Evaluation of Meal Gesture Dosing in Adults With Type 1 Diabetes
Phase: NA
Conditions: Type 1 Diabetes
Sponsor: Medtronic MiniMed, Inc.

 
Study Title  Evaluation of Meal Gesture Dosing in Adults with Type 1 Diabetes 
NCT Number NCT04964128 
Document Description Clinical Investigational Plan (Version F) 
Document Date 31-MAR-2022 
 

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Clinical Investigation Plan 
Clinical Investigation 
Plan/Study Title 
Evaluation of Meal Gesture Dosing in Adults with Type 1 Diabetes 
Clinical Investigation 
Plan Identifier 
339 
Study Product Name  Investigational Products: 

MiniMed™ 780G insulin pump, with investigational software version
1.0W.1003 – referred to as the study pump throughout this protocol 

Guardian™ Link 3 transmitter

Klue™ Health App by Klue, Inc. with investigational software release
tag 1.0

Klue™ Health App by Klue, Inc. with investigational software release
tag 2.0, once available

Roche Accu-Chek™ Guide Link Glucose Meter with modification to
allow communication with study pump  – referred to as the study
meter throughout this protocol
Non-Investigational Products: 

Guardian™ Sensor 3 – referred to as the sensor throughout this
protocol 

CareLink™ System (for clinical research) – referred to as CareLink
system throughout this protocol 

CareLink™ Personal (for clinical research) – referred to as CareLink
Personal throughout this protocol 

FoodPrint™ app by Nutrino™

MiniMed Clinical app, with software version 1.1.1

CareLink Clinical app, with software version 2.1.1

FreeStyle Optium Neo or other locally approved meter to be used
for blood ketone measurements only - referred to as the ketone
meter throughout this protocol

Roche Accu-Chek™ Guide Link Glucose Meter or other compatible
commercially available Roche glucose meter – referred to as the
study meter throughout this protocol
Other Commercially Available Products: 

Apple Watch®

Apple iPhone®
Other Products: 

 once available

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 once available 
 
Sponsor/Local 
Sponsor 
Medtronic MiniMed, Inc. (Global Sponsor) 
(“Medtronic”)  
18000 Devonshire St 
Northridge, CA 91325 
 
Medtronic International Trading Sàrl (Local) 
(“Medtronic”) 
Route du Molliau 31 
1131 Tolochenaz, Switzerland 
Document Version F
Version Date 31-MAR-2022 
Document Reference 
Number 
D00456959 
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. 
Accu-Chek™ is a registered trademark of Roche Diabetes Care, Inc. (“Roche”). 
 
Apple Watch® and Apple iPhone® are registered  trademarks of Apple Inc. 
 
DreaMed Diabetes is a trademark of DreaMed Diabetes, Ltd. The MiniMed™ 780G system algorithm includes 
technology developed by DreaMed Diabetes.  
 
Klue, Inc.  is a wholly-owned subsidiary of Medtronic. 
 
Nutrino, Inc.  is a wholly-owned subsidiary of Medtronic. 
 
  
 
The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such 
marks by Medtronic is under license. Other trademarks and trade names are those of their respective owners. 
 
© 2022 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of 
Medtronic. Third party brands are trademarks of their respective owners. All other brands are trademarks of a 
Medtronic company. 
 
 

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Study product 
Name 
Investigational Product 

MiniMed™ 780G insulin pump, with investigational software version 
1.0W.1003 - referred to as the study pump throughout this protocol 

Guardian™ Link 3 transmitter 

Klue™ Health App by Klue, Inc., with investigational software release 
tag 1.0  

Klue™ Health App by Klue, Inc., with investigational software release 
tag 2.0, once available 

Roche Accu-Chek™ Guide Link Glucose Meter with modification to 
allow communication with study pump – referred to as the study 
meter throughout this protocol 
Non-Investigational Product 

Guardian™ Sensor 3 - referred to as the sensor throughout this 
protocol 

CareLink™ System (for clinical research) – referred to as CareLink 
system throughout this protocol 

CareLink™ Personal software (for clinical research) – referred to as 
CareLink Personal throughout this protocol  

FoodPrint™ app by Nutrino™ 

MiniMed Clinical app, with software version 1.1.1 

CareLink Clinical app, with software version 1.1.2 

FreeStyle Optium Neo or other locally approved meter to be used for 
blood ketone measurements only - referred to as ketone meter 
throughout this protocol 

Roche Accu-Chek™ Guide Link Glucose Meter or other compatible 
commercially available Roche glucose meter – referred to as the study 
meter throughout this protocol 
 
Other Commercially Available Products:  

Apple Watch® 

Apple iPhone®
 
Other Products: 

, once available 

, once available 
 
Sponsor 
Medtronic International Trading Sàrl 
(“Medtronic”) 
Route du Molliau 31 
1131 Tolochenaz, Switzerland 

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Clinical 
Investigation Plan 
Identifier 
CIP339 
Version 
Number/Date  
Version F / Date 31-MAR-2022 
I have read the protocol, including all appendices, and I agree that it contains all necessary details for 
me and my staff to conduct this study as described. I will conduct this study as outlined herein and 
will make a reasonable effort to complete the study within the time designated. 
 
I agree to comply with International Standard ISO 14155:2020 (Clinical investigation of medical 
devices for human subjects — Good clinical practice), the Israeli MOH Guidelines for Clinical Trials in 
Human Subjects, the protocol, and the applicable regulatory authority requirements. I agree to 
ensure that the confidential information contained in this document will not be used for any purpose 
other than the evaluation and conduct of the clinical investigation without the prior written consent 
of Medtronic. 
 
I will provide all study personnel under my supervision copies of the protocol and access to all 
information provided by Medtronic. I will discuss this material with them to ensure that they are fully 
informed about the products and the study. 
Investigator’s 
Signature: 
 
 
Investigator’s 
Name: 
 
 
Institution: 
 
 
Date: 
 
 
 
 

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5.2.1 
Primary Endpoints ............................................................................................................... 20 
5.2.2 
Safety Endpoints ................................................................................................................. 20 
5.2.3 
Other Endpoints .................................................................................................................. 20 
5.2.4 
Subject Feedback ................................................................................................................ 21 
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7.1.1 
Investigational Devices ....................................................................................................... 24 
7.1.2 
Non-Investigational Product ............................................................................................... 25 
7.1.3 
 ......................................................................................................... 28 
7.1.4 
 ................................................................................................... 28 
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7.6.1 
Receipt and Inventory of Study Devices by Investigational Center .................................... 31 
7.6.2 
Storage of Study Devices at Investigational Center ............................................................ 31 

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7.6.3 
Disbursement of Study Devices .......................................................................................... 31 
7.6.4 
Return or Disposal of Study Devices ................................................................................... 31 
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10.2.1 
Visit 1: Consent and Screening ............................................................................................ 39 
10.2.2 
Visit 2: Start Run-In (Office), Day -6 (window of -90 days) ................................................. 39 
10.2.3 
Visit 3: Phone, Day -3 (window of +2 days)......................................................................... 39 
10.2.4 
Visit 4: Phone, Day -1 (window of -1, +2 days and may be combined with Visit 5) ............ 39 
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10.3.1 
Study Period – At-Home: Baseline Meal Challenge ............................................................ 40 
10.3.2 
Study Period – In-Clinic: Meal Challenge ............................................................................ 41 
10.3.3 
 .......................................................................................................................... 43 
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10.7.1 
Glucose Monitoring Risk ..................................................................................................... 51 
10.7.2 
Hypoglycemic/Hyperglycemic Risk ..................................................................................... 51 
10.7.3 
Calibration of CGM Risk ...................................................................................................... 51 
10.7.4 
Reuse Risk ........................................................................................................................... 51 
10.7.5 
Sterilization Risk .................................................................................................................. 52 

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10.7.6 
Misuse Risk .......................................................................................................................... 52 
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 *OXFRVHDQG*O\FHPLD0HDVXUHPHQWV 
10.9.1 
Daily Blood Glucose ............................................................................................................ 52 
10.9.2 
Sensor Glucose Values ........................................................................................................ 52 
10.9.3 
AHCL Use ............................................................................................................................. 52 
10.9.4 
CareLink Uploads ................................................................................................................ 52 
 
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 
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10.11.1 
Revisions in Patient Information and Informed Consent Form ...................................... 53 
 
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 
5HFRUGLQJ'DWD 
 
'HYLDWLRQ+DQGOLQJ 
10.14.1 
Request for Approval of Study Deviations ...................................................................... 55 
10.14.2 
Reporting Requirements for Study Deviations ............................................................... 55 
10.14.3 
Analyzing Deviations ....................................................................................................... 56 
 
6XEMHFW([LW:LWKGUDZDORU'LVFRQWLQXDWLRQ 
10.15.1 
Lost to Follow-Up ............................................................................................................ 56 
 5LVNVDQG%HQHILWV 
 3RWHQWLDO5LVNV 
 5LVN0LQLPL]DWLRQ 
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 5LVN%HQHILW5DWLRQDOH 
 $GYHUVH(YHQWVDQG'HYLFH'HILFLHQFLHV 
 'HILQLWLRQVDQG&ODVVLILFDWLRQVRI$GYHUVH(YHQWVDQG'HYLFH'HILFLHQFLHV 
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 'HYLFH'HILFLHQFLHVDQG7URXEOHVKRRWLQJ 
 'DWD5HYLHZ&RPPLWWHHV 
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14.5.1 
Primary Endpoints ............................................................................................................... 73 
14.5.2 
Safety Endpoints ................................................................................................................. 73 
14.5.3 
Other Endpoints .................................................................................................................. 73 
14.5.4 
Subject Feedback ................................................................................................................ 73 
14.5.5 
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 (WKLFV 
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 ,QYHVWLJDWRU5HVSRQVLELOLWLHV 
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 0RQLWRULQJ 
16.3.1 
Accessibility of Investigational Center Staff and Study Materials ...................................... 78 
16.3.2 
Audits and Investigational Center Inspections ................................................................... 78 
 'DWD0DQDJHPHQW 
16.4.1 
Electronic Case Report Forms (eCRFs) ................................................................................ 79 
16.4.2 
Paper Study Worksheets ..................................................................................................... 79 
16.4.3 
Medtronic Carelink System for Clinical ............................................................................... 79 
16.4.4 
Patient Questionnaires ....................................................................................................... 79 
16.4.5 
 .................................................................................................. 79 
16.4.6 
Time Windows for Completion and Submission of Case Report Forms ............................. 80 

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16.4.7 
Data Review and Processing ............................................................................................... 80 
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 
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16.10.1 
Investigator Records ....................................................................................................... 82 
16.10.2 
Sponsor Records ............................................................................................................. 83 
 
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16.11.1 
Sponsor Reports .............................................................................................................. 84 
 
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16.12.1 
Early Study Suspension or Termination .......................................................................... 85 
16.12.2 
Early Investigational Center Termination or Suspension ................................................ 85 
16.12.3 
Subject Follow-Up In Case of Termination ...................................................................... 85 
 
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18.1.1 
Investigational Centers Information ................................................................................... 87 
18.1.2 
Monitors Contact Information ............................................................................................ 87 
18.1.3 
Sponsors Contact Information ............................................................................................ 87 
18.1.4 
Vendors Contact Information ............................................................................................. 87 
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 Abbreviation 
Definition 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AHCL 
Advanced Hybrid Closed Loop 
ASIC 
Application Specific Integrated Circuit (ASIC) 
AUC 
Area Under Curve 
BG 
Blood Glucose 
CEC 
Clinical Event Committee 
CIP 
Clinical Investigation Plan 
CGM 
Continuous Glucose Monitoring 
CRO 
Clinical Research Organization 
CRF 
Case Report Form 
CTA 
Clinical Trial Agreement 
CV 
Curriculum Vitae 
DD 
Device Deficiency 
DKA 
Diabetic Ketoacidosis 
DoH 
Declaration of Helsinki 
eCRF 
Electronic Case Report Form 
EIS 
Electrochemical Impedance Spectroscopy 
EMEA 
Europe Middle East Africa 
EOS 
End of Study 
ER 
Emergency Room 
EC/HREB/Ethics Board
Ethics Committee 
FD 
Financial Disclosure 
GCP 
Good Clinical Practice 
IB 
Investigator Brochure 
ICF 
Informed Consent Form 
ICH 
International Conference of Harmonization 
IFU 
Instructions For Use 
ISO 
International Organization for Standardization 
MOH 
Ministry of Health 
OC-RDC 
Oracle Clinical Remote Data Capture 
QC 
Quality Control 
RA
Regulatory Authority 
RF 
Radio Frequency 
RT-CGM 
Real-Time Continuous Glucose Monitoring 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SG 
Sensor Glucose 
SID 
Subject Identification 
SMBG
Self-Monitoring of Blood Glucose 
TDD 
Total Daily Dose 

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 Abbreviation 
Definition 
USADE 
Unanticipated Serious Adverse Device Effect 
 

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Title 
Evaluation of Meal Gesture Dosing in Adults with Type 1 Diabetes  
Clinical Study Type 
Feasibility; Evaluation of meal gesture dosing within the Advanced Hybrid 
Closed Loop (AHCL) System in adults with type 1 diabetes 
Study Product 
Name & Product 
Status 
Investigational/Non-CE-Marked Products Provided During Study: 

MiniMed™ 780G insulin pump, with investigational software version 
1.0W.1003 – referred to as the study pump throughout this protocol 

Guardian™ Link 3 transmitter  

Klue™ Health App by Klue, Inc. with investigational software release 
tag 1.0  

Klue™ Health App by Klue, Inc. with investigational software release 
tag 2.0, once available 

Roche Accu-Chek™ Guide Link Glucose Meter with modification to 
allow communication with study pump – referred to as the study 
meter throughout this protocol 
 
Non-Investigational/CE-Marked Product Provided During Study: 

Guardian™ Sensor 3 – referred to as sensor throughout this protocol 

CareLink™ system (for clinical research) -– referred to as CareLink 
system throughout this protocol 

CareLink™ Personal (for clinical research) software – referred to as 
CareLink Personal throughout this protocol  

FoodPrint™ app by Nutrino™   

MiniMed Clinical app, with software version 1.1.1 

CareLink Clinical app, with software version 1.1.2 

FreeStyle Optium Neo or other locally approved meter to be used for 
blood ketone measurements only – referred to as ketone meter 
throughout this protocol 

Roche Accu-Chek™ Guide Link Glucose Meter or other compatible 
commercially available Roche glucose meter – referred to as the study 
meter throughout this protocol 
 
Other Commercially Available Products:  

Apple Watch® 

Apple iPhone® 
 
Other Products: 

, once available 

 once available 
 
Consumables and accessories will be provided during the study (detailed list in 
Appendix 18.5). 
Global Sponsor 
(Funding Source) 
Medtronic MiniMed, Inc. 
(“Medtronic”) 

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18000 Devonshire St 
Northridge, CA 91325 
866.948.6633 
Local Sponsor  
Medtronic International Trading Sàrl. 
(“Medtronic”) 
Route du Molliau 31 
1131 Tolochenaz, Switzerland 
Indication under 
investigation  
Type 1 diabetes 
Purpose 
The purpose of this study is to evaluate subject safety of using the Klue Health 
app utilizing meal gesture micro insulin dosing (meal gesture dosing) within 
the AHCL system in adult subjects with type 1 diabetes in a clinic setting. 
Objective(s) 
The objective of the study is to collect data for meal gesture dosing for 
unannounced meals within the AHCL System to be used for development of 
Medtronic Diabetes devices and products.  
Study Design 
This study is a single-center, single arm study in adult subjects with type 1 
diabetes utilizing AHCL System with meal gesture detection and micro dosing 
(meal gesture dosing). Meal gesture dosing is a mode whereby meal 
announcements are not entered manually by the user. Instead, when meal 
gesture dosing is active, meal announcements are generated automatically by 
the system based on the detection of eating gestures and micro doses of 
insulin are given. See Figure 1 for an overview. 
 
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Overall subject participation will be approximately 3 weeks to 6 months.   
 

A total of up to 40 subjects (aged 18-75) may be enrolled at one 
investigational center in Israel to have at least 16 subjects complete 
the study. Subjects may repeat participation in the study at the 
request of the Sponsor and at the discretion of the investigator but 
will only be counted once toward the total number of subjects. 
 
The study consists of a run-in period and a study period. The run-in period is 
intended to allow subjects to become familiar with using the study pump 
system with the SmartGuard feature active and wearing the watch. Subjects 
should use the same insulin they will be using during the study period. 
Subjects will also be using the
 with 
 
 
 
 
During the first week of the study period, subjects will undergo a 5-day at-
home baseline meal challenge at specific meal(s) on each day. The Klue app 
will be set to monitoring-mode.  After run-in period and completion of the 5-
day at-home study period with baseline meal challenges, study subjects will 
check into the clinic for a 5-day (4 nights) intervention. Study subjects will 
wear the system with Klue meal gesture dosing activated for the entire 
duration of the 5-day intervention. See Section 10 for more details. 
 
Sample Size and 
Investigational 
Site 
A total of up to 40 subjects will be enrolled at one investigational center in 
Israel to have at least 16 subjects complete the study. Subjects may repeat 
participation in the study at the request of the Sponsor and at the discretion of 
the investigator will only be counted once toward the total number of 
subjects.  
Duration 
The study is anticipated to last approximately 15 months from investigational 
center initiation to finalization of all data entry and monitoring procedures. 
Subject participation is expected to be approximately 3 weeks to 6 months. 
Inclusion Criteria 
General Inclusion Criteria: 
1. Is age 18-75 years at time of screening 
2. Has a clinical diagnosis of type 1 diabetes for 2 years or more as 
determined via source documentation  
3. Pump therapy for greater than 6 months prior to screening 
4. Real-time continuous glucose monitoring (RT-CGM) experience 
greater than 3 months prior to screening 
5. Must have a minimum daily insulin requirement (Total Daily Dose) of 
greater than or equal to 8 units 
6. Is willing to perform 2 fingerstick blood glucose measurements daily  
7. Is willing to perform required sensor calibrations  
8. Is willing to wear the system continuously throughout the study  

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9. If subject has celiac disease, it has been adequately treated as 
determined by the investigator 
10.If the subject has had any of the following cardiovascular events more 
than 1 year prior to of screening:  myocardial infarction, unstable 
angina, coronary artery bypass surgery, coronary artery stenting, 
transient ischemic attack, cerebrovascular accident, angina, congestive 
heart failure, or ventricular rhythm disturbances they should be 
cleared by a cardiologist prior to participation, if deemed necessary by 
the investigator.  
11.If the subject has had any of the following cardiovascular events within 
1 year of screening: myocardial infarction, unstable angina, coronary 
artery bypass surgery, coronary artery stenting, transient ischemic 
attack, cerebrovascular accident, angina, congestive heart failure, or 
ventricular rhythm disturbances, they should be cleared by a 
cardiologist prior to participation. 
12.Is of legal age and capable of providing consent 
13.Is fluent in speaking, reading and understanding English 
Exclusion Criteria 
General Exclusion Criteria: 
1. Has a history of 1 or more episodes of severe hypoglycemia, which 
resulted in any the following during the 6 months prior to Screening: 
a. Medical assistance (i.e. Paramedics, Emergency Room (ER) or 
Hospitalization) 
b. Coma 
c. Seizures 
2. Has been hospitalized or has visited the ER in the 6 months prior to 
Screening resulting in a primary diagnosis of uncontrolled diabetes 
3. Has had Diabetic Ketoacidosis (DKA) in the 6 months prior to 
Screening.  
4. Is unable to tolerate tape adhesive in the area of sensor placement  
5. Has any unresolved adverse skin condition in the area of sensor 
placement (e.g., psoriasis, dermatitis herpetiformis, rash, 
Staphylococcus infection) 
6. Women of child-bearing potential who have a positive pregnancy test 
at Screening or plan to become pregnant during the course of the 
study 
7. Women who are breastfeeding 
8. Females who are sexually active and able to conceive will be excluded 
if they are not using an effective method of contraception and do not 
agree to continue using an effective method of contraception for the 
duration of the study as determined by investigator. 
9. Is being treated for hyperthyroidism at time of Screening 
10.Has a diagnosis of adrenal insufficiency 
11.Is using hydroxyurea at time of screening or plans to use it during the 
study 

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12.Is actively participating in an investigational study (drug or device) 
wherein he/she has received treatment from an investigational study 
drug or investigational study device in the last 2 weeks 
13.Is currently abusing illicit drugs, marijuana, alcohol or prescription 
drugs (other than nicotine), per investigator judgement  
14.Is using pramlintide (Symlin), DPP-4 inhibitor, GLP-1 agonists (as 
liraglutide (Victoza or other), metformin, SGLT2 inhibitors (as 
canagliflozin (Invokana)) at time of screening 
15.Has a history of visual impairment which would not allow subject to 
participate in the study and perform all study procedures safely, as 
determined by the investigator 
16.Is diagnosed with current eating disorder such as anorexia or bulimia 
17.Has been diagnosed with chronic kidney disease that results in chronic 
anemia 
18.Is on dialysis 
19.Is a member of the research staff involved with executing the study. 
Study Procedures 
and Assessments 
Subjects will participate in a minimum of 7 planned study visits, as presented 
in Figure 2. If a subject is repeating participation in the study, the subject will 
participate in another minimum 8 planned visits. The description below is a 
high-level overview, for detailed information please see Section 10.  
 

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Run-in Period
(Approximately 1 week to 3 months)
Office 
Visit 1
Screening
Phone
Visit 4
Day -1 (-1,+2)
Check-In
Office 
Visit 2 
Day -6 (-90)
Start 780G, 
CGM, Apple 
Watch/Klue
Office
 Visit 7
Day 7 (+10)
5-Day/4-Night In-
Clinic
Visit Schedule
Study Period – In-Clinic 
Study Period 5-Day Meal Challenge
*Subjects may be called back to repeat a meal challenge
Phone
 Visit 5
Day 0 (-2, +1)
Meal Challenge & 
Sensor Change 
Reminder 
Day 1
-Long Meal/
Low Carb
-Large Meal/
Low Carb
Day 2
Small Meal/
High Carb
Day 3
-Large Drink/
No Carb
-Typical Meal/
Medium Carb
Day 4
-Typical Meal/
High Carb
-Long Meal/
High Carb
Day 5
-Large Drink
-Typical Meal/
Low Carb
Study Period – At-Home 
Baseline 5-Day Meal Challenge
Phone
Visit 3
Day -3 (-90, 
+2)
Auto Mode 
Activation
Phone
 Visit 6
Day 6 (-2)
In-Clinic Meal 
Challenge & Sensor 
Change Reminder 
End of 
Study*
Day 2 (±2)
At-Home 
Meal 
Challenge 
Start
Day 1
-Long Meal/
Low Carb
-Large Meal/
Low Carb
Day 2
Small Meal/
High Carb
Day 3
-Large Drink/
No Carb
-Typical Meal/
Medium Carb
Day 4
-Typical Meal/
High Carb
-Long Meal/
High Carb
Day 5
-Large Drink
-Typical Meal/
Low Carb 
*May occur at Visit 2 to Visit
7 or an unscheduled visit

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Safety 
Assessments 
All adverse events and device deficiencies will be collected and reported.  A 
Clinical Events Committee (CEC) will be responsible for assessing all Serious 
Adverse Events (SAEs), Serious Adverse Device Events (SADEs), Unanticipated 
Serious Adverse Device Events (USADEs), Severe Hypoglycemia, Diabetic 
Ketoacidosis (DKA) and Deaths.   
Statistical 
Analysis for 
Endpoints 
Analysis will be performed by Klue Health App software release version, if 
applicable. 
 
Primary Endpoints 
Post-prandial Time in range (% of SG within 70-180 mg/dl) at home and In-Clinic 
Period will be summarized, respectively. 
 
Safety Endpoints 
Number of (S)AEs, (S)ADEs, USADEs, Severe hypoglycemic events, DKA events, 
and Device Deficiencies  
 
Other Endpoints 
All measurements performed by Study Period (At-Home and In-Clinic period). 
 
x
Post-prandial Time in different ranges (% of SG): SG <54, 70 mg/dL, SG > 
180, 250 mg/dL
x
Change in post-prandial % of time in euglycemia (70-180 mg/dL) for 
meal challenges (intervention versus baseline) 
x
Change in post-prandial % of time in different ranges (% of SG): SG <54, 
70 mg/dL, SG > 180, 250 mg/dL for meal challenges (intervention versus 
baseline) 
x
24 hour Time in range (% of SG within 70-180 mg/dl) 
x
24 hour Time in different ranges (% of SG): SG <54, 70 mg/dL, SG >180, 
250 mg/dL 
x
Number of Events, Area Under Curve (AUC) and Time in the 
hyperglycemic range: sensor glucose (SG) >180, 250 mg/dL 
x
Number of Events, AUC and Time in the hypoglycemic range: SG < 54 
and 70 mg/dL 
x
Time spent in Auto Mode versus time spent in Manual Mode
x
Change of Total Daily Dose (TDD) of insulin from baseline to EOS Period
x
Change in BG values during meal challenge (BG prior and BG 2 hours 
after meal)
x
Insulin delivery at postprandial: Total unit of insulin in first 15 minutes, 
60 minutes, 120 minutes, and 240 minutes postprandial
x
Subgroup analysis by type of meals 
x
Between period analyses of all above (At-Home vs. In-Clinic) 
 
 

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Subject Feedback 
x
Descriptive summary will be used to characterize study questionnaire 
Final Report 
A final report will be generated once all subjects have completed the study 
period. Descriptive endpoints and safety data will be summarized and presented 
in the final report. 
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In patients with insulin dependent diabetes mellitus, glycemic control is influenced by numerous factors, 
such as insulin dosage, insulin absorption, timing, physiological/ lifestyle factors such as exercise, food 
intake, hormones and illness. These factors may contribute to significant variability in insulin 
requirements, which makes self-management of type 1 diabetes challenging. 
 
Patients who are using continuous glucose monitoring, including sensor-augmented pump therapy, 
experience improvements in glycemic control. Advanced features of sensor-augmented pump therapy 
are now being used in clinical practice; these include automatic suspension of insulin delivery when a 
pre-set glucose threshold is reached (low glucose suspend) or is predicted to be reached (predictive low 
glucose suspend). Both approaches have shown that a significant reduction in the risk and burden of 
hypoglycemia can be achieved, especially in patients who are prone to experiencing hypoglycemia.  
 
Medtronic’s latest system is the MiniMed 780G system, also referred to as the Advanced Hybrid Closed 
Loop (AHCL) system, a self-adjusting basal insulin pump with autocorrection dosing. Patients using the 
MiniMed 780G system are not required to confirm sensor glucose using a self-monitored blood glucose 
(SMBG) measurement before making therapy adjustments based on displayed sensor glucose values. 
Patients are still required to enter manual meal announcements (grams of carbs). With burden 
reduction in mind, the next generation of the AHCL system is focused on automated meal gesture dosing 
thereby eliminating the need for manual meal announcements. 
 
Meal gesture dosing is a mode whereby meal announcements are not entered manually by the user. 
Instead, when meal gesture dosing is active, meal announcements are generated automatically by the 
system based on the detection of eating gestures. Eating gestures are derived from analyzing the motion 
sensor data from the user’s Apple Watch (worn on the user’s hand of eating). When eating is detected, 
the system translates the detected eating activity into an equivalent carb amount and sent to the pump 
as a meal announcement. Sensor glucose based safety guardrails and rate control help ensure that 
automatic generation of meal announcements is safe.  

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The purpose of this study is to evaluate subject safety of using the Klue Health app utilizing meal gesture 
micro insulin dosing (meal gesture dosing) within the AHCL system in adult subjects with type 1 diabetes 
adult subjects in a clinic setting. 
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The objective of the study is to collect data for meal gesture dosing for unannounced meals within the 
AHCL system to be used for development of Medtronic Diabetes devices and products. 
 (QGSRLQWV
Analysis will be performed by Klue Health App software release version, if applicable. 
 3ULPDU\(QGSRLQWV
x
Post-prandial Time in range (% of SG within 70-180 mg/dl) at home and In-Clinic Period will be 
summarized, respectively. 
 6DIHW\(QGSRLQWV
x
Number of (S)AEs, (S)ADEs, USADEs, Severe hypoglycemic events, DKA events, and Device 
Deficiencies 
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All measurements performed by Study Period (At-Home and In-Clinic period). 
x
Post-prandial Time in different ranges (% of SG): SG <54, 70 mg/dL, SG > 180, 250 mg/dL
x
Change in post-prandial % of time in euglycemia (70-180 mg/dL) for meal challenges 
(intervention versus baseline) 
x
Change in post-prandial % of time in different ranges (% of SG): SG <54, 70 mg/dL, SG > 180, 250 
mg/dL for meal challenges (intervention versus baseline) 
x
24 hour Time in range (% of SG within 70-180 mg/dl) 
x
24 hour Time in different ranges (% of SG): SG <54, 70 mg/dL, SG > 180, 250 mg/dL 
x
Number of Events, Area Under Curve (AUC) and Time in the hyperglycemic range: sensor 
glucose (SG) > 180, 250 mg/dL 
x
Number of Events, AUC and Time in the hypoglycemic range: SG < 54 and 70 mg/dL 
x
Time spent in Auto Mode versus time spent in Manual Mode
x
Change of Total Daily Dose (TDD) of insulin from baseline to EOS Period
x
Change in BG values during meal challenge (BG prior and BG 2 hours after meal)
x
Insulin delivery at postprandial: Total unit of insulin in first 15 minutes, 60 minutes, 120 minutes, 
and 240 minutes postprandial
x
Subgroup analysis by type of meals 
x
Between period analyses of all above (At-Home vs. In-Clinic) 
 

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Descriptive summary will be used to characterize study questionnaire results  
6WXG\'HVLJQ
This study is a single-center, single arm study in adult subjects with type 1 diabetes utilizing AHCL 
System with meal gesture detection and micro dosing (meal gesture dosing). Meal gesture dosing is a 
mode whereby meal announcements are not entered manually by the user. Instead, when meal gesture 
dosing is active, meal announcements are generated automatically by the system based on the 
detection of eating gestures and micro doses of insulin are given. See Figure 3 for an overview. 
 
Overall subject participation will be approximately 3 weeks to 6 months.    

A total of up to 40 subjects (aged 18-75) may be enrolled at one investigational center in Israel 
to have at least 16 subjects complete the study. Subjects may repeat participation at the request 
of the Sponsor and at the discretion of the investigator but will only be counted once toward the 
total number of subjects.  
 'XUDWLRQ
The study is anticipated to last approximately 15 months from investigational center initiation to 
finalization of all data entry and monitoring procedures. Individual subject participation (per study 
participation) is expected to be approximately 3 weeks to 6 months. 
 5DWLRQDOH
Clinical evidence is required to evaluate meal gesture dosing for unannounced meals as the next step in 
the development of the AHCL system. Additionally, the study will collect biometric data for a novel, non-
invasive, wearable band. 
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The AHCL system with Meal Gesture Dosing evaluated in this study includes a commercial/CE-Marked 
insulin pump with investigational software and both CE-marked and investigational components, which 
will all be used as described in labelling and instructions for use for which CE mark has been obtained (as 
applicable). The AHCL system will also include the addition of the Klue Health mobile app with 
investigational software (installed on Apple Watch) for meal gesture detection and micro dosing. The 
AHCL system without meal gesture dosing is indicated for management of type 1 diabetes.  

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Device Name 
MDT Model number/ 
part number 
Device Status 
MiniMed 780G Insulin Pump, with 
investigational software version 
1.0W.1003 
MMT-1886 / 
MMT-1896WW (Kit) 
Investigational** 
Guardian Link 3 Transmitter* 
MMT-7910NA 
Investigational 
Klue™ Health App, with investigational 
software release tag 1.0 
N/A 
Investigational 
Klue™ Health App, with investigational 
software release tag 2.0 
N/A 
Investigational 
Roche Accu-Chek Guide Link Glucose 
Meter with modification to allow 
communication with study pump 
04015630067671 
Investigational 
Roche Accu-Chek Guide Link Glucose 
Meter 
08116083022 
Non-Investigational/CE-Marked 
MiniMed Clinical App, with software 
version 1.1.1 
MMT-6104 (iOS) 
N/A, not considered medical device 
CareLink Clinical App, with software 
version 1.1.2 
MMT-6114 (iOS) 
N/A, not considered medical device 
Guardian Sensor 3 
MMT-7020C1 
Non-Investigational/CE Marked 
Charger* 
MMT-7715 
Non-Investigational/CE Marked 
Tester* 
MMT-7736L 
Non-Investigational/CE Marked 
One-press Serter* 
MMT-7512W 
Non-Investigational/CE Marked 

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Device Name 
MDT Model number/ 
part number 
Device Status 
Apple Watch
N/A
N/A, not considered medical device
Apple iPhone 
N/A 
N/A, not considered medical device 
CareLink System  
MMT-7350 
Non-Investigational/CE Marked 
CareLink Personal 
MMT-7333 
Non-Investigational/CE Marked 
Other compatible commercially available 
Roche glucose meter
N/A 
Non-Investigational/CE Marked 
FreeStyle Optium Neo 
N/A 
Non-Investigational/CE Marked 
Consumables and Accessories 
See Appendix 18.5 
Non-Investigational/CE Marked 
 
 
N/A, not considered medical device 
 
N/A 
N/A, not considered medical device 
*Devices may be combined and distributed in kits 
**Pump is CE Marked but the software has been updated 
***Refer to user guides and IFU for a list of the materials in contact with the human tissue/body fluid 
 
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Item 
Units per Subject 
Participation 
MiniMed 780G insulin pump, with investigational software version 1.0W.1003 
1 
Guardian Link 3 Transmitter 
1 
Guardian Sensor (3) 
5* 
One-press Serter 
1 
Apple Watch™ 
1 
Apple iPhone™ 
1 
Reservoirs (boxes of 10) 
1*box of 10 
Infusion Sets (boxes of 10)
1*box of 10
Infusion Set Serter (if applicable) 
1 
AA Alkaline Battery 
4 
Roche Accu-Chek Guide Link Glucose Meter with modification to allow 
communication with study pump or other compatible commercially available Roche 
glucose meter 
1 
Roche Accu-Chek Strips  
75* 
FreeStyle Optium Neo 
1 
 
1 
 
1 
*If run-in phase is extended up to 3 months, sufficient quantities of consumables will be provided to subject 
accordingly.  

