Abstract
Background and Aims
We evaluated the function of the bihormonal iLet bionic pancreas delivering dasiglucagon when compared to the insulin-only iLet in a home-use study in adults with T1D.
Methods
Ten subjects used the bihormonal and insulin-only configurations of the iLet for one week each in random order. The bihormonal iLet delivered 4 mg/dl dasiglucagon, a glucagon analog stable in aqueous solution (Zealand Pharma). Sessions were initiated by entering the body weight; the iLet autonomously and continuously adapts to individual insulin needs. The primary outcome was iLet performance targets: CGM glucose (CGMG) readings capture ≥80%, drug delivery channel(s) availability ≥95%, and ratio of delivered to attempted doses 0.95 to 1.05. Secondary outcomes included measures of glycemic control.
Results
The iLet met the specified performance targets in both configurations. For the bihormonal vs. insulin-only configuration median percent time with CGMG < 54 mg/dL was 0.2% [0,0.3] vs. 0.6% [0.2,1.1] (p=0.16); mean daily carbohydrate to treat hypoglycemia was 13.0±9.6 vs. 16.1±13.0 grams/day; mean CGMG was 139±11 vs. 149±13 mg/dL (p <0.01); mean percent time within the 70-180 mg/dl range was 79±9% vs. 71±8% (p<0.01); and percentage of subjects with mean CGMG <154 mg/dl was 90% vs. 50%. There were no infusion set occlusions or site reactions.
Conclusions
The iLet performed to specifications in both the bihormonal and insulin-only configurations. Glycemic outcomes were very similar to those achieved with previous hardware implementations of the bionic pancreas. Dasiglucagon was well tolerated and the bihormonal iLet achieved similar glycemic outcomes to those previously achieved with freshly reconstituted human glucagon.
