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Automated Insulin Delivery System

Bionic Pancreas for Cystic Fibrosis

Phase 3

Recruiting

Research Sponsored by Jaeb Center for Health Research

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 14 years old at time of signing informed consent

Using a specific insulin regimen for ≥1 month prior to screening with no plans to change regimen during the study

Must not have

Pregnant, breast feeding, planning pregnancy in the next 7 months, or sexually active without contraception

Current use of the BP or an AID system not FDA approved for T1D

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 13 weeks

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial will compare the effectiveness and safety of using the iLet Bionic Pancreas System with insulin-only configuration versus the usual insulin delivery method and continuous glucose monitoring in individuals with cystic fibrosis

Who is the study for?

This trial is for individuals aged 14 or older with cystic fibrosis-related diabetes (CFRD) who have been on a stable insulin regimen for at least one month. Participants must be able to understand English, provide informed consent, and meet specific medical criteria like a daily insulin dose of ≥0.1 units/kg and certain genetic mutations.

What is being tested?

The study compares the iLet Bionic Pancreas System (BP), which delivers insulin only, against usual care methods over a period of 13 weeks. After this phase, all participants will use the BP system for another 13 weeks to further assess its efficacy and safety.

What are the potential side effects?

Potential side effects may include issues related to insulin delivery such as low blood sugar levels (hypoglycemia), skin irritation at the infusion site, or possible device malfunctions leading to incorrect insulin dosing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 14 years old or older.

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I have been on a stable insulin regimen for over a month and don't plan to change it.

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I take at least 0.1 units/kg of insulin daily.

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I won't travel outside the US for more than 14 days during the study.

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I have been diagnosed with cystic fibrosis based on symptoms and either a sweat test or genetic testing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant, breastfeeding, planning to become pregnant soon, or sexually active without using birth control.

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I am using a blood pressure or artificial insulin delivery system not approved by the FDA for Type 1 Diabetes.

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I have had my entire pancreas removed or I am currently on tube feeding.

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I have a known blood disorder, but not sickle cell trait.

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I am currently using hydroxyurea or cannot stop it for the study.

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I haven't had a lung flare-up or been hospitalized for it in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 13 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~13 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 13 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

CGM-measured Time In Range <54 mg/dL

Other study objectives

Body Mass Index (BMI)

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

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

+42 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BP GroupExperimental Treatment1 Intervention

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.

Group II: UC GroupActive Control2 Interventions

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).

0 / 11Eligibility criteria met