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

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

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Device: Omnipod 5 Automated Insulin Delivery System

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

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90022
      • University of California
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Emory University
    • Atlanta, Georgia, United States, 30318
      • Atlanta Diabetes
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55416
      • International Diabetes Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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:

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)
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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Basal-Bolus (Group A); 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; 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.
Experimental: Basal (Group B); 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, ORIf % 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; 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.

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

Collaborators and Investigators

• Sponsor: Insulet Corporation
• Investigators: Study Chair: Anders Carlson, MD, International Diabetes Center at Park Nicollet; Study Chair: Anne Peters, MD, Keck School of Medicine of USC

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2020
• Primary Completion (Actual): March 6, 2022
• Study Completion (Actual): March 6, 2022

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (Actual): November 5, 2020

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: T2D; Omnipod
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: OP5 in T2D Study G190270

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes