Evaluating the Safety and Effectiveness of the Omnipod Horizon™ CGM-informed Bolus Calculator in Patients With Type 1 Diabetes
Phase: NA
Conditions: Type 1 Diabetes
Sponsor: Insulet Corporation

 
 
Omnipod Horizon™ CGM-informed Bolus Calculator Protocol 
 
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Evaluating the Safety and Effectiveness of the Omnipod 
Horizon™ CGM-informed Bolus Calculator in Patients with Type 
1 Diabetes 
 
 
IDE G200018 
Version 3.0 
July 20, 2020 
 
 
Insulet Corporation 
100 Nagog Park 
Acton, MA 01720 
 
 
 
 
Confidentiality Statement: 
The information in this document contains trade secrets and commercial information that are 
privileged or confidential and may not be disclosed unless such disclosure is required by 
applicable law or regulations. In any event, persons to whom the information is disclosed must 
be informed that the information is privileged or confidential and may not be further disclosed by 
them. These restrictions on the disclosure shall apply equally to all future information supplied to 
you, which is indicated as privileged or confidential. 

Insulet Corporation 
PROTOCOL APPROVAL 
Evaluating the Safety and Effectiveness of the Omnipod 
Horizon TM CGM-informed Bolus Calculator in Patients with Type 
1 Diabetes 
IDE G200018 
Version 2.0 
April 24, 2020 
Trang Ly MBBS FRACP PhD - SVP, Clinical and 
Medical Director, lnsulet Corporation 
n 
Bonnie Dumais, Senior Director of Clinical Affairs, 
lnsulet Corporation 
Jur 
rkins - Senior Director, Quality and Regulatory, 
Ins 
t orporation 
rm 
2 
Date 
06 Jun 2020 
Date 
Pd 
2 
08June2020

 
 
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INVESTIGATOR STATEMENT 
 
Evaluating the Safety and Effectiveness of the Omnipod Horizon™ 
CGM-informed Bolus Calculator in Patients with Type 1 Diabetes 
IDE G200018 
Version 3.0 
July 20, 2020 
I agree to conduct the above referenced clinical study protocol in accordance with the 
design and specific provisions as designated in this protocol, the signed agreement with 
the sponsor, applicable FDA regulations, and any conditions of approval imposed by an 
Institutional Review Board (IRB) or Food and Drug Administration (FDA). Modifications 
to the study protocol are acceptable only in the form of a protocol amendment, except 
when necessary to protect the safety, rights, or welfare of subjects. I agree to await 
Institutional Review Board (IRB) and Insulet approval for the protocol, informed consent 
and documentation to be presented to subjects before initiating the study pursuant to 21 
CFR Part 56, to obtain informed consent from subjects prior to their enrollment into the 
study pursuant to 21 CFR Part 50, to collect and record data as required by this 
protocol and case report forms, to report non serious and serious adverse events that 
may occur for any subject participating in this study under my care, to report product 
complaints for any of the devices utilized in this protocol, and to maintain study related 
documentation (regulatory documentation) for the period of time required. I agree to 
supervise all utilization of investigational study devices and to ensure their usage is only 
in connection with the Study. I agree to provide a Financial Disclosure Statement to 
Sponsor and will also notify Sponsor if my disclosed financial information changes 
during the Study and up to one year following the closure of the Study. I have read and 
understand the contents of this protocol. I agree to follow and abide by the requirements 
set forth in this document. 
I understand the information in this document contains trade secrets and commercial 
information that are privileged or confidential and may not be disclosed unless such 
disclosure is required by applicable law or regulations. In any event, persons whom the 
information is disclosed must be informed that the information is privileged or 
confidential and may not be further disclosed by them. These restrictions on disclosure 
will apply equally to all future information supplied to me, which is indicated as 
privileged or confidential. 
___________________________________  
Clinical Site Investigator Name (print) 
 
___________________________________  
 
__________________ 
Clinical Site Investigator Signature 
 
 
 
 
Date 

 
 
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PRINCIPAL CONTACTS 
 
Sponsor Contacts:  
Trang Ly, MBBS FRACP PhD 
SVP, Clinical and Medical Director 
Insulet Corporation 
100 Nagog Park 
Acton, MA 01720 
Office: 978-600-7628 
E-mail: tly@insulet.com 
 
 
 
Julie Perkins 
Senior Director, Quality and Regulatory 
Insulet Corporation 
100 Nagog Park 
Acton, MA 01720 
Office: 978-600-7951 
E-mail: jperkins@insulet.com  
 
Protocol Chair: 
 
Jordan Pinsker, MD 
 
 
 
 
Director of Artificial Pancreas Technology 
 
 
 
 
Sansum Diabetes Research Institute 
 
 
 
 
2219 Bath Street 
 
 
 
 
Santa Barbara, CA  93105 
 
 
 
 
Email:  jpinsker@sansum.org  
 
 
 
 
 
 

 
 
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TABLE OF CONTENTS 
TITLE PAGE ......................................................…........................................................................1 
PROTOCOL APPROVAL ............................................................................................................... 2 
INVESTIGATOR STATEMENT ...................................................................................................... 3 
PRINCIPAL CONTACTS ................................................................................................................ 4 
TABLE OF CONTENTS ................................................................................................................. 5 
PROTOCOL SUMMARY ................................................................................................................ 8 
GLOSSARY OF ACRONYMS ...................................................................................................... 12 
1 
INTRODUCTION ................................................................................................................. 13 
2 
OMNIPOD HORIZON™ SYSTEM STUDY DEVICE OVERVIEW ...................................... 15 
2.1 
Device Description of the Omnipod Horizon™ System ................................. 15 
 
Omnipod Horizon™ Controller (App and Algorithm) .................................. 16 
 
Omnipod Horizon™ ACE Pump ................................................................ 18 
 
iCGM ........................................................................................................ 18 
 
CGM-informed Bolus Calculator ................................................................ 19 
3 
HORIZON™ DATA PORTAL ............................................................................................... 19 
4 
RESULTS FROM FEASIBILITY STUDIES .......................................................................... 19 
5 
STUDY SUMMARY ............................................................................................................. 19 
5.1 
Study Purpose .............................................................................................. 19 
5.2 
Study Design ................................................................................................ 19 
6 
OBJECTIVES AND ENDPOINTS ........................................................................................ 25 
6.1 
Primary Objective ......................................................................................... 25 
 
Primary Endpoints ..................................................................................... 25 
6.2 
Secondary Objective ..................................................................................... 25 
 
Secondary Endpoints ................................................................................ 25 
7 
SUBJECT SELECTION AND ELIGIBILITY ......................................................................... 26 
7.1 
Visit 1 ............................................................................................................ 26 
8 
OMNIPOD HORIZON™ MANUAL MODE ........................................................................... 29 
8.1 
Phase 1 ........................................................................................................ 29 
 
Visit 2 ........................................................................................................ 29 
 
Visit 3 ........................................................................................................ 31 
8.2 
Phase 2 ........................................................................................................ 32 
 
Visit 4 ........................................................................................................ 32 
 
Visit 5 ........................................................................................................ 32 
 
Visit 6 (End of Study) ................................................................................ 33 
8.3 
Unscheduled Visits ....................................................................................... 33 
8.4 
Early Withdrawal ........................................................................................... 33 
8.5 
Lost to Follow-up .......................................................................................... 34 
9 
SPONSOR REPRESENTATIVES ....................................................................................... 34 
10 
SAFETY ............................................................................................................................... 34 

 
 
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10.1 
Types of Known Risks and Benefits .............................................................. 34 
10.2 
Hypoglycemia/Hyperglycemia ....................................................................... 36 
10.3 
Adverse Events ............................................................................................. 36 
 
Definitions ............................................................................................. 36 
 
Reportable Adverse Events ................................................................... 38 
 
Hypoglycemic Events ............................................................................ 38 
 
Hyperglycemic/Ketotic Events ............................................................... 39 
 
Relationship of Adverse Event to Investigational Device ....................... 40 
 
Severity (Intensity) of Adverse Events ................................................... 40 
 
Outcome of Adverse Events .................................................................. 40 
10.4 
Reportable Device Issues ............................................................................. 41 
10.5 
Timing of Event Reporting............................................................................. 41 
10.6 
Stopping Criteria ........................................................................................... 42 
 
Participant Discontinuation of Study Participation .................................. 42 
 
Criteria for Suspending or Stopping Overall Study ................................ 43 
10.7 
Medical Monitor ............................................................................................ 43 
11 
STATISTICAL CONSIDERATIONS ..................................................................................... 44 
11.1 
General Statistical Methods .......................................................................... 44 
11.2 
Sample Size ................................................................................................. 44 
11.3 
Objectives and Endpoints ............................................................................. 45 
 
Primary Objective .................................................................................. 45 
 
Primary Endpoints ................................................................................. 45 
 
Secondary Objective ............................................................................. 45 
 
Secondary Endpoints ............................................................................ 45 
11.4 
Analysis Sets ................................................................................................ 46 
 
ITT (Intention to Treat) Analysis Set ...................................................... 46 
 
mITT (modified Intention to Treat) Analysis Set ..................................... 46 
 
PP (Per-Protocol) Analysis Set .............................................................. 46 
11.5 
Analysis of Primary and Secondary Endpoints .............................................. 46 
 
Calculation of Percentage of Time in Range ......................................... 47 
11.6 
Safety Analyses ............................................................................................ 47 
 
Evaluation of Adverse Events ................................................................ 47 
 
Evaluation of Device Deficiencies ......................................................... 47 
11.7 
Baseline Characteristics ............................................................................... 48 
11.8 
Missing Data ................................................................................................. 48 
11.9 
Statistical Software ....................................................................................... 48 
12 
DATA HANDLING AND QUALITY ASSURANCE ............................................................... 48 
12.1 
Electronic Case Report Forms (eCRFs) ........................................................ 48 
12.2 
Electronic Device Outputs ............................................................................. 49 
 
PDM Data ............................................................................................. 49 
 
CGM Data ............................................................................................. 49 
 
BG and Ketone Meter Data ................................................................... 49 
12.3 
Subject Identifiers ......................................................................................... 49 
12.4 
Monitoring Responsibilities ........................................................................... 49 
12.5 
Inspection of Records ................................................................................... 49 
12.6 
Study Record Retention ................................................................................ 50 
12.7 
Device Accountability .................................................................................... 50 
13 
STUDY ETHICS AND CONDUCT ....................................................................................... 50 

 
 
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13.1 
Role of the Sponsor ...................................................................................... 50 
13.2 
Ethical Conduct of the Study ......................................................................... 50 
13.3 
Institutional Review Board (IRB) ................................................................... 51 
13.4 
Informed Consent ......................................................................................... 51 
13.5 
Confidentiality ............................................................................................... 51 
13.6 
Modification of the Protocol ........................................................................... 52 
13.7 
Protocol Deviations ....................................................................................... 52 
13.8 
Study Reporting Requirements ..................................................................... 53 
13.9 
Selection of Investigators .............................................................................. 53 
 
Financial Disclosure .............................................................................. 53 
 
Investigator Documentation ................................................................... 53 
13.10 
Clinical Site Training ................................................................................. 54 
13.11 
Device Use ............................................................................................... 54 
13.12 
Device Returns ......................................................................................... 54 
13.13 
Policy for Publication and Presentation of Data ......................................... 55 
13.14 
Sponsor or Regulatory Agency Termination of the Study .......................... 55 
REFERENCES ............................................................................................................................. 56 
APPENDIX A ................................................................................................................................ 59 
 
 

 
 
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PROTOCOL SUMMARY 
Protocol title 
Evaluating the Safety and Effectiveness of the Omnipod Horizon™ CGM-
informed Bolus Calculator in Patients with Type 1 Diabetes 
Protocol ID 
G200018 
Purpose 
To evaluate the safety and effectiveness of the Omnipod Horizon™ CGM-
informed Bolus Calculator in patients with type 1 diabetes during Manual Mode 
operation.  
Design 
This study is a single-arm, multi-center, prospective clinical study  
Enrollment 
A total of up to 42 subjects will be enrolled in the study in order to obtain a 
minimum of 30 evaluable subjects. Subjects may be recruited from the 
Omnipod Horizon™ Pivotal Study (G190270) prior to their commencement or 
recommencement of the preschool pivotal study.  
 
