Safety and Efficacy of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 2 Diabetes
Phase: NA
Conditions: Type2 Diabetes
Sponsor: Insulet Corporation

 
SECURE T2D_PROTOCOL V3.2_27FEB2024_SYNOPSIS                                                 CONFIDENTIAL 
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Safety and Efficacy of the Omnipod® 5 Automated 
Insulin Delivery System in Adults with Type 2 Diabetes 
 
Protocol Identifying Number: SECURE-T2D 
IDE G230013 
IDE Sponsor: Insulet 
 
Funded by: Insulet Corporation 
Version Number: 3.2  
27 February 2024 
 

 
SECURE T2D_PROTOCOL V3.2_27FEB2024_SYNOPSIS                                                 CONFIDENTIAL 
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PROTOCOL SUMMARY 
1 
Title 
Safety and Efficacy of the Omnipod® 5 Automated Insulin Delivery System 
in Adults with Type 2 Diabetes 
Purpose 
This single-arm, multi-center, prospective study will evaluate the safety 
(primary) and efficacy (secondary) of the Omnipod® 5 Automated Insulin 
Delivery System in adults with type 2 diabetes requiring insulin therapy. 
Investigational Device 
Omnipod® 5 Automated Insulin Delivery System, comprised of the 
following components: 
• 
Omnipod 5 Pod 
• 
Omnipod 5 App (installed on the Insulet-provided Controller or smart 
phone) 
 
Objectives 
Primary Objective:  
• 
To evaluate the safety of the Omnipod 5 System in adults with 
type 2 diabetes.  
Secondary Objectives:  
• 
To evaluate the efficacy of the Omnipod 5 System in adults with 
type 2 diabetes. 
• 
To evaluate glycemia measures of efficacy of the Omnipod 5 
System and quality of life of Omnipod 5 System users. 
Study Design 
Single-arm, multi-center, prospective study 
Number of Sites 
~20-25 sites in the United States 
Endpoints 
Safety 
Primary Endpoint: Change in HbA1c at 13 weeks from baseline 
• 
Tested first for non-inferiority (non-inferiority limit 0.3%) and then 
if non-inferiority is demonstrated, tested sequentially for 
superiority 
 
Additional Safety Endpoints: 
1. Severe hypoglycemia  
2. Hospitalization/ER for severe hypoglycemia   
3. Hyperosmolar hyperglycemic syndrome (HHS)/ diabetic 
ketoacidosis (DKA) 
4. Hospitalizations or ER related to hyperglycemia or hypoglycemia 
in the previous 3 months vs. study 3 months 
5. Other related serious adverse events 
6. Reportable device-related adverse events 
 
Additional Key Secondary Endpoints 
 
The following secondary endpoints will be tested hierarchically if the 
primary HbA1c analyses for non-inferiority followed by testing for 
superiority are statistically significant 
 
1. Mean glucose (superiority) 
2. Change in % time 70-180 mg/dL (superiority) 

 
SECURE T2D_PROTOCOL V3.2_27FEB2024_SYNOPSIS                                                 CONFIDENTIAL 
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3. Change in % time 70-140 mg/dL (superiority) 
4. Change in % time ≥ 300 mg/dL (superiority) 
5. Change in % time > 250 mg/dL (superiority) 
6. Change in % time > 180 mg/dL (superiority) 
7. % time < 70 mg/dL (noninferiority; margin = 2.0%) 
8. % time < 54 mg/dL (noninferiority; margin = 0.5%) 
9. T2-DDAS total score (superiority) 
10. Change in % T2-DDAS total score >5.0 (high distress) 
11. PSQI total score (superiority) 
12. Change in % PSQI total score ≥2.0 (poor sleep) 
13. HCS total score (superiority) 
14. Change in HCS total score <3.0 (low confidence) 
15. % time <70 mg/dL (superiority) 
16. % time <54 mg/dL (superiority) 
17. Coefficient of variation (superiority) 
 
Population 
Inclusion Criteria: 
Participants must meet all of the following criteria to be included in the 
study: 
1. Age at time of consent 18-75 years 
2. Diagnosed with type 2 diabetes, on current insulin regimen for at 
least 3 months prior to screening (i.e. Basal-bolus, basal only or 
pre-mix) 
3. Basal bolus (long-acting insulin and rapid acting analog) or pre-
mix users with A1C <12.0% OR basal users on long or 
intermediate acting insulin only with A1C > 7.0% and < 12.0% 
4. Willing to use only the following types of U-100 insulin during the 
study: Humalog U-100, Novolog, or Admelog 
5. Participant agrees to provide their own insulin for the duration of 
the study 
6. Stable doses over the preceding 4 weeks of other glucose-
lowering medications as determined by Investigator 
7. Stable doses of weight loss medications over the preceding 4 
weeks and throughout the study that may affect glycemic control 
directly and/or indirectly, except for a dose reduction or 
discontinuation, 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 participant has the cognitive 
ability and can successfully operate all study devices and can 
adhere to the protocol 
11. Able to read and understand English or Spanish 
12. Willing and able to sign the Informed Consent Form (ICF) 
13. If female of childbearing potential, willing and able to have 
pregnancy testing 
 
Exclusion Criteria: 

