Use of the Guardian™ Connect System With Smart Connected Devices
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Sponsor: Medtronic MiniMed, Inc.

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Clinical Investigation Plan (CIP) 
Study Title  Use of the Guardian™ Connect system with Smart Connected Devices 
CIP Identifier 331 
Study Product 
Name & Study 
Product Model 
Investigational Devices 
•  Insulin capture devices and associated apps 
o InPen™ Basal smart cap, also referred to as InCap (MMT-155) 
o InPen™ Diabetes Management app, Version 6.0.0  by 
Companion Medical 
o Adapter 1 FlexTouch (Levemir, Tresiba) (SPC-00789) 
o Adapter 2 KwikPen (Basaglar) (SPC-00790) 
o Adapter 3 SoloStar (Lantus) (SPC-00791) 
o Adapter 4 SoloStar (Toujeo) (SPC-00792) 
o Adapter 5 Max SoloStar (Toujeo Max) (SPC-00793) 
 
Investigational Devices for Subjects 2-13 Years of Age and 76-80 Years of Age 
•  Guardian™ Connect app 
•  Guardian™ Connect transmitter kit (MMT-7820) 
o Guardian™ Connect transmitter 
o One-press serter, referred to as the serter throughout the 
protocol  
o Tester  
o Charger 
 
FDA Approved Devices Used in an Investigational Manner  
•  Guardian™ Connect app 
•  Guardian™ Connect transmitter kit (MMT-7820) 
o Guardian™ Connect transmitter 
o One-press serter, referred to as the serter throughout the 
protocol  
o Tester 

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o Charger  
Non-Investigational Devices 
•  Guardian™ Sensor (3) (MMT-7020) 
•  Insulin capture devices and associated apps (type, time, amount) 
o Companion Medical InPen for use with Humalog, NovoLog, 
Fiasp™* U100 (rapid-acting only) (MMT-105) 
o InPen™ Diabetes Management app, Version 5.4.4 by 
Companion Medical 
•  Klue™ Health app by Klue, Inc. 
•  FoodPrint™ food logging app by Nutrino™   
•  Apple Watch™* with Health™ app  
•  Sleep tracking device such as Fitbit™* tracker 
•  Sponsor-provided smartphone (Android or iPhone) with pre-loaded 
apps and cellular service  
•  CareLink™ Personal software – referred to as CareLink Personal 
throughout this protocol  
•  CareLink™ system – referred to as CareLink Professional throughout 
this protocol  
•  CONTOUR™* NEXT ONE blood glucose meter – referred to as the 
study meter or BG meter throughout this protocol 
•  CONTOUR™* DIABETES app  
•  BodyGuardian® MINI cardiac remote monitor (BC2003) 
Description of CIP This study will collect sensor, insulin, sleep, activity and food/meal data for a 
minimum of 90 days of device wear (Phase 1) and up to a maximum of 9 
months of device wear (Phase 2) with optional insulin injection video capture 
and/or menstrual cycle tracking and/or cardiac monitoring in subjects with 
insulin-requiring diabetes 2-80 years of age. 
Sponsor Medtronic MiniMed, Inc. 
(“Medtronic”) 
18000 Devonshire St 
Northridge, CA 91325 
866.948.6633  
Document Version Version C 
Document 
Reference Number 
D00323255 
Version Date 08-JUN-2021 

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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. 

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Table of Contents 
 
Table of Contents 
...................................................................................................................... 4 
1 
Glossary ........................................................................................................................... 9 
1.1 Glossary 
............................................................................................................................... 9 
1.2 List of Trademarks .............................................................................................................. 10 
2 
Synopsis 
......................................................................................................................... 11 
3 
Introduction .................................................................................................................. 23 
3.1 Background ........................................................................................................................ 23 
3.2 Purpose 
.............................................................................................................................. 24 
4 
Objectives and/or Endpoints 
......................................................................................... 24 
4.1 Objectives .......................................................................................................................... 24 
4.1.1 Primary Objective(s) 
................................................................................................... 24 
4.2 Endpoints 
........................................................................................................................... 24 
4.2.1 Other Descriptive Endpoints ........................................................................................ 24 
4.3 Safety ................................................................................................................................ 24 
4.4 Device Deficiencies 
.............................................................................................................. 25 
5 
Study Design 
.................................................................................................................. 25 
5.1 Duration 
............................................................................................................................. 26 
5.2 Rationale 
............................................................................................................................ 27 
6 
Product Description 
....................................................................................................... 27 
6.1 Intended Population 
............................................................................................................ 27 
6.2 Investigational Devices 
........................................................................................................ 27 
6.2.1 Insulin capture devices and associated apps 
................................................................. 27 
6.3 Investigational Devices for Subjects 2-13 Years of Age and 76-80 Years of Age 
........................ 28 
6.3.1 Guardian Connect App 
................................................................................................ 28 
6.3.2 Guardian Connect Transmitter Kit ................................................................................ 28 
6.4 Non-Investigational Devices 
................................................................................................. 29 
6.4.1 Guardian Sensor (3) ................................................................................................... 29 
6.4.2 Insulin capture devices and associated apps (type, time, date, amount) 
.......................... 30 
6.4.3 Klue Health App by Klue, Inc. 
...................................................................................... 30 

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6.4.4 FoodPrint Food Logging App by Nutrino ....................................................................... 30 
6.4.5 Apple Watch with HealthKit 
......................................................................................... 31 
6.4.6 Fitbit tracker 
.............................................................................................................. 31 
6.4.7 Sponsor-provided Smartphone (Android or iPhone) with pre-loaded apps and cellular service
  
31 
6.4.8 CareLink system – commercially-approved software referred to as CareLink Professional 
throughout this protocol 
.......................................................................................................... 31 
6.4.9 CareLink Personal Software – commercially-approved software – referred to as CareLink 
Personal throughout this protocol 
............................................................................................. 32 
6.4.10 CONTOUR NEXT ONE blood glucose meter – referred to as the study meter or BG meter 
throughout this protocol 
.......................................................................................................... 32 
6.4.11 CONTOUR DIABETES App ........................................................................................... 32 
6.4.12 BodyGuardian MINI 
.................................................................................................... 33 
6.5 Anticipated Device Changes ................................................................................................. 33 
6.6 Product Accountability ......................................................................................................... 33 
6.6.1 Receipt and Inventory of Investigational Devices by Investigational Center ..................... 33 
6.6.2 Dispensing of Study Devices 
........................................................................................ 34 
6.6.3 Return or Disposal of Study Devices 
............................................................................. 34 
7 
Selection of Subjects 
..................................................................................................... 36 
7.1 Study Population 
................................................................................................................. 36 
7.2 Subject Enrollment 
.............................................................................................................. 36 
7.3 Inclusion Criteria 
................................................................................................................. 36 
7.4 Exclusion Criteria................................................................................................................. 36 
8 
Study Site Requirements 
............................................................................................... 37 
8.1 Study Site Activation............................................................................................................ 37 
9 
Study Procedures........................................................................................................... 38 
9.1 Schedule of Events 
.............................................................................................................. 38 
9.1.1 Study Visit Schedule & Scheduled Follow-up Visit Windows 
............................................ 38 
9.2 Scheduled  Follow-up Visit Windows for Phase 1 and Phase 2, Subjects Participating in Study for 
Over 90 Days and Up to 9 Months, Visit Activities 
.......................................................................... 42 
9.3 Unscheduled Visit 
................................................................................................................ 50 
9.4 Subject Consent 
.................................................................................................................. 50 
9.5 Medical Oversight 
................................................................................................................ 51 
9.5.1 Medical Staff 
.............................................................................................................. 51 

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9.5.2 Qualification 
............................................................................................................... 52 
9.5.3 Experience 
................................................................................................................. 52 
9.6 Glucose and Glycemia Measurements 
.................................................................................... 52 
9.6.1 Daily Blood Glucose 
.................................................................................................... 52 
9.6.2 Sensor Glucose Values 
................................................................................................ 52 
9.7 Recording Data 
................................................................................................................... 52 
9.8 Deviation Handling 
.............................................................................................................. 53 
9.8.1 Documenting Requirements for Study Deviations .......................................................... 53 
9.9 Reporting Requirements for Study Deviations ........................................................................ 54 
9.9.1 Analyzing Deviations 
................................................................................................... 54 
9.10 
Subject Exit, Withdrawal or Discontinuation 
........................................................................... 54 
10 Risks and Benefits ......................................................................................................... 56 
10.1 
Potential Risks .................................................................................................................... 56 
10.2 
Risk Minimization ................................................................................................................ 58 
10.3 
Potential Benefits 
................................................................................................................ 58 
10.4 
Risk-Benefit Rationale 
.......................................................................................................... 58 
10.5 
Risk Determination 
.............................................................................................................. 58 
11 Adverse Events and Device Deficiencies ....................................................................... 58 
11.1 
Definitions and Classification of Adverse Events ..................................................................... 59 
11.2 
Reporting of Adverse Events ................................................................................................ 61 
11.3 
Notification of Adverse Events 
.............................................................................................. 62 
11.4 
Expedited Safety Reporting Requirements 
............................................................................. 62 
11.5 
Causality Assessment .......................................................................................................... 62 
11.6 
Anticipated or Unanticipated ................................................................................................ 64 
11.7 
AEs Related to Glucose Sensor Insertion Sites ....................................................................... 64 
11.8 
Device Deficiencies and Troubleshooting 
............................................................................... 65 
12 Data Review Committees .............................................................................................. 65 
12.1 
Clinical Events Committee 
.................................................................................................... 65 
13 Statistical Design and Methods 
..................................................................................... 66 
13.1 
General Aspects of Analysis 
.................................................................................................. 66 
13.2 
Subject Disposition 
.............................................................................................................. 66 
13.3 
Subject Demographics and Baseline Characteristics 
................................................................ 66 

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13.4 
Sample Size Considerations 
.................................................................................................. 66 
13.5 
CIP Deviations .................................................................................................................... 67 
13.6 
Primary Endpoint ................................................................................................................ 67 
13.7 
Other Descriptive Endpoints 
................................................................................................. 67 
13.8 
Safety Analysis 
.................................................................................................................... 67 
13.9 
Device Deficiencies 
.............................................................................................................. 67 
14 Ethics ............................................................................................................................. 68 
14.1 
Statement(s) of Compliance 
................................................................................................. 68 
14.2 
Investigator’s Responsibilities 
............................................................................................... 69 
15 Study Administration 
..................................................................................................... 70 
15.1 
Training of Clinical Staff 
....................................................................................................... 70 
15.2 
Monitoring 
.......................................................................................................................... 70 
15.3 
Accessibility of Investigational Center Staff and Study Materials .............................................. 70 
15.4 
Audits and Investigational Center Inspections 
........................................................................ 70 
15.5 
Investigational Center Disqualification 
................................................................................... 71 
15.6 
Data Management 
............................................................................................................... 71 
15.6.1 Data Collection 
........................................................................................................... 71 
15.7 
Direct Access to Source Data/Documents .............................................................................. 72 
15.8 
Confidentiality 
..................................................................................................................... 72 
15.9 
Liability .............................................................................................................................. 73 
15.10 CIP Amendments 
........................................................................................................... 73 
15.11 Records and Reports 
...................................................................................................... 73 
15.11.1 Investigator Records 
................................................................................................... 73 
15.11.2 Investigator reporting responsibilities 
........................................................................... 74 
15.12 Record Retention 
........................................................................................................... 75 
15.13 Suspension or Early Termination 
..................................................................................... 75 
15.14 Early Investigational Center Suspension or Termination .................................................... 75 
15.14.1 Subject Follow-up in Case of Termination 
..................................................................... 75 
15.15 Study Close Out 
............................................................................................................. 75 
15.16 Publication and Use of Information 
.................................................................................. 76 
16 References 
..................................................................................................................... 76 
17 Appendices .................................................................................................................... 76 

