Evaluating the Safety and Effectiveness of the Omnipod® 5 Automated Insulin Delivery System in Patients With Type 2 Diabetes
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Sponsor: Insulet Corporation

 
 
Omnipod 5 T2 Feasibility Study Protocol V5.0 
         
Confidential 
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Evaluating the Safety and Effectiveness of the Omnipod® 5 
Automated Insulin Delivery System in Patients with Type 2 
Diabetes 
 
 
IDE G190270 
Version 5.0 
27 July 2021 
 
 
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. 
 
 

 
 
Omnipod 5 T2 Feasibility Study Protocol V5.0 
         
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PROTOCOL SUMMARY 
Protocol title 
Evaluating the safety and effectiveness of the Omnipod 5 Automated Insulin 
Delivery System in patients with type 2 diabetes 
Protocol ID 
G190270 
Purpose 
To obtain feasibility data using the Omnipod 5 Automated Insulin Delivery 
System in patients with type 2 diabetes with suboptimal glycemic control.  
Design 
This study is a multi-center, feasibility study  
Enrollment 
A total of up to 36 subjects will be enrolled in the study to obtain a minimum of 
24 evaluable subjects enrolled across 3-6 clinical study sites. 
 
The study subjects will be separated into 2 groups (N=12 each), depending on 
their previous insulin therapy with approximately 50% of subjects from each 
group, CGM naive: 
 
Basal-Bolus – Group A 
• 
2 weeks standard therapy – using multiple daily injections (MDI) and 
Dexcom G6 CGM, followed by: 
• 
4 weeks OP5 in Automated Mode with optional bolus, followed by: 
• 
4 weeks OP5 in Automated Mode with simplified bolus 
• 
6 month extension using Automated Mode (optional) 
 
Basal – Group B 
• 
2 weeks standard therapy – using basal injection only and Dexcom G6 
CGM, followed by: 
• 
2 weeks OP5 in Manual Mode with Dexcom G6 CGM – with fixed basal 
rate, no bolus, followed by:  
• 
4 weeks OP5 in Automated Mode with optional bolus, followed by: 
o 
If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 
4 weeks OP5 in Automated Mode with simplified bolus, OR 
o 
If % time in range 70-180 mg/dL during Automated Mode is >50%, 
4 weeks OP5 in Automated Mode with optional bolus 
• 
6 month extension using Automated Mode(optional) 
Indication 
The Omnipod 5 (OP5) is a single hormone insulin delivery system intended for 
the management of diabetes in persons requiring insulin. Continuous 
subcutaneous insulin infusion may be delivered by user-defined settings 
(manual mode) or automatically adjusted in response to feedback from a 
continuous glucose monitor (CGM).  
 
The Omnipod 5 can automatically increase insulin delivery based on CGM 
sensor glucose values and can decrease or suspend delivery of insulin when 
the glucose value falls below or is predicted to fall below predefined threshold 
values. The Omnipod 5 is interoperable with compatible iCGMs and ACE 
pumps. 
 
The Omnipod 5 is designed to assist patients with diabetes in achieving 
glycemic targets set by their health care providers.  

 
 
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Study duration 
The study is expected to be completed within 18-months which includes clinical 
site initiation to completion and all data entry and monitoring procedures. The 
results from the 6 month extension for both groups will be evaluated and 
submitted separately from the other phases of the study. 
Investigational 
devices 
The Omnipod 5 is comprised of the following components: 
• 
Omnipod 5 tubeless, insulin delivery alternate controller enabled (ACE) 
pump (Pod) powered by the Horizon algorithm 
• 
Omnipod 5 Personal Diabetes Manager (PDM) which is a Samsung J3 
locked down Android device that operates the Horizon App.  
• 
Dexcom G6 - Continuous Glucose Monitoring (CGM) system  
Non-
investigational, 
commercially 
available devices 
• 
Contour® Next One blood glucose meter (Ascensia Diabetes Care, 5 Wood 
Hollow Road, Parsippany, NJ 07054 USA) 
 
Primary safety 
objective 
To evaluate the safety of the Omnipod 5 Automated Insulin Delivery System in 
patients with type 2 diabetes.  
Primary safety 
endpoints 
The primary safety objective will be evaluated by summarizing the following 
during Automated Mode:  
 
• 
Hyperglycemia - Overall percentage of time ≥250 mg/dL during all phases 
of Automated Mode 
• 
Hypoglycemia – Overall percentage of time <54 mg/dL during all phases of 
Automated Mode 
 
The results from the 6 month extension for both groups will be evaluated and 
submitted separately from the other phases of the study. 
Secondary 
objective 
To evaluate additional glycemic measures of effectiveness of the Omnipod 5 
Automated Insulin Delivery System. 
Secondary 
endpoints 
Per subject glucose metrics during Automated Mode use will be compared to 
the standard therapy phase overall, separately for Group A and Group B:  
 
• 
Mean glucose 
• 
% of time in range 70-180 mg/dL 
• 
% of time > 180 mg/dL 
• 
% of time ≥ 250 mg/dL 
• 
% of time ≥ 300 mg/dL 
• 
% of time < 70 mg/dL 
• 
% of time < 54 mg/dL 
• 
Standard deviation 
• 
Coefficient of variation 
• 
Total daily insulin (TDI) (units, units/kg) 
• 
End of study A1C vs. baseline A1C 
 
The results from the 6 month extension for both groups will be evaluated and 
submitted separately from the other phases of the study. 
Patient Reported 
Outcomes 
Various subject completed questionnaires will be used to evaluate general and 
disease-specific quality of life, and device usability. 
Eligibility criteria 
Inclusion Criteria 
Subjects must meet all the following criteria to be included in the study: 

 
 
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1. Age at time of consent 18-75 years 
2. Diagnosed with type 2 diabetes on insulin therapy by injection: basal-bolus 
(12 subjects) or basal only (12 subjects) regimens 
3. A1C 8.0-12.0% 
4. Has not used an insulin pump within 3 months of screening 
5. Willing to use only the following types of insulin during the study: Humalog, 
Novolog, Admelog or Apidra during the study  
6. Maximum insulin dose of 200 units/day 
7. Stable doses over the last 4 weeks of other glucose-lowering medications 
as determined by Investigator 
8. Willing to wear the system continuously throughout the study 
9. Deemed appropriate for pump therapy per investigator’s assessment 
considering previous history of severe hypoglycemic and hyperglycemic 
events, and other comorbidities 
10. Investigator has confidence that the subject has the cognitive ability and 
can successfully operate all study devices and can adhere to the protocol 
11. Must be willing to use the Dexcom App on the Omnipod 5 PDM as the sole 
source of Dexcom data (except for the Dexcom Follow App) during 
Automated Mode 
12. Subjects scoring ≥ 4 on the Clarke Questionnaire must agree to have an 
overnight companion, defined as someone who resides in the same home 
or building as the study subject and who can be available overnight 
13. Able to read and speak English fluently 
14. Willing and able to sign the Informed Consent Form (ICF)  
 
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. Planned major surgery during the study 
3. History of severe hypoglycemia in the past 6 months 
4. History of diabetic ketoacidosis (DKA) in the past 6 months, unrelated to an 
intercurrent illness, infusion set failure or initial diagnosis 
5. Diagnosed with a blood dyscrasia or bleeding disorder  
6. Plans to receive blood transfusion over the course of the study 
7. Currently diagnosed with anorexia nervosa or bulimia 
8. Currently on hemodialysis 
9. History of adrenal insufficiency 
10. Has taken oral or injectable steroids within the past 8-weeks or plans to 
take oral or injectable steroids during the study 
11. Unable to tolerate adhesive tape or has any unresolved skin condition in 
sensor or pump placement 
12. Plans to use insulin other than U-100 insulin during the Omnipod 5 phase of 
the study 
13. Cardiac disease with functional status New York Heart Association Class III 
or IV or 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.  
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) 

 
 
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15. Participation in another clinical study using an investigational drug or device 
other than the Omnipod 5 in the preceding 30-days or intends to participate 
during the study period  
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  
The study subjects will be separated into 2 groups, depending on their previous 
insulin therapy with approximately 50% of subjects from each group, CGM 
naive: 
 
