Dive Brief:
Beta Bionics said it received 510(k) clearance from the Food and Drug Administration for its automated insulin dosing (AID) system, teeing it up to challenge Insulet, Medtronic and Tandem Diabetes Care for the Type 1 diabetes market.
The system, iLet Bionic Pancreas, features an insulin pump and dosing software that combine with the Dexcom G6 continuous glucose monitor to automate the calculation and delivery of insulin doses.
Beta Bionics, which showed the AID system beat standard of care last year, has differentiated its device through simplification and automation, limiting the information users need to input and preventing them from modifying their insulin doses.

Dive Insight:
The launch of iLet Bionic Pancreas may serve as a test of whether people with Type 1 diabetes are willing to almost totally cede control of their insulin dosing to an algorithm. Users of existing hybrid closed-loop systems enter information such as basal rates, insulin-sensitivity factors and carbohydrate-to-insulin ratios when they start the system and enter the grams of carbohydrates in each meal they eat.

Beta Bionics has eliminated most of that data entry. Users input their body weight when they first set up the system and provide an estimate of their carbohydrate content for each meal, telling the system if they are eating the same, more or less than they usually do for breakfast, lunch and dinner.

The technology proved successful in a clinical trial of 326 patients, about two-thirds of whom were assigned to the iLet Bionic Pancreas arm. After 13 weeks, HbA1c levels in the iLet Bionic Pancreas arm decreased from 7.9% to 7.3%, while the standard of care group was unchanged.

While cross-trial comparisons can be unreliable, the data suggest iLet Bionic Pancreas is competitive. Medtronic linked its recently authorized MiniMed 780G to 0.5-percentage point improvement in HbA1c, compared to a 0.6 percentage point change in the Beta Bionics’ trial. The Medtronic trial lacked a control arm. Beta Bionics beat a standard of care that included users of Medtronic and Tandem devices.

Reference：
https://www.medtechdive.com/news/beta-bionics-fda-nod-challenge-medtronic-insulin-pump-MDT/650836/