Health TrialsbyHealthPanel

Bionic Pancreas in CFRD

ConditionCystic Fibrosis-related Diabetes
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age14+
SponsorJaeb Center for Health Research

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 14 years old at time of signing informed consent

Able to provide informed consent (and assent for participants <18 years old)

Sweat chloride equal to or greater than 60 mmol/liter by quantitative pilocarpine iontophoresis test (QPIT) (when not taking a cystic fibrosis transmembrane conductance regulator (CFTR) modulator)

Two well-characterized mutations in the CFTR gene

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: UC GroupActive comparator 2 interventions
Group B: BP GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

CGM-measured Time In Target Range of 70-180 mg/dL (TIR)

CGM-measured time in target range of 70-180 mg/dL (TIR)

Time frame
13 weeks

Secondary outcomes

1

CGM-measured Time In Range <54 mg/dL

CGM-measured time in range \<54 mg/dL

Time frame
13 weeks

Other outcomes

1

CGM-measured Mean Glucose

Average glucose value measured by CGM

Time frame
13 weeks
2

CGM-measured Time In Range >180 mg/dL

CGM-measured time in range \>180 mg/dL

Time frame
13 weeks
3

CGM-measured Time In Range >250 mg/dL

CGM-measured time in range \>250 mg/dL

Time frame
13 weeks
4

HbA1c At 13 Weeks

HbA1c at 13 weeks

Time frame
13 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jaeb Center for Health Research

Lead sponsor

Cystic Fibrosis Foundation

Collaborator

Massachusetts General Hospital

Collaborator

Beta Bionics, Inc.

Collaborator

Source ClinicalTrials.gov
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