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The MiniMed 780G Insulin Pump houses electronics, a pumping mechanism, a user interface, and a 
medication reservoir within the same physical device. The pump communicates via Bluetooth® Low 
Energy wireless communication protocol with the compatible devices in the MiniMed 780G System: 
Guardian Link 3 Transmitter, Roche’s Accu-Chek Guide Link Blood Glucose Meter, consumer electronic 
devices with the CareLink system software. 
The most notable enhancements to the MiniMed 780G System are the incorporation of modifications to 
the closed loop algorithm that includes the addition of adjustable target setpoints (100 mg/dL, 110 
mg/dL and 120 mg/dL), an auto correction bolus without user input or acknowledgement and fine 
tuning of safeguards in order to reduce auto mode exits and improve the user experience. 
In this study, the MiniMed 780G Pump will interact with the following devices: 

The MiniMed 780G Pump receives the sensor glucose values and sensor integrity check from the 
Guardian Link 3 Transmitter which is connected to the Guardian Sensor 3. 

The MiniMed 780G Pump receives blood glucose values from the Roche’s Accu-Chek Guide Link 
blood glucose meter 

In addition, the MiniMed 780G Pump transmits data to a compatible consumer electronic device 
with the MiniMed Clinical app, to provide a secondary display for passive monitoring of CGM 
and pump data for the user. 

The MiniMed 780G Pump also transmits data to CareLink system through the MiniMed Clinical 
app. 

The MiniMed 780G Pump firmware has been modified which makes the firmware and pump 
investigational within the study. The pump will transmit SG values and trends to the Klue Health 
App and to accept micro-meal announcements from the Klue Health App. Such micro-meal 
announcement is treated by the pump in the same way as a manual meal announcement 
entered by the user. To allow the Klue Health App to communicate with the pump, the pump 
firmware as well as the Klue Health App have been modified to create a direct data 
interface. The data interface piggybacks on a secure Bluetooth Low Energy 
connection established by the MiniMed Clinical App.   
 *XDUGLDQ/LQN7UDQVPLWWHU
The Guardian Link 3 transmitter is a device that reads the electronic signal generated by the sensor. In 
addition, the transmitter contains a custom Application Specific Integrated Circuit (ASIC), which enables 
Electrochemical Impedance Spectroscopy (EIS). The EIS measurements are used as diagnostics for the 
sensor, which are incorporated into the sensor calibration logic.   
In addition, the transmitter also contains the sensor calibration algorithm which converts the sensor 
signal to a SG value using calibration BG values from a meter relayed to the transmitter through the 
pump. The transmitter transmits the calculated glucose data to the pump via Bluetooth Low Energy. 
Some elements of the calibration logic include prompting the user to calibrate when needed, referred to 
as “Smart Cal,” instead of strictly scheduled time-based calibration requirements. The algorithm is 
designed to improve and optimize performance when paired with the sensors. In this study, the 

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Guardian Link 3 transmitter will be connected to the Guardian Sensor (3). Data will be transmitted to the 
pump which transmits data to the CareLink system via upload through the MiniMed Clinical app. The 
transmitter has been updated to make it compatible with other components.  
 .OXH+HDOWK$SS
The Klue Health app (installed on the Apple Watch) communicates with the Apple Watch for meal 
gesture detection. It analyzes motion sensor data from the user’s Apple Watch (worn on the user’s hand 
of eating) to detect eating and drinking gestures. The information collected by Klue is stored on the Klue 
data cloud. 
The Klue Health app includes investigational software that, from detected eating gestures, determines 
an appropriate carb amount to be transmitted to the MiniMed 780G Pump as a micro-meal 
announcement. SG-based safety guardrails and rate control help ensure safety of the automated micro-
meal announcements. In this study, The Klue Health app with investigational software release tag 1.0 
should be used until investigational software release tag 2.0 becomes available which contains updates 
to meal bolusing 
 5RFKH$FFX&KHN*XLGH/LQN*OXFRVH0HWHUZLWKPRGLILFDWLRQWRDOORZ
FRPPXQLFDWLRQZLWKVWXG\SXPS
The Roche’s Accu-Chek Guide Link meter is a home blood glucose meter designed to measure and 
transmit blood glucose (BG) values to the compatible insulin pumps via a Bluetooth Low Energy wireless 
communication protocol. The insulin pump then sends the BG values to the transmitter for calibration of 
the glucose sensor. The transmission of BG values from a compatible meter is an optional feature 
provided as a convenience to the user; it eliminates the need to manually enter BG values into the 
pump. The Accu-Chek Guide Link blood glucose meter a is compatible with Roche’s Accu-Chek test 
strips. 
 
The Roche’s Accu-Chek Guide Link meter used in this study is similar to the commercial device except 
that the study meter has been modified to allow pairing with the study pumps only (with a specific 
engineering SAKE key). All functionalities remain the same. In this study, the modified/investigational 
Roche meter will be used, pending study supply.  
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The following non-investigational devices designated for use in the study are described in this section. 
These devices are all CE-marked and will be used within their intended use according to the labelling and 
instructions for use. 
 *XDUGLDQ6HQVRU
The Guardian Sensor 3 glucose sensor, referred to as Guardian Sensor 3 in this protocol, is a sensor that 
contains one microelectrode with a thin coating of glucose oxidase beneath several layers of 
biocompatible membrane. The sensor is the latest generation of glucose sensor with design changes 
supporting improved accuracy. It is intended to penetrate the skin at a 90-degree angle. The sensor is 
tubeless. An introducer needle penetrates the skin surface and provides support for the sensor 
microelectrode during insertion. The sensor continuously converts small amounts of glucose from the 
subject’s interstitial fluid into an electronic signal that is received by a transmitter or recorder, the 

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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. 
 2QHSUHVV6HUWHU
The One-press Serter, referred to as the Serter in this protocol, is an insertion device that is used to 
ensure correct placement of the Guardian Sensor 3 into the user’s subcutaneous tissue. Insertion is 
triggered when the two spring loaded buttons on the sides of the Serter are pressed simultaneously. The 
Serter is intended as a single patient, non-sterile, multi-use device. 
 &KDUJHU
The Charger is used to recharge the Guardian Link 3 transmitter as needed. A fully charged battery 
provides up to 7 days of Guardian Link 3 transmitter use. The system includes a battery charger that will 
recharge the device according to the user guide. 
 7HVWHU
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. 
 &DUH/LQN3HUVRQDO6RIWZDUH
Medtronic CareLink Personal software  is an internet-based software system which allows the device 
data to be uploaded and reviewed by the subject. The CareLink Personal software allows subjects to 
upload data from Medtronic MiniMed insulin pumps and a range of system-supported, third-party BG 
meters. The data contained in CareLink Personal software is accessible to users using a standard 
browser, i.e., Microsoft® Internet Explorer or Google Chrome, on an Internet enabled personal computer 
(PC).  
The CareLink Personal software use standard Transport Layer Security (TLS) technology. TLS 
transmission protocol invokes encryption on both ends of the transmissions and is the standard for all 
security-based systems. The encryption remains in effect whether the data is moving to and from the 
client and server in the United States, or to and from a client in another country to the United States. 
The data is secure behind a three-tier industry standard architecture, which places the database behind 
three different firewalls, where each firewall separates a tier: 
x
The internet to the web server; 
x
Web server to the application server; 
x
Application server to the database server. 
 &DUH/LQN6\VWHP6RIWZDUH
Medtronic CareLink system software  is an internet-based software system which allows the device data 
to be uploaded, viewed and easily evaluated by the physician. The CareLink system software allows 
retrospective review of device data and was developed for use by the investigational center staff. The 
CareLink system software allows the investigational center staff to manage, create, and request for 
approval to link the subject’s account. The data contained in CareLink system software is accessible to 

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users using a standard browser, i.e., Microsoft® Internet Explorer or Google Chrome, on an Internet 
enabled PC.  
The CareLink system software use standard TLS technology. TLS transmission protocol invokes 
encryption on both ends of the transmissions and is the standard for all security-based systems. The 
encryption remains in effect whether the data is moving to and from the client and server in the United 
States, or to and from a client in another country to the United States. The data is secure behind a three-
tier industry standard architecture, which places the database behind three different firewalls, where 
each firewall separates a tier: 

The internet to the web server; 

Web server to the application server; 

Application server to the database server. 
 
 )RRG3ULQW$SS
The FoodPrint app by Nutrino is a meal and event logging app. It lets the user take pictures of a meal 
which are synced with the food diary. FoodPrint can also be used to log activity, sleep, medications, 
blood glucose, and insulin. In this study, subjects will log: 
x
Only baseline meal challenges and activity during the at-home study period 
x
All meals and activity during the in-clinic study period  
 
 0LQL0HG&OLQLFDO$SS
The MiniMed Clinical app is an optional accessory which receives pump data via Bluetooth Low Energy 
wireless communication from the pump. The MiniMed Clinical app provides users with the convenience 
to wirelessly transfer pump data to CareLink Personal/CareLink system software and also provides a 
mirroring display of the pump screen. The MiniMed Clinical app is not designed to control or monitor 
the performance of the insulin pump nor for direct monitoring of pump data. As a mirroring display, the 
app can provide alerts to the subject via the user interface. All alerts must be addressed on the insulin 
pump. In this study, the app will be installed on the iPhone (software has been updated to make it 
compatible with study devices). The MiniMed Clinical app is not considered a medical device.  
 
 &DUH/LQN&OLQLFDO$SS
The CareLink Clinical app is an optional accessory which receives pump data wirelessly from the CareLink 
server. The CareLink Clinical app provides a mirroring display of the MiniMed Clinical app screen, for 
remote monitoring by a care partner (i.e. caregiver or healthcare provider). As a mirroring display, the 
app can provide notifications to the care partner via the user interface. The CareLink Clinical app is not 
considered a medical device. 

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The Apple Watch is a commercially available wearable smartwatch that allows users to perform various 
activities. In this study, the Klue Health app (iOS app compatible with Apple Watch) will be installed and 
subjects will wear the smartwatch on the wrist of the hand used for eating. When the Klue Health app is 

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active, the Klue watch face will take over the default Apple Watch face. Subjects shall not use the Apple 
Watch Workout app during the study. 

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In this study, apps will be pre-loaded onto a sponsor-provided smartphone prior to subject’s use. 

)UHH6W\OH2SWLXP1HR
The FreeStyle Optium Neo Blood Glucose & Ketone Monitoring System, referred to as ketone meter 
throughout this protocol, can measure both blood glucose (sugar) and blood ß-Ketone. In this study, 
however, the meter will only be used to measure ß-Ketone levels, which will be collected for reporting 
and review (see Investigator/Coordinator binder for details) and as described in the body of this study 
protocol. This particular meter will be used because it is the only commercially available meter which 
allows quantification of blood ß-Ketone levels and is the preferred patient method of testing over urine 
testing. 
Note: In the event the blood ketone meter is not used to collect ketone values, urine ketones must be 
measured and entered into CareLink system instead (if available at the time of the study). 
 
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The Roche’s Accu-Chek Guide Link meter is a home blood glucose meter designed to measure and 
transmit blood glucose (BG) values to the compatible insulin pumps via a Bluetooth Low Energy wireless 
communication protocol. The insulin pump then sends the BG values to the transmitter for calibration of 
the glucose sensor. The transmission of BG values from a compatible meter is an optional feature 
provided as a convenience to the user; it eliminates the need to manually enter BG values into the 
pump. The Accu-Chek Guide Link blood glucose meter a is compatible with Roche’s Accu-Chek test 
strips. In this study, a commercial Roche meter will be used only if the modified/investigational Roche 
meter is unavailable. If used, it will require the subject to manually enter BG values into the pump.  
 
 

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x
Battery status 
x
Alert to reposition the wearable band if the signal strength is poor 
x
Alert that band is out of Bluetooth Low Energy range 
This application is exclusively for clinical investigations and does not present data or therapy 
recommendations to the user. 
 
 
 
 &RQVXPDEOH'HYLFHV
Infusion sets, reservoirs, infusion set serter devices, glucose meter accessories and other consumable 
materials will be provided to subjects for use in the study. See Appendix 18.5. 
 
3DFNDJLQJ
The labelling of the Investigational devices and CE marked devices will be provided in accordance with
local language requirements. The outer packaging of the Investigational devices will be labelled “For 
clinical trial use only” and as required by national regulations, in local language(s) of the participating 
country. 
 
 ,QVXOLQ
Subjects will use their own rapid-acting analogue insulin (Novolog™ [aspart insulin] or Humalog™ [lispro 
insulin]) during this study. 
 $QWLFLSDWHG'HYLFH&KDQJHV
There are no changes anticipated for any of the devices during the course of the study. 
 3URGXFW$FFRXQWDELOLW\
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 and that they will be used only by (on) 
subjects who have consented to participate in the research study and by investigational center staff 
trained on the study. 
Any investigational devices being used in clinical research must be strictly accounted for and will not be 
shipped to any investigational center unless all of the necessary approvals (e.g., regulatory authority and 
EC) have been received.  
 
The principal investigator or an authorized designee shall keep records documenting the receipt, use, 
return and disposal of the investigational devices. Additional details regarding device accountability and 
device disposition requirements are provided in Table 3. 

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Device 
Record on  
Site 
Received 
eCRF 
Record 
Disbursement, 
Returned or 
Not Returned 
from Subject on 
Subject Device 
Identification 
eCRF 
Subject Return 
Device to 
Investigational 
Center  
Record 
Returned or 
Not 
Returned to 
Sponsor on 
Site 
Returned 
eCRF  
Site Return 
Device to 
Sponsor at 
Conclusion of 
Study 
MiniMed 780G Insulin 
Pump, with 
investigational software 
version 1.0W.1003, 
MMT-1886 / MMT-
1896WW (Kit) 
Yes 
Yes 
Yes 
Yes 
Yes 
Guardian Sensor 3, MMT-
7020C1 
No 
No 
No 
No 
Dispose or 
return unused 
to sponsor 
Guardian Link 3 
Transmitter, MMT-
7910NA 
Yes 
Yes 
Yes 
Yes 
Yes 
Roche Accu-Chek Guide 
Link Study Meter with 
modification to allow 
communication with 
study pump, 
04015630067671 
Yes 
Yes 
Yes 
Yes 
Yes 
Roche Accu-Chek Guide 
Link Study Meter, 
08116083022  (or other 
compatible commercially 
available Roche glucose 
meter) 
Yes 
Yes 
Yes 
Yes 
Dispose or 
return unused 
to sponsor 
FreeStyle Optium Neo 
Ketone Meter 
No 
No 
Yes 
No 
Dispose or 
return unused 
to sponsor 
Apple iPhone 
Yes 
Yes 
Yes 
Yes 
Yes 
Apple Watch 
Yes 
Yes 
Yes 
Yes 
Yes 
 
Yes 
Yes 
Yes 
Yes 
Yes 

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Upon receipt of the study devices, investigational center staff must check the inventory of the 
shipment, making sure that information on the packing slips/invoices matches exactly the 
contents of the containers, as applicable, including: 
R Ship to Address 
R Reference Number 
R Device Type 
R Quantity 
R Quantity per package 
R Lot number (where applicable) 
R Serial number (where applicable) 
 

Ensure that devices and supplies received have not reached or exceeded their expiration date, 
then sign and date the packing slip/invoice, noting any discrepancies, send a copy to the 
Medtronic Study Team as an Acknowledgement of Receipt and file in appropriate study binder. 
Notify the Medtronic Study Team of any discrepancies. 
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Study devices are to be stored in a secure environment with access limited to authorized research 
personnel. Study devices are stored in the appropriate environmental conditions as identified in the 
IFU/labelling. 
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Each time a serialized study device is disbursed to a subject by the investigator or authorized member of 
the research team, all required eCRF and source documentation will be completed (see Table 3). 
Documentation may include: 

Date of disbursement 

Subject ID 

Serial Number 

Amount dispensed 
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After use by the subject, the investigational center is expected to accept and retain all devices as 
described in Table 3. Device Accountability Requirements and store them in a secure environment. If 
containers/units/devices are missing, the reasons should be documented. If discrepancies between the 
amounts used by subjects and the amounts expected to be returned exist, the reasons should be 
documented. 
 
Requirements for return of devices by subjects to the investigational center and return of device by the 
investigational center to the sponsor are listed in Table 3. The devices that are being returned to the 
investigational center may be returned to the sponsor as subjects complete the study, at study closure 
or upon sponsor request. 
 

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Other unused consumable devices (as listed in Appendix 18.5), will be disposed of appropriately by 
investigational center staff. 
 
Disposable and consumable devices that have been used by a subject will be disposed of appropriately 
by the subject or the investigational center staff during the conduct of the study. 
 
