RecruitingType 2 Diabetes Mellitus

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

Eligible age

18–75 yrs

Accepts

All genders

Locations

11 states

Healthy volunteers

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About this study

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

Sponsor: Insulet Corporation

You may qualify if…

✓ 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

You may not qualify if…

✕ 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