Bionic Pancreas in CFRD

A Randomized Trial of the Insulin-only Bionic Pancreas in Cystic Fibrosis Related Diabetes

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.

Study Overview

• Status: Recruiting
• Conditions: Cystic Fibrosis-related Diabetes
• Intervention / Treatment: Device: iLet Bionic Pancreas System (BP); Device: Usual Care (UC)

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Judy Sibayan, MPH; Phone Number: 813-975-8690; Email: jsibayan@jaeb.org

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado-Barbara Davis Center for Diabetes
      • Sub-Investigator: Erin Cobry, MD
      • Principal Investigator: Christine L Chan, MD
      • Sub-Investigator: Paul Wadwa, MD
      • Sub-Investigator: Gregory Forlenza, MD, MS
      • Contact: Christine Hovater; Phone Number: 3286 720-777-3286; Email: Christine.Hovater@childrenscolorado.org
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Recruiting
      • Yale University School of Medicine
      • Principal Investigator: Michelle Van Name, MD
      • Contact: Amy Steffen, BSN; Phone Number: 203-737-8852; Email: Amy.steffen@yale.edu
      • Sub-Investigator: Stuart Weinzimer, MD
      • Sub-Investigator: Marie Egan, MD
      • Sub-Investigator: Amy Darukhanavala, MD
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Recruiting
      • Emory University
      • Contact: Demetria Oliver; Phone Number: 404-543-1285; Email: dolive7@emory.edu
      • Principal Investigator: Tanicia Daley, MD, MPH
      • Sub-Investigator: Kristina Cossen, MD
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University School of Medicine
      • Principal Investigator: Viral Shah, MD
      • Contact: Melissa Lodato, MD; Phone Number: 317-278-4570; Email: melodato@iu.edu
      • Sub-Investigator: Zunera Tariq, MD, MPH
      • Sub-Investigator: Cynthia Brown, MD, MS
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins University School of Medicine
      • Contact: Lee Bromberger; Phone Number: 443-287-9032; Email: lbrombe1@jhmi.edu
      • Principal Investigator: Scott Blackman, MD, PhD
      • Sub-Investigator: Malinda Wu, MD, MSCR
      • Sub-Investigator: Aniket Sidhaye, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Principal Investigator: Melissa Putman, MD
      • Contact: Annabelle Ashley, BSN; Phone Number: 617-643-6702; Email: aashley1@mgb.org
      • Sub-Investigator: Kristen Flint, MD
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota
      • Sub-Investigator: Tasma Harindhanavudhi, MD
      • Contact: Cathy Larson; Phone Number: 612-625-2153; Email: sund0033@umn.edu
      • Principal Investigator: Amir Moheet, MD
      • Sub-Investigator: Antoinette Moran, MD
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Recruiting
      • Children's Mercy Hospital
      • Contact: Kelsye Howell; Phone Number: 816-760-5919; Email: klhowell@cmh.edu
      • Sub-Investigator: Hugo Escobar, MD
      • Sub-Investigator: Wayne Moore, MD, PhD
      • Principal Investigator: Cintya Schweisberger, DO
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Medical Center
      • Sub-Investigator: Robin Goland, MD
      • Principal Investigator: Kristen Williams, MD
      • Sub-Investigator: Jacqueline Lonier, MD
      • Sub-Investigator: Hossein Sadeghi, MD
      • Contact: Amy Doytchinov, BSN; Phone Number: 212-851-5505; Email: as8064@cumc.columbia.edu
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals of Cleveland
      • Sub-Investigator: Katherine Kutney, MD
      • Principal Investigator: Beth Kaminski, MD
      • Sub-Investigator: Erica Roesch, MD
      • Sub-Investigator: Alex Gifford, MD
      • Contact: Cindy Schaefer, BSN; Phone Number: 216-286-0709; Email: cindy.schaefer@uhhospitals.org
      • Contact: Terri Casey, BSN; Email: terri.casey@uhhospitals.org
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Completed
      • Children's Hospital of Philadelphia
  • Texas
    • Dallas, Texas, United States, 75235
      • Recruiting
      • UT Southwestern Medical Center
      • Contact: Lindsay Allen; Phone Number: 214-433-4059; Email: Lindsay.Allen@utsouthwestern.edu
      • Principal Investigator: Melissa Ham, MD
      • Sub-Investigator: Meghana Sathe, MD
      • Sub-Investigator: Preeti Sharma, MD
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor College of Medicine
      • Contact: Pavel Tuekam; Phone Number: 832-822-0030; Email: ornellapavel.tuekammeko@bcm.edu
      • Principal Investigator: Lina Merjaneh, MD
      • Sub-Investigator: Daniel DeSalvo, MD
      • Sub-Investigator: Fadel Ruiz, MD
      • Sub-Investigator: Michelle Mann, MD
      • Sub-Investigator: Jessica Farrell, NP-C
    • San Antonio, Texas, United States, 78207
      • Recruiting
      • University of Texas Health San Antonio
      • Contact: Sara Olivarri; Phone Number: 210-567-5283; Email: olivarri@uthscsa.edu
      • Principal Investigator: Maria S Rayas, MD
      • Sub-Investigator: Ruby Favela-Prezas, MSN, APRN, FNP
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Recruiting
      • University of Utah
      • Contact: Judy Jensen; Phone Number: 801-703-5353; Email: judy.jensen@hsc.utah.edu
      • Principal Investigator: Katie Kaput, DO
      • Sub-Investigator: Marie Couldwell, MD
      • Sub-Investigator: Karma Elliott, MD
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Recruiting
      • University of Virginia-Center for Diabetes Technology
      • Sub-Investigator: Jennifer Kirby, MD
