Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adult and Pediatric Subjects Utilizing Lyumjev® Insulin Lispro-aabc
Phase: NA
Conditions: Type 1 Diabetes
Sponsor: Medtronic MiniMed, Inc.

 
Study Title Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 
Adult and Pediatric Subjects Utilizing Lyumjev® insulin lispro-aabc  
NCT Number NCT05325294 
Document Description CIP335 Clinical Investigation Plan (Version E) 
Document Date 
10-MAR-2023  
 
 

CIP335 Clinical Investigation Plan 
 
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Table of Contents 
Table of Contents ...................................................................................................................... 3
1. 
Glossary .............................................................................................................................. 6 
2. 
Synopsis ............................................................................................................................. 8 
3. 
Introduction ..................................................................................................................... 27 
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Objectives and Endpoints ................................................................................................. 27 
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Study Design .................................................................................................................... 29 
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Product Description.......................................................................................................... 36 
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Study Site Requirements ................................................................................................. 46 
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Selection of Subjects ........................................................................................................ 47 
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Study Procedures ............................................................................................................. 49 
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Risks and Benefits ........................................................................................................ 73 
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Adverse Events ............................................................................................................. 80 
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Data Review Committees ............................................................................................. 85 
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Device Deficiencies and Troubleshooting ..................................................................... 90 
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Statistical Design and Methods .................................................................................... 90 
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CIP335 Clinical Investigation Plan 
 
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Ethics ............................................................................................................................ 95 
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Study Administration .................................................................................................... 98 
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17. 
References .................................................................................................................. 103 
18. 
Appendices ................................................................................................................. 104 
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19. 
Version History ........................................................................................................... 105 

CIP335 Clinical Investigation Plan 
 
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2. Synopsis 
Title 
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Form 
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Page 14 of 106 
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Synopsis Figure 1. Study Visit Schedule 
 
Run-in Period
Office
Visit 1
Consent & 
Screening
Office/Virtual 
Office
Visit 2
Start Study 
Pump& CGM
Visit Schedule
Study Period
Phone 
Visit 11
Day 21 
(±3 days) 
after Visit 7
Phone 
Visit 10
Day 14
 (±3 days) 
after Visit 7
Phone
Visit 9
Day 7 (±2 
days) after 
Visit 7
Visit 1 to Visit 6 should be completed within 30 days.
Phone 
Visit 5
Day 7 (±2 
days) after 
Visit 2
Office/Virtual 
Office
Visit 6
Day 14 (±3 days) 
after Visit 2
Phone 
Visit 3
Day 1 after 
Visit 2
Phone 
Visit 4
Day 3 after 
Visit 2
Phone
Visit 8
Day 2 after 
Visit 7
Office/Virtual 
Office
Visit 7
Day 7 (-7 days) 
after Visit 6
Office/Virtual 
Office
Visit 12
Day 28 (+7 days) 
after Visit 7
Office/Virtual 
Office
Visit 13
Day 44 (±3 days) 
after Visit 7
Office/Virtual 
Office
Visit 14
Day 60 (+7 days) 
after Visit 7
Office/Virtual 
Office
Visit 15
Day 90 (+7 days) 
after Visit 7 EOS
 
 
 

CIP335 Clinical Investigation Plan 
 
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Safety and 
Monitoring/Risk 
Analysis 
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Device 
Deficiencies  
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Statistical 
Analysis for 
Endpoints and 
Hypothesis 
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3. Introduction 
3.1 Background 
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4. Objectives and Endpoints
4.1 Objectives 
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Timing
Settings/Conditions
Meal Size
Meal Type
Notes
Run-in 
Period 
between 
visits 5 and 7 
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Study Period,  
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13 
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Missed meal bolus
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Regular Sized Meal Challenge with Missed Meal Bolus:  
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Timing 
Settings/Conditions
Exercise 
duration
Notes
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CIP335 Clinical Investigation Plan 
 
