Omnipod 5 System Compared to Pump Therapy

Study Overview
=================
Brief Summary
-----------------
Subject will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 90-day outpatient phase where subjects will either use the Omnipod 5 system or continue to use their personal insulin pump with the study provided continuous glucose monitoring system.

Detailed Description
-----------------
This is an outpatient study that consists of two phases, Phase 1 and Phase 2. There will be approximately 8 study visits conducted in person or via telehealth. Phase 1 is a 14-day period to collect baseline sensor and insulin data where subjects will manage their diabetes at home per their usual routine using the study continuous glucose monitoring system. Phase 2 is a 90-day period where subjects will be randomized into one of two groups. One group will use the Omnipod 5 system and the other group will continue to use their personal insulin pump with the study continuous glucose monitoring system.

Official Title
-----------------
Efficacy and Safety of the Omnipod 5 System Compared to Pump Therapy in the Treatment of Type 1 Diabetes: a Randomized, Parallel-group Clinical Trial

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Device: Omnipod 5 System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age at time of consent 18-70 years of age Diagnosed with type 1 diabetes for at least 1 year. Diagnosis is based on investigator's clinical judgment. On pump therapy for ≥ 3 months prior to screening and familiar with pump therapy concepts such as basal and bolus insulin delivery, and carbohydrate counting. Participants using automated insulin delivery (AID) devices, including devices with predictive low glucose suspend (PLGS), in the 3 months prior to screening, will be excluded from participating. A1C 7.0-11.0% by point-of-care taken at screening visit Willing to use and obtain U-100 insulin: (either insulin aspart (Novolog, NovoRapid), or insulin lispro (Humalog, Admelog)), as the primary insulin treatment Must have a smartphone that supports the Dexcom app download and participants must be willing to use the app throughout the study Investigator has confidence that the participant can safely operate all study devices and can adhere to the protocol Willing to wear the system continuously throughout the study Willing and able to sign the Informed Consent Form (ICF) Exclusion Criteria: Any medical condition, such as untreated malignancy, unstable cardiac disease, unstable or end-stage renal failure, eating disorders, or other conditions which in the opinion of the investigator, would put the participant at an unacceptable safety risk History of severe hypoglycemia in the past 6 months History of diabetic ketoacidosis (DKA) in the past 6 months, unrelated to an intercurrent illness or infusion set failure 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. Currently on systemic steroids or intends to receive systemic steroid treatment during study participation, including stable treatment for adrenal insufficiency. Inhaled, ophthalmic, topical, joint injection, and other locally applied steroids are allowed. Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement Use of non-insulin anti-hyperglycemic medication other than metformin, in the 12 weeks prior to the Baseline Visit. Participants taking metformin should remain on a steady dose during study participation. Pregnant or lactating, or is a woman of childbearing potential and not on acceptable form of birth control (acceptable forms of contraception include abstinence, barrier methods such as condoms, hormonal contraceptives, intrauterine device, surgical sterilization such as tubal ligation or hysterectomy, or vasectomized partner) Participation in another clinical study using an investigational drug or device within 30-days or 5 half-lives (whichever is longer) prior to screening, or intends to participate in any other study during this 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 of any of the aforementioned

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention Arm<br>Omnipod 5 System with Dexcom G6 continuous glucose monitoring system | Device: Omnipod 5 System<br>* Omnipod 5 System automates insulin delivery based on information received from the continuous glucose monitoring system every 5 minutes.<br>|
| No Intervention: Control Arm<br>Participant's current insulin pump with Dexcom G6 continuous glucose monitoring system | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of time in range 70-180 mg/dL | Glucose metric from study continuous glucose monitoring system | Comparing intervention group with control group during the 13-week study phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of time <54 mg/dL (non-inferiority) | Glucose metric from study continuous glucose monitoring system | Comparing intervention group with control group at the end of the 13-week study phase | 
| Percent of time >180 mg/dL | Glucose metric from study continuous glucose monitoring system | Comparing intervention group with control group at the end of the 13-week study phase | 
| Mean Glucose | Glucose metric from study continuous glucose monitoring system | Comparing intervention group with control group at the end of the 13-week study phase | 
| Change in A1C | Measures device effectiveness | Baseline compared to end of study visit (Day -30 to Day 90) | 
| Percent of time <70 mg/dL | Glucose metric from study continuous glucose monitoring system | Comparing intervention group with control group at the end of the 13-week study phase | 
| Change in Diabetes Distress Scale for Adults with Type 1 Diabetes (T1-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 study visit (Day -14 to Day 90) | 
| Change in Hypoglycemic Confidence Scale (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 of study visit (Day -14 to Day 90) | 
| Change in Diabetes Quality of Life (DQL)-brief total score | A questionnaire that assesses the relative burden of an intensive diabetes treatment regimen (15-item scale with 5 choices that range from 1 (Very Dissatisfied/All the Time) to 5 (Very Satisfied/Never)). The total score can range from 1 to 5, with a higher score indicating a better outcome. | Baseline compared to end of study visit (Day -14 to Day 90) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
T1D, Omnipod, Automated Insulin Delivery