Evaluation of the MiniMed 780 System in Young Paediatric Subjects (2-6 Years Old) With Type 1 Diabetes in a Home Setting (LENNY)
Phase: NA
Conditions: Diabetes type1, Children, Only
Sponsor: Medtronic MiniMed, Inc.

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CIP342 Clinical Investigation Plan
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Clinical Investigation Plan 
Clinical Investigation Plan 
(CIP)/Study Title  
EvaLuation of thE MiNiMed 780G System iN Young Paediatric 
Subjects (2-6 years old) with Type 1 Diabetes in a Home Setting 
(LENNY)  
CIP Identifier 342 
EUDAMED Number CIV-Sl-23-02-042435 
Study Product Name MiniMed™ 780G Insulin Pump system with Guardian™ Sensor 4 
Sensor  
MiniMed™ 780G BLE 2.0 Insulin Pump system with Disposable 
Sensor 5 
Description of CIP This study will evaluate the safety and performance of the MiniMed 
780G system in paediatric subjects (2-6 years old) with type 1 
diabetes in Europe.  
Sponsor Medtronic International Trading Sàrl  
 
Europe-based Legal 
representative of the 
Sponsor 
Medtronic Bakken Research Center  
 
 
 
Document Version E 
Version Date 30-OCT-2023  
Document Reference 
Number 
D00674412 
Confidentiality Statement 
The information contained in this document is confidential and the proprietary property of 
Medtronic. Any distribution, copying, or disclosure without the prior written authorization of 
Medtronic is strictly prohibited. Persons to whom the information is disclosed must know that it is 
confidential and that it may not be further disclosed by them. 
Android™ is a trademark of Google LLC. 
 
Accu-Chek™ is a registered trademark of Roche Diabetes Care, Inc. (“Roche”). 
 
DreaMed Diabetes is a trademark of DreaMed Diabetes, Ltd. The MiniMed™ 780G system algorithm 
includes technology developed by DreaMed Diabetes. 
 
Humalog® is a registered trademark of Eli Lilly and Company. 
 
IOS™ is a trademark or registered trademark of Cisco. 
 
NovoLog™ / Novorapid™ is a registered trademark of Novo Nordisk A/S. 
 
The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by 
Medtronic is under license. Other trademarks and trade names are those of their respective owners. 
 
© 2023 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, together are trademarks of Medtronic. Third 
party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company. 
 
 

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Table of Contents 
Table of Contents ...................................................................................................................... 2 
1 
Glossary .......................................................................................................................... 7 
2 
Synopsis .......................................................................................................................... 9 
3 
Introduction ................................................................................................................. 16 
3.1 Background ......................................................................................................................16 
3.2 Purpose ............................................................................................................................17 
4 
Objectives and/or Endpoints....................................................................................... 17 
4.1 Objectives ........................................................................................................................17 
4.2 Study Phase Endpoints ......................................................................................................17 
4.2.1 
Primary Endpoint...................................................................................................17 
4.2.2 
Secondary Endpoints .............................................................................................17 
4.3 Continuation Phase Endpoints ............................................................................................18 
4.3.1 
Primary Endpoint...................................................................................................18 
4.3.2 
Secondary Endpoints .............................................................................................18 
4.4 Safety Endpoints ...............................................................................................................18 
 
5 
Study Design................................................................................................................. 19 
5.1 Duration ...........................................................................................................................21 
5.2 Rationale ..........................................................................................................................21 
6 
Product Description ..................................................................................................... 21 
6.1 Intended Use ....................................................................................................................21 
6.2 General Overview of the MiniMed 780G System ..................................................................21 
6.2.1 
MiniMed 780G Insulin Pump / MiniMed 780G BLE 2.0 Insulin Pump .........................25 
6.2.2 
Guardian 4 Sensor .................................................................................................26 
6.2.3 
Guardian 4 Transmitter ..........................................................................................26 
6.2.4 
One-Press Serter ...................................................................................................27 
6.2.5 
Charger .................................................................................................................27 
6.2.6 
Tester ...................................................................................................................27 
6.2.7 
DS5 Sensor ............................................................................................................27 
6.2.8 
Roche Accu-Chek Guide Glucose Meter ..................................................................28 
6.2.9 
CareLink Personal Software ....................................................................................28 
6.2.10 
CareLink System Software ......................................................................................28 

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6.2.11 
Roche Accu-Chek Guide Glucose Meter ..................................................................29 
6.2.12 
Accessory Applications – MiniMed 780G system .....................................................29 
6.2.13 
Blue Adapter .........................................................................................................29 
6.2.14 
Smartphone ..........................................................................................................30 
6.3 Insulin ..............................................................................................................................30 
6.4 Consumable Devices and Accessories .................................................................................30 
6.5 Packaging .........................................................................................................................30 
6.6 Product Training Materials .................................................................................................30 
6.7 Anticipated Product Changes .............................................................................................30 
6.8 Product Accountability .......................................................................................................30 
6.8.1 
Receipt and Inventory of Study Devices by Investigational Center ............................31 
6.8.2 
Storage of Study Devices at Investigational Center ..................................................32 
6.8.3 
Dispensing of Study Devices ...................................................................................32 
6.8.4 
Return or Disposal of Study Devices ........................................................................32 
7 
Study Site Requirements ............................................................................................. 33 
7.1 Investigator/Investigation Site Selection .............................................................................33 
7.2 Study Site Activation .........................................................................................................33 
8 
Selection of Subjects.................................................................................................... 34 
8.1 Study Population ...............................................................................................................34 
8.2 Subject Enrollment ............................................................................................................34 
8.3 Inclusion Criteria ...............................................................................................................35 
8.4 Exclusion Criteria ..............................................................................................................35 
8.5 Randomization Criteria ......................................................................................................36 
8.5.1 
Study Phase...........................................................................................................36 
8.5.2 
Continuation Phase................................................................................................36 
9 
Study Procedures ......................................................................................................... 37 
9.1 Schedule of Events............................................................................................................37 
9.1.1 
Pump Settings and Sensor Site ...............................................................................48 
9.1.2 
Unscheduled Visit ..................................................................................................50 
9.1.3 
Early Termination Visit ...........................................................................................50 
9.1.4 
Study Exit ..............................................................................................................50 
9.2 Data Collection..................................................................................................................50 
9.3 Subject Consent ................................................................................................................50 

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9.3.1 
Reconsent for the updated Continuation phase.......................................................52 
9.4 Randomization and Treatment Assignment .........................................................................52 
9.4.1 
Study Phase...........................................................................................................52 
9.4.2 
Continuation Phase................................................................................................53 
9.5 Glucose and Glycemia Measurements .................................................................................53 
9.5.1 
Daily Blood Glucose ...............................................................................................53 
9.5.2 
Sensor Glucose Values ...........................................................................................53 
9.5.3 
HbA1c ...................................................................................................................53 
9.6 Recording Data .................................................................................................................53 
9.7 Deviation Handling ............................................................................................................54 
9.7.1 
Documenting Requirements for Study Deviations ....................................................54 
9.7.2 
Reporting Requirements for Study Deviations .........................................................55 
9.7.3 
Analyzing Deviations ..............................................................................................56 
9.8 Subject Exit, Withdrawal or Discontinuation ........................................................................56 
9.8.1 
End of Subject Participation in Study/ Completion of Study ......................................56 
9.8.2 
Lost to Follow-Up ..................................................................................................56 
10 
Risks and Benefits ........................................................................................................ 57 
10.1 Potential Risks ..................................................................................................................57 
10.2 Risk Minimization ..............................................................................................................62 
10.3 Potential Benefits ..............................................................................................................62 
10.4 Risk-Benefit Rationale .......................................................................................................63 
11 
Adverse Events ............................................................................................................. 63 
11.1 Adverse Events .................................................................................................................63 
11.2 Definitions and Classification of Adverse Events ..................................................................63 
11.3 Recording of Adverse Events .............................................................................................65 
11.4 Notification of Adverse Events............................................................................................66 
11.5 Adverse Event and Device Deficiency Classification .............................................................68 
11.6 Causality Assessment ........................................................................................................68 
11.7 Anticipated or Unanticipated ..............................................................................................70 
12 
Data Review Committees ............................................................................................ 70 
12.1 Clinical Events Committee..................................................................................................70 
12.2 Data Monitoring Committee ...............................................................................................71 
12.3 Central Lab .......................................................................................................................72 

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13 
Device Deficiencies ...................................................................................................... 72 
14 
Statistical Design and Methods ................................................................................... 73 
14.1 General Aspects of Analysis ...............................................................................................73 
14.2 Subject Disposition............................................................................................................73 
14.3 Subject Demographics and Baseline Characteristics.............................................................73 
14.4 Analysis Populations and Handling of Missing Data, Error ....................................................73 
14.5 Endpoints and Hypotheses.................................................................................................74 
14.5.1 
Analysis of Primary Endpoint – Study Phase ............................................................74 
14.5.2 
Analysis of Primary Endpoint – Continuation Phase .................................................75 
14.5.3 
Analysis of Secondary Endpoints – Study Phase and Continuation Phase...................75 
14.5.4 
Analysis of Exploratory Endpoints ...........................................................................76 
14.5.5 
Safety Data and Device Deficiencies, Adverse Event and Device Data Summary ........76 
 
14.6.1 
Expected Drop-out Rates .......................................................................................76 
14.7 Interim Analysis ................................................................................................................76 
14.8 Final Report ......................................................................................................................77 
15 
Ethics............................................................................................................................. 77 
15.1 Statement(s) of Compliance...............................................................................................77 
15.2 Role of the Sponsor’s Representatives ................................................................................78 
15.3 Investigator’s Responsibilities ............................................................................................78 
16 
Study Administration ................................................................................................... 80 
16.1 Training of Clinical Staff.....................................................................................................80 
16.2 Monitoring ........................................................................................................................80 
16.2.1 
Accessibility of Investigational Center Staff and Study Materials...............................81 
16.2.2 
Audits and Investigational Center Inspections .........................................................81 
16.2.3 
Investigational Center Disqualification ....................................................................81 
16.3 Data Management.............................................................................................................81 
16.3.1 
Electronic Case Report Forms (eCRFs) .....................................................................81 
16.3.2 
CareLink Personal/CareLink System Software ..........................................................82 
16.3.3 
Questionnaires ......................................................................................................82 
16.3.4 
Paper Study Worksheets ........................................................................................82 
16.3.5 
Time Windows for Completion and Submission of Case Report Forms ......................82 
16.3.6 
Data Review and Processing ...................................................................................83 

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16.4 Direct Access to Source Data/Documents ...........................................................................83 
16.5 Confidentiality...................................................................................................................83 
16.6 Liability and Subject Compensation ....................................................................................83 
16.6.1 
Insurance ..............................................................................................................83 
16.7 CIP Amendments ..............................................................................................................84 
16.8 Investigational Center Compensation .................................................................................84 
16.9 Records and Reports .........................................................................................................84 
16.9.1 
Investigator Records ..............................................................................................84 
16.10 
Record Retention .......................................................................................................85 
16.11 
Suspension or Early Termination .................................................................................85 
16.11.1 
Early Investigational Center Suspension or Termination ...........................................85 
16.11.2 
Subject Follow-Up In Case of Termination ...............................................................85 
16.12 
Study Close-Out.........................................................................................................85 
16.13 
Publication and Use of Information .............................................................................85 
17 
References .................................................................................................................... 86 
18 
Appendices ................................................................................................................... 87 
18.1 Names and addresses .......................................................................................................87 
18.1.1 
Investigational Centers and EC ...............................................................................87 
18.1.2 
Sponsor Contact Information .................................................................................87 
18.1.3 
Vendors Contact Information .................................................................................87 
18.2 Labeling of Devices ...........................................................................................................87 
18.3 Sample Consent Materials..................................................................................................87 
18.4 Sample CRF ......................................................................................................................87 
18.5 Questionnaires ..................................................................................................................87 
18.6 Sample Investigator Agreement .........................................................................................87 
18.7 List of Consumables and Accessories ..................................................................................87 
19 
Version History ............................................................................................................. 88 
 

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1 Glossary 
 
Abbreviations 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AHCL 
Advanced Hybrid Closed Loop 
AIT 
Active Insulin Time 
ASADE 
Anticipated Serious Adverse Device Effect 
AUC 
Area Under Curve 
BG 
Blood Glucose 
BLE 
Bluetooth Low Energy 
BMI 
Body Mass Index 
CEC 
Clinical Event Committee 
CGM 
Continuous Glucose Monitoring 
CIP 
Clinical Investigation Plan 
CRF 
Case Report Form 
CSII 
Continuous Subcutaneous Insulin Infusion 
CTA 
Clinical Trial Agreement 
CV 
Curriculum Vitae 
CV 
Coefficient of Variation 
DD 
Device Deficiency 
DKA 
Diabetic Ketoacidosis 
DoH 
Declaration of Helsinki 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
EU 
European Union 
EOS 
End of Study 
ER 
Emergency Room 
GCP 
Good Clinical Practice 
HbA1c 
Glycosylated hemoglobin 
IB 
Investigator’s Brochure 
ICF 
Informed Consent Form 
ICMJE 
International Committee of Medical Journal Editors 
ID 
Identification 
IDF 
International Diabetes Federation 
IFU 
Instructions For Use 
ISO 
International Organization for Standardization 
ITT 
Intention to Treat 
IV 
Intravenous 
MC2 
Medtronic Core Clinical Solutions 
MDI 
Multiple Daily Injections 

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Abbreviations 
MDR 
Medical Device Regulation 
MedDRA 
Medical Dictionary for Regulatory Activities 
NGSP 
National Glycohemoglobin Standardization Program 
PC 
Personal Computer 
PI 
Principal Investigator 
PP 
Per Protocol 
QC 
Quality Control 
 
RA 
Regulatory Authority 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SAP 
Sensor Augmented Pump 
SBL 
Suspend Before Low 
SD 
Standard Deviation 
SDS BMI 
Standardized BMI 
SG 
Sensor Glucose 
SMBG 
Self-Monitoring of Blood Glucose 
SOP 
Standard Operating Procedure 
T1D 
Type 1 diabetes 
TDD 
Total Daily Dose 
TIR 
Time in Range 
TLS 
Transport Layer Security 
USADE 
Unanticipated Serious Adverse Device Effect 
 
Definitions 
Auto Mode/SmartGuard 
Auto Mode (referred to as SmartGuard in the user guide) , is a feature in the 
MiniMed 780G system. In Auto Mode, the pump automatically adjusts basal 
insulin delivery to regulate glucose levels to a target sensor glucose amount. 
It also features automatic correction boluses.  
Manual Mode 
Manual Mode refers to when the function of the MiniMed 780G system when 
Auto Mode is not active.  
Suspend before low 
Suspend before low is a feature in the MiniMed 780G system. When Suspend 
before low is activated, the pump temporarily stops delivering insulin when 
the sensor glucose is at or within 70mg/dL above the set low limit and is 
predicted to reach or fall below a level that is 20mg/dL above the set low 
limit in 30 minutes. 
Suspend on low 
Suspend on low is a feature in the MiniMed 780G system. Suspend on low 
feature stops insulin delivery when SG readings reach or fall below the set 
low limit. When a Suspend on low event occurs, insulin delivery is suspended. 
 
 
 

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2 Synopsis 
Title 
EvaLuation of thE MiNiMed 780G System iN Young Paediatric Subjects (2-6 
years old) with Type 1 Diabetes in a Home Setting (LENNY) 
Clinical Study 
Type 
Pre-market, interventional, prospective, open-label, multi-center, 
randomized crossover study 
Indication under 
investigation  
Type 1 diabetes (T1D) in paediatric population (2-6 years old) 
Sponsor 
Medtronic International Trading Sàrl  
 
 
 
EU-based Legal 
Representative of 
the Sponsor 
Medtronic Bakken Research Center  
 
 
 
Study Products 
Study Products for Study Phase: 
The following CE-marked products evaluated in this study are considered 
investigational for the study population: 
 
 
MiniMed™ 780G Insulin Pump (MMT-1895 and MMT-1896)  
 
Guardian™ 4 Sensor (MMT-7040) 
 
Guardian™ 4 Transmitter Kit (MMT-7840) 
 
Study Products for Continuation Phase: 
Based on the randomization, the following products will be used. 
 
The following CE-marked products evaluated in this study are considered 
investigational for the study population: 
 
 
MiniMed™ 780G Insulin Pump  (MMT-1895 and MMT-1896) 
 
Guardian™ 4 Sensor (MMT-7040)  
 
Guardian™ 4 Transmitter Kit (MMT-7840) 
 
The following non-CE-marked products evaluated in this study are considered 
investigational for the study population: 
 
 
MiniMed 780G BLE 2.0 Insulin Pump (MMT-1895 and MMT-1896) 
 
Disposable Sensor labeled as DS5 and referred as DS5 throughout 
this CIP (MMT-5100)  
 
Commercialized devices, consumables and accessories will be provided 
during the study (detailed list in Section 6.2 and Appendix 18.7). 
Purpose 
The purpose of this study is to demonstrate the safety and performance of 
the MiniMed™ 780G system in paediatric subjects (2-6 years old) with type 1 
diabetes in a home setting. 

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Objective(s) 
The objective of this study is to evaluate the safety and performance of the 
MiniMed™ 780G system in Auto Mode firstly in comparison to the MiniMed™ 
780G system in Manual Mode with Suspend before low activated (currently 
available standard therapy) and secondly in comparison to the new 
MiniMed™ 780G BLE 2.0 system with DS5 sensor in Auto Mode among 
paediatric population (2-6 years old). 
Study Design 
This study is a pre-market, prospective, open-label, multi-center, randomized 
crossover trial in paediatric subjects aged 2-6 years with type 1 diabetes. The 
study consists of a run-in phase, a study phase and a continuation phase (see 
Synopsis Figure 1 for an overview).  
 
Run-in Phase (Visit 2-3): 
The purpose of the run-in phase (2 to 4 weeks) is to train subjects on the 
MiniMed™ 780G system and to collect 2 weeks of baseline data. At the end 
of Run-in Phase, subjects will be randomized into 2 sequences (A and B).  
 
Study Phase (Visit 3A-11): 
During the study phase, each sequence consists of 2 phases of 12 weeks 
each separated by a 2-week washout phase for a total of 26 weeks.  
• 
Sequence A: subjects will start using the MiniMed™ 780G system in 
Auto Mode for 12 weeks. The washout phase of 2 weeks will be 
followed by a 12-week phase where subjects will use MiniMed 780G 
system in Manual Mode with Suspend before low (SBL) activated. 
• 
Sequence B: subjects will continue to use MiniMed™ 780G system in 
Manual Mode with SBL activated for 12 weeks. After a washout phase 
of 2 weeks, subjects will start to use the MiniMed 780G system in 
Auto Mode for a 12-week phase.  
 
During the washout period, all subjects will use MiniMed™ 780G system in 
Manual Mode with SBL activated.  
 
Run-in Phase 2 (Visit 2a-3a): 
The purpose of the run-in phase 2 (2 to 12 days) is to collect a minimum of 
2 days baseline data for the subjects that will enroll only for the continuation 
phase (only applicable based on the interim analysis outcome). 
 
Continuation Phase (Visit 12-15): 
For the duration of the continuation phase.  
enrolled subjects will enter the continuation phase period 1 and will use 
MiniMed 780G system in Auto Mode. At the end of the continuation phase 
period 1, subjects will be randomized into 2 arms (A2 and B2) and enter 
period 2 for 12 weeks. 
• 
Arm A2: Subjects will start using the MiniMed™ 780G BLE 2.0 system 
with the DS5 sensor for 12 weeks 
• 
Arm B2: Subjects will continue to use MiniMed™ 780G system in Auto 
Mode for 12 weeks 
 

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See Section 5 for more details.  
Synopsis Figure 1. Study Design 
 
 
 
Study Visit 
Schedule 
Subjects may participate in up to 15 planned study visits, as presented in 
Synopsis Figure 2. A remote office visit (audio visual) may be performed 
for office visits in cases where an in-person office visit is not possible. For 
detailed information, see Section 9.  
 
Subjects who enroll only at the start of the continuation phase can participate 
in up to 7 planned study visits.  
 

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Synopsis Figure 2. Visit Schedule 
 
 
 
  
Sample Size & 
Investigational 
Centers 
Approximately 100 subjects with type 1 diabetes age 2-6 years will be 
enrolled at up to 18 investigational centers across Europe to achieve 
approximately 80 subjects randomized and have 72 completing the study 
phase and 64 completing the continuation phase. 
 
During the Continuation Phase period 1, the sample size will be re-estimated 
based on an interim analysis which will evaluate HbA1c Standard Deviation. 
Based on the interim analysis result, enrollment for the Continuation phase 
only will be opened.  
Duration 
The study is anticipated to last approximately 23 months from first 
investigational center initiation to study completion. The study will target 4 
months to complete enrollment. Individual subject participation is expected 
to be approximately 14 months from the run-in phase to end of study 
participation or 6-9 months for subjects enrolled for the continuation phase 
only. 
Inclusion Criteria 
1. Aged 2 – 6 years at time of screening  
2. Has a clinical diagnosis of type 1 diabetes for ≥6 months prior to 
screening as determined via medical record or source documentation by 
an individual qualified to make a medical diagnosis 
3. Is on MDI therapy or CSII with or without CGM prior to screening  

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4. Has a glycosylated hemoglobin (HbA1c) <11% (97 mmol/mol) at time 
of screening visit as processed by a Local Lab)  
5. Is using or willing to switch to one of the following commercialized 
available insulins: 
• 
Humalog™ (insulin lispro injection) 
• 
NovoLog™/ NovoRapid™ (insulin aspart) 
6. Must have a minimum daily insulin requirement (Total Daily Dose) of 
≥6 units  
7. Parent(s)/legal guardian(s) willing to upload data from the pump 
system, must have Internet access, a compatible computer or mobile 
phone that meets the requirements for uploading the study pump data 
at home. 
8. Is living with one or more parent(s)/legal guardian(s) knowledgeable 
about emergency procedures for severe hypoglycemia and able to 
contact emergency services and study staff. 
9. Investigator has confidence that the parent(s)/legal guardian(s) can 
successfully operate all study devices and is capable of adhering to the 
protocol 
10. Subject and parent(s)/legal guardian(s) willingness to participate in all 
training sessions as directed by study staff. 
11. Subject's parent(s)/legal guardian(s) must be willing and able to 
provide written informed consent. 
Exclusion Criteria 
1. Has Addison’s disease, growth hormone deficiency, hypopituitarism or 
definite gastroparesis, untreated coeliac disease, untreated thyroid 
disorder, or poorly controlled asthma, per investigator judgment.  
2. Is using any anti-diabetic medication other than insulin at the time of 
screening or plan on using during the study (e.g., pramlintide, DPP-4 
inhibitor, GLP-1 agonists/mimetics, metformin, SGLT2 inhibitors). 
3. Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 
8 weeks from time of screening visit, or plans to take any oral, 
injectable, or IV glucocorticoids during the course of the study.  
4. Has had renal failure defined by creatinine clearance <30 ml/min, as 
assessed by local lab test ≤ 6 months before screening or performed at 
screening at local lab, as defined by the creatinine-based Cockcroft, 
CKD-EPI or MDRD equations. 
5. Has any unresolved adverse skin conditions in the area of sensor 
placement (e.g. psoriasis, dermatitis herpetiformis, rash, 
Staphylococcus infection). 
6. Is under Control IQ or CamAPS FX, Omnipod 5 or other advanced 
hybrid closed loop therapy (e.g. DIY, MiniMed 780G) in the previous 3 
months before enrollment. Note: For the continuation phase only, 
subjects using MiniMed 780G can be enrolled.  
7. Is actively participating in an investigational study (drug or device) 
wherein he/she has received treatment from an investigational study 
drug or device in the last 2 weeks before enrollment into this study, as 
per investigator judgment. 