Basal-Bolus – Group A (N=12) 
• 
2 weeks standard therapy – using multiple daily injections (MDI) and 
Dexcom G6 CGM, followed by: 
• 
4 weeks OP5 in Automated Mode with optional bolus, followed by: 
• 
4 weeks OP5 in Automated Mode with simplified bolus 
• 
6 month extension using Automated Mode (optional) 
 
Basal – Group B (N=12) 
• 
2 weeks standard therapy – using basal injection only and Dexcom G6 
CGM, followed by: 
• 
2 weeks OP5 in Manual Mode with Dexcom G6 CGM – with fixed basal 
rate, no bolus, followed by:  
• 
4 weeks OP5 in Automated Mode with optional bolus, followed by: 
o 
If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 
4 weeks OP5 in Automated Mode with simplified bolus, OR 
o 
If % time in range 70-180 mg/dL during Automated Mode is >50%, 
4 weeks OP5 in Automated Mode with optional bolus 
• 
6 month extension using Automated Mode (optional) 
 
Following the subject screening, enrollment, and device training, subjects from 
both groups will commence the outpatient 2-week standard therapy phase 
using a Dexcom G6 CGM. After completion of the standard therapy phase, 
subjects will be trained on the use of Omnipod 5 and transition to either 
Automated Mode or Manual Mode use depending on which group they have 
been assigned.   
 
Current Dexcom G6 CGM users may provide data from a 14-day period within 
the last 30-days. For non-G6 users, subjects will wear a study CGM, in blinded 
mode, to record glucose measurements over 14-days while subjects manage 
their diabetes at home per their usual routine and remaining on their current 
MDI, and sensor, if applicable, for 14-days. 
 
Subjects in Group A will use Automated Mode for 4 weeks with optional 
boluses followed by 4 weeks of simplified boluses. Subjects will then be eligible 
to transition to the optional 6 month extension phase.  
 
Subjects in Group B will use the system for 2 weeks in Manual Mode with a 
CGM and a fixed basal rate and no bolus. After completion of Manual Mode, 
Group B subjects will commence using the system in Automated Mode for 4 
weeks with optional boluses. After completion of 4 weeks of Automated Mode, 
subjects will continue using Automated Mode for 4 weeks but will either 
continue using a simplified bolus or optional bolus depending on their time in 
range of 70-180 mg/dL over the previous 4 weeks of Automated Mode use. 

 
 
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Subjects will then be eligible to transition to the optional 6 month extension 
phase. 
 
Safety 
An independent Medical Monitor will be responsible for individual and timely 
review of adverse events. 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. 
Statistical 
Analysis 
General Statistical Methods 
Standard statistical methods will be employed to analyze all data. Data 
collected in this study will be presented using summary tables and subject data 
listings. Unless otherwise noted, all p-values will be considered significant at a 
two-sided significance level of 5%. Continuous variables will be summarized 
using descriptive statistics, including count, mean, median, standard deviation 
(SD), minimum and maximum, and first and third quartiles. 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. 
 
Sample Size 
This is a non-powered, multi-center, feasibility study. The sample size for the 
study is not hypothesis-driven and has been chosen to gather adequate safety 
and clinical performance data of the algorithm in the type 2 population. 
 
Primary Endpoint 
There are no hypotheses associated with the primary safety endpoints. The per 
subject percentage of time in each of the ranges will be summarized separately 
for each group no between-group analyses are planned. Standard summary 
statistics (i.e., mean, standard deviation, median, range) will be provided. Any 
statistical comparisons will be conducted at a two-sided significance level of 
5%. Data from all sites will be pooled for all analyses and summaries; no 
separate analyses by site or formal testing of poolability will be performed. 
 
Secondary Endpoint 
There are no hypotheses associated with the secondary endpoints. Each 
endpoint will be summarized separately for each group; no between-group 
analyses are planned. Standard summary statistics (i.e., mean, standard 
deviation, median, range) will be provided. Any statistical comparisons will be 
conducted at a two-sided significance level of 5%. 
 
Safety 
All adverse events reported over the course of the study will be summarized 
and tabulated by group, study phase if applicable, event category, seriousness, 
severity, and relationship to the study procedure 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).