RecruitingNot Applicable

Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery

United States240 participantsStarted 2026-01-16

Plain-language summary

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

Who can participate

Age range18 Years – 89 Years

SexALL

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Inclusion criteria

✓. Age at time of consent \>18 and \<89 years
✓. Either 2.a. or 2.b.:
✓. Clinical diagnosis of type 1 diabetes for at least one year and using insulin for at least 1 year
✓. Clinical diagnosis of type 2 diabetes, on current injected or infused insulin regimen for at least 3 months prior to screening (e.g., basal-bolus, basal only, or pre-mix)
✓. Stable doses of glucose lowering medications over the preceding 4 weeks as determined by Investigator, including GLP-1 receptor agonists (GLP-1 RA) and GLP-1/GIP RA agents
✓. Stable doses of weight loss medications (including GLP-1 RA and GLP-1/GIP RA agents) over the preceding 4 weeks as determined by the investigator.
✓. For those using the iLet Bionic Pancreas (during the RCT arm or observational extension phase), willingness to stay on current doses of medications throughout the study that may affect glycemia directly and/or indirectly, except for a dose reduction or discontinuation.
✓. Have a primary care clinician willing to refer them to the study, confirm their diabetes diagnosis (for example: type 1 diabetes or type 2 diabetes), and recommend and manage the iLet for the duration of the study

Exclusion criteria

What they're measuring

HbA1c between the BP and RC groups

Timeframe: RCT Week 13

Percentage of Time With CGM Glucose <54 mg/dl

Timeframe: RCT Weeks 1-13 and OEP Weeks 13-26

Trial details

NCT IDNCT07011147

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-01

Contact for this trial

Jessica Parascando, MPH

303-724-9525 primarycarediabeteslab@cuanschutz.edu

View on ClinicalTrials.gov More Type 1 Diabetes (T1D) trials