All study devices that are required to be entered into the study database must be accounted for as 
described above before they are returned to the sponsor. 
 'HYLFH5H8VH'LVFORVXUH
The durable devices in this study may be re-used. The site will clean the devices prior to redistributing 
per IFUs. 
6WXG\6LWH5HTXLUHPHQWV
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See Section 16.1 for details regarding investigator section and qualification. 
 6WXG\6LWH$FWLYDWLRQ
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 authority requirements shall be fulfilled, 
including but not limited to the following:  
x
EC approval (and voting list, as required by local law) of the current version of the CIP and 
Informed Consent Form (ICF) 
x
Regulatory authority approval or notification (as required per local law) 
x
Fully executed CTA  
x
Financial disclosure 
x
CV of investigators 
x
Documentation of delegated tasks 
x
Documentation of study training  
In addition, all participating investigational center staff must be trained on the current version of the CIP 
as well as on the applicable study requirements depending on their role and must be delegated by the 
principal investigator prior to performing delegated study activities.   
 
Medtronic will provide the investigational center with documentation of investigational 
center/investigator subject enrollment readiness; this letter must be received prior to subject 
enrollment. 

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A total of up to 40 adult subjects (aged 18-75) with type 1 diabetes will be enrolled at one 
investigational center in Israel to have at least 16 subjects complete the study. Subjects who are 
repeating the study will be counted once towards the total amount of subjects.  
 6XEMHFW(QUROOPHQW
Subjects will be considered enrolled in the study upon signing the ICF. A subject will be assigned a 
unique study subject identification (SID) via the eCRF, which is a 9-digit code (339-XXX-XXX). The first 
three digits refer to the CIP number (339), the next three digits refer to the investigational center 
number, and the last 3 digits refer to the subject number assigned during Visit 1 
(e.g., 339 002001 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 subject identification and contact information. 
 
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A subject who meets any of the following criteria will be excluded from participation in this study: 
1. Is age 18-75 years at time of screening 
2. Has a clinical diagnosis of type 1 diabetes for 2 years or more as determined via source 
documentation  
3. Pump therapy for greater than 6 months prior to screening 
4. Real-time continuous glucose monitoring (RT-CGM) experience greater than 3 months prior to 
screening 
5. Must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 
units 
6. Is willing to perform 2 fingerstick blood glucose measurements daily  
7. Is willing to perform required sensor calibrations  
8. Is willing to wear the system continuously throughout the study  
9. If subject has celiac disease, it has been adequately treated as determined by the investigator 
10.If the subject has had any of the following cardiovascular events more than 1 year prior to of 
screening:  myocardial infarction, unstable angina, coronary artery bypass surgery, coronary 
artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart 
failure, or ventricular rhythm disturbances they should be cleared by a cardiologist prior to 
participation, if deemed necessary by the investigator. 
11.If the subject has had any of the following cardiovascular events within 1 year of screening: 
myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, 

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transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or 
ventricular rhythm disturbances, they should be cleared by a cardiologist prior to participation. 
12.Is of legal age and capable of providing consent 
13.Is fluent in speaking, reading and understanding English 
 ([FOXVLRQ&ULWHULD
Subjects will be considered included in the study, if they meet all the following criteria and none of the 
exclusion criteria: 
1. Has a history of 1 or more episodes of severe hypoglycemia, which resulted in any the following 
during the 6 months prior to Screening: 
a. Medical assistance (i.e., Paramedics, Emergency Room (ER) or Hospitalization) 
b. Coma 
c. Seizures 
2. Has been hospitalized or has visited the ER in the 6 months prior to Screening resulting in a 
primary diagnosis of uncontrolled diabetes 
3. Has had Diabetic Ketoacidosis (DKA) in the 6 months prior to Screening.  
4. Is unable to tolerate tape adhesive in the area of sensor placement  
5. Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, 
dermatitis herpetiformis, rash, Staphylococcus infection) 
6. Women of child-bearing potential who have a positive pregnancy test at Screening or plan to 
become pregnant during the course of the study 
7. Women who are breastfeeding 
8. Females who are sexually active and able to conceive will be excluded if they are not using an 
effective method of contraception and do not agree to continue using an effective method of 
contraception for the duration of the study as determined by investigator. 
9. Is being treated for hyperthyroidism at time of Screening 
10.Has a diagnosis of adrenal insufficiency 
11.Is using hydroxyurea at time of screening or plans to use it during the study 
12.Is actively participating in an investigational study (drug or device) wherein he/she has received 
treatment from an investigational study drug or investigational study device in the last 2 weeks 
13.Is currently abusing illicit drugs, marijuana, alcohol or prescription drugs (other than nicotine), 
per investigator judgement  
14.Is using pramlintide (Symlin), DPP-4 inhibitor, GLP-1 agonists (as liraglutide (Victoza or other), 
metformin, SGLT2 inhibitors (as canagliflozin (Invokana)) at time of screening 
15.Has a history of visual impairment which would not allow subject to participate in the study and 
perform all study procedures safely, as determined by the investigator 
16.Is diagnosed with current eating disorder such as anorexia or bulimia 
17.Has been diagnosed with chronic kidney disease that results in chronic anemia 

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18.Is on dialysis 
19.Is a member of the research staff involved with executing the study. 
 6WXG\3URFHGXUHV
The section below describes the study procedures that the subject will undergo during the clinical study. 
 6FKHGXOHRI(YHQWV
Subjects will participate in a minimum of 8 planned study visits as presented in Figure 3 or 
approximately 3 weeks to 6 months of device wear. If a subject is repeating participation in the study, 
the subject will participate in another minimum 8 planned visits. Refer to Table 4 for additional visit 
details.  
If subject ends the study early (i.e. before their last scheduled visit), all requirements that apply to the 
final visit should be completed if possible.

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Figure 3. Visit Schedule 
Run-in Period
(Approximately 1 week to 3 months)
Office 
Visit 1
Screening
Phone
Visit 4
Day -1 (-1,+2)
Check-In
Office 
Visit 2 
Day -6 (-90)
Start 780G, 
CGM, Apple 
Watch/Klue
Office
 Visit 7
Day 7 (+10)
5-Day/4-Night In-
Clinic
Visit Schedule
Study Period – In-Clinic 
Study Period 5-Day Meal Challenge
*Subjects may be called back to repeat a meal challenge
Phone
 Visit 5
Day 0 (-2, +1)
Meal Challenge & 
Sensor Change 
Reminder 
Day 1
-Long Meal/
Low Carb
-Large Meal/
Low Carb
Day 2
Small Meal/
High Carb
Day 3
-Large Drink/
No Carb
-Typical Meal/
Medium Carb
Day 4
-Typical Meal/
High Carb
-Long Meal/
High Carb
Day 5
-Large Drink
-Typical Meal/
Low Carb
Study Period – At-Home 
Baseline 5-Day Meal Challenge
Phone
Visit 3
Day -3 (-90, 
+2)
Auto Mode 
Activation
Phone
 Visit 6
Day 6 (-2)
In-Clinic Meal 
Challenge & Sensor 
Change Reminder 
End of 
Study*
Day 2 (±2)
At-Home 
Meal 
Challenge 
Start
Day 1
-Long Meal/
Low Carb
-Large Meal/
Low Carb
Day 2
Small Meal/
High Carb
Day 3
-Large Drink/
No Carb
-Typical Meal/
Medium Carb
Day 4
-Typical Meal/
High Carb
-Long Meal/
High Carb
Day 5
-Large Drink
-Typical Meal/
Low Carb 
*May occur at Visit 2 to Visit
7 or an unscheduled visit

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The study is comprised of a run-in period of approximately 1 week to 3 months and a study period of 
approximately 10 days.  
 
Prior to study start, Investigator or authorized designee must obtain written informed consent from the 
patient before any clinical study related activity (including screening) takes place and document 
informed consent process in the medical chart of the patient (refer to Section  10.11 Subject Consent). 
 
Study staff will discuss with the participant the visit schedule and will make arrangements with the 
subjects for the contacts at investigational center and sponsor. Participants who are not compliant with 
the arranged contacts, which may impact patient’s safety, may be discontinued at the discretion of the 
investigator. 
 
Subjects will be using the Klue Health app and Apple Watch. The subject must wear the Apple watch on 
the wrist of the hand used for eating for the duration of the study.  
 
Subjects will also be using the
 
 
 
 
 
 
Run-in Period (approximately 1 week to 3 months in total after starting devices): 
The run-in period is intended to allow subjects to become familiar with the new study devices, while 
using the same insulin they will be using during the study period.  
For the duration of the at-home run-in period and the at-home study period (baseline meal challenges, 
see details below), study subjects will be using the study pump with SmartGuard Auto Mode turned ON 
(after warm-up period).    
For the run-in period, The Klue Health app will be configured in monitoring-only mode. The subject must 
wear the Apple watch on the wrist of the hand used for eating. 
Study Period – At-Home: Baseline Meal Challenge 
Study subjects will undergo a 5-day meal challenge at specific meal(s) on each day.  
5 days of baseline meal challenges at home: 

Day 1: long meal with low carb count (lunch) and large meal with low carb count (dinner) 

Day 2: small meal with high carb count (lunch) 

Day 3: large drink with no carbs (breakfast) and typical meal size with medium carb count 
(dinner) 

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Day 4: long meal with high carbs (lunch) 

Day 5: large drink with high carbs (breakfast) and typical meal size with low carb count 
(lunch) 
For the baseline meal challenges, study subjects will be asked by investigational center staff to eat a pre-
defined meal, while bolusing using the pump’s bolus calculator (manually announcing the meals) and 
logging the challenge meals in the FoodPrint app. For all other meals, subjects can consume their usual 
meals, but meals do not need to be logged in FoodPrint.  
The Klue Health app should remain configured in monitoring-only mode during this time. The subject 
must wear the Apple watch on the wrist of the hand used for eating. 
Study Period – 5 days (4 nights) In-Clinic: 
After the run-in period and completion of the 5-day at-home study period with baseline meal 
challenges, study subjects will check into the clinic for a 5-day (4 nights) intervention.   
Study subjects will be asked by investigational center staff to consume meals of the same size and 
content they consumed for the meal challenges during the baseline meal challenge (at-home study 
period). For example: If a large sized dinner meal with low carbohydrate content was consumed at 5 pm 
on Day 1 during the baseline meal challenge, that same dinner meal should be consumed at 
approximately the same time on Day 1 of the in-clinic study period. Subjects will be asked by 
investigational center staff to check BG at the start of the meal, as well as 2 hours and 4 hours after the 
start of the meal and provide correction as necessary. All meals consumed during the in-clinic study 
period should be logged in the FoodPrint app.  
Subjects will be instructed by investigational center staff to not use the pump’s meal bolus calculator (no 
manual meal announcements) for the duration of the intervention.  
Scheduled meal challenges during the study period (mirror baseline meal challenge): 

Day 1: long meal with low carb count  (lunch) and large meal with low carb count (dinner) 

Day 2: small meal with high carb count (lunch) 

Day 3: large drink with no carbs (breakfast) and typical meal size with medium carb count 
(dinner) 

Day 4: long meal with high carbs (lunch) 

Day 5: large drink with high carb (breakfast) and typical meal size with low carb count (lunch) 
On Day 5 of the in-clinic meal challenge, a subject may be asked to repeat a specific meal challenge 
which may require the subject to participate for an additional day.  
 

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The investigational center staff will: 

Obtain written informed consent  

Determine if subject meets eligibility criteria (Sections 9.3 and 9.4) 

Collect demographic information 

Review subject’s medical history 

Measure/Collect height and weight 
 
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The investigational center staff will: 

Dispense study devices 

Start Apple Watch with Klue Health app in monitoring mode 

Train subject on meal challenges and how to log meals/activities in FoodPrint 

Provide pump training and CGM training and start on pump system including MiniMed Clinical 
app 

Complete baseline subject questionnaire   

Ask subject about adverse events or device deficiencies 

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The investigational center staff will: 

Train subject and have subject activate SmartGuard Auto Mode feature 

Remind subject to wear Apple watch on dominant hand used for eating 

Ask subject about adverse events or device deficiencies 
 

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The investigational center staff will: 

Check in with subject to see how pump/CGM wear is going 

Remind subject to wear Apple watch on dominant hand used for eating 

Ask subject about adverse events or device deficiencies 
 

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The investigational center staff will: 

Remind subjects to do baseline meal challenge and to change sensor prior to starting baseline 
meal challenges 

Ask subjects about adverse events or device deficiencies 
 
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Day 1:  
R Long meal with low carbohydrate count (lunch): A meal of at least 30 minutes with many bites 
of food (less than 5 minutes between bite) that is smaller in carbohydrates than a regular lunch 
meal for an individual study subject. 
R Large meal with low carbohydrate count (dinner): A large meal consists of meal that is larger in 
size, but smaller in carbohydrates than a regular dinner meal for an individual study subject.  
 

Day 2:  
R Small meal with high carbohydrate count (lunch): A large meal consists of meal that is smaller in 
size, but higher in carbohydrate content than a regular lunch meal for an individual study 
subject. 
 

Day 3:  
R Large drink with no carbohydrate count (breakfast)  
R Typical meal size with medium carbohydrate count (dinner): A typical meal consists one that is 
typical in size and carbohydrate content, i.e. a regular dinner meal for an individual study 
subject. 
 

Day 4:  
R Long meal with high carbohydrate count (lunch): A meal of at least 30 minutes with many bites 
of food (less than 5 minutes between bite) that is higher in carbohydrates than a regular lunch 
meal for an individual study subject. 
 

Day 5:  
R Large drink with high carbohydrate count (breakfast) 

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R Typical meal size with low carbohydrate count (Lunch): This typical meal consists of meal that is 
regular in size, but lower in carbohydrate content than a typical lunch meal for an individual 
study subject. 
 
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The investigational center staff will: 

Remind subject to change sensor prior to starting in-clinic meal challenges 

Ask subject about adverse events or device deficiencies 
 
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The investigational center staff will: 

Activate automated meal gesture dosing feature in Klue Health app and confirm that system is 
working 

Instruct subject to eat: 
R Long meal with low carbohydrate count (lunch):  A timed meal that is smaller in 
carbohydrates than a regular lunch meal for an individual study subject. 
R Large meal with low carbohydrate count (dinner): A large meal consists of meal that is 
larger in size, but smaller in carbohydrates than a regular dinner meal for an individual 
study subject.   

Ask subject about adverse events or device deficiencies 
 

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The investigational center staff will: 

Instruct subject to eat: 
R Small meal with high carbohydrate count (lunch): A large meal consists of meal that is 
smaller in size, but higher in carbohydrate content than a regular lunch meal for an 
individual study subject. 

Ask subject about adverse events or device deficiencies 

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The investigational center staff will: 

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Instruct subject to eat: 
R Large drink with no carbohydrate count (breakfast) 
R Typical meal size with medium carbohydrate count (dinner): A typical meal consists one 
that is typical in size and carbohydrate content, i.e. a regular dinner meal for an 
individual study subject. 

Ask subject about adverse events or device deficiencies 
 

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The investigational center staff will: 

Instruct subject to eat: 
R Typical meal size with high carbohydrate count (breakfast): This typical meal consists of 
meal that is regular in size, but higher in carbohydrate content than a typical breakfast 
meal for an individual study subject. 
R Long meal with high carbohydrate count (lunch): A timed meal that is higher in 
carbohydrates than a regular lunch meal for an individual study subject. 

Ask subject about adverse events or device deficiencies 
 

'D\
The investigational center staff will: 

Instruct subject to eat: 
R Large drink with high carbohydrate count (breakfast) 
R Typical meal size with low carbohydrate count (lunch): This typical meal consists of meal 
that is regular in size, but lower in carbohydrate content than a typical lunch meal for an 
individual study subject. 

Determine if subject needs to repeat any of the meal challenges 

Ask subject about adverse events or device deficiencies  

Complete subject questionnaire 

 
 End of Study 
R Collect all study devices back from subject 
R End of study 

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Form 
D00456959 
Version F 
Page 51 of 93 
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 8QVFKHGXOHG9LVLW
In case an additional visit is performed for study purposes or in case of an early termination visit outside 
of a normal protocol visit, an unscheduled visit can be used to report data.  
 
Unscheduled visit procedures could include, but are not limited to: 

Insulin pump, CGM and/or app training 

Review adverse event or device deficiency, if any. 

Start of 
 
 
 (DUO\7HUPLQDWLRQ9LVLW
Whenever possible, the study staff will perform an Early Termination visit when a subject decides to 
withdraw from the study early or if the subject is withdrawn early upon decision of investigator (during a 
normal study visit or an unscheduled visit).  
Early Termination procedures: 

Review adverse event or device deficiency, if any. 

Collect all study supplies back from subjects. 

Collect questionnaire 
 6DIHW\$QDO\VLV5LVN$QDO\VLV

*OXFRVH0RQLWRULQJ5LVN
x
Subjects will be instructed to make sure they have clean fingers when performing fingerstick 
glucose testing.  
x
Subjects will have training on diabetes self-management principles.   

+\SRJO\FHPLF+\SHUJO\FHPLF5LVN
Intervention and treatment for hypoglycemia and hyperglycemia is addressed in Section 11.1. 

&DOLEUDWLRQRI&*05LVN
When an erroneous glucose value is used to calibrate a CGM, the bias is carried through until the next 
opportunity to calibrate the CGM. This can result in an incorrect bias. Subjects will be trained to 
appropriate calibration. 