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17.1 
Names and addresses 
.......................................................................................................... 76 
17.1.1 Investigational Centers and IRB 
................................................................................... 76 
17.1.2 Monitors Contact Information 
...................................................................................... 77 
17.2 
Labeling and IFUs of Devices ............................................................................................... 77 
17.3 
Sample Consent Materials 
.................................................................................................... 77 
18 Version History .............................................................................................................. 78 
 

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2 Synopsis 
Title 
Use of the Guardian™ Connect system with Smart Connected Devices 
Clinical Study Type  
Feasibility/Data Collection 
Sponsor   
Medtronic MiniMed, Inc. 
(“Medtronic”) 
18000 Devonshire St 
Northridge, CA 91325 
866.948.6633 
Indication under 
investigation  
Insulin-requiring type 1 and 2 diabetes who use multiple daily injections 
(MDI) insulin therapy 
Devices 
Investigational Devices 
•  Insulin capture devices and associated apps 
o InPen™ Basal smart cap, also referred to as InCap  (MMT-
155) 
o InPen™ Diabetes Management app, Version 6.0.0 by 
Companion Medical 
o Adapter 1 FlexTouch (Levemir, Tresiba) (SPC-00789) 
o Adapter 2 KwikPen (Basaglar) (SPC-00790) 
o Adapter 3 SoloStar (Lantus) (SPC-00791) 
o Adapter 4 SoloStar (Toujeo) (SPC-00792) 
o Adapter 5 Max SoloStar (Toujeo Max) (SPC-00793) 
 
Investigational Devices for Subjects 2-13 Years of Age and 76-80 Years of 
Age 
•  Guardian™  Connect app 
•  Guardian™  Connect transmitter kit (MMT-7820) 
o Guardian Connect transmitter 
o One-press serter, referred to as the serter throughout the 
protocol  
o Tester  
o Charger 
 
FDA Approved Devices Used in an Investigational Manner  

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•  Guardian™  Connect app 
•  Guardian™  Connect transmitter kit (MMT-7820) 
o Guardian™  Connect transmitter 
o One-press serter, referred to as the serter throughout the 
protocol  
o Tester  
o Charger 
Non-Investigational Devices 
•  Guardian™  Sensor (3) (MMT-7020) 
•  Insulin capture devices and associated apps (type, time, amount) 
o Companion Medical InPen for use with Humalog, NovoLog, 
Fiasp™ U100 (rapid-acting only) (MMT-105) 
o InPen™ Diabetes Management App, Version 5.4.4 by 
Companion Medical  
•  Klue™ Health app by Klue, Inc. 
•  FoodPrint™ food logging app by Nutrino™ 
•  Apple Watch™ with Health app  
•  Sleep tracking device such as Fitbit™ tracker 
•  Sponsor-provided smartphone (Android or iPhone) with pre-loaded 
apps and cellular service  
•  CareLink™ Personal software – referred to as CareLink Personal 
throughout this protocol  
•  CareLink™ system – referred to as CareLink Professional throughout 
this protocol  
•  CONTOUR™ NEXT ONE blood glucose meter – referred to as the 
study meter or BG meter throughout this protocol 
•  CONTOUR™ DIABETES app 
•  BodyGuardian® MINI cardiac remote monitor (BC2003) 
Purpose 
The purpose of this study is to collect sensor, insulin, sleep, activity and 
food/meal data for a minimum of 90 days of device wear (Phase 1) and up to 
a maximum of 9 months of device wear (Phase 2) with optional insulin 
injection video capture and/or menstrual cycle tracking and/or cardiac 
monitoring in subjects with insulin requiring diabetes 2-80 years of age. 

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Objective(s)  
The primary objective of this feasibility study is to collect data to be used for 
development of Medtronic Diabetes and Cardiac Diagnostics devices and 
products.  
Study Design  
The study is a multi-center, prospective single-arm design without controls. 
All subjects will participate for a minimum of 90 days (Phase 1) and some 
subjects 18 years of age or older will participate for up to 9 months (Phase 
2). All subjects will wear the Guardian Connect system (real-time continuous 
glucose monitoring (CGM)) continuously and use smart insulin pens or 
insulin pens with smart caps for multiple daily injections and continue their 
standard therapy throughout the duration of the study. 
Once trained, each subject 14 years of age or older or their parent or 
guardian (if applicable) may insert a sensor in the abdomen or arm. Subjects 
2-13 years of age or their parent or guardian may insert a sensor in the 
abdomen or buttocks. 
Only subjects 13 years of age and older will wear an Apple Watch (waking 
hours), a Fitbit (sleeping hours) and have the Klue app.   
The subject’s insulin delivery, sleep, physical activity (as applicable),food 
intake data, and medication (as applicable) will be collected through 
applications with meal logging and medication requiring manual entry. In 
addition, subjects may also participate in optional self-administered insulin 
injection video capture and upload using BOX and/or monthly menstrual 
cycle logging using Apple Health and/or cardiac monitoring using 
BodyGuardian MINI.  
Only subjects 13 years of age and older who choose to participate in 
optional video capturing of self-administered insulin injection will use the 
Klue app on the sponsor-provided smartphone to record insulin injection 
(capturing two videos per each injection location) any time during the study, 
and upload videos to BOX on the sponsor-provided smartphone. All other 
app data will be sent automatically to the cloud throughout study 
participation. Subjects will also be asked to enable location services on 
sponsor-provided smartphone throughout the study.   
Only subjects weighing more than 10 kg who choose to participate in 
optional cardiac monitoring using BodyGuardian MINI should wear the 
monitor for a minimum of 14 days. 
Electronic device data will be collected from the study devices using CareLink 
Personal software and the FoodPrint app and Nutrino cloud. Each site should 
create a new CareLink Professional account to review subjects’ CGM data. 
CareLink software uses TLS technology, which encrypts all data it stores (21 
CFR Part 11 compliant). Wearables will be reset to factory settings at 
subject’s end of study visit. Sponsor-provided smartphone will be reset to 
factory settings prior to device return to sponsor. 
Throughout the study, both in Phase 1 and Phase 2, subjects will continually 

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use the Guardian Connect system, track insulin delivery via the smart pen or 
pen caps, track sleep, track activity, and respond to prompts (as applicable). 
Subjects are instructed to use information from the Guardian Connect app in 
an adjunctive manner, per product labeling.  The general study timeline of 
activities is as follows: 
Phase 1 
 Day 1-30 
For 7 consecutive days during Days 8-27 (to ensure there is sufficient time 
for site to review surveillance report prior to Visit 4), each subject should log 
food consumption (meals, drinks and snacks) concurrent with CGM, sleep 
and activity tracking, insulin delivery data collection, and medication. The 
subject will be asked to check a fasting SMBG using the study meter after a 
minimum of 8 hours of fasting for two mornings during the week they log 
their food.  
 Day 31-90 
Each subject should log food consumption for a minimum of 7 consecutive 
days per month.  
Day 100 will be the End of Study (EOS) unless the subject is participating in 
Phase 2. If EOS, devices should be returned, wearables reset to factory 
settings, and subject’s participation in the study will be completed. 
Phase 2 
 Day 91-280 
Some subjects 18 years of age or older will continue to provide data for an 
additional 180 days based on adherence to study requirements 
demonstrated during Phase 1. Subjects will be asked to log food 
consumption (meals, drinks and snacks) for a minimum of 7 consecutive 
days per month concurrent with CGM, sleep and activity tracking, insulin 
delivery data collection, and medication. At End of Study (EOS, Day 280 (±7 
Days)) devices should be returned, wearables reset to factory settings and 
subject’s participation in the study will be completed.  
Sample Size and 
Investigational 
Centers 
Up to 500 subjects with insulin-requiring type 1 or type 2 diabetes age 2-80 
who use multiple daily injections (MDI) insulin therapy will be enrolled in the 
study in order to have a minimum of 260 subjects complete 90 days of data 
collection with some adult subjects completing 280 days. Up to 30 
investigational centers will be selected across the United States. Selection is 
based on each investigator’s experience and qualifications, availability of 
sufficient resources to carry out the required study procedures, and the 
investigator’s ability to recruit subjects into the study. 
Duration 
The study is anticipated to last approximately 24 months from first 
investigational center initiation to finalization of all data entry and 
monitoring procedures. Subject participation is expected to be 

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approximately 100 days, and approximately 280 days for adult subjects who 
complete Phase 2. 
Inclusion/ 
Exclusion Criteria 
Inclusion Criteria 
1. Individual is 2-80 years of age at time of consent. 
2. A clinical diagnosis of type 1 or type 2 diabetes as determined by 
investigator for:  
o at least the last 6 months for subjects 2-6 years of age 
o at least the last 12 months for subjects 7-80 years of age 
3. Subject is on multiple daily injection therapy (3 or more insulin 
injections per day one of which is a long acting insulin injection), is 
currently using or is willing and can afford to use insulin pen(s) and 
pen cartridge(s). 
4. Subject is currently using or is willing to use the Guardian Connect 
system during the study. 
5. Subject agrees to comply with the study protocol requirements. 
6. For adult subjects: Subject is capable of providing legal consent 
without a legal authorized representative.  
 
Exclusion Criteria 
1. Subject is using a syringe and unwilling or unable to use insulin 
pen(s). 
2. Subject is using an insulin pump. 
3. Subject is currently using a non-Medtronic standalone CGM system 
and unwilling to use only the Guardian Connect system during the 
study. 
4. Subject is using hydroxyurea at time of screening or plans to use it 
during the study. 
5. Subject will not tolerate tape adhesive in the area of device 
placement as assessed by a qualified provider. 
6. Subject has any unresolved adverse skin condition in the area of 
device placement (e.g. psoriasis, rash, Staphylococcus infection). 
7. Subject is actively participating in or plans to enroll in an 
investigational study (e.g. drug or device), other than this study, 
wherein they have received treatment from an investigational drug 
or device. 
8. Subject has a positive urine pregnancy test at time of screening. 

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9. Subject is female, sexually active without the use of contraception, 
able to become pregnant or plans to become pregnant during the 
course of the study. 
10. Subject is unwilling to participate in study procedures. 
11. Subject is directly involved in the study as research staff. 
 
Study Visit Schedule  Subjects will participate in a minimum of 6 planned study visits, as presented 
in Figure 1 for approximately 90 days of device wear and up to 12 planned 
study visits (up to 9 months of device wear) for some adult subjects 
participating in Phase 2. Telehealth (phone or video) visit may be performed 
for office visits in cases where an office visit is not possible (e.g. global 
pandemic). 
 
Phase 1 
 Visit 1 Enrollment (Office): Consent and screening. 
o Administer baseline questionnaire 
 
 Visit 2 Day 1 Device on Body (Office): (up to 14 days
 after Visit 1*): 
Study, device and app training. 
o Setup app settings, ensuring subjects accept app terms and 
conditions 
o Guardian Connect system start, including sensor insertion, 
and training 
o Provide app and wearables training 
o Dispense wearables 
o Dispense study supplies 
o Discuss and determine target date for completing one 7-day 
consecutive meal logging during Days 8-27, prior to Visit 4   
 
*Note: If additional time is needed for training, Visit 2 may be split 
up into two visits at investigator’s discretion. Site should complete 
an “Unscheduled Visit” eCRF to document additional visit.  
 
 
 Visit 3 Day 10 Follow-up (Phone): Day 10 (±4 days) after Visit 2. 
o Remind subjects to have continuous sensor wear 
o Remind subject to complete 7-day consecutive meal logging 
on targeted dates prior to Visit 4 
o Based on data surveillance reports as available (provided by 
sponsor), discuss subject compliance (e.g. meal logging, CGM 
use,
 sleep and insulin tracking etc.)   
 