The study will use the Omnipod Horizon™ System in Manual Mode and will 
consist of two outpatient phases:  
 
1) 7 days of Omnipod Horizon™ use in Manual Mode without a 
connected CGM using manual entry of BG values to deliver 
boluses (Phase 1) followed by; 
2) 7 days of Omnipod Horizon™ use in Manual Mode with a 
connected CGM using the CGM-informed bolus calculator to deliver 
boluses (Phase 2) 
 
Subjects will be enrolled across 4-7 clinical study sites. The 30 evaluable 
subjects will be comprised of three age cohorts as follows: 
• 
15 subjects aged 18-70 years 
• 
10 subjects aged 6-17.9 years 
• 
5 subjects aged 2-5.9 years 
 
Indication 
The Omnipod Horizon™ CGM-informed bolus calculator is intended to calculate 
a meal and correction bolus based upon carbohydrate entry, current CGM value 
and trend to reach a pre-specified target glucose level.    
Study duration 
The study is expected to be completed within 6 months which includes clinical 
site initiation to completion of all data entry and monitoring procedures.  As 
subjects aged 6-70 years are expected to complete the study prior to the start 
of enrollment of subjects aged 2-5.9 years, two separate clinical reports will be 
generated.   
Investigational 
devices 
The Omnipod Horizon™ Automated Insulin Delivery System is comprised of the 
following components: 
• 
Omnipod Horizon™ tubeless, insulin delivery alternate controller enabled 
(ACE) pump (Pod) 
• 
Omnipod Horizon™ Personal Diabetes Manager (PDM) which is a 
Samsung J3 locked down android device that operates the Omnipod 
Horizon™ Automated Insulin Delivery App 
• 
Dexcom G6 - Continuous Glucose Monitoring (CGM) system  
Non-
investigational, 
• 
Contour® Next One blood glucose meter (Ascensia Diabetes Care, 5 Wood 
Hollow Road, Parsippany, NJ 07054 USA) 

 
 
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commercially 
available devices 
• 
Precision Xtra ketone meter (Abbott Diabetes Care Inc., 1360 South Loop 
Road, Alameda, CA 94502 USA) 
Primary objective 
To evaluate the safety of the Omnipod Horizon™ CGM-informed bolus 
calculator in patients with type 1 diabetes during Manual Mode operation.  
Primary endpoints The primary objective will be to evaluate the safety of the CGM-informed bolus 
calculator (Phase 2) using the following endpoints as measured by the system 
CGM: 
 
Glucose metrics during the 4-hour post bolus period from Phase 2 will be 
compared to Phase 1: 
• 
% of time < 70 mg/dL 
• 
% of time > 180 mg/dL 
 
Secondary 
objective 
To evaluate additional glycemic measures of effectiveness of the Omnipod 
Horizon™ CGM-informed bolus calculator during Manual Mode operation. 
Secondary 
endpoints 
The secondary objective will be evaluated using the following per subject 
effectiveness endpoints:  
 
Glucose metrics during the 4-hour post bolus period from Phase 2 will be 
compared to Phase 1: 
• 
Mean glucose 
• 
% of time < 54 mg/dL 
• 
% of time ≥ 250 mg/dL 
• 
% of time ≥ 300 mg/dL 
• 
% of time in range 70-180 mg/dL 
 
Glucose metrics from Phase 2 will be compared to Phase 1 during the day 
(6AM up to 12AM), overnight (12AM up to 6AM), and overall: 
• 
Mean glucose 
• 
% of time < 54 mg/dL 
• 
% of time < 70 mg/dL 
• 
% of time > 180 mg/dL 
• 
% of time ≥ 250 mg/dL 
• 
% of time ≥ 300 mg/dL 
• 
% of time in range 70-180 mg/dL 
• 
% of time in range 70-140 mg/dL 
• 
Standard deviation 
• 
Coefficient of variation 
 
Eligibility criteria 
Inclusion Criteria 
Subjects must meet all the following criteria to be included in the study: 
1. Age at time of consent/assent 2-70 years 
2. Subjects aged < 18 years must be living with parent/legal guardian 
3. Diagnosed with type 1 diabetes for at least 6 months. Diagnosis is based on 
investigator’s clinical judgment 
4. Must be a current Omnipod user, or have used an Omnipod in the past 
5. Investigator has confidence that the subject, parent, or legal guardian, can 
successfully operate all study devices and can adhere to the protocol 
6. Willing to use only the following types of Insulin during the study: Humalog, 

 
 
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Novolog, Admelog, or Apidra  
7. Must be willing to use the Omnipod Horizon™ in Manual Mode only and 
agree not to use Automated Mode functionality 
8. Must be willing to use the Omnipod Horizon™ bolus calculator without a 
connected CGM for the first 7-days of Manual Mode (Phase 1) while 
manually entering BG values to deliver boluses 
9. Must be willing to use the Omnipod Horizon™ bolus calculator with a 
connected CGM for the last 7-days of Manual Mode (Phase 2) using 
the CGM-informed bolus calculator to deliver boluses 
10. Willing to wear the system continuously throughout the study 
11. For subjects not currently enrolled in the Omnipod Horizon™ Pivotal 
Study (G190270), A1C <10% 
12. Must be willing to use the Dexcom App on the Omnipod Horizon™ PDM as 
the sole source of Dexcom data (except for the Dexcom Follow App)  
13. Able to read and speak English fluently (if subject is a young child then 
Caregiver must meet the criteria) 
14. Willing and able to sign the Informed Consent Form (ICF) and/or has a 
parent/guardian willing and able to sign the ICF. Assent will be obtained 
from subjects aged < 18 years per State requirements. 
15. For subjects aged 2-5.9 years of age, parents or trained caregivers 
agree to be physically present during the decision and delivery of 
insulin boluses for this age group, as well as agree to be available for 
glucose monitoring and treatment during the 4-hour post bolus period. 
 
Exclusion Criteria 
Subjects who meet any of the following criteria will be excluded from the study: 
1. A medical condition, which in the opinion of the investigator, would put the 
subject at an unacceptable safety risk 
2. History of severe hypoglycemia in the past 6 months 
3. History of DKA in the past 6 months, unrelated to an intercurrent illness or 
infusion set failure 
4. Plans to receive blood transfusion over the course of the study 
5. Currently diagnosed with anorexia nervosa or bulimia 
6. Acute or chronic kidney disease or currently on hemodialysis 
7. History of adrenal insufficiency 
8. Has taken oral or injectable steroids within the past 8 weeks or plans to 
take oral or injectable steroids during the study 
9. Unable to tolerate adhesive tape or has any unresolved skin condition in the 
area of sensor or pump placement 
10. Plans to use insulin other than U-100 insulin intended for use in the study 
device during the study 
11. Use of non-insulin anti-diabetic medication other than metformin (e.g. GLP1 
agonist, SGLT2 inhibitor, DPP-4 inhibitor, pramlintide) 
12. Current or known history of coronary artery disease that is not stable with 
medical management, including unstable angina, or angina that prevents 
moderate exercise despite medical management, or a history of myocardial 
infarction, percutaneous coronary intervention, or coronary artery bypass 
grafting within the previous 12 months  
13. Clinical signs of hypothyroidism and hyperthyroidism 
14. Pregnant or lactating, or is a woman of childbearing potential and not on 
acceptable form of birth control (acceptable includes abstinence, condoms, 
oral/injectable contraceptives, IUD or implant) 
15. Currently participating or plans to participate in another clinical study using 
an investigational drug or device other than Omnipod Horizon™. Subjects 
may be recruited from the Omnipod Horizon Pivotal Study (G190270).   

 
 
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16. Unable to follow clinical protocol for the duration of the study or is otherwise 
deemed unacceptable to participate in the study per the investigator’s 
clinical judgment 
Study schedule 
overview 
The study schedule consists of the following two outpatient phases: 
 
 
1) 7 days of Omnipod Horizon™ use in Manual Mode without a connected 
CGM using manual entry of BG values to deliver boluses (Phase 1) 
followed by; 
2) 7 days of Omnipod Horizon™ use in Manual Mode with a connected 
CGM using the CGM-informed bolus calculator to deliver boluses 
(Phase 2) 
 
 
Following subject screening, system training and enrollment, subjects will 
commence Phase 1 of the study.  
 
Subjects will be trained to use the Manual Mode feature of the system including 
how to use the bolus calculator using manual entry of BG values and by using 
the CGM-informed bolus calculator.   
 
After completion of the first 7 days of the Manual Mode phase using the 
Omnipod Horizon™ without a connected CGM (Phase 1), subjects will 
transition to the next 7 days of the Manual Mode phase using the system with a 
connected CGM using the CGM-informed bolus calculator to deliver boluses 
(Phase 2). Upon completion of this study, subjects aged 6-70 previously 
enrolled in the Omnipod Horizon™ Pivotal Study (G190270) will recommence 
the pivotal study.  Upon completion, or withdraw from this study, subjects aged 
2-5.9 may commence the Standard Therapy phase of the preschool pivotal 
study. 
 
 
 
 

 
 
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GLOSSARY OF ACRONYMS 
ACE 
Alternate Controller Enabled 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AGC 
Automated Glucose Control 
BG 
Blood Glucose 
BLE 
Bluetooth Low Energy 
CFR 
Code of Federal Regulations 
CGM 
Continuous Glucose Monitoring 
CRA 
Clinical Research Associate 
CRO 
Contract Research Organization 
CV 
Curricula Vitae 
DD 
Device Deficiency 
DKA 
Diabetic Ketoacidosis 
dL 
Deciliter 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
ICF 
Informed Consent Form 
IDE 
Investigational Device Exemption 
IRB 
Institutional Review Board 
ITT 
Intention to Treat 
MD 
Doctor of Medicine 
mg 
Milligram 
mITT 
Modified Intention to Treat 
mmol 
Millimole 
MM 
Medical Monitor 
MPC 
Model Predictive Control 
PDM 
Personal Diabetes Manager 
POC 
Point of Care 
PI 
Principal Investigator 
pMPC 
Personalized Model Predictive Control 
PP 
Per Protocol 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SMP 
Safety Management Plan 
TSH 
Thyroid Stimulating Hormone 
TDI 
Total Daily Insulin 
UADE 
Unanticipated Adverse Device Effect 
 
 

 
 
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1 
INTRODUCTION 
Diabetes is a disorder affecting the normal homeostatic regulation of blood glucose. In 
type 1 diabetes, insulin insufficiency occurs due to autoimmune destruction of the beta 
cells in the pancreas resulting in persistently elevated glucose. The long-term effects of 
elevated blood glucose or hyperglycemia may result in a range of microvascular 
complications including retinopathy, nephropathy, and neuropathy. Diabetes is the 
leading cause of blindness, kidney disease, and amputation in the United States.1  
The risk for long-term complications of diabetes can be reduced, however, by 
minimizing patient exposure to hyperglycemia and maximizing the time in euglycemia. 
The landmark Diabetes Control and Complications Trial published in 1993 found that 
maintenance of near normal glucose levels reduced the risk of long-term microvascular 
complications. In 2005, the publication of the Epidemiology of Diabetes Interventions 
and Complications study found that despite the multifactorial etiology of heart disease, 
intensive insulin therapy in patients with type 1 diabetes was shown to reduce the 
incidence of nonfatal myocardial infarction, stroke, and death from cardiovascular 
disease.2 
Unfortunately, efforts to minimize hyperglycemia and maximize euglycemia are 
invariably accompanied by episodes of hypoglycemia. Indeed, the justifiable fear of 
hypoglycemia is often described as the single most significant barrier to improved 
glucose control in patients with diabetes.3 A paper by Weinstock et. Al. reported on data 
collected by the T1D Exchange and found an annual incidence of 11.8% of one or more 
severe hypoglycemic events defined as a seizure or loss of consciousness. The annual 
incidence of severe hypoglycemic events increased to 18.6% in patients with diabetes 
duration greater than 40 years.4  
Two other recent papers have highlighted the effect of acute and chronic complications 
on the longevity of patients with diabetes. Livingstone et. Al. found premature death in a 
Scottish registry of patients with diabetes of 11 years in males and 13 years in females.5 
Lind et. Al. found a twofold increase in mortality in a Swedish registry compared with 
age-matched non-diabetic cohorts even in patients with recommended levels of 
glycemic control (A1C < 7.0%).6The most recent treatment guidelines from the 
American Diabetes Association now recommend that adults with type 1 diabetes should 
aim for target A1C levels of 7.0% and that children and adolescents should aim for 
target A1C levels of 7.5%.7 These recommendations are equivalent to a mean blood 
glucose of 154 mg/dL in adults and 169 mg/dL in children and adolescents compared 
with mean blood glucose in patients without diabetes of 100 mg/dL or less.8  
The last 20 years have seen a number of significant improvements in diabetes care, 
most notably the advent of faster analog insulins, the widespread use of insulin pumps 
and the introduction of continuous glucose monitoring systems. Despite these 
advances, diabetes data registries continue to show that the majority of patients are 
unable to meet recommended glycemic targets with available medication and 
technology. In the 2012 report from the T1D Exchange Registry, Beck et. Al. found the 
average A1C across all ages greater than 8.0% or, equivalently, greater than 183 
mg/dL and only 30% of patients met the ADA target A1C of 7.0% (adults) and 7.5% 
(children).9 A more recent paper from the T1D Exchange Registry by Foster et. Al. 
comparing the 2016-2018 cohort with 2010-2012 cohort indicated that among the 9,657 

 
 
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participants that had data in both cohorts and at least 3 years of diabetes duration in 
2010-2012, mean HbA1c was higher in the 2016-2018 cohort. The increase in HbA1c 
over time was predominately seen in adolescents and young adults. The American 
Diabetes Association (ADA) HbA1c target as of 2018 of < 7.5% for children and 
adolescents was achieved by only a small percentage of youth < 18 years of age (17%); 
only 21% of adults achieved the ADA treatment goal of < 7.0%.10 
The current dilemma of persistent poor diabetes outcomes despite significant 
improvements in diabetes technology such as modern blood glucose meters, insulin 
pumps and continuous glucose monitoring systems is summarized in the FDA 
Guidance Document on Artificial Pancreas Device Systems: “Even with the aid of these 
devices, maintaining blood glucose concentrations within a suggested optimal range is 
a daily struggle for people living with diabetes mellitus and the risk of hypoglycemia 
associated with attempts at improved glycemic control remains an ever-present 
danger”.11  
Insulet has developed the Omnipod Horizon™ Automated Insulin Delivery System 
(hereafter named Omnipod Horizon™ System or Omnipod Horizon™) which is similar 
in function to the systems described in the FDA guidance document dated November 9, 
2012. The system provides automated glucose control at all times, but for optimum 
performance, requires user input for meal boluses. The commercial system will consist 
of an Omnipod® tubeless, insulin delivery ACE pump, a Personal Diabetes Manager 
(PDM), and the Dexcom G6 CGM. The control algorithm will reside on the Pod.  
A novel feature of Omnipod Horizon™ is the design of the bolus calculator which allows 
the user to import the CGM value and trend by pressing a simple button – Enter CGM – 
within the bolus calculator to calculate a correction dose. Both the CGM value and trend 
are important inputs for correction dose recommendation. Existing insulin delivery 
systems require the user to manually enter a blood glucose or sensor glucose value into 
the bolus calculator and this is subject to human error and places additional burden on 
the user to calculate the dose based on trend: “If I’m 200mg/dL and rising quickly, how 
much extra should I give? A little extra or a lot extra?”. The Omnipod Horizon™ bolus 
calculator has been designed to seamlessly and safely suggest a bolus amount to the 
user by incorporating available inputs that are available with CGM integration with 
insulin delivery, including insulin on board.   
Through extensive in-silico testing, a proprietary bolus calculator has been developed 
by Insulet and is embedded in the Omnipod Horizon™ system. The bolus calculator can 
import CGM and trend as long as the pod has an available CGM value. A 3-month 
outpatient pivotal trial of Omnipod Horizon™ is currently underway however, it is 
expected that users will primarily use the system in Automated Mode. This study is 
designed to evaluate the safety and effectiveness of Omnipod Horizon™ System CGM-
informed bolus calculator during Manual Mode operation. These data will supplement 
the extensive in-silico analysis to support safety and effectiveness of the Omnipod 
Horizon bolus calculator in clinical use. 
 