5HXVH5LVN
Durable study devices will be cleaned before each patient use.  
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D00456959 
Version F 
Page 52 of 93 
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The following devices will be supplied sterilized: 
x
Infusion sets 
x
Insulin reservoirs 
x
Sensors

0LVXVH5LVN
Comprehensive training will take place at the initiation visit for investigational center staff regarding the 
operation of the AHCL, to include all of its functional components and all other study devices to be used 
during the study at the investigational center. 
 
 (QGRI6WXG\9LVLW
After the study has been completed (at Visit 7 or in case of early termination), the subjects will complete 
their end of study visit. The subjects will continue to be treated following the routine practice of each 
center. 
 *OXFRVHDQG*O\FHPLD0HDVXUHPHQWV
During the course of the study, the subjects’ BG levels and SG levels will be assessed using the methods 
outlined in this section. 

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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. 

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Throughout the study, SG data will be collected using CGM. 

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Subjects will be trained to wear the pump and CGM continuously by investigational center staff. 

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CareLink uploads of the pump will occur automatically via MiniMed Clinical app. 

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A subject questionnaire will be administered at baseline and the end of the study to collect user 
experience.  
 

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D00456959 
Version F 
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Informed Consent will be obtained in accordance to ISO 14155:2020. 
 
The investigator or authorized designee must obtain written informed consent from the patient before 
any clinical study related activity takes place. 
In advance of the consent discussion, the patient should receive the EC approved Informed Consent 
Form (ICF). The process of informed consent shall be documented. Documentation can be sent by mail 
to the subject (two copies of the ICF will be sent for signature). During the consent discussion the 
investigator or his/her authorized designee must fully inform the patient of all aspects of the clinical 
study that are relevant to the patient’s decision to participate in the clinical study. Illiterate patients will 
not be enrolled in this study. All items addressed in the ICF must be explained. The language used shall 
be as non-technical as possible and must be understandable to the patient and the impartial witness, 
where applicable. 
 
The patient must have ample time and opportunity to read and understand the ICF to inquire about 
details of the clinical study, and to decide whether or not to participate in the clinical study. All 
questions about the clinical study should be answered to the satisfaction of the patient. 
 
Neither the investigator, nor the investigation site staff shall coerce or unduly influence a patient to 
participate or to continue to participate in the clinical study. The informed consent process shall not 
waive or appear to waive the patient’s rights. 
 
A subject’s participation in study procedures cannot begin before the consent process has been properly 
executed. When the patient decides to participate in the clinical study, the ICF must be signed and 
personally dated by the patient and investigator or authorized designee.  
 
After all persons have signed and dated the ICF, the investigator must provide the patient with a copy of 
the Patient Information and the signed and dated Informed Consent Form. A subject’s participation in 
study procedures cannot begin before the consent process has been properly executed. 
 
Based on the definition of vulnerable adult in ISO14155:2020, legally incompetent and illiterate persons, 
or vulnerable populations will not be included in this clinical study. 
 
A patient contact card will be provided to the patient. 
 

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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 in a timely manner. 
Medtronic will revise the written Patient Information and Informed Consent Form whenever new 
information becomes available that may be relevant to the subject’s confirmed participation in the 

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D00456959 
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clinical study. Study sponsor will send the revised information to the EC and RA (Regulatory Authority), if 
applicable, for approval. After approval by the EC and RA, if applicable, a copy of this information must 
be provided to the participating subjects, and the informed consent process as described above needs 
to be repeated. 
 $VVHVVPHQWRI6DIHW\
All AE information is collected in this study. See Section 12 for further information on the collection of 
AEs and safety information. 
 5HFRUGLQJ'DWD
Data 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, except for 
the Lab eCRFs which will be considered as source data (results directly transferred from the central lab 
into eCRF. 
 
Electronic device data will be collected from the study pump using CareLink™ Personal For Clinical 
Research software. The system uses TLS technology, which encrypts all data it stores. Certain data points 
stored in the downloaded information may also be captured on the appropriate eCRF. 
 
The investigator will ensure that all eCRFs are completed promptly, completely, and accurately. 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 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. eCRF content will be reviewed by a study monitor, as described in the 
Monitoring Plan. In addition, specific eCRFs must also be reviewed and electronically signed by the 
investigator, indicating his/her agreement with the accuracy of all recorded data. It is expected that the 
investigator and his/her staff will cooperate with the monitoring team and provide any missing data in a 
timely manner. 
'HYLDWLRQ+DQGOLQJ
A deviation is any instance(s) of failure to follow, intentionally or unintentionally, the requirements of 
the CIP or the CTA. 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. Deviations will not be issued for the following situations: 
x
If subjects do not follow the fingerstick recommendations or upload devices unless the site staff 
did not train the subject on SMBG study procedures or upload procedures. 
x
If subjects miss or delay protocol visits unless the investigational center staff did not plan the 
visit according to the protocol schedule. 
x
If subject did not (fully or partly) complete the Diary. 

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D00456959 
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It is otherwise prohibited to use waivers from the CIP. 

5HTXHVWIRU$SSURYDORI6WXG\'HYLDWLRQV
The investigator shall obtain documented approval from Medtronic, before implementation, for any 
change in- or deviation from the Clinical Investigation Plan (CIP). In case of study deviations that can 
affect the subject’s rights, safety and well-being or the scientific integrity of the clinical study, approval 
from the EC and regulatory authority must also be obtained before implementation. The investigator 
shall timely contact the Clinical Study Manager for review of the proposed change/deviation. 
 
Prior approval is not always realistic in situations where unforeseen circumstances are beyond the 
investigator’s control. However, also in these cases, the event is considered a deviation, and shall be 
reported. 
 
In any emergency situation the investigator shall exercise his/her judgment to safeguard the subject’s 
interest. Such deviations from the CIP do not require the prior approval of Medtronic. The investigator 
shall report the deviation as soon as possible to Medtronic and the reviewing EC, if applicable. 
Medtronic will inform EC and/or RA, if required. 

5HSRUWLQJ5HTXLUHPHQWVIRU6WXG\'HYLDWLRQV
All study deviations must be recorded on the eCRF regardless of whether medically justifiable, an 
inadvertent occurrence or taken to protect the subject in an emergency. The date, description and 
reason for each deviation will be documented. 
 
Investigator must report deviations to Medtronic as soon as possible upon the center becoming aware 
of the deviation, especially in the following examples of deviations that could impact subject safety, 
affect the integrity of study data and/or affect subject’s willingness to participate in the study: 
 

Failure to obtain informed consent, i.e., there is no documentation of informed consent 

Informed consent obtained after initiation of study procedures 

Enrollment of a subject who did not meet all inclusion/exclusion criteria 

Performing study procedure not approved by the EC and RA 
 
For medically justifiable conditions that pre-empt a subject’s ability to complete a study-required 
procedure, it may be permitted to report only one deviation that will apply to all visits going forward. 
This may also apply to other unforeseen situations (e.g. the subject permanently refuses to complete a 
study required procedure and the data will not contribute to the primary endpoint analysis). However, 
prior approval from sponsor is required for such situations. 
 
Reporting of deviations by investigator and Medtronic must comply with EC policies, local laws, 
and/or regulatory authorities’ requirements, as applicable. 

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D00456959 
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Medtronic is responsible for reviewing and analyzing deviations, assessing their significance, and 
identifying if any additional corrective and/or preventive actions (e.g. amend the CIP, conduct additional 
training, terminate the investigation) are needed. 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. 

6XEMHFW([LW:LWKGUDZDORU'LVFRQWLQXDWLRQ
Subjects may choose to withdraw from the study at any time by notifying investigational center staff of 
their intent. Whenever possible, the investigational center staff will perform an Early Termination visit 
when a subject decides to withdraw from the study early or if the subject is withdrawn early upon 
decision of investigator (during a normal study visit or an unscheduled visit) (described in Section 10.6). 
 
Subjects may also be withdrawn from the study at the discretion of the investigator. If a subject chooses 
to end his or her study participation or if the subject is removed from the study at the investigator’s 
discretion or for failure to meet the study requirements, the reason for withdrawal must be 
documented both in source documents and on the End of Study eCRF. All study devices and supplies 
must be returned (as applicable) and documented in the appropriate eCRF. 
 
After subject ends his participation, he will continue to be treated according to routine practice. 

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If a subject does not return to the investigational center for required follow-up visit(s) and cannot be 
reached, the investigation center personnel should make 3 documented attempts to contact the subject 
by phone to verify if the subject should be considered “lost to follow-up” - and only if those 3 attempts 
are unsuccessful, will the patient be considered lost to follow-up. In the event the subject is not able to 
perform follow-up visits at the investigation center, subject will be considered “lost to follow-up” and 
this needs to be documented in the End of Study eCRF. All efforts will be made by investigation center 
personnel to collect all study devices and supplies back from subject, if applicable. 
 5LVNVDQG%HQHILWV
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The potential risks and mitigations associated with the devices used during this study are listed in Table 
5. Risks associated with the commercially available devices and other products used in the study are 
listed in the associated device labelling/user guides/instructions for use or investigator brochure.  

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D00456959 
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Risks with Infusion Sets 
Prevention and Mitigation 
Risks with infusion sets may include:  
x
Localized infection 
x
Skin irritation/redness 
x
Bruising 
x
Discomfort/pain 
x
Bleeding 
x
Irritation 
x
Rash 
x
Hyperglycemia secondary to infusion set 
occlusion or infusion site failure including 
DKA 
x
Hyperglycemia secondary to site falling off 
including DKA 
x
Anxiety associated with insertion 
Prevention and mitigation include: 
x
Follow the provided user guides for insertions 
and care of infusion sets. 
x
If an infusion site becomes irritated or 
inflamed, the infusion set will be removed and 
another placed in a new location.  
x
In case of hyperglycemia secondary to infusion 
set occlusion, remove current infusion set and 
replace with new infusion set and give 
correction insulin if needed with syringe.  
x
Follow the provided user guides for insulin 
pump management.   
x
Train prior to study device use on appropriate 
device use and diabetes management 
principles and instruct to call investigator with 
problems.  
Risks with Insulin Administration and Pumps 
Prevention and Mitigation 
Risks with the use of an insulin infusion pump may 
include the risk of malfunction of the components of 
the system (pump, software, infusion set and 
reservoir) as well as the risk of use error during use 
of the system. Device deficiencies or use errors can 
result in administration of too much or too little 
insulin which can lead to the following clinical 
consequences: 
x
Hypoglycemia 
x
Hyperglycemia 
x
Diabetic ketoacidosis  
x
Severe hypoglycemia with or without 
associated seizure, coma or death 
x
Kinked cannula leading to hyperglycemia  
x
Infusion set disconnection from pump 
leading to hyperglycemia 
x
Subject removes the reservoir from the 
pump but forgets to disconnect the infusion 
set from the body which results in 
hypoglycemia or severe hypoglycemia  
x
Dislodged cannula leading to hyperglycemia 
x
A pump error may lead to under delivery or 
over-delivery of insulin 
x
Battery failure – no insulin delivered 
Prevention and mitigation include: 
x
Follow the provided user guides & instructions 
for insulin pump management which includes 
information on infusion set change.   
x
Train prior to study device use on appropriate 
device use and diabetes management 
principles and instruct to call investigator with 
problems.  
x
Instruct to check their meter glucose if their 
high or low symptoms do not match their 
sensor alerts or sensor glucose readings in 
order to make diabetes treatment decisions.  
x
Instruct to have glucose on hand for 
hypoglycemia. 
x
Instruct to change infusion set if suspected 
catheter occlusion or administer insulin with 
syringe for persistent hyperglycemia especially 
if ketones develop.  
x
During the in-clinic portion of study period, 
subjects will be under constant surveillance by 
investigational center staff 
 

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D00456959 
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x
Insulin deterioration leading to 
hyperglycemia 
x
Incomplete priming; fails to prime tubing 
and/or cannula, leading to hyperglycemia 
x
Remove a reservoir, without suspending 
and reconnecting after a while resulting in a 
hypoglycemia 
x
Patient not filling pump reservoir when 
needed leading to hyperglycemia 
x
Magnetic resonance imaging resulting in 
pump transmitter malfunction 
x
Inaccurate insulin delivery due to sudden 
altitude changes. 
x
Hypoglycemia or hyperglycemia from 
manual bolus 
x
Hypoglycemia or hyperglycemia from the 
use of the AHCL Auto Mode feature where 
sensor glucose values may be used to 
calculate insulin bolus amounts  
x
Hypoglycemia or hyperglycemia from 
computer hacking  
Risks with hyperglycemia may include  
x
Diabetic ketoacidosis  
x
Symptomatic ketosis 
x
Cardiovascular event  
x
Dehydration  
x
Potassium and sodium imbalance 
x
Shock 
x
Altered mental status  
x
Coma  
x
Acidosis 
Prevention and mitigation include: 
x
Follow the provided user guides for insulin 
pump management.   
x
Parent(s)/guardian(s)/companion(s) will be 
present at night with subjects and will be 
trained on study device and diabetes 
management principles and instructed to call 
investigator with problems.  
x
Train prior to study device use on appropriate 
device use and diabetes management 
principles and instruct to call investigator with 
problems. 
x
Instruct to check their meter glucose if their 
high symptoms do not match their sensor 
alerts or sensor glucose readings in order to 
make diabetes treatment decisions.  
x
Instruct to check their meter glucose if there 
are any concerns that the sensor glucose value 
is not accurate.  
x
Alternative method of managing glucose levels 
will be available (insulin and syringe for 
example). 
x
During the in-clinic portion of study period, 
subjects will be under constant surveillance by 
investigational center staff  

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Risks with hypoglycemia may include: 
x
Seizure  
x
Coma  
x
Altered mental status  
x
Loss of consciousness  
x
Cardiovascular event  
x
Death  
x
Risk of rebound hyperglycemia with ketosis 
Prevention and mitigation include: 
x
Follow the provided user guides for insulin 
pump management.   
x
Parent(s)/guardian(s)/companion(s) will be 
present at night with subjects and will be 
trained on study device and diabetes 
management principles and instructed to call 
investigator with problems.  
x
Train prior to study device use on appropriate 
device use and diabetes management 
principles and instruct to call investigator with 
problems. 
x
Instruct to check their meter glucose if their 
low symptoms do not match their sensor alerts 
or sensor glucose readings in order to make 
diabetes treatment decisions.  
x
Instruct to check their meter glucose if there 
are any concerns that the sensor glucose value 
is not accurate).  
x
Instruct to have glucose on hand for 
hypoglycemia. 
x
During the in-clinic portion of study period, 
subjects will be under constant surveillance by 
investigational center staff  
Risk with Sensors 
Prevention and Mitigation 
Risks with sensors may include: 
x
Skin irritation or reaction to adhesives
x
Bruising 
x
Discomfort 
x
Redness 
x
Bleeding 
x
Excessive bleeding due to anticoagulants 
x
Pain 
x
Rash 
x
Infection 
x
Irritation from tapes used with glucose-
sensing products 
x
Raised bump 
x
Appearance of a small “freckle-like” dot 
where needle was inserted 
x
Allergic reaction 
x
Syncopal episode secondary to needle 
insertion 
x
Soreness or tenderness 
x
Swelling at insertion site 
x
Sensor fracture, breakage or damage 
x
Minimal blood splatter associated with 
Prevention and mitigation include: 
x
Follow the provided user guides for insertions 
and care of sensors. 
x
If a sensor site becomes infected or inflamed, 
the sensor will be removed and another placed 
in a new location 
x
Instruct to check their meter glucose if their 
high or low symptoms do not match their 
sensor alerts or sensor glucose readings in 
order to make diabetes treatment decisions.  
x
Instruct to check their meter glucose if there 
are any concerns that the sensor glucose value 
is not accurate.  
x
Instruct if there are no sensor values, no 
treatment decisions will be made until a BG is 
confirmed.  
 

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sensor needle removal 
x
Residual redness associated with adhesive 
and/ or tapes 
x
Scarring 
x
Scab 
x
Blister 
x
Itchiness 
x
Inflammation 
x
Anxiety 
x
Incorrect sensor glucose reading results in 
incorrect diabetes management 
x
Subject over-treating secondary to alarms 
which can result in hyperglycemia or 
hypoglycemia 
x
Anxiety associated with insertion 
Risks with Transmitter 
Prevention and Mitigation 
Risks with transmitter may include: 
x
Skin irritation or reaction to adhesives 
x
Bruising 
x
Discomfort 
x
Redness 
x
Pain 
x
Rash 
x
Infection 
x
Irritation from tapes used with glucose-
sensing products 
x
Raised bump 
x
Allergic reaction 
x
Soreness or tenderness 
x
Residual redness associated with adhesive 
and/ or tapes 
x
Scarring 
x
Scab 
x
Blister 
x
Itchiness 
x
Inflammation 
 
Prevention and mitigation include: 
x
Follow the provided user guides.  
x
Train on the proper use of the transmitters.  
Risks with Serter 
Prevention and Mitigation 
Risks with serters may include: 
x
Improper insertion may lead to device 
performance issue or hyperglycemia   
Prevention and mitigation include: 
x
Follow the provided user guides for insertions 
and care of device. 
x
Train on the proper use of the serter and skin 
preparation prior to insertion. 
Risks with Fingersticks 
Prevention and Mitigation 
Risks with frequent fingerstick testing may include: 
Prevention and mitigation include: 
x
Follow the provided user guides for use of the 
study meter with fingerstick testing. 

