NCT07521475
Evaluation of the Fully Closed Loop Omnipod® System in Type 2 Diabetes
Recruiting
NAAges 18–75InterventionalTreatmentInsulet Corporation
~350 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:Device: Omnipod M System with study CGMStandard Therapy plus study CGM
At a glance
Recruiting sites
26 of 27 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
HbA1c
Measured over 15 and 26 weeks
Conditions
Where it's being run
27 sites across 16 statesCalifornia4
Georgia3
Texas3
Florida2
Minnesota2
New York2
North Carolina2
Colorado1
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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%.
What this trial measures
- HbA1c15 and 26 weeks
Change in HbA1c (%) from baseline between the intervention and control groups