OP5-005 Using Omnipod 5 in Adults With Type 2

Study Overview
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Brief Summary
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This is a single arm, multi-center, prospective study that will evaluate the safety and efficacy of the Omnipod 5 Automated Insulin Delivery System in adults with type 2 diabetes requiring insulin therapy.

Detailed Description
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This outpatient study consists of 2 phases. Phase 1 is a 14-day period to collect baseline glucose and insulin data. Participants will manage their diabetes as an outpatient per their usual routine. During this time participants will wear a blinded continuous glucose monitor to collect baseline glycemic information. Phase 2 is a 13 week treatment period during which participants will use the Omnipod 5 System consisting of the Omnipod 5 pod, Omnipod 5 app as well as a Dexcom G6 continuous glucose monitor. Participants will do in-clinic or virtual visits at least monthly for a total of 8 visits. During the treatment period all participants will undergo supervised exercise and meal challenges.

Official Title
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Safety and Efficacy of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 2 Diabetes

Conditions
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Type2 Diabetes

Intervention / Treatment
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* Device: Omnipod 5 Automated Glucose Control System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age at time of consent 18-75 years 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) 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% Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog Participant agrees to provide their own insulin for the duration of the study Stable doses over the preceding 4 weeks of other glucose-lowering medications as determined by Investigator 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 Willing to wear the system continuously throughout the study Deemed appropriate for pump therapy per investigator's assessment considering previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities Investigator has confidence that the participant has the cognitive ability and can successfully operate all study devices and can adhere to the protocol Able to read and understand English or Spanish Willing and able to sign the Informed Consent Form (ICF) If female of childbearing potential, willing and able to have pregnancy testing Exclusion Criteria: Use of an AID pump in automated mode within 3 months prior to screening 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) 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 Any planned surgery during the study which could be considered major in the opinion of the investigator History of more than 1 severe hypoglycemic event in the 6 months prior to screening 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 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 Plans to receive blood transfusion over the course of the study Has taken oral or injectable steroids within 8 weeks prior to screening or plans to take oral or injectable steroids during the study Unable to tolerate adhesive tape or has any unresolved skin condition that could impact sensor or pump placement 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) 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 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>All subjects wearing the Omnipod 5 Automated Glucose Monitoring System | Device: Omnipod 5 Automated Glucose Control System<br>* The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c | The change in HbA1c at 13 weeks from baseline | Comparing the change in HbA1c during the 13 weeks study phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Glucose | Glucose metric from study provided continuous glucose monitor (CGM) | Measuring mean glucose during the 13 weeks study phase | 
| Percentage of time in range 70-180 mg/dL | Glucose metric from CGM | Measured during 13 weeks study phase | 
| Percent of Time in Range 70-140 mg/dL | Glucose metric from study CGM | Measured during 13 weeks study phase | 
| Percent of Time ≥ 300 mg/dL | Glucose metric from CGM | Measured during 13 weeks study phase | 
| Percent of Time ≥ 250 mg/dL | Glucose metric from CGM | Measured during 13 weeks study phase | 
| Percent of Time >180 mg/dL | Glucose metric from CGM | Measured during 13 weeks study phase | 
| Percent of Time < 70 mg/dL | Glucose metric from CGM | Measured during 13 weeks study phase | 
| Percent of Time < 54 mg/dL | Glucose metric from CGM | Measured during 13 weeks study phase | 
| Change from baseline in T2-DDS total score | A questionnaire that measures seven critical dimensions of distress (28-item scale with 6 choices that range from 1 (Not a Problem) to 6 (A Very Serious Problem)). The total score can range from 1 to 6, with a lower score indicating a better outcome. | Baseline compared to end of week 13 visit | 
| Change from baseline in HCS total score | A questionnaire that examines the degree to which people with diabetes feel able, secure, and comfortable regarding their ability to stay safe from hypoglycemic-related problems (9-item scale with 4 choices that range from 1 (Not Confident At All) to 4 (Very Confident)). The total score can range from 1 to 4, with a higher score indicating a better outcome. | Baseline compared to end week 13 visit | 
| Change from baseline in PSQI total score | Used to measure sleep disturbance and usual sleep habits | Baseline compared to end of week 13 visit | 
| Percentage of time <70 mg/dL | Glucose metric from CGM | Measured during 13 weeks study phase | 
| Percentage of time <54 mg/dL | Glucose metric from CGM | Measured during 13 weeks study phase | 
| Coefficient of variation | Glucose metric from CGM measured glucose variability with the coefficient of variation (CV) | Measured during 13 weeks study phase and compared to standard therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T2D, Omnipod, Automated Insulin Delivery