Training and operation of the Omnipod Horizon™ System is identical in order to use the 
product with CGM informed Manual Mode or Automated Mode i.e. it is not possible to 
disable the Automated Mode functionality and still enable CGM integration. Therefore, 
this clinical protocol is similar to protocols under IDE G190267 and G190270.   
 

 
 
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2 
OMNIPOD HORIZON™ SYSTEM STUDY DEVICE OVERVIEW 
This study is designed to evaluate the safety and effectiveness of Omnipod Horizon™ 
System CGM-informed bolus calculator during Manual Mode operation.  Manual Mode 
operation has similar functionality comparable to commercially available standalone 
pumps such as Omnipod Insulin Management System and Omnipod® DASH and may 
be chosen by the user when they desire full control of their insulin delivery as opposed 
to automated insulin delivery offered with Automated Mode.  The Omnipod Horizon™ 
System is described below, however, this study will be restricted to Manual Mode 
operation ONLY. 
 
2.1 
Device Description of the Omnipod Horizon™ System 
The Omnipod Horizon™ System intended for commercialization is composed of three 
primary components as shown in Figure 1: 
 
• 
Omnipod Horizon™ Controller – Horizon™ App (PDM) and Algorithm 
• 
Omnipod Horizon™ ACE Pump – Pod  
• 
iCGM – Dexcom G6 
The Omnipod Horizon™ System will provide automated insulin delivery when 
connected to CGM. The system is expected to reduce hypoglycemia without incurring 
an unacceptable increase in hyperglycemia and mean glucose. The system is also 
expected to reduce the extent and magnitude of hyperglycemia associated with meals. 
Optimal post-prandial control requires the user to deliver meal boluses as in current 
open-loop therapy, but the normal operation of the control algorithm will be expected to 
compensate for mismatched meal boluses and prevent prolonged hyperglycemia. The 
system uses a control-to-target strategy that attempts to achieve and maintain a set 
target glucose level.  The system also operates in Manual Mode and uses the user-
entered programmed basal and bolus calculator settings.  

 
 
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Figure 1:  System components of the Omnipod Horizon™ System  
 Omnipod Horizon™ Controller (App and Algorithm) 
The Omnipod Horizon™ Controller is composed of two parts: the Horizon™ application 
(“app”) and the model predictive control (MPC) algorithm on the Pod. The MPC 
algorithm provides insulin micro-boluses once every 5 minutes based upon the 
predicted glucose over a 60-minute prediction horizon. Optimal post-prandial control will 
require the user to give meal boluses in the same manner as current pump therapy, but 
normal operation of the MPC algorithm will compensate for missed meal boluses and 
mitigate prolonged hyperglycemia. The MPC algorithm uses a control-to-target strategy 
that attempts to achieve and maintain a set target glucose value, thereby reducing the 
duration of prolonged hyperglycemia and hypoglycemia. The MPC algorithm resides on 
the Pod (Pump) component of the Omnipod Horizon™ System (similar to the DASH 
ACE pump cleared in K191679), as described further below). 
 
The Omnipod Horizon™ app will be the primary user interface and will be used to start 
and stop a Pod, program basal and bolus calculator settings for Manual Mode as well 
as program settings specific for Automated Mode (hybrid closed-loop).  
 
Manual Mode 
 
In Manual Mode, the Horizon™ System will function equivalently to the Omnipod® 
DASH System, which was first cleared under K180045, most recently under K191679. 
This includes delivering insulin at programmed basal rates and bolus amounts with the 
option to set temporary basal profiles. The Omnipod Horizon™ Controller will also have 
the ability to function as a sensor augmented pump in Manual Mode, using sensor 
glucose data provided by the iCGM to populate the bolus calculator. 
 
Automated Mode 
 

 
 
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In Automated Mode, the system will support the use of multiple target glucose values, 
currently intended to be 110-150 mg/dL at commercialization, in 10 mg/dL increments. 
The experience for the user will reflect current setup flows whereby the health care 
provider assists the user to program basal rates, glucose targets and bolus calculator 
settings. These in turn will inform the MPC algorithm for insulin dosing parameters. The 
insulin dosing parameters will be adapted over time based on the total daily insulin 
(TDI) delivered during each Pod use. A temporary hypoglycemia protection mode (Hypo 
Protect) may be implemented by the user for various time durations during Automated 
Mode. With Hypo Protect, the algorithm reduces insulin delivery and is intended for use 
over temporary durations when insulin sensitivity is expected to be higher, such as 
during exercise. 
 
In this study, participants will be instructed to NOT use Automated Mode. This study will 
be restricted to Manual Mode operation ONLY. 
 
The Omnipod Horizon™ System will include two apps on a locked-down smartphone 
(Samsung J3), referred to as Personal Diabetes Manager (PDM): the Horizon™ App 
and the Dexcom App. The Horizon™ App, which will have a similar interface to the 
cleared Omnipod® DASH System (K191679), will allow the use of large text, graphics, 
and on-screen instructions to prompt the user through set-up processes. It will also be 
used to program the user’s custom basal insulin delivery profile, check the Pod status, 
initiate bolus doses of insulin, make changes to a patient’s insulin delivery profile, 
handle system alerts and alarms, and enter Automated Mode.  
 
The Dexcom App interface is identical to the current app of the interoperable Dexcom 
G6 Continuous Glucose Monitoring System (K191450) and will provide CGM data, 
alerts, and alarms to the user.  
 
The Horizon™ App and Dexcom App will not directly communicate with one another. 
Instead, the iCGM transmitter will communicate EGV (estimated glucose values) 
directly to the Pod. The Dexcom transmitter number must be entered into the Horizon™ 
App, and this information is sent to the Pod to allow transmission of EGV. The Pod will 
pair directly to the transmitter to receive EGV for the algorithm and also sends the EGV 
back to the Horizon™ App as shown in Figure 1. 
 
The Omnipod Horizon™ provides the ability to calculate a suggested bolus dose 
through the use of the bolus calculator. The bolus calculator will have the option for 
user-selected population of the sensor glucose, which is communicated to the app via 
the Pod. This suggested bolus calculation feature is provided as a convenience to the 
user to aid in determining the suggested bolus dose based on ingested carbohydrates, 
most recent sensor glucose reading (or blood glucose reading if using fingerstick), 
programmable correction factor, insulin to carbohydrate ratio, target glucose value and 
insulin on board (IOB). IOB is calculated by the algorithm taking into account any 
manual bolus and insulin delivered by the algorithm. 
 
As with the cleared Omnipod® DASH System, Insulet will utilize a proprietary encrypted 
security stack embedded within the Bluetooth Low Energy (BLE) communication 
between the Horizon™ app and Pod. The communication to the iCGM will use 
Dexcom’s communication protocol. The proprietary security stack increases the 
resilience of the device and improves the ability of the system to be protected in the 
event of future identification of vulnerabilities in standard communication protocols. 

 
 
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 Omnipod Horizon™ ACE Pump 
The Pod component of the Omnipod Horizon™ System is similar to the Omnipod® 
DASH ACE Pump cleared under K191679. Compared to the DASH ACE Pump 
(K191679), the Horizon™ ACE Pump (Pod) has additional software to optimize 
communication to accept inputs from the iCGM (initially the Dexcom G6) and the 
Horizon™ Controller.  The insulin delivery mechanism and the patient and fluid 
contacting components are identical to the DASH Pod. 
 
The Pod is a lightweight, self-adhesive device that the user fills with U-100 rapid-acting 
insulin and wears directly on their body. The Pod delivers insulin into the user’s body 
through a small flexible tube, called a cannula, based on the commands from the 
compatible controller. In the Omnipod Horizon™ System, the Pod will house the MPC 
algorithm and communicate directly with the iCGM and the Horizon App. The algorithm 
commands the Pod’s insulin delivery in the form of micro-boluses based on predicted 
glucose values. As with the cleared Omnipod® DASH System, the Pod of the Omnipod 
Horizon™ System will come pre-packaged in a sterile container with a fill needle and a 
fill syringe. Figure 2 below is a representation of the Pod.  
 
 
Figure 2:  The Pod of the Omnipod Horizon™ ACE pump 
 
 
 iCGM 
The third component of the Omnipod Horizon™ System is the iCGM. The Omnipod 
Horizon™ System will be interoperable with a compatible iCGM, currently the Dexcom 
G6 Continuous Glucose Monitoring System (K191450). The Omnipod Horizon™ Pod 
will communicate with the Dexcom G6 via Bluetooth Low Energy (BLE). Glucose values 
from the Dexcom transmitter will be sent to the MPC algorithm residing on the Pod and 
used in insulin dosing adjustments. The glucose values from the Dexcom transmitter 
will be sent independently to the Dexcom App on the controller.  

 
 
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 CGM-informed Bolus Calculator 
Omnipod Horizon™ will allow for ease of population of CGM values within the bolus 
calculator, to allow for safe and improved usability for the calculation of meal and 
correction boluses. 
 
The system uses estimated glucose values from Dexcom’s G6 iCGM to guide both the 
automatic insulin delivery algorithm in Automated Mode and in calculating correction 
boluses when initiated by the user in both Manual and Automated Mode.  
 
 
3 
HORIZON™ DATA PORTAL 
Data are securely uploaded from the PDM to Insulet Cloud by cellular connection.  Data 
are then transferred from Insulet Cloud to the Horizon Data Portal (HDP), which is a 
platform for data review and management. The HDP runs on an Amazon-based web 
server. The HDP will provide insights including but not limited to: time in range (with 
connected CGM), time at each target BG, automated/manual mode comparisons, and 
time spent in each mode. 
 
Investigators will have access to all uploaded data and be able to view historical trends.  
The HDP will function as the data management review platform for this study.  
 
 
4 
RESULTS FROM FEASIBILITY STUDIES 
The Omnipod Horizon™ System has been tested in 194 subjects across IDE G160169, 
G170012, G170143 yielding approximately 13,000 subject hours of hybrid closed-loop 
control. The study results were presented in part at ATTD 2017, 2018, ADA 2017, 2018, 
and 2019, and have also been published in Diabetes Technology and Therapeutics.13, 
14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 29. 
 
5 
STUDY SUMMARY 
5.1 
Study Purpose 
The purpose of this study is to assess the safety and effectiveness of the 
Omnipod Horizon™ System’s CGM-informed bolus calculator in patients with type 
1 diabetes during Manual Mode operation.     
5.2 
Study Design 
This is a single-arm, multi-center, prospective clinical study. A total of up to 42 
subjects aged 2-70 years with type 1 diabetes will be enrolled in the study in order 
to obtain a minimum of 30 evaluable.  Subjects aged 6-70 may be recruited from 
the Omnipod Horizon™ Pivotal Study (G190270) prior to their recommencement 
of the pivotal study after study pause.  Subjects aged 2-5.9 may be recruited from 

 
 
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the pivotal study but must complete, or withdraw from this study before 
commencement of the Standard Therapy phase of the preschool pivotal study.   
The study schedule consists of two outpatient phases: 
1) 7 days of Omnipod Horizon™ use in Manual Mode without a connected 
CGM using manual entry of BG values to deliver boluses (Phase 1) followed 
by; 
2) 7 days of Omnipod Horizon™ use in Manual Mode with a connected CGM 
using the CGM-informed bolus calculator to deliver boluses (Phase 2) 
 
Subjects will be enrolled across 4-7 clinical study sites. The 30 evaluable 
subjects will be comprised of three age cohorts as follows: 
 
• 
15 subjects aged 18-70 years 
• 
10 subjects aged 6-17.9 years 
• 
5 subjects aged 2-5.9 years 
 
Following subject screening, and enrollment, subjects will commence the first 7-
day Manual Mode phase of the study.  
 
Subjects not currently enrolled in the Omnipod Horizon™ Pivotal Study 
(G190270) will train to use the Manual Mode feature of the system including how 
to use the bolus calculator using manual entry of BG values or by using the 
CGM-informed bolus calculator.   
 
After completion of the first 7 days of the Manual Mode phase using the 
Omnipod Horizon™ without a connected CGM, subjects will transition to the 
next 7 days of the Manual Mode phase using the system with a connected CGM 
using the CGM-informed bolus calculator to deliver boluses.  
 
Table 1 outlines the schedule of assessments for each phase of the study. 