      • Principal Investigator: Sue Brown, MD
      • Contact: Sara Prince; Phone Number: 434-320-5599; Email: SP4SA@uvahealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); 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.; Device: Usual 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.
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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CGM-measured Time In Target Range of 70-180 mg/dL (TIR)	CGM-measured time in target range of 70-180 mg/dL (TIR)	13 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CGM-measured Time In Range <54 mg/dL	CGM-measured time in range <54 mg/dL	13 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Weight	13 weeks
Body Mass Index (BMI)	Body Mass Index (BMI)	13 weeks
CGM-measured Mean Glucose	Average glucose value measured by CGM	13 weeks
Percentage of Total Insulin Delivered Via Basal	Percentage of total insulin delivered via basal	13 weeks
CGM-measured Time In Range >180 mg/dL	CGM-measured time in range >180 mg/dL	13 weeks
CGM-measured Time In Range >250 mg/dL	CGM-measured time in range >250 mg/dL	13 weeks
HbA1c At 13 Weeks	HbA1c at 13 weeks	13 weeks
Glucose Variability Measured With the Standard Deviation (SD)	Glucose variability measured with the standard deviation (SD)	13 weeks
CGM-measured Time In Range <70 mg/dL	CGM-measured time in range <70 mg/dL	13 weeks
Glucose Variability With the Coefficient of Variation (CV)	Glucose variability with the coefficient of variation (CV)	13 weeks
HbA1c <7.0% At 13 Weeks	HbA1c <7.0% at 13 weeks	13 weeks
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%	13 weeks
HbA1c <8.0% At 13 Weeks	HbA1c <8.0% at 13 weeks	13 weeks
HbA1c Improvement From Baseline To 13 Weeks >0.5%	HbA1c improvement from baseline to 13 weeks >0.5%	13 weeks
HbA1c Improvement From Baseline To 13 Weeks >1.0%	HbA1c improvement from baseline to 13 weeks >1.0%	13 weeks
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	13 weeks
CGM-measured Time In Tight Range (TITR) 70-140 mg/dL	CGM-measured time in tight range (TITR) 70-140 mg/dL	13 weeks
CGM-measured Area Over the Curve (70 mg/dL)	CGM-measured area over the curve (70 mg/dL)	13 weeks
CGM-measured Low Sensor Glucose Events	CGM-measured low sensor glucose events	13 weeks
CGM-measured Prolonged High Sensor Glucose Events	CGM-measured prolonged high sensor glucose events	13 weeks
CGM-measured Time >300 mg/dL	CGM-measured time >300 mg/dL	13 weeks
CGM-measured Area Under the Curve (180 mg/dL)	CGM-measured area under the curve (180 mg/dL)	13 weeks
CGM-measured TIR >70%	CGM-measured TIR >70%	13 weeks
CGM-measured TIR Improvement From Baseline To 13 Weeks ≥5%	CGM-measured TIR improvement from baseline to 13 weeks ≥5%	13 weeks
CGM-measured TIR Improvement From Baseline To 13 Weeks ≥10%	CGM-measured TIR improvement from baseline to 13 weeks ≥10%	13 weeks
CGM-measured Time <70 mg/dL <4%	CGM-measured time <70 mg/dL <4%	13 weeks
CGM-measured Time <54 mg/dL <1%	CGM-measured time <54 mg/dL <1%	13 weeks
CGM-measured TIR >70% and Time <54 mg/dL <1%	CGM-measured TIR >70% and time <54 mg/dL <1%	13 weeks
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%	13 weeks
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	Screening, 13 weeks
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	Screening, 13 weeks
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	Screening, 13 weeks
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	Screening, 13 weeks
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)	Screening, 13 weeks
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"	Screening, 13 weeks
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	Screening, 13 weeks
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"	Screening, 13 weeks
Total Daily Insulin (Units/kg)	Total daily insulin (Units/kg)	13 weeks
Percentage of Total Insulin Delivered Via Bolus	Percentage of total insulin delivered via bolus	13 weeks
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	13 weeks
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	13 weeks
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)	13 weeks
Number of Unanticipated Adverse Device Effects (UADE)	Number of Unanticipated Adverse Device Effects (UADE)	13 weeks
Number of Infusion Set Failures	Number of infusion set failures	13 weeks
Other Device Malfunctions/Device Issues	Number of other malfunctions/issues related to the study device	13 weeks

Collaborators and Investigators

• Sponsor: Jaeb Center for Health Research
• Collaborators: Massachusetts General Hospital; Cystic Fibrosis Foundation; Beta Bionics, Inc.
• Investigators: Study Chair: Melissa Putman, MD, Massachusetts General Hospital; Study Director: Judy Sibayan, MPH, Jaeb Center for Health Research

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 30, 2027

Study Registration Dates

• First Submitted: May 20, 2024
• First Submitted That Met QC Criteria: June 3, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Continuous glucose monitoring; Automated insulin delivery; Cystic fibrosis-related diabetes (CFRD); iLet bionic pancreas
• Additional Relevant MeSH Terms: Pathologic Processes; Genetic Diseases, Inborn; Respiratory Tract Diseases; Digestive System Diseases; Lung Diseases; Infant, Newborn, Diseases; Pancreatic Diseases; Fibrosis; Cystic Fibrosis; Gastrointestinal Agents; Pancrelipase
• Other Study ID Numbers: BPCFRD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No