Omnipod® 5 Automated Insulin Delivery System in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The study subjects will be separated into 2 groups, depending on their previous insulin therapy with approximately 50% of subjects from each group, continuous glucose monitoring (CGM) naive. Group A will complete a 2-week Standard Therapy Phase followed by 8 weeks of Omnipod 5 system use. Group B will complete a 2-week Standard Therapy Phase followed by 10 weeks of Omnipod 5 system use. Group A and Group B will have an optional 6-month extension of Omnipod 5 system use

Detailed Description
-----------------
Basal-Bolus - Group A (N=12) 2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 continuous glucose monitoring (CGM) , followed by: 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by: 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus 6-month optional extension using Automated Mode Basal - Group B (N=12) 2 weeks standard therapy - using basal injection only and Dexcom G6 continuous glucose monitoring (CGM) , followed by: 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 continuous glucose monitoring (CGM) - with fixed basal rate, no bolus, followed by: 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by: If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR If % time in range 70-180 mg/dL during Automated Mode is >50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus 6-month optional extension using Automated Mode

Official Title
-----------------
Evaluating the Safety and Effectiveness of the Omnipod® 5 Automated Insulin Delivery System in Patients With Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: Omnipod 5 Automated Insulin Delivery System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age at time of consent 18-75 years Diagnosed with type 2 diabetes on insulin therapy by injection: basal-bolus (12 subjects) or basal only (12 subjects) regimens A1C 8.0-12.0% Has not used an insulin pump within 3 months of screening Willing to use only the following types of insulin during the study: Humalog, Novolog, Admelog or Apidra during the study Maximum insulin dose of 200 units/day Stable doses over the last 4 weeks of other glucose-lowering medications 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 subject has the cognitive ability and can successfully operate all study devices and can adhere to the protocol 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 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 Able to read and speak English fluently Willing and able to sign the Informed Consent Form (ICF) Exclusion Criteria: A medical condition, which in the opinion of the investigator, would put the subject at an unacceptable safety risk Planned major surgery during the study History of severe hypoglycemia in the past 6 months History of diabetic ketoacidosis (DKA) in the past 6 months, unrelated to an intercurrent illness, infusion set failure or initial diagnosis Diagnosed with a blood dyscrasia or bleeding disorder Plans to receive blood transfusion over the course of the study Currently diagnosed with anorexia nervosa or bulimia Currently on hemodialysis History of adrenal insufficiency Has taken oral or injectable steroids within the past 8-weeks or plans to take oral or injectable steroids during the study Unable to tolerate adhesive tape or has any unresolved skin condition in sensor or pump placement Plans to use insulin other than U-100 insulin during the Omnipod 5 phase of the study 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. 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) 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 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

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Basal-Bolus (Group A)<br>2 weeks standard therapy - using multiple daily injections (MDI) and Dexcom G6 Continuous Glucose Monitor (CGM), followed by: 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by: 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus 6-month optional extension using Automated Mode | Device: Omnipod 5 Automated Insulin Delivery System<br>* The Omnipod 5 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 sensor glucose values from the continuous glucose monitor (CGM) 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 designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.<br>|
| Experimental: Basal (Group B)<br>2 weeks standard therapy - using basal injection only and Dexcom G6 Continuous Glucose Monitor (CGM), followed by: 2 weeks Omnipod 5 system use in Manual Mode with Dexcom G6 Continuous Glucose Monitor (CGM) - with fixed basal rate, no bolus, followed by: 4 weeks Omnipod 5 system use in Automated Mode with optional bolus, followed by: If % time in range 70-180 mg/dL during Automated Mode is ≤50%, 4 weeks Omnipod 5 system use in Automated Mode with simplified bolus, OR If % time in range 70-180 mg/dL during Automated Mode is >50%, 4 weeks Omnipod 5 system use in Automated Mode with optional bolus 6-month optional extension using Automated Mode | Device: Omnipod 5 Automated Insulin Delivery System<br>* The Omnipod 5 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 sensor glucose values from the continuous glucose monitor (CGM) 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 designed to assist patients with diabetes in achieving glycemic targets set by their health care providers.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hyperglycemia | Overall percentage of time ≥250 mg/dL during all phases of Automated Mode | 8-10 weeks and after 6-month optional extension | 
| Hypoglycemia | Overall percentage of time <54 mg/dL during all phases of Automated Mode | 8-10 weeks and after 6-month optional extension | 

Secondary 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 | Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B | 
| Percent of time > 180 mg/dL | Glucose metric from study continuous glucose monitoring system | Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B | 
| Percent of time ≥ 250 mg/dL | Glucose metric from study continuous glucose monitoring system | Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B | 
| Percent of time ≥ 300 mg/dL | Glucose metric from study continuous glucose monitoring system | Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B | 
| Percent of time < 70 mg/dL | Glucose metric from study continuous glucose monitoring system | Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B | 
| Percent of time < 54 mg/dL | Glucose metric from study continuous glucose monitoring system | Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B | 
| Standard Deviation | Glucose metric from study continuous glucose monitoring system-measured glucose variability with the standard deviation | Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B | 
| Coefficient of Variation | Glucose metric from study continuous glucose monitoring system-measured glucose variability with the coefficient of variation | Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B | 
| Mean glucose | Glucose metric from study continuous glucose monitoring system | Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B | 
| Total daily Insulin (units) | Measure of insulin requirements | Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B | 
| Total daily insulin (units/kg) | Measure of insulin requirements | Automated Mode use (8-10 weeks and after 6-month optional extension) will be compared to the standard therapy phase (2 weeks) overall, separately for Group A and Group B | 
| Change in Hemoglobin A1c (HbA1c) | Measures average blood sugar levels over the past 3 months | End of study (8-10 weeks) and during extension (21-23 weeks and 24-26 weeks) compared to baseline (Days 57, 147, and 237 (Group A) or Days 71, 161, and 251 (Group B) compared to Day -30 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
T2D, Omnipod