 
 
 
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Table 1:  Schedule of Assessments 
Assessment Schedule 
Screening 
Horizon™ Manual Mode (MM) 
EWa 
 
 
PHASE 1 
7-days of MM  
(without CGM connected) 
PHASE 2 
7-days of MM 
(with CGM connected) 
 
 
Visit Number 
1e 
2 e 
3 
4 
5 
6 
UVb 
  
Study Day/Visit Window 
Within 30 
days 
prior to 
or same 
day as 
Phase 1 
startg 
1d 
3d 
±1d 
8d 
±1d 
10 
±1d 
14 
±1d 
N/A 
  
Telephone (T) or Office (O) Visit 
T/Oh 
T/Oh 
T/Od 
T/Od 
T/Od 
T/Od 
T/Od 
T/O 
Laboratory Assessments 
A1C (POC)g 
X 
  
 
  
  
  
  
  
Pregnancy Testi 
X 
  
 
  
  
  
  
Clinical Assessments 
Informed Consent 
X 
  
 
  
  
  
  
  
Medical History (including 
demographics) g 
X 
  
 
  
  
  
  
  
Confirm Eligibility 
X 
  
 
  
  
  
  
  
Concomitant medications 
X 
Xc 
Xc 
Xc 
Xc 
Xc 
Xc 
Xc 
Heightg 
X 
  
 
  
  
  
  
  
Weightg 
X 
  
 
  
  
  
  
  
Vital signsg 
X 
  
 
 
  
X 
 
X 
Adverse events 
  
X 
Xc 
Xc 
Xc 
Xc 
Xc 
Xc 
 

 
 
 
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Assessment Schedule 
Screening 
Horizon™ Manual Mode (MM) 
EWa 
 
 
PHASE 1 
7-days of MM 
(without connected CGM) 
PHASE 2 
7-days of MM 
(with connected CGM) 
 
 
Visit Number 
1e 
2 
3 
4 
5 
6 
UVb 
  
Study Day/Visit Window 
Within 30 
days 
prior to 
or same 
day as 
Phase 1 
startg 
1d 
3d 
±1d 
8d 
±1d 
10 
±1d 
14 
±1d 
N/A 
  
Telephone (T) or Office (O) Visit 
T/Oh 
T/Oh 
T/Od 
T/Od 
T/Od 
T/Od 
T/Od 
T/Od 
Study Devices 
Training on Glucagon 
administration and information on 
treatment of hypo/hyperglycemiaf 
 
X 
 
 
 
 
 
 
Study device training 
Omnipod Horizon™ (including 
CGM), BG/Ketone meterf 
  
X 
 
 
 
 
 
 
Dispense/Return 
Omnipod Horizon™ (including 
CGM), QC tested BG/Ketone 
meterf 
  
X 
 
 
 
X 
 
X 
Removal of subject’s personal 
insulin pumpf 
 
X 
 
 
 
 
 
 
Placement of the Omnipod 
Horizon™ on bodyf 
 
X 
 
 
 
 
 
 
Enrollment 
 
X 
 
 
 
 
 
 
Pairing the CGM transmitter to the 
Dexcom App on the PDM 
 
 
 
X 
 
 
 
 

 
 
 
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Assessment Schedule 
Screenin
g 
Horizon™ Manual Mode (MM) 
EWa 
 
 
PHASE 1 
7-days of MM 
(without connected CGM) 
PHASE 2 
7-days of MM 
(with connected CGM) 
 
 
Visit Number 
1e 
2 
3 
4 
5 
6 
UVb 
  
Study Day/Visit Window 
Within 30 
days 
prior to 
or same 
day as 
Phase 1 
startg 
1d 
3d 
±1d 
8d 
±1d 
10 
±1d 
14 
±1d 
N/A 
  
Telephone (T) or Office (O) Visit 
T/Oh 
T/Oh 
T/Od 
T/Od 
T/Od 
T/Od 
T/Od 
T/Od 
 
 
 
 
 
 
 
 
 
Complaints/device deficiencies 
 
X 
Xc 
Xc 
Xc 
Xc 
Xc 
Xc 
Data review 
 
 
X 
X 
X 
X 
X 
X 
BG/Ketone Device uploads 
 
 
 
Xd 
 
Xd 
Xd 
X 
Abbreviations:  S=Screening; MM=Manual Mode; EW=Early Withdrawal; QC=Quality Control; UV=Unscheduled Visit 
aEarly withdrawal visit will be conducted for enrolled subjects that did not complete both Manual Mode phases.   
bUnscheduled visits will serve as extra study visits, if needed. All unscheduled visits must obtain the defined schedule of assessments.  These visits should 
not be documented for appointment confirmation, device shipments, general inquiries, or for activities covered by other assessments.   
cDocumentation only applicable if there are changes from previous assessment. 
dVisits identified as “T/O” can either be conducted in person at the clinical site or over the telephone.  If conducted over the telephone, vital signs and device 
uploads are not required.  Visits identified as “O” can only be conducted in person at the clinical site.   
eVisit 1 and Visit 2 may occur on the same day - Any assessment required by both visits will only need to be completed once.  All Visit 1 assessments do not 
need to occur on the same day as long as the assessments occur within 30 days prior to Visit 2, or for subjects currently enrolled in Omnipod Horizon™ 
Pivotal Study (G190270).  
fOnly applicable if subject is not currently enrolled in the Omnipod Horizon™ Pivotal Study (G190270). 
gFor subjects aged 6-70 currently enrolled in the Omnipod Horizon™ Pivotal Study (G190270), specified screening assessments are not required if they were 
done for the Pivotal study, and there are no significant changes from the Pivotal study screening assessments.  For subjects aged 2-5.9 that plan to 

 
 
 
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participate in the Pivotal study, the specified screening assessments only need to be collected once as long as they are completed within the timeframe 
required by both studies. 
hFor subjects not currently enrolled in the Omnipod Horizon™ Pivotal Study (G190270) this visit must be conducted in person at the clinical study site.  
iIf subject is currently enrolled in the Omnipod Horizon™ Pivotal Study (G190270) and not able to attend in person, they may conduct the pregnancy test at 
home and report result to the site.   
 

 
 
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6 
OBJECTIVES AND ENDPOINTS 
6.1 
Primary Objective 
The primary objective of this study is to evaluate the safety of the Omnipod 
Horizon™ CGM-informed bolus calculator in patients with type 1 diabetes during 
Manual Mode operation. 
 Primary Endpoints 
The primary objective will be to evaluate the safety of the CGM-informed bolus 
calculator using the following endpoints as measured by the system: 
 
Glucose metrics during the 4-hour post bolus period from Phase 2 will be 
compared to Phase 1: 
 
• 
% of time < 70 mg/dL 
• 
% of time > 180 mg/dL 
6.2 
Secondary Objective 
The secondary objective of this study is to evaluate additional glycemic measures 
of effectiveness of the Omnipod Horizon™ CGM-informed bolus calculator during 
Manual Mode operation.  
 Secondary Endpoints 
The secondary objective will be evaluated using the following per subject 
effectiveness endpoints:  
 
Glucose metrics during the 4-hour post bolus from Phase 2 will be compared to 
Phase 1: 
• 
Mean glucose 
• 
% of time < 54 mg/dL 
• 
% of time ≥ 250 mg/dL 
• 
% of time ≥ 300 mg/dL 
• 
% of time in range 70-180 mg/dL 
 
Glucose metrics from Phase 2 will be compared to Phase 1, during the day (6AM 
up to 12AM), overnight (12AM up to 6AM), and overall: 
• 
Mean glucose 
• 
% of time < 54 mg/dL 
• 
% of time < 70 mg/dL 
• 
% of time > 180 mg/dL 
• 
% of time ≥ 250 mg/dL 
• 
% of time ≥ 300 mg/dL 
• 
% of time in range 70-180 mg/dL 
• 
% of time in range 70-140 mg/dL 
• 
Standard deviation 

 
 
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• 
Coefficient of variation 
 
7 
SUBJECT SELECTION AND ELIGIBILITY 
Potential subjects for this study will include individuals who have been diagnosed with 
type 1 diabetes for at least 6 months and are current or prior Omnipod users. Subjects 
aged 6-70 from the Omnipod Horizon™ Pivotal Study (G190270) may participate in this 
study during the study pause and must complete this study prior to their 
recommencement of the pivotal study.  Subjects aged 2-5.9 may be recruited from the 
pivotal study but must complete or withdraw from this study before commencement of 
the Standard Therapy phase of the preschool pivotal study. Potential subjects will be 
selected at each clinical study site and screened accordingly. Every effort will be made 
to establish eligibility of the patient prior to enrollment. Only patients who appear to 
meet all eligibility criteria will be enrolled in the study. Subject eligibility will be confirmed 
by study staff during a screening visit. A point of care (POC) A1C will be used at 
screening to determine eligibility. 
7.1 
Visit 1 
Visit 1 will be conducted either over the telephone or in person at the clinical 
study site.  This visit will assess subject’s eligibility and will include: 
 
• 
Signing of informed consent/assent 
• 
Review of inclusion/exclusion criteria 
• 
Screening assessments performed following Table 1:  Schedule of 
Assessments 
   
Informed Consent 
 
Subjects who appear to meet the eligibility criteria will be asked to sign an 
Informed Consent Form (ICF) approved by each respective Institutional Review 
Board (IRB) for participation in the study prior to completing any screening 
assessments. A parent/guardian must sign the ICF for subjects <18 years of age. 
Assent will be obtained from subjects aged <18 years per State requirements. 
Failure to provide informed consent/assent will render the subject ineligible for the 
study.  Due to utilizing screening assessments for subjects aged 6-70 years that 
are participating in the Omnipod Horizon™ Pivotal Study, the date of consent for 
this study will occur much later than the date of the screening assessments. 
 
Due to restrictions in place for the COVID-19 pandemic, sites may perform the 
informed consent process over the telephone per their site’s procedures.  
Subjects must also have a signed HIPAA (Health Insurance Portability and 
Accountability Act) release of protected health information (PHI). The release may 
be a stand-alone document or part of the informed consent. 
After informed consent/assent is obtained, a subject identification number will be 
issued to uniquely identify each subject. The unique identifier will be used to 
identify the subject throughout the study and will be used for all source documents 
and electronic Case Report Forms (eCRFs). If the subject is also participating in 

 
 
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the Omnipod Horizon™ Pivotal Study, they may retain their same subject 
identification number for both studies. 
Inclusion Criteria 
Subjects must meet all the following criteria in order to be enrolled in the study: 
1. Age at time of consent/assent 2-70 years 
2. Subjects aged < 18 years must be living with parent/legal guardian 
3. Diagnosed with type 1 diabetes for at least 6 months. Diagnosis is based on 
investigator’s clinical judgment 
4. Must be a current Omnipod user, or have used an Omnipod in the past 
5. Investigator has confidence that the subject, parent, or legal guardian, can 
successfully operate all study devices and can adhere to the protocol 
6. Willing to use only the following types of Insulin during the study: Humalog, 
Novolog, Admelog, or Apidra  
7. Must be willing to use the Omnipod Horizon™ in Manual Mode only and 
agree not to use Automated Mode functionality 
8. Must be willing to use the Omnipod Horizon™ bolus calculator without a 
connected CGM for the first 7-days of Manual Mode (Phase 1) while 
manually entering BG values to deliver boluses  
9. Must be willing to use the Omnipod Horizon™ bolus calculator with a 
connected CGM for the last 7-days of Manual Mode (Phase 2) using the 
CGM-informed bolus calculator to deliver boluses 
10. Willing to wear the system continuously throughout the study 
11. For subjects not currently enrolled in the Omnipod Horizon™ Pivotal Study 
(G190270), A1C <10% 
12. Must be willing to use the Dexcom App on the Omnipod Horizon™ PDM as 
the sole source of Dexcom data (except for the Dexcom Follow App)  
13. Able to read and speak English fluently (if subject is a young child then 
Caregiver must meet the criteria) 
14. Willing and able to sign the Informed Consent Form (ICF) and/or has a 
parent/guardian willing and able to sign the ICF. Assent will be obtained from 
subjects aged <18 years per State requirements. 
15. For subjects aged 2-5.9 years of age, parents or trained caregivers agree to 
be physically present during the decision and delivery of insulin boluses for 
this age group, as well as agree to be available for glucose monitoring and 
treatment during the 4-hour post bolus period. 
 
 
  
Exclusion Criteria 
 
Subjects who meet any of the following criteria will be excluded from the study: 
 
1. A medical condition, which in the opinion of the investigator, would put the 
subject at an unacceptable safety risk 
2. History of severe hypoglycemia in the past 6 months 
3. History of DKA in the past 6 months, unrelated to an intercurrent illness or 
infusion set failure 
4. Plans to receive blood transfusion over the course of the study 
5. Currently diagnosed with anorexia nervosa or bulimia 

 
 
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6. Acute or chronic kidney disease or currently on hemodialysis 
7. History of adrenal insufficiency 
8. Has taken oral or injectable steroids within the past 8 weeks or plans to take 
oral or injectable steroids during the study 
9. Unable to tolerate adhesive tape or has any unresolved skin condition in the 
area of sensor or pump placement 
10. Plans to use insulin other than U-100 insulin intended for use in the study 
device during the study 
11. Use of non-insulin anti-diabetic medication other than metformin (e.g. GLP1 
agonist, SGLT2 inhibitor, DPP-4 inhibitor, pramlintide) 
12. Current or known history of coronary artery disease that is not stable with 
medical management, including unstable angina, or angina that prevents 
moderate exercise despite medical management, or a history of myocardial 
infarction, percutaneous coronary intervention, or coronary artery bypass 
grafting within the previous 12 months  
13. Clinical signs of hypothyroidism and hyperthyroidism 
14. Pregnant or lactating, or is a woman of childbearing potential and not on 
acceptable form of birth control (acceptable includes abstinence, condoms, 
oral/injectable contraceptives, IUD or implant) 
15. Currently participating or plans to participate in another clinical study using 
an investigational drug or device other than Omnipod Horizon™. Subjects 
may be recruited from the Omnipod Horizon™ Pivotal Study (G190270). 
16. Unable to follow clinical protocol for the duration of the study or is otherwise 
deemed unacceptable to participate in the study per the investigator’s clinical 
judgment 
 
Screening Assessments 
Subjects who appear to meet the eligibility criteria and have signed the informed 
consent will continue to the screening visit which will be performed either over the 
phone (for subjects currently enrolled in the Omnipod Horizon™ Pivotal Study 
(G190270) or at the clinical study site.  
Screening assessments must be completed within 30 days prior to the Phase 1 
start date (assessments do not need to but may be completed on the same day).  
The assessments will include: 
• 
Medical history (including prior and current medical conditions and surgical 
history)* 
• 
Demographics (age, gender, race) 
• 
Point of care A1C*  
• 
Pregnancy test for women of childbearing potential  
• 
Review of concomitant medications 
• 
Height (if visit is conducted in person at the clinical study site)* 
• 
Weight (if visit is conducted in person at the clinical study site)* 
• 
Vital signs (if visit is conducted in person at the clinical study site)* 
 
*For subjects currently enrolled in the Omnipod Horizon™ Pivotal Study (G190270), 
specified screening assessments are not required if they were done for the Pivotal 
study, and there are no significant changes from the Pivotal study screen 

 
 
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assessments.  For subjects aged 2-5.9 that plan to participate in the Pivotal study, 
the specified screening assessments only need to be collected once, as long as 
they are completed within the timeframe required by both studies. 
 