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Potential risks associated with frequent 
meter testing of blood glucose and blood 
ketones include discomfort and ecchymosis 
at tips of fingers 
x
Potential risks associated with fingerstick 
testing include discomfort and bruising 
x
Train on the proper use of the study meter and 
fingerstick testing. 
Risk with Closed Loop Therapy with Meal Gesture 
Dosing 
Prevention and Mitigation 
The risks associated with using the insulin pump in 
closed loop mode with meal gesture dosing are 
related to the potential for delivery of too much or 
too little insulin which can result in: 
x
Hypoglycemia 
x
Severe hypoglycemia 
x
Hyperglycemia 
x
Diabetic ketoacidosis  
x
User entry error 
R
Patient entering false glucose values for 
any reason leading to hypoglycemia 
and hyperglycemia  
R
Patient entering false BG values for 
calibration leading to hypoglycemia or 
hyperglycemia 
x
Sensor failure resulting from patient failure 
to calibrate leading to hypoglycemia or 
hyperglycemia 
x
Sensor over-reading resulting in 
hypoglycemia  
x
Sensor under-reading resulting in 
hyperglycemia 
x
Sensor missed transmission, or any other 
fault resulting in no SG value, leading to 
hyperglycemia or hypoglycemia  
x
Voluntary insulin delivery (with the pump 
or with a syringe) immediately prior to 
entering Auto Mode may result in severe 
hypoglycemia despite shutting down 
insulin delivery by the algorithm 
x
Hypoglycemia related to patient taking 
insulin via injection while in Closed Loop 
(Auto Mode) 
x
Hypoglycemia or hyperglycemia related to 
entering or exiting Closed Loop (Auto 
Mode) 
x
Insulin over-delivery due to potential 
interference from acetaminophen 
x
Cyber security hacking into pump 
Prevention and mitigation include:  
x
Closed Loop Therapy with meal gesture dosing
will only be active during the in-clinic portion of 
study period.  Subjects will be under constant 
surveillance by investigational center staff. 
x
Follow the provided user guides for insulin 
pump management.   
x
Train prior to study device use on appropriate 
device use and diabetes management 
principles and told to call with problems and 
instruct to call investigator with problems.  
x
Instruct to check their meter glucose if their 
high or low symptoms do not match their 
sensor alerts or sensor glucose readings in 
order to make diabetes treatment decisions.  
x
Instruct to check their meter glucose if there 
are any concerns that the sensor glucose value 
is not accurate.  
x
Instruct if there are no sensor values, no 
treatments decision will be made until a BG is 
confirmed.  
x
Instruct to have glucose on hand for 
hypoglycemia. 
x
Instruct to avoid the use of products containing 
acetaminophen 
x
If acetaminophen is taken, subjects will be 
instructed to use additional BG meter readings 
(they are not to calibrate with those readings) 
to verify their glucose levels.  
x
If acetaminophen is taken, subjects will turn off 
Auto Correction and exit Auto Mode 
x
Pump has cybersecurity encryptions to prevent 
hacking.  
x
Instruct subjects to keep their own insulin 
pump supplies in a safe place and to have back 
up supplies in the event they are asked to 
revert back to their own therapy during the 
study 

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During the in-clinic portion of study period, 
subjects will be under constant surveillance by 
investigational center staff  
 
 
Risks with hyperglycemia may include: 
x
Diabetic ketoacidosis 
x
Symptomatic ketosis 
x
Cardiovascular event  
x
Dehydration  
x
Potassium and sodium imbalance 
x
Shock 
x
Altered mental status  
x
Coma  
x
Acidosis 
Prevention and mitigation include: 
x
Closed Loop Therapy with meal gesture dosing 
will only be active during the in-clinic portion of 
study period.  Subjects will be under constant 
surveillance by investigational center staff. 
x
Follow the provided user guides for insulin 
pump management.   
x
Train prior to study device use on appropriate 
device use and diabetes management 
principles and instruct to call investigator with 
problems.  
x
Instruct to check their meter glucose if their 
high symptoms do not match their sensor 
alerts or sensor glucose readings in order to 
make diabetes treatment decisions.  
x
Instruct to check their meter glucose if there 
are any concerns that the sensor glucose value 
is not accurate.  
x
Instruct if there are no sensor values, no 
treatments decision will be made until a BG is 
confirmed.  
 
Risks with hypoglycemia may include: 
x
Seizure 
x
Coma 
x
Altered mental status 
x
Loss of consciousness 
x
Cardiovascular event  
x
Death   
x
Risk of rebound hyperglycemia with 
ketosis 
Prevention and mitigation include:
x
Closed Loop Therapy with meal gesture dosing 
will only be active during the in-clinic portion of 
study period.  Subjects will be under constant 
surveillance by investigational center staff. 
x
Follow the provided user guides for insulin 
pump management.   
x
Train prior to study device use on appropriate 
device use and diabetes management 
principles and instruct to call investigator with 
problems.  
x
Instruct to check their meter glucose if their 
low symptoms do not match their sensor alerts 
or sensor glucose readings in order to make 
diabetes treatment decisions.   
x
Instruct to check their meter glucose if there 
are any concerns that the sensor glucose value 
is not accurate.  

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x
Instruct if there are no sensor values, no 
treatment decisions will be made until a BG is 
confirmed  
x
Instruct to have glucose on hand for 
hypoglycemia 
Risk with Acetaminophen Use 
Prevention and Mitigation 
Potential risks with acetaminophen may include: 
x
False elevation of sensor glucose readings. 
The level of inaccuracy depends on the 
amount of acetaminophen active in 
subject’s body and may be different for 
each subject 
x
Liver damage, liver failure and/or rare but 
fatal liver failure can occur 
x
Skin rash and/or serious and potentially 
fatal skin reactions have been reported  
x
Allergic reactions including those which are 
serious and potentially fatal can occur 
x
Kidney disease 
x
Lowered blood counts (red cells, and white 
cells)  
Prevention and mitigation include: 
x
Follow the user guide  
x
Instruct to avoid the use of products containing 
acetaminophen 
x
If acetaminophen is taken, subjects will be 
instructed to use additional BG meter readings 
(they are not to calibrate with those readings) 
to verify their glucose levels 
x
If acetaminophen is taken while the 
SmartGuard feature is active, subjects will be 
instructed to use the temp target 
 
 5LVN0LQLPL]DWLRQ
Refer to “Prevention and Mitigation” column in the table under Section 11.1. 
 3RWHQWLDO%HQHILWV
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. 
 5LVN%HQHILW5DWLRQDOH
Access to automated insulin devices during the trial may offer improved glycemic control for 
participants, and may increase understanding of the disorder, due to the fact that the participants will 
be followed with higher frequency of visits, which will allow a closer medical follow-up when compared 
to standard of care. 
 
Furthermore, with any externally worn device there are small risks of insulin infusion site reactions, 
infection, and skin reactions to tapes – however it should be noted that this is no different to standard 
of care insulin pump therapy and utilizing continuous glucose monitoring. 
 
In addition, any potential risks with this study are minimized by selecting qualified investigators 
experienced with insulin pump therapy, careful assessment of each subject during the study conduct to 
effectively monitor and rapidly remedy the problem. Furthermore, subjects can call the site to obtain 
technical support, if needed. 

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Medtronic has further minimized the possibility of risks by completing product testing prior to the use of 
the system in this clinical study, implementing quality control measures into production processes, 
providing guidelines for subject selection and evaluation, and providing adequate instructions and 
labelling according to local requirements. 
All above these risks are contained within the patient information sheet, and indications and 
contraindications are provided in the Instructions for Use given to all patients. 
 $GYHUVH(YHQWVDQG'HYLFH'HILFLHQFLHV
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 
adverse events (AEs) from the subject at each visit (including phone calls) starting at the time of signing 
the informed consent documenting the medical diagnosis, date of event start and end, causality 
(relationship to device or procedure), treatment, outcome, and description that includes the details of 
the event. 
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Medtronic uses the definitions provided in ISO 14155:2020 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 actions1. 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. 
 
 
Severe Hyperglycemia is defined as hyperglycemia (blood glucose greater than (>) 300 mg/dL or 16.7 
mmol/L) with blood glucose ketones greater than (>) 1.5 mmol/L, and/or accompanied by symptoms of 
nausea, vomiting or abdominal pain.   
 
The meter and ketone test strips are supplied for the evaluation of ketone monitoring. Only blood ketones 
will be recognized (not urine ketones) for assisting in diagnosis of severe hyperglycemia. The monitors/test 
strips are quality controlled prior to dispensing to subjects. Blood ketones provide contemporaneous 
understanding of ketone levels associated with elevations in glucose. 

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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 facility2.  
Hyperglycemic events will be recorded as DKA if the event includes the presence of all of the following: 
x
Arterial blood pH less than (<) 7.30 or serum bicarbonate less than (<) 15 mEq/L 
x
Blood glucose greater than (>) 250 mg/dL or greater than (>) 13.9 mmol/L 
x
Serum ketones or large/moderate urine ketones 
x
Symptoms such as polyuria, polydipsia, nausea, or vomiting 
x
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 to entry: This definition includes events related to the investigational medical device or the 
comparator. 
Note 2 to entry: This definition includes events related to the procedures involved. 
Note 3 to entry: For users or other persons, this definition is restricted to events related to the use of 
investigational medical devices or comparators. 
Adverse Device Effect (ADE) (ISO 14155:2020) 
Adverse event related to the use of an investigational medical device.  
Note 1 to entry: This definition includes adverse events resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation, or operation, or any 
malfunction of the investigational medical device. 
Note 2 to entry: This definition includes any event resulting from use error or from intentional 
misuse of the investigational medical device. 
Note 3 to entry:  This includes ‘comparator’ if the comparator is a medical device. 
 
Serious Adverse Event (SAE) (ISO 14155:2020) 
Adverse event that led to any of the following 
a) death, 

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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 
 
Note 1 to entry: Planned hospitalization for a pre-existing condition, or a procedure required by the CIP, 
without serious deterioration in health, is not considered a serious adverse event. 
 
Serious Adverse Device Effect (SADE) (ISO 14155:2020) 
Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse 
event 
 
Unanticipated Serious Adverse Device Effect (USADE) (ISO 14155:2020)  
Serious adverse device effect which by its nature, incidence, severity or outcome has not been identified 
in the current risk assessment. 
 
Note 1: Anticipated serious adverse device effect (ASADE) is an effect which by its nature, incidence, 
severity or outcome has been identified in the risk assessment.  
Serious Health Threat (ISO 14155:2020) 
Signal from any adverse event or device deficiency that indicates an imminent risk of death or a serious 
deterioration in the health in subjects, users or other persons, and that requires prompt remedial action 
for other subjects, users or other persons 
 Note 1 to entry: This would include events that are of significant and unexpected nature such that they 
become alarming as a potential serious health hazard or possibility of multiple deaths occurring at short 
intervals.  
Device Deficiency (ISO 14155:2020) 
A device deficiency is any inadequacy of a medical device with respect to its identity, quality, durability, 
reliability, safety, or performance.  
Note 1: Device deficiencies include malfunctions, use errors, and inadequacy in the information supplied 
by the manufacturer including labelling.  

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Note 2: This definition includes device deficiencies related to the investigational medical device or the 
comparator.  
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The investigator or designee will record all AEs and DDs 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: insertion site infection 

Serious adverse device effect: cellulitis at device insertion site requiring hospitalization 

Procedure related AE: meal challenge procedure 
 
 
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 on an AE eCRF as this is 
not considered an untoward event, but rather an expected occurrence. Any glycemic excursion that 
meets the protocol definition of Severe Hypoglycemia, Severe Hyperglycemia or DKA is considered an 
untoward event and a worsening from the subject’s baseline and would be reported to sponsor on an 
AE eCRF. 
 
Baseline medical conditions should only be reported to sponsor on an AE eCRF, if there is a worsening 
from the subject’s baseline. For example, a subject previously diagnosed with Asthma is hospitalized for 
severe asthma attack would be a reportable event. 
 
Adverse events will be documented in the subject source file and reported to sponsor on an eCRF. The 
investigational center is responsible for documentation of AEs including obtaining source documents 
related to the event, such as emergency medical technician/paramedic reports, hospital records 
(admission summary; lab results, test results, discharge summary) or device uploads to support the 
event. Source documents will be reviewed to determine if additional AEs have occurred and require 
reporting. 
 
Adverse events that have not resolved at the time of the subject’s discontinuation or completion of the 
study should have an “outcome” of Not Recovered/Not Resolved at study end in subject source and on 
an eCRF. The investigator should ensure that subject is aware of any follow-up or additional treatment 
that is required for any ongoing AE at end of study participation; however, there will be no eCRF entry 
for the ongoing follow-up. 
 

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Event Type to Report 
Timeframe for Reporting to 
Medtronic 
Reporting to Regulatory Authority 
and Ethics Committee 

Serious Adverse Device Effect 
(SADE) 

Unanticipated Serious Adverse 
Device Effect (USADE) 

Serious Adverse Event (SAE) 

Device Deficiency that might 
have led to a SADE 
Report immediately, but no later 
than 24 hours after investigational 
center study personnel’s first 
awareness of the event (or sooner 
if required by local regulation) 
Submit per local reporting 
requirements 

Adverse Event (AE) 

Adverse Device Effect (ADE) 

Device Deficiency (DD) 
Report in a timely manner from the 
investigator’s / investigational 
center first knowledge of the event 
Submit per local reporting 
requirements 
Medtronic is obligated to report adverse events and device deficiencies that occur during this study to 
the regulatory authorities and EC as per local requirements. 
 
Adverse Event and Device Deficiency Classification 
All AE and DD will be reviewed by a Medtronic representative. AEs will be classified according to the 
responsibilities and definitions provided in Table 7 and Section 12.4.  
Upon receipt of AE/DD at Medtronic, a Medtronic representative will review the AE/DD for 
completeness and accuracy and when necessary will request clarification and/or additional information 
from the Investigator. Medtronic will utilize MedDRA for Regulatory Activities, to assign a MedDRA term 
for each AE based on the information provided by the investigator.  
Regulatory reporting of AEs and DDs will be completed according to local regulatory requirements. Refer 
to Table 6 for a list of required investigator and Medtronic reporting requirements and timeframes. It is 
the responsibility of both to abide by any additional AE reporting requirements stipulated by the EC 
responsible for oversight of the study. 
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What is classified?  
Who classifies? 
Classification Parameters 
Relatedness 
Investigator 
Device, Procedure 
Sponsor 
Device,  Procedure
Seriousness 
Investigator 
SAE, DD with SADE potential 
Sponsor 
SAE, USADE, DD with SADE potential  

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What is classified?  
Who classifies? 
Classification Parameters 
Diagnosis 
Investigator 
Based on presenting signs and symptoms and other 
supporting data 
Sponsor 
MedDRA term assigned based on the data provided by 
Investigator 
 1RWLILFDWLRQRI$GYHUVH(YHQWVDQG'HYLFH'HILFLHQFLHV
Sponsor Notification: 
The investigational center staff must report all reportable AEs and DDs to Medtronic in a timely manner. 
All Severe Hypoglycemia, DKAs, USADEs, DDs with SADE potential, SAEs, 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. Do not 
include any patient-identifiable information in the e-mail.  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 personal information (full 
name, address, etc.) prior to providing to the sponsor. Each source page should be identified with the 
subject ID. 
 &DXVDOLW\$VVHVVPHQW
An AE is not automatically related to the study device or procedure simply because the subject is 
wearing the device and participating in the study. The event should be reviewed to determine if the 
device or study procedure could have possibly caused the event and therefore is related to the study 
device or procedure. 
Causality assessment is the determination of the relationship between an AE and the device being 
studied. It is expected that the investigational center will review all elements surrounding the AE to 
properly assess the causality of the event to the study device or to a study procedure. 
 
Investigators should classify the relationship between the AE and the study device or study procedures 
using one of the four possible causality categories listed below: 
 

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1) Not related: relationship to the device, comparator or procedures can be excluded when: 

The event has no temporal relationship with the use of the investigational device or the 
procedures related to the application of the investigational device 

The event does not follow a known response pattern to the medical device (if the response 
pattern is previously known) and is biologically implausible; 

The discontinuation of medical device application or the reduction of the level of 
activation/exposure – when clinically feasible – and reintroduction of its use (or increase of the 
level of activation/exposure), do not impact on the event; 

The event involves a body-site, or an organ not expected to be affected by the device or 
procedure; 

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); 

The event does not depend on a false result given by the investigational device used for 
diagnosis1, when applicable; 
 
In order to establish the non-relatedness, not all the criteria listed above might be met at the same time, 
depending on the type of device/procedures and the event. 
 
 
2) Possible: the relationship with the use of the investigational device or comparator is weak but cannot 
be ruled out completely. Alternative causes are also possible (e.g. an underlying or concurrent illness/ 
clinical condition or/and an effect of another device, drug or treatment). Cases were relatedness cannot 
be assessed or no information has been obtained should also be classified as possible. 
 
3) Probable: the relationship with the use of the investigational device or comparator seems relevant 
and/or the event cannot reasonably be explained by another cause, but additional information may be 
obtained. 
 
