Bionic Pancreas for Diabetes

(PREPARE 4 AID Trial)

Not yet recruiting at 1 trial location

Overseen By Jessica Parascando, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must be taking: Insulin

Must not be taking: Sulfonylureas, Pramlintide, SGLT-2 inhibitors

Disqualifiers: MODY, Bariatric surgery, Blood disorders, others

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

Compensation: Varies

Number of Visits: 1

Duration: 13 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the iLet Bionic Pancreas, designed to help people with insulin-treated diabetes (both type 1 and type 2) manage blood sugar levels more effectively. The researchers aim to determine if using this device in everyday healthcare settings can lower A1c levels (a measure of average blood sugar over a few months) more effectively than standard diabetes care. Participants will either use the iLet Bionic Pancreas for 13 weeks or continue with their usual diabetes care. This trial may suit those who have been using insulin for a while and are open to trying a new device for diabetes management. As an unphased trial, it offers a unique opportunity to explore innovative diabetes management solutions.

Do I have to stop taking my current medications for the trial?

Participants using the iLet Bionic Pancreas are required to stay on their current doses of medications that affect blood sugar levels, unless a dose reduction or discontinuation is necessary. The trial does not specify a need to stop other medications.

What prior data suggests that the iLet Bionic Pancreas is safe for adults with insulin-treated diabetes?

Research has shown that the iLet Bionic Pancreas (BP) is generally well-tolerated by patients. One study found that people using the device had better control of their blood sugar levels. However, serious low blood sugar episodes occurred at a rate of 17.7 times per 100 participant-years.

Thus, while the iLet BP can help manage blood sugar, it might still cause some low blood sugar incidents. Prospective trial participants should consider this information when deciding whether to join a trial using this device. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The iLet Bionic Pancreas is unique because it automates insulin delivery, mimicking a healthy pancreas. Unlike traditional insulin pumps and continuous glucose monitors, which require frequent user intervention, the iLet system continuously adjusts insulin dosing in real-time based on glucose levels. Researchers are excited about this treatment because it has the potential to significantly reduce the burden of diabetes management, offering a more seamless and effective way to maintain blood sugar control.

What evidence suggests that the iLet Bionic Pancreas is effective for diabetes?

Research has shown that the iLet Bionic Pancreas (BP), which participants in this trial may receive, effectively manages diabetes. Studies have found that it significantly improves blood sugar control, with users experiencing a drop in average blood sugar levels from 7.9% to 7.3% over 13 weeks. Additionally, the iLet BP maintains blood sugar levels within the target range more frequently, reducing the risk of both high and low blood sugar episodes. For people with type 1 diabetes, the time spent with dangerously low blood sugar levels decreased to just 0.3%. These findings suggest that the iLet BP could help people manage their diabetes better than standard care, the comparator in this trial. ^{1 2 4 6 7}

Who Is on the Research Team?

Sean Oser, MD, MPH, CDCES

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for adults with insulin-treated diabetes, either type 1 or type 2. Participants should be receiving care from primary providers and willing to use the iLet Bionic Pancreas (BP) System or continue their routine care for 13 weeks. They must also agree to virtual visits, follow-up calls, surveys, and blood tests.

Inclusion Criteria

Have a primary care clinician willing to refer them to the study, confirm their diabetes diagnosis, and recommend and manage the iLet for the duration of the study

I am willing to use lispro or aspart insulin.

If capable of becoming pregnant, willing and able to have pregnancy testing and use an acceptable method of contraception during the study period

Exclusion Criteria

Employed by, or having immediate family members employed by Beta Bionics, or being directly involved in conducting the clinical trial, or having a first-degree relative who is directly involved in conducting the clinical trial

Current participation in another diabetes-related clinical trial

Unable to safely comply with study procedures and reporting requirements

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (virtual)

Treatment

Participants use the iLet Bionic Pancreas or continue routine care for 13 weeks

13 weeks

Mid-period follow-up calls and a final visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Observational Extension

Routine care participants have the option to wear the iLet BP for an additional 13 weeks

13 weeks

What Are the Treatments Tested in This Trial?

Interventions

• iLet Bionic Pancreas

Trial Overview The study is testing the iLet BP System against standard diabetes care in a real-world primary care setting. It's looking at whether using the iLet BP can better reduce HbA1c levels over a period of 13 weeks compared to usual treatment routines.

How Is the Trial Designed?

Group I: Bionic Pancreas Experimental Treatment 1 Intervention

Group II: Routine Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Beta Bionics, Inc.

Industry Sponsor

Trials

8

Recruited

2,600+

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborator

Trials

275

Recruited

5,182,000+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Citations

1. betabionics.com betabionics.com/hcp/real-world-data/

Real-world evidence from year one of iLet commercial ... Discover real-world data on the iLet Bionic Pancreas. Explore insights and outcomes that showcase its impact on diabetes management in clinical settings.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12568523/

Efficacy and Safety of iLet Bionic Pancreas in Patients With ... Results demonstrated that the iLet BP significantly improved glycaemic control. The pooled analysis showed a standardised mean difference (SMD) ...

3. diabetesjournals.org diabetesjournals.org/diabetes/article/74/Supplement_1/947-P/159125/947-P-Real-World-Efficacy-of-the-iLet-Bionic

947-P: Real-World Efficacy of the iLet Bionic Pancreas in ... The time with CGM glucose <54 mg/dl was 0.3% [0.1-0.7] in users with type 1 diabetes and 0.1% [0.0-0.2] in users with type 2 diabetes. The ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2205225

Multicenter, Randomized Trial of a Bionic Pancreas in Type ... Efficacy Outcomes. The mean glycated hemoglobin level at 13 weeks (primary outcome) decreased from 7.9% at baseline to 7.3% in the bionic- ...

5. diabetes.org diabetes.org/newsroom/the-ilet-bionic-pancreas

The iLet Bionic Pancreas Increased Time in Range ... The iLet bionic pancreas (BP)¹ significantly increased the percentage of time adults with type 1 diabetes (T1D) had glucose levels between 70– ...

6. diabetesjournals.org diabetesjournals.org/clinical/article/43/3/388/157928/Assessing-the-iLet-Bionic-Pancreas-Deployed-in

Assessing the iLet Bionic Pancreas Deployed in Primary Care ... The iLet Bionic Pancreas system can improve glycemia in individuals with type 1 diabetes with its simple interface, setup, and maintenance.

7. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm?t_id=388&c_id=7775

522 Postmarket Surveillance Studies Database - FDA The study will compare outcomes data during iLet use to efficacy and safety outcomes data derived from epidemiological studies, such as data published by the ...