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Safety Considerations with the Use of Lyumjev insulin: 
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5.1 Duration 
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6. Product Description 
6.1 Intended Use 
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6.2 General Overview of MiniMed 780G Insulin Pump System Components 
and Consumables 
Table 1. MiniMed 780G Insulin Pump: System Components and consumable materials 
Device name
MDT Model number/ 
part number
Device Regulatory Status
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6.3 Investigational Product 
6.3.1 MiniMed 780G Insulin Pump 
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6.4 Non-Investigational Product(s) 
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8. Selection of Subjects 
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9. Study Procedures
9.1 Schedule of Events 
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9.1.1 Study Visit Schedule & Scheduled Follow-Up Visit Windows 
Figure 4. Study Visit Schedule 
Run-in Period
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Visit 1
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Office/Virtual 
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Start Study 
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Visit Schedule
Study Period
Phone 
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Day 21 
(±3 days) 
after Visit 7
Phone 
Visit 10
Day 14
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after Visit 7
Phone
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Day 7 (±2 
days) after 
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Visit 1 to Visit 6 should be completed within 30 days.
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days) after 
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Day 14 (±3 days) 
after Visit 2
Phone 
Visit 3
Day 1 after 
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Phone 
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Day 3 after 
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Phone
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Office/Virtual 
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Visit 12
Day 28 (+7 days) 
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Office/Virtual 
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Visit 13
Day 44 (±3 days) 
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Office/Virtual 
Office
Visit 14
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Study Period 
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Visit 2 
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and 4**
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Visit 5 
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Virtual 
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Visit 7 
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8**
(Phone) 
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& 11
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Visit Window
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Day 1 
and Day 
3 after 
Visit 2  
Day 7 
(±2 
days) 
after 
Visit 2 
Day 14 
(±3 
days) 
after 
Visit 2  
Day 7  
(-7 
days) 
after 
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after 
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Day 7 (±2 
days),  
Day 14 (±3 
days), and 
Day 21 (±3 
days) after 
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Day 28 
(+7 
days) 
after 
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Day 44 
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days) 
after 
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Day 60 
(+7 
days) 
after 
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Day 90 
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Day 1 
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Day 7 
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after 
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Day 14 
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(-7 
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Page 57 of 106 
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Visit 12 
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Visit 15* 
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Day 1 
and Day 
3 after 
Visit 2  
Day 7 
(±2 
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after 
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Day 14 
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days) 
after 
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Day 7  
(-7 
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Day 28 
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Day 1 
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3 after 
Visit 2  
Day 7 
(±2 
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Day 14 
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Day 7  
(-7 
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Day 44 
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Day 7 
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9.4 Safety Monitoring/Risk Analysis 
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Serious Adverse Event (SAE) (ISO 14155:2020) 

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Page 84 of 106 
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12. Data Review Committees 
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Adverse Event 
Reference 
Reference 
Rate > 25 
years old 
Reference 
Rate 
15-25 years 
old 
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Reference 
Reference 
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13. Device Deficiencies and Troubleshooting 
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Device Deficiency (ISO 14155:2020) 
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14. Statistical Design and Methods 
14.1 General Aspects of Analysis 
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14.2 Subject Disposition 
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14.3 Subject Demographics and Baseline Characteristics 
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14.4 Endpoints and Hypotheses 
14.4.1.1 
Primary Safety Endpoint  
Age 18-80: 
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Age 7-17: 
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14.4.1.2 
Primary Effectiveness Endpoint  
 
Age 18-80: 
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14.4.1.3 
Analysis of Secondary Effectiveness Endpoints 
Age 18-80:
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14.4.2 Descriptive Endpoints 
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14.4.3  Safety Data Summarized 
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14.4.4  Device Deficiencies  
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14.4.5  Subject Feedback 
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14.5 Sample Size Considerations/Sample Size Justification 
14.5.1  Age 18-80 
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14.5.2  Age 7-17 
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16.8 Records and Reports 
16.8.1 Investigator Records 
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16.8.2 Investigator Reporting Responsibilities  
Table 6. Investigator Reporting Requirements 
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16.10 Suspension or Early Termination 
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16.10.1  Early Investigational Center Suspension or Termination 
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17. References 
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18. Appendices 
18.1 Names and addresses 
18.1.1 Investigational Centers and IRB 
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18.3 Sample Consent Materials 
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