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 Visit 4 Day 30 Follow-up (Office): Day 30 (±7 days) after Visit 2. 
o Dispense study supplies 
o Based on data surveillance reports as available (provided by 
sponsor), discuss subject compliance (e.g. meal logging, CGM 
use,
 sleep and insulin tracking etc.) 
o Discuss and determine target date for completing one 7-day 
consecutive meal logging prior to Visit 5 
 
 Visit 5 Day 60 Follow-up (Office or Phone): Day 60 (±7 days) after 
Visit 2. 
o If subject is participating in cardiac monitoring: 
 Train subject on cardiac monitor 
 Dispense cardiac monitor and supplies 
o Based on data surveillance reports as available (provided by 
sponsor), discuss subject compliance (e.g. meal logging, CGM 
use, sleep and insulin tracking etc.) 
o Discuss and determine target date for completing one 7-day 
consecutive meal logging prior to Visit 6 
o Determine if subject will participate in Phase 2 
o If not participating in Phase 2, determine Day 90 when 
subject may stop data collection and schedule Visit 6 (EOS) 
 
 Visit 6 (Office): Day 100 (±7
 days) after
 Visit 2. 
o If EOS: 
 Return study meter, transmitter, wearables and 
sponsor-provided smartphone  
 Wipe data off
 (perform
 factory
 reset)
 wearables 
 Administer EOS questionnaire 
Note: EOS questionnaires will be administered to all 
subjects at the end of their participation in the study. 
This includes subjects who are terminated or who 
voluntarily discontinue participation in the study. 
o If moving onto Phase 2, see below. 
 
Phase 2:  Subjects participating in study for over 90 days (up to 9 months): 
 Visit 6 Day 90 Follow-up (Office): Day 90 (±14 days) after Visit 2. 
o Dispense study supplies.  
 
o Based on data surveillance reports as available (provided by 
sponsor), discuss subject compliance (e.g. meal logging, CGM 
use, sleep and insulin tracking etc.) 

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o Discuss and determine target dates for completing one 7-day 
consecutive meal logging prior to Visit 7 
 
 Visit 7 Day 120 Follow-up (Phone): Day
 120 (±14 days)
 after Visit 2. 
o Based on data surveillance reports as available (provided by 
sponsor), discuss subject compliance (e.g. meal logging, CGM 
use, sleep and insulin tracking etc.) 
o Discuss and determine target date for completing one 7-day 
consecutive meal logging prior to Visit 8 
 
 Visit 8 Day 150 Follow-up (Phone): Day
 150 (±14 days)
 after Visit 2. 
o Based on data surveillance reports as available (provided by 
sponsor), discuss subject compliance (e.g. meal logging, CGM 
use, sleep and insulin tracking etc.) 
o Discuss and determine target date for completing one 7-day 
consecutive meal logging prior to Visit 9 
 
 Visit 9 Day 180 Follow-up (Office): Day 180 (±14
 days) after Visit 2.  
o Dispense study supplies. 
o Based on data surveillance reports as available (provided by 
sponsor), discuss subject compliance (e.g. meal logging, CGM 
use, sleep and insulin tracking etc.) 
o Discuss and determine target dates for completing one 7-day 
consecutive meal logging prior to Visit 10 
 
 Visit 10 Day
 210 Follow-up (Phone): Day 210 (±14 days) after Visit 2. 
o Based on data surveillance reports as available (provided by 
sponsor), discuss subject compliance (i.e. meal logging, CGM 
use, sleep and insulin tracking etc.) 
o Discuss and determine target date for completing one 7-day 
consecutive meal logging prior to Visit 11 
 
 Visit 11 Day
 240 Follow-up (Phone): Day 240 (±14 days) after Visit 2. 
o Based on data surveillance reports as available (provided by 
sponsor), discuss subject compliance (e.g. meal logging, CGM 
use, sleep and insulin tracking etc.) 
o Discuss and determine target date for completing one 7-day 
consecutive meal logging prior to Visit 12 
o Determine date for Day 280 when subject may stop data 
collection and schedule
 Visit
 12 (EOS) 
 
 Visit 12 End of study (EOS) (Office): Day 280 (±7 days) after Visit 2. 

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o Administer EOS questionnaire 
Note: EOS questionnaires will be administered to all subjects 
at the end of their participation in the study. This includes 
subjects who are terminated or who voluntarily discontinue 
participation in the study. 
o Return study meter, transmitter, wearables and sponsor-
provided smartphone 
o Wipe data off (perform factory reset)
 wearables 

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Figure 1.  Study Visit Schedule for Phase 1 and Phase 2, 90 Days and 280 Days of Guardian Connect system Wear  
 
 
 

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Safety and 
Monitoring/Risk 
Analysis 
Safety monitoring/risk analysis details are outlined in Section 10.  
Device Deficiencies  Device deficiencies reported directly to the investigational center staff by a 
subject should either be reported to the Medtronic support line by the subject 
or investigational center staff. All applicable device deficiencies that are 
reported to the Medtronic support line will be documented. Depending on the 
study device or app, the subject and/or investigational center may be 
instructed by the support line to contact the respective device manufacturer. 
Device deficiencies for commercially released devices or apps should be 
captured according to local regulatory requirements and is the responsibility of 
the Investigator. For additional information, see Section 11.8. 
Subject Stopping 
Rules  
Refer to Section 9.10 on “Subject Exit, Withdrawal or Discontinuation”.  
Study Stopping 
Rules for Entire 
Study   
There are no predefined study stopping rules. 

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Statistical Analysis 
for Endpoints and 
Hypothesis 
 
During Phase 1 and Phase 2 
 
Primary Endpoint 
Descriptive statistics will be performed; no statistically powered analyses or 
hypothesis testing will be performed. 
 
•  Glycemic control: Percentage of Time in Range (SG <70 mg/dL, 70-
180 mg/dL, and >180 mg/dL)  
Other Descriptive Endpoints 
•  Summary of completed data collection/available data 
•  Summary of study questionnaire results  
Safety 
Descriptive summary will be used to characterize safety events: 
 
• Serious adverse events (SAE)  
• Device related adverse events (AEs) 
• Procedure
 related AEs 
• Serious adverse
 device effect (SADE) 
• Unanticipated adverse device effect (UADE) 
• Severe hypoglycemia 
• Diabetic
 ketoacidosis (DKA) 
Device Deficiencies 
Descriptive summary will be used to characterize device deficiencies. 
 
Final Report  
A final report will be generated once all subjects have completed Phase 1 and 
Phase 2. Descriptive endpoints and safety data will be summarized and 
presented in the final report.  

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3 Introduction 
3.1 Background 
In patients with insulin dependent diabetes mellitus, glycemic control is influenced by numerous factors, 
such as insulin dosage, insulin absorption, timing, physiological/lifestyle factors such as exercise, food 
intake, sleep, hormones and illness. These factors may contribute to significant variability in insulin 
requirements, which makes self-management of diabetes challenging. 
Today, there are 55 million patients globally taking insulin through injections as compared to the 1 million 
administering insulin via pump therapy. Some of these patients will move to insulin pump therapy over 
the course of their lifetime, but the majority will continue using injections. Their rationale to continue 
with insulin injections include the following reasons: 
•  There is higher patient out-of-pocket cost associated with pump therapy; 
•  The physical experience of wearing a pump device is not appealing; and 
•  There has been growth in new therapy options available to injection users, such as CGM, 
smart pens, and decision support apps.
[1] 
While CGM has greatly improved a patient’s ability to get rapid and accurate glucose readings, patients 
are still required to make hundreds of decisions a day with little guidance on what to eat, what to dose, 
when to dose, and how to manage activities such as exercise. Without actionable therapy guidance, the 
following key needs remain unmet for these patients: 
•  Understanding how specific foods, physical activity, sleep patterns, and other routines affect 
their personal glucose levels; 
•  Recovering quickly from low and high glucose levels; 
•  Avoiding overnight lows; 
•  Optimizing physical exercise to stay in range; and 
•  Knowing exactly how much insulin to take, and when, at mealtime and throughout the day.[2] 
Due to the lack of guidance on the key needs listed above, multiple daily injections (MDI) patients on the 
current state of the art therapies spend an average of 45-51% of their time within a healthy glycemic 
range, known as Time in Range (TIR)
[3], which is well below the TIR outcomes for pump users
[4, 5]. The 
overall goal of the Smart CGM system is to significantly improve TIR and quality of life (QOL) for injection-
based insulin users by improving the user experience in three key areas: 
(1) Personalizing dosing recommendations that are tailored to the patient’s own physiology, 
lifestyle, and diabetes state;  
(2) Providing holistic decision support to the user in point-of-care situations; and, 

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(3) Reducing the burden of logging information relevant to diabetes management. 
The Smart CGM system will accomplish this by providing the patient with intelligent automation, 
detection, insights,
 and
 recommendations that
 will enable
 them
 to achieve significantly
 improved
 TIR
 and 
QOL as an MDI user. 
3.2 Purpose 
The purpose of this study is to collect sensor, insulin, sleep, activity and food/meal data for a minimum 
of 90 days of wear (Phase 1) and up to a maximum of 9 months of device wear (Phase 2) with optional 
insulin injection video capture and/or menstrual cycle tracking and/or cardiac monitoring in subjects 
with insulin requiring diabetes 2-80 years of age. 
4 Objectives and/or Endpoints 
4.1 Objectives 
4.1.1 Primary Objective(s) 
The primary objective of this feasibility study is to collect data to be used for development of Medtronic 
Diabetes and Cardiac Diagnostics devices and products.  
4.2 Endpoints 
Descriptive statistics will be performed; no statistically powered analyses or hypothesis testing will be 
performed. 
•  Glycemic control: Percentage of Time in Range (SG <70 mg/dL, 70-180 mg/dL, and >180 
mg/dL)  
4.2.1 Other Descriptive Endpoints 
•  Summary of completed data collection/available data 
•  Summary of study questionnaire results  
4.3 Safety 
Descriptive summary will be used to characterize safety events: 
 

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• Serious adverse events (SAE)  
• Device related AEs 
• Procedure
 related AEs 
• Serious adverse
 device effect (SADE) 
• Unanticipated adverse device effect (UADE) 
• Severe hypoglycemia 
• Diabetic
 ketoacidosis (DKA) 
 
4.4 Device Deficiencies 
Descriptive summary will be used to characterize device deficiencies. 
5 Study Design  
The study is a multi-center, prospective single-arm design without controls. All subjects will participate 
for a minimum of 90 days (Phase 1) and some subjects 18 years of age or older will participate for up to 
9 months (Phase 2). All subjects will wear the Guardian Connect system (real-time CGM) continuously 
and use smart insulin pens or insulin pens with smart caps for multiple daily injections and continue 
their standard therapy throughout the duration of the study.  
Once trained, each subject 14 years of age or older or their parent or guardian (if applicable) may insert 
a sensor in the abdomen or arm. Subjects 2-13 years of age or their parent or guardian may insert a 
sensor in the abdomen or buttocks. 
Only subjects 13 years of age and older will wear an Apple Watch (waking hours), a Fitbit (sleeping 
hours) and have the Klue app.  
The subject’s insulin delivery, sleep, physical activity (as applicable), food intake data, and medication 
(as applicable) will be collected through applications with meal logging and medication requiring manual 
entry. In addition, subjects may also participate in optional self-administered insulin injection video 
capture and upload using a secure cloud-based site and/or monthly menstrual cycle logging using Apple 
Health and/or cardiac monitoring using BodyGuardian MINI.  
Only subjects 13 years of age and older who choose to participate in optional video capturing of self-
administered insulin injection will use the Klue app on the sponsor-provided smartphone to record 
insulin injections (capturing two videos per each injection location) any time during the study, and 
upload videos to a secure cloud-based site on the sponsor-provided smartphone.  All other app data will 
be sent automatically to the cloud throughout study participation. Subjects will also be asked to enable 
location services on the sponsor-provided smartphone throughout the study.  
Only subjects weighing more than 10 kg who choose to participate in optional cardiac monitoring using 

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the BodyGuardian MINI monitor, should wear the monitor for a minimum of 14 days.  
Electronic device data will be collected from the study devices using CareLink Personal and the 
FoodPrint mobile app and Nutrino cloud. Each site should create a new CareLink Professional account to 
review subjects’ CGM data. CareLink software uses TLS technology, which encrypts all data it stores (21 
CFR Part 11 compliant). Wearables will be reset to factory settings at subject’s end of study visit. 
Sponsor-provided smartphone and watch will be reset to factory settings after subject exits study and 
prior to device return to sponsor. 
Throughout the study, both in Phase 1 and Phase 2, subjects will continually use the Guardian Connect 
system, track insulin delivery via the smart pen or pen caps, track sleep, track activity, and respond to 
prompts (as applicable). Subjects are instructed to use information from the Guardian Connect app in an 
adjunctive manner, per product labeling. The general study timeline of activities is as follows:  
Phase 1 
 Day 1-30 
For 7 consecutive days during Days 8-27 (to ensure there is sufficient time for site to review surveillance 
report prior to Visit 4), each subject should log food consumption (meals, drinks and snacks) concurrent 
with CGM, sleep and activity tracking, and insulin delivery data collection. The subject is required to 
check a fasting SMBG using the study meter after a minimum of 8 hours of fasting for two mornings 
during the week they log their food.  
 Day 31-90 
Each subject should log food consumption for a minimum of 7 consecutive days per month.  
Day 100 will be the EOS unless the subject is participating in Phase 2. If EOS, devices should be returned, 
wearables reset to factory settings, and subject’s participation in the study will be completed. 
 
