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Type 2 Diabetes MellitusEVOLVENCT07521475

Evaluation of the Fully Closed Loop Omnipod® System in Type 2 Diabetes

A study testing Device: Omnipod M System with study CGM and Standard Therapy plus study CGM in people with Type 2 Diabetes Mellitus, run by Insulet Corporation at 27 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

A multi-center, 26-week randomized controlled trial (RCT) to evaluate the safety and efficacy of the fully closed loop Omnipod M System in adults with type 2 diabetes using basal/bolus insulin therapy or basal-only insulin therapy, with the primary endpoint after 15 weeks and secondary analysis at 26 weeks; followed… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Device: Omnipod M System with study CGM and Standard Therapy plus study CGM
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
27 sitesUnited States
Study dates
30 Apr 2026to 23 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age at time of consent 18-75 years (inclusive)
  • Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least 6 months at time of screening
  • 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
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  • 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
  • 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
  • Willing to use only study-provided Libre 2 Plus or 3 Plus sensor during the study and not use another sensor
  • Deemed appropriate for pump therapy per Investigator's assessment considering previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities
  • 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)
  • 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).
  • Investigator has confidence that the participant can safely operate all study devices and can adhere to the protocol
  • Willing to wear the system, including Pods, continuously throughout the 26-week trial phase
  • Willing and able to sign the Informed Consent Form (ICF)
  • Able to read and understand English
  • If of childbearing potential, willing and able to have pregnancy testing

Who cannot join

  • Use of an automated insulin delivery pump 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. 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.
  • 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
  • Any planned surgery during the study which could be considered major in the opinion of the Investigator
  • 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.
  • 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
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  • Unable to tolerate adhesive tape or has any unresolved skin condition that could impact sensor or pump placement
  • Blood disorder or dyscrasia within 3 months prior to screening, which in the Investigator's opinion could interfere with determination of HbA1c
  • Plans to receive blood transfusion over the course of the 26-week trial phase.
  • 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).
  • 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.
  • 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
  • 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 a member of Investigator's study team, or immediate family member of any of the aforementioned

Trial locations and contacts

27 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Trang Ly, MBBS, PhD contact

978-600-7000

APClinical@insulet.com

Bonnie Dumais, RN contact

978-600-7000

APClinical@insulet.com

27 sites in 1 country

United States27 sites, 26 recruiting

  • Mountain Area Health Education Center

    Asheville, North Carolina, 28803

    Michelle Chapman, (828) 708-8281, michelle.chapman@mahec.net

    Casey Wells

    Recruiting

  • EMORY

    Atlanta, Georgia, 30308

    Laya Chadalawada, 610-256-9201, lchadal@emory.edu

    Georgia Davis

    Recruiting

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30318

    Amanda Maxson, (404) 355-4393, studyadmin@atlantadiabetes.com

    Bruce Bode

    Recruiting

  • Texas Diabetes and Endocrinology

    Austin, Texas, 78749

    Jennifer Perez, (512) 334-3505, jperez@tderesearch.com

    Thomas Blevins

    Recruiting

  • Indiana University

    Bloomington, Indiana, 47405

    Kathy Bohanan, (317) 278-0651, kkremer@iu.edu

    Viral Shah

    Recruiting

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215

    Louise Ambler-Osborn, 617-975-8206, louise.ambler-osborn@joslin.harvard.edu

    Lori Laffel

    Recruiting

  • University of Diabetes and Endocrine Consultants

    Chattanooga, Tennessee, 37411

    Kaitlyn Harden, (423) 265-3561, kharden@drhuffman.com

    David Huffman

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Evelyn Fronczyk, 312-908-9002, evelyn.guevara@northwestern.edu

    Grazia Aleppo

    Recruiting

  • University of Colorado Denver

    Denver, Colorado, 80204

    Cari Berget, (303) 742-8377, cari.berget@cuanschutz.edu

    Erik Kramer

    Recruiting

  • Henry Ford Health

    Detroit, Michigan, 48202

    Lydia Oehring, (313) 916-3906, loehrin1@hfhs.org

    Davida Kruger

    Recruiting

  • Rocky Mountain Diabetes

    Idaho Falls, Idaho, 83404

    Joann Malone, (208) 528-9650, joann.malone@rmclinicalresearch.com

    David Liljenquist

    Recruiting

  • University of Southern California

    Los Angeles, California, 90022

    Martha Walker, 323-362-1322, mawalker@usc.edu

    Anne Peters

    Recruiting

  • Tekton Research

    McKinney, Texas, 75072

    Idolina Garcia, (214) 831-7137, idolina.garcia@tektonresearch.com

    Pablo Mora

    Recruiting

  • International Diabetes Center

    Minneapolis, Minnesota, 55416

    Landon Haber, 952-993-3042, landon.haber@healthpartners.com

    Anders Carlson

    Recruiting

  • The Mount Sinai Hospital

    New York, New York, 10029

    Sophie Baum, (212) 241-4301, sophie.baum@mssm.edu

    Carol Levy

    Recruiting

  • HOAG

    Newport Beach, California, 92663

    Brittany Dennis, 949-764-6896, brittany.dennis@hoag.org

    David Ahn

    Recruiting

  • Riverside Family Medicine Residency Program

    Newport News, Virginia, 23601

    Elizabeth Eckhart, (757) 534-5374, elizabeth.eckhart@rivhs.com

    Beth Klug

    Recruiting

  • Oregon Health and Science University

    Portland, Oregon, 97239

    Desiree Odgers, odgers@ohsu.edu

    Rodica Busui

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55902

    Shafaq Rizvi, 507-255-2914, miller.chloe@mayo.edu

    Yogish Kudva

    Recruiting

  • Endocrine Research Solutions, Inc.

