Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
iLet Bionic Pancreas System, Usual Care · 1 trial · 1 indication
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...
The iLet Bionic Pancreas System is an investigational automated insulin delivery system being studied for the management of Cystic Fibrosis-related Diabetes (CFRD). It is currently in Phase 3 clinical development, with an active trial enrolling 150 participants aged 14 years and older in the United States.
The iLet Bionic Pancreas System is an automated insulin delivery system designed to manage blood glucose levels in people with Cystic Fibrosis-related Diabetes. It is being evaluated in a Phase 3 clinical trial to assess its safety and effectiveness in this patient population.
The iLet Bionic Pancreas System is developed by Beta Bionics, Inc., a company publicly traded under the ticker symbol BBNX. The system is currently in Phase 3 clinical development for the treatment of Cystic Fibrosis-related Diabetes.
The iLet Bionic Pancreas System is in Phase 3 clinical development for Cystic Fibrosis-related Diabetes. It is an investigational device, not yet approved by regulatory authorities, and is currently being evaluated in a randomized, active-controlled clinical trial.
The iLet Bionic Pancreas System is being studied in a Phase 3 clinical trial identified as NCT06449677, titled "Bionic Pancreas in CFRD." This trial is actively recruiting 150 participants with Cystic Fibrosis-related Diabetes in the United States, with a minimum age of 14 years.
No, the iLet Bionic Pancreas System is not the same as usual care. It is an investigational automated insulin delivery system being compared against usual care in a Phase 3 clinical trial for Cystic Fibrosis-related Diabetes. The trial is active-controlled, meaning participants receive either the iLet system or standard diabetes management.