Tubeless, On-Body Automated Insulin Delivery System Shows Benefits for Glucose Control

Data on a tubeless, on-body automated insulin delivery system with customizable targets is suggesting the technology is both safe and can improve HbA1c and glycemic measures in children with type 1 diabetes.

The single-arm, multicenter trial of over 110 children and 120 adults with type 1 diabetes included a 2-week standard treatment phase, which was then followed by a 3-month period of automated insulin delivery.

Improvements in HbA1c was achieved in patients, regardless of their age group, with HbA1c dropping by 0.71% (7.8 mmol/mol) in children and by 0.38% (4.2 mmol/mol) in adults. According to the researchers, improvements were seen regardless of baseline glycemic control. The time that patients spent in the range of glycemic control also improved, extending by 15.6% among children and by 8.1% among adults.

The insulin delivery system was associated with a decrease in hypoglycemia among adults and a decrease in hyperglycemia in both age groups.

“In both age-groups, the glycemic improvements were particularly prominent overnight and were driven by a clinically meaningful reduction in hyperglycemia,” explained the researchers.

“While using the system, 82% of children and 69% of adults met established clinical targets for time in range (children >60%, adults >70%), and 53% of children and 66% of adults had an HbA1c <7% (<53 mmol/mol). Importantly, gains in glycemic control were not associated with a concomitant rise in hypoglycemia.”

Throughout the study, the researchers observed lower rates of sever hypoglycemia (4.8 vs 25.2 events per 100 person-years) and diabetic ketoacidosis (1.2 vs 10.8 events per 100 person-years) with the delivery system compared with the incidences documented in the U.S. T1D Exchange registry. There were a reported 3 severe hypoglycemia events in the study, 2 among adults following user-initiated boluses, and among 1 child after delayed eating after a preprandial bolus.

The researchers also highlighted the convenience of the system, which used a wearable tubeless insulin pump that included an embedded algorithm to communicate directly from a glucose sensor through Bluetooth wireless technology.

“The study used a remote data monitoring system that allowed for cloud-based transmission of data, obviating the need for manual uploads initiated by the user,” wrote the researchers. “This critical component of care to allow for seamless data review may help to alleviate the burden sometimes generated by diabetes technologies. While in this study a mobile app on a pro- vided locked-down Android phone was used to interact with the system, it is planned for this app to be available for download and use on compatible personal smartphones when the system becomes commercially available.”

Reference

Brown S, Forlenzo G, Bode B, et al. Multicenter trial of a tubeless, on-body automated insulin delivery system with customizable glycemic targets in pediatric and adult participants with type 1 diabetes. Diabetes Care. 2021;44(7):1630-1640.