Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT07011147
Status
Recruiting
Apply to this trial

Conditions

  • Diabetes
  • Diabetes Mellitus
  • Diabetes Mellitus Type 2
  • Diabetes Mellitus Type II
  • Diabetes Mellitus, Insulin-Dependent
  • Diabetes Mellitus, Type I
  • Diabetes Type 2 on Insulin
  • Diabetes, Autoimmune
  • Diabetes, Type II
  • Type 1 Diabetes (T1D)
  • Type 2 Diabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Bionic Pancreas — DEVICE
    The intervention group will use the iLet Bionic Pancreas (BP) for 13-weeks. They will be trained on the iLet BP system and its components by a Certified iLet Trainer. They will also be trained on how to use the study continuous glucose monitor (CGM) system, blood glucose meter, and ketone meter. Participants will have four mid-period follow up phone calls to review medications, ongoing eligibility, and solicit any occurrences of adverse events and device issues. At the end of 13-weeks, they will complete final visit tasks and will be transitioned back to their pre-study insulin delivery method with guidance provided by a study investigator.
  • Routine Care — OTHER
    Participants will continue with their current diabetes treatment. Participants will be trained on the use of the study blood glucose meter. They will have four mid-period follow up phone calls to review medications, ongoing eligibility, and solicit any occurrences of adverse events. At the end of 13-weeks, they will complete final visit tasks and will be asked if they would like to participate in the observational extension phase where they will use the iLet Bionic Pancreas for 13 weeks.

Study Details

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

Key Dates

Start date
Jan 16, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Apr 1, 2029

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Bionic Pancreas
  • Active Comparator: Routine Care

Primary Outcome Measure

HbA1c between the BP and RC groups [ Time Frame: RCT Week 13 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Colorado Anschutz Medical CampusAuroraColorado80045
Jessica Parascando, MPH
[email protected]
303-724-9525
Elizabeth Westfeldt, BSN, RN
[email protected]
303-724-9525
Sean Oser, MD, MPH, CDCES (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Amy Sabean, RN
[email protected]
Melissa Putman, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of Colorado Anschutz Medical Campus· Aurora, COMassachusetts General Hospital· Boston, MA

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