Bionic Pancreas for Cystic Fibrosis

Recruiting at 15 trial locations

Overseen By Colleen Bauza, PhD, MPH

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Jaeb Center for Health Research

Must be taking: Insulin

Must not be taking: Hydroxyurea, Opioids, Benzodiazepines

Disqualifiers: Pregnancy, Transplant, Severe liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 13 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the iLet Bionic Pancreas System (BP), to determine its effectiveness in helping people with cystic fibrosis-related diabetes (CFRD) manage blood sugar levels. The study will compare the BP system to usual insulin methods over a 13-week period, followed by another 13 weeks where all participants will use the BP system. It is open to individuals with CFRD who have used insulin for at least three months and manage their diabetes with regular insulin doses. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in diabetes management.

Will I have to stop taking my current medications?

The trial requires that you do not use any non-insulin glucose-lowering medications, except metformin, during the study. If you are not currently using a rapid-acting insulin approved for the iLet pump, you must be willing to switch to an approved insulin. Other medications may need to be reviewed by the study team to ensure they don't interfere with the trial.

What prior data suggests that the iLet Bionic Pancreas System is safe for individuals with cystic fibrosis-related diabetes?

Research has shown that the iLet Bionic Pancreas System, which helps control blood sugar levels, is generally safe. In a recent study, people using the iLet system experienced no serious side effects. The system uses fast-acting insulin to manage blood sugar, and users can set their preferred blood sugar target. Tested in everyday situations, users have tolerated it well.

Moreover, the FDA has approved the iLet Bionic Pancreas System's software, indicating a certain level of safety and effectiveness. While no treatment is completely risk-free, current evidence suggests that this system is generally safe to use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cystic fibrosis-related diabetes?

The iLet Bionic Pancreas System is unique because it automates insulin delivery, providing a more hands-off approach compared to traditional methods like manual insulin pumps or multiple daily injections. This system uses continuous glucose monitoring (CGM) to adjust insulin doses in real-time, which can lead to more precise blood sugar control. Researchers are excited about this treatment because it reduces the burden on patients with cystic fibrosis-related diabetes, potentially leading to better health outcomes and improved quality of life.

What evidence suggests that the iLet Bionic Pancreas System is effective for cystic fibrosis-related diabetes?

Research has shown that the iLet Bionic Pancreas System, which participants in this trial may use, can help people with cystic fibrosis-related diabetes (CFRD) manage their blood sugar more effectively. One study found that adults using this device improved their blood sugar levels without experiencing more low blood sugar episodes compared to their usual insulin methods. The system automatically adjusts insulin levels based on continuous glucose monitoring (CGM) to reach specific blood sugar goals. By changing insulin doses throughout the day, it helps maintain steady blood sugar levels. The evidence supports its potential effectiveness for managing CFRD. ^{1 2 4 5 6}

Who Is on the Research Team?

Melissa Putman, MD

Principal Investigator

Massachusetts General Hospital

Colleen Bauza, PhD, MPH

Principal Investigator

Jaeb Center for Health Research

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Investigator believes that the participant can safely use the iLet and will follow the protocol

I am 14 years old or older.

Exclusion Criteria

Current participation in another diabetes-related interventional trial

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

Established history of allergy or severe reaction to adhesive or tape used in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants use either the iLet Bionic Pancreas System or their usual care insulin delivery method with continuous glucose monitoring for 13 weeks

13 weeks

Extension

Participants in the Usual Care group initiate use of the BP system, while the BP group continues using it for an additional 13 weeks

13 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• iLet Bionic Pancreas System (BP)
• Usual Care (UC)

Trial Overview 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.

How Is the Trial Designed?

Group I: BP Group Experimental Treatment 1 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 Group Active Control 2 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).

iLet Bionic Pancreas System (BP) is already approved in United States for the following indications:

Approved in United States as iLet Bionic Pancreas System for:

• Type 1 diabetes in individuals 6 years of age and older

Who Is Running the Clinical Trial?

Jaeb Center for Health Research

Lead Sponsor

Trials

162

Recruited

36,200+

Beta Bionics, Inc.

Industry Sponsor

Trials

8

Recruited

2,600+

Cystic Fibrosis Foundation

Collaborator

Trials

199

Recruited

37,800+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

A pilot study on cystic fibrosis-related diabetes (CFRD) showed that using a bionic pancreas, which can deliver both insulin and glucagon, resulted in good glycemic control with average glucose levels below 150 mg/dl and minimal instances of hypoglycemia.

Participants using the bionic pancreas reported higher satisfaction with their treatment and found diabetes management to be less burdensome compared to traditional insulin injections, suggesting a promising alternative for CFRD management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated glycemic control with the bionic pancreas in cystic fibrosis-related diabetes: A pilot study. Sherwood, JS., Jafri, RZ., Balliro, CA., et al.[2021]

The iLet® bionic pancreas significantly reduced HbA1c levels from 7.6% to 7.1% over 13 weeks in adults with type 1 diabetes, compared to a smaller reduction in the standard care group, indicating its efficacy in managing blood sugar levels.

