First experience of a new glucose-sensor integrated pump system with predictive insulin suspension for hypoglycemia prevention in German pediatric patients

Introduction Predictive insulin supension is established as a system for the prevention of hypoglycemia in Germany (Smartguard). Since 2020, a second system is available in Germany (Basal-IQ). Differences relate to a non-modifiable predictive suspend threshold of 80 mg/dl (vs. 50-90 mg/dl), a suspension time of a minimum of 5 minutes (vs. 30 minutes), and the determination of the resuming of insulin infusion at a higher value than before (vs. a distance of 20 mg/dl above the threshold and prediction of glucose rise). The new systems was tested in an age group at particular risk of hypoglycemia. Methodology Pediatric patients (age 6 to 13 years), with pump and sensor experience (no AID) were offered the trial of Basal-IQ for a duration of 3 months. Endpoints of the observation were CGM parameters of time below target range (TBR < 70mg/dl), in target range (TIR 70-180 mg/dl), glycemic variability (coefficient of variance CV%) and HbA1c. Patient-related outcomes (PRO's) were assessed with the Diabskids parent questionnaire and a device questionnaire. Results Nine participants were included (mean: all male, 9.7 years, duration 6.1 years, HbA1c 6.8%, time in range (TIR) 61.9%, time below range (TBR) 4.5%, mean glucose (MW) 164 mg/dl, (CV) 40). After 3 months, improvements in glycemic parameters were found (HbA1c 6.5%, TIR 69.2%, TBR 2.8%, MW 159, CV 40; controls HbA1c 7.2%, TIR 64.9%, TBR 4.3%, MW 158, CV 39) which was comparable to a contemporary group of pediatric Smartguard users. PRO's showed a decrease in diabetes and treatment burden, as well as satisfaction with the system. Discussion The new system with predictive insulin-suspension for the prevention of hypoglycemia showed improvement in glycemic parameters and PRO's after 3 months. A statistical comparison before/after a was not done due to the small number of patients, but the data at least prove non-inferiority compared to baseline and was similar to results obtained in users of the established system . Thus, two different efficient systems with predictive insulin suspension are currently available in Germany for children and adolescents with diabetes, so that an informed choice can be made.