OP5-005 Using Omnipod 5 in Adults With Type 2

NCT ID: NCT05815342

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 343 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-11
• Study Completion Date: 2024-03-01

Brief 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.

Conditions

Type2 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

All subjects wearing the Omnipod 5 Automated Glucose Monitoring System

Group Type: EXPERIMENTAL

Omnipod 5 Automated Glucose Control System

Intervention Type: DEVICE

The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery

Interventions

Omnipod 5 Automated Glucose Control System

The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery

Intervention Type: DEVICE

Eligibility Criteria

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

11. Able to read and understand English or Spanish

12. Willing and able to sign the Informed Consent Form (ICF)

13. If female of childbearing potential, willing and able to have pregnancy testing

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

11. Pregnant or lactating, planning to become pregnant during the study, 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); childbearing potential means that menstruation has started, and the participant is not surgically sterile or greater than 12 months post-menopausal)

12. Participation in another clinical study using an investigational drug or device other than the Omnipod 5 in the 30 days prior to screening or intends to participate during the study period

13. 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

14. Participant is an employee of Insulet, an Investigator or Investigator's study team, or immediate family member (spouse, biological or legal guardian, child, sibling, parent) of any of the aforementioned

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

Sponsors

Jaeb Center for Health Research

OTHER

Sponsor Role: collaborator

Insulet Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francisco J Pasquel, MD

Role: STUDY_CHAIR

Emory School of Medicine

Locations

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

Health Partners

Minneapolis, Minnesota, United States

Albert Einstein College of Medicine

The Bronx, New York, United States

MAHEC

Asheville, North Carolina, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Physicians East

Greenville, North Carolina, United States

AccellaCare

Wilmington, North Carolina, United States

Ohio State

Columbus, Ohio, United States

University Diabetes and Endocrine Consultants

Chattanooga, Tennessee, United States

Texas Diabetes and Endocrinology

Austin, Texas, United States

Diabetes and Thyroid Center

Fort Worth, Texas, United States

Diabetes and Glandular Disease Clinic

San Antonio, Texas, United States

Countries

United States

References

Pasquel FJ, Davis GM, Huffman DM, Peters AL, Parker JC, Laffel LM, Romeo GR, Mathew J, Castorino KN, Kruger DF, Dungan KM, Kipnes M, Jauch EC, Oser TK, Shah VN, Horowitz B, Carlson AL, Warren ML, Deeb W, Buse JB, Reed JH, Berner J, Blevins T, Bajaj C, Kollman C, Raghinaru D, Ly TT, Beck RW; Omnipod 5 SECURE-T2D Consortium. Automated Insulin Delivery in Adults With Type 2 Diabetes: A Nonrandomized Clinical Trial. JAMA Netw Open. 2025 Feb 3;8(2):e2459348. doi: 10.1001/jamanetworkopen.2024.59348.

Reference Type: DERIVED

PMID: 39951268 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

G230013

Identifier Type: -

Identifier Source: org_study_id