Bionic Pancreas in CFRD

Conditions

• Cystic Fibrosis-related Diabetes

Eligibility Criteria

Sex

ALL

Age

14 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Sep 24, 2024

Status verified

Feb 2026

Primary completion

Sep 30, 2026

Completion

Mar 30, 2027

Study Design

Enrollment

150 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: UC Group
  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).
• Experimental: BP Group
  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.

Primary Outcome Measure

CGM-measured Time In Target Range of 70-180 mg/dL (TIR) [ Time Frame: 13 weeks ]

Central Contacts

• Judy Sibayan, MPH
  813-975-8690
  [email protected]

Locations (16)

Find similar trials in Aurora, CO

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