Evaluation of the Fully Closed Loop Omnipod® System in Type 2 Diabetes
ConditionType 2 Diabetes Mellitus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInsulet Corporation
About this trial
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
Eligibility criteria
Qualifiers
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).
Disqualifiers
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
Trial design
Treatments tested in this trial
- Device: Omnipod M System with study CGM
- Standard Therapy plus study CGM
Treatment groups
350 Participants
are divided into 2 treatment groupsLocations
19California
Sansum Diabetes Research Institute93105, Santa Barbara United States
Touro University94592, Vallejo United States
Touro University California94592, Vallejo United States
Colorado
University of Colorado Denver80204, Denver United States
Sponsors and collaborators
Insulet Corporation
Lead sponsor
Jaeb Center for Health Research
Collaborator
Source ClinicalTrials.gov