Beta Bionics has received FDA approval to begin recruitment for home-use studies testing the insulin-only configuration of its iLet bionic pancreas system in a series of trials in adults and children with Type 1 diabetes (T1D). The US-based multicentre, multi-arm, cross-over, clinical trial is the first of its kind, testing Novo Nordisk’s recently approved, fast-acting insulin Fiasp with the iLet bionic pancreas system in adults with T1D, and insulin lispro and conventional insulin aspart using the iLet in adults and children with T1D. This trial is also the first to use the new Beta Bionics-manufactured iLet device, which is capable of dosing only insulin, only glucagon, or both hormones as needed.
The iLet consists of a dual-chamber, autonomous, infusion pump that mimics a biological pancreas. Embedded in the system are clinically tested mathematical dosing algorithms driven by machine learning to autonomously calculate and dose insulin and/or glucagon as needed (referred to as being bi-hormonal), based on data from a continuous glucose monitor. Simple to use, the iLet requires only body weight for initialization. Once initialized, the iLet engages its machine-learning, artificial intelligence to autonomously control the individual’s blood-glucose levels, and to continuously adapt to the individual’s ever-changing insulin needs. The iLet to be used in this trial integrates glucose data from the Dexcom G5 Continuous Glucose Monitoring (CGM) System.
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