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

NCT ID: NCT04617795

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-23
• Study Completion Date: 2022-03-06

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

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Omnipod 5 Automated Insulin Delivery System

Intervention Type: DEVICE

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.

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, 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

Group Type: EXPERIMENTAL

Omnipod 5 Automated Insulin Delivery System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insulet Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anders Carlson, MD

Role: STUDY_CHAIR

International Diabetes Center at Park Nicollet

Anne Peters, MD

Role: STUDY_CHAIR

Keck School of Medicine of USC

Locations

University of California

Los Angeles, California, United States

Emory University

Atlanta, Georgia, United States

Atlanta Diabetes

Atlanta, Georgia, United States

International Diabetes Center

Saint Louis Park, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

OP5 in T2D Study G190270

Identifier Type: -

Identifier Source: org_study_id