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Smart insulin pump aims to simplify diabetes management

NCT ID NCT07521475

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 3 times

Summary

This study tests a new automatic insulin pump (Omnipod M) in 350 adults with type 2 diabetes who already use insulin. The pump adjusts insulin delivery on its own to keep blood sugar in a healthy range. The goal is to see if it improves blood sugar control and is safe to use.

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

About 350 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Sep 2027

An estimate. End dates often move.

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 (inclusive) 2. Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least 6 months at time of screening 3. On insulin therapy for at least 3 months at time of screening, with no change to insulin regimen for 6 weeks prior (AID use within past 3 months excluded) to initiating baseline CGM data collection. * Regimen is defined as (1) Basal-bolus insulin therapy (a) using multiple daily injections of insulin (MDI), (b) non-automated insulin pump, or (c) MDI with premix insulin; or (2) basal insulin only (without bolus insulin). * Basal-bolus insulin therapy defined as use of a basal insulin (either long-acting or intermediate-acting (e.g., NPH) plus at least one mealtime insulin dose per day, or a non-automated insulin pump * Inhaled insulin may be used in addition to or instead of mealtime injections pre-study and as part of the Control group 4. For basal only users, screening A1C ≥7.5% and \<14.0%. For basal bolus users (i.e., all others), screening A1C ≥6.0% and \<14.0%. • A1C measurement within 28 days prior to enrollment is acceptable 5. Willing to use only the following types of U-100 insulin while using the study pump: Humalog, Novolog, Admelog, Kirsty, Fiasp, Lyumjev or their generic/biosimilar equivalents 6. Willing to use only study-provided Libre 2 Plus or 3 Plus sensor during the study and not use another sensor 7. Deemed appropriate for pump therapy per Investigator's assessment considering previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities 8. No anticipated need to newly initiate noninsulin glucose-lowering medications (such as GLP-1 receptor agonist, SGLT2 inhibitor, or other) or weight-reduction medications that have a glucose lowering effect during the 26-week RCT phase. (Additions or changes in these medications will be permitted during the Extension Phase) 9. If using noninsulin glucose-lowering medications (such as GLP-1 receptor agonist, SGLT2 inhibitor, or other) or weight-reduction medications that have a glucose-lowering effect, prescribed dose has been stable for 6 weeks prior to baseline CGM collection; and there is not an anticipated need to increase the dose during the 26-week trial phase (dose reductions will be permitted for safety). 10. Investigator has confidence that the participant can safely operate all study devices and can adhere to the protocol 11. Willing to wear the system, including Pods, continuously throughout the 26-week trial phase 12. Willing and able to sign the Informed Consent Form (ICF) 13. Able to read and understand English 14. If of childbearing potential, willing and able to have pregnancy testing Exclusion Criteria: 1. Use of an automated insulin delivery pump 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. This may include untreated malignancy, unstable cardiac disease, unstable or end-stage renal disease, unstable proliferative retinopathy, unstable psychiatric conditions such as eating disorders, drug or alcohol abuse. 3. Current or known history of coronary artery disease that is not stable with medical management in the opinion of the investigator, including unstable angina, 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 episode of severe hypoglycemia in the past 6 months. Severe hypoglycemia is defined as an event that requires the assistance of another person due to altered consciousness, and requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions. 6. History of more than 1 episode of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the past 6 months, unrelated to an intercurrent illness; kinked, dislodged, or occluded cannula; or initial diabetes diagnosis 7. Unable to tolerate adhesive tape or has any unresolved skin condition that could impact sensor or pump placement 8. Blood disorder or dyscrasia within 3 months prior to screening, which in the Investigator's opinion could interfere with determination of HbA1c 9. Plans to receive blood transfusion over the course of the 26-week trial phase. 10. Pregnant or lactating, or is of childbearing potential and not using an acceptable form of birth control (acceptable forms of contraception include abstinence, barrier methods such as condoms, hormonal contraceptives, intrauterine device, surgical sterilization such as tubal ligation or hysterectomy, or vasectomized partner); childbearing potential means that menstruation has started, and the participant is not surgically sterile or greater than 12 months post-menopausal). 11. Has taken systemic corticosteroids (oral or injectable) within 4 weeks or has had a local steroid injection (intraarticular, epidural) within 1 week prior to baseline CGM collection or plans to take oral or injectable steroids during the 26-week trial phase. 12. Participation in another clinical study using an investigational drug or device within prior 30 days or intends to participate in any other interventional study during the 26-week trial phase 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 a member of Investigator's study team, or immediate family member 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.

Type 2 diabetes mellitus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    26 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Accellacare

    RECRUITING

    Wilmington, North Carolina, 28401, United States

  • Atlanta Diabetes Associates

    RECRUITING

    Atlanta, Georgia, 30318, United States

    Contact Email: •••••@•••••

  • EMORY

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • Endocrine Research Solutions, Inc.

    RECRUITING

    Rosewell, Georgia, 30076, United States

  • HOAG

    RECRUITING

    Newport Beach, California, 92663, United States

  • Henry Ford Health

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Indiana University

    RECRUITING

    Bloomington, Indiana, 47405, United States

  • International Diabetes Center

    RECRUITING

    Minneapolis, Minnesota, 55416, United States

  • Joslin Diabetes Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55902, United States

  • Metabolic Research Institute

    RECRUITING

    West Palm Beach, Florida, 33401, United States

  • Mountain Area Health Education Center

    RECRUITING

    Asheville, North Carolina, 28803, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Oregon Health and Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Riverside Family Medicine Residency Program

    RECRUITING

    Newport News, Virginia, 23601, United States

  • Rocky Mountain Diabetes

    RECRUITING

    Idaho Falls, Idaho, 83404, United States

  • SUNY Syracuse

    RECRUITING

    Syracuse, New York, 13210, United States

  • Sansum Diabetes Research Institute

    RECRUITING

    Santa Barbara, California, 93105, United States

  • Tekton Research

    RECRUITING

    McKinney, Texas, 75072, United States

  • Tekton Research

    RECRUITING

    San Antonio, Texas, 78258, United States

  • Texas Diabetes and Endocrinology

    RECRUITING

    Austin, Texas, 78749, United States

  • The Mount Sinai Hospital

    RECRUITING

    New York, New York, 10029, United States

  • Touro University California

    RECRUITING

    Vallejo, California, 94592, United States

  • University of Colorado Denver

    RECRUITING

    Denver, Colorado, 80204, United States

  • University of Diabetes and Endocrine Consultants

    RECRUITING

    Chattanooga, Tennessee, 37411, United States

  • University of South Florida

    ACTIVE_NOT_RECRUITING

    Tampa, Florida, 33612, United States

  • University of Southern California

    RECRUITING

    Los Angeles, California, 90022, United States

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