On May 22nd, Beta Bionics and Zealand Pharma announced the beginning of an in-home trial of the iLet Bionic Pancreas system, a dual-hormone pump system designed to automatically deliver insulin and dasiglucagon – an experimental form of glucagon designed by Zealand Pharma to be stable in liquid form- based on blood sugar readings from a continuous glucose monitor (CGM).
This will mark the first in-home full-scale trial of a fully operational dual-hormone pump system for the treatment of type 1 diabetes. In 2018, Beta Bionics launched in-home clinical trials of the ILet in an insulin-only configuration.
For its part, Zealand Pharma is in the midst of Phase 3 clinical trials of its HypoPal rescue pen with dasiglucagon. These trials are designed to provide real-world data to demonstrate that the ready-to-use HypoPal can effectively treat hypoglycemia in people with type 1 diabetes.
For the in-home iLet trial, adults with type 1 diabetes will be divided into two groups – those who will use the iLet system in an insulin-only mode and those who will use the the bihormonal configuration of the pump system. The primary goal of the trial is to ensure that the device works as designed, although researchers will also gather data about how the pump system may impact or improve glycemic control and quality of life among participants. The home trial is being administered by researchers at Massachusetts General Hospital.
To read the full press release of the launch of the in-home clinical trial of the iLet Bionic Pancreas system, click here.
About the iLet
The iLet bionic pancreas system is a pocket-sized, wearable medical device that autonomously controls blood-sugar levels in people with diabetes. The lifelong, machine-learning, mathematical dosing algorithms integrated into the iLet were licensed by Beta Bionics from Boston University. In previous home-use studies in adults and children with T1D, these algorithms demonstrated dramatic improvements in glycemic control relative to the standard of care. These improvements included significant reductions in blood-glucose levels, in hypoglycemia, and in intersubject and intrasubject glycemic variability (New England Journal of Medicine. 2014, 371:313-25; Lancet Diabetes and Endocrinology. 2016, 4:233-43; Lancet. 2016, 389:369-80).
To initialize the iLet, users enter only their body weight. Immediately thereafter, the iLet begins controlling blood-sugar levels automatically, without requiring the user to count carbohydrates, set insulin delivery rates, or deliver bolus insulin for meals or corrections. The iLet is effectively three medical devices in one. It can be configured as an insulin-only bionic pancreas, a glucagon-only bionic pancreas, or a bihormonal bionic pancreas (insulin and glucagon). The glucagon-only configuration may be helpful in rare, chronic, low blood-sugar conditions, such as congenital hyperinsulinism (CHI) and insulinoma syndrome. Beta Bionics is committed to obtaining regulatory approval and commercializing all three iLet configurations.