Beta Bionics has partnered with Zealand Pharma to study at-home use of its iLet Bionic Pancreas System with dasiglucagon for autonomous bihormonal treatment of people living with type 1 diabetes.
Developed by Beta Bionics, iLet is a wearable device that uses artificial intelligence and machine learning algorithms to autonomously deliver insulin and glucagon analogues.
Meanwhile, dasiglucagon is a glucagon analogue developed by Zealand Pharma and formulated as a ready-to-use aqueous solution.
The randomised, two-arm, cross-over home-use trial will assess the operational performance of the iLet Bionic Pancreas System in its insulin-only configuration versus its bihormonal configuration.
In addition, the trial will evaluate the effect of both the configurations on glycaemic control, quality of life and treatment satisfaction of study participants, their caregivers, partners and/or family members.
Beta Bionics co-founder, president and CEO Ed Damiano said: “The start of this home-use clinical trial with the iLet in its bihormonal configuration – autonomously and independently pumping both insulin and Zealand’s dasiglucagon – marks the achievement of a long awaited and eagerly anticipated milestone.”
Beta Bionics has partnered with Zealand Pharma on co-development activities, aiming to secure regulatory approval for the use of dasiglucagon in the bihormonal configuration of the iLet system.
Zealand Pharma president and CEO Emmanuel Dulac said: “Fully automated diabetes care, realised by a dual-hormone artificial pancreas system using insulin together with dasiglucagon, could significantly improve life for millions of people living with type 1 diabetes.”