of 
life with insulin glargine plus insulin lispro compared with NPH insulin plus unmodified human 
insulin in individuals with type 1 diabetes. Diabetes Care. 2008 Jun;31(6):1112-7. doi: 
10.2337/dc07-1183. Epub 2008 Mar 13. 
10. The DCCT Research Group, “Reliability and validity of a diabetes quality-of-life measure for the 
diabetes control and complications trial (DCCT),” Diabetes Care, vol. 11, no. 9, pp. 725–732, 1988. 
11. The Diabetes Control and Complications Trial Research Group, “Influence of intensive diabetes 
treatment on quality-of-life outcomes in the diabetes control and complications trial,” Diabetes 
Care, vol. 19, no. 3, pp. 195–203, 1996. 

 
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12. Bergenstal RM, Garg S, Weinzimer SA, Buckingham BA, Bode BW, Tamborlane WV, Kaufman FR. 
Safety of a Hybrid Closed-Loop Insulin Delivery System in Patients With Type 1 Diabetes. JAMA. 
2016 Oct 4;316(13):1407-1408 
13. Garg SK, Weinzimer SA, Tamborlane WV, Buckingham BA, Bode BW, Bailey TS, Brazg RL, Ilany J, 
Slover RH, Anderson SM, Bergenstal RM, Grosman B, Roy A, Cordero TL, Shin J, Lee SW, Kaufman 
FR. Glucose Outcomes with the In-Home Use of a Hybrid Closed-Loop Insulin Delivery System in 
Adolescents and Adults with Type 1 Diabetes. Diabetes Technol Ther. 2017 Mar;19(3):155-163. 
14. Bradley CIrvine A, Cox D, Gonder-Frederick L. The Fear of Hypoglycaemia Scale. In Handbook of 
Psychology and Diabetes. Bradley C, Ed. Great Britain, Harwood Academic Publishers, 1994, p. 
133–155 
15. Cox DJ, Irvine A, Gonder-Frederick L, Nowacek G, Butterfield J. Fear of hypoglycemia: 
quantification, validation, and utilization. Diabetes Care 1987;10:617–621 
16. Gonder-Frederick LA, Fisher CD, Ritterband LM, et al. Predictors of fear of hypoglycemia in 
adolescents with type 1 diabetes and their parents. Pediatr Diabetes 2006;7:215–
222pmid:169110 
 
 

 
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 Updated Carelink Personal for Clinical Research 
connectivity throughout the document 
 Updated Background Section and moved paragraph 
on HCL technology from Section 6.1 Rational to 
Background  
 Updated Table 1, 2, 3, 4 
 Updated Figure 1, 3, 6. Added Figure 8, 9 
 Updated or added Sections 4.2, 6, 7.1, 7.6, 7.7, 7.8, 8, 
10, 11.2, 14.2, 14.5, 14.7.5, 14.9.1 due to GAP analysis 
between new CIP Template 056-F275 v.B and v.A 
 Moved information on Site and Investigator selection, 
clinical investigational agreement and curriculum 
vitae from Section 10 to Section 8 due to GAP analysis 
between CIP Template 056-F275 v.B and v.A 
 Added the Sub-Section 11.2 Risk Minimization due to 
GAP analysis between CIP Template 056-F275 v.B and 
v.A 
 And moved 
information on Specific Rosks from Section 
11.1 to 11.2 due to GAP analysis between CIP 
Template 056-F275 v.B and v.A 
 Added information on The Hypoglycemia Fear Survey, 
Section 6.1 
 Updated the Section 7 Product Description. Moved 
paragraph on Glucose Sensor from Background and 
added the Sub-Sections for: Accu-Chek® Guide Link 
Blood Glucose Meter, MiniMed Mobile App Patients, 
CareLink™ BLE USB [Blue Adaptor], Product 
Accountability 
 Updated Data Analysis “use ITT as a primary dataset 
and PP as a sensitivity analysis dataset” 
in Section 12.3 
and throughout the document 
 Updated References