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Cystic Fibrosis-related DiabetesPhase 3NCT06449677

Bionic Pancreas in CFRD

A Phase 3 study testing iLet Bionic Pancreas System (BP) in people with Cystic Fibrosis-related Diabetes, run by Jaeb Center for Health Research at 16 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 14 years and older
Conditions the study is for
Cystic Fibrosis-related Diabetes
What is being tested?
iLet Bionic Pancreas System (BP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
16 sitesUnited States
Study dates
24 Sep 2024to 31 May 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age ≥ 14 years old at time of signing informed consent
  • Able to provide informed consent (and assent for participants <18 years old)
  • 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
  • Clinical diagnosis of CFRD, defined as a person with CF and diabetes mellitus, treated with insulin for ≥3 months prior to screening
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  • 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)
  • Total daily insulin dose must be ≥0.1 units/kg
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • Participant has commercial glucagon available for treatment of severe hypoglycemia or will obtain it prior to randomization
  • Willing to authorize the study team to contact the participant's primary physician to inform them about their participation in this study.
  • Enrolled in the Cystic Fibrosis Foundation Patient Registry (participants may enroll in the Registry at the time of enrollment if not already enrolled).
  • No plans for trips of more than 14 consecutive days outside the United States during the period of study participation
  • 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.

Who cannot join

  • Current use of the BP or an AID system not FDA approved for T1D
  • Known hemoglobinopathy (sickle cell trait is not an exclusion)
  • Current participation in another diabetes-related interventional trial
  • Established history of allergy or severe reaction to adhesive or tape that must be used in the study
  • 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
  • Current use of hydroxyurea or unable to avoid hydroxyurea use during the study (interferes with accuracy of Dexcom sensor)
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  • Have started or stopped a CFTR modulator in the 4 weeks prior to screening.
  • Modifications of the dosing of a CFTR modulator is acceptable
  • Anticipated lung or liver transplant (on transplant list)
  • 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.
  • Acute pulmonary exacerbation or hospitalization within the 4 weeks prior to screening or treatment with IV antibiotics in the 4 weeks prior to screening
  • History of a complete pancreatectomy
  • Currently using enteral tube feedings for nutritional support
  • 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
  • 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.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Emory University

    Atlanta, Georgia, 30329

  • University of Colorado-Barbara Davis Center for Diabetes

    Aurora, Colorado, 80045

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21287

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • University of Virginia-Center for Diabetes Technology

    Charlottesville, Virginia, 22903

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • UT Southwestern Medical Center

    Dallas, Texas, 75235

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Yale University School of Medicine

    New Haven, Connecticut, 06511

  • Columbia University Medical Center

    New York, New York, 10032

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • University of Utah

    Salt Lake City, Utah, 84132

  • University of Texas Health San Antonio

    San Antonio, Texas, 78207

Other trials in United States

About this study

Official title: 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.

Being tested
iLet Bionic Pancreas System (BP), Usual Care (UC)
Keywords
Cystic fibrosis-related diabetes (CFRD), iLet bionic pancreas, Automated insulin delivery, Continuous glucose monitoring

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 groups in NCT06449677
Study groupRoleWhat they receive
UC GroupActive comparatorParticipants 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).
Receives: Device: iLet Bionic Pancreas System (BP); Device: Usual Care (UC)
BP GroupExperimentalParticipants 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.
Receives: Device: iLet Bionic Pancreas System (BP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 13 weeks

Secondary outcomes (1)

  1. CGM-measured Time In Range <54 mg/dL

    CGM-measured time in range <54 mg/dL

    Measured: 13 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2024
  2. Study start24 Sep 2024
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
13-week RCT followed by a 13-week Extension Phase in which all participants use the iLet BP System
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06449677
Sponsor's protocol ID
BPCFRD
Status last verified
Sep 2026
First submitted
20 May 2024
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing iLet Bionic Pancreas System (BP) in people with Cystic Fibrosis-related Diabetes, run by Jaeb Center for Health Research at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CGM-measured Time In Target Range of 70-180 mg/dL (TIR) (time frame: 13 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06449677.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.

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