An Evaluation of the Omnipod® M System in Adults With Type 2 Diabetes (NCT07276776) | Clinical Trial Compass
CompletedNot Applicable
An Evaluation of the Omnipod® M System in Adults With Type 2 Diabetes
United States40 participantsStarted 2025-12-12
Plain-language summary
This is a single arm feasibility study to evaluate the Omnipod M System in adults with Type 2 Diabetes with the aim to enroll to 40 participants aged 18-75 years with type 2 diabetes to have a minimum of 20 participants initiate the use of Omnipod M System and the goal of 16 participants completing the 6-week treatment period.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 current insulin regimen for at least 3 months prior to screening (i.e. basal-bolus, basal insulin only or premix)
✓. Basal-bolus (AID or non-AID pump \& MDI) or premix users with A1C \< 14% OR basal users on long or intermediate acting insulin only with A1C \> 8.0% and \< 14%
✓. Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, Admelog, Kirsty, Fiasp, Lyumjev or their generic equivalents
✓. Deemed appropriate for pump therapy per Investigator's assessment considering previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities
✓. If using noninsulin glucose-lowering medications (such as GLP-1 receptor agonist, SGLT2 inhibitor, or other) or weight-reduction medications, dose has been stable for 6-weeks prior to screening; and participant is willing to not change the dose unless required for safety purposes.
✓. Investigator has confidence that the participant can safely operate all study devices and can adhere to the protocol
Exclusion criteria
✕. 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.
What they're measuring
1
Percent of time in hypoglycemic range <70mg/dL
Timeframe: Comparing baseline metrics to the end of the treatment period (Day45)
2
Percent of time in hyperglycemic range >180 mg/dL
Timeframe: Comparing baseline metrics to the end of the treatment period (Day45)
✕. Current or known history of coronary artery disease that is not stable with medical management, including unstable angina, 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 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 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
✕. 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