Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06449677 | Bionic Pancreas in CFRD | PHASE3 | RECRUITING | 150 | — | — | Sep 24, 2024 | Mar 30, 2027 | Feb 23, 2026 | 16 | United States |
CGM-measured time in target range of 70-180 mg/dL (TIR)
| Arm | Type | Description |
|---|---|---|
| UC Group | ACTIVE_COMPARATOR | Participants randomized to the Usual Care (UC) group will use their existing insulin delivery method in conjunction with a study CGM during the first 13-week of the study (RCT phase). The UC group will then initiate use of the BP System for the remaining 13 weeks of the study (Extension Phase). |
| BP Group | EXPERIMENTAL | Participants randomized to the intervention group will use the BP group using the iLet Bionic Pancreas System (BP) and continuous glucose monitoring (CGM) during the first 13-week of the study (RCT phase). After the RCT phase, participants will continue in a 13-week Extension Phase in which the BP group will continue to use the BP system. |
| Name | Type | Description |
|---|---|---|
| iLet Bionic Pancreas System (BP) | DEVICE | The iLet Bionic Pancreas System (BP) consists of an integrated infusion pump, touchscreen display, Bluetooth radio, and insulin dosing algorithms, that automatically controls insulin delivery based on glucose values obtained by communicating with a CGM sensor. |
| Usual Care (UC) | DEVICE | Usual Care consists in the participant existing insulin therapy (prior to enrollment) in conjunction with a study CGM. Existing insulin therapies are defined as multiple daily injections of insulin (MDI) or use of an insulin pump. |
Inclusion 1. Age ≥ 14 years old at time of signing informed consent 2. Able to provide informed consent (and assent for participants \<18 years old) 3. 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 cri...