OP5-005 Using Omnipod 5 in Adults With Type 2

NCT05815342 | Completed Results DMC FDA Device

• 1 other identifier: G230013
• Study Type: interventional
• Target: 343
• Locations: 1 country
• Sites: 21

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.

Conditions

Type2 Diabetes

Keywords

T2D; Omnipod; Automated Insulin Delivery

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  The change in HbA1c at 13 weeks from baseline

  Comparing the change in HbA1c during the 13 weeks study phase

Secondary Outcomes (17)

• Mean Glucose

  Measuring mean glucose during the 13 weeks study phase

• Percentage of Time in Range 70-180 mg/dL

  Measured during 13 weeks study phase

• Percent of Time in Range 70-140 mg/dL

  Measured during 13 weeks study phase

• Percent of Time ≥ 300 mg/dL

  Measured during 13 weeks study phase

• Percent of Time > 250 mg/dL

  Measured during 13 weeks study phase

Study Arms (1)

Treatment

EXPERIMENTAL

All subjects wearing the Omnipod 5 Automated Glucose Monitoring System

Device: Omnipod 5 Automated Glucose Control System

Interventions

Omnipod 5 Automated Glucose Control System DEVICE

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

Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age at time of consent 18-75 years
• 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)
• 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%
• Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog
• Participant agrees to provide their own insulin for the duration of the study
• Stable doses over the preceding 4 weeks of other glucose-lowering medications as determined by Investigator
• 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
• 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 participant has the cognitive ability and can successfully operate all study devices and can adhere to the protocol
• Able to read and understand English or Spanish
• Willing and able to sign the Informed Consent Form (ICF)
• If female of childbearing potential, willing and able to have pregnancy testing

You may not qualify if:

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

Sponsors & Collaborators

• Insulet Corporation: lead
• Jaeb Center for Health Research: collaborator

Study Sites (21)

University of Southern California

Los Angeles, California, 90022, United States

Location

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

East Coast Institute for Research

Jacksonville, Florida, 32216, United States

Location

Metabolic Research Institute

West Palm Beach, Florida, 33401, United States

Location

Emory

Atlanta, Georgia, 30303, United States

Location

East Coast Institute for Research

Canton, Georgia, 30114, United States

Location

Endocrine Research

Roswell, Georgia, 30076, United States

Location

Joslin Diabetes

Boston, Massachusetts, 02215, United States

Location

Henry Ford

Detroit, Michigan, 48202, United States

Location

Health Partners

Minneapolis, Minnesota, 55416, United States

Location

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

MAHEC

Asheville, North Carolina, 28803, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Physicians East

Greenville, North Carolina, 27834, United States

Location

AccellaCare

Wilmington, North Carolina, 28401, United States

Location

Ohio State

Columbus, Ohio, 43203, United States

Location

University Diabetes and Endocrine Consultants

Chattanooga, Tennessee, 37411, United States

Location

Texas Diabetes and Endocrinology

Austin, Texas, 78731, United States

Location

Diabetes and Thyroid Center

Fort Worth, Texas, 76132, United States

Location

Diabetes and Glandular Disease Clinic

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• 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.

  PMID: 39951268 DERIVED

Results Point of Contact

• Title: Dr. Trang Ly
• Organization: Insulet Corporation

Tly@insulet.com

9786007628

Study Officials

• Francisco J Pasquel, MD

  Emory School of Medicine

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 18, 2023
• Study Start: April 11, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: September 29, 2025
• Results First Posted: September 29, 2025

Record last verified: 2025-09

Locations

US (21)