    Rosewell, Georgia, 30076

    Jessica Tapia, (678) 878-4750, jtapia.ers@gmail.com

    John Reed

    Recruiting

  • Tekton Research

    San Antonio, Texas, 78258

    Sharon Jones, (210) 996-2600, sharon.jones@tektonresearch.com

    Jara McDonald

    Recruiting

  • Sansum Diabetes Research Institute

    Santa Barbara, California, 93105

    Maggie Shuiman, (805) 350-8941, mshuirman@sansum.org

    Kristin Castorino

    Recruiting

  • SUNY Syracuse

    Syracuse, New York, 13210

    Suzan Bzdick, (315) 464-9006, BzdickS@upstate.edu

    Malek El Muayed

    Recruiting

  • University of South Florida

    Tampa, Florida, 33612

    Active, not recruiting

  • Touro University California

    Vallejo, California, 94592

    Tess Calinawan, (707) 638-5969, mcalinaw@touro.edu

    Jay Shubrook

    Recruiting

  • Metabolic Research Institute

    West Palm Beach, Florida, 33401

    Amanda Calderon, (561) 802-3060, acalderon@metabolic-institute.com

    Barry Horowitz

    Recruiting

  • Accellacare

    Wilmington, North Carolina, 28401

    Cara Insco, 910-799-5500, cara.insco@accellacare.com

    John Parker

    Recruiting

Other trials in United States

About this study

Official title: EVOLVE: Evaluation of the Fully Closed Loop Omnipod® System for Safety and Efficacy in Adults With Type 2 Diabetes

A multi-center, 26-week randomized controlled trial (RCT) to evaluate the safety and efficacy of the fully closed loop Omnipod M System in adults with type 2 diabetes using basal/bolus insulin therapy or basal-only insulin therapy, with the primary endpoint after 15 weeks and secondary analysis at 26 weeks; followed by an extension phase after completion of the 26-week trial where the Intervention group will continue to use Omnipod M and the Control group will crossover to use Omnipod M for 26 weeks

Being tested
Device: Omnipod M System with study CGM, Standard Therapy plus study CGM
Keywords
Automated Insulin Delivery, T2D, Type 2 Diabetes, Omnipod, AID, Fully closed loop, FCL
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Device: Omnipod M System with study CGMDevice

    Also called Omnipod M System

    The Omnipod M system with the study CGM

  • Standard Therapy plus study CGMDevice

    Also called Control group

    Standard therapy is continuation of pre-study insulin regimen and study CGM.

Study groups in NCT07521475
Study groupRoleWhat they receive
Intervention group - Omnipod MExperimentalThe Intervention group will be assigned the Omnipod M system with the study CGM
Receives: Device: Device: Omnipod M System with study CGM
Control group - Pre-study insulin regimenActive comparatorThe control group will continue the use of pre-study insulin regimen with the study CGM.
Receives: Device: Standard Therapy plus study CGM

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c

    Change in HbA1c (%) from baseline between the intervention and control groups

    Measured: 15 and 26 weeks

Secondary outcomes (11)

  1. Mean glucose

    Change in mean CGM glucose mg/dL from baseline, compared between the intervention and control groups

    Measured: 15 and 26 weeks

  2. Time in Range 70-180 mg/dL

    Change in CGM percent time 70-180 mg/dL from baseline, compared between the intervention and control groups

    Measured: 15 and 26 weeks

  3. Time > 180 mg/dL

    Change in CGM percent time >180 mg/dL from baseline, compared between the intervention and control groups

    Measured: 15 and 26 weeks

  4. Time > 250 mg/dL

    Change in CGM percent time >250 mg/dL from baseline, compared between the intervention and control groups

    Measured: 15 and 26 weeks

  5. Time in Range 70-140 mg/dL

    Change in CGM percent time 70-140 mg/dL from baseline, compared between the intervention and control groups

    Measured: 15 and 26 weeks

  6. Prolonged hyperglycemia events per week

    Change in number of prolonged hyperglycemia events (>90 minutes with a CGM glucose >250 mg/dL within a 120 minute period) from baseline, compared between the intervention and control groups

    Measured: 15 and 26 weeks

  7. Time <70 mg/dL

    Change in CGM percent time <70 mg/dL from baseline, compared between the intervention and control groups

    Measured: 15 and 26 weeks

  8. Time <54 mg/dL

    Change in CGM percent time <54 mg/dL from baseline, compared between the intervention and control groups

    Measured: 15 and 26 weeks

  9. Time >300 mg/dL

    Change in CGM percent time >300 mg/dL from baseline, compared between the intervention and control groups

    Measured: 15 and 26 weeks

  10. Type 2 Diabetes Distress Assessment System (T2-DDAS)

    Measured: 15 and 26 weeks

  11. Standard Deviation

    Change in standard deviation from baseline, compared between the intervention and control groups

    Measured: 15 and 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2026
  2. Study start30 Apr 2026
  3. Primary completion24 Dec 2026 (estimated)
  4. Study completion23 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07521475
Sponsor's protocol ID
EVOLVE
Acronym
EVOLVE
Status last verified
Jul 2026
First submitted
3 Apr 2026
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Device: Omnipod M System with study CGM and Standard Therapy plus study CGM in people with Type 2 Diabetes Mellitus, run by Insulet Corporation at 27 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trang Ly, MBBS, PhD (978-600-7000, APClinical@insulet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: 15 and 26 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07521475.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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