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Active, not recruitingNCT06449677Updated Sep 18, 2026

Bionic Pancreas in CFRD

A Phase 3 interventional study of iLet Bionic Pancreas System (BP) and Usual Care (UC) in Cystic Fibrosis-related Diabetes, sponsored by Jaeb Center for Health Research. Active, not recruiting at 16 sites in United States. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by Jaeb Center for Health Research · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
14 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cystic Fibrosis-related Diabetes

Keywords

  • Cystic fibrosis-related diabetes (CFRD)
  • iLet bionic pancreas
  • Automated insulin delivery
  • Continuous glucose monitoring
03

In context

Lead sponsor

Jaeb Center for Health Research is the lead sponsor of 126 studies on the registry; 17 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 14 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  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 criteria:

    • 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
  4. Clinical diagnosis of CFRD, defined as a person with CF and diabetes mellitus, treated with insulin for ≥3 months prior to screening
  5. Using the same insulin regimen for ≥1 month prior to screening and collection of baseline CGM data, with no plans to change regimen during the study: either multiple daily injections of insulin (MDI), basal-only without bolus insulin, an insulin pump without automation, or an automated insulin delivery (AID) system other than the BP (which is an exclusion)
  6. Total daily insulin dose must be ≥0.1 units/kg

  7. Able to speak and read English sufficient to understand the pump user interface and provide written materials for safe operation of the BP

    • For pediatric participants, this applies to both the participant and caregiver
  8. 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.
  9. 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.
  10. 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.
  11. 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.
  12. Participant has commercial glucagon available for treatment of severe hypoglycemia or will obtain it prior to randomization
  13. Willing to authorize the study team to contact the participant's primary physician to inform them about their participation in this study.
  14. Enrolled in the Cystic Fibrosis Foundation Patient Registry (participants may enroll in the Registry at the time of enrollment if not already enrolled).
  15. No plans for trips of more than 14 consecutive days outside the United States during the period of study participation
  16. Investigator believes that the participant can safely use the iLet and will follow the protocol • The investigator will take into account the participant's HbA1c level (there is no upper limit for eligibility), compliance with current diabetes management, prior acute diabetic complications, cognitive ability, and general medical condition. For this reason, there is no upper limit on HbA1c specified for eligibility.

Exclusion criteria

Exclusion

  1. Current use of the BP or an AID system not FDA approved for T1D
  2. Known hemoglobinopathy (sickle cell trait is not an exclusion)
  3. Current participation in another diabetes-related interventional trial
  4. Established history of allergy or severe reaction to adhesive or tape that must be used in the study
  5. Pregnant (positive urine hCG), breast feeding, plan to become pregnant in the next 7 months, or sexually active and can become pregnant but not using contraception
  6. Current use of hydroxyurea or unable to avoid hydroxyurea use during the study (interferes with accuracy of Dexcom sensor)

  7. Have started or stopped a CFTR modulator in the 4 weeks prior to screening.

    • Modifications of the dosing of a CFTR modulator is acceptable
  8. Anticipated lung or liver transplant (on transplant list)

  9. Lung or liver transplant within one year prior to screening. If they have had a transplant more than a year ago, but they:

    • Have had a rejection episode occur in prior 8 weeks, individual is excluded.
    • Their doses of corticosteroids and/or calcineurin inhibitors have not been stable for one month prior to enrollment and/or is expected to change significantly over the course of the study, individual is excluded.
  10. Acute pulmonary exacerbation or hospitalization within the 4 weeks prior to screening or treatment with IV antibiotics in the 4 weeks prior to screening
  11. History of a complete pancreatectomy
  12. Currently using enteral tube feedings for nutritional support

  13. Presence of a medical condition or use of a medication that, in the judgment of the investigator, clinical protocol chair, or medical monitor, could compromise the results of the study or the safety of the participant. Conditions to be considered by the investigator may include the following:

    • Alcohol or drug abuse
    • Use of prescription drugs that may dull the sensorium, or hinder decision-making during the period of participation in the study such has opioids or short-acting benzodiazepines
    • Coronary artery disease that is not stable with medical management, including unstable angina, angina that prevents moderate exercise (e.g., climbing a flight of stairs) despite medical management; or within the last 12 months before screening: a history of myocardial infarction, percutaneous coronary intervention, enzymatic lysis of a presumed coronary occlusion, or coronary artery bypass grafting
    • Congestive heart failure with New York Heart Association (NYHA) Functional Classification III or IV
    • History of TIA or stroke in the last 12 months
    • Severe liver disease such as end-stage cirrhosis
    • Renal failure requiring dialysis or known eGFR \<30
    • Untreated or inadequately treated mental illness
    • History of untreated or inadequately treated eating disorder within the last 2 years, such as anorexia, bulimia, or diabulimia or omission of insulin to manipulate weight
    • History of intentional, inappropriate administration of insulin leading to severe hypoglycemia requiring treatment
  14. Employed by, or having immediate family members employed by Beta Bionics, or being directly involved in conducting the clinical trial, or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study 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).

    Device: iLet Bionic Pancreas System (BP) · Device: Usual Care (UC)

  • 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.

    Device: iLet Bionic Pancreas System (BP)

Interventions

  • DeviceiLet Bionic Pancreas System (BP)

    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.

  • DeviceUsual Care (UC)

    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.

06

What researchers measure

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

  5. Glucose Variability Measured With the Standard Deviation (SD)

    Glucose variability measured with the standard deviation (SD)

    Time frame: 13 weeks

  6. CGM-measured Time In Range <70 mg/dL

    CGM-measured time in range \<70 mg/dL

    Time frame: 13 weeks

  7. Glucose Variability With the Coefficient of Variation (CV)

    Glucose variability with the coefficient of variation (CV)

    Time frame: 13 weeks

  8. HbA1c <7.0% At 13 Weeks

    HbA1c \<7.0% at 13 weeks

    Time frame: 13 weeks

  9. HbA1c <7.0% At 13 Weeks In Participants With Baseline HbA1c >7.5%

    HbA1c \<7.0% at 13 weeks in participants with baseline HbA1c \>7.5%

    Time frame: 13 weeks

  10. HbA1c <8.0% At 13 Weeks

    HbA1c \<8.0% at 13 weeks

    Time frame: 13 weeks

  11. HbA1c Improvement From Baseline To 13 Weeks >0.5%

    HbA1c improvement from baseline to 13 weeks \>0.5%

    Time frame: 13 weeks

  12. HbA1c Improvement From Baseline To 13 Weeks >1.0%

    HbA1c improvement from baseline to 13 weeks \>1.0%

    Time frame: 13 weeks

  13. HbA1c Improvement From Baseline To 13 Weeks >1.0% Or HbA1c <7.0% At 13 Weeks

    HbA1c improvement from baseline to 13 weeks \>1.0% or HbA1c \<7.0% at 13 weeks

    Time frame: 13 weeks

  14. CGM-measured Time In Tight Range (TITR) 70-140 mg/dL

    CGM-measured time in tight range (TITR) 70-140 mg/dL

    Time frame: 13 weeks

  15. CGM-measured Area Over the Curve (70 mg/dL)

    CGM-measured area over the curve (70 mg/dL)

    Time frame: 13 weeks

  16. CGM-measured Low Sensor Glucose Events

    CGM-measured low sensor glucose events

    Time frame: 13 weeks

  17. CGM-measured Prolonged High Sensor Glucose Events

    CGM-measured prolonged high sensor glucose events

    Time frame: 13 weeks

  18. CGM-measured Time >300 mg/dL

    CGM-measured time \>300 mg/dL

    Time frame: 13 weeks

  19. CGM-measured Area Under the Curve (180 mg/dL)

    CGM-measured area under the curve (180 mg/dL)

    Time frame: 13 weeks

  20. CGM-measured TIR >70%

    CGM-measured TIR \>70%

    Time frame: 13 weeks

  21. CGM-measured TIR Improvement From Baseline To 13 Weeks ≥5%

    CGM-measured TIR improvement from baseline to 13 weeks ≥5%

    Time frame: 13 weeks

  22. CGM-measured TIR Improvement From Baseline To 13 Weeks ≥10%

    CGM-measured TIR improvement from baseline to 13 weeks ≥10%

    Time frame: 13 weeks

  23. CGM-measured Time <70 mg/dL <4%

    CGM-measured time \<70 mg/dL \<4%

    Time frame: 13 weeks

  24. CGM-measured Time <54 mg/dL <1%

    CGM-measured time \<54 mg/dL \<1%

    Time frame: 13 weeks

  25. CGM-measured TIR >70% and Time <54 mg/dL <1%

    CGM-measured TIR \>70% and time \<54 mg/dL \<1%

    Time frame: 13 weeks

  26. CGM-measured Improvement In TIR By >10% Without An Increase In Time <54 mg/dL By >0.5%

    CGM-measured improvement in TIR by \>10% without an increase in time \<54 mg/dL by \>0.5%

    Time frame: 13 weeks

  27. Type 1 Diabetes Distress Scale (T1-DDS)

    The T1-DDS is to evaluate diabetes-related emotional distress in type 1 diabetic patients. The scale consists of 17 items, contains 4 domains (emotional burden subscale, physician-related subscale, regimen-related distress subscale, and diabetes-related interpersonal distress). Each item is rated on a 6-point Likert scale from 1 (no problem) to 6 (serious problem). Patients with higher scores are considered with more distress

    Time frame: Screening, 13 weeks

  28. Problem Areas In Diabetes - Teens (PAID-T) and Parents of Teens (P-PAID-T)

    The PAID-T and P-PAID-T questionnaires consist of 26 items that are scored on a 6-point Likert scale from 1-2 (not a problem) to 5-6 (serious problem). The derived total score (26 questions) ranges between 26 and 156, where high scores represent a higher burden

    Time frame: Screening, 13 weeks

  29. Hypoglycemia Confidence Scale (≥18)

    A person-reported outcome measure (PROM) that examines the degree to which people with diabetes feel able, secure, and comfortable regarding their ability to stay safe from hypoglycemic-related problems (9-item scale with 4 choices that range from 1 (Not Confident At All) to 4 (Very Confident)). The total score can range from 1 to 4, with a higher score indicating a better outcome

    Time frame: Screening, 13 weeks

  30. INSPIRE Survey (Insulin Delivery Systems: Perceptions, Ideas, Reflections, and Expectations)

    INSPIRE 5-point Likert scale from strongly agree to strongly disagree, along with an N/A option

    Time frame: Screening, 13 weeks

  31. Fear of Hypoglycemia Survey (HFS-II) - Total Score, 2 Subscales and 4 Factor Scores

    Fear of Hypoglycemia Survey (HFS-II) - total score, 2 subscales and 4 factor scores: Behavior (avoidance, maintain high BG), Worry (helplessness, social consequences)

    Time frame: Screening, 13 weeks

  32. The EuroQol 5 Dimension 5 Level (EQ-5D-5L)

    The EQ-5D-5L is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical appraisal. The EQ-5D evaluates 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) using a 5-level severity scale from 1 (no problems) to 5 (extreme problems), and is converted to a single summary index by applying a formula that essentially attaches weight to each of the levels in each dimension. The visual analogue score (VAS) evaluates the health condition assessed by patients to producae a quantitive measure of health outcome that reflects the patient's own judgement on a range from "the worst health you can imagine" to "the best health you can imagine"

    Time frame: Screening, 13 weeks

  33. World Health Organization Well-being Index (WHO-5)

    WHO-5 is a 5-item questionnaire of the World Health Organization that measures health related quality of life. Each item is scored on a scale of 0 (at no time) to 5 (all the time). Higher scores indicate greater well-being

    Time frame: Screening, 13 weeks

  34. Perceived Benefits and Burdens of AID Systems

    A 35-item survey that assesses user expectations of a hybrid closed loop AID system using a 5-point Likert scale from "strongly disagree" to "strongly agree"

    Time frame: Screening, 13 weeks

  35. Total Daily Insulin (Units/kg)

    Total daily insulin (Units/kg)

    Time frame: 13 weeks

  36. Percentage of Total Insulin Delivered Via Basal

    Percentage of total insulin delivered via basal

    Time frame: 13 weeks

  37. Percentage of Total Insulin Delivered Via Bolus

    Percentage of total insulin delivered via bolus

    Time frame: 13 weeks

  38. Weight

    Weight

    Time frame: 13 weeks

  39. Body Mass Index (BMI)

    Body Mass Index (BMI)

    Time frame: 13 weeks

  40. Number of Severe Hypoglycemia (SH) Events and SH Event Rate Per 100 person-years

    Number of Severe Hypoglycemia (SH) events and SH event rate per 100 person-years

    Time frame: 13 weeks

  41. Number of Diabetes Ketoacidosis (DKA) Events and DKA Event Rate Per 100 person-years

    Number of Diabetes Ketoacidosis (DKA) events and DKA event rate per 100 person-years

    Time frame: 13 weeks

  42. Number of Other Serious Adverse Events (SAEs other than SH events and DKA events)

    Number of Other Serious Adverse Events (SAEs other than SH events and DKA events)

    Time frame: 13 weeks

  43. Number of Unanticipated Adverse Device Effects (UADE)

    Number of Unanticipated Adverse Device Effects (UADE)

    Time frame: 13 weeks

  44. Number of Infusion Set Failures

    Number of infusion set failures

    Time frame: 13 weeks

  45. Other Device Malfunctions/Device Issues

    Number of other malfunctions/issues related to the study device

    Time frame: 13 weeks

07

Study locations

16 sites
  • University of Colorado-Barbara Davis Center for Diabetes
    Aurora, Colorado 80045, United States
  • Yale University School of Medicine
    New Haven, Connecticut 06511, United States
  • Emory University
    Atlanta, Georgia 30329, United States
  • Indiana University School of Medicine
    Indianapolis, Indiana 46202, United States
  • Johns Hopkins University School of Medicine
    Baltimore, Maryland 21287, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
  • Children's Mercy Hospital
    Kansas City, Missouri 64108, United States
  • Columbia University Medical Center
    New York, New York 10032, United States
  • University Hospitals of Cleveland
    Cleveland, Ohio 44106, United States
  • Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania 19104, United States
  • UT Southwestern Medical Center
    Dallas, Texas 75235, United States
  • Baylor College of Medicine
    Houston, Texas 77030, United States
  • University of Texas Health San Antonio
    San Antonio, Texas 78207, United States
  • University of Utah
    Salt Lake City, Utah 84132, United States
  • University of Virginia-Center for Diabetes Technology
    Charlottesville, Virginia 22903, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06449677
Lead sponsor
Jaeb Center for Health Research
Collaborators
Cystic Fibrosis Foundation, Massachusetts General Hospital, Beta Bionics, Inc.
Responsible party
Sponsor
First posted
Jun 10, 2024
Start date
Sep 24, 2024
Primary completion
Sep 30, 2026 (estimated)
Completion
May 31, 2027 (estimated)
Last update
Sep 18, 2026

Study contacts

Melissa Putman, MD
study chair · Massachusetts General Hospital
Judy Sibayan, MPH
study director · Jaeb Center for Health Research

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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