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8. Has any other disease or condition that may preclude the patient from 
participating in the study, per investigator judgment. 
9. History of >1 DKA event not related to illness or initial diagnosis in the 
last 3 months. 
10. Parent(s)/legal guardian(s) are part of research staff involved with the 
study. 
11. Parent(s)/legal guardian (s) are illiterate 
Statistical 
Analysis for 
Endpoints and 
Hypothesis 
Primary Endpoint – Study Phase 
 
The primary endpoint for study phase is the between-treatment difference in 
the percentage of time that the sensor glucose measurement is in the target 
range, 70 to 180 mg/dL (3.9-10.0 mmol/L).  
 
The endpoint will be assessed for non-inferiority with an absolute margin of 
7.5% time in target range. 
 
Secondary Endpoints – Study Phase 
The secondary endpoints will be the between-treatment difference in the 
study phase for: 
 
• 
Mean HbA1c at the end of each 12-week period, non-inferiority with 
an absolute margin of 0.4% HbA1c.  
• 
% Time spent in target range (70 to 180 mg/dL [3.9-10.0 mmol/L]), 
simple superiority test. 
• 
Mean HbA1c at the end of each 12-week period, simple superiority 
test. 
 
Primary Endpoint – Continuation Phase 
The primary endpoint for continuation phase is the between-treatment 
difference in the mean HbA1c (%) at the end of 12-week continuation phase 
period 2. 
   
The endpoint will be assessed for non-inferiority with an absolute margin of 
0.4% HbA1c. 
 
 
Secondary Endpoints – Continuation Phase 
The secondary endpoints will be the between-treatment difference in the 
continuation phase period 2 for: 
• 
Mean HbA1c at the end of the 12-week continuation phase period 2, 
simple superiority test.  
• 
% Time spent in target range (70 to 180 mg/dL [3.9-10.0 mmol/L]) 
during the end 12-week continuation phase period 2, non-inferiority 
with a margin of 7.5%. 

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• 
% Time spent in target range (70 to 180 mg/dL [3.9-10.0 mmol/L]) 
during the end 12-week continuation phase period 2, simple 
superiority test. 
 
Safety Endpoints 
The following safety endpoints will be assessed for each treatment during 
each period in the study phase and continuation phase:  
 
• 
Number of severe hypoglycemic events 
• 
Number of Diabetic Ketoacidosis events (DKA) 
• 
Number of Serious Adverse Events (SAEs) 
• 
Number of Serious Adverse Device Events (SADEs) 
• 
Number of Unanticipated Serious Adverse Device Events (USADEs)  
 
Final Report 
The study results will be summarized and presented in the final report. 
 

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3 Introduction 
3.1 Background 
The global incidence of newly diagnosed cases of type 1 diabetes (T1D) in children and adolescents is 
increasing. In 2019, the International Diabetes Federation (IDF) indicated that every year, 98,200 
children and adolescents aged 0–14 years are diagnosed with T1D worldwide1.  
 
In T1D, 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. The use of 
sensor-augmented pump therapy with predictive low-glucose suspend features, available in the 
commercialized MiniMed 640G System, in which the pump stops insulin delivery when an algorithm 
predicts glucose levels to drop below the prespecified low-glucose threshold, is accompanied by 
improvements in glycemic control in children, but the management of the therapy remains challenging 
in the young children due to high variability of insulin requirements, marked insulin sensitivity and 
unpredictable eating and activity patterns.  
 
In 2020, a sensor-augmented pump system, called the MiniMed 780G system, with an advanced hybrid 
closed loop (AHCL) algorithm became commercially available in Europe. The system features 
SmartGuard technology which allows the pump to automatically adjust the amount of insulin delivered 
based on sensor glucose (SG) readings. The system can also automatically deliver correction boluses 
and has multiple adjustable glucose targets (100 mg/dL, 110mg/dL, 120 mg/dL and 150 mg/dL) (5.5 
mmol/L, 6.1 mmol/L, 6.7 mmol/L and 8.3 mmol/L). 
 
Several studies have been completed and are ongoing on the AHCL MiniMed 780G system to 
demonstrate its safety and effectiveness in children, adolescents and adults (Table 1). In a pivotal 
study, it was demonstrated that the MiniMed 780G system helped children over 7 years old to reach 
better time in range (TIR) and better mealtime glycaemia without increasing time below range (TBR), 
severe hypoglycemia or ketoacidosis 2. Furthermore, real-life data analysis in 3,211 users, reporting 
age <15, demonstrated a GMI of 6.8±0.3%, TIR of 73.9±8.7%, and TBR (70 mg%) of 3.2%, while 
spending 92.7% of time in AHCL3.  
 
These studies and real-life usage of the MiniMed 780G system have shown to improve glycemic control 
and reduce the burden of management of T1D in children and adolescents. However, studies involving 
very young children remain limited, and therefore this randomized trial is being conducted to evaluate 
safe usage of the MiniMed 780G system in comparison with the currently available standard sensor-
augmented pump therapy for young children 2 to 6 years old. 
 
In the continuation phase, an advanced MiniMed 780G system will be used. The system is comprised 
of the MiniMed 780G BLE 2.0 insulin pump used in combination with the DS5 sensor, which combines 
the glucose sensor and transmitter into one disposable device thereby simplifying the insertion process. 
Additionally, the user will no longer need to charge the transmitter, reducing user burden. The 
modifications to the MiniMed 780G insulin pump include DS5 sensor compatibility, communication 
enhancements to the mobile app, and improved adaptation process and insulin on board calculation.  
 
 
 

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Table 1. AHCL Clinical Studies 
Study  
Design 
Primary Endpoints 
Status 
 
New Zealand 
4 weeks; randomized vs predictive low 
glucose suspend, two-sequence cross-
over with 60 subjects >7 – 70 years old 
with Type 1 Diabetes  
Safety and Effectiveness Time 
in Range 3.9-10 mmol/L and 
Time in Hyperglycemia >10 
mmol/L 
Completed 
Medtronic study  
United States 
12 weeks; single arm in 250 subjects >7 
years old with Type 1 Diabetes  
Safety, HbA1c 
Completed 
 
Finland 
3-month study, single arm in 35 subjects 
2-6 years old with Type 1 Diabetes in 
Finland 
Time in Ranges  
3 months completed 
12 months ongoing 
Medtronic ADAPT 
Study 
UK, France, 
Germany 
6-month study and 6 months 
continuation, randomized vs multiple daily
injections with CGM, >18 years old with 
Type 1 Diabetes 
Safety and Effectiveness, 
HbA1c, Time in Ranges 
Completed 
HyCLIP Study 
Australia 
4 month; randomized vs standard therapy 
children age 2 to ≤7 years 
Time in Range 
Ongoing 
Medtronic CIP337 
Study 
USA 
4-month; single arm in 250 subjects >7 
years old with Type 1 
Safety and Effectiveness 
Ongoing  
 
 
3.2 Purpose 
The purpose of this study is to demonstrate the safety and performance of the MiniMed 780G system 
in paediatric subjects (2-6 years old) with type 1 diabetes in a home setting. 
4 Objectives and/or Endpoints 
4.1 Objectives 
The objective of this study is to evaluate the safety and performance of the MiniMed 780G system in 
Auto Mode firstly in comparison to the MiniMed 780G system in Manual Mode with Suspend before 
low activated and secondly in comparison to the new MiniMed 780G BLE 2.0 system with DS5 sensor 
in Auto Mode among paediatric population (2-6 years old). 
4.2 Study Phase Endpoints 
4.2.1 Primary Endpoint 
The primary end point is the between-treatment difference in the percentage of time that the sensor 
glucose measurement is in the target range, 70 to 180 mg/dL (3.9-10.0 mmol/L). 
 
The endpoint will be assessed for non-inferiority with an absolute margin of 7.5% time in target range. 
4.2.2 Secondary Endpoints 
The secondary endpoints will be the between-treatment difference in the study phase for: 

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• 
Mean HbA1c at the end of each 12-week period, non-inferiority test with an absolute margin 
of 0.4% HbA1c.  
• 
% Time spent in target range (70 to 180 mg/dL [3.9-10.0 mmol/L]), simple superiority test. 
• 
Mean HbA1c at the end of each 12-week period, simple superiority test.  
 
4.3 Continuation Phase Endpoints 
4.3.1 Primary Endpoint 
The primary end point for continuation phase is the between-treatment difference in the mean HbA1c 
at the end of the 12-week continuation phase period 2. 
 
The endpoint will be assessed for non-inferiority with an absolute margin of 0.4% HbA1c. 
4.3.2 Secondary Endpoints 
The secondary endpoints will be the between-treatment difference in the continuation phase period 2 
for: 
• 
Mean HbA1c at the end of the 12-week continuation phase period 2, simple superiority test.  
• 
% Time spent in target range (70 to 180 mg/dL [3.9-10.0 mmol/L]) during the continuation 
phase period 2, non-inferiority with an absolute margin of 7.5% time in range. 
• 
% Time spent in target range (70 to 180 mg/dL [3.9-10.0 mmol/L]) during the continuation 
phase period 2, simple superiority test. 
4.4 Safety Endpoints 
The following safety endpoints will be assessed for each treatment during each period in the study 
phase and continuation phase:  
 
• 
Number of severe hypoglycemic events 
• 
Number of Diabetic Ketoacidosis events (DKA) 
• 
Number of Serious Adverse Events (SAEs) 
• 
Number of Serious Adverse Device Events (SADEs) 
• 
Number of Unanticipated Serious Adverse Device Events (USADEs)  
 
 
 
 
 
 
  
 
  
 
  
 
  
 
  
 
  
 
 

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5 Study Design 
This study is a pre-market, prospective, open-label, multi-center, randomized crossover trial in 
paediatric subjects (2-6 years old) with type 1 diabetes. The study consists of a run-in phase, a study 
phase and a continuation phase (see Figure 3 for an overview).  
 
Run-in Phase (Visit 2-3): 
The purpose of the run-in phase (2 to 4 weeks) is to train subject’s parent(s)/legal guardian(s) on the 
MiniMed 780G system in Manual Mode with Suspend before low activated and to collect 2 weeks of 
baseline data. At the end of Run-in Phase, subjects will be randomized into 2 sequences (A and B).  

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Successful completion of run-in phase requires sensor usage ≥70% over the previous 2 weeks during 
the run-in phase. If this is not achieved (e.g. sensor felt off) the run-in phase can be extended for 
another 7 to 14 days to achieve sensor usage ≥70%. 
 
Study Phase (Visit 3A-11): 
During the study phase, each sequence consists of 2 phases of 12 weeks each separated by a 2-week 
washout phase for a total of 26 weeks.  
 
• 
Sequence A: subjects will start using the MiniMed 780G system in Auto Mode for 12 weeks 
(Treatment). The washout phase of 2 weeks will be followed by a 12-week phase where 
subjects will use 780G system in Manual Mode with SBL activated (Control). 
 
• 
Sequence B: subjects will continue to use MiniMed 780G system in Manual Mode with SBL 
activated for 12 weeks (Control). After a washout phase of 2 weeks, subjects will start to use 
the MiniMed 780G system in Auto Mode for a 12-week phase (Treatment).  
 
During washout period all the subjects will use MiniMed 780G system in Manual Mode with SBL 
activated.  
 
Continuation Phase (Visit 12-15): 
The continuation phase consists of 2 periods.  
Enrolled subjects will enter the continuation phase period 1 and will use MiniMed 780G system in Auto 
Mode for 18 weeks +/- 6 weeks. At the end of the continuation phase period 1, subjects will be 
randomized into 2 arms (A2 and B2). 
• 
Arm A2: Subjects will start using the MiniMed 780G BLE 2.0 system with the DS5 sensor for 12 
weeks 
• 
Arm B2: Subjects will continue to use MiniMed 780G system in Auto Mode for 12 weeks 
Based on the interim analysis results, enrollment may be re-opened for the Continuation phase with a 
dedicated run-in 2. 

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Figure 3. Study Design 
 
 
5.1 Duration 
The study is anticipated to last approximately 23 months from first investigational center initiation to 
study completion. Individual subject participation is expected to be approximately 14 months from the 
run-in phase to end of study participation or 6-9 months for subjects enrolled for the continuation phase 
only. 
5.2 Rationale 
Previous clinical investigations (Table 1) and real-world usage have confirmed safe usage of the 
MiniMed 780G system for people living with type 1 diabetes. However, data on very young children of 
2 years of age and older remains limited and therefore this study assesses the safety and performance 
in this young age group. 
6 Product Description 
6.1 Intended Use 
In this study, the MiniMed 780G system will be used by people 2-6 years old with type 1 diabetes who 
require at least 6 units of insulin per day.  
6.2 General Overview of the MiniMed 780G System  
Study Phase and Continuation Phase Period 1 + Arm B2: The system is composed by 
commercially available products used outside their approved indication and commercially available 
components which will be used within their intended use according to the labeling and instruction for 
use (for additional details please refer to Table 2). 
 
The MiniMed 780G insulin pump is approved (CE-Marked) with the indication for use by patients aged 
7-80 years with Type 1 Diabetes, whose total daily dose of insulin is 8 units per day or more. In the 

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study, the MiniMed 780G insulin pump will be used by 2-6 years old children with Type 1 Diabetes who 
require at least 6 units of insulin per day, therefore its use will be considered outside its approved 
indication. Guardian 4 Sensor and Guardian 4 Transmitter are approved (CE-Marked) with the indication 
for use by patients aged 7 years and older. During the study, Guardian 4 Sensor and Guardian 4 
Transmitter will be used by 2-6 years old children with Type 1 Diabetes, therefore their use will be 
considered outside their approved indication. 
 
Continuation Phase Arm A2: The system is composed by investigational products, MiniMed 780G 
BLE 2.0 insulin pump and DS5 Sensor.  
Table 2. MiniMed 780G Insulin Pump: System Components and Consumable Materials 
Device name* 
MDT Model number 
Device Regulatory Status 
MiniMed 780G Insulin Pump** 
MMT-1895 and MMT-1896 (kits) 
MMT-1885 and MMT-1886 (pump 
only) 
CE-Marked, used outside of its 
approved indication 
MiniMed 780G BLE 2.0 Insulin 
Pump**  
MMT-1895 and MMT-1896 (kits) 
MMT-1885 and MMT-1886 (pump 
only) 
Investigational 
Guardian 4 Sensor  
MMT-7040 
CE-Marked, used outside of its 
approved indication 
Guardian 4 Transmitter** 
MMT-7840 (kits) 
MMT-7841 (transmitter only) 
CE-Marked, used outside of its 
approved indication 
DS5 Sensor 
MMT-5100 
Investigational 
One-Press Serter** 
MMT-7512 
CE-Marked 
Charger** 
MMT-7715 
CE-Marked 
Tester** 
MMT-7736L 
CE-Marked 
CareLink Personal  
MMT-7333 
CE-Marked 
CareLink system  
MMT-7350 
CE-Marked 
Roche Accu-Chek Guide Link 
Glucose Meter*** 
 
08116083016 (Italy) 
08116113018 (United Kingdom) 
08116113343 (Slovenia) 
08116113370 (Finland) 
08116083016 (France) 
CE-Marked 
MiniMed Clinical App 
MMT-6103 Android; MMT-6104 
IOS 
Not a medical device 
CareLink Clinical App  
MMT-6113 Android; MMT-6114 
IOS 
Not a medical device 
Blue Adapter 
ACC-1003911 
Not a medical device 
Consumables and accessories 
See Appendix 18.7 
CE-marked 
*For detailed information on the characteristics’ materials, see device instructions for use (IFU). 
** Devices may be distributed in kits.  
***For additional country model numbers, refer to Appendix 18.7 
Table 3. Estimated Numbers of Devices Per Subject During The Study 
Item 
Units per Subject  
Entire Study 
MiniMed 780G Insulin Pump 
1 

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Item 
Units per Subject  
Entire Study 
MiniMed 780G BLE 2.0 Insulin Pump) (Continuation Phase, Arm 
A2 only) 
1 
Guardian 4 Sensor (Boxes of 5) 
10 (Arm A2) 
or 14 (Arm B2) 
DS5 Sensor (Boxes of 5) (Continuation Phase, Arm A2 only) 
4 
Guardian 4 Transmitter Kit (includes serter, charger, and tester) 
 1 
Extended infusion set (Boxes of 10) 
 6 
Extended Reservoir (Boxes of 10) 
 14 
Roche Accu-Chek Guide Link Study Meter 
1 
Roche Accu-Chek strips (Boxes of 50) 
17 
Blue Adapter 
1 
 
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) 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 SG value. The 
MiniMed 780G Pump receives the SG values and sensor integrity (SI) check from the Guardian 4 
Transmitter, which is connected to the Guardian 4 Sensor. The 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 also receives BG 
values from the Roche’s Accu-Chek Guide Link BG meter for calibration. 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.  
 
The data are sent from the pump to a compatible consumer electronic device with the MiniMed Clinical 
app, to provide a secondary display for passive monitoring of CGM and pump data for the user. 
 
The pump also transmits data to CareLink Personal/CareLink system software through the Blue Adapter 
or MiniMed Clinical app. 
 
The MiniMed 780G Pump System interacts as follows: 
• 
MiniMed 780G insulin pump and components (including Guardian 4 CGM) presented in Figure 
4 
• 
MiniMed 780G BLE 2.0 insulin pump with and components (including the DS5 sensor) presented 
in Figure 5 
 

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Figure 4. MiniMed 780G System and Components 
 

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Figure 5. MiniMed 780G BLE 2.0 System with DS5 Sensor and Components (Continuation Phase Arm 
A2 only) 
 
 
6.2.1 MiniMed 780G Insulin Pump / MiniMed 780G BLE 2.0 Insulin Pump 
The MiniMed 780G Insulin Pump houses electronics, a pumping mechanism, a user interface, and a 
medication reservoir within the same physical device. The pump communicates via Bluetooth® Low 
Energy wireless communication protocol with the compatible devices in the MiniMed 780G System. 
 
The MiniMed™ 780G Insulin Pump is intended for the continuous delivery of basal insulin at selectable 
rates, and the administration of insulin boluses at selectable amounts. When used with the CGM 
components (Guardian™ Sensor (4), Guardian™ Link (4) Transmitter, DS5 Sensor), 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 system includes SmartGuard 
technology, which can be programmed to provide an automatic adjustment of insulin delivery based 
SmartGuard technology adjusts insulin delivery based on sensor glucose (SG) readings. The MiniMed 
780G insulin pump operates in two modes: Manual mode and Auto Mode (SmartGuard). Manual Mode 
is active when the Auto Mode is inactive. 
 
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 below a predetermined threshold (Suspend before low 

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and Suspend on low). 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.  
 
When Auto Mode is enabled on the MiniMed™ 780G insulin pump, the sensor glucose values received 
from the Guardian™ Link (4) 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. In SmartGuard the system can automatically adjust basal insulin by continuously 
increasing, decreasing, or suspending delivery of insulin based on CGM values. Although SmartGuard 
feature can automatically adjust basal insulin delivery without input from the user, the user must still 
manually deliver insulin therapy during meals according to the user carbohydrate ratio. This ratio is 
determined by the Health Care Professional (HCP)/patient.  
 
The MiniMed 780G BLE 2.0 insulin pump modifications include DS5 sensor compatibility, communication 
enhancements to the mobile app, and other performance enhancements.  
Figure 6. MiniMed 780G Insulin Pump / MiniMed 780G BLE 2.0 Insulin Pump  
 
 
6.2.2 Guardian 4 Sensor 
The Guardian 4 sensor is a subcutaneous sensor that contains one microelectrode with a thin coating 
of glucose oxidase beneath several layers of biocompatible membrane. The Guardian 4 sensor will be 
used with the 780G system. The sensor is an iteration of previously approved glucose sensors with 
design changes for supporting improved accuracy. It is intended to penetrate the skin at a 90-degree 
angle. The sensor is tubeless. An introducer needle penetrates the skin surface and provides support 
for the sensor microelectrode during insertion. The sensor continuously converts small amounts of 
glucose from the subject’s interstitial fluid into an electronic signal that is received by a transmitter or 
recorder, the strength of which is proportional to the amount of glucose present in the blood. The 
electrode is composed of embedding, signal-conducting and insulating layers. 
6.2.3 Guardian 4 Transmitter  
The Guardian 4 Transmitter is a portable, electrical current meter intended to process, store, and 
transmit glucose sensor values to the compatible insulin pump. The transmitter sends SG values and 

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SI data from the sensor to compatible insulin pumps via a Bluetooth Low Energy wireless 
communication protocol. 
 
6.2.4 One-Press Serter  
The One-Press Serter (Figure 7) referred to as the Serter in this protocol, is an insertion device that is 
used to ensure correct placement of the Guardian 4 sensor into the user’s subcutaneous tissue. 
Insertion is triggered when the two spring loaded buttons on the sides of the Serter are pressed 
simultaneously. The Serter is intended as a single patient, non-sterile, multi-use device.  
Figure 7. One-Press Serter 
 
6.2.5 Charger  
The Charger (Figure 8) is used to recharge the Guardian 4 transmitter as needed. A fully charged 
battery provides up to 7 days of transmitter use. The system includes a battery charger that will 
recharge the device according to the user guide.  
Figure 8. Charger 
 
6.2.6 Tester  
The Tester operates as a Guardian 4 sensor simulator creating signal current at a level that is within 
the range of an in-vivo sensor during normal operation. 
6.2.7 DS5 Sensor 
The Disposable Sensor 5 Sensor (DS5) (Figure 9) is a disposable integrated sensor-transmitter 
platform which does not require calibration and is non-adjunctive. The sensor is packaged into a single-
use insertion device, called the inserter, resulting in an all-in-one device out of the box. The inserter is 
designed to simplify the insertion process. The sensor flex is inserted subcutaneously with an introducer 
needle, which is retracted by the inserter upon removal.  

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6.2.8 Roche Accu-Chek Guide Glucose Meter 
The Roche's Accu-Chek Guide Link meter, referred to as the Study Meter throughout protocol, is a 
home BG meter designed to measure subject’s capillary blood glucose level using the Accu-Chek® 
Guide Link by Roche and transmit BG values to the compatible insulin pumps via a Bluetooth Low 
Energy wireless communication protocol. The transmission of BG values from a compatible meter is an 
optional feature provided as a convenience to the user; it eliminates the need to manually enter BG 
values into the pump.   
6.2.9 CareLink Personal Software  
Medtronic CareLink Personal software is an internet-based software system which allows the device 
data to be uploaded and reviewed by the subject. The CareLink Personal software allows subject’s 
parent/legal guardian to upload data from Medtronic MiniMed insulin pumps and a range of system-
supported, third-party BG meters. The data is only accessible to the subject, caregivers, and 
investigational center staff. The data contained in CareLink Personal software is accessible to users 
using a standard browser, e.g. Google Chrome, on an Internet enabled personal computer (PC).  
 
The CareLink Personal software use standard Transport Layer Security (TLS) technology. TLS 
transmission protocol invokes encryption on both ends of the transmissions and is the standard for all 
security-based systems. The encryption remains in effect whether the data is moving to and from the 
client and server in the United States, or to and from a client in another country to the United States. 
The data is secure behind a three-tier industry standard architecture, which places the database behind 
three different firewalls, where each firewall separates a tier: 
• 
The internet to the web server; 
• 
Web server to the application server; 
• 
Application server to the database server. 
6.2.10 CareLink System Software  
Medtronic CareLink system software is an internet-based software system used by investigators which 
allows the device data to be uploaded, viewed and easily evaluated by the physician. The CareLink 
system software allows retrospective review of device data and was developed for use by the 
investigational center staff. The CareLink system software allows the investigational center staff to 
manage, create, and request for approval to link the subject’s account. The data contained in CareLink 
Figure 9. DS5 Sensor 

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system software is accessible to users using a standard browser, e.g.  Google Chrome, on an Internet 
enabled PC.  
 
The CareLink system software use standard TLS technology. TLS transmission protocol invokes 
encryption on both ends of the transmissions and is the standard for all security-based systems. The 
encryption remains in effect whether the data is moving to and from the client and server in the United 
States, or to and from a client in another country to the United States. The data is secure behind a 
three-tier industry standard architecture, which places the database behind three different firewalls, 
where each firewall separates a tier: 
• 
The internet to the web server; 
• 
Web server to the application server; 
• 
Application server to the database server. 
 
6.2.11 Roche Accu-Chek Guide Glucose Meter  
The Roche's Accu-Chek Guide Link meter, referred to as the Study Meter throughout protocol, is a 
home BG meter designed to measure subject’s capillary blood glucose level using the Accu-Chek® 
Guide Link by Roche and transmit BG values to the compatible insulin pumps via a Bluetooth Low 
Energy wireless communication protocol. The transmission of BG values from a compatible meter is an 
optional feature provided as a convenience to the user; it eliminates the need to manually enter BG 
values into the pump.   
6.2.12 Accessory Applications – MiniMed 780G system 
6.2.12.1 MiniMed Clinical app 
The MiniMed Clinical app is an accessory, which receives pump data via Bluetooth Low Energy wireless 
communication from the pump. The app provides a secondary display of data from the insulin pump 
on a compatible mobile device and provides users with the convenience to wirelessly transfer pump 
data to CareLink Personal/CareLink system software. The MiniMed Clinical app is not designed to control 
or monitor the performance of the insulin pump nor for direct monitoring of pump data. As a mirroring 
display, the app can provide alarms, alerts, messages and reminders from the insulin pump to the 
subject via the user interface. All alerts must be addressed on the insulin pump.  
 
The app is available for Android™* (MMT-6103) and for iOS™* (MMT-6104) operating systems.  
6.2.12.2 CareLink Clinical app 
The CareLink Clinical app is an optional accessory which receives pump data wirelessly from the 
CareLink server. The CareLink Clinical app provides a mirroring display of the MiniMed Clinical app 
screen, for remote monitoring by a care partner (e.g., caregiver). The CareLink Clinical app is not 
designed to monitor the performance of the insulin pump nor for direct monitoring of pump data. As a 
mirroring display, the app can provide notifications to the care partner via the user interface.  
 
The app is available for Android™* (MMT-6113) and for iOS™* (MMT-6114) operating systems.  
6.2.13 Blue Adapter  
The Blue Adapter is an optional accessory with Bluetooth technology that facilitates the communication 
between a PC and the insulin pump, via a Bluetooth Low Energy wireless communication protocol. The 

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Blue Adapter is an off-the-shelf non-medical device intended to transfer data to CareLink server. The 
Blue Adapter does not have any computation, diagnostic, monitoring or therapeutic function/benefit. 
Medtronic will provide the Blue Adapter as a convenience to subject’s parent/legal guardian as an 
alternative for subjects when automatic uploads via the MiniMed Clinical are not possible. 
6.2.14 Smartphone 
Sponsor may provide a smartphone, if applicable. 
6.3 Insulin  
Subjects will use their own rapid-acting analogue insulin (Novolog/NovoRapid or Humalog) during the 
study.  
6.4 Consumable Devices and Accessories 
Commercially available and compatible infusion sets, reservoirs, serter devices, glucose meter 
accessories and other consumables and accessories will be provided to subjects for use in the study. 
See Appendix 18.7. 
6.5 Packaging 
The labelling of the investigational devices and commercially available devices will be provided in 
accordance with local language requirements. 
 
The outer packaging of the investigational devices will be labelled “Exclusively for clinical investigations” 
and as required by national regulations, in local language(s) of the participating countries. 
6.6 Product Training Materials 
The MiniMed 780G system is a commercially available device on which sites have already experience 
on. Complementary device training for the Investigational center staff will be organized prior to a clinical 
site’s first subject enrollment. Training of the investigation center’s staff will be provided by Medtronic 
educators and/or clinical team.  
 
For specific study training requirements needed for activation please refer to Section 15.1. 
6.7 Anticipated Product Changes 
There are no changes anticipated for any of the products/device during the course of the study. 
6.8 Product Accountability 
Good clinical research practice requires that investigators and research teams ensure accurate 
accountability for any investigational devices used in a research trial. It is expected that all 
investigational devices will be used in the manner intended during the study and that they will be used 
only by (on) subjects who have had their parent/legal guardian consent to the subject’s participation 
in the research study and by investigational center staff trained on the study. 
 
Any investigational device being used in clinical research must be strictly accounted for and will not be 
shipped to any investigational center unless all of the necessary approvals (e.g., regulatory authority 
and EC) have been received.  

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The principal investigator (PI) or an authorized designee shall keep records documenting the receipt, 
use, return, and disposal of the investigational devices. Additional details regarding device 
accountability and device disposition requirements are provided in and Table 4. 
Table 4. Device Accountability Requirements 
Device 
Site Receipt: 
Device 
Acknowledgement 
of Receipt (AoR) at 
Investigational 
Site level (Site to 
sign packing slip) 
Record 
Disbursement to 
Subject on 
Subject Device 
Disposition 
eCRF 
Record Subject 
Return Device to 
Investigational 
Center (Subject 
Device 
Disposition 
eCRF) 
Investigationa
l Center 
Return Device 
to Sponsor at 
Conclusion of 
Study 
MiniMed 780G Insulin 
Pump  
(MMT1895 and MMT-
1896) 
Yes 
Yes 
Yes 
Yes 
MiniMed 780G BLE 
2.0 Insulin Pump  
(MMT-1895 and 
MMT-1896) 
Yes 
Yes 
Yes 
Yes 
Guardian 4 Sensor 
(MMT-7040) 
Yes 
No3 
No 
No2 
DS5 Sensor (MMT-
5100) 
Yes 
Yes 
Only Unused 
Only Unused 
Guardian 4 
Transmitter1 
(MMT-7840) 
Yes 
Yes 
Yes 
Yes 
Roche Accu-Chek 
Guide Link Study 
Meter  
Yes 
Yes 
Yes 
No2 
Mobile Phone, if 
applicable  
Yes4 
Yes 
Yes 
Yes 
1Devices may be combined and distributed in kits.  
2If subject/investigational center is unable to dispose, return unused products to sponsor for disposal. 
3Only serialized devices will be tracked on Subject Device Identification eCRF. Consumables will be tracked only at site level. 
4Acknowledgement of Receipt (site to sign packing slip) for Mobile Phone if applicable. 
 
The investigational center will promptly notify the sponsor of any device handling violation that might 
impact either the safety and/ or welfare of subjects or data integrity.  
 
6.8.1 Receipt and Inventory of Study Devices by Investigational Center 
• 
Upon receipt of the study devices, investigational center staff will take inventory of the shipment, 
making sure that information on the packing slips/invoices matches exactly the contents of the 
containers, as applicable, including:  
o 
Ship to address 
o 
Reference number 
o 
Device type 
o 
Quantity  

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o 
Quantity per package  
o 
Lot number (where applicable) 
o 
Serial number (where applicable) 
• 
Ensure that devices and supplies received have not reached or exceeded their expiration date  
• 
Sign and date the packing slips/invoices, noting any discrepancies, send a copy to the Medtronic 
Study Team as an Acknowledgment of Receipt and file in appropriate study binder 
• 
Notify the Medtronic Study Team of any discrepancies 
6.8.2 Storage of Study Devices at Investigational Center 
Study devices are to be stored in a secure environment with access limited to authorized research 
personnel. Study devices are stored in the appropriate environmental conditions as identified in the 
IFU/user guide/labeling. 
6.8.3 Dispensing of Study Devices 
Each time a serialized study device is dispensed to a subject by the investigator or authorized member 
of the research team, eCRF, and/or source documentation will be completed as required. 
Documentation may include:  
• 
Device type 
• 
Dispensing date 
• 
Subject identification (ID) 
• 
Serial number (where applicable) 
6.8.4 Return or Disposal of Study Devices 
After use by the subject, the investigational center is expected to accept and retain all devices as 
described in Table 4. and store them in a secure environment. If containers/units/devices are missing, 
the reasons should be documented. If discrepancies between the amounts used by subjects and the 
amounts expected to be returned exist, the reasons should be documented.  
 
Requirements for return of devices by subjects to the investigational center and return of device by the 
investigational center to the sponsor are listed in Table 4. The devices that are being returned to the 
investigational center may be returned to the sponsor as subjects complete the study, at the study 
closure or upon sponsor request.  
 
Other consumable devices (e.g., alcohol wipes, study meter supplies, and tape), and accessories 
shipped in kits, supplies or materials may be returned to the sponsor, they may be retained by 
investigational centers for educational purposes only, or they may be disposed of appropriately by the 
investigational center staff.  
 
Disposable and consumable devices that have been used by a subject will be disposed of appropriately 
by the subject or the investigational center staff during the conduct of the study.  
 
All used and unused devices cannot be retained by the subject. 
 
All study devices that are required to be entered into the study database and/or source document 
must be accounted for as described above before they are returned to the sponsor.  

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7 Study Site Requirements 
7.1 Investigator/Investigation Site Selection 
In order to conduct the study, it is required that the investigator and investigational center staff have 
the appropriate medical training. 
 
The following requirements will be evaluated for each investigator/site considered for participation in 
the clinical study: 
 
Investigator/site is qualified by training, education, and relevant experience appropriate to 
the use of the product and associated procedures (Paediatric Endocrinology or Diabetology 
expertise with very young children) 
 
Investigator/site has Medtronic MiniMed 640G or 670G System experience, including 
CareLink usage 
 
Investigator/site expects to have adequate time and resources to conduct the study 
throughout the duration, including Internet access 
 
Investigator/site has access to an adequate number of eligible subjects 
 
Investigator/site has past experience in conducting clinical studies 
 
Investigator/site has interest in participating in pre-market interventional studies with 
devices 
 
Investigator/site has the ability to comply with applicable IRB/EC and regulatory 
requirements 
 
Investigator is not debarred, disqualified, or working under sanctions in applicable regions 
7.2 Study Site Activation 
During the activation process (prior to subject enrollment), Medtronic will train investigational center 
staff on devices and study requirements.  
 
If new members join the study investigational center team, they will receive training on the applicable 
study requirements relevant to their role before contributing to the study. 
 
Prior to performing study related activities, all regulatory requirements shall be fulfilled, including but 
not limited to the following:  
 
EC approval (and voting list, as required by local law) of the current version of the CIP 
Informed Consent Form (ICF), and report of prior investigations/IB 
 
Regulatory authority approval or notification (as required per local law) 
 
Fully executed Clinical Trial Agreement (CTA)  
 
Financial disclosure (if applicable)  
 
Curriculum vitae (CV) of investigators 
 
Documentation of delegated tasks 
 
Documentation of study training  
 

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In addition, all participating investigational center staff must be trained on the current version of the 
CIP as well as on the applicable study requirements depending on their role and must be delegated by 
the PI prior to performing delegated study activities.  
 
Medtronic will provide each study investigational center with documentation of study investigational 
center/investigator subject enrollment readiness; this letter must be received prior to subject 
enrollment. 
8 Selection of Subjects 
8.1 Study Population 
Approximately 100 paediatric (aged 2-6 years of age) subjects with type 1 diabetes will be enrolled at 
up to 18 investigational centers across Europe in order to have approximately 72 subjects completing 
the study phase and 64 subjects completing the continuation phase. 
 
Each participating investigational site should attempt to enroll approximately a minimum of 5 and a 
maximum of 20 subjects who meet all study eligibility criteria. 
 
During the continuation phase period 1, the sample size will be re-estimated based on an interim 
analysis which will evaluate HbA1c Standard Deviation. Based on the interim analysis result, enrollment 
for the Continuation phase only will be opened. 
8.2 Subject Enrollment 
Subjects will be considered enrolled in the study upon signing the Inform Consent Form (ICF). 
 
A subject will be assigned a unique study subject ID via the eCRF, which is a 9-digit code (342XXXXXX). 
The first three digits refer to the CIP number (342), the next three digits refer to the investigational 
center number, and the last 3 digits refer to the subject number assigned during Visit 1 (e.g., 
342002001 is subject 001 from investigational center 002). 
 
The investigator will maintain a log of all subjects enrolled in the clinical study, assigning a subject ID 
linked to their names, alternative subject identification and contact information.  
 
During the continuation phase period 1, the sample size will be re-estimated based on an interim 
analysis which will evaluate HbA1c Standard Deviation. Based on the interim analysis result, enrollment 
for the Continuation phase only will be opened.  
 
If enrollment needs to be opened for the Continuation phase, all active sites will be notified at the same 
time for the additional number of subjects to be enrolled. 
 
 

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8.3 Inclusion Criteria 
1. Aged 2 – 6 years at time of screening  
2. Has a clinical diagnosis of type 1 diabetes for ≥ 6 months prior to screening as determined 
via medical record or source documentation by an individual qualified to make a medical 
diagnosis 
3. Is on MDI therapy or CSII with or without CGM prior to screening  
4. Has a glycosylated hemoglobin (HbA1c) < 11% (97 mmol/mol) at time of screening visit as 
processed by a Local Lab 
5. Is using or willing to switch to one of the following commercialized available insulins: 
• 
Humalog (insulin lispro injection) 
• 
NovoLog/Novorapid (insulin aspart) 
6. Must have a minimum daily insulin requirement (Total Daily Dose) of ≥ 6 units  
7. Parent(s)/legal guardian(s) willing to upload data from the pump system, must have Internet 
access, a compatible computer or mobile phone that meets the requirements for uploading 
the study pump data at home. 
8. Is living with one or more parent(s)/legal guardian(s) knowledgeable about emergency 
procedures for severe hypoglycemia and able to contact emergency services and study staff. 
9. Investigator has confidence that the parent(s)/legal guardian(s) can successfully operate all 
study devices and is capable of adhering to the protocol 
10. Subject and parent(s)/legal guardian(s) willingness to participate in all training sessions as 
directed by study staff. 
11. Subject's parent/legal guardian must be willing and able to provide written informed consent. 
8.4 Exclusion Criteria 
1. Has Addison’s disease, growth hormone deficiency, hypopituitarism or definite gastroparesis, 
untreated coeliac disease, untreated thyroid disorder, or poorly controlled asthma, per 
investigator judgment.  
2. Is using any anti-diabetic medication other than insulin at the time of screening or plan of using 
during the study (e.g. pramlintide, DPP-4 inhibitor, GLP-1 agonists/mimetics, metformin, SGLT2 
inhibitors). 
3. Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of 
screening visit, or plans to take any oral, injectable, or IV glucocorticoids during the course of 
the study.  
4. Has had renal failure defined by creatinine clearance <30 ml/min, as assessed by local lab test 
≤6 months before screening or performed at screening at local lab, as defined by the creatinine-
based Cockcroft, CKD-EPI or MDRD equations. 
5. Has any unresolved adverse skin conditions in the area of sensor placement (e.g. psoriasis, 
dermatitis herpetiformis, rash, Staphylococcus infection). 
6. Is under Control IQ,  CamAPS FX, Omnipod 5 or other advanced hybrid closed loop therapy 
(e.g. DIY, MiniMed 780G in Auto Mode) in the previous 3 months before enrollment. Note: For 
the continuation phase only, subjects using MiniMed 780G can be enrolled. 
7. Is actively participating in an investigational study (drug or device) wherein he/she has received 
treatment from an investigational study drug or device in the last 2 weeks before enrollment 
into this study, as per investigator judgment. 
8. Has any other disease or condition that may preclude the patient from participating in the 
study, per investigator judgment. 

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9. History of >1 DKA event not related to illness or initial diagnosis in the last 3 months. 
10. Parent(s)/legal guardian(s) are part of research staff involved with the study. 
11. Parent(s)/legal guardian(s) are illiterate 
8.5 Randomization Criteria  
8.5.1 Study Phase 
If subjects meet the above criteria, as well as all the following criteria (assessed at the end of the run-
in phase), they may continue to participate in the study phase: 
 
 
Subject has a percentage of Guardian 4 sensor use ≥70% over 2 weeks (based on sensor 
usage from the download of CareLink report over 2 weeks prior randomization). 
 
Subject has shown acceptable tolerance to sensor wear, per investigator judgment. 
 
Subject has shown compliance with study procedures, per investigator judgment. 
 
Randomization will be performed at Visit 3 via the electronic CRF. 
8.5.2 Continuation Phase 
All subjects completing the study phase will participate to the continuation phase and will be randomized 
into two arms (A2 and B2) at the end of continuation phase period 1: 
 
Randomization will be performed at Visit 13 via the electronic CRF. 
 
For the newly enrolled subjects for the continuation phase only, subjects may continue to participate 
in the continuation phase period 2, if they meet the above inclusion/exclusion criteria, as well as all the 
following randomization criteria (assessed at the end of the continuation phase period 1): 
 
 
Subject has a percentage of Guardian 4 sensor use ≥70% over 2 weeks (based on sensor 
usage from the download of CareLink report over 2 weeks prior the second randomization). 
 
Subject has shown acceptable tolerance to sensor wear, per investigator judgment. 
 
Subject has shown compliance with study procedures, per investigator judgment. 
 
 
 

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9 Study Procedures 
9.1 Schedule of Events 
Subjects may participate in up to 15 planned study visits, as presented in Figure 10. A remote office 
visit (audio visual) may be performed for office visits in cases where an office visit is not possible.  
 
Figure 10. Visit Schedule 
 
 
 
 
 
Prior to study start, Investigator or authorized designee must obtain written informed consent from the 
parents/legal guardian before any clinical study related activity (including screening) takes place and 
document informed consent process in the medical chart of the subject (Visit 1).  
 
Subject enrolled will start the Run-in phase. During Run-in phase MiniMed 780G -system training 
program will be provided, including e.g. infusion set insertions/replacements, meal bolus procedure, 
what to do with significant illness, how to react on safety/alert notifications, when to perform BG 
measurements and when to contact site staff with the contact information provided.  
 
During Run-in Phase subject will use 780G system in Manual Mode + SBL set at 65 mg/dL (3.6 mmol/L) 
(standard of care therapy- Visit 2). Study staff will conduct at the minimum a subject visit, 2 weeks 

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after Manual Mode + SBL has been started (Visit 3). Additional phone contacts or visits may be 
conducted (unscheduled visits), as needed. 
 
Eligible subjects must successfully complete the run-in phase by demonstrating tolerance to sensor 
wear and sensor usage ≥ 70% in the last 2 weeks before being randomized. If this is not achieved 
(e.g. sensor felt off) the run-in phase can be extended for another 7 to 14 days. 
 
Subject randomized in Sequence A will be trained on the use of MiniMed 780G system in Auto Mode 
(Visit 3A) and they will start to use the system with follow up visits at 2 weeks (Visit 4), 4 weeks (Visit 
5) 8 weeks (Visit 6) and 12 weeks (Visit 7) after Auto mode Start.  
 
At 12 weeks (Visit 7) subjects will stop Auto Mode and will start using the system in Manual Mode + 
SBL set at 65 mg/dL (3.6 mmol/L) for the washout period.  
 
Following the end washout period (Visit 8), follow up visits will be done respectively every 4 weeks 
(Visit 9, 10 and 11). Additional phone contacts or visits may be conducted (unscheduled visits), as 
needed. 
 
Subject randomized in Sequence B will continue to use the system in Manual Mode + SBL set at 65 
mg/dL (3.6 mmol/L) with follow up visits will follow respectively at 2 weeks (Visit 4), 4 weeks (Visit 5) 
8 weeks (Visit 6) and 12 weeks (Visit 7) after randomization. After the end of the washout period of 2-
week, subject will start to use system in Auto Mode (Visit 8) and follow up visit will follow respectively 
every 2 weeks (Visit 8A), 4 weeks (Visit 9) 8 weeks (Visit 10) and 12 weeks (Visit 11) after Auto mode 
Start. Additional phone contacts or visits may be conducted (unscheduled visits), as needed. 
 
All subjects who completed the Study Phase will enter the Continuation Phase and start using the 780G 
system in Auto Mode for 18 weeks +/- 6 weeks. After a second randomization subjects will be assigned 
to arm A2 (MiniMed 780G BLE 2.0 system and DS5 Sensor) or arm B2 and continue treatment for 
another 12 weeks. Follow-up visits will follow every 6 weeks respectively (Visit 12, 13, 14 ,15). 
Additional phone contacts or visits may be conducted (unscheduled visits), as needed. 
 
Subjects who will start with the Continuation Phase will start using the 780G system in Auto Mode after 
Run-In 2 is completed. 
 
Clinical Investigation Plan (CIP)-required procedures (Please refer to Table 5 details) for this study 
that deviate from normal clinical practice (outside standard of care) include the following: 
 
Baseline blood draws for HbA1c testing 
 
Questionnaires 
 
Schedule of Events for subjects enrolling for the entire study duration: 
 
• 
Visit 1 (Office): Consent & Screening  
o 
Obtain subject’s consent from parent/legal guardian 
o 
Determine if subject meets eligibility criteria  
o 
Collect demographic information (age, gender) 
o 
Review subject’s Medical history:  

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 
Date of Type 1 DM diagnosis 
 
Type of current Diabetes Treatment (MDI, CSII with or without CGM) 
 
Diabetes-related complications, if any 
 
Mean daily insulin dose 
 
Type of insulin used  
o 
Measure/Collect height and weight 
o 
Perform blood sample collection for creatinine clearance at local lab. If creatinine 
clearance test was performed ≤ 6 months prior to screening, only confirm date of 
collection at local lab and creatinine clearance value in medical chart. Note: Creatinine 
clearance threshold for exclusion< 30 mL/min and must be calculated with the Cockcroft, CKD-EPI or 
MDRD equations. The sites will follow routine practice for evaluation of the creatinine clearance. 
o 
Perform blood sample collection for HbA1c at the Local Lab. 
o 
Collect number of DKA in the last 3 months. 
 
 
Run-In Phase:  
 
• 
Visit 2* (Office/Remote): Start Manual Mode + SBL [Visit 1 + 0-3 days (Window + 
5 days)] 
Note: Visit 2 and Visit 1 can be combined to start Pump Therapy in Manual Mode + SBL. 
o 
Train subject and parent(s)/guardian(s) on the MiniMed 780G system 
o 
Train the subject and parent(s)/guardian(s) on the use of pump therapy in Manual 
Mode + SBL set at 65 mg/dL (3.6 mmol/L) 
o 
Set-up subject CareLink Account. 
o 
CareLink Training 
o 
Start pump therapy in Manual Mode + SBL  
o 
Collection of sensor site location  
o 
Collection of questionnaires 
o 
Review adverse events or device deficiencies, if any. 
 
• 
Visit 3 (Office/Remote): End of Run-in & Randomization [Visit 2 + 14 days 
(Window + 14 days)] 
o 
Ensure CareLink upload was done 
o 
Review Pump therapy/adjust settings (see Table 6) 
o 
Retrain subject on 780G system as needed 
o 
Collection of sensor site location   
o 
Review adverse events or device deficiencies, if any  
o 
Investigator will review randomization criteria 
 
If subject is eligible will be randomized to one of the two sequences: 
 
Sequence A: start pump therapy in Auto Mode (Treatment) 
 
Sequence B: continue pump therapy in Manual Mode + SBL set at 65 mg/dL (3.6 
mmol/L) (Control) 
 
If subject is not eligible:  
 
Subject will be withdrawn from the study. All devices and unused consumables will 
have to be returned to the site. 
 

