Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
56 participants
INTERVENTIONAL
2025-07-18
2026-01-31
Brief Summary
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There is a precursory evaluation before the main, randomized trial. Participation in the precursory evaluation could last up to 12 weeks and participation in the randomized trial could last up to 6 weeks. During both the evaluation and the randomized trial, participants will manage their diabetes using the Omnipod M System in Automated Mode.
An optional 12-weeks of continued Omnipod M System use is available upon completion of the randomized trial.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Omnipod M System with lower starting dose
Active Comparator: Omnipod M System with lower starting dose
Omnipod M Automated Insulin Delivery System with Dexcom G6 continuous glucose monitoring system
Omnipod M System with higher starting dose
Active Comparator: Omnipod M System with higher starting dose
Omnipod M Automated Insulin Delivery System with Dexcom G6 continuous glucose monitoring system
Interventions
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Active Comparator: Omnipod M System with lower starting dose
Omnipod M Automated Insulin Delivery System with Dexcom G6 continuous glucose monitoring system
Active Comparator: Omnipod M System with higher starting dose
Omnipod M Automated Insulin Delivery System with Dexcom G6 continuous glucose monitoring system
Eligibility Criteria
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Inclusion Criteria
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 (non-AID pump \& MDI), pre-mix, or basal only users suitable for conversion to AID pump therapy for at least 3 months prior to screening. For basal-bolus and premix users, they must have A1c \<14%. For basal only users must have A1c \>7% and \<14%.
4. Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, Admelog, or their generic equivalents.
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 plans to maintain 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. Participant agrees to provide their own compatible smartphone for use with the Dexcom G6 CGM
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
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
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. Arrhythmias or other cardiac conditions confirmed by ECG (within past 30 days) which in the opinion of the Investigator, would put the participant at an unacceptable safety risk
4. 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
5. Any planned surgery during the study which could be considered major in the opinion of the Investigator
6. History of more than 1 severe hypoglycemic event in 6 months prior to screening
7. 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
8. Blood disorder or dyscrasia within 3 months prior to screening, which in the Investigator's opinion could interfere with determination of HbA1c
9. Use of hydroxyurea
10. Has taken systemic steroids (oral or injectable) within 4 weeks or has had a local steroid injection (intraarticular, epidural) within 1 week prior to screening or plans to take oral or injectable steroids during the study
11. Unable to tolerate adhesive tape or has any unresolved skin condition that could impact sensor or pump placement
12. 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)
13. Planned international travel during the study
14. Participation in another clinical study using an investigational drug or device other than the Omnipod in the 30 days prior to screening or intends to participate during the study period
15. 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
16. 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
18 Years
75 Years
ALL
No
Sponsors
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Insulet Corporation
INDUSTRY
Responsible Party
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Locations
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University of Colorado
Aurora, Colorado, United States
Emory University
Atlanta, Georgia, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
MassResearch LLC.
Waltham, Massachusetts, United States
AccellaCare
Wilmington, North Carolina, United States
Disease & Glandular Disease Clinic
San Antonio, Texas, United States
Countries
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Other Identifiers
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SIMPLEUSE
Identifier Type: -
Identifier Source: org_study_id