A day before the American Diabetes Association 79th Scientific Sessions in San Francisco, Beta Bionics and Zealand Pharma announced positive results of a small, in-home trial of the iLet Bionic Pancreas, an automated insulin and dasiglucagon pump system.
According to a press release, the Phase 2 trial tracked 10 people with type 1 diabetes who were given an iLet to use at home for a week. One group of participants were allowed to use the full features of the iLet – which includes automated delivery of insulin and dasiglucagon, a stable, premixed formula of glucagon produced by Zealand Pharma. The other group were only allowed to use the automated insulin delivery features of the iLet.
Researchers measured blood glucose levels of the participants on Day 2 through Day 7 of the trial, as recorded by continuous glucose monitors. When compared to those who used the automated insulin features only, those who used the full features of the iLet:
-Spent 8% more time in a blood glucose range of 70 mg/dL to 180 mg/dL during the bihormonal period.
-Had an average blood glucose level of 10 mg/dL lower during the bihormonal period.
-Spent roughly 33% less time below 70 mg/dL during the bihormonal period.
These results, though promising, will need to be backed up by more extensive data before the two companies can submit the iLet for FDA approval. In late May, the two companies announced the kickoff of a Phase 3 in-home trial of the iLet system. The trial will be similar to this trial, but larger in scale and longer in duration.
You can read the complete announcement of the results of the Phase 2 trial here.