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Study Phase: 
 
Sequence A Only: 
 
• 
Visit 3A** (Office/Remote): Auto Mode Start [Visit 3 +0- 3 days (Window + 2 
days max)] 
** Note: Visit 3A and Visit 3 can be combined to start pump therapy in Auto Mode  
o 
Train the subject and parent(s)/guardian(s) on the use of pump therapy in Auto 
Mode 
o 
Subject to start pump therapy in Auto Mode. 
o 
Collection of sensor site location  
o 
Ensure CareLink upload was done 
o 
Review pump therapy/adjust settings (see Table 6). 
o 
Retrain subject on 780G system as needed. 
o 
Review adverse events or device deficiencies, if any. 
 
Sequence A and B: 
• 
Visit 4 (Office/Remote): Follow up visit [Visit 3+14 days (Window ± 5 days)] 
o 
Ensure CareLink upload was done 
o 
Collection of sensor site location  
o 
Review Pump therapy/adjust settings (see Table 6). 
o 
Retrain subject on 780G system as needed. 
o 
Review adverse events or device deficiencies, if any. 
 
• 
Visit 5 (Office/Remote): Follow up visit [Visit 3+28 days (Window ± 5 days)] 
o 
Ensure CareLink upload was done  
o 
Collection of sensor site location  
o 
Review Pump therapy/adjust settings (see Table 6). 
o 
Retrain subject on 780G system as needed. 
o 
Review adverse events or device deficiencies, if any. 
 
• 
Visit 6 (Office/Remote): Follow up visit [Visit 3+56 days (Window ± 5 days)] 
o 
Ensure CareLink upload was done 
o 
Collection of sensor site location 
o 
Review Pump therapy/adjust settings (see Table 6). 
o 
Retrain subject on 780G system as needed. 
o 
Review adverse events or device deficiencies, if any. 
 
• 
Visit 7 (Office/Remote): End of Period 1 [Visit 3 + 84 days (Window ± 5 days)] 
o 
Perform blood sample collection for HbA1c at Local Lab. 
o 
Ensure CareLink upload was done 
o 
Collection of sensor site location  
o 
Review Pump therapy/adjust settings (see Table 6). 
o 
Retrain subject on 780G system as needed 
o 
Measure/Collect height and weight. 

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o 
Collection of questionnaires 
o 
Review adverse events or device deficiencies, if any. 
 
For subjects randomized in Sequence A: 
 
Stop Auto Mode and start using Pump therapy in Manual Mode with SBL set at 65 
mg/dL (3.6 mmol/L). 
 
Re-train the subject and parent(s)/guardian(s) on the use of pump therapy in 
Manual Mode as needed 
 
• 
Visit 8 (Office/Remote): Start of Period 2 [Visit 7 + 14 days (Window + 3 days 
max)] 
o 
Ensure CareLink upload was done 
o 
Collection of sensor site location  
o 
Review Pump therapy/adjust settings (see Table 6). 
o 
Retrain subject on 780G system therapy as needed. 
o 
Review adverse events or device deficiencies, if any. 
 
For subjects subject randomized in Sequence B: 
 
Train the subject and parent(s)/guardian(s) on the use of pump therapy in Auto 
Mode 
 
To start Pump therapy in Auto Mode.  
 
Sequence B Only: 
 
• 
Visit 8A (Office/Remote): Follow up visit [Visit 7 + 28 days (Window ± 5 days)]  
o 
Ensure CareLink upload was done 
o 
Collection of sensor site location  
o 
Review Pump therapy/adjust settings (see Table 6). 
o 
Retrain subject on 780G system as needed. 
o 
Review adverse events or device deficiencies, if any. 
 
Sequence A and B: 
 
• 
Visit 9 (Office/Remote): Follow up visit [Visit 7 + 42 days (Window ± 5 days)] 
o 
Ensure CareLink upload was done 
o 
Collection of sensor site location  
o 
Review Pump therapy/adjust settings (see Table 6). 
o 
Retrain subject on 780G system as needed 
o 
Review adverse events or device deficiencies, if any. 
 
• 
Visit 10 (Office/Remote): Follow up visit [Visit 7 + 70 days (Window ± 5 days)] 
o 
Ensure CareLink upload was done 
o 
Collection of sensor site location 
o 
Review Pump therapy/adjust settings (see Table 6). 
o 
Retrain subject on 780G system as needed 
o 
Review adverse events or device deficiencies, if any. 

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• 
Visit 11 (Office): End of Study Phase [Visit 7 + 98 days (Window ± 5 days)] 
o 
Perform blood sample collection for HbA1c at local lab. 
o 
Ensure CareLink upload was done 
o 
Collection of sensor site location  
o 
Review Pump therapy/adjust settings (see Table 6). 
o 
Retrain subject on 780G system as needed 
o 
Measure/Collect height and weight.  
o 
Collection of questionnaires 
o 
Review adverse events or device deficiencies, if any 
 
 
For subjects randomized in Sequence A: 
 
Start using Pump therapy in Auto Mode. 
 
Retrain the subject and parent(s)/guardian(s) on the use of pump therapy in 
Auto Mode if needed 
 
Continuation Phase: 
 
Schedule of Events for subjects enrolling for the Continuation phase only: 
 
• 
Visit 1A (Office): Consent & Screening (only applicable for subject entering the 
study for the continuation phase) 
o 
Obtain subject’s consent from parent/legal guardian 
o 
Determine if subject meets eligibility criteria  
o 
Collect demographic information (age, gender) 
o 
Review subject’s Medical history:  
 
Date of Type 1 DM diagnosis 
 
Type of current Diabetes Treatment (MDI, CSII with or without CGM) 
 
Diabetes-related complications, if any 
 
Mean daily insulin dose 
 
Type of insulin used  
o 
Measure/Collect height and weight 
o 
Perform blood sample collection for creatinine clearance at local lab. If creatinine 
clearance test was performed ≤ 6 months prior to screening, only confirm date of 
collection at local lab and creatinine clearance value in medical chart. Note: Creatinine 
clearance threshold for exclusion< 30 mL/min and must be calculated with the Cockcroft, CKD-EPI or 
MDRD equations. The sites will follow routine practice for evaluation of the creatinine clearance. 
o 
Perform blood sample collection for HbA1c at the Local Lab. 
o 
Collect number of DKA in the last 3 months. 
 
Run-In Phase 2:  
 
• 
Visit 2A* (Office/Remote): Start Manual Mode + SBL [Visit 1A + 0-3 days (Window 
+ 5 days)] 
Note: Visit 2A and Visit 1A can be combined to start Pump Therapy in Manual Mode + 
SBL. 

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o 
Train subject and parent(s)/guardian(s) on the MiniMed 780G system 
o 
Train the subject and parent(s)/guardian(s) on the use of pump therapy in Manual 
Mode + SBL set at 65 mg/dL (3.6 mmol/L) 
o 
Set-up subject CareLink Account. 
o 
CareLink Training 
o 
Start pump therapy in Manual Mode + SBL  
o 
Collection of sensor site location  
o 
Collection of questionnaires 
o 
Review adverse events or device deficiencies, if any. 
 
• 
Visit 3A (Office/Remote): Follow-up & Auto Mode start [Visit 2A + 7 days 
(Window +/- 5 days)] 
o 
Switch to Auto Mode 
o 
Ensure CareLink upload was done 
o 
Review Pump therapy/adjust settings (see Table 6) 
o 
Retrain subject on 780G system as needed 
o 
Collection of sensor site location   
o 
Review adverse events or device deficiencies, if any  
 
Schedule of Events for subjects enrolling for the entire study duration as well as for the 
Continuation phase only: 
 
• 
Period 1 
o 
Visit 12 (Office/Remote): Follow up visit [Visit 11/1A + 42 days (Window 
± 5 days)] 
 
Ensure CareLink upload was done 
 
Collection of sensor site location  
 
Review Pump therapy/adjust settings (see Table 6). 
 
Retrain subject on 780G system as needed 
 
Review adverse events or device deficiencies, if any 
 
o 
Visit 13 (Office): Follow up visit [Visit 11/1A + 126 days (Window ± 42 
days)] 
 
Ensure subject’s reconsent from legal/guardian on protocol C or subsequent 
version was obtained before Visit 13 procedures are performed (if applicable) 
 
Ensure CareLink upload was done 
 
Collection of sensor site location  
 
Review Pump therapy/adjust settings (see Table 6). 
 
Retrain subject on 780G system as needed 
 
Review adverse events or device deficiencies, if any 
 
Collection of questionnaires 
 
Perform blood sample collection for HbA1c (Central Lab) 
 
Randomize to one of the 2 arms: 
• 
Arm A2: Start pump therapy with MiniMed 780G BLE 2.0 system and 
DS5 Sensor in Auto Mode (treatment 2) 
• 
Arm B2: Continue pump therapy in Auto Mode (Treatment) 

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For subjects randomized in Arm A2: 
 
Train subject on MiniMed 780G BLE 2.0 system and DS5 sensor 
 
• 
Period 2 
• 
Visit 14 (Office/Remote): Follow up visit [Visit 13+ 42 days (Window ± 5 
days)] 
o 
Ensure CareLink upload was done 
o 
Collection of sensor site location  
o 
Review Pump therapy/adjust settings (see Table 6). 
o 
Retrain subject on MiniMed 780G system/MiniMed 780G BLE 2.0 system with DS5 
sensor as needed 
o 
Review adverse events or device deficiencies, if any. 
 
• 
Visit 15 (Office): End of Continuation Phase [Visit 13 + 84 days (Window ± 5 
days)] 
o 
Perform blood sample collection for HbA1c (Central Lab) 
o 
Ensure CareLink upload was done 
o Collection of sensor site location  
o 
Measure/Collect height and weight. 
o 
Return of devices 
 
o 
Collection of questionnaires 
o 
Review adverse events or device deficiencies, if any. 

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Table 5. Visit Details and Data Collection 
Visit 
1 
2 
3 
3A 
4 
5 
6 
7 
8 
8A 
9 
10 
11 
1A 
2A 
3A 
12 
13 
14 
15 
Visit Name 
Consent & 
Screening 
Start 
Manual 
Mode 
End of Run-in 
& 
Randomization 
Auto 
Mode 
Start 
Follow-
up 
Follow-
up 
Follow-
up 
End of 
Period 1 
Start of 
Period 2 
Auto 
Mode 
Start 
Follow-
up 
Follow-
up 
End of 
Study 
Phase 
Consent & 
Screening 
Start 
Manual 
Mode + 
SBL 
Follow up & 
Auto Mode 
start 
Start 
Continuation 
Phase - 
Period 1 
End of 
Continuation 
phase Period 1 
& randomization 
Start of 
Period 2 
End of 
continuation 
phase period 2 
- End of Study 
Visit Type 
Office 
O/R 
O/R 
O/R 
O/R 
O/R 
O/R 
Office 
O/R 
O/R 
O/R 
O/R 
Office 
Office 
O/R 
O/R 
O/R 
O 
O/R 
Office 
Target date 
- 
V1 + 
0-3d 
V2 + 
14d 
V3 + 
0-3d 
V3 + 
14d 
V3 + 
28d 
V3 + 
56d 
V3 + 
84d 
V7 + 
14d 
V7 + 
28d 
V7 + 
42d 
V7 + 
70d 
V7 + 
98d 
 
V1a + 
0-3d 
V2 + 
7d 
V11/1A 
+ 42d 
V11/1A 
+ 126d 
V13 + 
42d 
V13 +84d 
Window 
- 
+ 5d 
+ 14d 
+ 2d 
± 5d 
± 5d 
± 5d 
± 5d 
+3d 
± 5d 
± 5d 
± 5d 
± 5d 
 
+ 5d 
± 5d 
± 5d 
± 42d 
± 5d 
± 5d 
Informed 
consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
As 
needed 
 
 
 
 
 
 
Eligibility 
criteria 
X 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
X2 
 
 
 
Review of 
Randomization 
Criteria 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
Randomization 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
Height and 
weight 
X 
 
 
 
 
 
 
X 
 
 
 
 
X 
X 
 
 
 
 
 
X 
HbA1c (Local 
lab) 
X 
 
 
 
 
 
 
X 
 
 
 
 
X 
X 
 
 
 
 
 
X 
HbA1c (Central 
lab) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
X 
Creatinine test 
(Local lab) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
DKA in the last  
3 Months 
X 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 

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Visit 
1 
2 
3 
3A 
4 
5 
6 
7 
8 
8A 
9 
10 
11 
1A 
2A 
3A 
12 
13 
14 
15 
Visit Name 
Consent & 
Screening 
Start 
Manual 
Mode 
End of Run-in 
& 
Randomization 
Auto 
Mode 
Start 
Follow-
up 
Follow-
up 
Follow-
up 
End of 
Period 1 
Start of 
Period 2 
Auto 
Mode 
Start 
Follow-
up 
Follow-
up 
End of 
Study 
Phase 
Consent & 
Screening 
Start 
Manual 
Mode + 
SBL 
Follow up & 
Auto Mode 
start 
Start 
Continuation 
Phase - 
Period 1 
End of 
Continuation 
phase Period 1 
& randomization 
Start of 
Period 2 
End of 
continuation 
phase period 2 
- End of Study 
Visit Type 
Office 
O/R 
O/R 
O/R 
O/R 
O/R 
O/R 
Office 
O/R 
O/R 
O/R 
O/R 
Office 
Office 
O/R 
O/R 
O/R 
O 
O/R 
Office 
Target date 
- 
V1 + 
0-3d 
V2 + 
14d 
V3 + 
0-3d 
V3 + 
14d 
V3 + 
28d 
V3 + 
56d 
V3 + 
84d 
V7 + 
14d 
V7 + 
28d 
V7 + 
42d 
V7 + 
70d 
V7 + 
98d 
 
V1a + 
0-3d 
V2 + 
7d 
V11/1A 
+ 42d 
V11/1A 
+ 126d 
V13 + 
42d 
V13 +84d 
Window 
- 
+ 5d 
+ 14d 
+ 2d 
± 5d 
± 5d 
± 5d 
± 5d 
+3d 
± 5d 
± 5d 
± 5d 
± 5d 
 
+ 5d 
± 5d 
± 5d 
± 42d 
± 5d 
± 5d 
Questionnaires 
 
X 
 
 
 
 
 
X 
 
 
 
 
X 
 
X 
 
 
X 
 
X 
Training on 
780G system 
 
X 
As needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
 
X 
 
As needed 
As needed 
As 
needed 
 
Training on 780 
Therapy +SBL 
 
X 
 
 
 
 
 
Seq. A 
Only 
 
 
 
 
 
 
X 
 
 
 
 
 
Start Manual 
Mode + SBL 
 
X 
 
 
 
 
 
Seq. A 
Only 
 
 
 
 
 
 
X 
 
 
 
 
 
Training on 780 
Therapy + Auto 
Mode 
 
 
 
Seq. A 
Only 
 
 
 
 
Seq. B 
Only 
Seq. B 
Only, 
as 
needed 
 
 
Seq. A 
Only 
 
 
As needed 
As needed 
 
 
 
Training on 
MiniMed 780G 
BLE 2.0 and 
DS5 sensor 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Arm A2 only 
As 
needed 
 
Start Auto 
Mode 
 
 
 
Seq. A 
Only 
 
 
 
 
Seq. B 
Only 
 
 
 
Seq. A 
Only 
 
 
X 
 
 
 
 
CareLink 
subject account 
set up 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
CareLink 
training 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 

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 1Upload can be done by subject or by site staff 
 2For subjects entering the continuation phase only 
 3For subjects where visit 2 is managed remotely and eligibility criteria are met 
Visit 
1 
2 
3 
3A 
4 
5 
6 
7 
8 
8A 
9 
10 
11 
1A 
2A 
3A 
12 
13 
14 
15 
Visit Name 
Consent & 
Screening 
Start 
Manual 
Mode 
End of Run-in 
& 
Randomization 
Auto 
Mode 
Start 
Follow-
up 
Follow-
up 
Follow-
up 
End of 
Period 1 
Start of 
Period 2 
Auto 
Mode 
Start 
Follow-
up 
Follow-
up 
End of 
Study 
Phase 
Consent & 
Screening 
Start 
Manual 
Mode + 
SBL 
Follow up & 
Auto Mode 
start 
Start 
Continuation 
Phase - 
Period 1 
End of 
Continuation 
phase Period 1 
& randomization 
Start of 
Period 2 
End of 
continuation 
phase period 2 
- End of Study 
Visit Type 
Office 
O/R 
O/R 
O/R 
O/R 
O/R 
O/R 
Office 
O/R 
O/R 
O/R 
O/R 
Office 
Office 
O/R 
O/R 
O/R 
O 
O/R 
Office 
Target date 
- 
V1 + 
0-3d 
V2 + 
14d 
V3 + 
0-3d 
V3 + 
14d 
V3 + 
28d 
V3 + 
56d 
V3 + 
84d 
V7 + 
14d 
V7 + 
28d 
V7 + 
42d 
V7 + 
70d 
V7 + 
98d 
 
V1a + 
0-3d 
V2 + 
7d 
V11/1A 
+ 42d 
V11/1A 
+ 126d 
V13 + 
42d 
V13 +84d 
Window 
- 
+ 5d 
+ 14d 
+ 2d 
± 5d 
± 5d 
± 5d 
± 5d 
+3d 
± 5d 
± 5d 
± 5d 
± 5d 
 
+ 5d 
± 5d 
± 5d 
± 42d 
± 5d 
± 5d 
CareLink 
Upload 
 
 
X1 
X1 
X1 
X1 
X1 
X1 
X1 
X1 
X1 
X1 
X1 
 
 
X1 
X1 
X1 
X1 
X1 
Sensor site 
location 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
Review Pump 
therapy / 
Adjust settings 
 
 
As needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
 
 
As needed 
As needed 
As needed 
As 
needed 
 
AEs and DDs  
Reported upon awareness 
Study 
Deviations 
Reported upon awareness 
Device 
Accountability 
X3 
X 
As needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
 
X 
As needed 
As needed 
As needed 
As 
needed 
X 
Distribution 
supplies 
X3 
X 
As needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
As 
needed 
 
X 
 
As needed 
As needed 
As 
needed 
 
Return supplies 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 

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9.1.1 Pump Settings and Sensor Site  
Preferred Guardian 4/DS5 sensor site insertion for studied population should be arm or buttocks unless there is a justification, and the rationale will be collected in 
eCRF.  
 
During the study phase the following pump settings are recommended for subjects using the MiniMed 780G system in Auto Mode. All pump settings will be adjusted 
based on subject’s needs, per investigator judgment. 
      Table 6. Pump Settings for subjects starting within study phase 
Initial Setting (VISIT 
3A/8*) 
Week 2  (VISIT 4/8A*) 
Week 4 (VISIT 5/9*) 
From Week 8 (VISIT 6/10*) to EOS 
Target 
Setting  
AIT 
Setting  
Option 
Target 
Setting  
AIT 
Setting  
Option 
Target 
Setting  
AIT 
Setting  
Option 
Target 
Setting  
AIT 
Setting  
120 mg/dL 
(6.7 mmol/L)  2 hours 
Option 1: 
TIR > 70% 
No Hypo 
Concerns 
120 mg/dL 
(6.7 mmol/L) 
2 hours 
Option 1: 
TIR > 70% & 
No Hypo Concerns 
120 mg/dL 
(6.7 mmol/L) 
2 hours 
To continue with the same settings 
Option 2: 
TIR < 70% & 
No Hypo Concerns 
110 mg/dL 
(6.1 mmol/L) 
2 hours 
To continue with the same settings 
Option 3: 
Hypo Concern  
120 mg/dL 
(6.7 mmol/L) 
3 hours 
Option 1:  
No Hypo Concerns: 
120 mg/dL 
(6.7 mmol/L) 
2 hours 
Option 2:  
Hypo Concerns: 
To continue with the 
same settings 
Option 2: 
TIR < 70% 
No Hypo 
Concerns 
110 mg/dL 
(6.1 mmol/L) 
2 hours 
Option 1: 
TIR > 70% & 
No Hypo Concerns 
110 mg/dL 
(6.1 mmol/L) 
2 hours 
To continue with the same settings 
Option 2: 
TIR < 70% & 
No Hypo Concerns 
100 mg/dL 
(5.5 mmol/L) 
2 hours 
To continue with the same settings 

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Initial Setting (VISIT 
3A/8*) 
Week 2  (VISIT 4/8A*) 
Week 4 (VISIT 5/9*) 
From Week 8 (VISIT 6/10*) to EOS 
Target 
Setting  
AIT 
Setting  
Option 
Target 
Setting  
AIT 
Setting  
Option 
Target 
Setting  
AIT 
Setting  
Option 
Target 
Setting  
AIT 
Setting  
Option 3: 
Hypo Concern  
120 mg/dL 
(6.7 mmol/L) 
2 hours 
To continue with the same settings 
Option 3: 
Hypo Concern  
120 mg/dL 
(6.7 mmol/L) 
3 hours 
 
Option 1: 
TIR > 70% & 
No Hypo Concerns 
120 mg/dL 
(6.7 mmol/L) 
3 hours 
To continue with the same settings 
Option 1:  
No Hypo Concerns: 
120 mg/dL 
(6.7 mmol/L) 
2 hours 
 
Option 2: 
TIR < 70% & 
No Hypo Concerns 
120 mg/dL 
(6.7 mmol/L) 
2 hours 
Option 1 :  
Hypo Concerns: 
To continue with the 
same settings 
 
Option 3: 
Hypo Concern  
120 mg/dL 
(6.7 mmol/L) 
4 hours 
Option 1:  
No Hypo Concerns: 
120 mg/dL 
(6.7 mmol/L) 
2 hours 
Option 2:  
Hypo Concerns: 
To continue with the 
same settings 
* Visits 8; 9 and 10 are for Subjects randomized in Sequence B Period 2. 
 
For subjects starting in the continuation phase, it is recommended to start using the MiniMed 780G / MiniMed 780G BLE 2.0 system in Auto Mode with a glycemic 
target of 120 mg/dL (6.7 mmol/L) and 2 hours Active Insulin Time and adjust similarly to the above recommendations. All pump settings will be adjusted based on 
subject’s needs, per investigator judgment. 
 
 
 
 
 
 
 
 
 
 

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9.1.2 Unscheduled Visit  
In case an additional visit is performed for study purposes or in case of an early termination visit outside 
of a normal protocol visit, an unscheduled visit can be used to report data. This visit can be conducted 
onsite or remotely. 
 
Unscheduled visit procedures could include, but are not limited to: 
 
MiniMed 780G system training 
 
DS5 Sensor training 
 
CareLink upload/training 
 
Review adverse events or device deficiencies, if any. 
9.1.3 Early Termination Visit 
Whenever possible, the study staff will perform an Early Termination visit when a subject decides to 
withdraw from the study early or if the subject is withdrawn early upon decision of investigator or sponsor 
(during a normal study visit or an unscheduled visit). This visit can be conducted onsite or remotely.  
 
The subjects will continue to be treated following the routine practice of each center. 
 
Early Termination procedures: 
 
Collect blood sample for HbA1c (Study Phase: Local Lab, Continuation: Central Lab), if possible. 
 
Collect questionnaires, if possible. 
 
Review adverse events or device deficiencies, if any. 
 
Collect all study supplies back from subjects. 
 
CareLink upload  
9.1.4 Study Exit 
After the study has been completed (at Visit 15 or in case of early termination), the subjects will be exited 
from the study. The subjects will continue to be treated following the routine practice of each center 
Samples collected during the study for study assessments (i.e. blood collected for HbA1c testing) will be 
destroyed according to the internal procedure of each Local Lab.  
9.2 Data Collection 
All data collection and study procedure requirements are described at the subject visits in Section 9. 
9.3 Subject Consent 
Informed Consent will be obtained in accordance with ISO14155:2020.  
 
