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
Age at time of consent >18 and <89 years
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
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
Crossover
Bionic Pancreas
DeviceThe 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.
Routine Care
Other interventionParticipants 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.
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.
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.
Percentage of Time With CGM Glucose in the 70-180 mg/dl Range
Calculated from all individual CGM values from RCT weeks 1-13 for each participant.
Percentage of Time in Tight Range With CGM Glucose in the 70-140 mg/dl
Calculated from all individual CGM values from weeks 1-13 for each participant.
Mean CGM Glucose
Individual CGM values from weeks 1-13 averaged together for each participant.
Percentage of Time With CGM Glucose >250 mg/dl Range
Calculated from all individual CGM values from weeks 1-13 for each participant.
Click on the lead sponsor to view all of their trials.
University of Colorado, Denver
Lead sponsor
Massachusetts General Hospital
Collaborator
Beta Bionics, Inc.
Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborator
