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").
Key findings of the study include:
- A total of 235 participants (98% of enrolled, including 111 children and 124 adults) completed the study.
- HbA1c was significantly reduced in children by 0.71% (7.8 mmol/mol) and in adults by 0.38% (4.2 mmol/mol).
- Time in range was improved from standard therapy by 15.6 ± 11.5% or 3.7 h/day in children and 9.3 ± 11.8% or 2.2 h/day in adults. This was accomplished with a reduction in time in hypoglycemia <70 mg/dL among adults (median: 2.00% to 1.09%), while this parameter remained the same in children.
- There were three severe hypoglycemia events not attributable to automated insulin delivery malfunction and one diabetic ketoacidosis event from an infusion site failure.
"This tubeless automated insulin delivery system was safe and allowed participants to significantly improve HbA1c levels and time in target glucose range with a very low occurrence of hypoglycemia," wrote the authors.
Reference:
The study titled, "Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes," is published in the journal Diabetes Care.
DOI: https://care.diabetesjournals.org/content/early/2021/05/21/dc21-0172
