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Study identifier: NCT07011147 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery

Condition: Type 1 Diabetes (T1D) · Type 2 Diabetes · Diabetes, Autoimmune  ·  Sponsor: University of Colorado, Denver

PhaseNA
Planned participants240
Who can joinAll sexes, 18 Years to 89 Years
Healthy volunteersNo

About this study

The goal of this randomized controlled trial is to compare the efficacy and safety of the iLet Bionic Pancreas (BP) System in adults with insulin-treated diabetes (type 1 diabetes or type 2 diabetes) compared to standard of care when ordered by primary care providers. The main question it aims to answer is: Can the iLet BP by deployed in primary care settings to adults with insulin-treated diabetes (type 1 diabetes or type 2 diabetes)? Researchers will compare 13-weeks of iLet BP use to routine care to see if iLet BP use has a greater reduction in HbA1c compared to13-weeks of routine care. Participants will: Use the iLet BP for 13-weeks or continue their routine care Be trained to use the study devices or continue their routine care Complete a virtual screening visit, mid-period follow up calls and a final visit Complete baseline CGM collection Complete surveys and fingerstick a1c blood tests Routine care participants will have the option to complete an observational extension phase where they will wear the iLet BP for 13-weeks

This description comes directly from the study's public registry record.

Talk to the study team

Jessica Parascando, MPH  ·  303-724-9525  ·  primarycarediabeteslab@cuanschutz.edu

Elizabeth Westfeldt, BSN, RN  ·  303-724-9525  ·  elizabeth.westfeldt@cuanschutz.edu

Always discuss trial participation with your own doctor first.

Locations (2)

University of Colorado Anschutz Medical CampusAurora, Colorado, United StatesRecruiting
Massachusetts General HospitalBoston, Massachusetts, United StatesNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT07011147