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OP5-005 Using Omnipod 5 in Adults With Type 2

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

NCT05815342•Insulet Corporation

Summary

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

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age at time of consent 18-75 years
•2. 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)
•3. 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%
•4. Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog
•5. Participant agrees to provide their own insulin for the duration of the study
•6. Stable doses over the preceding 4 weeks of other glucose-lowering medications as determined by Investigator
•7. 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
•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 participant has the cognitive ability and can successfully operate all study devices and can adhere to the protocol
+3 more criteria

Exclusion Criteria

•1. Use of an AID pump in automated mode within 3 months prior to screening
•2. 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)
•3. 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
•4. Any planned surgery during the study which could be considered major in the opinion of the investigator
•5. History of more than 1 severe hypoglycemic event in the 6 months prior to screening
•6. 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
•7. 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
•8. Plans to receive blood transfusion over the course of the study
•9. Has taken oral or injectable steroids within 8 weeks prior to screening or plans to take oral or injectable steroids during the study
•10. Unable to tolerate adhesive tape or has any unresolved skin condition that could impact sensor or pump placement
+4 more criteria

Locations (21)

University of Southern California

Los Angeles, California, United States

Sansum Diabetes Research Institute

Santa Barbara, California, United States

University of Colorado

Aurora, Colorado, United States

East Coast Institute for Research

Jacksonville, Florida, United States

Metabolic Research Institute

West Palm Beach, Florida, United States

Emory

Atlanta, Georgia, United States

East Coast Institute for Research

Canton, Georgia, United States

Endocrine Research

Roswell, Georgia, United States

Joslin Diabetes

Boston, Massachusetts, United States

Henry Ford

Detroit, Michigan, United States

Key Dates

Start Date

April 11, 2023

Primary Completion Date

March 1, 2024

Completion Date

March 1, 2024

Last Updated

September 29, 2025

Enrollment

343

ACTUAL participants

Conditions

Type2 Diabetes

Interventions

Omnipod 5 Automated Glucose Control System

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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OP5-005 Using Omnipod 5 in Adults With Type 2

Inclusion Criteria

Exclusion Criteria

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