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
130 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
Researchers are evaluating how well the iLet Bionic Pancreas (BP) System works and how safe it is for adults with insulin-treated diabetes, including type 1 and type 2 diabetes. The study aims to find out if the iLet BP can be effectively used in primary care settings compared to the standard care given by primary care providers. This randomized controlled trial focuses on whether using the iLet BP for 13 weeks leads to a greater reduction in HbA1c levels than continuing routine diabetes care. Participants will be randomly assigned to either use the iLet Bionic Pancreas system or continue with their usual diabetes care for 13 weeks. Those in the iLet BP group will be trained on how to use the device and accompanying tools like continuous glucose monitors (CGM), blood glucose meters, and ketone meters. Both groups will have regular follow-up phone calls during the study. After 13 weeks, participants complete final assessments. Those originally in routine care may choose to join an additional 13-week observational phase where they use the iLet BP. During the study, participants will complete virtual screening visits, mid-study follow-up calls, and a final visit. They will wear CGM devices to track glucose levels and perform fingerstick blood tests to measure HbA1c. Researchers will monitor glucose control, including time spent in various glucose ranges, and collect survey data. Safety and medication use will be reviewed regularly. The study runs from January 2026 to April 2029, with ongoing assessments to measure outcomes related to glucose management and device use.
CONDITIONS
Brief 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 one year with insulin use for at least one year
- Or clinical diagnosis of type 2 diabetes on injected or infused insulin for at least three months prior to screening
- Stable doses of glucose-lowering medications and weight loss medications over the past four weeks as determined by the investigator
- Willingness to maintain current medication doses affecting blood sugar during the study, except dose reduction or discontinuation
- Have a primary care clinician willing to refer, confirm diabetes diagnosis, and manage the iLet during the study
- Willing to comply with all study procedures and wear the Dexcom CGM device and iLet system during assigned periods
- Willing to use lispro or aspart insulin types
- Investigator confident in participant's ability to operate study devices and follow protocol
- Able to sign informed consent
- For those capable of pregnancy, willing to have pregnancy testing and use acceptable contraception during the study
- Agreement to follow lifestyle considerations during the 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 impairments like vision or memory problems
- Unable to speak or read English, as study materials are in English only
- Diagnosis of maturity-onset diabetes of the young (MODY)
- Planning changes to usual diabetes regimen between screening and randomization, including changing insulin delivery method or starting new diabetes medications, except insulin dose adjustments
- Weighing more than 255 kg (561 pounds)
- History of or planned bariatric surgery within 12 months of study participation
- Current use of non-FDA-cleared closed-loop insulin delivery systems
- Blood disorders affecting hemoglobin or conditions interfering with HbA1c accuracy
- Planned or recent blood transfusions within three months
- Current participation in another diabetes clinical trial
- History of diabetes due to pancreatic diseases or complete pancreatectomy
- Recent intermittent steroid use or plans for such use during study
- History of more than one episode of diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome in past six months unrelated to illness or device issues
- Severe allergy to adhesives used in the study
- Current or recent treatment with sulfonylurea, pramlintide, or SGLT-2 inhibitors
- Planned major surgery during study
- Pregnant, lactating, or planning pregnancy within six months
- Severe kidney disease or dialysis
- Any other condition that may interfere with safe or effective study participation as judged by investigator
- Plans to travel outside the US for more than four consecutive weeks
- Lack of internet or video/phone access for more than one week consecutively
- Employment or close relation to staff involved in the trial
- Previous use of the iLet system for more than four weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 13 weeks
Participants will be trained on the use of the iLet Bionic Pancreas system, continuous glucose monitor, blood glucose meter, and ketone meter. They will use the iLet Bionic Pancreas device for 13 weeks with ongoing support.
4 mid-period follow-up phone calls and a final in-person visit
Duration - 13 weeks
Participants will continue with their current diabetes treatment and use the study blood glucose meter. They will receive ongoing support during this period.
4 mid-period follow-up phone calls and a final in-person visit
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
E
Elizabeth Westfeldt, BSN, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here