Actively Recruiting
Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery
Led by University of Colorado, Denver · Updated on 2026-04-02
240
Participants Needed
2
Research Sites
167 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
M
Massachusetts General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 89 years at time of consent
- Clinical diagnosis of type 1 diabetes for at least 1 year and using insulin for at least 1 year, or clinical diagnosis of type 2 diabetes on injected or infused insulin regimen for at least 3 months prior to screening
- Stable doses of glucose-lowering medications including GLP-1 receptor agonists for at least 4 weeks
- Stable doses of weight loss medications including GLP-1 receptor agonists for at least 4 weeks
- Willingness to maintain current medication doses affecting blood sugar during the study, allowing dose reduction or discontinuation
- Have a primary care clinician willing to refer, confirm diagnosis, and manage iLet use during the study
- Willing to comply with all study procedures
- Willing to wear a Dexcom CGM device and iLet system during assigned study periods
- Willing to use insulin lispro or aspart types
- Ability to operate study devices and adhere to the protocol
- Willing and able to sign informed consent
- If capable of pregnancy, willing to have pregnancy testing and use acceptable contraception during the study
- Agreement to follow lifestyle considerations during study
- Have hardware and internet access for two-way video and audio communication
You will not qualify if you...
- Unable to safely follow study procedures due to vision, dexterity, memory, or other impairments
- Cannot speak or read English as study materials are in English only
- Diagnosis of maturity-onset diabetes of the young (MODY)
- Planning to change usual diabetes regimen between screening and randomization (except insulin dose adjustments or changes within same medication class)
- Weight over 255 kg (561 pounds)
- Bariatric surgery within 12 months before enrollment or planned during study
- Current use of non-FDA-cleared closed-loop insulin systems
- Blood disorders affecting hemoglobin A1c accuracy
- Planned or recent blood transfusions
- Participation in another diabetes-related clinical trial
- Diabetes due to cystic fibrosis, pancreatitis, pancreatic tumor, insulinoma, or complete pancreatectomy
- Recent intermittent glucocorticoid treatment or planned during study (stable chronic use acceptable)
- More than one episode of diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome in past 6 months unrelated to illness or device issues
- History of severe allergy to adhesives used in study
- Recent or planned use of sulfonylurea, pramlintide, or SGLT-2 inhibitors
- Planned major surgery during study
- Pregnant, lactating, or planning pregnancy in next 6 months
- Renal failure on dialysis or chronic kidney disease with low filtration rate
- Conditions that could interfere with safe study completion or affect results, including unstable heart conditions, recent stroke, untreated mental illness or eating disorders, and substance use disorders
- Plans for travel outside the US for more than 4 weeks consecutively
- Plans for internet or phone outage longer than 1 week consecutively
- Employment or close relation to staff involved in the clinical trial
- Previous use of the iLet device for more than 4 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
Research Team
J
Jessica Parascando, MPH
CONTACT
E
Elizabeth Westfeldt, BSN, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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