8 
OMNIPOD HORIZON™ MANUAL MODE 
The Omnipod Horizon™ Manual Mode will consist of two outpatient phases: 
 
1. 7 days of Omnipod Horizon™ use in Manual Mode without a connected 
CGM using manual entry of BG values to deliver boluses (Phase 1) followed 
by; 
2. 7 days of Omnipod Horizon™ use in Manual Mode with a connected CGM 
using the CGM-informed bolus calculator to deliver boluses (Phase 2) 
 
 
Enrollment 
Subjects who meet all eligibility criteria and have completed all screening 
assessments will continue to enrollment. A subject is enrolled in the study at the 
commencement of Visit 2. Subjects that do not meet the eligibility criteria will not 
continue in the study and will be considered screen failures.  
If for any reason a subject is no longer eligible for the study before enrollment, the 
subject will not continue in the study. No additional study assessments will be 
required. The reason for study exit will be clearly documented. 
8.1 
Phase 1 
 Visit 2 
Visit 2 represents the commencement of the first 7 days of Manual Mode (Phase 
1) and will be conducted either over the telephone or in person at the clinical study 
site on Day 1. This visit will include: 
 
• 
Review of concomitant medications 
• 
Assessment of adverse events 
• 
Training on Glucagon administration and information on treatment of 
hypo/hyperglycemia (if training was not previously performed while 
participating in the Omnipod Horizon™ Pivotal Study (G190270)   
• 
Study device training per manufacturer’s instructions (BG and ketone 
meters), (if training was not previously performed while participating in the 
Omnipod Horizon™ Pivotal Study (G190270)   
• 
Omnipod Horizon™ System device training conducted by trained clinical 
site staff (if training was not previously performed while participating in the 
Omnipod Horizon™ Pivotal Study (G190270)   
o Subjects will be trained on operating Omnipod Horizon™ in Manual 
Mode.  
o This will include first time device set-up with entry of basal profile, 
bolus calculator settings with insulin:carbohydrate ratio, target 

 
 
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glucose and correction factor. Subjects should enter settings similar 
to their usual settings as appropriate.   
o The Pod will be filled with the subject’s own U-100 rapid-acting 
insulin and placed on body.  
o Subjects will also be trained on use of Dexcom G6 CGM, setting up 
low (recommended to be 70 mg/dL or higher) and high glucose 
alerts (recommended to be 300 mg/dL or lower), setting up 
Dexcom Follow as desired, and calibrating their CGM as required, 
per the manufacturer’s instructions   
o Subjects will be trained to use the Bolus Calculator, entering in 
estimated carbs for meals and manually entering a BG value 
o Subjects may choose their desired target BG ranging between 110-
150 mg/dL in increments of 10 mg/dL for the bolus calculator 
 
• 
Dispense Omnipod Horizon™ System, including CGM (if System was not 
previously dispensed while participating in the Omnipod Horizon™ Pivotal 
Study (G190270) 
• 
QC testing of BG and ketone meter (if devices were not previously 
dispensed while participating in the Omnipod Horizon™ Pivotal Study 
(G190270) 
o Must pass as least one level of quality control testing prior to 
dispensing.  QC testing may occur at any time prior to dispensing 
to subject. 
• 
Removal of the subject’s personal insulin pump (if not currently using the 
Omnipod Horizon™ System in Manual Mode)  
o Investigators should use the Insulet-provided Patient Therapy 
Order Form (PTOF) to document pump settings (Appendix A) 
• 
Placement of the Omnipod Horizon™ on body (if not currently using the 
Omnipod Horizon™ System in Manual Mode) 
• 
CGM sensor placement (if not currently wearing Omnipod Horizon™ study 
CGM) 
o Approved anatomical locations for CGM sensor placement will be 
reinforced as well as the importance of using approved locations 
• 
Assessment of complaints and/or device deficiencies 
• 
Each subject will initiate their treatment marking their commencement of 
the first 7 days of Manual Mode (Enrollment and Phase 1). 
 
Subjects will be dispensed the following devices and supplies (if not currently 
enrolled in the Omnipod Horizon™ Pivotal Study (G190270)): 
• 
Omnipod Horizon™ PDM and Pods 
• 
Dexcom transmitter 
• 
Dexcom sensors 
• 
Contour® Next One blood glucose meter 
• 
Contour® Next One blood glucose meter test strips 
• 
Lancets 
• 
Precision Xtra blood ketone meter 
• 
Precision Xtra blood ketone meter test strips 
 
 
During the first 7 days of Manual Mode, subjects will be instructed to: 

 
 
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• 
Use the bolus calculator to administer meal boluses for all meals when 
carbohydrates are consumed as well as to administer correction boluses, 
when desired. For meal boluses, subjects will estimate the grams of 
carbohydrates for each meal, enter the carbohydrate estimate into the 
bolus calculator, check and manually enter their BG value into the bolus 
calculator and administer their meal bolus. For correction boluses, subjects 
will check and enter their BG value into the bolus calculator and administer 
their correction bolus. The timing of the bolus delivery will be per each 
subject’s typical dosing routine. 
• 
Consume meals and snacks of their own choosing.  
• 
Subjects may adjust their basal rates or use advanced features such as 
Temp Basal and Extended Bolus per usual 
• 
Follow their pre-exercise management such as insulin reduction for meal 
boluses, consumption of snacks, or adjusting their insulin delivery settings 
• 
Treat themselves per their usual routine if they become hypoglycemic or 
hyperglycemic or have symptoms of either at any time during the study 
• 
Change their CGM per manufacturer’s instructions or sooner if necessary 
• 
Change the Pod at least once every 72 hours 
• 
For subjects aged 2-5.9 years of age, parents or trained caregivers will be 
instructed that they need to be physically present during the decision and 
delivery of insulin boluses for this age group, as well as be available for 
glucose monitoring and treatment during the 4-hour post bolus period. 
 
Subjects and caregivers will be reminded to NOT use the system in Automated 
Mode for the duration of the 14-day study.  Any use of automated mode will be 
considered a protocol deviation.  
 
Subjects not currently enrolled in the Omnipod Horizon™ Pivotal Study (G190270) 
will be provided, by the site, information regarding treatment of hypoglycemia and 
hyperglycemia including sick day management and emergency management of 
severe hypoglycemia and diabetic ketoacidosis. Instructions will be given to 
subjects on how to contact clinical study staff 24-hours per day to report any study 
related problems. Subjects will be encouraged to call the clinical study site at any 
time with any concerns. 
 
 
 Visit 3 
Visit 3 will be conducted either over the telephone or in person at the clinical 
study site on Day 3 ±1d.  This visit will include: 
 
• 
Review of concomitant medications 
• 
Assessment of adverse events 
• 
Assessment of complaints and/or device deficiencies 
• 
Data review by clinician to ensure that subject is delivering boluses as 
instructed during Visit 2 
 

 
 
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8.2 
Phase 2 
 Visit 4 
Visit 4 will be conducted either over the telephone or in person at the clinical site 
on Day 8 ±1d.  This visit will mark the start of Phase 2, which is 7-days of Manual 
Mode with a connected CGM using the CGM-informed bolus calculator to deliver 
boluses.  This visit will include: 
 
• 
Review of concomitant medications 
• 
Assessment of adverse events 
• 
Pairing the CGM transmitter to the Horizon App on the PDM 
• 
Assessment of complaints and/or device deficiencies 
• 
Data review by clinician to ensure that subject was delivering boluses as 
instructed during Visit 2. 
• 
Upload BG and ketone meter data (if visit is conducted in person at the 
clinical study site) 
 
During this visit subjects will be instructed to: 
 
• 
Use the CGM-informed bolus calculator to administer meal boluses for all 
meals when carbohydrates are consumed as well as to administer 
correction boluses, when desired.  For meal boluses, subjects will estimate 
the grams of carbohydrates for each meal, enter the carbohydrate estimate 
into the bolus calculator, choose ‘Enter CGM’ to populate the bolus 
calculator and administer their meal bolus. For correction boluses, subjects 
will choose ‘Enter CGM’ to populate the bolus calculator and administer 
their correction bolus. The timing of the bolus delivery will be per each 
subject’s typical dosing routine. 
• 
Consume meals and snacks of their own choosing.  
• 
Subjects may adjust their basal rates or use advanced features such as 
Temp Basal and Extended Bolus per usual 
• 
Follow their pre-exercise management such as insulin reduction for meal 
boluses, consumption of snacks, or adjusting their insulin delivery settings 
• 
Treat themselves per their usual routine if they become hypoglycemic or 
hyperglycemic or have symptoms of either at any time during the study 
• 
Change their CGM per manufacturer’s instructions or sooner if necessary 
• 
Change the Pod at least once every 72 hours 
• 
For subjects aged 2-5.9 years of age, parents or trained caregivers will be 
instructed that they need to be physically present during the decision and 
delivery of insulin boluses for this age group, as well as be available for 
glucose monitoring and treatment during the 4-hour post bolus period. 
 
 Visit 5 
Visit 5 will be conducted either over the telephone or in person at the clinical 
study site on Day 10 ±1d.  This visit will include: 
 
• 
Review of concomitant medications 

 
 
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• 
Assessment of adverse events 
• 
Assessment of complaints and/or device deficiencies 
• 
Data review by clinician to ensure that subject is delivering boluses as 
instructed during Visit 4 
 
 Visit 6 (End of Study) 
Visit 6 will be conducted either over the telephone or in person at the clinical 
study site on Day 14 ±1d. This visit will include: 
• 
Review of concomitant medications 
• 
Assessment of vital signs (if visit is conducted in person at the clinical 
study site) 
• 
Assessment of adverse events 
• 
Return of devices (if not commencing or recommencing their participation 
in the Omnipod Horizon™ Pivotal Study (G190270).  Subjects aged 2-5.9 
may hold onto their devices if continuing onto the Pivotal study, but must 
return to using their standard therapy for the Pivotal study Standard 
Therapy Phase.) 
• 
Assessment of complaints and/or device deficiencies 
• 
Data review by clinician to ensure that subject was delivering boluses as 
instructed during Visit 4 
• 
Upload BG and ketone meter data (if visit is conducted in person at the 
clinical study site) 
This visit will mark the end of this study for each subject.    
8.3 
Unscheduled Visits 
Aside from scheduled visits, subjects may require Unscheduled Visits (UV) 
either by telephone or in person at the clinical study site. This visit will include: 
 
• 
Review of concomitant medications 
• 
Assessment of adverse events 
• 
Assessment of complaints and/or device deficiencies 
• 
Data review by clinician to ensure that subject was delivering boluses 
according to the correct study phase 
• 
Upload BG and ketone meter data (if visit is conducted in person at the 
clinical study site) 
 
All UVs must obtain the defined schedule of assessments.  Additional 
assessments may be warranted at the discretion of the investigator.  UVs should 
not be documented for appointment confirmation, device shipments, general 
inquiries, or for activities covered by other assessments. 
 
8.4 
Early Withdrawal 
Any subject may withdraw early from the study at any time for any reason. The 
investigator may also terminate a subject’s participation in the study if it is in the 

 
 
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best interest of the subject or if the sponsor or local regulatory agency (e.g., FDA) 
terminates the study.  Upon withdrawal, assessments will be performed according 
to the Table 1:  Schedule of Assessments. This visit will include: 
 
• 
Review of concomitant medications 
• 
Assessment of vital signs (if visit is conducted in person at the clinical 
study site) 
• 
Assessment of adverse events 
• 
Return of devices (if not commencing or recommencing their participation 
in the Omnipod Horizon™ Pivotal Study (G190270). Subjects aged 2-5.9 
may hold onto their devices if continuing onto the Pivotal study, but must 
agree to return to using their standard therapy for the Pivotal study 
Standard Therapy Phase)   
• 
Assessment of complaints and/or device deficiencies 
• 
Data review by clinician ensure that subject was delivering boluses 
according to the correct study phase 
• 
Upload BG and ketone meter data (if visit is conducted in person at the 
clinical study site) 
 
An early withdrawal visit should be conducted at the clinical study site when 
possible. The subject will be requested to return their study devices to the site, the 
reason for withdrawal will be recorded, and their participation in the study will end. 
In the event of a subject’s death during the study, the subject’s participation will be 
considered terminated and the date of death will be used as the date of study exit. 
8.5 
Lost to Follow-up 
Every effort will be made to contact a subject in the event of a missed scheduled 
visit. A subject will be considered lost to follow-up if they are inaccessible by two 
or more different methods of contact and fail to show up for two scheduled visits. 
The site will document each attempt made to contact the subject and specify the 
reason for early withdrawal as lost to follow-up.      
 
9 
SPONSOR REPRESENTATIVES 
One or more representatives of the Sponsor may be present at the clinical study site 
visits under supervision of the investigator. 
 