4) Causal relationship: the event is associated with the investigational device, comparator or with 
procedures beyond reasonable doubt when: 

The event is a known side effect of the product category the device belongs to or of similar 
devices and procedures; 

The event has a temporal relationship with investigational device use/application or procedures; 

 The event involves a body-site or organ that: 
R The investigational device or procedures are applied to; 
R The investigational device or procedures have an effect on; 

The event follows a known response pattern to the medical device (if the response pattern is 
previously known); 
1 If an investigational device gives an incorrect diagnosis, the patient might, for example, receive an unnecessary 
treatment and incur all the risks that accompany that treatment, or might be incorrectly diagnosed with a serious 
disease. In other cases, the patient might not receive an effective treatment (thereby missing out on the benefits 
that treatment would confer) or might not be diagnosed with the correct disease or condition. 

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
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); 

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; 

Harm to the subject is due to error in use; 

The event depends on a false result given by the investigational device used for diagnosis, when 
applicable; 
 
In order to establish the relatedness, not all the criteria listed above might be met at the same time, 
depending on the type of device/procedures and the event. 
 
Example: A severe hyperglycemia AE with the following event description would have the following causality 
assessment for device relatedness: 
Improved glucose without an infusion set/site 
change 
Not related 
Changed infusion set with glucose improvement 
Possible 
Infusion Set Fell Out, Bent Cannula, Occlusion 
Alarm 
Causal Relationship 
 'HYLFH'HILFLHQFLHVDQG7URXEOHVKRRWLQJ
The investigational center will be consulted for device troubleshooting if assistance is needed by subject 
to operate study devices and apps. If DD is detected the investigational center staff will complete the 
appropriate eCRF(s). All Device Deficiencies that did not lead to an Adverse Event should be reported on 
the Device Deficiency eCRF, one for each Device Deficiency, completing as much information as is 
available.  
  
Note that device deficiencies that result in an AE to the subject should be captured as an AE CRF only. 
Each device deficiency will be assessed for SADE potential defined as: 
 
A Device Deficiency that did not lead to an Adverse Event, but could have led to a SADE: 
a) if either suitable action had not been taken, 
b) if intervention had not been made, or 
c) if circumstances had been less fortunate   
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A Clinical Event Committee (CEC) consisting of external (non-Medtronic employed) physicians with an 
expertise in endocrinology and the management of diabetes, including insulin pumps and CGM will be 
convened. The CEC will review on periodic basis AEs and may include reports of: 

Serious Adverse Event (SAE) 

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Serious Adverse Device Effect (SADE) 

Unanticipated Serious Adverse Device Effect (USADE) 

Severe Hypoglycemia 

Diabetic Ketoacidosis (DKA)ġġ

Deaths 
 
The CEC will assess events to determine agreement or disagreement with the investigator classification 
of an event.  
 
If the CEC disagrees with the investigator’s classification of the event, the rationale will be provided to 
the investigator. If the investigator agrees with the CEC’s adjudication, the CRF documenting the AE will 
be updated accordingly. 
If the investigator does not agree with the CEC’s adjudication classification, both determinations will be 
provided within the final report; however, the CEC’s adjudication will be used for data analysis. The 
disagreement will also be included in reporting to ECs and regulatory authorities, if required. 
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All data collected from the time of screening until the end of the study will be collected either on eCRFs 
and electronically by uploading the various devices. Data and analysis will be summarized in a Clinical 
Study Report. Any deviations from original statistical plan and the rationale will be described in the 
Clinical Study Report. 
No interim analysis is planned. 
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The number of subjects enrolled, completed, early terminated the study will be presented. The reasons 
for discontinuing prior to study completion will be summarized. 
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Subject demographics and baseline characteristics will be summarized by descriptive statistics (mean, 
standard deviation, minimum, median, and maximum) for continuous variables and by counts and 
percentages for categorical variables. 
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Given that this study is not statistically powered, no sample size calculation was performed. A total of up 
to 40 subjects will be enrolled at one investigational center in Israel to have at least 16 subjects 
complete the study. Subjects may repeat participation in the study at the request of the Sponsor and at 
the discretion of the investigator but will only be counted once toward the total number of subjects. 
 

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Analysis will be performed by Klue Health App software release version, if applicable. 
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Post-prandial Time in range (% of SG within 70-180 mg/dl) At-Home and In-Clinic Period will be 
summarized, respectively.  
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Number of (S)AEs, (S)ADEs, USADEs, Severe hypoglycemic events, DKA events, and Device 
Deficiencies 
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All measurements performed by Study Period (At-Home and In-Clinic period). 
x
Post-prandial Time in different ranges (% of SG): SG <54, 70 mg/dL, SG > 180, 250 mg/dL
x
Change in post-prandial % of time in euglycemia (70-180 mg/dL) for meal challenges 
(intervention versus baseline) 
x
Change in post-prandial % of time in different ranges (% of SG): SG <54, 70 mg/dL, SG > 180, 250 
mg/dL for meal challenges (intervention versus baseline) 
x
24 hour Time in range (% of SG within 70-180 mg/dl) 
x
24 hour Time in different ranges (% of SG): SG <54, 70 mg/dL, SG > 180, 250 mg/dL 
x
Number of Events, Area Under Curve (AUC) and Time in the hyperglycemic range: sensor 
glucose (SG) > 180, 250 mg/dL 
x
Number of Events, AUC and Time in the hypoglycemic range: SG < 54 and 70 mg/dL 
x
Time spent in Auto Mode versus time spent in Manual Mode
x
Change of Total Daily Dose (TDD) of insulin from baseline to EOS Period
x
Change in BG values during meal challenge (BG prior and BG 2 hours after meal)
x
Insulin delivery at postprandial: Total unit of insulin in first 15 minutes, 60 minutes, 120 minutes, 
and 240 minutes postprandial
x
Subgroup analysis by type of meals 
x
Between period analyses of all above (At-Home vs. In-Clinic) 
 
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Descriptive summary will be used to characterize study questionnaire 
 
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All available data will be included in the data listings and tabulations. No imputation will be applied for 
the missing data. 

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This clinical study will be conducted in compliance with the principles originating from the Declaration of 
Helsinki (2013), the international standard ISO 14155:2020 (‘Clinical Investigation of medical devices for 
human subjects’), laws and regulations of the countries in which the clinical study is conducted, 
including data protection laws, the Clinical Investigation Agreement and the Clinical Investigation Plan. 
 
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 independent ethic 
committee (EC) and Regulatory authority before initiating the investigation, ongoing review of the 
investigation by an EC and RA and obtaining and documenting the freely given informed consent of the 
subject before their participation in the investigation. 
 
All principles originating from the Declaration of Helsinki (2013) have been implemented in this clinical 
study including but not limited to informed consent process, EC and RA approvals, study training, 
preclinical testing, risk benefit assessment, publication policy. 
 
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. 
 
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This CIP, any subsequent amendments to this CIP, the ICF, subject material, and any form of subject 
recruitment information (e.g. advertisements), if applicable, relating to this study will be approved by 
the responsible EC. 
 
The investigational center will not initiate any subject activities until EC 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. 
 
If the EC imposes any additional requirements, Medtronic will prepare required documents and send 
them to the EC. 
 
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In countries where submission to the regulatory authority is required per local law, no patients will be 
enrolled in the clinical study until the particular regulatory authority has approved the current Clinical 

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Investigation Plan (and amendments) of the clinical study and other documents as required according to 
the local requirements. 
 
If the regulatory authority imposes any additional requirements (e.g. safety reports, progress reports 
etc.), Medtronic will prepare the required documents and send them to the respective authority. 
 
Other documents that are referred to in this CIP will be made available upon request. 
 
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This study will be conducted at the investigational centers where all study-related activities will be 
performed and will be led by a PI. Per ISO14155:2020, an investigator means “individual member of the 
investigation center designated and supervised by the principal investigator at an investigation site to 
perform critical clinical-investigation-related procedures or to make important clinical-investigation 
related decisions.” 
The investigator’s responsibilities include but are not limited to: 

Conduct of the investigation in accordance with the CIP and Clinical Trial Agreement, applicable 
regulations, and any conditions of approval imposed by the reviewing EC or regulatory authority 
requirements 

Conduct of investigation in accordance to International guidelines for clinical trials on medical 
devices ISO 14155:2020 
R  To supervise a clinical study in which some study tasks are delegated to employees or 
colleagues of the investigator or other third parties, and  
R To protect the rights, safety, and welfare of study subjects. 

Protecting the rights, safety, and welfare of subjects under the investigator’s care 
R Providing reasonable medical care for study subjects for medical problems that arise 
during participation in the trial that are, or could be, related to the study intervention 
R Providing reasonable access to needed medical care, either by the investigator or by 
another identified, qualified individual (e.g., when the investigator is unavailable, when 
specialized care is needed) 
R Adhering to the CIP so that study subjects are not exposed to unreasonable risks 

Controlling devices under investigation 

Investigator is responsible for providing adequate supervision of those to whom tasks have been 
delegated. The investigator is accountable for regulatory violations resulting from failure to 
adequately supervise the conduct of a clinical study. 

Ensuring that the requirements for obtaining informed consent are met in accordance with ISO 
14155:2020 

Disposing of device properly. Upon completion or termination of a clinical investigation or the 
investigator’s part of an investigation, or at the sponsor’s request, an investigator shall return to 

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the sponsor any remaining supply of the device or otherwise dispose of the device as the 
sponsor directs. 

Allowing study devices to be used only with subjects under the investigator’s supervision and to 
supply study devices only to persons authorized to receive it 

Ensuring that investigational center staff are adequately trained to perform their assigned duties 

Maintenance of accurate, complete, and current records relating to the investigator’s part of an 
investigation, to include: 
R all relevant correspondence with another investigator, an EC, the sponsor, a monitor, 
regulatory authorities, including required reports. 
R records of receipt, use or disposition of study devices 
R records of each subject’s case history and exposure to the device 
R the CIP, with documents showing the dates of and reasons for each deviation from the 
CIP 

Preparation and submission to Medtronic and, when required, regulatory agency and the 
reviewing EC, the following complete, accurate, and timely reports: 
R any reportable AEs (see Section 12.3) occurring during an investigation 
R progress reports on the investigation as required by the regulatory agency and EC 
R any deviation from the CIP made to protect the life or physical well-being of a subject in 
an emergency any use of the device without obtaining informed consent 
R any further information requested by the regulatory agency and EC about any aspect of 
the investigation 
R any other records the regulatory agency requires to be maintained by regulations or by 
specific requirement for a category of investigations or a particular investigation 

Permitting regulatory authorities to inspect and copy any records pertaining to the investigation 
including, in certain situations, those which identify subjects 

Meeting with the monitor to discuss study progress and findings 

Ensuring that investigational center resources are adequate to fulfill the obligations of the study 

Ensuring completion of eCRF to include entry and addressing discrepancies in a timely fashion 
and approving selected eCRFs. 
Only authorized study personnel as listed on the Delegation of Authority Log are permitted to consent 
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. 
The investigator’s signature on the Investigator Statement confirms that the investigator is familiar with 
the CIP in its entirety and agrees to conduct this study in accordance with the provisions of the CIP and 
all applicable regulations. The investigator, prior to the initiation of any study related activity, will sign 
the Investigator Statement. If the sponsor discovers that an investigator is not complying with the 

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Investigator Agreement, CIP, or other regulatory requirements, the sponsor shall promptly secure 
compliance or discontinue that investigator’s participation in the study. 
 5ROHRIWKH6SRQVRU¶V5HSUHVHQWDWLYHV
Sponsor’s representatives may provide support as required for the study including providing study 
specific training to the investigational center personnel conducting study activities. Sponsor’s 
representatives may also provide technical support under supervision of the PI following routine 
practice in the participating countries (i.e. pump or CGM training) and for study specific activities (i.e. 
data uploads, IT support). In the applicable participating investigational centers where sponsor is 
involved in subject device trainings, the sponsor’s representatives providing technical support will be 
listed on the sponsor technical support list. No data entry on the eCRF shall be performed by Medtronic 
personnel or their representatives. 
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The following requirements will be evaluated for each investigator considered for participation in the 
clinical study: 

Investigator/investigational center is qualified by training, education, and relevant experience 
appropriate to the 
use of the product and associated procedures (Endocrinology or Diabetology expertise) 

Investigator/investigational center has Medtronic MiniMed 670G or 780G System experience, 
including CareLink usage 

Investigator/investigational center expects to have adequate time and resources to conduct the 
study throughout the duration  

Investigator/investigational center has access to an adequate number of eligible subjects 

Investigator/investigational center has past experience in conducting clinical studies 

Investigator/investigational center has interest in participating in pre-market interventional 
studies with devices 

Investigator/investigational center has the ability to comply with applicable EC and regulatory 
requirements 

Investigator is not debarred, disqualified, or working under sanctions in applicable regions 
 
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In order to conduct the study, investigational center staff must have the appropriate medical training 
required. Training of the investigational center staff on the conduct of the study and system being 
studied will be initiated before the CIP is implemented. All participating physicians and coordinators will 
be familiarized with the system. Other members of the investigational center staff may require training 
depending on their role listing in the Delegation of Authority Log. 
 

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The PI is responsible for ensuring that investigational center staff are trained to perform their assigned 
duties per the Delegation of Authority Log. Individual investigational center staff must be appropriately 
trained prior to performing study related tasks. 
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Monitoring visits will be conducted at the start, during and at the closure of the clinical study in 
accordance with Medtronic SOPs and the Monitoring Plan and conducted by a vendor.  At minimum, it 
will be verified whether signed and dated informed consent forms have been obtained from each 
subject at the point of enrollment and that AEs discussed in Section 12 were reported via completion of 
the Adverse Event CRFs. More details regarding the monitoring activities (frequency of monitoring visits, 
planned extent of source data verification) are described in the Monitoring Plan. 
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The principal investigator(s), his/her delegate(s) and the study coordinator(s) shall be accessible to 
Medtronic field personnel, monitor and the Clinical Study Manager. This accessibility is of particular 
importance for reviewing data in the electronic Case Report Form (eCRF). 
 
Medtronic clinical representatives or delegates will be granted access by the investigational center to all 
source documents including electronic source documents, if applicable, for the purposes of monitoring, 
audit, or inspection. Source data access should be prepared by investigational center staff prior to any 
visit. If applicable, where copies of the original source document as well as printouts of original 
electronic source documents are retained, these shall be signed and dated by a member of the 
investigational center team with a statement that it is a true and complete reproduction of the original 
source document (“certified copy”). 
 
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In addition to regular monitoring visits, Medtronic may conduct quality 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, verify adherence to 
external regulations and internal policies and procedures; assess adequacy and effectiveness of clinical 
policies and procedures; assure compliance with critical study document requirements; confirm integrity 
and accuracy of clinical study data; and protect the safety, rights and welfare of study subjects. 
 
Regulatory authorities may also perform inspections at participating investigational centers. Any 
regulatory authority inspection announcements shall be forwarded immediately to the Clinical Study 
Manager. 
 
The investigator and/or institution shall permit Medtronic and regulatory authorities direct access to 
source data and documents, taking into account any restrictions due to local law, to perform clinical 
study related monitoring, audits, EC review, and regulatory inspections. 
 
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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 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 Binder. The OC-RDC system 
maintains an audit trail on entries, changes, and corrections in the eCRFs. 
A copy of the eCRFs to be used in this clinical study is available under a separate cover, upon request to 
the Sponsor and in the Investigator Site File. Investigational centers will be trained in the use of 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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All investigational centers will receive paper worksheets upon request, which specify the required data 
collection in the CRFs, and some additional instructions to ensure correct completion. The study 
worksheets are a supplement of the patient’s hospital/clinic file and completed worksheets will be 
considered as source documents. Only authorized persons can complete the worksheets as specified on 
the Delegation of Authority Log included in the Investigator Site File. 
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During the course of the study, subject’s BG values may be assessed from the Accu-Chek Guide Link 
study meter. The SG values may be assessed from the study pump. The study pump will be uploaded in 
Carelink system by the investigator or designated investigational center staff and subjects at home. The 
system uses TLS technology, which encrypts all data it stores. The data in the different databases are 
linked to each other via the subject’s ID. 
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The questionnaires will be provided in local language in the countries. The data will initially be collected 
on paper questionnaires that will be kept at the investigational center. For more information, please 
refer to questionnaire instructions. 
 
The investigator, or designated investigational center personnel, will then copy the answers of the 
subject from the paper questionnaires into the OC-RDC system. It is important that the investigator or 
designated investigational center personnel verifies the questionnaires for completeness before subject 
leaves the investigational center. 
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It is expected that eCRFs are completed in a timely manner, with the exception of reportable events (see 
Table 6), which need to be recorded immediately after awareness of the investigational center staff on 
the Adverse Event or Device Deficiency eCRFs. After data entry, eCRFs should be submitted (i.e. saved) 
so that monitors can proceed with data verification without delay.  
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Data management will be done according to Medtronic SOPs and the Data Management Plan for this 
clinical study. 
 
Collected data will be reviewed for completeness, correctness, and consistency, as per the monitoring 
plan. In case of issues, queries will be entered on the respective eCRF for the investigator to complete, 
correct, or comment on the data. 
 
