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Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery | Clinical Trials | Clareo Health

RECRUITINGNA

Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery

NCT07011147•University of Colorado, Denver

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

Eligibility

Age

18 - 89 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age at time of consent \>18 and \<89 years
•2. Either 2.a. or 2.b.:
•1. Clinical diagnosis of type 1 diabetes for at least one year and using insulin for at least 1 year
•2. 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)
•3. 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
•4. 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.
•5. 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.
•6. 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
•7. Willing to comply with all study procedures for the duration of the study
•8. Willing to wear a Dexcom CGM device and iLet system for duration of time randomized to iLet use or OEP
+12 more criteria

Exclusion Criteria

•1. Unable to safely comply with study procedures and reporting requirements (e.g. impairment of vision or dexterity that prevents safe operation of the bionic pancreas, impaired memory)
•2. Unable to speak and read English, as iLet BP support materials and device menus are currently available in English only
•3. Diagnosis of maturity-onset diabetes of the young (MODY)
•4. Plan to change usual diabetes regimen between screening and study randomization
•1. This would include changing from MDI to pump or from pump to MDI, starting a new class of type 2 diabetes medication, or starting or increasing GLP-1 RA or GLP-1/GIP RA medication
•2. This would NOT include changes to any insulin doses, including pump settings, short- and/or long-acting insulin doses and type of insulin; changing type 2 diabetes medication dosing (except GLP-1 RA or GLP-1/GIP RA); or changing type of type 2 diabetes medication within the same class
•5. Weigh more than 255 kg (561 pounds) as this is the maximum weight that can be entered into the iLet user interface
•6. History of bariatric surgery within 12 months prior to enrollment or plans for bariatric surgery within the period of study participation
•7. Current use of a closed-loop or hybrid closed-loop insulin delivery system that is not FDA-cleared (e.g. "DIY Loop", "AAPS", "iAPS" or "Open APS")
•8. Diagnosed blood disorder or dyscrasia associated with hemolysis, including for example: sickle cell disease and thalassemia, which in the Investigator's opinion could interfere with HbA1c accuracy
+16 more criteria

Locations (2)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Key Dates

Start Date

February 1, 2026

Primary Completion Date

October 1, 2026

Completion Date

April 1, 2029

Last Updated

January 21, 2026

Enrollment

240

ESTIMATED participants

Conditions

Type 1 Diabetes (T1D)Type 2 DiabetesDiabetes, AutoimmuneDiabetes MellitusDiabetes Mellitus Type 2Diabetes Mellitus, Type IDiabetes, Type IIDiabetesDiabetes Mellitus, Insulin-DependentDiabetes Mellitus Type IIDiabetes Type 2 on Insulin

Interventions

Bionic Pancreas

DEVICE

Routine Care

OTHER

Contacts

Jessica Parascando, MPH

CONTACT

303-724-9525 primarycarediabeteslab@cuanschutz.edu

Elizabeth Westfeldt, BSN, RN

CONTACT

303-724-9525 elizabeth.westfeldt@cuanschutz.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 21, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

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