Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery
PREPARE 4 AID
2 other identifiers
interventional
240
1 country
2
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2026
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2025
CompletedFirst Posted
Study publicly available on registry
June 8, 2025
CompletedStudy Start
First participant enrolled
January 16, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2029
April 2, 2026
April 1, 2026
9 months
May 30, 2025
April 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
HbA1c between the BP and RC groups
Superiority testing for HbA1c at 13 weeks between the BP and RC groups using linear mixed effects regression models adjusting for baseline HbA1c.
RCT Week 13
Percentage of Time With CGM Glucose <54 mg/dl
Non-inferiority testing for ordinal TBR\<54mg/dL will be determined using a two-sided 95% confidence interval on the mean difference in % time \<54 mg/dL between BP and RC groups using a linear mixed effects regression model adjusting for baseline % time \<54 mg/dL, diabetes type, and clinical center.
RCT Weeks 1-13 and OEP Weeks 13-26
Secondary Outcomes (9)
Percentage of Time With CGM Glucose in the 70-180 mg/dl Range
RCT Weeks 1-13 and OEP Weeks 13-26
Percentage of Time in Tight Range With CGM Glucose in the 70-140 mg/dl
RCT Weeks 1-13 and OEP Weeks 13-26
Mean CGM Glucose
RCT Weeks 1-13 and OEP Weeks 13-26
Percentage of Time With CGM Glucose >250 mg/dl Range
RCT Weeks 1-13 and OEP Weeks 13-26
Percentage of Time With CGM Glucose >180 mg/dl Range
RCT Weeks 1-13 and OEP Weeks 13-26
- +4 more secondary outcomes
Study Arms (2)
Bionic Pancreas
EXPERIMENTALRoutine Care
ACTIVE COMPARATORInterventions
The intervention group will use the iLet Bionic Pancreas (BP) for 13-weeks. They will be trained on the iLet BP system and its components by a Certified iLet Trainer. They will also be trained on how to use the study continuous glucose monitor (CGM) system, blood glucose meter, and ketone meter. Participants will have four mid-period follow up phone calls to review medications, ongoing eligibility, and solicit any occurrences of adverse events and device issues. At the end of 13-weeks, they will complete final visit tasks and will be transitioned back to their pre-study insulin delivery method with guidance provided by a study investigator.
Participants will continue with their current diabetes treatment. Participants will be trained on the use of the study blood glucose meter. They will have four mid-period follow up phone calls to review medications, ongoing eligibility, and solicit any occurrences of adverse events. At the end of 13-weeks, they will complete final visit tasks and will be asked if they would like to participate in the observational extension phase where they will use the iLet Bionic Pancreas for 13 weeks.
Eligibility Criteria
You may qualify if:
- 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
- Willing to comply with all study procedures for the duration of the study
- Willing to wear a Dexcom CGM device and iLet system for duration of time randomized to iLet use or OEP
- Willing to use the following insulin: lispro (including non-branded lispro and Humalog) or aspart (including non-branded aspart, Fiasp, and Novolog)
- Investigator has confidence that the participant has the cognitive ability and can successfully operate all study devices and can adhere to the protocol
- Willing and able to sign and date the Informed Consent Form (ICF)
- If capable of becoming pregnant, willing and able to have pregnancy testing and use an acceptable method of contraception during the study period
- a. Capable of becoming pregnant means that menstruation has started and the participant is not surgically sterile or post-menopausal (12 months without menses) b. Acceptable methods of contraception include: i. Combined estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal).
- +7 more criteria
You may not qualify if:
- 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
- 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")
- 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
- Planned use of hydroxyurea at any dose and/or of acetaminophen at doses exceeding 1 gram (1000 mg) every 6 hours.
- Plans to receive a blood transfusion over the course of the study or has received a transfusion within 3 months prior to enrollment
- Current participation in another diabetes-related clinical trial
- History of diabetes due to cystic fibrosis, pancreatitis, or other pancreatic disease, including pancreatic tumor or insulinoma, or history of complete pancreatectomy
- Have a history of intermittent oral or injectable glucocorticoid treatment within 8 weeks prior to screening or plans to take intermittent oral or injectable glucocorticoid during the study (chronic, stable treatment is acceptable, unplanned use is acceptable)
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- Massachusetts General Hospitalcollaborator
- Beta Bionics, Inc.collaborator
- Ann & Robert H Lurie Children's Hospital of Chicagocollaborator
Study Sites (2)
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sean Oser, MD, MPH, CDCES
University of Colorado, Denver
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2025
First Posted
June 8, 2025
Study Start
January 16, 2026
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
April 1, 2029
Last Updated
April 2, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
Deidentified glucose data and psychosocial data will be shared with research collaborators.