Join Trial Testing Automated Insulin Delivery for Cystic Fibrosis-Related Diabetes
A clinical trial is recruiting teens and adults with cystic fibrosis-related diabetes to see if the iLet Bionic Pancreas AID system can help improve blood sugar management.
Trial Status: Recruiting
Clinical Trials Identifier: NCT06449677
Trial Name: Bionic Pancreas in CFRD
Diabetes Type: Cystic fibrosis-related diabetes
Trial Sponsor: Jaeb Center for Health Research
Why is this study important?
This trial is testing whether Beta Bionic’s iLet Bionic Pancreas is safe and effective for people with cystic fibrosis-related diabetes (CFRD).
Like other automated insulin delivery (AID) systems, the iLet is designed to reduce the number of decisions you have to make for daily diabetes management. It consists of a tubed insulin pump, a continuous glucose monitor (CGM), and a connected smartphone application. The system’s algorithm uses CGM blood sugar readings to determine how much insulin to dose throughout the day.
The FDA has already approved the iLet for people with type 1 diabetes, but CFRD is a unique form of diabetes that differs from both type 1 and type 2.
Cystic fibrosis (CF) is a genetic disorder that causes a person to produce thick, sticky mucus, which plugs airways in the lungs and clogs ducts in the pancreas. CF’s wide-ranging effects on the body can cause people to develop both insulin deficiency and insulin resistance.
Although diabetes is common among people with CF, the disorder’s main complication is progressive lung disease, which is already a major burden to manage. Adding on blood sugar monitoring and insulin therapy, which are key to treating CFRD, can be even more overwhelming. However, if AID technology proves to be safe and effective, it could significantly lighten the load of diabetes management for people with CF.
How does the trial work?
Researchers are aiming to recruit 150 people who are at least 14 years old and have CFRD. Half of the participants will receive a new CGM to monitor their blood sugar, but will continue to use their usual insulin delivery methods. The other half will switch to the iLet Bionic Pancreas.
The researchers will collect time in range data from both groups’ CGMs for 13 weeks. After that, the group that had been using their usual care methods will switch to the iLet AID system, and all of the participants will continue submitting time in range data for another 13 weeks. Throughout the study, the researchers will also collect other CGM measurements, A1C values, and survey responses.
Are you interested in participating?
You may be eligible to participate if you are 14 or older and:
- Have been diagnosed with CFRD and have been treated with insulin for at least three months
- Have been using your current insulin regimen for at least a month, and your insulin dose is at least 0.1 units
People who are taking other medications than insulin to manage their blood sugar are only eligible to participate if it’s metformin. In addition, people are ineligible if they recently started or stopped using a cystic fibrosis transmembrane conductance regulator modulator, have recently been hospitalized for lung complications, or have received a lung or liver transplant within a year of screening.
The trial is currently recruiting in several locations throughout the U.S. See a full list of inclusion/exclusion criteria here.
Learn more about AID systems for blood sugar management here: