At the American Diabetic Association (ADA) 82nd Scientific Sessions, a panel of experts shared some impressive results from a recent trial of the iLet Bionic Pancreas pivotal trial, claimed to be “the closest automated insulin delivery (AID) system to an FDA-approved fully closed loop system – requiring minimal input from the user and no carb counting.
The iLet Bionic Pancreas system uses a tubed insulin pump the size of a credit card, a Dexcom G6, and a smartphone or other device. It is worn similar to other AID devices, with the pump attaching on the abdomen and the Dexcom G6 being worn on the upper arm or abdomen.
There were 440 participants included in this trial (165 children and teens and 275 adults): 88% of the participants were already using a continuous glucose monitor (CGM), and 31% were already on a hybrid closed-loop AID system.
Compared to those using their standard insulin delivery method, adults using the bionic pancreas in the trial with Humalog and Novolog saw their A1C decrease by an average of 0.5 percentage points (compared to 0.1 percentage points in the control group) at 13 weeks. 43% of those using the bionic pancreas with Humalog/Novolog saw their A1C decrease by more than 0.5 percentage points and 23% saw it decrease by more than 1.0 percentage points. In addition, Time in Range (TIR) improvements (on average there was an 11 percentage point increase in TIR) were observed after only one day. Adults using the bionic pancreas with Fiasp saw almost identical results, while youth participants also saw similar outcomes.
The results are extremely impressive. The bionic pancreas showed significant improvements in A1C and Time in Range even when compared to people who were already on a hybrid closed-loop AID system. It also included a relatively diverse group of participants across a wide age range and insulin delivery distribution – resembling more closely the general population than many other comparative AID trials.
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