Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery (NCT07011147) | Clinical Trial Compass
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 range
18 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing a 'best practices' group to a 'real-world care' group for automated insulin delivery — can you explain which group I would likely be in, and how that would affect the support and monitoring I receive during the study?
2The trial is measuring HbA1c and the percentage of time my glucose drops below 54 mg/dl, which is a dangerously low level — given my current history with low blood sugars, is it safe for me to participate, and what safeguards are built in if I experience more frequent lows?
3Since this is a pragmatic, real-world study rather than a controlled phase trial, does that mean I might receive less intensive oversight than I would in a traditional clinical trial, and how does that compare to the standard diabetes care I'm already getting?
4Automated insulin delivery systems require consistent use of a continuous glucose monitor and an insulin pump — do I currently have access to that technology, or would the trial provide it, and how much time and effort would managing this equipment add to my daily routine?
5Before considering this trial, should I first make sure my current diabetes management is as optimized as possible with standard treatments, or is this study designed for people whose control hasn't been ideal so far?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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
. 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)
. Unable to speak and read English, as iLet BP support materials and device menus are currently available in English only
. Diagnosis of maturity-onset diabetes of the young (MODY)
. Plan to change usual diabetes regimen between screening and study randomization
. 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
. 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
. Weigh more than 255 kg (561 pounds) as this is the maximum weight that can be entered into the iLet user interface
. History of bariatric surgery within 12 months prior to enrollment or plans for bariatric surgery within the period of study participation