Phase 2 
 Day 91-280 
Some subjects 18 years of age or older will continue to provide data for an additional 180 days based on 
adherence to study requirements demonstrated during Phase 1. Subject will be asked to log food 
consumption (meals, drinks and snacks) for a minimum of 7 consecutive days per month concurrent 
with CGM, sleep and activity tracking, and insulin delivery data collection. At End of Study (EOS, Day 280 
(±7 days)) devices should be returned,  wearables reset to factory settings, and subject’s participation in 
the study will be completed.  
5.1 Duration 
The study is anticipated to last approximately 24 months from first investigational center initiation to 
finalization of all data entry and monitoring procedures. Subject participation is expected to be 

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approximately 100 days and approximately 280 days for some adult subjects participating in Phase 2. 
5.2 Rationale  
This study is intended to allow collection of sensor, insulin, activity and food/meal data for use in the 
development of Medtronic Diabetes and Cardiac devices and products. 
6 Product Description 
6.1 Intended Population 
A diverse population of type 1 or type 2 insulin-requiring subjects who use multiple-daily injections 
(MDI) insulin therapy will be studied. The study population will have a large range of duration of 
diabetes and glycemic control.  
6.2 Investigational Devices 
The investigational devices used in this study will be described in this section. Instructions for intended 
use, including indications, contraindications, and precautions of the components used in this study, are 
provided in their respective user guide(s). 
6.2.1 Insulin capture devices and associated apps  
6.2.1.1 InPen Basal smart cap 
The InPen Basal smart cap , also referred to as InCap, is a reusable electronic pen injector cap for single-
patient use by people with diabetes. 
The Cap is compatible with Levemir®, Tresiba®, Lantus®, Basaglar®, 
and Toujeo® prefilled pens. In this study, the smart cap should be used under the supervision of an adult 
caregiver or by a patient age 7 and older for the tracking of long-acting insulin doses.  
6.2.1.2 InPen Diabetes Management App, Version 6.0.0 
The InPen app uses data from a user’s InPen smart insulin pen system or InPen Basal smart cap to keep 
track of the user’s data and helps the user make decisions. It automatically records insulin doses, tracks 
active insulin, recommends mealtime and correction doses, shares therapy data with the user’s doctor 
or caregiver. The information collected by the InPen Diabetes Management app is stored on the 
Companion Medical data cloud and will be sent to the Nutrino data servers. 

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6.2.1.3 Adapters 
The InPen Basal smart cap requires one of five adapters to fit the subject’s long-acting insulin pen. The 
adapter is an accessory which makes the smart cap compatible with Levemir®, Tresiba®, Basaglar®, 
Lantus®, Toujeo®, and Toujeo® Max prefilled pens. 
 
6.3 Investigational Devices for Subjects 2-13 Years of Age and 76-80 Years 
of Age 
The investigational devices used in this study will be described in this section. Instructions for intended 
use, including indications, contraindications, and precautions of the components used in this study, are 
provided in their respective user guide(s). 
6.3.1 Guardian Connect App 
The Guardian Connect app is a mobile application downloaded onto a sponsor-provided smartphone or 
tablet device. This device serves as a CGM system only with no insulin delivery capabilities. The Guardian 
Connect system receives data from the Glucose Sensor Transmitter (GST) via Bluetooth Low Energy 
radio signal. Refer to the device IFU for further information on such use for onboarding in aircraft. The 
sensor data is displayed numerically and graphically. Additionally, the Guardian Connect app sends 
blood glucose data to the transmitter to calibrate the sensor. Blood glucose values are entered manually 
by the user into the Guardian Connect app. 
In this study, the Guardian Connect app will be pre-loaded onto a sponsor-provided smartphone. 
Additionally, data will be sent to the Nutrino data servers. 
6.3.2 Guardian Connect Transmitter Kit  
6.3.2.1 Guardian Connect Transmitter 
The Guardian Connect transmitter is a device that reads the electronic signal generated by the sensor. In 
addition, the transmitter contains a custom ASIC, which enables EIS. The EIS measurements are used as 
diagnostics for the sensor, which are incorporated into the sensor calibration logic algorithm. 
Calibrations must be entered manually into the Guardian app to be relayed to the transmitter. The 
transmitter transmits the calculated glucose data to the Guardian app via 2.4GHz RF technology (BLE).  
In this study, the Guardian Connect transmitter will be connected to a Guardian Sensor (3).  

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6.3.2.2 One-press Serter  
The One-press serter (Figure 2), referred to as the serter throughout the protocol, is an insertion device 
that is used to ensure correct placement of the sensors into the user’s subcutaneous tissue. Insertion is 
triggered when the two spring loaded buttons on the sides of the serter are pressed simultaneously. All 
other functionality and requirements are the same. The serter is intended as a single patient, non-sterile 
multi-use device. 
Figure 2.One-press serter 
 
 
6.3.2.3 Tester 
The tester operates as a sensor simulator creating signal current at a level that is within the range of an 
in-vivo sensor during normal operation. The tester is also used for device cleaning.  
6.3.2.4 Charger  
The charger is used to recharge the transmitter after each use. The charger is also used when pairing the 
transmitter with the smartphone during setup. 
6.4 Non-Investigational Devices 
The non-investigational devices used in this study will be described in this section. Instructions for 
intended use, including indications, contraindications, and precautions of the components used in this 
study, are provided in their respective user guide(s). 
6.4.1 Guardian Sensor (3) 
The Guardian Sensor (3) is a sensor that contains one microelectrode with a thin coating of glucose 

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oxidase beneath several layers of biocompatible membrane. The sensor represents the next generation 
in the Enlite sensor family with design changes in the engineering reports for improved accuracy. It is 
intended to penetrate the skin at a 90-degree angle, similar to the Enlite Sensor. The sensor is tubeless 
and as a result has a smaller volume than previous Medtronic MiniMed sensors. 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. 
6.4.2 Insulin capture devices and associated apps (type, time, date, amount) 
 
6.4.2.1 
 Companion Medical InPen for use with Humalog, NovoLog, Fiasp U100 
(rapid-acting only) 
Companion Medical InPen smart insulin pen system that combines a reusable, Bluetooth® insulin pen 
and an intuitive mobile app that helps users take insulin doses. In this study, the InPen pen and InPen 
Diabetes Management app should be used under the supervision of an adult caregiver or by a subject 
age 7 and older for the self-injection of a desired dose of insulin.  
6.4.2.2 
 InPen Diabetes Management App, Version 5.4.4 
The InPen app uses data from a user’s InPen to keep track of the user’s data and helps the user make 
decisions. It automatically records insulin doses, tracks active insulin, recommends mealtime and 
correction doses, shares therapy data with the user’s doctor or caregiver. The information collected by 
the InPen Diabetes Management app is stored on the Companion Medical data cloud and will be sent to 
the Nutrino data servers. 
6.4.3 Klue Health App by Klue, Inc. 
Klue Health app is a smartwatch app that tracks food and drink intake. It can tell from how the arm 
wearing the smartwatch moves when you are taking a bite or a sip. Klue will helps track food and 
hydration and, once it has learned the user’s behavior patterns, it can coach the user to eat mindfully 
and check blood sugar at key times. The information collected by Klue is stored on the Klue data cloud 
and will be sent to the Nutrino data servers. In this study, only subjects 13 years of age or older may use 
the Klue app. 
6.4.4 FoodPrint Food Logging App by Nutrino 
The FoodPrint food logging app by Nutrino is a meal logging app. It lets the user take pictures of a meal 

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which are synced with the food diary. FoodPrint can also be used to log workouts, sleep, medications, 
blood glucose, and insulin. In this study, data from this and all of the other apps used in this study will be 
sent to the Nutrino data servers. 
6.4.5 Apple Watch with HealthKit  
Apple Watch with HealthKit is a commercially available accelerometer that continuously monitors 
energy expenditure, sleep, and other physiological data for basic and applied medical research. Data 
collected by the Apple Watch will be sent to the Nutrino data servers. In this study, data collected 
includes but is not limited to blood glucose, menstrual cycle, heart rate and physical activity. 
Additionally, only subjects 13 years of age or older will wear an Apple Watch during waking hours. 
6.4.6 Fitbit tracker  
Fitbit tracker is a commercially available accelerometer that continuously monitors energy expenditure, 
sleep, and other physiological data for basic and applied medical research. The information collected by 
Fitbit is stored on the Fitbit data cloud and will be sent to the Nutrino data servers. In this study, only 
subjects 13 years of age or older will wear a Fitbit tracker during sleeping hours.  
 
6.4.7 Sponsor-provided Smartphone (Android or iPhone) with pre-loaded apps and 
cellular service 
In this study, apps and cellular service will be pre-loaded onto a sponsor-provided smartphone prior to 
subject’s use. The smartphones will be distributed with investigational labeling due to the fact that the 
Guardian Connect app is considered investigational for subjects 2-13 years of age and subjects 76-80 
years of age. Subjects 14-75 years of age will also be issued smartphones with investigational labeling 
but will use the Guardian Connect app within labeled indications for use.    
6.4.8 CareLink system – commercially-approved software referred to as CareLink 
Professional throughout this protocol 
CareLink Professional is a web-based system diabetes therapy management software. Clinical study sites 
can create accounts to manage data gathered from a subject’s device. Data from insulin pumps, 
continuous glucose monitors, and blood glucose meters can be uploaded to the software. This data can 
be stored, and then used to generate reports. CareLink Professional can also interface with the subject’s 
CareLink Personal software, allowing access to device data stored in the software. Therapy reports can 
be generated from the device data.  
CareLink Professional is password protected and uses standard Transport Layer Security (TLS), which 
ensures a secure link between the computer and the server. The 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. The data is 

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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. 
In this study, sites can review the subject’s CGM data using Carelink Professional but will not upload the 
subject’s CGM device. 
6.4.9 CareLink Personal Software – commercially-approved software – referred to 
as CareLink Personal throughout this protocol 
CareLink Personal is a web-based system. It uploads data from the insulin pump, continuous glucose 
monitors, and supported blood glucose (BG) meters. Uploaded data stored on CareLink Personal is used 
to generate reports, which users can access using a standard web browser. Care partners can be invited 
to see device data. CareLink Personal uses the same Transport Layer Security (TLS) technology that 
CareLink system does.  
In this study, CareLink Personal will be used to collect CGM data from the Guardian Connect system 
automatically.  
6.4.10 
CONTOUR NEXT ONE blood glucose meter – referred to as the study meter or 
BG meter throughout this protocol 
The CONTOUR NEXT ONE meter and app system consists of a Bluetooth-enabled BG meter that sends 
BG meter readings to the CONTOUR DIABETES app on the users smartphone. CONTOUR NEXT test strips, 
control solution, lancets and a lancet device are also a part of the system. The meter measures glucose 
in fresh capillary whole blood drawn from the fingertips.  
In this study, if a subject is dispensed the CONTOUR NEXT ONE blood glucose meter, subjects will check 
their blood glucose with this meter and use the readings to calibrate the Guardian Connect system. Data 
(blood glucose readings) from this meter will be automatically synced and logged in the app, which is 
also compatible with the Apple Health app.   
6.4.11 CONTOUR DIABETES App 
The CONTOUR DIABETES app syncs with the CONTOUR NEXT ONE blood glucose meter to collect blood 
glucose readings. In this study, data (blood glucose readings) will stored on the Ascensia CONTOUR data 
cloud and will be sent to the Nutrino data servers. 

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6.4.12 BodyGuardian MINI 
The BodyGuardian MINI is an ambulatory, wearable, portable, externally applied ECG recorder. It 
monitors patient ECG and generates event markers using arrhythmia detection algorithms and stores all 
data on its internal memory.  
6.5 Anticipated Device Changes 
There are no anticipated changes to any of the devices during the course of the study. 
6.6 Product Accountability 
Good clinical research practice requires that investigators and research teams ensure accurate 
accountability for any investigational device used in a research trial. It is expected that all investigational 
devices will be used in the manner intended during the study, that they will be stored under 
appropriately controlled conditions and that they will be used only by (on) subjects who have consented 
to participate in the research study. 
Any investigational device being used in clinical research must be strictly accounted for and will not be 
shipped to any site unless all of the necessary approvals (e.g. Regulatory, Institutional Review Board 
(IRB)) have been received.  
The principal investigator or an authorized designee shall keep records documenting the receipt, use, 
return and disposal of the investigational devices. The accountability logs may be maintained at each 
study site. Additional details regarding device accountability and device disposition requirements are 
provided in Table 1. 
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.  
6.6.1 Receipt and Inventory of Investigational Devices by Investigational Center 
Upon receipt of the study devices, the investigational center staff will take inventory of the shipment, 
making sure that information on the packing slips/invoices matches exactly the contents of the 
containers, as applicable, including:  
o Ship to Address 
o Reference Number 
o Device Type 
o Quantity  
o Quantity per package  
o Lot number (where applicable) 
o Serial number (where applicable) 
•  Ensure that devices and supplies received have not reached or exceeded their expiration date 

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•  Sign and date the packing slips/invoices, noting any discrepancies, and file in appropriate study 
binder 
•  Notify the study monitor of any discrepancies 
•  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 proper environmental conditions, as identified in the user 
guide/labeling.  
6.6.2 Dispensing of Study Devices 
Each time a study device is dispensed to a subject by the investigator or authorized member of the 
research team source documentation will be completed as required. Documentation may include:  
•  Date dispensed 
•  Subject ID 
•  Lot number(s)  
•  Serial Number 
•  Device Type 
•  Amount dispensed  
6.6.3 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 1 and store them in a secure environment. If containers/units/devices are missing, 
the reasons should be documented in the applicable source document. If discrepancies between the 
amounts used by subjects and the amounts expected to be returned exist, the reasons should be 
documented in the applicable source document.  
Requirements for return of devices by subjects to the investigational center and return of device by the 
investigational center to the sponsor are listed in Table 1. The devices that are being returned to the 
investigational center may be returned to the sponsor as subjects complete the study, at the end of 
study (EOS) or upon sponsor request.  
Other consumable devices (i.e., alcohol wipes, study meter 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 properly by the investigational center staff.   
Disposable devices and supplies that have been used by a subject will be disposed properly by the 
subject or the investigational center staff during the conduct of the study.  
All study devices that are required to be entered into the source document must be accounted for as 
described above before they are returned to the sponsor.  
The investigator or authorized member of the research team is to record dispensement and return of 
study devices from subject on the Subject Device Identification eCRF. 

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7 Selection of Subjects 
7.1 Study Population 
Up to 500 subjects with insulin-requiring type 1 or type 2 diabetes age 2-80 who use multiple-daily 
injections (MDI) insulin therapy will be enrolled in the study in order to have minimum of 260 subjects 
complete approximately 100 days of study participation with some adult subjects completing 
approximately 280 days in Phase 2. 
7.2 Subject Enrollment 
Subjects will be considered enrolled in the study upon signing the Informed Consent Form (ICF) and 
assent form (if applicable). 
 A subject will be assigned a unique study subject identification (ID) via the eCRF, which is a 9-digit code 
(331XXXXXX). The first three numbers refer to the clinical investigation plan (CIP) number (331), the next 
three numbers refer to the investigational center number, and the last three numbers refer to the 
subject number, assigned during Visit 1 (e.g., 331002001 is subject 001 from site 002). 
The investigator will maintain a log of all subjects enrolled in the clinical study, assigning a SID linked to 
their names, alternative SID or contact information. 
7.3 Inclusion Criteria 
1. Individual is 2-80 years of age at time of consent. 
2. A clinical diagnosis of type 1 or type 2 diabetes as determined by investigator for: 
o at least the
 last 6 months for subjects 2-6 years of age 
o at least the last 12 months for subjects 7-80 years of age 
3. Subject is on multiple daily injection therapy (3 or more insulin injections per day one of which is a 
long acting insulin injection), is currently using or is willing and can afford to use insulin pen(s) and 
pen cartridge(s). 
4. Subject is currently using or is willing to use the Guardian Connect system during the study. 
5. Subject agrees to comply with the study protocol requirements. 
6. For adult subjects: Subject is capable of providing legal consent without a legal authorized 
representative.  
7.4 Exclusion Criteria 
1. Subject is using a syringe and unwilling or unable to use insulin pen(s). 
2. Subject is using an insulin pump. 

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3. Subject is currently using a non-Medtronic standalone CGM system and unwilling to use only the 
Guardian Connect system during the study. 
4. Subject is using hydroxyurea at time of screening or plans to use it during the study. 
5. Subject will not tolerate tape adhesive in the area of device placement as assessed by a qualified 
provider. 
6. Subject has any unresolved adverse skin condition in the area of device placement (e.g. psoriasis, 
rash, Staphylococcus infection). 
7. Subject is actively participating in or plans to enroll in an investigational study (e.g. drug or device), 
other than this study, wherein they have received treatment from an investigational drug or device. 
8. Subject has a positive urine pregnancy test at time of screening. 
9. Subject is female, sexually active without the use of contraception, able to become pregnant or 
plans to become pregnant during the course of the study. 
10. Subject is unwilling to participate in study procedure. 
11. Subject is directly involved in the study as research staff. 
 
8 Study Site Requirements 
8.1 Study Site Activation 
During the activation process (prior to subject enrollment), Medtronic will train investigational center 
staff. If new members join the study investigational center team, they will receive training on the 
applicable study requirements relevant to their role before contributing to the study. 
 
Prior to performing study related activities, all regulatory requirements shall be fulfilled, including, but 
not limited to the following:  
•  IRB approval (and voting list, as required by local law) of the current version of the CIP and 
IC 
•  Fully executed CTA  
•  Financial disclosure (if applicable)  
•  CV of investigators 
•  Documentation of delegated tasks 
•  Documentation of study training  
In addition, all participating study site staff must be trained on the current version of the CIP as well as 
on the applicable study requirements depending on their role and must be delegated by the principal 
investigator prior to performing delegated study activities.  

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Medtronic will provide each study site with documentation of study site/investigator readiness; this 
letter must be received prior to performing delegated study activities. 
9 Study Procedures  
9.1 Schedule of Events 
9.1.1 Study Visit Schedule & Scheduled Follow-up Visit Windows 
Subjects will participate in a minimum of 6 planned study visits, as presented in Figure 3 for 
approximately 90 days of device wear and up to 12 planned study visits (up to 9 months of sensor wear) 
for some adult subjects participating in Phase 2. Telehealth (phone or video) visit may be performed for 
office visits in cases where an office visit is not possible (e.g. global pandemic). 
Phase 1 
 Visit 1 Enrollment (Office): Consent and screening. 
o Administer baseline questionnaire 
 
 Visit 2 Day 1 Device on Body (Office): (up to 14 days after Visit 1*): Study, device and app 
training. 
o Setup app settings, ensuring subjects accept app terms and conditions, and provide 
training 
o Guardian Connect system start, including sensor insertion 
o Dispense wearables 
o Dispense study supplies 
o Discuss and determine target date for completing one 7-day consecutive meal logging 
during Day 8-27, prior to Visit 4 
 
*Note: If additional time is needed for training, Visit 2 may be split up into two visits at investigator’s 
discretion. Site should complete an “Unscheduled Visit” eCRF to document additional visit.  
 Visit 3 Day 10 Follow-up (Phone): Day 10 (±4 days) after Visit 2. 
o Remind subject to have continuous sensor wear 
o Remind subject to complete 7-day consecutive meal logging on targeted dates prior to 
Visit 4 
o Based on data surveillance reports as available (provided by sponsor), discuss subject
 
compliance (e.g. meal logging, CGM use, sleep and insulin tracking etc.)   
 
 Visit 4 Day 30 Follow-up (Office): Day 30 (±7 days) after Visit 2. 
o Dispense study supplies 

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o Based on data surveillance reports as available (provided by sponsor), discuss subject
 
compliance (e.g. meal logging, CGM use, sleep and insulin tracking etc.) 
o Discuss and determine target date for completing one 7-day consecutive meal logging 
prior to Visit 5 
 
 Visit 5 Day 60 Follow-up (Office or Phone): Day 60 (±7
 days) after
 Visit 2. 
o If subject is participating in cardiac monitoring: 
 Train subject on cardiac monitor 
 Dispense cardiac monitor and supplies 
o Based on data surveillance reports as available (provided by sponsor), discuss subject
 
compliance (e.g. meal logging, CGM use, sleep and insulin tracking etc.) 
o Discuss and determine target date for completing one 7-day consecutive meal logging 
prior to Visit 6 
o Determine if subject will participate in Phase 2 
o If not participating in Phase 2, determine Day 90 when subject may stop data collection 
and schedule Visit 6 (EOS) 
 
 Visit 6 (Office): Day 100 (±7
 days) after
 Visit 2. 
o If EOS: 
 Return study meter, transmitter, wearables, sponsor-provided smartphone and 
cardiac monitor (if applicable) 
 Wipe data off
 (perform
 factory
 reset)
 wearables 
 Administer EOS questionnaire 
Note: EOS questionnaires will be administered to all subjects at the end of their 
participation in the study. This includes subjects who are terminated or who 
voluntarily discontinue participation in the study. 
o If
 moving onto Phase 2, see below. 
 