10 SAFETY 
10.1 Types of Known Risks and Benefits 
There are known risks and benefits. Most of the risks are not unique to the study 
and are typical for patients using insulin pumps, CGM, and BG meters. 
The known risks are as follows: 

 
 
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• 
Hypoglycemia and/or hyperglycemia as a result of change in diet, activity, 
diabetes management or insulin regimen during the study. 
• 
Hypoglycemia and/or hyperglycemia as a result of over or under delivery of 
insulin due to a device defect, failure or malfunction of any of the system 
components. 
• 
Hypoglycemia, hyperglycemia, diabetic ketoacidosis, seizure, coma or death 
related to insulin administration, pump use or misuse, or Horizon™ System 
use or misuse or malfunction. 
• 
Use of the Pod (Omnipod® tubeless, insulin delivery pump) - Because the 
Pod uses only rapid-acting insulin, users are at increased risk for developing 
hyperglycemia if insulin delivery is interrupted. If it is untreated, prolonged 
hyperglycemia can quickly lead to diabetic ketoacidosis (DKA). DKA can 
cause symptoms such as breathing difficulties, shock, coma, or death. 
Further, occlusions can interrupt insulin delivery and lead to hyperglycemia 
or DKA. Other potential risks associated with using the Pod are: 
o Anaphylaxis (allergic shock) 
o Bruising at the Pod site 
o Bleeding at the Pod site 
o Erythema (redness at the Pod site) 
o Excoriation (raw skin at Pod site) 
o Pruritus (itching) 
o Induration (hardening of the skin at the Pod site) 
o Infection (can include heat, redness, swelling, pain, and drainage) 
o Inflammation (redness, swelling) 
o Skin reaction to adhesive at the Pod site 
o Papule (small, solid raised area on the skin similar to a pimple) 
o Pain or discomfort 
o Ulceration (skin sores) 
o Vesicles (blisters) 
• 
Use of the CGM - risk of bruising, infection, pain and/or bleeding at the site 
of insertion, and skin site reaction to adhesive 
• 
On rare occasions, the CGM sensor may break and leave a small portion of 
the sensor under the skin that may cause redness, swelling, or pain at the 
insertion site, and may require surgical removal. 
• 
Blood sampling with fingerstick - minor discomfort and risk of infection at site 
of fingerstick 
There are potential benefits from this study. The Omnipod Horizon™ CGM-
informed bolus calculator is intended to utilize both CGM value and trend to 
deliver a safe correction bolus and improve ease of use.   

 
 
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10.2 Hypoglycemia/Hyperglycemia 
Subjects will be asked to treat per their usual routine if they suspect either 
hypoglycemia or hyperglycemia, either by confirmation of hypoglycemia with a 
fingerstick BG, symptoms, or perceived risk.  
Subjects will be encouraged to manage their hyperglycemia per their usual 
routine.  This includes checking for ketones using the study-approved ketone 
meter and administering a correction bolus if needed.   
In the event of unexplained hyperglycemia, where the CGM is >300 mg/dL for ≥1 
hour or >250 mg/dL for ≥2 hours, blood glucose (measured with BG meter) and 
ketones should be checked. If BG is ≥300 mg/dL and ketones are >1.0 mmol/L, an 
occlusion or dislodged cannula should be suspected. The Pod should be 
removed, and the subject will be instructed to replace the Pod. Subjects should 
contact the clinical site for further instructions to determine whether an additional 
injection of insulin is required.  
10.3 Adverse Events 
 Definitions 
Adverse Event (AE): is defined as any untoward medical occurrence, unintended 
disease or injury, or any untoward clinical signs (including an abnormal laboratory 
finding) in subjects, users or other persons, whether or not related to the 
investigational medical device. 
NOTE 1: This includes events related to the investigational medical device or the 
comparator.28  
NOTE 2: This definition includes events related to the procedures involved (any 
procedure in the clinical investigation plan).28  
Serious Adverse Event (SAE): Any untoward medical occurrence that: 
o Led to death 
o Led to serious deterioration in the health of the subject, that either 
resulted in: 
 
a life-threatening illness or injury, or 
 
a permanent impairment of a body structure or a body function, or 
 
in-patient or prolonged hospitalization, or 
 
medical or surgical intervention to prevent life-threatening illness 
or injury or permanent impairment to a body structure or a body 
function. 
o Led to fetal distress, fetal death, or a congenital abnormality or birth defect. 
 
NOTE: Planned hospitalization for a pre-existing condition, or a 
procedure required by the clinical investigational plan, without serious 
deterioration in health, is not considered a serious adverse event.28  

 
 
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Unanticipated Adverse Device Effect (UADE): Any serious adverse effect on 
health or safety or any life-threatening problem or death caused by, or associated 
with, a device, if that effect, problem, or death was not previously identified in 
nature, severity, or degree of incidence in the investigational plan or application 
(including a supplementary plan or application), or any other unanticipated serious 
problem associated with a device that relates to the rights, safety, or welfare of 
participants.28  
Adverse Device Effect (ADE): An adverse device effect (ADE) is an adverse 
event related to the use of an investigational medical device. 28 
NOTE 1: This definition includes any adverse event resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or 
operation, or any malfunction of the investigational medical device.28  
NOTE 2: This definition includes any event resulting from user error or from 
intentional misuse of the investigational medical device.28  
An event that occurs solely due to participant (i.e., user) error in which the device 
functions properly generally will not be considered an ADE unless it is determined 
that the instructions on the screen of the device or user manual (or similar training 
materials) may have contributed to the event (note: the event may still meet 
criteria for reporting as an adverse event). 
Serious Adverse Device Effect (SADE): A serious adverse device effect is 
defined as an adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event. 28 
Device Deficiency (DD): A device deficiency is defined as a device related 
complaint or malfunction or any inadequacy of a device with respect to its identity, 
quality, durability, reliability, safety or performance and includes misuse or use 
errors and inadequate labeling. A device deficiency is something that happens to 
a device or is related to device performance, whereas an adverse event happens 
to a participant. A device deficiency may occur independently from an AE, or 
along with an AE. An AE may occur without a device deficiency or there may be 
an AE related to a device deficiency. 
Note: for reporting purposes, sites will not be asked to distinguish between device 
complaints and malfunctions.  
For any event where there is suspicion that the study device is involved, the 
Sponsor will request that the investigator return the device for evaluation. 
All device complaints or malfunctions involving any investigational component of 
the Omnipod Horizon™ System used in the study will be reported to the Sponsor 
within 5 business days of knowledge of the deficiency and documented on an 
appropriate eCRF. All study product associated with a reported device deficiency 
(PDM, Pod, and CGM) should be retained at the clinical site and returned to the 
Sponsor or CGM manufacturer for investigation and analysis. 

 
 
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  Reportable Adverse Events 
Adverse events will be assessed on an ongoing basis throughout the study. 
Adverse event reporting will begin at the time of enrollment (i.e., insertion of the 
CGM sensor) and continue until the subject’s participation has ended. All adverse 
events must be followed until resolution, or until the AE has stabilized, or until the 
study has been completed. 
Pre-existing medical conditions or symptoms observed prior to enrollment will not 
be recorded as an AE and should be collected in the subject’s medical history. In 
the event there is a change (i.e., worsening) in the pre-existing medical condition 
or symptoms after enrollment meeting the criteria of a reportable adverse event, 
then an AE must be reported. 
For this protocol, a reportable adverse event includes any untoward medical 
occurrence that meets one of the following criteria: 
1. An SAE 
2. An ADE unless excluded from reporting in Hypoglycemic Events and 
Hyperglycemic/Ketotic Events sections below 
3. An AE occurring in association with a study procedure 
4. An AE not related to a study device issue which leads to temporary or 
permanent discontinuation of the study device 
5. An AE that affects the participant’s ability to complete any study 
procedures 
6. An AE for which a visit is made to a hospital emergency department   
7. Hypoglycemic Events as defined below 
8. Hyperglycemia/Ketotic Events as defined 
Skin reactions from sensor or pod placement are only reportable if severe and/or 
required treatment. 
For the purpose of this protocol, mild symptoms of hypoglycemia and 
hyperglycemia (i.e., clinically non-significant) or blood glucose values out of the 
normal range (whether or not they resulted in delayed meals or correction 
boluses) will not be reported as AEs unless determined to meet the reportable 
criteria in the Hypoglycemic Events and Hyperglycemic/Ketotic Events sections 
below. 
All reportable AEs—whether volunteered by the participant, discovered by study 
personnel during questioning, or detected through physical examination, 
laboratory test, or other means—will be reported on an AE eCRF. 
  
 Hypoglycemic Events 
Hypoglycemia is only reportable as an adverse event when one of the following 
criteria is met:   

 
 
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• 
Severe Hypoglycemia: The event required assistance of another person 
due to altered consciousness, and required another person to actively 
administer carbohydrate, glucagon, or other resuscitative actions.25 This 
means that the participant was impaired cognitively to the point that he/she 
was unable to treat himself/herself, was unable to verbalize his/her needs, 
was incoherent, disoriented, and/or combative, or experienced seizure or 
loss of consciousness. These episodes may be associated with sufficient 
neuroglycopenia to induce seizure or loss of consciousness.  If plasma 
glucose measurements are not available during such an event, 
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. 
• 
Hypoglycemia resulting in an SAE that may not otherwise meet the 
definition of Severe Hypoglycemia defined above. 
When a hypoglycemic event meets the above reporting requirements, an Adverse 
Event Form should be completed. A severe hypoglycemia event should be 
considered a serious adverse event and follow the SAE reporting requirements. 
 
 Hyperglycemic/Ketotic Events 
Hyperglycemia is only reportable as an adverse event when any of the following 
criteria is met:   
• 
The event involved DKA, as defined by the Diabetes Control and 
Complications Trial (DCCT)24 and described below 
• 
Evaluation or treatment was obtained at a health care provider facility for 
an acute event involving hyperglycemia or ketosis, or the participant 
contacted the site and received guidance on how to manage the 
hyperglycemia/ketosis 
• 
Prolonged hyperglycemia: defined as meter BG ≥300 mg/dL and ketones 
>1.0 mmol/L 
• 
Hyperglycemia resulting in an SAE that may not otherwise meet the above 
criteria 
 
Hyperglycemic events are classified as DKA24 if all of the following are present: 
• 
Symptoms such as polyuria, polydipsia, nausea, or vomiting; 
• 
Serum ketones >1.5 mmol/L or large/moderate urine ketones; 
• 
Either arterial blood pH <7.30 or venous pH <7.24 or serum bicarbonate 
<15; and 
• 
Treatment provided in a health care facility 
 
When a hyperglycemia/ketotic event meets the above reporting requirements, 
Adverse Event Form should be completed.  
 
Events meeting DKA criteria should be considered a serious adverse event and 
follow the SAE reporting requirements. Hyperglycemia events not meeting criteria 
for DKA generally will not be considered as serious adverse events unless one of 
the SAE criteria above is met. 
 

 
 
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 Relationship of Adverse Event to Investigational Device 
The investigator will be responsible for making a determination on the causal 
relationship of the AE. Specifically, the investigator will report whether the AE was 
related to study procedures and/or related to the investigational device. 
To ensure consistency of adverse event causality assessments, investigators 
should apply the following general guideline when determining whether an 
adverse event is related. 
The causal relationship to the study procedures and the investigational device for 
each adverse event will be rated as follows:  
• 
Unrelated: The event is not related to the procedures or the investigational 
device.  
• 
Possibly Related: The temporal sequence is such that the relationship is 
not unlikely or there is no contradicting evidence that can reasonably 
explain the subject’s condition. There is a possibility of any relation 
between the event and the procedures or the investigational device.  
• 
Related: The temporal sequence is relevant or the event abates upon 
completion of the procedure/ investigational device, or the event cannot be 
reasonably explained by the subject’s condition or comorbidities. The 
event is related or most likely associated with the procedures or the 
investigational device. 
 
 Severity (Intensity) of Adverse Events 
The severity (intensity) of an adverse event will be rated on a three-point scale: (1) 
mild, (2) moderate, or (3) severe. A severity assessment is a clinical determination 
of the intensity of an event. Thus, a severe adverse event is not necessarily 
serious. For example, itching for several days may be rated as severe, but may 
not be clinically serious. 
• 
MILD: Usually transient, requires no special treatment, and does not 
interfere with the participant’s daily activities. 
• 
MODERATE: Usually causes a low level of inconvenience, discomfort or 
concern to the participant and may interfere with daily activities but is 
usually ameliorated by simple therapeutic measures and participant is able 
to continue in study. 
• 
SEVERE: Interrupts a participant’s usual daily activities, causes severe 
discomfort, may cause discontinuation of study device, and generally 
requires systemic drug therapy or other treatment. 
 
 Outcome of Adverse Events 
The outcome of each reportable adverse event will be classified by the 
investigator as follows: 
• 
RECOVERED/RESOLVED - The participant recovered from the AE/SAE 
without sequelae. Record the AE/SAE stop date. 

 
 
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• 
RECOVERED/RESOLVED WITH SEQUELAE - The event persisted and 
had stabilized without further anticipated change in the event status. 
Record the AE/SAE stop date. 
• 
FATAL - A fatal outcome is defined as the SAE that resulted in death. Only 
the event that was the cause of death should be reported as fatal.  
AEs/SAEs that were ongoing at the time of death; however, were not the 
cause of death, will be recorded as “resolved” at the time of death. 
• 
NOT RECOVERED/NOT RESOLVED (ONGOING) - An ongoing AE/SAE 
is defined as the event was ongoing with an undetermined outcome. 
• 
An ongoing outcome will require follow-up by the site in order to 
determine the final outcome of the AE/SAE or until participant 
completes the study. 
• 
The outcome of an ongoing event at the time of death that was not the 
cause of death, will be updated and recorded as “resolved” with the 
date of death recorded as the stop date. 
• 
UNKNOWN - An unknown outcome is defined as an inability to access the 
participant or the participant’s records to determine the outcome (for 
example, a participant that was lost to follow-up). 
 
