Novel automated insulin delivery system well-tolerated in type 1 diabetes patients: Study

USA: A pivotal study of the first tubeless, on-body automated insulin delivery system with customizable glycemic targets found the system to be well tolerated. Also, its use was associated with reductions in hypoglycemia in adults-only, reduced A1c, and improved time in range in adults and children. 

The findings of the study are published in the journal Diabetes Care.

Advances in diabetes technology have changed the treatment paradigm for type 1 diabetes patients, yet the disease burden is significant. Sue A. Brown, Division of Endocrinology, Center for Diabetes Technology, University of Virginia, Charlottesville, VA, and colleagues report on a pivotal safety study of the first tubeless, on-body automated insulin delivery system with customizable glycemic targets.

For this purpose, the researchers conducted a single-arm, multicenter, prospective study. It enrolled 112 children (age 6–13.9 years) and 129 adults (age 14–70 years). A 2-week standard therapy phase (usual insulin regimen) was followed by 3 months of automated insulin delivery.

Primary safety outcomes were incidence of severe hypoglycemia and diabetic ketoacidosis. Primary effectiveness outcomes were change in HbA1c and percent time in sensor glucose range 70–180 mg/dL ("time in range").