New iLet Bionic Pancreas System Begins Clinical Trial Testing
Beta Bionics has officially received IDE approval from the FDA to begin a clinical trial, testing the new iLet Bionic Pancreas System.
The innovative medical technology company’s new system will utilize NovoNordisk’s new ultra-fast acting insulin called Fiasp, and the trial will also take advantage of the Dexcom continuous glucose monitoring system.
Fiasp is the first fast-acting insulin that does not have a pre-meal dosing recommendation, and becomes active in the blood in just 2.5 minutes, approximately.
Beta Bionics’ recent FDA approval will now allow for home-use studies of the world’s first autonomous bionic pancreas system. Massachusetts General Hospital and Stanford University will recruit adults ages 18+ with Type 1 diabetes, while Nemours Children’s Health System will reach out to children ages 6 -17 to participate in the upcoming series of trials.
NovoNordisk’s Fiasp insulin will be tested using the iLet Bionic Pancreas System on certain adult patients, and insulin lispro and conventional insulin aspart will be used for both adults and children involved in the study.
The iLet system contains a dual-chamber infusion pump which allows for the independent release of insulin, glucagon, or both – closely mimicking a biological pancreas’ functions.
Beta Bionics’ trial using the iLet system will mark a number of new territories in the Type 1 diabetes research realm. In addition to being the very first study to test Fiasp using autonomous insulin delivery, the study will use an equal number of adults and children currently using insulin pumps as well as those who are currently on MDI (multiple daily injections.)
The iLet Bionic Pancreas System is pocket sized device that will be worn similarly to that of an insulin pump, but only requires the patient to enter body weight, and does not require any carbohydrate counting nor the configuring of any basal or bolus rates or correction ratios.
Previous studies in both adults and children with T1D, using Beta Bionics’ unique algorithms resulted in improvements in overall glycemic control, including significant reductions in blood-glucose levels, and reduced hypoglycemia.
Following the trials, Beta Bionics seeks to obtain regulatory approval and commercialize the iLet Bionic Pancreas System, making it available to all who live with Type 1 diabetes.