If any UADEs are ongoing when a participant completes the study (or withdraws), 
the subject will continue to be followed until the event resolves or has no prospect 
of improvement or change, even after the participant has completed all applicable 
study visits/contacts, unless that subject has withdrawn their consent. For all other 
reportable adverse events, data collection will end at the time the participant 
completes the study. Note: Participants should continue to receive appropriate 
medical care for an adverse event after their participation in the study ends.  
10.4 Reportable Device Issues 
Device complaints and device malfunctions will be reported except in the following 
circumstances. These occurrences are expected and will not be reported on a 
Device Deficiency Form: 
• 
CGM sensor, transmitter or Pod lasting fewer days than expected per 
manufacturer 
• 
CGM tape or Pod adherence issues 
• 
Battery lifespan deficiency due to inadequate charging or extensive wireless 
communication 
• 
Intermittent device component disconnections/communication failures not 
requiring system replacement or workaround/resolution not specified in user 
guide/manual. 
• 
Device issues clearly addressed in the user guide manual that do not require 
additional troubleshooting 
10.5 Timing of Event Reporting 
SAEs possibly related or related to a study device or study procedures and 
UADEs must be reported to the Sponsor/CRO within 2 business days of the site 
becoming aware of the event. This can occur via phone or email, or by completion 
of the AE eCRF. If the form is not initially completed, it should be competed as 
soon as possible after there is sufficient information to evaluate the event. All 

 
 
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other reportable AEs should be submitted by completion of the AE eCRF within 5 
business days of the site becoming aware of the event.  
Each principal investigator is responsible for reporting adverse events required by 
this protocol and abiding by any other reporting requirements specific to his/her 
Institutional Review Board or Ethics Committee.  
Upon receipt of a UADE report, the Sponsor will investigate the UADE and if 
indicated, report the results of the investigation to all participating investigators, 
overseeing IRBs, and the FDA within 10 business days of the Sponsor becoming 
aware of the UADE per 21CFR 812.46(b). Copies of the associated reports and 
correspondence with the investigators, regulatory authorities, and Sponsor must 
be retained with study records. 
The Medical Monitor must determine if the UADE presents an unreasonable risk 
to participants. If so, the Sponsor must ensure that all investigations, or parts of 
investigations presenting that risk, are terminated as soon as possible but no later 
than 5 working days after the Medical Monitor makes this determination and no 
later than 15 working days after first notice of the UADE. 
Device deficiencies will be handled by the Sponsor or designee as described 
below.  
If the subject is hospitalized because of or during the course of an SAE, then a 
copy of the hospital discharge summary must be requested for inclusion with the 
SAE documentation. In case of death, the investigator must make every effort to 
obtain a copy of the death certificate to submit to the Sponsor. When submitting 
copies of documentation, all subject identifying information must be redacted and 
only the unique subject number will be used to label the forms for identification 
purposes. 
For any event where there is suspicion that the study device is involved, the 
investigator will return the device for evaluation when possible. 
 
10.6 Stopping Criteria 
 Participant Discontinuation of Study Participation 
In the case of a UADE, the Medical Monitor will determine if the use of the study 
device will be suspended while the problem is diagnosed. The use of the study 
device may continue if the Medical Monitor believes the event is explainable, 
unlikely to reoccur and that it is safe for the subject to continue using the device. 
Alternately, the Medical Monitor may request the study subject, or all study 
subjects, to stop using the study device or to only use in Manual Mode. Should all 
study subjects be required to stop using the study device or to only use in Manual 
Mode due an UADE, use of the study device or Automated Mode will not be 
restarted until approval is received from the IRB, DSMB and FDA.  
Use of the study device by a participant will be discontinued if any of the following 
occur:  
• 
The investigator believes it is unsafe for the participant to continue on the 
intervention. This could be due to the development of a new medical 

 
 
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condition or worsening of an existing condition; or participant behavior 
contrary to the indications for use of the device that imposes on the 
participant’s safety. 
• 
The participant requests that the treatment be stopped 
• 
Participant pregnancy 
• 
Two distinct episodes of DKA as defined above 
• 
Two distinct severe hypoglycemia events as defined above 
• 
One episode of DKA and one severe hypoglycemia event as defined 
above 
 
An additional requirement for continued study device use following a single DKA 
or severe hypoglycemia event will be that (1) the site investigator believes that 
the event is explainable, unlikely to recur, and that it is safe for the participant to 
continue to use the system and (2) the Medical Monitor concurs. If the Medical 
Monitor determines that the occurrence of the event indicates that it is not safe 
for the participant to continue to use the system, use will be discontinued, and the 
subject will be withdrawn from the study. 
 
 Criteria for Suspending or Stopping Overall Study 
Study activities will be suspended if the manufacturer of any component of the 
investigational study device requires stoppage of device use for safety reasons 
(e.g. product recall).  
 
The affected study activities may resume if the underlying problem can be 
corrected by a protocol or system modification that will not invalidate the results 
obtained prior to suspension.  
 
The study Medical Monitor will review all adverse events that are reported during 
the study. The Medical Monitor may recommend suspension of study activities or 
stoppage of the study to the Sponsor if deemed necessary based on the totality of 
safety data available. 
10.7 Medical Monitor 
An independent Medical Monitor will be responsible for individual and timely 
review of adverse events as defined below. The Medical Monitor will be a 
physician with relevant therapeutic and medical expertise that is not participating 
as an Investigator in the study and does not have a financial, scientific, or other 
conflict of interest with the clinical study. 
 
Specific responsibilities of the Medical Monitor include:  
 
• 
Review of all adverse events reported during the study 
• 
Review all serious study procedure-related and/or investigational device-
related adverse events to determine if the adverse event warrants 
consideration as a UADE and facilitate the reporting of UADEs if applicable  
• 
Adjudicate the following(a) all SAEs; (b) any events of Diabetic Ketoacidosis 
or Severe Hypoglycemia; (c) all AEs reported by the site as related or 

 
 
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possibly related to the investigational device; and/or (d) any additional 
events as requested by the Sponsor.  
• 
The specified events will be adjudicated to determine: 
o event relatedness to the study procedures and/or the 
investigational device 
o event categorization and assess seriousness and severity 
o whether an adverse event is anticipated or unanticipated 
The adjudication decision of the Medical Monitor will be used for the final 
classification of events, including relatedness to the study procedures and/or the 
investigational device, for the determination of safety endpoints and for all 
regulatory reports, product labeling, and publications or presentations. 
 
The study Medical Monitor will review all adverse events and adverse device 
events that are reported during the study.  SAEs will typically be reviewed within 
24-hours of reporting.  Other AEs will typically be reviewed approximately weekly.  
 
The Medical Monitor’s roles and responsibilities are described in the Safety 
Management Plan (SMP).  
 
11 STATISTICAL CONSIDERATIONS 
11.1 General Statistical Methods 
Standard statistical methods will be employed to analyze all data. All data 
collected in this study will be documented using summary tables and subject data 
listings. Continuous variables will be summarized using descriptive statistics, 
including counts, mean, median, standard deviation (SD), minimum and 
maximum. Where appropriate, 95% two-sided confidence intervals for the means 
or medians will be presented. If the observed data are found not to follow a normal 
distribution, appropriate non-parametric methods may be employed. Categorical 
variables will be summarized by frequencies and percentages. Unless explicitly 
stated otherwise, percentages will utilize a denominator corresponding to the 
number of unique subjects. 
Data from different centers will be pooled for all analyses. Data will be 
summarized by age cohort.  
As subjects aged 6-70 years are expected to complete the study prior to the start 
of enrollment of subjects aged 2-5.9 years, two separate clinical reports will be 
generated.   
11.2 Sample Size 
This is a non-powered, single-arm, multi-center, observational study. The sample 
size for the study is not hypothesis-driven and has been chosen to gather 
adequate clinical data on the performance of the Omnipod HorizonTM System’s 
CGM-informed bolus calculator and summarize its safety profile. 

 
 
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Up to 42 subjects may be enrolled in the study cross 4-7 clinical study sites in 
order to obtain approximately 30 evaluable subjects. The evaluable subjects will 
be comprised of three age cohorts as follows: 
• 
15 subjects aged 18-70 years 
• 
10 subjects aged 6-17.9 years 
• 
5 subjects aged 2-5.9 years 
11.3 Objectives and Endpoints 
 Primary Objective 
The primary objective of this study is to evaluate the safety of the Omnipod 
Horizon™ System’s CGM-informed bolus calculator in patients with type 1 
diabetes during Manual Mode operation. 
 
Primary Endpoints 
The primary objective will be to evaluate the safety of the CGM-informed bolus 
calculator (Phase 2) using the following endpoints as measured by the system 
CGM: 
 
Glucose metrics during the 4-hour post bolus period from Phase 2 will be 
compared to Phase 1: 
 
• 
% of time < 70 mg/dL 
• 
% of time > 180 mg/dL 
 
 
 
Secondary Objective 
The secondary objective of this study is to evaluate additional glycemic measures 
of effectiveness of the Omnipod Horizon™ CGM-informed bolus calculator during 
Manual Mode operation.  
 
Secondary Endpoints 
The secondary objective will be evaluated using the following per subject 
effectiveness endpoints:  
 
Glucose metrics during the 4-hour post bolus period from Phase 2 will be 
compared to Phase 1: 
• 
Mean glucose 
• 
% of time < 54 mg/dL 
• 
% of time ≥ 250 mg/dL 
• 
% of time ≥ 300 mg/dL 
• 
% of time in range 70-180 mg/dL 
 
Glucose metrics from Phase 2 will be compared to Phase 1 during the day (6AM 
up to 12AM), overnight (12AM up to 6AM), and overall: 
• 
Mean glucose 

 
 
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• 
% of time < 54 mg/dL 
• 
% of time < 70 mg/dL 
• 
% of time > 180 mg/dL 
• 
% of time ≥ 250 mg/dL 
• 
% of time ≥ 300 mg/dL 
• 
% of time in range 70-180 mg/dL 
• 
% of time in range 70-140 mg/dL 
• 
Standard deviation 
• 
Coefficient of variation 
11.4 Analysis Sets 
The following analysis sets are planned for the study: 
 
ITT (Intention to Treat) Analysis Set 
The ITT analysis set includes all subjects that are enrolled in the study. All safety 
analyses (other than primary analysis of primary endpoints) will be based on the 
ITT analysis set. 
 
mITT (modified Intention to Treat) Analysis Set 
The modified Intention to Treat (mITT) analysis set is a subset of the ITT analysis 
set. The mITT analysis set will consist of subjects who have entered the Manual 
Mode with a connected CGM phase of the study (Phase 2) successfully. The 
mITT analysis set will be used as the primary analysis for the primary and 
secondary endpoints and other clinical outcome data. 
 
PP (Per-Protocol) Analysis Set 
The Per-Protocol (PP) analysis set is a subset of the mITT analysis set. Subjects 
will be included in the PP analysis set if they have a minimum of 80% system use 
(approximately 5.6 days) during Phase 2 of the study without major protocol 
deviations. The PP analysis set will be used as supportive analysis for the 
endpoints. The following will be considered major protocol deviations: 
• 
Major inclusion/exclusion criterion deviation 
• 
Significant protocol non-compliance that may confound the study objective 
data (e.g., use of prohibited medications) 
The list of subjects excluded from the PP analysis set will be determined prior to 
analysis. If the PP analysis set does not differ from the mITT analysis set, 
separate analyses will not be presented. 
11.5 Analysis of Primary and Secondary Endpoints 
There are no hypotheses associated with any of the primary or secondary 
endpoints. Summary statistics will be presented by age cohort for all endpoints, 
stratified by time points of interest (e.g., day vs. night, overall). The primary and 
secondary endpoints will be summarized for modified Intention to Treat (mITT) 

 
 
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and Per Protocol (PP) analysis sets. If the PP analysis set does not differ from the 
mITT analysis set, separate analyses will not be presented. The data may be 
stratified by phase of the study, where the data collected during Phase 2 of the 
study will be compared to the data collected during Phase 1 of the study. 
All statistical comparisons will be conducted at a two-sided significance level of 
5% using a paired t-test or two sample t-test, as appropriate. If the assumptions 
for parametric test are grossly violated, a non-parametric method such as 
Wilcoxon signed rank test may be used. Since the results of endpoint analyses will 
not be used to support clinical claims, no adjustment for multiplicity will be 
performed. 
 
Calculation of Percentage of Time in Range  
Several effectiveness endpoints involve calculation of percentage of time in a 
specific glycemic range, including primary endpoints. These endpoints will be 
based on the direct output from a device (either a CGM or The Omnipod 
HorizonTM Automated Glucose Control System). The percentage of time in range 
(TIR) will be calculated as: 
100 × # 𝑜𝑜𝑜𝑜 𝐶𝐶𝐶𝐶𝐶𝐶 𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟 𝑖𝑖𝑖𝑖 𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟 
# 𝑜𝑜𝑜𝑜 𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒 𝐶𝐶𝐶𝐶𝐶𝐶 𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟= 𝑇𝑇𝑇𝑇𝑇𝑇% 
The following CGM records will be excluded from analysis, and therefore, from 
calculation of TIR endpoints: 
 
• 
No glucose value is provided in the device output, such as due to an error 
or device deficiency during which the device does not record glucose 
readings 
11.6 Safety Analyses 
 
Evaluation of Adverse Events  
All adverse events reported over the course of the study will be summarized and 
tabulated by study phase, event category, seriousness, severity, and relationship 
to the study and the investigational device. For the purposes of summarization, an 
event will be considered “Related” if the relationship was deemed as “Possibly 
Related” or “Related”. In cases where the same event is reported more than once 
per subject, the event will only be counted once in the incidence table(s).  
Adverse events leading to death or to discontinuation from the study will be listed 
separately. A listing of all adverse events will be provided.  
 Evaluation of Device Deficiencies  
Device deficiencies will be tabulated and listed in a manner similar to the methods 
described for adverse events. Any device deficiency leading to an AE or to study 
termination will be listed separately. 

 
 
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11.7 Baseline Characteristics 
The distribution of each baseline characteristic or demographic parameter of 
interest (such as age, gender, medical history, etc.) will be presented. Data on all 
enrolled subjects will be presented. Continuous variables will be summarized 
using count, mean, median, standard deviation, and range. Categorical variables 
will be summarized using counts and percentages. 
11.8 Missing Data 
All practical monitoring and follow-up steps will be taken to ensure complete and 
accurate data collection. All analyses will be based on available data only; no 
imputation for missing data is planned. 
11.9 Statistical Software 
The statistical software package SAS® 9.4 or later will be used for all the data 
derivations, summarization, data listings and statistical analyses. Additional 
software such as Splus or R may be used for graphics or validation as 
appropriate. 
12 DATA HANDLING AND QUALITY ASSURANCE 
Data in this study will be collected on Electronic Case Report Forms as well as via 
electronic device outputs. 
12.1 Electronic Case Report Forms (eCRFs) 
Study data are collected through a combination of subject electronic CRFs 
(eCRFs) and electronic device data files.  eCRF Data will be recorded in a 21 CFR 
Part 11 compliant database that will reside on a central server accessible via the 
Internet. 
Electronic data files contain the primary source data for study devices.  When data 
are directly collected in the eCRFs, this will be considered source data.  When 
data is not directly collected in the eCRFs, electronic or paper documents 
containing source data that is transcribed into the eCRF are the source. 
The investigator is responsible for the accuracy and completeness of data 
reported on the eCRFs. Each set of subject eCRFs must be reviewed and signed 
by the investigator in the EDC system. The investigator also agrees to maintain 
accurate source documentation supporting the data. When pertinent supportive 
information is available for data entered directly into the eCRFs, this supporting 
documentation will also be maintained. Source documents may include chart 
notes, laboratory reports, images, study specific source worksheets, eCRFs, 
device data files, etc. 

 
 
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12.2 Electronic Device Outputs 
 
PDM Data 
This study will utilize insulin delivery data from the PDM device. All insulin delivery 
data and all CGM readings (when there is a connected transmitter) from the 
Manual Mode phase will be stored on the PDM and exported to Insulet Cloud. 
Data will be saved in a compatible format that will be extractable for statistical 
analysis purposes.  
 
CGM Data 
This study will utilize CGM measurements from the CGM device. CGM data will be 
saved in a compatible format that will be extractable for statistical analysis 
purposes.  
 
BG and Ketone Meter Data 
This study will also utilize measurements from a BG and ketone meter. BG and 
Ketone meter data, in any format, will be uploaded to the database.  
12.3 Subject Identifiers 
All data used in the analysis and reporting of the study will be without identifiable 
reference to the subject. Only the unique subject number will be used to identify 
subject data submitted to the Sponsor, and only the investigating clinical site will 
be able to link the unique subject ID to the subject’s name. 
12.4 Monitoring Responsibilities 
This study will be monitored for compliance with the protocol and applicable 
regulatory requirements. A study specific monitoring plan will specify the minimum 
frequency, scope, and general conduct of monitoring visits as well as identify any 
relevant study-specific monitoring responsibilities. 
Monitors for this study will be qualified by education, experience and training. The 
monitor will document any non-compliance with the protocol, applicable 
regulations, or any conditions imposed by the IRB or local regulatory authority. If 
compliance cannot be secured, device shipments to the Investigator may be 
discontinued and the Investigator’s participation in the study terminated. 
Investigators and clinical site coordinators are expected to make source files and 
other records and reports available to the monitors as required. 
12.5 Inspection of Records 
The Sponsor or its designee may perform quality assurance site and study file 
audits at the site. Investigators and institutions involved in the study will permit 
trial-related monitoring, audits, IRB review, and regulatory inspection by providing 
direct access to all study records. In the event of an audit or inspection, the 
investigator agrees to allow the Sponsor, representatives of the Sponsor, the FDA, 
or other regulatory authorities access to all study records. 

 
 
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The investigator should promptly notify the Sponsor of any study inspections 
scheduled by the regulatory authorities and promptly forward copies of any audit 
reports received to the Sponsor. 
12.6 Study Record Retention 
Records and reports must remain on file at the investigational site for a minimum 
of two years after the later of either the completion/termination of the study or the 
date of market approval for the indication being studied. They may be discarded 
only upon approval from the Sponsor. The Principal Investigator must contact the 
Sponsor before destroying any records and reports pertaining to the study to 
ensure that they no longer need to be retained. In addition, the Sponsor must be 
contacted if the investigator plans to leave the investigational site to ensure that 
arrangements for a new investigator or records transfer are made prior to 
investigator departure. 
12.7 Device Accountability 
Investigators will be responsible for investigational device accountability, 
reconciliation, and records maintenance throughout the course of the 
investigation. As it is expected most subjects will participate in both studies, all 
device accountability will be tracked as part of the Omnipod Horizon Pivotal Study 
and the inventory can be used for either study. Accountability records will include 
receipt, use and final disposition of investigational product.  
Study devices must be stored according to the conditions set forth for the device 
on the label in a controlled, locked area. All device shipment records (packing 
lists, etc.) must be maintained at the clinical site.  
The study monitor will verify accountability of the study devices during routine 
monitoring visits to the clinical site. 
13 STUDY ETHICS AND CONDUCT 
13.1 Role of the Sponsor 
As the Sponsor of this clinical study, Insulet has the overall responsibility for the 
conduct of the study, including assurance that the study meets the requirements 
of the appropriate regulatory bodies. In this study, the Sponsor will have certain 
direct responsibilities and may delegate certain study tasks to the Contract 
Research Organization (CRO). 
13.2 Ethical Conduct of the Study 
The investigation will be conducted according to the applicable FDA regulations 
(21CFR 812, 56, 54, 50). The investigator will conduct all aspects of this study in 
accordance with all state, and local laws or regulations. 

 
 
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13.3 Institutional Review Board (IRB) 
Federal regulations (21 CFR 812) require that approval be obtained from an IRB 
prior to participation of subjects in research studies. Prior to subject enrollment, a 
signed copy of the IRB approval letter must be submitted to the Sponsor. In 
addition, the protocol, informed consent, advertisements to be used for subject 
recruitment, and any other written information regarding this study to be provided 
to the subject must be approved by the IRB. Documentation of all IRB approvals 
will be maintained by the clinical site and will be available for review by the 
Sponsor or its designee. 
All IRB approvals should be signed by the IRB chairperson or designee and must 
identify the IRB by name and address, the clinical protocol by title and/or protocol 
number, and the date approval was granted. 
The Investigator is responsible for submitting and obtaining initial and continuing 
review of the trial at intervals not exceeding 1 year or as otherwise directed by the 
IRB. The investigator must supply the Sponsor, or its designee written 
documentation of continued review of the study. 
13.4 Informed Consent 
A written informed consent in compliance with 21 CFR 50 shall be obtained from 
each subject prior to participating in the study or performing any unusual or non-
routine procedure that involves risk to the subject. An informed consent form (ICF) 
template will be provided by the Sponsor or designee to investigative clinical sites. 
If any institution-specific modifications to study-related procedures are proposed 
or made by the clinical site, the consent must be reviewed by the Sponsor prior to 
IRB submission. Once reviewed, the consent will be submitted by the investigator 
to their IRB for review and approval prior to the start of the study. 
Before recruitment and enrollment, each prospective subject will be given a full 
explanation of the study and be allowed to read the approved ICF. Once the 
investigator or designee is assured that the subject understands the implications 
of participating in the study, the subject will be asked to give consent to participate 
in the study by signing the ICF. 
The investigator or designee shall provide a copy of the signed ICF to the subject. 
The original form shall be maintained in the subject binder at the clinical site. 
13.5 Confidentiality 
All information and data sent to the Sponsor concerning study subjects or their 
participation in this trial will be considered confidential. Only authorized personnel 
will have access to these confidential files. All records will be kept in secure 
storage areas and on password-protected computers.  
This includes, but is not limited to the following: 
• 
Subjects will be identified on all eCRFs by a unique subject ID 

 
 
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• 
eCRFs are confidential documents and will only be available to the Sponsor 
(including delegates, such as CRAs), Medical Monitor, CRO, the investigator 
and study staff, and if requested, to the IRB or regulatory authorities. The 
investigator will maintain, as part of the investigation file, a list identifying all 
subjects entered into the study. 
All laboratory specimens, evaluation forms, reports, and other records will be 
identified in a manner designed to maintain subject confidentiality. Clinical 
information will not be released without the written permission of the subject, 
except as necessary for monitoring and auditing by the Sponsor, its designee, the 
FDA, or the IRB. 
The investigator and all clinical site staff involved in this study may not disclose (or 
use for any purpose other than performance of the study), any data, record, or 
other unpublished confidential information disclosed to those individuals for the 
purpose of the study. Prior written agreement from the Sponsor or its designee 
must be obtained for the disclosure of any said confidential information to other 
parties. 
13.6 Modification of the Protocol 
Any changes in this research activity, except those necessary to remove an 
apparent immediate hazard to the subject, must be reviewed and approved by the 
Sponsor. The protocol amendment(s) must be signed by the investigator and 
approved by the IRB before implementation. The protocol amendment(s) will be 
filed with the appropriate regulatory agency(s) having jurisdiction over the conduct 
of the study. 
Substantial changes will require approval from the Sponsor, FDA, and IRB prior to 
implementation. 
13.7 Protocol Deviations 
The investigator will not deviate from the protocol without prior written approval 
from the Sponsor except in medical emergencies or inadvertently. In medical 
emergencies, prior approval for protocol deviations will not be required, but the 
Sponsor must be notified within 2 working days of the incident. Periodic monitoring 
of protocol compliance will be performed for each clinical site. The Sponsor has 
the right to suspend enrollment at clinical sites deemed to have excessive protocol 
compliance issues. 
All deviations related to study inclusion or exclusion criteria, conduct of the study, 
subject management or subject assessment must be appropriately documented 
and reported. Other protocol deviations to be considered include non-adherence 
to the protocol that results in a significant additional risk to the subject, or non-
adherence to FDA regulations.  
The investigator must document and explain any protocol deviation in the 
subject’s eCRF. Protocol deviations should be reported to the IRB according to 
their requirements. Deviations will also be reviewed by the monitor during clinical 
site visits and those observations may be discussed with the investigator. 

 
 
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The Sponsor will evaluate circumstances where the investigator deviates from the 
study protocol and will retain the right to remove either the investigator or the 
investigational clinical site from the study. 
13.8 Study Reporting Requirements 
By participating in this study, the investigator agrees to submit SAE reports 
according to the timeline and method outlined in this protocol. In addition, the 
investigator agrees to submit annual reports to his/her IRB as appropriate. 
Upon completion or termination of the study, the principal investigator (PI) must 
submit a final written report to the Sponsor and IRB. The report must be submitted 
within 3 months (90 days) of completion or termination of the trial. 
The Sponsor will submit all reports required by the appropriate regulatory 
authorities, including unanticipated adverse device effects, withdrawal of IRB 
approval, list of current investigators, annual progress reports, recall information, 
final reports and protocol deviations. 
13.9 Selection of Investigators 
The Sponsor will select qualified investigators, ship devices only to participating 
investigators, obtain a signed Investigator’s Agreement and provide all 
investigators with the information and training necessary to conduct the study. 
 
Financial Disclosure 
Investigators and sub-investigators are required to provide financial disclosure 
information to allow the Sponsor to submit the complete and accurate certification 
or disclosure statements required under 21 CFR 54. In addition, the investigator 
must notify the Sponsor promptly of any relevant changes that occur during the 
course of the study, at the completion of the study, and 1 year following the 
completion of the study. 
 
Investigator Documentation 
Prior to beginning the study, the investigator will be asked to comply with 21 CFR 
812 by providing the following essential documents, including but not limited to: 
• 
An investigator-signed Investigator Agreement page of the protocol  
• 
An IRB approved informed consent, samples of clinical site advertisements 
for recruitment for this study, and any other written information regarding this 
study that is to be provided to the subject 
• 
IRB approval of the investigator, protocol, and acknowledgement of the user 
guide 
• 
Curricula vitae (CV) for the PI and each investigator participating in the 
study. Current licensure must be noted on the CV or a copy of the license 

 
 
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provided. CVs must be signed and dated by the investigators within 1 year of 
study start-up, indicating that they are accurate and current. 
• 
Financial disclosure information (as stated above) and a commitment to 
promptly update this information if any relevant changes occur 
13.10 Clinical Site Training 
The training of appropriate clinical site personnel will be the responsibility of the 
Sponsor or its designee. Sites will not be required to be retrained on the study 
devices since the sites have previously been trained during the execution of the 
Omnipod Horizon™ Pivotal Study (G190270).  To ensure proper device usage, 
uniform data collection, and protocol compliance, the Sponsor or designee will 
present a training overview to relevant clinical study site personnel. Clinical 
study personnel trained by the Sponsor may also train additional clinical study 
personnel at their site. The Sponsor reserves the right to enforce retraining for 
clinical sites who have demonstrated study or procedure compliance issues. 
Protocol-specific training will occur for all research personnel and key ancillary 
staff who will be involved in subject care. 
13.11 Device Use 
The Omnipod Horizon™ System consists of the following primary components: 
an Omnipod Horizon™ Pod, Omnipod Horizon™ Controller, and the iCGM. 
The Pod and PDM are intended for single use only. The PDMs will be returned 
to the Sponsor after completion of the study if the subject is not continuing in the 
Omnipod Horizon™ Pivotal Study (G190270). 
The Dexcom G6 CGM sensor (the component of the system that enters the 
skin), and the Dexcom G6 CGM transmitter (the component of the system that 
attaches to the sensor to transmit the signal). 
Study blood glucose meters and ketone meters will not be cleaned or reused by 
subjects. A new meter will be used for each subject. 
13.12 Device Returns 
Any unused or damaged investigational devices or investigational devices 
related to a suspected deficiency or adverse event must be returned to the study 
Sponsor. To initiate the return, the clinical site will contact the Sponsor 
representative and provide the following information: 
• 
Part number/Lot number 
• 
Quantities 
• 
Tracking number 

 
 
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13.13 Policy for Publication and Presentation of Data 
All data and results and all intellectual property rights in the data and results 
derived from the study will be the property of the study Sponsor, Insulet.  
13.14 Sponsor or Regulatory Agency Termination of the Study 
Although the Sponsor intends to complete the study, the Sponsor reserves the 
right to stop the study at any time for clinical or administrative reasons, or if 
required by the local regulatory authority, with suitable written notice to the 
investigators and regulatory authorities as appropriate. 
Similarly, investigators may withdraw from the study by providing written 
notification to the Sponsor within 30 days of intent to withdraw. However, the 
Sponsor and investigators will be bound by their obligation to complete the 
follow-up of subjects already enrolled in the trial. Subjects must be followed 
according to the clinical protocol and information obtained during subject follow-
up shall be reported on the eCRF. 
 
 

 
 
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APPENDIX A