Prior to entry into the study, the EC (Ethics Committee) and Medtronic approved ICF form will be presented 
to each subject’s parent(s)/legal guardian(s) to review and sign, as applicable. The subject’s parent(s)/legal 

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guardian(s) will be given ample time and offered the opportunity to review these documents away from 
the investigational center. 
 
The investigator or authorized designee must obtain written informed consent from the parent/legal 
guardian before any clinical study related activity takes place. 
 
The following will be provided to or explained to the subject’s parent(s)/legal guardian(s) and by the 
investigator or designee: the purpose and duration of the study, the requirements expected to be adhered 
to by the subject during the study and the potential risks/potential benefits associated with participation in 
the study. Every attempt will be made to answer the subject’s and their parent’s, or legal guardian’s 
questions during the informed consent process. The language used shall be as non-technical as possible 
and must be understandable to the subject’s parent(s)/legal guardian(s). 
 
Neither the investigator, nor the investigation center staff shall coerce or unduly influence a subject or their 
parent or legal guardian to participate or to continue to participate in the clinical study. The informed 
consent process shall not waive or appear to waive the subject’s rights.  
 
Subject’s parent(s)/legal guardian(s) will complete the IC form.  
 
The consenting process must be documented in the subject’s source documents. The subject’s 
parent(s)/legal guardian(s) will receive copies of the fully executed documents. A subject’s participation in 
study procedures cannot begin before the consent process has been properly executed. When the 
parent(s)/legal guardian(s) decide to allow subject to participate in the study, the ICF must be signed and 
personally dated by the subject’s parent(s)/legal guardian(s) and investigator or authorized designee, as 
required by the ICF. A patient contact card will be provided to the subject’s parent(s)/legal guardian(s).  
 
Medtronic will inform the investigators whenever information becomes available that may be relevant to 
the subject’s confirmed participation in the clinical study. The investigator or his/her authorized designee 
should inform the subject’s parent(s) or legal guardian(s) in a timely manner.  
 
Medtronic will revise the written ICF 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 subject’s parent(s)/legal guardian(s), and the 
informed consent process as described above needs to be repeated. 
 
Subjects and their parent or legal guardian will be informed that qualified personnel from the investigational 
center, the sponsor (Medtronic), regulatory authorities and/or the EC, may have access to the clinic records 
that reveal their identity and health care information. 
 
The investigational center must report the following informed consent violations to their EC (if applicable) 
and sponsor: 
 
Failure to obtain informed consent from subject’s parent(s) or legal guardian(s) 
 
Failure to obtain informed consent prior to performing one or more study procedures. 

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 
Failure to maintain ICFs forms on file for all subject’s parent(s) or legal guardian(s) who have 
provided informed consent. 
 
Use of an ICF form that has not received approval from the EC. 
 
Use of an incorrect version of the ICF form. 
9.3.1 Reconsent for the updated Continuation phase 
When applicable, the subject/subject’s parent(s) or legal guardian(s) will be reconsented with an amended 
ICF based on this protocol update, to continue participating into the amended continuation phase. In case 
the reconsent occurs during the Study Phase and the subject/subject’s parent(s) or legal guardian(s)does 
not agree with this change, the initial signed ICF will remain applicable until the end of the study phase. 
 
9.4 Randomization and Treatment Assignment 
Both randomizations will be performed via the electronic CRF. 
 
The randomizations will follow a block randomization with blocks of different sizes and the order of the 
block sizes will be selected randomly and the 1:1 allocation will be performed within each block. 
Investigators will be blinded to the number and size of the blocks. 
 
Block randomizations were chosen to preserve a 1:1 randomization ratio as much as possible, while 
minimizing the likelihood of predicting treatment allocation to the next participant. 
 
For first randomization, confounding is addressed by the random allocation and the cross-over nature of 
the design that allows within subject comparison, for second randomization confounding is addressed by 
the random allocation, with the aim that any confounding variable should be equally distributed in the study 
groups to give balanced comparisons. 
 
9.4.1 Study Phase 
 
At the end of the run-in phase (Visit 3) eligible subjects will be randomized in a 1:1 ratio to one of the 
following sequences composed of two periods of 12 weeks each:  
 
Sequence A:  
 
Period 1: MiniMed 780G system in Auto Mode (Treatment) 
 
Period 2: MiniMed 780G system in Manual Mode with SBL activated (Control) 
 
Sequence B:  
 
Period 1: MiniMed 780G system in Manual Mode with SBL activated (Control)  
 
Period 2: MiniMed 780G system in Auto Mode (Treatment) 
 
 

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9.4.2 Continuation Phase 
 
At the end of the continuation phase period 1 (Visit 13) all subjects completing the study phase or newly 
eligible subjects will be randomized in a 1:1 ratio to one of the following arms and followed up for a period 
of 12 weeks: 
 
• 
Arm A2: subjects will start using the MiniMed 780G BLE 2.0 system with the DS5 sensor in Auto 
Mode for 12 weeks 
• 
Arm B2: subjects will continue to use MiniMed 780G system with Guardian 4 Sensor in Auto Mode 
for 12 weeks 
9.5 Glucose and Glycemia Measurements 
During the course of the study, the subjects’ BG levels, SG levels, and HbA1c will be collected using the 
methods outlined in this section. 
9.5.1 Daily Blood Glucose 
Values will be assessed during the study by all subjects using the Accu-Chek Guide Link study meter, as 
needed. The control solution test will be performed following the manufacturer’s user guide. Subjects will 
be trained on the use of the Accu-Chek Guide Link study meter per the manufacturer’s instructions.  
9.5.2 Sensor Glucose Values 
SG data will be collected by subject’s study pump and, if needed, calibrated by each subject’s Accu-Chek 
Guide Link study meter.  
9.5.3 HbA1c 
HbA1c is collected at Visit 1, Visit 7, Visit 11, Visit 13 and Visit 15; if subjects have completed run-in phase 
and are in the study phase and exit early, a HbA1c will be collected as described in Early Termination Visit. 
HbA1c will be collected at the Local Lab for Visit 1, Visit 7, Visit 11. HbA1c will be collected at the Central 
Lab for Visit 13 and 15.   
 
All HbA1c blood specimens from the Continuation phase will be sent to and tested by a National 
Glycohemoglobin Standardization Program (NGSP) certified Central Laboratory. The blood sample will be 
destroyed according to the Central laboratory procedure after analysis. 
 
9.6 Recording Data 
Data entered by the investigational center staff will be captured on eCRFs using the Electronic Data Capture 
(EDC) system. Original eCRFs will not be considered as source data and supporting documentation will be 
required.  
 
Electronic device data will be collected from the study pump using CareLink Personal/CareLink system 
software. The system uses TLS technology, which encrypts all data it stores (21 CFR Part 11 compliant). 
Certain data points stored in the downloaded information may also be captured on the appropriate eCRF. 
Electronic device data could also be collected by the MiniMed Clinical app and the CareLink Clinical app. 

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The investigator will ensure that all eCRFs are completed promptly, completely, and accurately. Medtronic 
will provide detailed instructions to assist with eCRF completion. In the event of data discrepancies, 
investigational centers will be asked to resolve queries electronically in the EDC system; otherwise, 
irresolvable data-related issues will be routed to the sponsor for review and final disposition. An audit trail 
is maintained in the EDC system to capture any corrections or changes of the eCRFs. System backups for 
data stored in the EDC system will be consistent with Medtronic SOPs. 
 
Medtronic will only consider eCRFs to be complete when all discrepancies between source data and eCRF 
have been resolved. eCRF content will be reviewed by a study monitor, as described in the Monitoring Plan. 
In addition, specific eCRFs must also be reviewed and electronically signed by the investigator, indicating 
his/her agreement with the accuracy of all recorded data. It is expected that the investigator and his/her 
staff will cooperate with the monitoring team and provide any missing data in a timely manner. 
9.7 Deviation Handling 
A deviation is any instance(s) of failure to follow, intentionally or unintentionally, the requirements of the 
CIP. It is expected that the investigator will conduct this clinical trial in compliance with the CIP and all 
applicable regulations governing the conduct of clinical research involving human subjects. Failure to do so 
could result in one or all of the following: 
• 
Investigational center disqualification  
• 
Notification to the regulatory authorities/EC depending on the severity of the deviation and 
reporting requirements 
 
Deviations will not be issued for the following situations: 
• 
If subject’s parent/legal guardian do not upload devices, unless the site staff did not train the 
subject’s parent/legal guardian on upload procedures.  
• 
Recommended settings for the use of MiniMed 780G pump in Auto Mode are not being 
followed. 
• 
Suggested site for sensor insertion not being followed.  
• 
If subjects miss or delay protocol visits, unless the site staff did not plan the visit according 
to the protocol schedule.  
 
The investigator should not implement any deviation from, or changes to, the CIP without agreement by 
the sponsor and prior review and documented approval/favorable opinion from the regulatory authority (if 
applicable) or EC (if applicable), except where necessary to eliminate an immediate hazard(s) to trial 
subjects. The use of waivers from the CIP are prohibited in this study. 
9.7.1 Documenting Requirements for Study Deviations 
9.7.1.1 Unplanned CIP Deviations 
The investigator may encounter the need to deviate from the CIP when necessary to protect the safety, 
rights or well-being of a subject in an emergency or in unforeseen situations beyond the investigator’s 

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control (e.g., subject failure to attend scheduled follow-up visits, inadvertent loss of data due to computer 
malfunction, inability to perform required procedures due to subject illness). 
 
Deviations from the CIP, regardless of the reason should be documented as soon as possible, after the 
deviation occurs or is identified. This documentation should include deviation date, description of the 
deviation, the reason for deviation, and the corrective action. Refer to Table 8 for reporting timelines for 
emergency deviations.  
 
CIP deviations should be reported as follows: 
a) To the EC (if applicable) for notification/acknowledgement; 
b) To the sponsor and, if required; 
c) To the applicable regulatory authority (reported by sponsor). 
9.7.2 Reporting Requirements for Study Deviations 
All study deviations must be reported on the eCRF regardless of whether medically justifiable, an 
inadvertent occurrence, or taken to protect the subject in an emergency. The date, description, and reason 
for each deviation will be documented.  
 
The following examples are deviations that could impact subject safety, affect the integrity of study data 
and/or affect subject’s willingness to participate in the study. These deviations are significant and require 
immediate sponsor notification upon investigator awareness:  
 
 
Failure to obtain informed consent/assent, i.e., there is no documentation of consenting 
 
Informed consent/assent obtained after initiation of study procedures 
 
Continuation of a subject who did not meet all inclusion/exclusion criteria 
 
Performing study procedure not approved by the EC and RA  
 
Failure to inform EC and sponsor of reportable AEs (see Section 11) 
 
Investigational study device dispensed without obtaining informed consent/assent 
 
In the event the deviation involves a failure to obtain a subject’s consent, or is made to protect the life or 
physical well-being of a subject in an emergency, the deviation must be reported to Medtronic as well as 
the EC, if applicable per local regulations, within five (5) working days. 
 
Reporting of all other study deviations should comply with: 
• 
EC/IRB policies and/or 
• 
local laws and/or 
• 
regulatory authority requirements 
 
They must be reported to Medtronic as soon as possible upon the center becoming aware of the deviation. 
Refer to Investigator Reports and Table 8 for specific deviation reporting requirements and timeframes for 
reporting to Medtronic, EC, and regulatory authority (if applicable). 

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9.7.3 Analyzing Deviations 
Medtronic is responsible for reviewing deviations, assessing their significance, and identifying any additional 
corrective and/or preventive actions (e.g., amend the CIP, conduct additional training, terminate the 
investigation). Repetitive or serious investigator compliance issues may result in initiation of a corrective 
action plan with the investigator and investigational center, and in some cases, necessitate suspending 
enrollment until the problem is resolved or ultimately terminating the investigator’s participation in the 
study.  
9.8 Subject Exit, Withdrawal or Discontinuation 
Subjects and/or their parent/legal guardian may choose to withdraw from the study at any time by 
notifying investigational center staff of their intent. 
 
Whenever possible, the investigational site staff will perform an Early Termination visit when a subject 
decides to withdraw from the study early or if the subject is withdrawn early upon decision of the 
investigator or sponsor (during a normal study visit or an unscheduled visit) (described in Section 9.1). 
If a subject chooses to end his or her study participation or if the subject is removed from the study at 
the Investigator’s discretion or for failure to meet the study requirements, the reason for withdrawal must 
be documented. All study devices and supplies must be returned (as applicable) and documented both in 
source documents and on an eCRF. Following study exit, withdrawal or discontinuation subjects will receive 
standard medical care from their own providers. 
 
A subject will be withdrawn from the study if: 
 
In the opinion of the investigator, the subject’s health or safety would be compromised by 
continuing in the study (e.g., infection at skin site, severe skin reaction to adhesive). 
 
In the opinion of the investigator, it is in the subject’s best interest to discontinue participation in 
the study. 
 
During the course of the study, subject is taking oral, injectable, or IV glucocorticoids  
 
During the course of the study, subject begins participation in another investigational study (drug 
or device). 
 
Documentation of the reason(s) leading to subject withdrawal will be kept in the subject’s source 
documentation. 
9.8.1 End of Subject Participation in Study/ Completion of Study  
After the study has been completed (at Visit 15 or in case of early termination), subjects will be exited 
from the study. Subjects will continue to work with their physician after study exit per normal standard of 
care. The clinical investigation is considered completed once the last subject has exited the study. 
9.8.2 Lost to Follow-Up 
If a subject does not return to the site for required follow-up visit(s) and cannot be reached, the 
investigation site personnel should make 3 documented attempts to contact the subject by phone to verify 
if the subject should be considered “lost-to follow up”. In the event the subject is not able to perform 
follow-up visits at the investigation site, subject will be considered “lost to follow up” and this needs to be 

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documented in the Study Exit eCRF. All efforts will be made by investigation site personnel to collect all 
study devices and supplies back from subject, if applicable. 
10 Risks and Benefits 
10.1 Potential Risks 
The potential residual risks and mitigations associated with the devices used during this study are listed in 
Table 7. Risks associated with the commercially available devices used in the study are listed in the 
associated device labeling/user guides/instructions for use or IBs. 
 
The clinical investigation has been designed to involve as little pain, discomfort, fear and any other 
foreseeable risk as possible for the subjects, and both the risk threshold and the degree of distress are 
specifically defined in the CIP and constantly monitored. There is no additional risks associated with the 
new devices of the continuation phase. 
Table 7. Risks, Prevention and Mitigation 
Risks with Infusion Sets 
Prevention and Mitigation 
Risks with infusion sets may include:  
• 
Localized infection 
• 
Skin irritation/redness 
• 
Bruising 
• 
Discomfort/pain 
• 
Bleeding 
• 
Irritation 
• 
Rash 
• 
Hyperglycemia secondary to infusion set occlusion 
or infusion site failure including DKA 
• 
Hyperglycemia secondary to site falling off including 
DKA 
• 
Anxiety associated with insertion 
Prevention and mitigation include: 
• 
Follow the provided user guides for 
insertions and care of infusion sets. 
• 
If an infusion site becomes irritated or 
inflamed, the infusion set will be 
removed and another placed in a new 
location.  
• 
In case of hyperglycemia secondary to 
infusion set occlusion, remove current 
infusion set and replace with new 
infusion set and give correction insulin if 
needed with syringe.  
• 
Follow the provided user guides for 
insulin pump management.  
• 
Train prior to study device use on 
appropriate device use and diabetes 
management principles and instruct to 
call investigator with problems.  
Risks with Insulin Administration and Pumps 
Prevention and Mitigation 
Risks with the use of an insulin infusion pump may include 
the risk of malfunction of the components of the system 
(pump, software, infusion set and reservoir) as well as the 
risk of use error during use of the system. DDs or use errors 
can result in administration of too much or too little insulin 
which can lead to the following clinical consequences: 
 
• 
Hypoglycemia 
• 
Hyperglycemia 
Prevention and mitigation include: 
• 
Follow the provided user guides & 
instructions for insulin pump 
management which includes information 
on infusion set change.  
• 
Train prior to study device use on 
appropriate device use and diabetes 
management principles and instruct to 
call investigator with problems.  

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• 
Diabetic ketoacidosis  
• 
Severe hypoglycemia with or without associated 
seizure, coma or death 
• 
Kinked cannula leading to hyperglycemia  
• 
Infusion set disconnection from pump leading to 
hyperglycemia 
• 
Subject removes the reservoir from the pump but 
forgets to disconnect the infusion set from the body 
which results in hypoglycemia or severe 
hypoglycemia  
• 
Dislodged cannula leading to hyperglycemia 
• 
A pump error may lead to under delivery or over-
delivery of insulin 
• 
Battery failure – no insulin delivered 
• 
Insulin deterioration leading to hyperglycemia 
• 
Incomplete priming; fails to prime tubing and/or 
cannula, leading to hyperglycemia 
• 
Remove a reservoir, without suspending and 
reconnecting after a while resulting in a 
hypoglycemia 
• 
Patient not filling pump reservoir when needed 
leading to hyperglycemia 
• 
Magnetic resonance imaging resulting in pump 
transmitter malfunction 
• 
Inaccurate insulin delivery due to sudden altitude 
changes. 
• 
Hypoglycemia or hyperglycemia from manual bolus 
• 
Hypoglycemia or hyperglycemia from the use of the 
SmartGuard feature where SG values may be used 
to calculate insulin bolus amounts  
• 
Hypoglycemia or hyperglycemia from computer 
hacking  
• 
Instruct to check their meter glucose if 
their high or low symptoms do not match 
their sensor alerts or SG readings in 
order to make diabetes treatment 
decisions.  
• 
Instruct to check their meter glucose if 
there are any concerns that the SG value 
is not accurate.  
• 
Instruct to have glucose and glucagon 
on hand for hypoglycemia. 
• 
Instruct to change infusion set if 
suspected catheter occlusion or 
administer insulin with syringe for 
persistent hyperglycemia especially if 
ketones develop.  
• 
Parent(s)/guardian(s) should be present 
at night with subjects and will be trained 
on study device and diabetes 
management principles and instructed to 
call investigator with problems. 
 
 
Risks with hyperglycemia may include  
• 
Diabetic ketoacidosis  
• 
Symptomatic ketosis 
• 
Cardiovascular event  
• 
Dehydration  
• 
Potassium and sodium imbalance 
• 
Shock 
• 
Altered mental status  
• 
Coma  
• 
Acidosis 
Prevention and mitigation include: 
• 
Follow the provided user guides for 
insulin pump management.  
• 
Parent(s)/guardian(s) should be present 
at night with subjects and will be trained 
on study device and diabetes 
management principles and instructed to 
call investigator with problems. 
• 
Parent/caregivers should also be present 
during meal and exercise challenges.  
• 
Train prior to study device use on 
appropriate device use and diabetes 
management principles and instruct to 
call investigator with problems. 

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• 
Instruct to check their meter glucose if 
their high symptoms do not match their 
sensor alerts or SG readings in order to 
make diabetes treatment decisions.  
• 
Instruct to check their meter glucose if 
there are any concerns that the SG value 
is not accurate.  
• 
Alternative method of managing glucose 
levels will be available (insulin and 
syringe for example). 
Risks with hypoglycemia may include: 
• 
Seizure  
• 
Coma  
• 
Altered mental status  
• 
Loss of consciousness  
• 
Cardiovascular event  
• 
Death  
• 
Risk of rebound hyperglycemia with ketosis 
Prevention and mitigation include: 
• 
Follow the provided user guides for 
insulin pump management.  
• 
Parent(s)/guardian(s) should be present 
at night with subjects and will be trained 
on study device and diabetes 
management principles and instructed to 
call investigator with problems. 
• 
Parent/caregivers should also be present 
during meal and exercise challenges. 
• 
Train prior to study device use on 
appropriate device use and diabetes 
management principles and instruct to 
call investigator with problems. 
• 
Instruct to check their meter glucose if 
their low symptoms do not match their 
sensor alerts or SG readings in order to 
make diabetes treatment decisions.  
• 
Instruct to check their meter glucose if 
there are any concerns that the SG value 
is not accurate).  
• 
Instruct to have glucose on hand for 
hypoglycemia. 
Risk with Sensors  
Prevention and Mitigation 
Risks with sensors may include: 
• 
Skin irritation or reaction to adhesives 
• 
Bruising 
• 
Discomfort 
• 
Redness 
• 
Bleeding 
• 
Pain 
• 
Rash 
• 
Infection 
• 
Irritation from tapes used with glucose-sensing 
products 
• 
Raised bump 
• 
Appearance of a small “freckle-like” dot where 
needle was inserted 
Prevention and mitigation include: 
• 
Follow the provided user guides for 
insertions and care of sensors. 
• 
If a sensor site becomes infected or 
inflamed, the sensor will be removed 
and another placed in a new location. 
• 
Instruct to check their meter glucose if 
their high or low symptoms do not 
match their sensor alerts or SG readings 
in order to make diabetes treatment 
decisions.  
• 
Instruct to check their meter glucose if 
there are any concerns that the SG value 
is not accurate.  

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• 
Allergic reaction 
• 
Syncopal episode secondary to needle insertion 
• 
Soreness or tenderness 
• 
Swelling at insertion site 
• 
Sensor fracture, breakage or damage 
• 
Minimal blood splatter associated with sensor needle 
removal 
• 
Residual redness associated with adhesive and/ or 
tapes 
• 
Scarring 
• 
Scab 
• 
Blister 
• 
Itchiness 
• 
Inflammation 
• 
Anxiety 
• 
Incorrect SG reading results in incorrect diabetes 
management 
• 
Subject over-treating secondary to alarms which can 
result in hyperglycemia or hypoglycemia 
• 
Instruct if there are no sensor values, no 
treatment decisions will be made until a 
BG is confirmed.  
 
