Smart insulin pump shows promise for type 2 diabetes control

NCT ID NCT05815342

Disease control Sponsor: Insulet Corporation Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested the Omnipod 5, a wearable device that automatically delivers insulin, in 343 adults with type 2 diabetes. Participants used the system for 13 weeks to see if it improved blood sugar levels. The goal was to make diabetes management simpler and more effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Omnipod 5 Automated Insulin Delivery System (a device that automatically delivers insulin)
What this could lead to: If successful, this device could make managing type 2 diabetes easier and more effective by automating insulin delivery, reducing the need for manual injections and fingerstick checks.
What could go wrong: This was a single-arm study without a comparison group, so results may not be definitive. The device is not a cure and requires ongoing use. Some users may experience skin reactions or device malfunctions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

343 people

The number who actually took part.

Started

Apr 2023

Finished

Mar 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

TYPE2 diabetes

Contacts and locations

Locations

AccellaCare

Wilmington, North Carolina, 28401, United States
Albert Einstein College of Medicine

The Bronx, New York, 10461, United States
Diabetes and Glandular Disease Clinic

San Antonio, Texas, 78229, United States
Diabetes and Thyroid Center

Fort Worth, Texas, 76132, United States
East Coast Institute for Research

Jacksonville, Florida, 32216, United States
East Coast Institute for Research

Canton, Georgia, 30114, United States
Emory

Atlanta, Georgia, 30303, United States
Endocrine Research

Roswell, Georgia, 30076, United States
Health Partners

Minneapolis, Minnesota, 55416, United States
Henry Ford

Detroit, Michigan, 48202, United States
Joslin Diabetes

Boston, Massachusetts, 02215, United States
MAHEC

Asheville, North Carolina, 28803, United States
Metabolic Research Institute

West Palm Beach, Florida, 33401, United States
Ohio State

Columbus, Ohio, 43203, United States
Physicians East

Greenville, North Carolina, 27834, United States
Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States
Texas Diabetes and Endocrinology

Austin, Texas, 78731, United States
University Diabetes and Endocrine Consultants

Chattanooga, Tennessee, 37411, United States
University of Colorado

Aurora, Colorado, 80045, United States
University of North Carolina

Chapel Hill, North Carolina, 27514, United States
University of Southern California

Los Angeles, California, 90022, United States

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