The bionic pancreas improved time in range (TIR) and reduced mean glucose levels without increasing the risk of hypoglycemia, demonstrating a safe profile for insulin delivery in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multicenter Randomized Trial Evaluating the Insulin-Only Configuration of the Bionic Pancreas in Adults with Type 1 Diabetes. Kruger, D., Kass, A., Lonier, J., et al.[2023]

In a study involving 20 adults with cystic fibrosis-related diabetes (CFRD), the iLet bionic pancreas significantly improved glucose control, achieving 75% time in the target glucose range compared to 62% with usual care.

While the bionic pancreas did not increase the time spent in hypoglycemia as measured by continuous glucose monitoring, there were more self-reported episodes of symptomatic hypoglycemia, indicating a need for careful monitoring despite overall improved glucose management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Trial of the Insulin-Only iLet Bionic Pancreas for the Treatment of Cystic Fibrosis- Related Diabetes. Sherwood, JS., Castellanos, LE., O'Connor, MY., et al.[2023]

The insulin-only configuration of the iLet® bionic pancreas significantly improved HbA1c levels in youth aged 6-17 with type 1 diabetes, decreasing from 8.1% to 7.5% over 13 weeks, compared to no change in the standard care group.

Participants with higher baseline HbA1c levels (≥9.0%) saw even greater improvements, with HbA1c dropping from 9.7% to 7.9%, while the bionic pancreas also increased time in the target glucose range by 10% without increasing the risk of hypoglycemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive Impact of the Bionic Pancreas on Diabetes Control in Youth 6-17 Years Old with Type 1 Diabetes: A Multicenter Randomized Trial. Messer, LH., Buckingham, BA., Cogen, F., et al.[2023]

In a 13-week study involving 90 participants with type 1 diabetes, transitioning to the insulin-only configuration of the iLet® bionic pancreas significantly improved glycemic control, with mean HbA1c decreasing from 7.7% to 7.1%.

The use of the bionic pancreas also increased the time spent in the target glucose range (70-180 mg/dL) by 12% and reduced mean glucose levels, indicating enhanced efficacy in managing blood sugar levels compared to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Insulin-Only Bionic Pancreas Pivotal Trial Extension Study: A Multi-Center Single-Arm Evaluation of the Insulin-Only Configuration of the Bionic Pancreas in Adults and Youth with Type 1 Diabetes. Lynch, J., Kanapka, LG., Russell, SJ., et al.[2023]

In a study involving 24 adults with type 1 diabetes, the insulin-only configuration of the iLet® bionic pancreas using faster aspart showed no safety concerns, with less than 1% time spent in low blood glucose levels across different dosing settings.

Adjusting the time to maximal serum concentration (tmax) settings improved mean sensor glucose levels without increasing the risk of hypoglycemia, indicating effective glucose control with the iLet® system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvements in Glycemic Control Achieved by Altering the tmax Setting in the iLet® Bionic Pancreas When Using Fast-Acting Insulin Aspart: A Randomized Trial. Russell, SJ., Balliro, C., Ekelund, M., et al.[2021]

The iLet bionic pancreas significantly improved glycemic control in both non-Hispanic White individuals and Minorities with type 1 diabetes, showing a reduction in HbA1c levels by -0.45% and -0.53% respectively over 13 weeks.

Additionally, the bionic pancreas increased the time in the target glucose range by 10% in Whites and 14% in Minorities, suggesting it may help reduce health care disparities in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Insulin-Only Bionic Pancreas Improves Glycemic Control in Non-Hispanic White and Minority Adults and Children With Type 1 Diabetes. Castellanos, LE., Russell, SJ., Damiano, ER., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37874987/

Randomized Trial of the Insulin-Only iLet Bionic Pancreas for ... Conclusions: Adults with CFRD had improved glucose control without an increase in CGM-measured hypoglycemia with the BP compared with their UC, ...

2. betabionics.com betabionics.com/wp-content/uploads/LA000154_A-iLet-User-Guide.pdf

iLet® Bionic Pancreas System User Guide The iLet Dosing Decision Software is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller ...

3. chop.edu chop.edu/research-studies/utilizing-bionic-pancreas-cystic-fibrosis-related-diabetes

Utilizing the Bionic Pancreas in Cystic Fibrosis Related ... In this study, we will assess the safety and effectiveness of the iLet Bionic Pancreas, an automated insulin delivery system.

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/K220916.pdf

A 510(k) Number K220916 B Applicant Beta The iLet Dosing Decision software works to control glucose to a user-set glucose target of “lower” (110 mg/dL), “usual” (120 mg/dL), or “higher” (130 mg/dL) ...

5. pedsendo.org pedsendo.org/new-meds-and-tech/ilet-bionic-pancreas/

iLet® Bionic Pancreas The iLet Bionic Pancreas (BP; Beta Bionics, Inc). is an automated insulin delivery system is designed to use body weight to initialize insulin delivery.

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06891898?draw=2&rank=1

Study Details | NCT06891898 | The iLet Experience Study A one-year, prospective single-arm cohort study to collect safety and effectiveness data on the iLet Dosing Decision Software during real-world use in ...