Artificial pancreases took center stage at this year’s annual meeting of the American Diabetes Association, with Medtronic, Insulet and more touting clinical trial successes for components of their respective closed-loop insulin delivery systems.
Though much of those data represented technology already cleared by the FDA, several devices still preparing for regulatory review proved just as promising. Among these were the iLet bionic pancreas from Beta Bionics, which demonstrated meaningful drops in blood sugar levels and other Type 1 diabetes factors in a recently completed pivotal trial.
The system is already on the FDA’s radar: It was awarded breakthrough device designation in December 2019. As it closed a $57 million financing round earlier this year, Beta Bionics said it would use the funding to support its upcoming regulatory submissions to the FDA and, if cleared by the agency, the costs of its subsequent commercial rollout.
A typical artificial pancreas links an insulin pump and continuous glucose monitor—either developed by the same company, as is the case with Medtronic’s, or combining devices from two different makers in what’s known as a hybrid closed-loop insulin delivery system.
Algorithms pick up glucose readings from the CGM and use them to calculate an appropriate insulin dosage, which is then communicated to the insulin pump. The entire process is done automatically, without requiring much, if any, input from the user, thoroughly simplifying the insulin delivery process and diabetes management as a whole.
Beta Bionics’ offering is a pocket-sized device that’s equipped with algorithms to automatically dose insulin. Unlike other insulin pumps, however, the iLet system doesn’t require users to set insulin basal rates, glucose correction factors or other insulin regimen parameters, nor do they have to calculate carbohydrates at every meal to determine bolus insulin doses. Instead, the device takes into account only the user’s body weight and readings from a separate CGM, like the Dexcom G6 sensor used in the pivotal trial.
In the study, more than 400 people with Type 1 diabetes ages 6 and up either used the iLet device and Dexcom CGM or their existing insulin dosing regimen for several months. Across all age groups and insulin types in the experimental group, by the 13-week mark, average blood sugar levels had dropped about 0.5%—results comparable to those of a study Insulet presented at the conference testing its FDA-cleared Omnipod 5 insulin pump in young children.
An analysis of the study’s participants between the ages of 6 and 17 who started the study with A1C levels over 9% found that using the bionic pancreas helped improve the amount of time they spent in their ideal glucose range by more than 30%, which shakes out to about 7.5 extra hours per day spent in range.
On a more qualitative level, adults who used Beta Bionics’ technology in the study were significantly more likely than member of the control group to report drops in their diabetes distress and fear of hypoglycemia. Similarly, parents of the study’s pediatric participants reported a higher increase in diabetes treatment satisfaction than did those in the standard-of-care group.