The bionic pancreas (BP) is initialized with body weight only, makes all insulin dosing decisions autonomously, and uses meal announcements without carbohydrate counting. In the event of device malfunction, BP users may need guidance for managing their glucose. The BP generates and continuously updates a table with back-up insulin doses for either injection or pump users, including a long-acting insulin dose, a four-period basal insulin profile, short-acting meal doses for breakfast, lunch, and dinner depending on meal size (Usual, Less, More) , and a glucose correction factor. At the end of the 13-week Pivotal RCT of the BP in type 1 diabetes, participants in the BP group (6-83 years old) were randomized 1:1 to their Pre-study Insulin Regimen (N=148) or BP Guidance (N=149) , and took insulin by injection or pump according to their pre-study modality, for a 2-4 day Transition Phase. There was high adherence to the regimen in the BP Guidance group and no episodes of severe hypoglycemia or DKA. Glycemic outcomes in the BP Guidance group were similar to those the Pre-study Insulin Regimen group, and comparable to their own pre-randomization baseline. Both groups had higher mean glucose and less time in range in the Transition Phase than while using the BP during the RCT (Table) . A back-up insulin regimen automatically generated by the BP can be safely implemented if need arises to discontinue use of the BP.
N. Mauras: Research Support; AbbVie Inc., Beta Bionics, Inc., Novo Nordisk, Pfizer Inc.
Funding from National Institute of Diabetes and Digestive and Kidney Diseases (grant #1UC4DK108612-01) Funding and bionic pancreas devices from Beta Bionics, Inc. Fast-acting insulin aspart and insulin aspart provided by Novo Nordisk Insulin lispro by Eli LillyBlood glucose meters and test strips (Contour?Next One Blood Glucose Monitoring System) provided by Ascensia Diabetes Care, Basel, CH. Continuous glucose monitor sensors and transmitters were purchased from Dexcom, Inc. at a discounted price.