Phase 2: Subjects participating in study for over 90 days (up to 9 months): 
 Visit 6 Day 90 Follow-up (Office): Day 90 (±14 days) after Visit 2. 
o Dispense study supplies.  
o Based on data surveillance reports as available (provided by sponsor), discuss subject
 
compliance (e.g. meal logging, CGM use, sleep and insulin tracking etc.) 
o Discuss and determine target dates for completing one 7-day consecutive meal logging 
prior to Visit 7 
 
 Visit 7 Day 120 Follow-up (Phone): Day 120 (±14 days) after Visit 2. 
o Based on data surveillance reports as available (provided by sponsor), discuss subject
 
compliance (e.g. meal logging, CGM use, sleep and insulin tracking etc.) 
o Discuss and determine target date for completing one 7-day consecutive meal logging 

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prior to Visit 8 
 
 Visit 8 Day 150 Follow-up (Phone): Day 150 (±14 days) after Visit 2. 
o Based on data surveillance reports as available (provided by sponsor), discuss subject
 
compliance (e.g. meal logging, CGM use, sleep and insulin tracking etc.) 
o Discuss and determine target date for completing one 7-day consecutive meal logging 
prior to Visit 9 
 
 Visit 9 Day 180 Follow-up (Office): Day 180 (±14 days) after Visit 2.  
o Dispense study supplies. 
o Based on data surveillance reports as available (provided by sponsor), discuss subject
 
compliance (e.g. meal logging, CGM use, sleep and insulin tracking etc.) 
o Discuss and determine target dates for completing one 7-day consecutive meal logging 
prior to Visit 10 
 
 Visit 10 Day
 210 Follow-up (Phone): Day 210 (±14 days) after Visit 2. 
o Based on data surveillance reports as available (provided by sponsor), discuss subject
 
compliance (e.g. meal logging, CGM use, sleep and insulin tracking etc.) 
o Discuss and determine target date for completing one 7-day consecutive meal logging 
prior to Visit 11 
 
 Visit 11 Day
 240 Follow-up (Phone): Day 240 (±14 days) after Visit 2. 
o Based on data surveillance reports as available (provided by sponsor), discuss subject
 
compliance (e.g. meal logging, CGM use, sleep and insulin tracking etc.) 
o Discuss and determine target date for completing one 7-day consecutive meal logging 
prior to Visit 12 
o Determine date for Day 280 when subject may stop data collection and schedule
 Visit 12 
(EOS) 
 
 Visit 12 End of study (EOS) (Office): Day 280 (±7 days) after Visit 2. 
o Administer EOS questionnaire 
Note: EOS questionnaires will be administered to all subjects at the end of their 
participation in the study. This includes subjects who are terminated or who voluntarily 
discontinue participation in the study. 
o Return study meter, transmitter, wearables and sponsor-provided smartphone  
o Wipe data off
 (perform
 factory
 reset)
 wearables 
 

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Figure 3. Study Visit Schedule for Phase 1 and Phase 2, 90 Days and 280 Days of Guardian Connect system Wear 
 
 

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9.3 Unscheduled Visit 
If the subject visits the investigational center outside of the scheduled study visits, a Visit eCRF will be 
completed to document the reason for the unscheduled visit.  
Examples of reasons for an unscheduled visit and completion of the appropriate eCRF include, but are 
not limited to: 
•  Replacement of a study sensor(s) within 24 hours of the initial sensor insertion if there is need 
of replacement. 
•  Subject requests investigational center staff to examine sensor insertion site(s) 
•  Subject has an AE and/or device deficiency that requires a visit prior to next scheduled visit 
•  For subject re-training (e.g. subject expected activities and/or app use)  
9.4 Subject Consent 
Informed Consent and Assent will be obtained in accordance with the Code of Federal Regulations (CFR) 
Title 21, Part 50. Prior to entry into the study, the California Experimental Subject’s Bill of Rights (if 
applicable), the Institutional Review Board (IRB) and Medtronic approved ICF and assent form and an 
Authorization Form required by the Health Insurance Portability and Accountability Act (HIPAA) will be 
presented to each subject to review and sign as applicable. The subject and their parent or guardian will 
be offered the opportunity to review these documents away from the investigational center. 
The following will be provided to or explained to the subject and their parent or guardian 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 
guardian’s questions during the informed consent and assent process. The language used shall be as 
non-technical as possible and must be understandable to the subject or their parent or guardian.  
The subject must have ample time and opportunity to read and understand the ICF, to inquire about 
details of the study, and to decide whether or not to participate in the study. All questions about the 
study should be answered to the satisfaction of the subject. 
Neither the investigator, nor the investigation center staff shall coerce or unduly influence a subject or 
their parent or guardian to participate or to continue to participate in the clinical study. The informed 
consent and assent process shall not waive or appear to waive the subject’s rights. 
Subjects will complete California Experimental Subject’s Bill of Rights (if applicable), the HIPAA Form, 
and the ICF and assent form. The consenting process must be documented in the subject’s source 
documents. The subject and their parent or guardian will receive copies of the documents.  A subject’s 
participation in study procedures cannot begin before the consent process has been properly executed. 

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When the subject decides to participate in the study, the ICF must be signed and personally dated by the 
subject and investigator or authorized designee, as required by the ICF. 
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 and their parent or guardian in a timely manner.  
Medtronic will revise the written ICF and assent form whenever new information becomes available that 
may be relevant to the subject’s confirmed participation in the clinical study. The revised information 
will be sent to the investigator for approval by the IRB. After approval by the IRB, a copy of this 
information must be provided to the participating subjects, and the informed consent and assent 
process as described above needs to be repeated. 
If the ICF and assent form are amended during the course of the study, the IRB will determine: 
•  Whether or not active subjects and their parent or guardian should be re-consented at their 
next visit  
•  Whether or not subjects who have completed the study at the time of the amendment should 
repeat the informed consent and assent process.  
Subjects and their parent or guardian will be informed that qualified personnel from the investigational 
center, the sponsor (Medtronic), agencies such as the FDA and/or the IRB, may have access to the clinic 
records that reveal their identity and health care information. 
The investigational center must report the following informed consent and assent violations to their IRB 
and sponsor: 
•  Failure to obtain informed consent and assent from subject and their parent or guardian 
•  Failure to obtain informed consent and assent prior to performing one or more study 
procedures. 
•  Failure to maintain ICFs and assent forms on file for all subjects who have provided informed 
consent. 
•  Use of an ICF and assent form that has not received approval from the IRB. 
•  Use of an incorrect version of the ICF and assent form. 
9.5 Medical Oversight 
In order to conduct the study, investigational center staff that have the appropriate medical training is 
required. 
9.5.1 Medical Staff 
A physician (or designee) who has managed patients on both CGM and intensive insulin therapy will be 
included in the study as the principal investigator. 

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9.5.2 Qualification 
The investigator (or designee) will need to have one of the following qualifications: endocrinology 
fellowship or management in patients with diabetes in a clinical practice. The provider must be qualified 
to treat diabetic emergencies. 
9.5.3 Experience 
Investigator (or designee) must also have at least one-year experience in managing patients with insulin 
carbohydrate ratios and insulin sensitivity ratios in his/her practice. 
9.6 Glucose and Glycemia Measurements 
During the course of the study, the subjects’ BG levels and SG levels will be assessed using the methods 
outlined in this section. 
9.6.1 Daily Blood Glucose 
Values will be assessed during the study by all subjects using the study meter. The control solution test 
will be performed following the manufacturer’s user guide. Subjects will be trained on the use of the 
study meter per the manufacturer’s instructions.   
9.6.2 Sensor Glucose Values 
Sensor Glucose (SG) data will be collected by subject’s Guardian Connect system. 
9.7 Recording Data 
Data, excluding uploads, will be captured on eCRFs using Oracle Clinical Remote Data Capture (OC-RDC) 
module. Original eCRFs will not be considered as source data and supporting documentation will be 
required.  
Electronic device data will be collected from the Guardian Connect transmitter, wearables, smartphone 
apps, smart pen cap/smart pen, cardiac monitor, and study meter. Electronic data collected will be 
collected by smartphone apps and stored on their respective data cloud. Data from all apps used in this 
study will be sent to the Nutrino data servers, where it will be processed. Klue video capture data files 
will be sent to the sponsor electronically using the internet and a secure cloud-based site. The CareLink 
software system uses TLS technology, which encrypts all data it stores (21 CFR Part 11 compliant). 
Electronic device data will be collected from the transmitters utilizing the respective software.  
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 OC-RDC 
system; otherwise, irresolvable data-related issues will be routed to the sponsor for review and final 

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disposition. An audit trail is maintained in OC-RDC to capture any corrections or changes of the eCRFs. 
System backups for data stored in the Oracle Clinical system will be consistent with Medtronic Standard 
Operating Procedures (SOPs). 
Medtronic will only consider eCRFs to be complete when all discrepancies between source data and 
eCRF have been resolved and applicable eCRF content has been reviewed by a Study Monitor. 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. 
9.8 Deviation Handling  
A deviation is any instance(s) of failure to follow, intentionally or unintentionally, the requirements of 
the CIP. It is expected that the investigator will conduct this clinical trial in compliance with the CIP and 
all applicable regulations governing the conduct of clinical research involving human subjects. Failure to 
do so could result in one or all of the following: 
•  Investigational center disqualification  
•  Notification to the regulatory authorities/IRB depending on the severity of the deviation 
and reporting requirements 
The investigator should not implement any deviation from, or changes to, the CIP without agreement by 
the sponsor and prior review and documented approval/favorable opinion from the IRB, except where 
necessary to eliminate an immediate hazard(s) to trial subjects or when the change does not affect the 
scientific soundness of the plan or the rights, safety, and welfare of the subjects. 
9.8.1 Documenting Requirements for Study Deviations 
9.8.1.1 Unplanned CIP Deviations 
The investigator may encounter the need to deviate from the CIP when necessary to protect the safety, 
rights or well-being of a subject in an emergency or in unforeseen situations beyond the investigator’s 
control (e.g., subject failure to attend scheduled follow-up visits, inadvertent loss of data due to 
computer malfunction, inability to perform required procedures due to subject illness). 
Deviations from the CIP, regardless of the reason should be documented as soon as possible, after the 
deviation occurs or is identified. This documentation should include deviation date, description of the 
deviation, the reason for deviation, and the corrective action. Refer to Table 3 for reporting timelines for 
emergency deviations. 
CIP deviations should be reported as follows: 
a) To the IRB for notification/acknowledgement; 
b) To the sponsor and, if required; 
c) To the applicable regulatory agency (reported by sponsor) 

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9.9 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 and reason for each 
deviation will be documented (21 CFR 812.140 Records).   
The following examples are deviations that could impact subject safety, affect the integrity of study data 
and/or affect subject’s willingness to participate in the study. These deviations are significant and 
require immediate sponsor notification upon investigator awareness:  
•  Failure to obtain informed consent and assent, i.e., there is no documentation of consenting 
•  Informed consent and assent obtained after initiation of study procedures 
•  Continuation of a subject who did not meet all inclusion/exclusion criteria 
•  Performing study procedure not approved by the IRB 
•  Failure to inform IRB and sponsor of reportable AEs (see Section 11) 
•  Investigational study device dispensed without obtaining informed consent and assent 
 
Reporting of all other study deviations should comply with: 
• IRB policies and/or 
• local laws and/or 
• regulatory agency requirements 
 
They must be reported to Medtronic as soon as possible upon the center becoming aware of the 
deviation. Refer to Investigator Reports, Table 3, for specific deviation reporting requirements and 
timeframes for reporting to Medtronic, IRB, and regulatory agency (if applicable). 
9.9.1 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.  
9.10 
Subject Exit, Withdrawal or Discontinuation  
Subjects may choose to withdraw from the study at any time by notifying investigational center staff of 
their intent. 
If a subject chooses to end his or her study participation or if the subject is removed from the study at 
the Investigator’s discretion or for failure to meet the study requirements, the reason for withdrawal 

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must be documented. All study devices and supplies must be returned (as applicable) and documented 
both in source documents and on an eCRF.  
Subjects may also be withdrawn from the study at the discretion of the Investigator. 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 
•  In the opinion of the investigator, it is in the subject’s best interest to discontinue participation 
in the study 
•  During the course of the study, subject begins participation in another investigational study 
(drug or device). 
•  The subject is found to no longer meet all inclusion criteria, or is found to meet one or more 
exclusion criteria 
•  The subject fails to comply with one or more study requirements 
•  During the study, (female) subject becomes pregnant. 
 
Documentation  of  
the  
reason(s)  
leading  to subject  withdrawal  will be kept  
in  
the subject’s source 
documentation. 
 