Risks with Transmitter 
Prevention and Mitigation 
Risks with transmitter may include: 
• 
Skin irritation or reaction to adhesives 
• 
Bruising 
• 
Discomfort 
• 
Redness 
• 
Pain 
• 
Rash 
• 
Infection 
• 
Irritation from tapes used with glucose-sensing 
products 
• 
Raised bump 
• 
Allergic reaction 
• 
Soreness or tenderness 
• 
Residual redness associated with adhesive and/ or 
tapes 
• 
Scarring 
• 
Scab 
• 
Blister 
• 
Itchiness 
• 
Inflammation 
 
Prevention and mitigation include: 
• 
Follow the provided user guides.  
• 
Train on the proper use of the 
transmitters.  
Risks with Serter 
Prevention and Mitigation 
Risks with serters may include: 
• 
Improper insertion may lead to device performance 
issue  
Prevention and mitigation include: 
• 
Follow the provided user guides for 
insertions and care of device. 
• 
Train on the proper use of the serter and 
skin preparation prior to insertion. 
Risk with Closed Loop Therapy 
Prevention and Mitigation 

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Risks with Closed Loop may include:  
• 
Hypoglycemia 
• 
Severe hypoglycemia 
• 
Hyperglycemia 
• 
Diabetic ketoacidosis  
• 
User entry error 
o 
Patient administering boluses by entering false 
carb doses leading to hypoglycemia or 
hyperglycemia 
o 
Patient entering false glucose values for any 
reason leading to hypoglycemia and 
hyperglycemia  
o 
Patient entering false BG values for calibration 
leading to hypoglycemia or hyperglycemia 
• 
Sensor failure resulting from patient failure to 
calibrate leading to hypoglycemia or hyperglycemia 
• 
Sensor over-reading resulting in hypoglycemia  
• 
Sensor under-reading resulting in hyperglycemia 
• 
Sensor missed transmission, or any other fault 
resulting in no SG value, leading to hyperglycemia 
or hypoglycemia  
• 
Voluntary insulin delivery (with the pump or with a 
syringe) immediately prior to entering SmartGuard 
may result in severe hypoglycemia despite shutting 
down insulin delivery by the algorithm 
• 
Hypoglycemia related to patient taking insulin via 
injection while in Closed Loop (SmartGuard) 
• 
Hypoglycemia or hyperglycemia related to entering 
or exiting Closed Loop (SmartGuard) 
• 
Insulin over-delivery due to potential interference 
from acetaminophen, which may include false 
elevation of SG readings potentially resulting in an 
over-delivery of insulin which may cause 
hypoglycemia. The level of inaccuracy depends on 
the amount of acetaminophen active in subject’s 
body and may be different for each subject 
• 
Cyber security hacking into pump 
Prevention and mitigation include:  
• 
Follow the provided user guides for 
insulin pump management.  
• 
Train prior to study device use on 
appropriate device use and diabetes 
management principles and instruct to 
call investigator with problems.  
• 
Instruct to check their meter glucose if 
their high or low symptoms do not 
match their sensor alerts or SG readings 
in order to make diabetes treatment 
decisions.  
• 
Instruct to check their meter glucose if 
there are any concerns that the SG value 
is not accurate.  
• 
Instruct if there are no sensor values, no 
treatments decision will be made until a 
BG is confirmed.  
• 
Instruct to have glucose on hand for 
hypoglycemia. 
• 
Instruct to avoid the use of products 
containing acetaminophen 
• 
If acetaminophen is taken, subjects will 
be instructed to use additional BG meter 
readings to verify their glucose levels.  
• 
If acetaminophen is taken, while the 
SmartGuard feature is active, subjects 
will be instructed to use the temp target 
feature (when used, Auto Correction is 
not available).  
• 
Instruct subjects that in case of 
prolonged use of acetaminophen, the 
temp target feature can be used 
repeatedly and in succession. 
• 
Pump has cybersecurity encryptions to 
prevent hacking.  
 
 
Risks with hyperglycemia may include  
• 
Diabetic ketoacidosis 
• 
Symptomatic ketosis 
• 
Cardiovascular event  
• 
Dehydration  
• 
Potassium and sodium imbalance 
• 
Shock 
• 
Altered mental status  
• 
Coma  
Prevention and mitigation include: 
• 
Follow the provided user guides for 
insulin pump management.  
• 
Train prior to study device use on 
appropriate device use and diabetes 
management principles and instruct to 
call investigator with problems.  
• 
Instruct to check their meter glucose if 
their high symptoms do not match their 

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• 
Acidosis 
sensor alerts or SG readings in order to 
make diabetes treatment decisions.  
• 
Instruct to check their meter glucose if 
there are any concerns that the SG value 
is not accurate.  
• 
Instruct if there are no sensor values, no 
treatments decision will be made until a 
BG is confirmed.  
 
Risks with hypoglycemia may include: 
• 
Seizure 
• 
Coma 
• 
Altered mental status 
• 
Loss of consciousness 
• 
Cardiovascular event  
• 
Death  
• 
Risk of rebound hyperglycemia with ketosis 
Prevention and mitigation include: 
• 
Follow the provided user guides for 
insulin pump management.  
• 
Train prior to study device use on 
appropriate device use and diabetes 
management principles and instruct to 
call investigator with problems.  
• 
Instruct to check their meter glucose if 
their low symptoms do not match their 
sensor alerts or SG readings in order to 
make diabetes treatment decisions.  
• 
Instruct to check their meter glucose if 
there are any concerns that the SG value 
is not accurate.  
• 
Instruct if there are no sensor values, no 
treatment decisions will be made until a 
BG is confirmed  
• 
Instruct to have glucose on hand for 
hypoglycemia. 
 
10.2 Risk Minimization 
Refer to “Prevention and Mitigation” column in the table under Section 10.1. 
 
10.3 Potential Benefits 
The objective of this study is to evaluate the safety and performance of the MiniMed 780G system, it is 
anticipated that the system will allow improved glycemic control in the selected population of young patients 
in MDI or CSII with or without CGM.  
 
Currently MiniMed 780G pump use is approved for subject older than 7 years old so the study will give the 
opportunity for subjects, ages 2-6 to have access to this system used both in Manual and Auto Mode during 
the study.  
 
The information gathered in this study will help to extend labeling for MiniMed 780G system and the data 
collected in the study might help the patients and physicians determine the best treatment options in the 
future. 
 

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10.4 Risk-Benefit Rationale 
The main benefit of this study is that paediatric subjects (2-6 years old) may experience improved glucose 
control, due to the fact that the participants will be followed with higher frequency of visits, which will allow 
closer medical follow-up when compared to standard of care.  
 
Parents/legal guardians of the subject may also increase their understanding of the disorder.  
 
Risks related to the pump delivering too much or not enough insulin are minimized through a variety of 
safety checks that are an integral part of the MiniMed 780G closed loop algorithm. 
 
11 Adverse Events  
11.1 Adverse Events 
Throughout the course of the study, investigational centers will make all efforts to remain alert to possible 
reportable adverse events (AEs) or untoward findings. The study personnel will elicit reports of AEs from 
the subject at each visit (including phone calls) starting at the time of signing the informed consent 
documenting the medical diagnosis, date of event start and end, causality (relationship to device or 
procedure), treatment, outcome, assessment of seriousness, and description that includes the details of 
the event.  
 
11.2 Definitions and Classification of Adverse Events 
All adverse events (including non-subject AEs) will be collected and classified by using the ISO 14155:2020 
definitions, as defined below. Where the definition indicates “device”, it refers to any device used in the 
study. This might be the device under investigation, or any market released component of the system.  
 
Severe Hypoglycemia is an event requiring assistance of another person due to altered consciousness 
to actively administer carbohydrate, glucagon, or other resuscitative actions. This means that the subject 
was impaired cognitively to the point that he/she was unable to treat himself or herself, was unable to 
verbalize his or her needs, and was incoherent, disoriented and/or combative. 
 
These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma 
glucose measurements may not be available during such an event, but neurological recovery attributable 
to the restoration of plasma glucose to normal is considered sufficient evidence that the event was induced 
by a low plasma glucose concentration.4 
 
 
Diabetic Ketoacidosis/DKA diagnostic criteria: BG greater than (>) 250 mg/dL or greater than (>) 
13.9 mmol/L, arterial pH less than (<) 7.3, bicarbonate less than (<) 15 mEq/L, moderate ketonuria or 
ketonemia and requiring treatment within a health care facility.5 
 
Hyperglycemic events will be recorded as DKA if the event includes the presence of all of the following: 
• 
Arterial blood pH less than (<) 7.30 or serum bicarbonate less than (<) 15 mEq/L 
• 
Blood glucose greater than (>) 250 mg/dL or greater than (>) 13.9 mmol/L 

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• 
Serum ketones or large/moderate urine ketones 
• 
Symptoms such as polyuria, polydipsia, nausea, or vomiting 
• 
Treatment provided in a health care facility 
 
Adverse Event (AE) (ISO 14155:2020) 
 
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal 
laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical 
device and whether anticipated or unanticipated. 
 
Note 1 to entry: This definition includes events related to the investigational medical device or the 
comparator. 
 
Note 2 to entry: This definition includes events related to the procedures involved. 
 
Note 3 to entry: For users or other persons, this definition is restricted to events related to the use of 
investigational medical devices or comparators. 
 
Adverse Device Effect (ADE) (ISO 14155:2020) 
 
Adverse event related to the use of an investigational medical device.  
 
Note 1 to entry: This definition includes adverse events resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation, or operation, or any malfunction of the 
investigational medical device. 
 
Note 2 to entry: This definition includes any event resulting from use error or from intentional misuse of 
the investigational medical device. 
 
Note 3 to entry: This includes ‘comparator’ if the comparator is a medical device. 
 
 
Serious Adverse Event (SAE) (ISO 14155:2020) 
 
Adverse event that led to any of the following 
a) death, 
b) serious deterioration in the health of the subject, users, or other persons as defined by one or 
more of the following: 
1. a life-threatening illness or injury, or 
2. a permanent impairment of a body structure or a body function including chronic diseases, or 
3. in-patient or prolonged hospitalization, or 
4. medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function,  

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c) foetal distress, foetal death or a congenital abnormality or birth defect including physical or mental 
impairment 
 
Note 1 to entry: Planned hospitalization for a pre-existing condition, or a procedure required by the CIP, 
without serious deterioration in health, is not considered a serious adverse event. 
 
Serious Adverse Device Effect (SADE) (ISO 14155:2020) 
 
Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event 
 
Unanticipated Serious Adverse Device Effect (USADE) (ISO 14155:2020) 
 
Serious adverse device effect which by its nature, incidence, severity or outcome has not been identified 
in the current risk assessment. 
 
Note 1 to entry: Anticipated serious adverse device effect (ASADE) is an effect which by its nature, 
incidence, severity or outcome has been identified in the risk assessment. 
 
Serious Health Threat (ISO 14155:2020) 
Signal from any adverse event or device deficiency that indicates an imminent risk of death or a serious 
deterioration in the health in subjects, users or other persons, and that requires prompt remedial action 
for other subjects, users or other persons 
 
Note 1 to entry: This would include events that are of significant and unexpected nature such that they 
become alarming as a potential serious health hazard or possibility of multiple deaths occurring at short 
intervals. 
 
11.3 Recording of Adverse Events 
The investigator or designee will record ALL AEs and DDs while the subject is enrolled in the clinical study 
(Refer to Section 13 for DD reporting). 
  
Each AE needs to be assessed for its device or procedure relatedness. A device related AE is associated 
with the use of the study device (e.g., infection of sensor site or infusion set occlusion resulting in DKA). A 
procedure related AE is associated with testing related to the study procedures specified in the CIP (e.g., 
needle (blood draw) insertion pain). 
  
Examples of device or procedure related AEs include: 
• 
Device related (ADE): insertion site infection 
• 
Serious adverse device effect: cellulitis at device insertion site requiring hospitalization 
• 
Procedure related AE: bruising at needle (blood draw) insertion site 
 

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An outside standard of care CIP procedure related AE in this study is associated with a study procedure 
that is required per the study protocol and is in addition to the standard of care for the device (see Study 
Design under Section 9).  
 
Subjects participating in the study have diabetes and are expected to experience hypoglycemia and or 
hyperglycemia. These normal events are not expected to be reported to sponsor as this is not considered 
an untoward event, but rather an expected occurrence. Any glycemic excursion that meets the protocol 
definition of severe hypoglycemia or DKA is considered an untoward event and a worsening from the 
subject’s baseline and would be reported to sponsor on an AE eCRF.  
 
Baseline medical conditions should only be reported to sponsor on an AE eCRF if there is a worsening from 
the subject’s baseline. For example, a subject previously diagnosed with asthma is hospitalized for severe 
asthma attack would be a reportable event. 
 
Adverse events will be documented in the subject source file and reported to sponsor on an eCRF. The 
investigational center is responsible for documentation of AEs including obtaining source documents related 
to the event, such as emergency medical technician/paramedic reports, hospital records (admission 
summary; lab results, test results, discharge summary) or device uploads to support the event. Source 
documents will be reviewed to determine if additional AEs have occurred and require reporting. 
 
Adverse events that have not resolved at the time of the subject’s discontinuation or completion of the 
study should have an “outcome” of Not Recovered/Not Resolved at study end in subject source and on an 
eCRF. The investigator should ensure that subject is aware of any follow-up or additional treatment that is 
required for any ongoing AE at EOS participation; however, there will be no eCRF entry for the ongoing 
follow-up. 
 
11.4 Notification of Adverse Events 
Sponsor Notification: 
The investigational center staff must report all AEs to Medtronic in a timely manner. All severe 
hypoglycemia, DKA, SAE, SADE, and DD with SADE potential should be reported immediately to 
Medtronic (but not later than 72 hours).  For the previously mentioned events, the AE eCRF will be 
completed with all known details as soon as possible, this will serve as notification to Medtronic. If the 
study database cannot be accessed due to technical problems, contact the sponsor via email at 
dl.diabetesclinicalresearchsafety@medtronic.com and provide the de-identified known details of the 
event. Once the access issue has been corrected, the event should be entered onto an AE eCRF. 
 
Source documents that support the event (e.g., clinic notes, hospital admission and discharge records, 
lab reports, EMT reports, ER/Urgent Care) should be provided to the sponsor via Medtronic’s secure 
upload application. All source documents/medical records should be redacted of patient identifiers (full 
name, address, etc.) prior to providing to the sponsor. Each source page should be identified with the 
subject ID. 

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Table 8. Investigator Reports to Sponsor 
Event Type To Report 
Timeframe for Reporting 
 
Serious Adverse Device Effect (SADE) 
 
Unanticipated Serious Adverse Device Effect (USADE) 
 
Serious Adverse Event (SAE) 
 
Adverse Device Effect (ADE)  
 
Device Deficiency that might have led to a SADE (see 
Section 13) 
Immediately, but no later than 72 hours after 
investigational site study personnel’s awareness 
of the event (or sooner if required by local 
regulation) 
 
Adverse Event (AE) 
 
Device Deficiency (DD) (see Section 13) 
In a timely manner from the investigator’s / 
site’s first knowledge of the event 
 
 
Sponsor Reports:  
Regulatory reporting of AEs and DDs will according to local regulatory requirements. 
 
In countries following EU MDR 2017/745, AEs will be reported according to EU MDR 2017/745 Art. 80(2) 
and Medical Device Coordination Group (MDCG) 2020-10/1 guidance and additional local requirements if 
applicable.  
 
In accordance with EU MDR Art. 80(2) the following events are considered reportable:  
a) any serious adverse event that has a causal relationship with the investigational device, 
the comparator or the investigation procedure or where such causal relationship is 
reasonably possible; 
b) any device deficiency that might have led to a serious adverse event if appropriate 
action had not been taken, intervention had not occurred, or circumstances had been 
less fortunate; 
c) any new findings in relation to any event referred to in points a) and b). 
Table 9. Sponsor Adverse Events Reporting Requirements to National Competent Authority  
Events To Report in EU/EEA 
Reporting Requirements and Timeframe 
 
Any device and/or procedure related Serious 
Adverse Events (SAE) and/or Device Deficiency 
(DD) that may have led to a SADE which indicates 
an imminent risk of death, serious injury, or 
serious illness and that requires prompt remedial 
action for other patients/subjects, users or other 
persons or a new finding to it (occurred in the 
study under same CIP) 
 
Immediately, but no later than 2 calendar days after 
awareness by sponsor of a new reportable event or 
of new information in relation with an already 
reported event 
 
Any device and/or procedure related SAE and DD 
that may have led to an SADE (occurred in the 
study under same CIP*) – including updates 
Immediately, but not later than 7 calendar days 
after awareness  
Events To Report in UK 
Reporting Requirements and Timeframe 

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 
Any SAE and/or DD that may have led to a SADE 
which indicates an imminent risk of death, serious 
injury, or serious illness and that requires prompt 
remedial action for other patients/subjects, users 
or other persons or a new finding to it (occurred 
in the study under same CIP) 
Immediately, but no later than 2 calendar days after 
awareness by sponsor of a new reportable event or 
of new information in relation with an already 
reported event 
 
Any SAE and DD that may have led to an SADE 
(occurred in the study under same CIP*)– 
including updates 
Immediately, but not later than 7 calendar days 
after awareness by the sponsor of the new 
reportable event or of new information in relation 
with an already reported event  
 
All SAEs 
Quarterly report according to CA ‘letter of no 
objection’. Quarterly after CA approval date 
 
In addition, it is the responsibility of the investigator and the sponsor to abide by the AE reporting 
requirements stipulated by local law and the study site’s EC. 
 
11.5 Adverse Event and Device Deficiency Classification 
All AEs and DDs will be reviewed by sponsor and will be classified according to the responsibilities as 
outlined below in Table 10. 
 
Upon sponsor’s receipt of an event, a Safety representative will review the AE/DD for completeness 
and accuracy and when necessary, will request clarification and/or additional information from the 
Investigator. 
 
It is the responsibility of the investigator and sponsor to abide by any additional AE reporting 
requirements stipulated by the EC and RA responsible for oversight of the study. 
Table 10. Adverse Event Classification Responsibilities 
What is classified?  
Who classifies? 
Classification Parameters 
Relatedness 
Investigator 
Device, Procedure, Outside Standard of Care CIP procedure 
Sponsor 
Device, Procedure, Outside Standard of Care CIP procedure 
Seriousness 
Investigator 
SAE, DD with SADE potential 
Sponsor 
SAE, USADE, and DD with SADE potential  
Diagnosis 
Investigator 
Based on presenting signs and symptoms and other supporting 
data 
Sponsor 
MedDRA term assigned based on the data provided by Investigator 
 
11.6 Causality Assessment 
An AE is not automatically related to the study device or procedure simply because the subject is wearing 
the device and participating in the study. The event should be reviewed to determine if the device or study 
procedure could have possibly caused the event and therefore is related to the study device or procedure. 
  

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Causality assessment is the determination of the relationship between an AE and the device being studied. 
It is expected that the investigational center will review all elements surrounding the AE to properly assess 
the causality of the event to the study device or to a study procedure. The eCRF may be used as original 
source data for the assessment of causality and severity. 
 
This review would include the subjects’ (or parent/legal guardian) description of the event, study device 
uploads and medical records (if applicable) from the treating facility. These records will be made available 
to sponsor. 
  
Investigators should classify the relationship between the AE and the study device or study procedures 
using one of the four possible causality categories listed below: 
 
• 
Not related: relationship to the device, comparator, or procedures can be excluded when: 
o 
the event has no temporal relationship with the use of the investigational device or the 
procedures related to the application of the investigational device; 
o 
the event does not follow a known response pattern to the medical device (if the response 
pattern is previously known) and is biologically implausible; 
o 
the discontinuation of medical device application or the reduction of the level of 
activation/exposure – when clinically feasible – and reintroduction of its use (or increase 
of the level of activation/exposure), do not impact on the event; 
o 
the event involves a body-site or an organ not expected to be affected by the device or 
procedure; 
o 
the event can be attributed to another cause (e.g., an underlying or concurrent illness/ 
clinical condition, an effect of another device, drug, treatment or other risk factors); 
o 
the event does not depend on a false result given by the investigational device used for 
diagnosis, when applicable; 
 
In order to establish the non-relatedness, not all the criteria listed above might be met at the same 
time, depending on the type of device/procedures and the event. 
 
 
• 
Possible: the relationship with the use of the investigational device, comparator, or the 
relationship with procedures, is weak but cannot be ruled out completely. Alternative causes are 
also possible (e.g., an underlying or concurrent illness/clinical condition or/and an effect of another 
device, drug or treatment). Cases where relatedness cannot be assessed, or no information has 
been obtained should also be classified as possible. 
 
• 
Probable: the relationship with the use of the investigational device, comparator, or the 
relationship with procedures, seems relevant and/or the event cannot reasonably be explained by 
another cause. 
 

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• 
Causal relationship: the event is associated with the investigational device, comparator, or with 
procedures beyond reasonable doubt when: 
 
o 
the event is a known side effect of the product category the device belongs to or of similar 
devices and procedures; 
o 
the event has a temporal relationship with investigational device use/application or 
procedures; 
o 
the event involves a body-site or organ that 
 
the investigational device or procedures are applied to; 
 
the investigational device or procedures have an effect on; 
o 
the event follows a known response pattern to the medical device (if the response pattern 
is previously known); 
o 
the discontinuation 
of medical device application (or reduction of the level of 
activation/exposure) 
and reintroduction of its use (or increase of the level of 
activation/exposure), impact on the event (when clinically feasible); 
o 
other possible causes (e.g., an underlying or concurrent illness/clinical condition or/and an 
effect of another device, drug or treatment) have been adequately ruled out; 
o 
harm to the subject is due to error in use; 
o 
the event depends on a false result given by the investigational device used for diagnosis, 
when applicable; 
 
In order to establish the relatedness, not all the criteria listed above might be met at the same time, 
depending on the type of device/procedures and the event. 
 
11.7 Anticipated or Unanticipated 
If an AE is determined to be related to the study device the sponsor will then assess the event to 
determine if it is anticipated or unanticipated. 
• 
Anticipated: the event is identified in the CIP; labeling; Investigator’s Brochure (IB) or user guide. 
• 
Unanticipated: the event has not been previously identified in the CIP; labeling; IB or user guide. 
12 Data Review Committees 
12.1 Clinical Events Committee 
A CEC consisting of external physicians with an expertise in endocrinology and the management of diabetes 
including insulin pumps and CGM will be convened. The CEC will review AEs as required per protocol, which 
include reports of: 
• 
Serious adverse event 
• 
Serious adverse device effect 
• 
Unanticipated serious adverse device effect (USADE) 
• 
Severe hypoglycemia 

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Diabetic ketoacidosis 
 
The CEC will assess events to determine agreement or disagreement with the investigator classification of 
an event.  
 
If the CEC disagrees with the investigator’s classification of the event, the rationale will be provided to the 
investigator. If the investigator agrees with the CEC’s adjudication, the CRF documenting the AE will be 
updated accordingly. 
 
If the investigator does not agree with the CEC’s adjudication classification, both determinations will be 
provided within the final report; however, the CEC’s adjudication will be used for data analysis. The 
disagreement will also be included in reporting to Ecs and regulatory authorities, if required. 
 
The CEC may review applicable information for device related AEs which may include: 
 
• 
Whether or not the event was unanticipated 
• 
Review of sensor data from CareLink Personal/CareLink system software report (when applicable) 
• 
Review of pump data from CareLink Personal/CareLink system software report (when applicable) 
• 
Misuse of the device by the user 
 
Review of events may require the following information. Final disposition may be delayed based on 
obtaining this information:  
 
• 
Monitoring by sponsor at investigational center 
• 
Device return and failure analysis 
• 
CareLink Personal/CareLink system software upload and review of software reports  
• 
Subject clarification to investigational center regarding details about the event 
• 
Source documents that support event: Paramedic records; ER records; Lab records; Hospital 
admission and discharge summary  
12.2 Data Monitoring Committee 
A Data Monitoring Committee (DMC) consisting of external physicians with an expertise in Endocrinology 
and the management of insulin-requiring diabetes including pump and CGM therapy, will be convened to 
review study progress and safety. The board will convene periodically. The DMC Charter is available 
under a separate cover.  
 
The DMC will perform 2 main functions: 
 
First: DMC will track and trend the overall safety of the study. 
 
Event rate, defined as number of events per 100 patient years will be reviewed by the DMC with respect 
to the following: 
• 
Event rate of all SAE   

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Event rate of severe hypoglycemia 
• 
Event rate of DKA 
• 
Event rate of device related AE 
    
Second: Based on their meeting, DMC will recommend a decision to the sponsor regarding the following:  
• 
Whether or not enrollment should be halted. 
• 
Whether or not the entire study will need to be stopped including for those subjects who have 
received study devices already.  
12.3  Central Lab 
This information may be subject to change during the course of the study. Periodic updates to study contact 
information will be sent to study sites as needed. 
Table 11. Core Laboratory Information 
Contact Information 
Role 
ACM Global Laboratories  
 
 
 
 
Analysis of HbA1c samples collected during the 
Continuation Phase 
 
13 Device Deficiencies  
The subject’s parent/legal guardian will be instructed to contact the investigational center staff for questions 
or concerns regarding study devices. 
 
All device deficiencies will be collected and classified by using the ISO 14155:2020 definition, as defined 
below. All DDs reported directly to the investigational center staff by a subject and those experienced by 
the investigational center staff will be reported on the appropriate eCRF. In addition, an eCRF should also 
be completed by the investigational center staff for each reported DD that did not lead to an Adverse Event. 
A DD that results in an AE should be captured on an AE CRF only. 
 