 
SECURE T2D_PROTOCOL V3.2_27FEB2024_SYNOPSIS                                                 CONFIDENTIAL 
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Participants who meet any of the following criteria will be excluded from 
the study: 
1. Use of an AID pump in automated mode within 3 months prior to 
screening 
2. Any medical condition which in the opinion of the investigator, would 
put the participant at an unacceptable safety risk, such as untreated 
malignancy, unstable cardiac disease, unstable or end-stage renal 
disease, and/or eating disorders (i.e. anorexia/bulimia) 
3. 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 12 months prior to 
screening 
4. Any planned surgery during the study which could be considered 
major in the opinion of the investigator 
5. History of more than 1 severe hypoglycemic event in the 6 months 
prior to screening 
6. History of more than 1 episode of diabetic ketoacidosis (DKA) or 
Hyperosmolar hyperglycemic syndrome (HHS) in the 6 months prior 
to screening; unrelated to an intercurrent illness; kinked, dislodged, or 
occluded cannula; or initial diabetes diagnosis 
7. Blood disorder or dyscrasia within 3 months prior to screening, 
including use of hydroxyurea, which in the investigator’s opinion could 
interfere with determination of HbA1c  
8. Plans to receive blood transfusion over the course of the study 
9. Has taken oral or injectable steroids within 8 weeks prior to screening 
or plans to take oral or injectable steroids during the study 
10. Unable to tolerate adhesive tape or has any unresolved skin condition 
that could impact sensor or pump placement 
11. Pregnant or lactating, planning to become pregnant during the study, 
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); childbearing potential 
means that menstruation has started, and the participant is not 
surgically sterile or greater than 12 months post-menopausal) 
12. Participation in another clinical study using an investigational drug or 
device other than the Omnipod 5 in the 30 days prior to screening or 
intends to participate during the study period 
13. 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 
14. Participant is an employee of Insulet, an Investigator or Investigator’s 
study team, or immediate family member (spouse, biological or legal 
guardian, child, sibling, parent) of any of the aforementioned 
 
Sample Size 
Up to 400 screened participants to provide a cohort of 300 initiating use 
of the Omnipod 5 system and at least 275 completing the trial. A 
minimum of 60 and maximum of 125 participants using basal only. 
Treatment Groups 
Single-arm intervention that consists of 13 weeks of treatment using the 
Omnipod 5 System 

 
SECURE T2D_PROTOCOL V3.2_27FEB2024_SYNOPSIS                                                 CONFIDENTIAL 
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Participant Duration 
~15-17 weeks (allowing for screening and scheduling) 
Study Duration (planned) 
~8-10 months 
Study Methods 
The study will consist of a 14-day standard therapy phase to capture 
baseline glycemic management followed by 13 weeks of treatment using 
the Omnipod 5 System. This is an outpatient study with unrestricted 
meals and activity, designed to emulate real world use. After the initial 
screening and enrollment visits, participants will have an in-clinic or virtual 
visit at least monthly. Devices will be returned at the end of the 13-week 
treatment period.  
During the treatment period participants will undergo supervised exercise 
and meal challenges. Meal challenges will take place over 4 days. Meal 
challenges will consist of matched meals where participants will bolus on 
Days 1 and 3 for their selected meal. On Days 2 and 4 participants will 
consume a matched meal to Days 1 and 3 and not bolus. The exercise 
challenges will take place on 3 days and will consist of 1 hour of mild 
intensity and 30 minutes of moderate intensity exercise.  
Statistical Methods 
A hierarchical testing scheme will be used to test for statistical 
significance of the change in the primary and key secondary outcomes 
listed above over 13 weeks of treatment. 
The primary outcome of interest is HbA1c. Change in HbA1c will be 
tested for non-inferiority, comparing the HbA1c results from the Standard 
Therapy period to the Treatment period; if non-inferiority is established, 
superiority will be tested. The details are as follows: 
• 
Non-inferiority test for mean change in HbA1c from the Standard 
Therapy period to the Treatment period (e.g., HbA1cTreatment - 
HbA1cStandard = μ_δ) at alpha=0.025 with non-inferiority 
margin on 0.3%. 
• 
Superiority test (two-sided) for μ_δ = 0 at alpha=0.05. 
Summary statistics appropriate to the distribution will be generated for the 
Standard Therapy and Treatment periods, as well as for the difference 
(HbA1cTreatment – HbA1cStandard).  
A paired t-test will be used to compare the change in HbA1c from 
Standard Therapy to the end of the Treatment periods. It is expected the 
change in HbA1c will follow a relatively normal distribution. If not normally 
distributed, robust regression using M-estimation with the Huber weight 
function will be used instead of a pair t-test. A point estimate and 95% 
confidence interval will be given for the mean change in HbA1c from 
baseline to 13 weeks. 
If statically significant results (i.e., p ≥ 0.05) are obtained for the primary 
endpoints, the key secondary outcomes will be tested hierarchical in the 
order listed above. If any of the key secondary outcomes fail to give a 
statistically significant result, then formal testing will stop and p-values will 
not be given for any outcomes further down on the list. Summary 
statistics and confidence intervals will be given for each outcome 
regardless of statistical significance. Note that each of the CGM metrics 
in the hierarchical listing refers to the overall 24-hour version. 
All adverse events and additional safety outcomes listed above will be 
tabulated for each period (Standard Therapy and Treatment). The 
number of events and event rate per 100 person-years during the 
Treatment period will also be calculated.  

 
SECURE T2D_PROTOCOL V3.2_27FEB2024_SYNOPSIS                                                 CONFIDENTIAL 
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McNemar’s test will be used to compare the percentage of participants 
with hospitalization or ER visits related to hyper- or hypoglycemia during 
the 13-week Treatment period compared with the 13-week period prior to 
enrollment. 
All variables will be examined for normality of their distributions and, if 
applicable, standard residual diagnostics will be performed. If values are 
highly skewed, then a nonparametric or robust regression M-estimation 
method will be used instead. 
 
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