 

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10.2 
Risk Minimization 
Refer to “Prevention and Mitigation” column in Table 2. 
10.3 
Potential Benefits 
Subjects are not expected to benefit from participation in this study; however, they may gain increased 
awareness of emerging technologies for diabetes management as a result of their participation. 
10.4 
Risk-Benefit Rationale 
The data collected has the potential to facilitate the development and availability of improved 
Medtronic devices that may provide significant benefits to patients in the future. In light of this, we 
believe that the overall future potential benefits to the general population of patients with diabetes 
outweigh any risk to subjects who choose to participate in the investigation. 
10.5 
Risk Determination 
In the opinion of the sponsor, this study is considered to be a non-significant risk (NSR) study. Results of 
an evaluation of the requirements per 21 CFR Part 812.3, led to the NSR determination as follows: 
•  The devices are not intended as an implant and do not present potential for serious risk to 
subject health, safety, or welfare. 
•  The devices are not to be used for supporting or sustaining human life and do not present 
potential for serious risk to subject health, safety, or welfare. 
•  The devices are not for a use of substantial importance in diagnosing, curing, mitigating or 
treating disease, or otherwise preventing impairment of human health and do not present 
potential for serious risk to subject health, safety, or welfare. 
•  Review of the device risk analysis did not identify potential for serious risk to subject health, 
safety, or welfare. 
The NSR determination is also based on the commensurate safety experience of continuous glucose 
monitoring in commercial use. Furthermore, subjects should be instructed to make all treatment 
decisions based on a fingerstick glucose measurement and not on sensor glucose information provided 
by CGM system. 
11 Adverse Events and Device Deficiencies 
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 

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consent documenting the medical diagnosis, date of event start and end, causality (relationship to 
device or procedure), treatment, outcome, and description that includes the details of the event. 
11.1 
Definitions and Classification of Adverse Events  
Medtronic uses the definitions provided in ISO 14155:2020 and 21 CFR 812 for AE definitions. Where the 
definition indicates “device”, it refers to any device used in the study. This might be the device under 
investigation, or any market released component of the system.  
Severe Hypoglycemia is an event requiring assistance of another person due to altered consciousness to 
actively administer carbohydrate, glucagon, or other resuscitative actions
[6]. 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. 
Diabetic Ketoacidosis/DKA diagnostic criteria: blood glucose 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
[7]. 
Hyperglycemic events will be recorded as DKA if the event includes the presence of all of the following: 
•  Arterial blood pH less than (<) 7.30 or serum bicarbonate less than (<) 15 mEq/L 
•  Blood glucose greater than (>) 250 mg/dL or greater than (>) 13.9 mmol/L 
•  Serum ketones or large/moderate urine ketones 
•  Symptoms such as polyuria, polydipsia, nausea, or vomiting 
•  Treatment provided in a health care facility 
 
Adverse Event (AE) (ISO 14155-2020) 
Any 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:   
This definition includes events related to the investigational medical device or the 
comparator. 
Note 2:   
This definition includes events related to the procedures involved. 
Note 3:   
For users or other persons, this definition is restricted to events related to the use of 

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investigational medical devices or comparators. 
 
Adverse Device Effect (ADE) (ISO 14155-2020) 
Adverse event related to the use of an investigational medical device.  
Note 1 to entry:  
This definition includes adverse events resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation, or operation, or any 
malfunction of the investigational medical device. 
Note 2 to entry:   
This definition includes any event resulting from use error or from intentional 
misuse of the investigational medical device. 
Note 3 to entry:   
This includes ‘comparator’ if the comparator is a medical device. 
 
Serious Adverse Event (SAE) (ISO 14155-2020) 
Adverse event that led to any of the following 
a) death, 
b) serious deterioration in the health of the subject, users or other persons as defined by one or 
more of the following: 
1. a life- threatening illness or injury, or 
2. a permanent impairment of a body structure or a body function including chronic 
diseases, or 
3. in-patient* or prolonged hospitalization, or 
4. medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function  
c)  fetal distress, fetal death or a congenital abnormality or birth defect including physical or 
mental impairment 
*For the purpose of this study, Inpatient Hospitalization is defined as: admission to the hospital for a 
period of 24 hours or more based on urgent medical need rather than elective admission. 
Note 1 to entry: Planned hospitalization for a pre-existing condition, or a procedure required by the CIP, 
without a serious deterioration in health, is not considered a serious adverse event. 
For the purpose of this study, the term “life-threatening” in the definition of “serious” refers to an event 
in which the patient was at risk of death at the time of the event; it does not refer to an event which 
hypothetically might have caused death if it were more severe[8].  
 

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Serious Adverse Device Effect (SADE) (ISO 14155-2020) 
Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse 
event. 
 
Unanticipated Adverse Device Effect (UADE) (21 CFR 812.3(s)) 
Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or 
associated with, a device, if that effect, problem, or death was not previously identified in nature, 
severity, or degree of incidence in the investigational plan or application (including a supplementary 
plan or application), or any other unanticipated serious problem associated with a device that relates to 
the rights, safety, or welfare of subjects. 
11.2 
Reporting of Adverse Events 
The Investigator or designee will record AEs that are device related and procedure related, SAEs, SADEs, 
Severe Hypoglycemia, and DKA while the subject is enrolled in the clinical study. Each AE needs to be 
assessed for its device or procedure relatedness.  A device related AE is associated with the use of the 
study device (e.g. infection of sensor site or infusion set occlusion resulting in DKA). A procedure related 
AE is associated with testing related to the study procedures specified in the CIP. 
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 fingertips from FST/ bruising at IV insertion site 
Subjects participating in the study have diabetes and are expected to experience hypoglycemia and or 
hyperglycemia.  These normal events are not expected to be reported to sponsor as this is not 
considered an untoward event, but rather an expected occurrence. Any glycemic excursion that meets 
the protocol definition of Severe Hypoglycemia 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. 

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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. 
11.3 
Notification of Adverse Events 
Sponsor Notification: 
The investigational center staff must report all reportable AEs to Medtronic in a timely manner.  All 
Severe Hypoglycemia, DKA, SAE, and SADEs should be reported as soon as possible (desired within 
24 hours of investigator or study coordinator awareness) to Medtronic. For the previously 
mentioned events, the AE eCRF will be completed with all known details as soon as possible, this will 
serve as notification to Medtronic. If the study database cannot be accessed due to technical 
problems, contact the sponsor via email at dl.diabetesclinicalresearchsafety@medtronic.com and 
provide the 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 the 
Medtronic BOX safety folder.  All source documents/medical records should be redacted of patient 
identifiers (full name, address, etc.) prior to providing to the sponsor. Each source page should be 
identified with the subject ID. 
11.4 
Expedited Safety Reporting Requirements 
For device studies, investigators are required to submit a report of a UADE to the sponsor and the 
reviewing IRB as soon as possible, but in no event later than 10 working days after the investigator first 
learns of the event (812.150(a)(1)).  
The sponsor will notify the investigator and IRB of any event that results in a safety report per 
regulations to the FDA. Documentation of IRB notification of any safety event must be kept at the 
investigational center and a copy sent to the sponsor. 
It is the responsibility of the investigator to follow their IRB reporting requirements. 
11.5 
Causality Assessment 
An AE is not automatically related to the study device or procedure simply because the subject is 
wearing the device and participating in the study. The event should be reviewed to determine if the 
device or study procedure could have possibly caused the event and therefore is related to the study 
device or procedure.  
Causality assessment is the determination of the relationship between an AE and the device being 

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studied. It is expected that the investigational center will review all elements surrounding the AE to 
properly assess the causality of the event to the study device or to a study procedure.  
This review would include the subjects’ description of the event, study device uploads and medical 
records (if applicable) from the treating facility. These records will be made available to sponsor.  
Investigators should classify the relationship between the AE and the study device or study procedures 
using one of the five possible causality categories listed below: 
•  Not related: relationship to the device or procedures can be excluded when: 
o the event is not a known side effect of the product category the device belongs to or of 
similar devices and procedures 
o the event has no temporal relationship with the use of the investigational device or the 
procedures; 
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 serious 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; 
o harms to the subject are not clearly due to use error; 
o 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 serious event. 
•  Unlikely: the relationship with the use of the device seems not relevant and/or the event can be 
reasonably explained by another cause, but a relationship to the device cannot be completely 
ruled out. 
•  Possible:  the relationship with the use of the investigational device is weak. 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 should also be 
classified as possible. 
•  Probable:  the relationship with the use of the investigational device seems relevant and/or the 
event cannot reasonably be explained by another cause. 
•  Causal relationship: the event is associated with the investigational device or with procedures 

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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; 
o 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 serious event. 
11.6 
Anticipated or Unanticipated 
If an AE is determined to be related to the study device the sponsor will then assess the event to 
determine if it is anticipated or unanticipated. 
•  Anticipated: the event is identified in the CIP, labeling, report of priors/IB, or user guide. 
•  Unanticipated: the event has not been previously identified in the CIP, labeling, report of 
priors/IB, or user guide. 
11.7 
AEs Related to Glucose Sensor Insertion Sites 
It is expected that subjects will experience mild irritation, redness, bleeding or bruising associated with 
the insertion and or wear of the glucose sensor and devices.  An AE eCRF will be completed only if the 
following criteria are met: 
• Redness/Irritation (i.e., abrasion, scab, blisters, bumps, itchy bumps, raised ridge or other) 
which required medical or emergency medical treatment 
• Bruising greater than or equal to 6 cm or required emergency medical treatment 

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11.8 
Device Deficiencies and Troubleshooting 
The Medtronic support line will be consulted for device troubleshooting if assistance is needed by 
subject to operate study devices and apps. When subjects call the support line, they are instructed to 
notify the support line operator that they are currently participating in a clinical research study. 
 
Depending on the study device or app, the subject and/or investigational center may be instructed by 
the support line to contact the respective device manufacturer for device troubleshooting and device 
complaints. Device deficiencies for commercially released devices or apps should be captured according 
to local regulatory requirements and is the responsibility of the Investigator. 
 
The investigational center will be provided with a copy of support line calls for their subjects. The 
support line calls should be reviewed for investigational center staff awareness for the possibility of an 
AE. If an AE is detected the investigational center staff will complete the appropriate eCRF(s). 
 
Device deficiencies reported directly to the investigational center staff by a subject should either be 
reported to the Medtronic support line by the subject or investigational center staff. All applicable 
device deficiencies that are reported to the Medtronic support line will be documented.
 A device 
deficiency is any inadequacy of a medical device with respect to its identity, quality, durability, 
reliability, safety, or performance. NOTE: Device deficiencies include malfunctions, use errors, and 
inadequate labeling. This definition includes device deficiencies related to the investigational medical 
device or comparator. (SO14155:2020) 
To return a study device as part of a device deficiency, the subject is to contact the investigational 
center staff, and the investigational center should then follow the study procedures for returning 
products with device deficiencies.  
It is the responsibility of the Investigator to follow their IRB reporting requirements. 
12 Data Review Committees  
12.1 
Clinical Events Committee 
A clinical events committee (CEC) consisting of external physicians with an expertise in endocrinology 
and the management of diabetes including insulin pumps and CGM will be convened. The CEC will 
review AEs as required per protocol, which include reports of: 
•  Serious Adverse Event 
•  Serious Adverse Device Effect 
•  Unanticipated Adverse Device Effect 
•  Severe Hypoglycemia 

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injections (MDI) insulin therapy will be enrolled. 
13.5 
CIP Deviations 
All CIP deviations will be presented in the listings. 
13.6 
Primary Endpoint 
Descriptive statistics will be performed; no statistically powered analyses or hypothesis testing will be 
performed. 
•  Glycemic control: Percentage of Time in Range (SG <70 mg/dL, 70-180 mg/dL, and >180 
mg/dL)  
13.7 
Other Descriptive Endpoints 
•  Summary of completed data collection/available data 
•  Summary of study questionnaire results 
13.8 
Safety Analysis 
Descriptive summary will be used to characterize adverse events: 
• Serious Adverse Events (SAE) 
• Device Related AEs 
• Procedure Related AEs 
• Serious Adverse Device Effect (SADE) 
• Unanticipated Adverse Device Effect (UADE)  
• Severe hypoglycemia 
• Diabetic
 Ketoacidosis (DKA) 
 
13.9 
Device Deficiencies 
Descriptive summary will be used to characterize device deficiencies. 
 
 
 

