An automated tubeless insulin delivery system can safely and effectively stabilize glycated hemoglobin levels among children and adults with type 1 diabetes, according to findings, from a single-arm, multicenter, prospective study published in Diabetes Care.
Patients (N=240) with type 1 diabetes were recruited at 17 sites in the US between 2019 and 2020. A 2-week standard therapy phase was conducted to assess blood glucose patterns to automate care. The system comprised a tubeless insulin pump, continuous glucose monitor, and automated insulin delivery algorithm which could be controlled with a mobile application.
When needed, the system delivered insulin microboluses every 5 minutes until the glucose target was reached. Clinical outcomes from the 2-week standard care phase were compared with 3 months of the tubeless insulin delivery system.
Children (n=112) and adults (n=128) in the study had mean ages of 10.3±2.2 and 36.9±13.9 years, respectively. Participants included53.6% girls and 60.9% adult women, 92.9% and 91.4% of whom were White, respectively, diabetes was diagnosed 4.7±2.6 and 17.9±11.6 years previously, and baseline glycated hemoglobin was 7.67%±0.95% and 7.16%±0.86%, respectively.
The children and adults spent 96.4% and 96.7% of the study period in automated mode. Device deficiencies occurred once per person-month, according to the report.
Glycated hemoglobin was reduced by the automated system by 0.71% (P <.0001) among the children and 0.38% (P <.0001) among the adults. The time spent in the target range was increased by 15.6% (P <.0001) for the children and 9.3% (P <.0001) for the adults.
The observed response was quicker among the adult patients, in which during the first 3 days of use, adults spent 73.5% of time in range compared with 62.6% for the children. At days 4-6, time spent in range increased to 68.0% for the children and remained stable thereafter.
Time spent in the hypoglycemic range (<70 mg/dL) was decreased to 0.89% (P <.0001) for the adults but was unchanged for the children. Time spent in >180 mg/dL was decreased by 15.1% for children (P <.0001) and 7.7% for adults (P <.0001).
Total daily insulin required by children was increased (mean, 0.85±0.24 vs 0.92±0.25 units/kg; P <.0001) and by adults was decreased (mean, 0.61±0.22 vs 0.59±0.21 units/kg; P =.02).
Rates of severe hypoglycemia (4.8 per 100 person-years) and diabetic ketoacidosis (1.2 per 100 person-years) were lower than is reported by the US Type 1 Diabetes Exchange Registry.
This study was limited by its single-arm design and shorter treatment duration during the standard care phase.
The study authors concluded that this tubeless automated insulin delivery system was safe and improved glycemic control among both adult and pediatric patients with type 1 diabetes.
Disclosure: Multiple study authors declared affiliations with the biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Brown SA, Forlenza GP, Bode BW, 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(6):dc210172. doi:10.2337/dc21-0172