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The subject’s clinic file, CareLink Personal/CareLink system software data, laboratory reports, survey 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. 
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The investigator will ensure that the subject’s confidentiality maintained. All records and other 
information about subjects participating in this clinical study will be treated as confidential. Subject 
confidentiality will be maintained throughout the clinical study to the extent permitted by law. That is, 
every attempt will be made to remove subject identifiers from clinical study documents. For this 
purpose, a unique subject identification code (study – investigational center – subject number) will be 
assigned and used to allow identification of all data reported for each subject. This will also ensure that 
the information can be tracked back to the source data. All laboratory specimens, evaluation forms, 
reports, and other records that leave the investigational center will be identified only by the subject ID 
code in order to maintain subject confidentiality. All records will be kept in a secure environment and all 
computer entry and networking programs will be done with coded numbers only. 
 

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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. Study data may also be made 
available to third parties, e.g., in the case of an audit or inspection performed by regulatory authorities, 
provided the data are treated confidentially and that the subject’s privacy is guaranteed. 
 
Subjects will not be identified in any publicly released reports of this study.  
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The subjects may receive compensation for participation in this study in the form of paid 
accommodation during the clinic stay. Travel fees to the investigational center may be reimbursed for 
study specific visits if required by local regulations. Refer to the ICF for details of the subject’s 
compensation.  
The Medtronic International Trading Sàrl is a wholly owned subsidiary of Medtronic, which as the parent 
company of such entity maintains appropriate clinical study liability insurance coverage as required 
under applicable laws and regulations and will comply with applicable law and custom concerning 
specific insurance coverage. If required, a Clinical Trial Insurance statement/certificate will be provided 
to the EC or regulatory authority.  
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An investigator or study team member can propose any appropriate modification(s) of the Clinical 
Investigation Plan or investigational device/product or investigational device/product use. Medtronic 
will review this proposal and decide whether the modification(s) will be implemented. 
 
Medtronic can decide to revise the CIP based on new information and will submit any significant 
amendment to the CIP, including a justification for this amendment, to the appropriate regulatory 
authorities for their approval and to the investigators to obtain approval from their EC. The investigator 
will only implement the amendment after approval from the EC, regulatory authority and sponsor. 
Administrative amendments to the CIP will be submitted to the EC for notification. Furthermore, the 
principal investigator shall sign any approved amendment for agreement. 
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Medtronic contracts with participating institutions/investigators through a Clinical Trial Agreement that 
defines the scope and responsibilities and associated compensation related to carrying out the 
obligations under a clinical study sponsored by Medtronic. 
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The Principal Investigator will retain all records and documents pertaining to this study in accordance 
with local law and regulations for a minimum period of 15 years (or longer if local laws require) after 
market release in his/her region or termination of the study, whichever is longer. In case of 
investigational center closing with no patients enrolled, the documents shall be obtained by all entities 
(PI, EC and CA) at the investigational at least 1 year, from the closing of the investigational center. They 
will be available for inspection by the appropriate regulatory authorities. In addition, the investigator 

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will retain the source documents from which the information entered on the eCRF was derived. The 
investigator should take measures to prevent accidental or early destruction of the clinical study related 
materials and will ensure that essential study documents are not destroyed until written permission has 
been obtained from Medtronic. Medtronic will retain the study records according to Medtronic policy. 
 
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The investigator is responsible for the preparation and retention of the records cited below. All of the 
below records, with the exception of case history records and case report forms, should be kept in the 
Investigator Site File (i.e., the study binder provided to the investigator) or Subject Study Binder. CRFs 
must be maintained and signed electronically within the electronic data capture system during the 
study. The following records are subject to inspection and must be retained for a period of two years (or 
longer as local law or hospital administration requires) after product approval or the date on which the 
investigation is terminated. 
x
All correspondence between the EC, sponsor, monitor, RA and the investigator that 
pertains to the investigation, including required reports.  
x
Subject’s case history records, including:  
R Signed and dated ICF signed by subject and investigator.  
R Observations of AEs/ADEs/DDs 
R Medical history 
R Follow-up data 
R Documentation of the dates and rationale for any deviation from the protocol 
x
List of investigational centers 
x
FD (if applicable) 
x
Subject screening log & SID log  
x
Lab certificate  
x
Device Disposition Logs containing Model and serial/lot numbers, subject IDs of the 
subjects receiving device, receive and return date by patient, returned-to-sponsor dates, 
disposal /destruction date, initials of all persons who received device from sponsor or 
subject, returned or disposed/destruct device, and reason and method of 
disposal/destruction. 
x
All approved versions of the CIP and ICF 
x
Signed and dated CTA.  
x
CV signed and dated of principal investigators  
x
Documentation of delegated tasks 
x
EC approval documentation. Written information that the investigator or other study 
staff, when member of the EC, did not participate in the approval process. Approval 
documentation must include the Ecs composition, where required per local law.   
x
RA notification, correspondence and approval, where required per local law. 

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Study training records for investigational center staff.  
x
Insurance certificates  
x
Final Study Report including the statistical analysis. 
 
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Medtronic shall maintain the following accurate, complete, and current records: 
x
All correspondence which pertains to the investigation 
x
 Investigational device traceability record containing Model and serial numbers of 
devices, shipping date and name and address of person that received shipped device, 
location (if different than person shipped to), transfer and receipt by Medtronic dates. 
x
Signed Investigator Trial Agreements, FD (if applicable) and current signed and dated 
(Europe only) CV of principal investigator and key members of the investigational center 
team (as required by local law), delegated task list 
x
All approved IC templates, and other information provided to the subjects and 
advertisements, including translations 
x
Copies of all EC approval letters and relevant EC correspondence and EC voting 
list/roster/letter of assurance 
x
Names of the institutions in which the study will be conducted 
x
RA correspondence, notification and approval as required by national legislation 
x
Insurance certificates   
x
Names/contact addresses of monitors 
x
Monitoring visit reports 
x
Statistical analyses and underlying supporting data 
x
Final report of the study 
x
The CIP, IB/Report of Prior Investigations summary and study related reports, and 
revisions 
x
Study training records for investigational center personnel and Medtronic personnel 
involved in the study 
x
Any other records that local regulatory agencies require to be maintained.  
 
Medtronic records and reports will be maintained in a password-protected document management 
system, and paper documents (where applicable) will be stored in stored in secured file cabinets at 
Medtronic during the course of this study.  
After closure of the study Medtronic will archive records and reports indefinitely. 
 

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Medtronic shall prepare and submit the following complete, accurate, and timely reports listed in the 
tables below (by geography).  In addition to the reports listed below, Medtronic shall, upon request of 
the reviewing EC or RA, provide accurate, complete and current information about any aspect of the 
investigation. Safety data Medtronic reporting requirements are listed in Section 12. 
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Report  
Submit to 
Description/Constraints 
Premature 
termination or 
suspension of the 
clinical investigation 
Investigators, EC, 
RAs and Head of the 
Institution 
Provide prompt notification of termination or 
suspension and reason(s). (ISO 14155:2020) 
Withdrawal of  EC 
approval 
Investigators, Head of 
Institution,  EC and RAs 
Investigators, ECs will be notified only if required by 
local laws or by the  EC. 
Withdrawal of CA 
approval 
Investigators, Head of 
Institution,  EC, and RAs 
Investigators, ECs will be notified only if required by 
local laws or by the EC. 
Final report 
Investigators,  
 EC, and 
RAs if required 
x
 The investigator shall have the opportunity 
to review and comment on the final report.   
x
If a clinical investigator does not agree with 
the final report, his/her comments shall be 
communicated to the other investigator(s).   
x
The coordinating investigator shall sign the 
report. If no coordinating investigator is 
appointed, then the signature of the principal 
Investigator in each study site should be 
obtained. (ISO 14155:2020) 
Study deviation  
Investigators and RAs, if 
required 
Ensure that all deviations from the CIP are reviewed 
with the appropriate clinical investigator(s), are 
reported on the CRFs and the final report of the 
clinical investigation.  (ISO 14155:2020) 
 
Study site specific study deviations will be submitted 
to investigators periodically.   

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Sponsor or 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, if interim analysis indicates that the results significantly differ from expectations relative to 
study objectives or statistical endpoints, or because of a business decision). If the clinical study is 
terminated prematurely or suspended, Medtronic shall promptly notify the Regulatory Authority and 
inform the investigators of the termination or suspension and the reason(s) for this. The investigator 
shall then promptly inform the reviewing EC and the study subjects, as applicable by local laws and 
regulations. 
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Sponsor, EC or a Regulatory Authority may decide to suspend or prematurely terminate an 
investigational center (e.g. in case of non-compliance to the CIP, lack of enrollment). If an investigational 
center is suspended or prematurely terminated, sponsor shall promptly inform the investigator(s) and 
the Regulatory Authority of the termination or suspension and the reason(s) for this. The investigator 
shall then promptly inform the reviewing EC and the study subjects, as applicable by local laws and 
regulations. 
 
When the risks are found to outweigh the potential benefits or when there is conclusive proof of 
definite outcomes, investigators must assess whether to continue, modify, or immediately stop the 
clinical study in the respective investigational center and immediately inform the sponsor and EC, if 
applicable. 
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In case of early investigational center suspension or termination, all subjects should be called to plan an 
Early Termination visit (described in Section 10.8) 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. 
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At the time of a study close-out, the investigators will be notified by the sponsor. Appropriate 
notification and final study report will be provided to EC and Regulatory Authority, if required per local 
laws and regulations. 
 
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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. Publications and presentations 
referring to this clinical study will be coordinated by Medtronic to allow the use of all available data.  
 

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The identity of the subjects may not be disclosed, unless required by law, to any persons not 
immediately involved in the study or the study procedures. The study will be publicly registered on 
http://www.clinicaltrials.gov and https://my.health.gov.il prior to subject enrollment. 
 

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1. 
Cryer PE. Defining and reporting hypoglycemia in diabetes: A report from the American diabetes 
association workgroup on hypoglycemia. Diabetes Care 2005;28:1245-9. 
2. 
Hyperglycemic Crises in Diabetes. Diabetes Care 2004;27:S94-S102. 
3. 
EMEA. Clinical Safety Data Management: Definitions and Standards for Expedited Reporting. ICH 
Topic E2A 2006. 
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The names and addresses of investigators and participating investigational centers will be kept under 
separate cover. This list will be provided to the participating investigators and sponsor shall inform the 
investigators in case changes occur in the list of participating investigational center. The most current list 
is available upon request. 
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The names and addresses of monitors will be kept under separate cover. This list will be provided to the 
participating investigators and sponsor shall inform the investigators in case changes occur in the list. 
The most current list is available upon request. 
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The names and addresses of sponsor team will be kept under separate cover. The most current list of 
the contact persons is available upon request. 
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The names and addresses of vendors providing services for the study will be kept under separate cover. 
The most current list of the contact persons is available upon request. 
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The current labelling and IFU for the study devices will be provided to the investigators under a separate 
cover. 
 6DPSOH,QIRUPHG&RQVHQW)RUP
Informed Consent template is provided under a separate cover upon request to the Sponsor. 
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Sample Investigator Agreement will be provided under a separate cover upon request to the Sponsor. 
 /LVWRI&RQVXPDEOHVDQG$FFHVVRULHV

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INFUSION SETS 
MMT-386 
MiniMed Quick-set 80cm tubing with 9mm cannula (box of 10) 
MMT-965 
MiniMed Mio 80cm tubing with 6mm cannula (box of 10) 
MMT-975 
MiniMed Mio 80cm tubing with 9mm cannula (box of 10) 
 
INFUSION SET INSERTION DEVICES 
MMT-305QS 
MiniMed Quick-serter (for use with Quick Set Infusion Sets) 
 
RESERVOIRS 
MMT-326A 
1.8 mL reservoirs (box of 10) 
MMT-332A 
3.0 mL reservoirs (box of 10) 
 
OTHER 
N/A 
 
Roche Accu-Chek Strips 
N/A 
 
Roche Accu-Check Solution 
ACC-LR6 
AA Battery (Alkaline) 
MMT-174 
Tape HMS-174 ADH IV3000 1-hand 13L 
MMT-7015WW Guardian Sensor 3 Over tape 
HMS-180 
Skin Tac Adhesive Wipe (box of 50) 
MMT-7747 
USB cable and wall-powered adapter 
N/A 
 
Urinary pregnancy test, if needed 
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The questionnaires are available, when possible, in local language and will be provided under a separate 
cover if a request is made to the Sponsor. 

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Version 
Summary of changes 
Justification of changes 
Potential impact of the 
change on 
performance, 
effectiveness, or safety 
or other endpoints 
Identification of the 
affected study 
documents 
Author(s)/Title 
A 
Not Applicable, New Document 
Not Applicable, New 
Document 
Not Applicable, New 
Document 
Not Applicable, New 
Document 
 
Medical Writer 
B 
x
Added investigational Roche meter and 
updated relevant sections throughout 
x
Updated software versions for 
MiniMed 780G insulin pump and 
MiniMed Clinical app and updated 
relevant sections throughout 
x
Removed language in 13.1 Clinical 
Events Committee Review  
x
Updated device deficiency language in 
12.1 Definitions and Classifications of 
Adverse Events 
x
Updated CIP to match most current 
corporate CIP template 
x
Typo/formatting corrections 
throughout document 
x
To include 
additional device 
used during study 
x
To update software 
version used 
during study 
x
To clarify how CEC 
will perform 
assessments and 
update device 
deficiency 
definition to match 
ISO14155:2020 
definition 
None 
None 
 
Medical Writer 

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Version 
Summary of changes 
Justification of changes 
Potential impact of the 
change on 
performance, 
effectiveness, or safety 
or other endpoints 
Identification of the 
affected study 
documents 
Author(s)/Title 
C 
x
See “Attachment 1: CIP339 Description 
of Protocol Changes Version B to C” for 
details on changes 
x
Added CareLink Clinical App and 
updated relevant sections throughout 
x
Removed Blue Bluetooth Low Energy 
Adapter and updated relevant sections 
throughout 
x
Updated “Table 3. Device 
Accountability Requirements” to 
update requirements for Guardian 
Sensor 3 
x
Updated visit day for Visit 3 and visit 
windows for Visit 5, Visit 6 , and Visit 7  
x
Typo/formatting corrections 
throughout document 
x
To include 
additional app 
used during study 
x
To remove device 
that will not be 
used during study 
x
To clarify 
requirements for 
Guardian Sensor 3 
x
To update visit day 
and windows 
None 
None 
 
Sr. Medical 
Writer 

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D00456959 
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Version 
Summary of changes 
Justification of changes 
Potential impact of the 
change on 
performance, 
effectiveness, or safety 
or other endpoints 
Identification of the 
affected study 
documents 
Author(s)/Title 
D 
x
 See “Attachment 1: CIP339 Description 
of Protocol Changes Version C to D” for 
details on changes 
x
Added product (Klue Health App 
release tag 2.0) and clarification for 
endpoint analysis  
x
Increased number of subjects to enroll 
and complete 
x
Increased duration of subject 
participation 
x
Added subject repeat participation 
x
Increased overall study duration 
x
Adjusted visit days and visit windows 
for Visit 2 through Visit 7 
x
Updated meals for at-home baseline 
and in-clinic meal challenge 
x
Added device re-use disclosure 
x
Typo/formatting/wording  corrections 
throughout document 
x
To add product for 
use in the study 
x
To allow for more 
subjects and 
subject repeat 
participation in the 
study 
x
To optimize visit 
days and visit 
windows 
x
To include 
additional 
meals/beverages 
during the meal 
challenge  
x
To clarify device re-
use 
x
To correct/clarify 
CIP language 
x
Clarifications made 
to endpoints 
x
Updates required 
for informed 
consent and 
investigator’s 
brochure 
 
Sr. Medical 
Writer 

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Version 
Summary of changes 
Justification of changes 
Potential impact of the 
change on 
performance, 
effectiveness, or safety 
or other endpoints 
Identification of the 
affected study 
documents 
Author(s)/Title 
E 
x
See “Attachment 1: CIP339 Description 
of Protocol Changes Version D to E” for 
details on changes 
x
Typo/formatting/wording  corrections 
throughout document 
x
Added product 
 
 
x
Revised device re-use disclosure 
x
 
 
 
 
 
x
To correct/clarify 
CIP language 
x
To clarify device re-
use 
 
x
None 
x
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for informed 
consent 
 
Sr. Medical 
Writer 

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D00456959 
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Version 
Summary of changes 
Justification of changes 
Potential impact of the 
change on 
performance, 
effectiveness, or safety 
or other endpoints 
Identification of the 
affected study 
documents 
Author(s)/Title 
F 
x
See “Attachment 1: CIP339 Description
of Protocol Changes Version E to F” for
details on changes
x
Updated “Duration”
x
Updated “Schedule of Events”
 
R
Removed breakfast meal
challenge on Day 4 (at home
and in-clinic)
R
Updated window for Visit 3
R
Updated questionnaire timing
x
x
Updated “Table 4. Study Visit Details”
x
Typo/formatting corrections
throughout document
See “Attachment 1: CIP339 Description of 
Protocol Changes Version E to F” for details 
Updates required for 
informed consent 
Sr. Medical 
Writer