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14 Ethics 
14.1 
Statement(s) of Compliance  
IRB 
This CIP, any subsequent amendments to this CIP, the ICF/Assent form (if applicable), subject materials, 
and any form of subject recruitment 
information (e.g., advertisements) relating to this study will be 
approved by the responsible IRB in accordance with 21 CFR Part 56.  
The investigational center will not initiate any subject activities until IRB approval has been granted, 
the 
sponsor has cleared the investigational center to begin the study, and the investigational center staff has 
been appropriately trained to conduct 
the study.  
Regulatory Compliance 
This clinical study will be conducted in compliance with the Clinical Investigation Agreement; the CIP; 
United States CFR Title 21 Part 812.2(b) (abbreviated requirements under Investigational Device 
Exemptions), Part 50 (Protection of Human Subjects), Part 54 (Financial Disclosure by Clinical 
Investigators), Part 11 (Electronic Records; Electronic Signatures), and Part 56 (IRBs); and all other 
applicable federal and local regulatory requirements. 
The study will also be conducted in compliance with the principles of good clinical practice (GCP) 
meaning that the study design, conduct, performance, monitoring, auditing, recording, analysis and 
reporting will assure that the data and results are credible and accurate and that the rights, safety and 
well-being of subjects are protected. GCP includes review and approval by an IRB before initiating the 
investigation, ongoing review of the investigation by an IRB and obtaining and documenting the freely 
given informed consent of the subject (or the subject’s parent or guardian) before their participation in 
the investigation. 
The ethical principles that have their origin in the Declaration of Helsinki have been implemented in this 
clinical study by means of the informed consent process and assent (if applicable), IRB approval, study 
training, clinical trial registration, preclinical testing, risk benefit assessment, publication policy, etc. 
If the subject is not of legal age per local requirements, he/she should be informed about the study to 
the extent compatible with the subject’s understanding. If the subject could give consent to decisions 
about participation in research, the investigator must obtain that consent in addition to the consent of 
their guardian. 
Ethical Considerations 
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. 
Sponsor’s Support  
Sponsor representatives may provide support as required for the study including providing study 

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training relevant and pertinent to the involvement of personnel conducting study activities and 
investigator responsibilities. 
14.2 
Investigator’s Responsibilities 
Per 21 CFR 56.102, an Investigator means “an individual who actually conducts a clinical investigation 
(i.e., under whose immediate direction the test article is administered or dispensed to, or used 
involving, a subject) or, in the event of an investigation conducted by a team of individuals, is the 
responsible leader of that team.” Each investigational center shall designate a primary investigator who 
will have overall responsibility for the conduct of the investigation at the investigational center. 
The primary investigators (and co-investigators if applicable) are responsible for conducting the study in 
accordance with this investigational plan and 21 CFR 812.2(b) that apply to NSR device studies. These 
requirements include, but are not limited to: 
 Obtaining informed consent and assent (if applicable) for all subjects prior to study 
participation as described in 21 CFR Part 50. 
 Maintaining records of each subject’s case history and exposure to the device as described in 
§812.140(a)(3)(i). Case histories include case report forms and supporting data, including 
signed and dated consent forms and medical records, progress notes of the physician, the 
individual’s hospital chart(s), and the nurses’ notes. 
 Making the following required reports: 
 Unanticipated Adverse Device Effects [§812.150(a)(1)] 
 Withdrawal of IRB Approval [§812.150(a)(2)] 
 Failure to obtain informed consent
 [§812.150(a)(5)] 
 Other reports requested by a reviewing IRB or FDA [§812.150(a)(7)] 
 Providing sufficient financial information to allow the sponsor to submit certification or 
disclosure of financial interests. The investigator must update the information if any relevant 
changes occur during the course of the investigation and for one year following completion of 
the study. (§ 812.110) 
 
Only authorized study personnel as listed on the Delegation of Authority Log are permitted to consent 
subjects, receive, dispense, dispose of and return investigational products, conduct subject visits, insert 
devices, and enter data on eCRFs. These tasks may be delegated by the Investigator. However, the 
Investigator is ultimately responsible to ensure investigational center-staff are qualified and perform the 
tasks that have been delegated to them correctly. In addition, the Investigator is responsible for the 
conduct of investigational center in the execution of the clinical trial. 
 
 
 

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15 Study Administration 
15.1 
Training of Clinical Staff  
Training of the investigational center staff on the conduct of the study and system being studied will be 
initiated before the CIP is implemented. All participating physicians and coordinators will be familiarized 
with the system. Other members of the investigational center staff may require training depending on 
their role listed on the Delegation of Authority Log. Training may contain both lecture and hands-on 
experience. 
The PI is responsible for ensuring that investigational center staff are trained to perform their assigned 
duties per Delegation of Authority Log. Individual investigational center staff must be appropriately 
trained prior to performing study related tasks.  
15.2 
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 and assent form (if applicable) have been obtained from each subject at the point 
of enrollment and that AEs discussed in Section 11 were reported via completion of the AE eCRFs. More 
details regarding the monitoring activities (frequency of monitoring visits, planned extent of source data 
verification) are described in the Monitoring Plan. 
15.3 
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, regulatory agency personnel and the Clinical Study Manager. This accessibility is of particular 
importance for reviewing data in the eCRF. Direct access to subject’s medical files for source data 
verification will need to be granted and prepared prior to any monitoring visits.  
15.4 
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 agencies 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 agencies direct access to source 
data and documents, taking into account any restrictions due to local law, to perform clinical study-
related monitoring, audits, IRB review, and regulatory inspections. 
 

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15.5 
Investigational Center Disqualification 
Sponsor and/or the IRB retain the right to disqualify an investigational center and remove all study 
materials at any time. Specific instances, that may precipitate investigational center disqualification, 
include but are not limited to: 
•  Unsatisfactory subject enrollment with regards to quantity. 
•  Persistent non-compliance to protocol procedures on the part of an 
investigator/investigational center  
•  Inaccurate, incomplete, and/or untimely data recording on a recurrent basis. 
•  The incidence and/or severity of adverse experiences in this or other studies indicating a 
potential health hazard caused by the device. 
•  Unsatisfactory accountability of investigational devices. 
A written statement fully documenting the reasons for such a termination will be provided to sponsor, 
the IRB, investigational center(s) and other regulatory authorities, as required. 
15.6 
Data Management 
15.6.1 
Data Collection 
All device data will be obtained from the various study devices. 
15.6.1.1 Electronic Case Report Forms (eCRFs) 
The investigator must ensure accuracy, completeness and timeliness of the data reported in the eCRFs 
and in all other required reports. Data reported on the eCRFs, which are derived from source 
documents, such as subject medical records, must be consistent with the source documents and the 
discrepancies need to be justified in a documented rationale. 
Only authorized persons can complete eCRFs. eCRFs shall be signed by investigational center staff as 
specified on the Delegation of Authority Log included in the Investigator Site File. The OC-RDC system 
maintains an audit trail on entries, changes, and corrections in 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 center 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.  
 
 

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15.6.1.2 CareLink Personal Software 
During the course of the study, subject’s BG values may be assessed from the study meter. 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 IDs to prevent patient identification by the 
sponsor. 
15.6.1.3 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 11.2). After data entry, eCRFs should be submitted (i.e., saved) so that sponsor can proceed 
with data verification without delay.  
15.6.1.4  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 by sponsor. In case of 
issues, queries will be entered on the respective eCRF for the investigator to complete, correct, or 
comment on the data.  
15.7 
Direct Access to Source Data/Documents 
The subject’s clinic file, CareLink data, and source documents are handled as source data.  
Medtronic clinical representatives or delegates will be granted access by the investigational center to all 
source documents including electronic source documents or copies of electronic source documents, if 
applicable, for the purposes of monitoring, audit, or inspection.  
15.8 
Confidentiality 
The investigator will ensure that the subject’s anonymity is maintained. Subjects will not be identified in 
any publicly released reports of this study. All records will be kept confidential to the extent provided by 
federal, state and local law. The study monitors and other authorized representatives of the sponsor 
may inspect all documents and records required to be maintained by the investigator, including but not 
limited to, medical records. The investigator will inform the subjects that the above-named 
representatives will review their study-related records without violating the confidentiality of the 
subjects. All laboratory specimens, evaluation forms, reports, and other records that leave the site will 
be identified only by the subject ID code in order to maintain subject confidentiality. In the device re-use 
instances between subjects, the data from the study devices will be wiped out before re-issuing it to 
another subject. All records will be kept locked and all computer entry and networking programs will be 
done with coded numbers only.   

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15.9 
Liability 
Subjects will be paid for participation. Refer to the ICF on the details of the subject’s compensation. 
 
15.10 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 (i.e. from an investigator, the CEC or the 
study team) and will submit any significant amendment to the CIP, including a justification for this 
amendment, to the appropriate regulatory agency (if applicable) and to the investigators to obtain 
approval from their IRB. The investigator will only implement the amendment after approval of the IRB, 
regulatory agency (if applicable), and sponsor. Administrative amendments to the CIP will be submitted 
to the IRB for notification.  
15.11 Records and Reports 
15.11.1  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 
•  User guide(s) 
•  Medtronic and IRB approved Subject ICF and assent form (if applicable) 
•  IRB and Regulatory authority approval or notification 
•  Fully signed clinical study agreements (i.e. including Form of Investigator Statement, Clinical 
Trial Agreement, Financial Disclosure 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 and assent forms (if applicable) 
•  Source documentation 
•  Fully executed eCRFs and corrections  
•  Report of AEs and Device Deficiencies 

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15.12 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 agencies. 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. 
15.13 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 of the termination or suspension and the 
reason(s) for this. The investigator shall then promptly inform the reviewing IRB and the study subjects.  
15.14 Early Investigational Center Suspension or Termination 
Sponsor, IRB or a Regulatory Authority may decide to suspend or prematurely terminate an 
investigational center (e.g., in case of expiring approval of the reviewing IRB, non-compliance to the CIP, 
or lack of enrollment). The suspended clinical studies cannot be resumed without permission from IRB. If 
an investigational center is suspended or prematurely terminated, sponsor shall promptly inform the 
investigator(s) of the termination or suspension and the reason(s) for this. The investigator shall then 
promptly inform the reviewing IRB and the study subjects.  
When the risks are found to outweigh the potential benefits or when there is conclusive proof of 
definite outcomes, investigators must assess whether to continue, modify, or immediately stop the 
clinical study in the respective investigational center and immediately inform the sponsor and IRB, if 
applicable. 
15.14.1 Subject Follow-up in Case of Termination 
In case of early investigational center suspension or termination, all subjects should be contacted to 
plan an early Termination visit at the investigational center. All efforts will be made to complete and 
report all study observations at the time of termination. The subject will return the study devices to the 
investigational center.  
15.15 Study Close Out 
At the time of a study close-out, the investigators will be notified by sponsor. Appropriate 
notification/report to IRB and Regulatory Authority will be provided if required per local laws and 

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regulations. 
15.16 Publication and Use of Information 
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://clinicaltrials.gov prior to subject enrollment. 
 
16 References 
1.  
Tanenbaum ML, H.S., Miller KM, Naranjo D, Bensen R, Hood KK, Diabetes Device Use in Adults 
with Type 1 Diabetes: Barriers to Uptake and Potential Intervention Targets. Diabetes Care, 2017. 40(2): 
p. 181-187. 
2.  
Medtronic data on file. 
3.  
Beck RW, R.T., Ruedy K, et al., Effect of continuous glucose monitoring on glycemic control in 
adults with type 1 diabetes using insulin injections. JAMA, 2017. 317: p. 371-378. 
4.  
Garg SK, W.S., Tamborlane WV, et al., Glucose outcomes with the in-home use hybrid closed-loop 
insulin delivery system in adolescents and adults with type 1 diabetes. Diabetes Technology 
Therapeutics, 2017. 19: p. 1-9. 
5.  
Bergenstal RM, G.S., Weinzimer SA, et al., Safety of a hybrid closed-loop insulin delivery system 
in Patients with type 1 diabetes. JAMA, 2016. 316: p. 1407-1408. 
6.  
Cryer, P., Defining and reporting hypoglycemia in diabetes: A report from the American diabetes 
association workgroup on hypoglycemia. Diabetes Care, 2005. 28(5): p. 1245-1249. 
7.  
Hyperglycemic Crises in Diabetes. Diabetes Care., 2004. 27: p. S94-S102. 
8.  
EMEA, Clinical Safety Data Management: Definitions and Standards for Expedited Reporting. ICH 
Topic E2A, 2006. 
 
17 Appendices  
17.1 
Names and addresses 
17.1.1 
Investigational Centers and IRB 
Table 4 below provides a list of the investigators and investigational centers currently approved to 
participate in the study.