Bionic Pancreas in CFRD (NCT06449677) | Clinical Trial Compass
RecruitingPhase 3
Bionic Pancreas in CFRD
United States150 participantsStarted 2024-09-24
Plain-language summary
This multi-center randomized controlled trial (RCT) will compare efficacy and safety endpoints using the insulin-only configuration of the iLet Bionic Pancreas System (BP) versus a control group using their usual care insulin delivery method and continuous glucose monitoring (CGM) during a 13-week study period in individuals ≥14 years old with cystic fibrosis-related diabetes (CFRD). After 13 weeks, participants will continue in a 13-week Extension Phase in which the BP group will continue to use the BP system and the Usual Care group will initiate use of the BP system.
Who can participate
Age range14 Years
SexALL
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Inclusion criteria
✓. Age ≥ 14 years old at time of signing informed consent
✓. Able to provide informed consent (and assent for participants \<18 years old)
✓. Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
✓. Clinical diagnosis of CFRD, defined as a person with CF and diabetes mellitus, treated with insulin for ≥3 months prior to screening
Exclusion criteria
✕. Total daily insulin dose must be ≥0.1 units/kg
✕. Able to speak and read English sufficient to understand the pump user interface and provide written materials for safe operation of the BP
✕. For participants \<18 years old, living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia. A designated care partner must be willing to be linked to the participant's Dexcom Follow application with location sharing on.
✕. For participants \>18 years old who live alone, participant has a relative or acquaintance who lives within 30 minutes of participant and is willing to be contacted to check on participant if study staff feel that participant may be experiencing a medical emergency and cannot be reached. A designated care partner must be willing to be linked to the participant's Dexcom Follow application with location sharing on.
✕0. No use of a non-insulin glucose-lowering medication, except metformin, that is not approved for use in T1D within 3 months prior to signing informed consent and willing to not use any such medications during the course of the trial. Note: such drugs cannot be used even if prescribed for weight loss rather than glucose-lowering.
What they're measuring
1
CGM-measured Time In Target Range of 70-180 mg/dL (TIR)
✕1. If not currently using a rapid-acting insulin that is approved for use in the iLet pump, willing and able to switch to an approved insulin when using the BP.
✕2. Participant has commercial glucagon available for treatment of severe hypoglycemia or will obtain it prior to randomization
✕3. Willing to authorize the study team to contact the participant's primary physician to inform them about their participation in this study.