Beta Bionics has announced favourable outcomes from a home-use study of its iLet Bionic Pancreas System using pre-filled cartridges of Zealand Pharma’s dasiglucagon.
iLet Bionic Pancreas is a wearable, autonomous system that uses artificial intelligence and machine learning to deliver insulin and glucagon analogues for treating type 1 diabetes.
Initiated last month, the randomised, two-period, cross-over home-use trial evaluated iLet’s operational performance when used with bihormonal configuration compared to insulin-only configuration.
The study was conducted for one week in ten adult type 1 diabetes patients who began therapy by entering their body weight into the device, without any training period or physician intervention to optimise therapy.
Beta Bionics noted that the device is intended for autonomous and continuous adaption to individual patient’s changing insulin needs.
According to preliminary data analysis, the bihormonal configuration using dasiglucagon was observed to offer superior glycaemic control compared to the insulin-only iLet.
Patients experienced a mean glucose level of 139mg/dL on days two to seven of use in the bihormonal period, while the figure was 149mg/dL during the insulin-only period.
The mean glucose level was measured using continuous glucose monitoring (CGM).
During the bihormonal period, subjects spent 79% of the time with their CGM glucose level in range on days two to seven of use versus 71% during the insulin-only period.
Beta Bionics co-founder, president and CEO Ed Damiano said: “We are extremely pleased to have now tested the performance of our bihormonal iLet Bionic Pancreas System with dasiglucagaon – the first-ever, liquid-stable glucagon analogue – in a convenient ready-to-use, pre-filled cartridge designed to fit our system.
“Preliminary results from this trial have helped reaffirm the final implementation of our dosing algorithms in the bihormonal configuration of the iLet.”
Beta Bionics partnered with Zealand Pharma for multiple development activities, including regulatory filing for the use of dasiglucagon in the bihormonal iLet.
The companies intend to conduct a Phase III trial of the bihormonal configuration with dasiglucagon next year. Data from this study is expected to support regulatory submissions in type 1 diabetes patients.