Subjects participating in the study are expected to have mild irritation from device wear at times. Only 
discomfort occurring at a threshold resulting in early removal of the device should be reported as a DD or 
adverse event.  
 
Device Deficiency (ISO 14155:2020) 
A device deficiency is any inadequacy of a medical device with respect to its identity, quality, durability, 
reliability, usability, safety, or performance.  
 

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Note 1 to entry: Device deficiencies include malfunctions, use errors, and inadequacy in the information 
supplied by the manufacturer including labeling.  
 
Note 2 to entry: This definition includes device deficiencies related to the investigational medical device 
or the comparator.  
 
Each DD will be assessed for SADE potential defined as: 
A DD that did not lead to an Adverse Event, but could have led to a SADE: 
a) if either suitable action had not been taken, 
b) if intervention had not been made, or 
c) if circumstances had been less fortunate  
 
To return a study device as part of a DD, the subject is to contact the investigational center staff, and the 
investigational center staff should then follow the study procedures for returning products with DDs. For a 
list of study devices that needs to be return to the sponsor, please consult your study materials. 
 
It is the responsibility of the investigator to follow  their EC reporting requirements. 
14 Statistical Design and Methods 
14.1 General Aspects of Analysis 
All data collected from the time of screening until the end of the study will be collected on eCRFs and 
electronically by uploading the various devices. Data and analysis will be summarized in a Clinical Study 
Report. Any deviations from original statistical plan and the rationale will be described in the Clinical Study 
Report. Both the study and continuation phases of the study are used for confirmatory analysis.  
14.2 Subject Disposition 
The number of subjects enrolled, randomized, completed, and early terminated in the study will be 
presented. The reasons for discontinuing prior to study completion will be summarized. 
14.3 Subject Demographics and Baseline Characteristics 
Subject characteristics, including age, gender, medical diagnosis, height, weight, BMI, and baseline HbA1c 
will be summarized by descriptive statistics (n, mean, standard deviation, minimum, median, and 
maximum) for continuous variables and by counts and percentages for categorical variables. 
14.4 Analysis Populations and Handling of Missing Data, Error 
• 
Intention to Treat (ITT) Population 
The ITT population will include all randomized subjects. These subjects will be assessed and 
analyzed as members of the intended period, irrespective of their compliance to the planned course 
of treatment or deviations from protocol. For the primary and secondary endpoints, efficacy 
analyses will be performed in the Intent to Treat (ITT) basis. 
• 
Per Protocol (PP) Population 

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The PP population will include all randomized subjects, excluding any subject with at least one of 
the following deviations:     
• 
Auto Mode use during the active study phase is less than 75%  
• 
Sensor use during the active study phase is less than 70% 
• 
Subject did not complete the study phase 
• 
Subject did not meet screening criteria but continued the study 
• 
Subject did not meet randomization criteria but continued the study  
Efficacy analysis of the primary endpoint will also be performed in the Per Protocol set. 
• 
Safety Population 
The Safety Population will include all subjects with signed inform consent and safety data will be 
presented by phase (run-in phase, study phase and continuation phase). Safety reporting will be 
done separately for the run-in phase, the study phase and continuation phase. 
 
The treatment interventions will be compared with the use of a repeated measures mixed model that uses 
available data and accounts for possible missing at random data. Data entry errors will be resolved before 
data analysis. No imputations will be done for missing data.  
 
14.5 Endpoints and Hypotheses 
14.5.1 Analysis of Primary Endpoint – Study Phase 
 
The goal is to assess the non-inferiority in the percentage of time that the sensor glucose measurement is 
in the target range, 70 to 180 mg/dL (3.9-10.0 mmol/L), during each 12-week period in the Treatment 
780G in Auto Mode compared to Control MiniMed 780G System + SBL. The between-treatment difference 
will be compared using the following hypotheses: 
 
𝐻𝐻0: ∆𝑇𝑇𝑇𝑇𝑇𝑇 ≤−7.5% 
𝐻𝐻𝛼𝛼: ∆𝑇𝑇𝑇𝑇𝑇𝑇> −7.5%. 
 
Where ∆𝑇𝑇𝑇𝑇𝑇𝑇 is the average of the cross-over differences in time in range in Treatment 780G in Auto Mode 
vs Control MiniMed 780G System + SBL (𝑇𝑇𝑇𝑇𝑇𝑇𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴−𝑇𝑇𝑇𝑇𝑇𝑇𝑆𝑆𝑆𝑆𝑆𝑆), and the test will be against at the 0.025 (one-
sided) significance level.  
 
The non-inferiority absolute margin of 7.5% TIR was chosen in consensus with physicians as the maximum 
acceptable decrease of TIR in comparison with the current approved therapy. In addition, the non-inferiority 
margin of 7.5 % TIR is equivalent to a less than 0.3 % change in HbA1c which is considered non clinically 
significant 3. This is in line with the recommendations from the International Consensus on Time in Range 
(quoted ‘an increase in TIR of 10% (2.4 h per day) corresponded to a decrease in A1C of approximately 
0.5% (5.0 mmol/mol)”) 3.  
 

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Carryover effect will be test using repeated measures mixed model with period, randomization sequence, 
and treatment as fixed effects, and subject as the random effect.  
 
The 97.5% lower confidence limit of between-treatment difference will be calculated. If it is greater than -
7.5%, the non-inferiority will be concluded. 
 
If the p value of the coefficient of randomization sequence is ≤0.1 (there is a carryover effect), data from 
period 1 will be used for analysis only. The 97.5% lower confidence limit of between-treatment difference 
at period 1 will be calculated. If it is greater than -7.5%, the non-inferiority will be concluded. 
 
Descriptive summary statistics of the primary endpoint will be presented stratified by study phase, 
treatment arm, investigational study site and other variables. 
 
Pass/Fail Criteria: 
The study pass/fail criteria is based on statistical hypothesis of the primary endpoint. The study will be 
considered as success when the evaluation criteria meets the predefined threshold for both ITT and PP 
sets. 
14.5.2 Analysis of Primary Endpoint – Continuation Phase 
 
• The goal is to assess the non-inferiority in the mean Hba1c during the 12-week continuation phase 
period 2 in the Treatment MiniMed 780G BLE 2.0 system with the DS5 sensor in Auto Mode compared 
to Control MiniMed 780G System + SBL in Auto Mode. The between-treatment difference will be 
compared using the following hypotheses: 
 
𝐻𝐻0: ∆𝐻𝐻𝐻𝐻𝐻𝐻1𝑐𝑐 ≥0.4% 
𝐻𝐻𝛼𝛼: ∆𝐻𝐻𝐻𝐻𝐻𝐻1𝑐𝑐< 0.4%. 
 
 
 
Where ∆𝐻𝐻𝐻𝐻𝐻𝐻1𝑐𝑐 is the difference of the averages of HbA1c for Treatment MiniMed 780G BLE 2.0 system 
and DS5 sensor in Auto Mode vs Control MiniMed 780G System + SBL in Auto Mode at the end of the 12-
week continuation phase period 2, and the test will be against at the 0.025 (one-sided) significance level.  
 
The choice of the non-inferiority margin of 0.4% reduction in HbA1c was based on well-established 
historical evidence and accepted for diabetes clinical trials according to FDA guidance6.   
3 
The 97.5% lower confidence limit of between-treatment difference will be calculated. If it is greater than 
0.4%, the non-inferiority will be concluded. 
 
 
14.5.3 Analysis of Secondary Endpoints – Study Phase and Continuation Phase 
 

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A fixed-sequence testing method will be applied to address the multiple comparison. If the primary endpoint 
analysis is significant, the procedure tests hierarchically the ordered hypotheses in sequence as the order 
in 4.2.2., at level α=0.025 (one-sided) until one of the hypotheses is non-rejected.  
Analysis on each secondary endpoint will be performed using the same methodology in primary endpoint 
on the ITT population. 
14.5.4 Analysis of Exploratory Endpoints 
Descriptive summary statistics will be presented for all exploratory endpoints.  
14.5.5 Safety Data and Device Deficiencies, Adverse Event and Device Data 
Summary 
All safety summaries and analyses will be presented for the Safety Population. Total number of Severe 
hypoglycemic events, diabetic ketoacidosis events, serious adverse events, serious adverse device effects, 
unanticipated serious adverse device effects and device deficiencies will be reported for run-in, study phase 
and continuation phase, categorized by treatment. The listing of these events will also be reported. 
 
 
 
 
 
 
 
  
 
 
 
 
 
14.6.1 Expected Drop-out Rates 
The following drop-out assumptions have been considered, based on experience with previous studies. At 
screening: 10%; After run-in: 5%; During study phase/continuation phase: 10%. 
 
Incorporating the expected drop-out rates, a total of up to 100 participants will be enrolled to have 
approximately 72 participants randomized and completing the study phase and approximately 64 subjects 
completing the continuation phase. 
14.7 Interim Analysis 
 
An interim analysis will be performed during continuation phase, when at least 50% of subjects complete 
the continuation phase period 1, to evaluate sample size justification assumption on HbA1c standard 
deviation and re-assess sample size, if needed. 

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No treatment effect evaluation will be performed at the time of interim analysis. If the assumption on 
HbA1c standard deviation is not met, the sample size for continuation phase only will be increased 
accordingly. 
 
14.8 Final Report 
The primary study results from the study phase will be summarized and presented in the 6-month final 
report. The study results from the continuation phase will be summarized and presented in the final report.  
15 Ethics 
15.1  Statement(s) of Compliance 
This study will be conducted in compliance with international ethical and scientific quality standards, known 
as Good Clinical Practice (GCP). GCP includes review and approval by an independent EC before initiating 
a study, continuing review of an ongoing study by an EC, and obtaining and documenting the freely given 
informed consent of a subject’s parent/legal guardian before initiating the study. 
 
The CIP342 study was designed to reflect the GCP principles outlined in ISO 14155:2020 and other 
international clinical requirements outlined below. These include the protection of the rights, safety and 
well-being of human subjects, controls to ensure the scientific conduct and credibility of the clinical 
investigation and the definition of responsibilities of the sponsor and investigators.  
 
In accordance with ISO 14155:2020, the sponsor shall avoid improper influence on, or inducement of, the 
subject, monitor, any investigator(s) or other parties participating in, or contributing to, the clinical 
investigation. All investigators shall avoid improper influence on or inducement of the subject, sponsor, 
monitor, other investigator(s) or other parties participating in or contributing to the clinical investigation.  
 
AE and DD handling in the CIP342 is ISO 14155:2020 compliant for all participating geographies.  
 
The principles of the Declaration of Helsinki (DoH) have been implemented through the IC process, EC and 
RA approvals, study training, clinical trial registration, pre-clinical testing, risk-benefit assessment and 
publication policy.  
 
Following ISO14155:2020, children with legally incompetent and illiterate parent(s)/legal guardian(s) will 
not be included in this clinical study. 
 
Ultimately, all study sites in all geographies will follow and comply with: 
• 
Principles of DoH 
• 
The CTA 

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• 
The procedures described within this CIP 
• 
Local EC Requirements 
 
In addition to the regulatory requirements outlined above, the study will be conducted according to federal, 
national and local laws, regulations, standards, and requirements of the countries/geographies where the 
study is being conducted. These include but are not limited to ISO14155:2020, DoH version 2013, and in 
member states of the EU/EEA Regulation (EU) 2017/745 on Medical Devices (MDR).  
 
The study will be publicly registered prior to in accordance with the DoH on http://clinicaltrials.gov (PL 
110-85, section 810(a)). In addition, the study may be registered in local regulatory databases where 
required by local law.  
 
Approval of any subsequent amendments to this CIP, the ICF, subject material, and any form of subject 
recruitment information (e.g. advertisements), if applicable, relating to this study will be approved by the 
responsible EC and geography specific Regulatory Authorities. 
 
The investigational center will not initiate any subject activities until EC and geography specific Regulatory 
Authorities approvals has been granted, the sponsor has cleared the investigational center to begin the 
study, and the investigational center staff has been appropriately trained to conduct the study. 
15.2 Role of the Sponsor’s Representatives 
Sponsor’s representatives may provide Study specific training to the site personnel conducting study 
activities. Sponsor representatives may also provide technical support at investigational centers. Sponsor 
representatives may provide technical support as required for the study under supervision of the PI, 
including: 
1) Provide study training relevant and pertinent to the involvement of personnel conducting study 
activities and investigator responsibilities 
2) Technical support will be provided during study phase. 
3) Technical support will be under the supervision of a study investigator, but no data entry on the 
eCRF shall be performed by Medtronic personnel or their representatives at investigational centers. 
4) Technical support to conduct device interrogations.  
 
In the applicable participating sites where sponsor is involved in subject device trainings, the sponsor’s 
representatives providing technical support will be listed on the sponsor technical support list. 
The sponsor shall avoid improper influence on, or inducement to, the subject, monitor, any investigator(s) 
or other parties participating in or contributing to this study. 
15.3 Investigator’s Responsibilities 
Per ISO14155:2020, an investigator means “individual member of the investigation site team designated 
and supervised by the PI at an investigation site to perform critical clinical-investigation-related procedures 
or to make important clinical-investigation related decisions.” 
 

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Each investigational center shall designate a primary investigator who will have overall responsibility for 
the conduct of the investigation at the investigational center. 
 
The primary investigators (and co-investigators if applicable) are responsible for conducting the study in 
accordance with this CIP, CTA, ISO14155:2020, applicable regulations, and any conditions of approval 
imposed by the reviewing EC or regulatory authority requirements. The investigator’s responsibilities 
include but are not limited to: 
 
• 
Conduct of investigation in accordance to International guidelines for clinical trials on medical 
devices ISO 14155:2020, to meet responsibilities with respect to protect human subjects and 
ensuring the integrity of the data from clinical investigations. This guidance is also intended to 
clarify regulatory authority’s expectations concerning the investigator’s responsibility:  
1) to supervise a clinical study in which some study tasks are delegated to 
employees or colleagues of the investigator or other third parties, and  
2) to protect the rights, safety, and welfare of study subjects. 
• 
Protecting the rights, safety, and welfare of subjects under the investigator’s care 
o 
Providing reasonable medical care for study subjects for medical problems that arise during 
participation in the trial that are, or could be, related to the study intervention 
o 
Providing reasonable access to needed medical care, either by the investigator or by 
another identified, qualified individual (e.g., when the investigator is unavailable, when 
specialized care is needed) 
o 
Adhering to the CIP so that study subjects are not exposed to unreasonable risks 
• 
Controlling devices under investigation  
• 
Providing adequate supervision of those to whom tasks have been delegated. The investigator 
is accountable for regulatory violations resulting from failure to adequately supervise the 
conduct of a clinical study.  
• 
Ensuring that the requirements for obtaining informed consent are met in accordance with ISO 
14155:2020 
• 
Supervising the use of investigational device. An investigator shall permit an investigational 
device to be used only with subjects under the investigator’s supervision. An investigator shall 
not supply an investigational device to any person not authorized to receive it. 
• 
Disposing of device properly. Upon completion or termination of a clinical investigation or the 
investigator’s part of an investigation, or at the sponsor’s request, an investigator shall return 
to the sponsor any remaining supply of the device or otherwise dispose of the device as the 
sponsor directs.  
• 
Allowing study devices to be used only with subjects under the investigator’s supervision and 
to supply study devices only to persons authorized to receive it 
• 
Ensuring that investigational center staff are adequately trained to perform their assigned 
duties 
• 
Maintenance of accurate, complete, and current records relating to the investigator’s part of 
an investigation, to include: 
o 
attribution, legibility, and timeliness of source data 
o 
all relevant correspondence with another investigator, an EC, the sponsor, a monitor, or 
regulatory authority, including required reports 

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o 
records of receipt, use or disposition of study devices 
o 
records of each subject’s case history and exposure to the device, including information 
reported in the eCRFs and in all other required reports 
o 
the CIP, with documents showing the dates of and reasons for each deviation from the CIP 
 
any other records the regulatory authority requires to be maintained by regulations or by 
specific requirement for a category of investigations or a particular investigation 
• 
Preparation and submission to Medtronic and, when required, regulatory authority and the 
reviewing EC, the following complete, accurate, and timely reports: 
o 
any reportable AEs (see Section 11) occurring during an investigation 
o 
progress reports on the investigation as required by the regulatory authority and EC 
o 
any deviation from the CIP made to protect the life or physical well-being of a subject in 
an emergency 
o 
any use of the device without obtaining informed consent 
o 
any further information requested by the regulatory authority and EC about any aspect of 
the investigation 
• 
Permitting regulatory authorities to inspect and copy any records pertaining to the investigation 
including, in certain situations, those which identify subjects  
• 
Meeting with the monitor to discuss study progress and findings 
• 
Ensuring that investigational center resources are adequate to fulfill the obligations of the study 
• 
Ensuring completion of eCRF to include entry and addressing discrepancies in a timely fashion 
and approving selected eCRFs.  
 
Only authorized study personnel as listed on the Delegation of Authority Log are permitted to consent 
subject’s parent(s)/legal guardian(s), receive, dispense, dispose of and return investigational products, 
conduct subject visits, insert devices, and enter data on eCRFs. These tasks may be delegated by the 
investigator. However, the investigator is ultimately responsible to ensure investigational center-staff are 
qualified and perform the tasks that have been delegated to them correctly. In addition, the investigator is 
responsible for the conduct of investigational center in the execution of the clinical trial. 
16 Study Administration 
16.1 Training of Clinical Staff 
Training of the investigational center staff on the conduct of the study and system being studied will be 
initiated before the CIP is implemented, depending on their role listing on the Delegation of Authority Log, 
as per Training Plan. Training may contain both lecture and hands-on experience. 
 
The PI is responsible for ensuring that investigational center staff are trained to perform their assigned 
duties per Delegation of Authority Log. Individual investigational center staff must be appropriately trained 
prior to performing study related tasks.  
16.2 Monitoring 
Monitoring visits may be conducted at the start, during and at the closure of the clinical study in accordance 
with Medtronic SOPs and the Monitoring Plan. At minimum, it will be verified whether signed and dated ICF 

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have been obtained from each subject’s parent(s)/legal guardian at the point of enrollment and that AEs 
discussed in Section 11 were reported via completion of the AE eCRFs. More details regarding the 
monitoring activities (frequency of monitoring visits, planned extent of source data verification) are 
described in the Monitoring Plan. 
16.2.1 Accessibility of Investigational Center Staff and Study Materials 
The PI(s), his/her delegate(s) and the study coordinator(s) shall be accessible to Medtronic field personnel, 
monitor, regulatory authority personnel, and the Clinical Study Manager. This accessibility is of particular 
importance for reviewing data in the eCRF. Access to subject’s medical files for source data verification will 
need to be granted prior to any monitoring visits.  
16.2.2 Audits and Investigational Center Inspections 
In addition to regular monitoring visits, the sponsor may conduct audits at participating investigational 
centers. The purpose of an audit is to verify the adequate performance of the clinical study related activities 
independent of the employees involved in the clinical study. Regulatory authorities may also perform 
inspections at participating investigational centers. Any regulatory authority inspection announcements 
shall be forwarded immediately to the Clinical Study Manager. 
 
The Investigator and/or institution shall permit sponsor and regulatory authorities direct access to source 
data and documents, taking into account any restrictions due to local law, to perform clinical study-related 
monitoring, audits, EC review, and regulatory inspections. 
16.2.3 Investigational Center Disqualification 
Sponsor and/or the EC retain the right to disqualify an investigational center and remove all study materials 
at any time. Specific instances that may precipitate investigational center disqualification include but are 
not limited to: 
 
• 
Unsatisfactory subject enrollment with regards to quantity. 
• 
Persistent non-compliance to protocol procedures on the part of an investigator/investigational 
center  
• 
Inaccurate, incomplete, and/or untimely data recording on a recurrent basis. 
• 
The incidence and/or severity of adverse experiences in this or other studies indicating a 
potential health hazard caused by the device. 
• 
Unsatisfactory accountability of investigational devices. 
 
A written statement fully documenting the reasons for such a termination will be provided to sponsor, the 
EC, investigational center(s) and other regulatory authorities, as required. 
16.3 Data Management 
16.3.1 Electronic Case Report Forms (eCRFs) 
The investigator must ensure accuracy, completeness and timeliness of the data reported in the eCRFs and 
in all other required reports. Data reported on the eCRFs, which are derived from source documents, such 

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as subject medical records, must be consistent with the source documents and the discrepancies need to 
be justified in a documented rationale. 
 
Only authorized persons can complete eCRFs. eCRFs shall be signed by investigational center staff as 
specified on the Delegation of Authority Log included in the Investigator Site File. The EDC system maintains 
an audit trail on entries, changes, and corrections in the eCRFs.  
 
A copy of the eCRFs to be used in this clinical study is available under a separate cover upon request to 
the sponsor and in the Investigator Site File.  
 
Investigational centers will be trained to the use of the eCRFs. Access to final eCRFs for study conduct will 
be granted after training is performed and prior to patient’s enrollment.  
16.3.2 CareLink Personal/CareLink System Software 
During the course of the study, subject’s BG values may be assessed from the Accu-Chek Guide Link study 
meter. The SG values may be assessed from the study pump. The study pump will be uploaded in CareLink 
Personal/CareLink system software by the investigator or designated investigational center staff and 
subject’s parent/legal guardian at home. The system uses TLS technology, which encrypts all data it stores 
(21 CFR Part 11 compliant). The data in the different databases are linked to each other via the subject’s 
ID. 
16.3.3 Questionnaires 
The questionnaires will be provided in local language in the countries. Subject’s parent/legal guardian will 
be provided a link to complete the questionnaires online or a paper copy. Refer to CIP342 Questionnaire 
Guide. If the online link cannot be accessed due to technical problems, subject’s parent/legal guardian will 
complete the questionnaire using a paper format. The investigator, or designated investigational center 
staff, will then enter the subject’s parent/legal guardian responses from the paper questionnaires to online 
once it becomes available. If paper format is used, the investigator or designated investigational center 
staff should maintain the original paper source in the subject’s source file. 
16.3.4 Paper Study Worksheets 
All investigational centers will receive paper worksheets, which specify the required data collection in the 
CRFs, and some additional instructions to ensure correct completion. The study worksheets are a 
supplement of the patient’s hospital/clinic file and completed worksheets might be considered as source 
documents. Only authorized persons can complete the worksheets as specified on the Delegation of 
Authority Log included in the Investigator Site File. 
16.3.5 Time Windows for Completion and Submission of Case Report Forms 
It is expected that eCRFs are completed in a timely manner with the exception of the reportable AEs (see 
Section 11). After data entry, eCRFs should be submitted (i.e., saved) so that monitors can proceed with 
data verification without delay. 

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16.3.6 Data Review and Processing 
Data management will be done according to sponsor SOPs and the Data Management Plan for this clinical 
study.  
 
Collected data will be reviewed for completeness, correctness, and consistency, as per the monitoring plan. 
In case of issues, queries will be entered on the respective eCRF for the investigator to complete, correct, 
or comment on the data.  
16.4 Direct Access to Source Data/Documents 
The subject’s clinic file, CareLink Personal/CareLink system software data, laboratory reports and source 
documents are handled as source data.  
 
Medtronic clinical representatives or delegates will be granted access by the investigational center to all 
source documents including electronic source documents or copies of electronic source documents, 
completed worksheet if applicable, for the purposes of monitoring, audit, or inspection.  
16.5 Confidentiality 
The investigator will ensure that the subject’s anonymity is maintained. Subjects will not be identified in 
any publicly released reports of this study. All records will be kept confidential to the extent provided by 
federal, state and local law. The study monitors and other authorized representatives of the sponsor may 
inspect all documents and records required to be maintained by the investigator, including but not limited 
to, medical records. The investigator will inform the subject’s parent/legal guardian that the above-named 
representatives will review their study-related records without violating the confidentiality of the subject’s 
parent/legal guardian. All laboratory specimens, evaluation forms, reports, and other records that leave the 
investigational center will be identified only by the subject ID code in order to maintain subject 
confidentiality. All records will be kept locked and all computer entry and networking programs will be done 
with coded numbers only. Study data may also be made available to third parties, e.g., in the case of an 
audit or inspection performed by regulatory authorities, provided the data are treated confidentially and 
that the subject’s privacy is guaranteed. 
16.6 Liability and Subject Compensation 
 
Travel fees to the site may be reimbursed for study specific visits if required by local regulations.  
16.6.1 Insurance  
Medtronic International Trading Sarl is a wholly owned subsidiary of Medtronic, 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 local law and custom concerning specific 
insurance coverage. If required, a Clinical Trial insurance statement/certificate will be provided to the EC 
or regulatory authority. 

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16.7 CIP Amendments 
An investigator or study team member can propose any appropriate modification(s) of the CIP or study 
device/product or study device/product use. Medtronic will review this proposal and decide whether the 
modification(s) will be implemented.  
 
Sponsor can decide to review the CIP based on new information, or for other reasons, and will submit any 
amendment to the CIP, including a justification for this amendment, to the appropriate regulatory authority 
for their approval or as notification, and to the investigators to obtain approval from their EC. The 
investigator will only implement the amendment after the sponsor has obtained regulatory authority 
approval (if applicable) and the amendment has been approved by the EC. Administrative amendments to 
the CIP will be submitted to the EC/IRB for notification. 
16.8 Investigational Center Compensation 
Medtronic contracts with participating institutions/investigators through a CTA that defines the scope and 
responsibilities and associated compensation related to carrying out the obligations under a clinical study 
sponsored by Medtronic. 
16.9 Records and Reports 
16.9.1 Investigator Records 
At a minimum, the following records must be kept by the investigator: 
• 
All essential study documents and correspondence that pertains to the clinical study 
• 
CIP and, if applicable, any amendments 
• 
IB/report of prior investigations and/or user guide 
• 
Medtronic and EC-approved Subject ICF 
• 
EC and regulatory authority approval or notification 
• 
Fully signed clinical study agreements (i.e., including Investigator Statement and Signature 
Page, Clinical Trial Agreement and Confidential Disclosure Agreement) 
• 
Completed Delegation of Authority Log  
• 
Training documentation of all investigational center staff 
• 
Subject Screening log and/or subject ID log  
• 
Signed, dated and fully executed Subject ICF  
• 
Source documentation 
• 
Fully executed eCRFs and corrections  
• 
Report of AEs and DDs 
• 
Device accountability records 
• 
CIP Deviation/ CIP Non-Compliance, if any 
• 
Current signed and dated CV of PI (and key study team members if required per local 
requirements) 
• 
Study reports 
 

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16.10 Record Retention 
The sponsor and investigator will retain all records and documents pertaining to this study. They will be 
available for inspection by the appropriate regulatory authorities. In addition, the investigator will retain the 
source documents from which the information entered on the eCRF was derived. These records are to be 
retained in a secure storage facility maintained by the investigational center until 2 years (or longer if local 
laws require) after approval of the above-listed study devices or termination of the study, whichever is 
longer. The investigator should not dispose of these records without the approval of the sponsor. 
16.11 Suspension or Early Termination 
Sponsor or a regulatory authority may decide to suspend or prematurely terminate the clinical study (e.g., 
if information becomes available that the risk to study subject is higher than initially indicated, lack of 
enrollment or because of a business decision). If the clinical study is terminated prematurely or suspended, 
sponsor shall promptly inform the investigators and regulatory authorities (if applicable) of the termination 
or suspension and the reason(s) for this. The investigator shall then promptly inform the reviewing EC and 
the study subject’s parent/legal guardian as applicable by local laws and regulations.  
16.11.1  Early Investigational Center Suspension or Termination 
Sponsor, EC or a regulatory authority may decide to suspend or prematurely terminate an investigational 
center (e.g., in case of expiring approval of the reviewing EC, non-compliance to the CIP, or lack of 
enrollment). Suspended clinical studies cannot be resumed without permission from EC and regulatory 
authority (if applicable). If an investigational center is suspended or prematurely terminated, sponsor shall 
promptly inform the investigator(s) of the termination or suspension and the reason(s) for this. The 
investigator shall then promptly inform the reviewing EC and the study subjects as applicable by local laws 
and regulations.  
 
When the risks are found to outweigh the potential benefits or when there is conclusive proof of definite 
outcomes, investigators must assess whether to continue, modify, or immediately stop the clinical study in 
the respective investigational center and immediately inform the sponsor and EC, if applicable. 
16.11.2 Subject Follow-Up In Case of Termination 
In case of early investigational center suspension or termination, all subject’s parent/legal guardian should 
be contacted to plan an early termination visit at the investigational center. All efforts will be made to 
complete and report all study observations at the time of termination. The subject will return the study 
devices to the investigational center. Following suspension or early termination, subjects will receive 
standard medical care from their own health care providers. 
16.12 Study Close-Out 
At the time of a study close-out, after last patient last visit, the investigators will be notified by sponsor. 
Appropriate notification/report to EC and regulatory authority will be provided if required per local laws and 
regulations. 
16.13 Publication and Use of Information 
Publications from this CIP will be handled according to SOPs and as indicated in the CTA. A separate 
Publication Plan will describe the publication strategy and processes for publications of the study. 

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Publications will adhere to authorship criteria defined by the International Committee of Medical Journal 
Editors (ICMJE, Uniform requirements for manuscripts submitted to biomedical journals, www.icmje.org).  
Individual authorship criteria defined by the target journal or conference will be followed when it differs 
from ICMJE criteria. 
Authors, including Medtronic personnel, must at a minimum meet all of the conditions below: 
• 
Substantial contributions to conception and design of the work, or the acquisition, analysis, 
or interpretation of data for the work; AND 
• 
Drafting the work or revising it critically for important intellectual content; AND 
• 
Final approval of the version to be published; AND 
• 
Agreement to be accountable for all aspects of the work in ensuring that questions related 
to the accuracy or integrity of any part of the work are appropriately investigated and 
resolved.  
 
Decisions regarding authorship and contributor-ship will be made by a publication planning committee. The 
selected authors will be responsible for drafting the publication. All selected authors must fulfill the 
authorship conditions stated above to be listed as authors, and all contributors who fulfill the conditions 
must be listed as authors. 
 
The contents of this CIP, documentation, and results pertaining to this study are confidential and may not 
be published or disclosed without the written consent of Medtronic. The identity of the subjects may not 
be disclosed, unless required by law, to any persons not immediately involved in the study or the study 
procedures. The study will be publicly registered on http://www.clinicaltrials.gov prior to subject 
enrollment. Study results, when available, will be posted in this database. 
17 References 
1. 
Federation ID. IDF Diabetes Atlas, 9th edn. International Diabetes Federation. 
http://www.diabetesatlas.org. Published 2019. Accessed. 
2. 
Carlson AL, Sherr JL, Shulman DI, et al. Safety and Glycemic Outcomes During the MiniMed 
Advanced Hybrid Closed-Loop System Pivotal Trial in Adolescents and Adults with Type 1 
Diabetes. Diabetes Technol Ther. 2022;24(3):178-189. 
3. 
Arrieta A, Battelino T, Scaramuzza AE, et al. Comparison of MiniMed 780G system performance in 
users aged below and above 15 years: Evidence from 12,870 real-world users. Diabetes Obes 
Metab. 2022. 
4. 
Cryer PE. Defining and reporting hypoglycemia in diabetes: A report from the American diabetes 
association workgroup on hypoglycemia. Diabetes Care. 2005;28(5):1245-1249. 
5. 
Hyperglycemic Crises in Diabetes. Diabetes Care. 2004;27(SUPPL. 1):S94-S102. 
6. 
Food and Drug Administration Center for Drug Evaluation and Research and Center for Biologics 
Evaluation and Research. Guidance for Industry: Non-Inferiority Clinical Trials to Establish 
Effectiveness. In: Maryland F, ed2016. 
7. 
Tuomaala AK. Glycemic outcomes and safety with MiniMed 780G system in children with type 1 
diabetes aged 2‐6 years. Diabetes Technology & Therapeutics. 2022;24(S1):A-1-A-237. 

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18 Appendices 
18.1 Names and addresses 
18.1.1 Investigational Centers and EC 
The names and addresses of investigators, coordinating clinical investigator if appointed, and participating 
investigational centers will be kept under separate cover.  
 
This list will be provided to the participating investigators and sponsor shall inform the investigators in case 
changes occur in the list of participating sites. The most current list is available upon request.  
 
18.1.2 Sponsor Contact Information 
The names and addresses of sponsor representatives, including monitors will be kept under separate cover. 
This list will be provided to the participating investigators and sponsor shall inform the investigators in case 
changes occur in the list. The most current list is available upon request. 
18.1.3 Vendors Contact Information 
The names and addresses of vendors providing service for the study will be kept under separate cover. 
The most current list of the contact persons is available upon request.  
18.2 Labeling of Devices 
The current labels and IFUs for the study devices will be provided to the investigators in a separate cover.  
18.3 Sample Consent Materials 
Samples of the following consent forms/materials will be provided under separate cover. 
18.4 Sample CRF 
Case Report Form is provided under a separate cover upon request to the Sponsor. 
18.5 Questionnaires 
The questionnaires are available in local language and will be provided under a separate cover upon request 
to the sponsor.   
18.6 Sample Investigator Agreement 
Sample Investigator Agreement will be provided under a separate cover upon request to the Sponsor. 
18.7 List of Consumables and Accessories 
A list of all compatible consumables and accessories will be kept under a separate cover upon request to 
the Sponsor. 
 
 

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19 Version History 
 
Version 
Summary of changes 
Justification of changes 
Potential impact of the 
change on performance, 
effectiveness, or safety 
or other endpoints 
Identification 
of the affected 
study 
documents 
Author(s)/
Title 
A 
Not Applicable, New Document  
Not Applicable, New 
Document  
Not Applicable, New 
Document 
Not Applicable, 
New Document 
 
, Sr. 
Medical 
Writer 

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B1) Synopsis and Section 8.3 Inclusion criteria: 
Inclusion criteria#5 Novorapid™ added together 
with Novolog throughout the document 
 
2) Synopsis and Section 8.4 Exclusion Criteria: 
Exclusion criteria #1: added “untreated” to coeliac 
disease 
 
3) Synopsis and Section 8.4 Exclusion criteria: 
Exclusion criteria #2: comma removed after GLP-1 
 
4) Section 5.3 Study Oversight and subsequent 
section 5.3.1 Steering Committee modified. 
Removal of the sentence ‘and external physicians 
with an expertise in endocrinology and the 
management of diabetes including insulin pumps 
and CGM’ 
 
5) Section 6.28 CareLink personal software and 
Section 6.29 CareLink System software:  reference 
to “Microsoft® Internet Explorer” browser delated 
 
6) Section 9.1 – Visit 1: deleted the word “severe” 
from severe DKA, page 32 
 
 
7) Table 6 Pump setting correction f typos 
 
 
8) Section 14.4 Analysis Populations and Handling of 
Missing Data, Error: PP population definition was 
changed as following:” The PP population will 
include all randomized subjects, excluding any 
subject with at least one of the following deviations: 
1) Novorapid is the brand 
name used in Europe for 
Insulin Aspart 
 
2) Omitted in previous 
version by mistake  
 
 
3) Typographic mistake in the 
previous version 
 
4) No external Steering 
Committee was finally 
convene, as DMC and CEC 
are responsible for study 
oversight duties.   
 
 
5) Obsolete browser 
 
 
 
6) Typographic mistake in the 
previous version 
 
 
7) Typographic mistake in the 
previous version 
 
8) Requested from MHRA to 
define study deviation for PP 
exclusion  
 
 
1) None  
 
 
 
2) None 
 
 
 
3) None  
 
 
4) None 
 
 
 
 
 
 
5) None 
 
 
 
6) None 
 
 
 
7) None 
 
 
8) None 
 
 
 
 
ICF 
 
, Sr. 
CRS 

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Version 
Summary of changes 
Justification of changes 
Potential impact of the 
change on performance, 
effectiveness, or safety 
or other endpoints 
Identification 
of the affected 
study 
documents 
Author(s)/
Title 
Auto Mode use during the active study phase is less 
than 75% 
Sensor use during the active study phase is less 
than 70% 
Subject did not complete the study phase 
Subject did not meet screening criteria but 
continued the study 
Subject did not meet randomization criteria but 
continued the study 
 
9) Section 14. 5.1 Analysis primary endpoint, the 
following addition were made: 
A. Rational on 7.5% for choosing 7,5 % non-
inferiority margin 
B: Removal of the phrase: “If the p value of the 
coefficient of randomization sequence is >0.1, 
randomization sequence will be removed from the 
model” 
 
10) Update to template version E 
 
 
 
 
 
 
 
 
 
 
9) MHRA requested rational 
for choosing 7,5% non-
inferiority margin and to 
request randomization 
sequence will be included in 
the model to evaluate the 
primary endpoint.  
 
 
10) New template version 
released on 26MAY2022 
 
 
 
 
 
 
 
 
 
 
9) None 
 
 
 
 
 
 
 
 
10) None  
C 
1) Protocol first page: EUDAMED Number added 
1) Not available at the time of 
the previous Protocol update 
 
1) None 
ICF, CRF 
 
 Pr. 
CRS 
2) Glossary updated with new acronym: BLE, NGSP 
 
2) To be exhaustive with this 
protocol update 
 
2) None 
 
3) Synopsis and section 6 Product updated to 
include details about the 2 new investigational 
devices for the Continuation Phase: MiniMed 780G 
BLE2.0 Insulin Pump and Disposable Sensor 5 
3) Added devices to the study 
for the continuation phase 
which subsequently requires 
3) None 
 
 
 

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Summary of changes 
Justification of changes 
Potential impact of the 
change on performance, 
effectiveness, or safety 
or other endpoints 
Identification 
of the affected 
study 
documents 
Author(s)/
Title 
• 
Table 2, 3 and 4 updated 
• 
Figure 5 added 
• 
Section 6.2.7 DS5 Sensor added 
 
4) Section 6.2: paragraph from the CIP342 Clinical 
Investigation Plan Addendum Slovenia Version 1.0 
2023 01 23 incorporated. This updated Protocol 
version obsoletes Addendum for Slovenia 
 
changes throughout the 
protocol 
 
 
4) Slovenian CIP Addendum 
created based on Slovenia CA 
request. Incorporated into 
the main CIP for other 
countries to benefit from it 
 
 
 
 
 
4) None 
 
5) Synopsis and Section 5 Study Design:  
• 
updated to include 2 new investigational 
devices for the Continuation Phase: MiniMed 
780G BLE2.0 Insulin Pump and Disposable 
Sensor 5 
• 
Extension of Period 1 duration to 
accommodate subjects enrolled for the 
continuation phase only. It is changed from 
12 weeks to 18 weeks +/- 6 weeks 
• 
Randomization added at V13 to assign one 
of the 2 treatments  
 
 
 
 
6) Study design graph updated (Synopsis Figure 1, 
Synopsis Figure 2, Figure 3) 
5) The new sensor DS5 is the 
last generation one, 
combining with the 
transmitter. The applicable 
being simpler, subject burden 
is decreased. This sensor 
requires the updated version 
of the 780G insulin pump, the 
BLE2.0 version.  
Duration of continuation 
phase extended based on 
added devices 
 
 
6) Enrolment could be 
opened for the Continuation 
phase only to secure 
statistical analysis of the 
Continuation Phase 
endpoints. 
5) None 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6) None 
 
 
7) Synopsis Study visit schedule  
 
7) Per updated Study Design 
 
 
7) None 

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effectiveness, or safety 
or other endpoints 
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updated to include subjects enrolling for the 
continuation phase only 
 
 
8) Synopsis and Sample Size & Investigational 
Centers, Section 8.1 Study Population, Section 8.2 
Subject Enrollment: 
• 
Specification about completed subjects 
needed for both study phases 
• 
Interim analysis added to evaluation 
sample size and open enrollment for the 
continuation phase only 
 
8) Per updated Study Design 
 
8) None 
 
 
9) Synopsis Duration and Section 5.1 updated to 
reflect study design changes, extending the study 
duration subjects joining for the Continuation phase 
only 
 
 
9) Per updated Study Design 
 
9) None 
10) Synopsis and section 8.3 Exclusion criteria 
Exclusion criteria #6 updated to correct Control IQ 
name and be specific about Omnipod 5 
 
 
10) Typographic mistake and 
clarification about OmniPod 5 
being an advanced hybrid 
closed loop therapy 
10) None 
11) Synopsis Statistical Analysis for Endpoints and 
Hypothesis, Section 4 and Section 14: 
• 
Endpoints divided for each study phase 
• 
Study Phase endpoints clarified 
• 
Continuation Phase primary and secondary 
endpoints added 
 
11) Per updated Study Design 
11) Continuation Phase 
primary and secondary 
endpoints added 
 
12) Section 3.1 Background 
• 
Paragraph added about the 2 new 
investigational devices used to the 
Continuation Phase 
12) Per updated Study Design 
 
 
 
12) None 
 
 
 

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effectiveness, or safety 
or other endpoints 
Identification 
of the affected 
study 
documents 
Author(s)/
Title 
 
13) Table 1 AHCL Clinical Studies updated with most 
recent information on status and Studies 
 
 
14) Section 5.3 Study Oversight and subsequent 
section 5.3.1 Steering Committee deleted 
 
 
13) To reflect and update 
status at the time of the 
revision 
 
14)  The internal overview 
procedures ensure sufficient 
oversight and guidance for 
the conduct of the trial as 
well as evidence 
dissemination and ensure 
that appropriate stakeholders 
are contacted. This obsoletes 
the need of an internal 
Steering Committee. 
 
 
13) None 
 
 
 
14) None 
 
15) Section 8.5 Randomization Criteria and Section 
8.5.2 Continuation Phase added 
 
16) Section 9 Study Procedures and subsequent 
sections 
 
 
15) Per updated endpoints 
 
 
16) Per updated Study Design 
 
15) None 
 
 
16) None 
 
 
17) Section 9.1 Schedule of Events 
• 
Figure 10 Visit schedule scheme updated 
• 
Visit 1A, 2A and 3A added for the subjects 
enrolling for the Continuation Phase only 
• 
Visit 12 window start from visit 1A added 
on top of Visit 11 
• 
Visit 13  
o 
window start from visit 1A added 
on top of Visit 11 
o 
duration extended from 12 weeks 
to 18 weeks +/- 6 weeks 
17) Per updated Study Design 
 
 
 
 
 
 
 
 
 
 
17) None 
 
 
 
 
 
 
 
 
 
 

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effectiveness, or safety 
or other endpoints 
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study 
documents 
Author(s)/
Title 
o 
procedures added (questionnaires 
collection, HbA1c sample analyzed 
at Central Lab, randomization, 
training on new devices based on 
randomization) 
• 
Visit 14  
o 
window start from visit 13 
o 
retraining added about new 
devices (780G BLE 2.0 insulin 
pump and DS5) 
• 
Visit 15 
o 
window start from visit 13 
o 
HbA1c samples analyzed at 
Central Lab in place of local lab 
 
18) Table 5. Visit Details and Activities updated 
accordingly 
 
19) Section 9.1.1 Pump Settings and Sensor Site  
 
20) Sentence added to guide subjects enrolling for 
the Continuation Phase only 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
18) Per updated Study Design 
 
 
19) Per updated study visits 
 
20) Per updated Study Design 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
18) None 
 
 
19) None 
 
20) None 
 
 
 
 
 
 
 
21) Section 9.1.2 Unscheduled Visit updated with 
DS5 sensor training 
21) Per updated Study Design 
21) None 
 
22) Section 9.1.3 Early Termination Visit updated to 
specify analysis location between local and central 
lab 
 
 
22) Per updated Study Design 
 
22) None 
23) Section 9.3.1 Reconsent for the updated 
Continuation Phase 
 
 23) Per updated Study 
Design 
 
 
23) None 
 
 
 

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Potential impact of the 
change on performance, 
effectiveness, or safety 
or other endpoints 
Identification 
of the affected 
study 
documents 
Author(s)/
Title 
24) Paragraph added to offer the possibility for the 
subject to stay until the end of the study phase in 
case of no reconsent 
24) Per updated Study Design 
 
24) None 
 
 
25) Section 9.4 Randomization and Treatment 
Assignment updated to include second 
randomization added at V13 
 
26) Section 9.4.2 Continuation phase added 
 
25) To be in line with 
updated endpoints of the 
Continuation Phase 
 
26) Per updated Study Design 
 
 
25) None 
 
 
 
26) None 
 
27) Section 9.5.3 HbA1c updated to reflect HbA1c 
samples analyzed at the Central Lab under National 
Glycohemoglobin Standardization Program (NGSP) 
27) Per updated Study Design 
 
 
 
27) None 
 
28) Section 10 Risks and Benefits updated about the 
2 new investigational device, sentence added: There 
is no additional risks associated with the new 
devices of the continuation phase. 
28) Per updated Study Design 
28) None 
 
 
 
29) Section 11.4 Notification of Adverse Events 
 
30) Table 9 updated (previously Table 10) to reflect 
report requirements 
 
29) Per updated Study Design 
 
30) Per updated Study Design 
 
29) None 
 
30) None 
 
31) Section 12.3 Central Lab added and Table 11 
added 
 
31) Per updated Study Design 
 
31) None 
 
32) Administrative changes throughout the 
document 
 
32) Updates made as needed 
to formatting throughout 
document 
 
32) None 
D 
1) Updated Table 4 to clarify return of unused DS5 
1) Correction 
1) None 
Not applicable 
 
, Sr. 
Medical 
Writer 

CIP342 Clinical Investigation Plan 
 
 
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CONFIDENTIAL 056-F275 Rev E Clinical Investigation Plan Template 
Version 
Summary of changes 
Justification of changes 
Potential impact of the 
change on performance, 
effectiveness, or safety 
or other endpoints 
Identification 
of the affected 
study 
documents 
Author(s)/
Title 
 
2) Updated Section 8.1 to add “approximately” 
 
 
2) To include sites that are 
enrolling less than 5 
 
2) None 
 
 
 
 
 Sr. 
CRS 
 
3) Updated Table 5 to add clarification about remote 
management and make footnotes uniformed 
3) Correction 
 
3) None 
 
 
 
 
4) Updated Section 9.3.1 to add “amended” 
 
4) Correction 
 
 
4) None 
 
 
 
 
5) Updated Section 14.4 for clarity around analysis 
 
5) Per MHRA request 
 
5) Yes 
 
 
 
 
6) Updated Section 14.5.1 to add rationale around 
non-inferiority margin and correct margins 
 
6) Per MHRA request 
 
 
6) Yes 
 
 
 
 
 
7) Updates to formatting/spelling mistakes 
throughout 
7) Corrections  
 
7) None 
 
 
 
E 
1) updated Study Product Name to add DS5 
2) updated Objective (Synopsis and Section 4.1) to 
align with Continuation Phase objective  
3) updated Exclusion criteria (Synopsis and Section 
8.4)  
4) Updated Section 8.5.2 to correct a typo 
5) Updated section 9.1 to move reconsent 
procedure from V11 to V13 
 
1) Correction 
2) Per FIMEA request 
 
3) Correction 
 
4) Correction 
5) Correction 
 
1) None 
2) None 
 
3) None 
 
4) None 
5) None 
Not applicable 
 
 Pr. 
CRS