First pediatric use of an AID system with automated correction bolus in Germany

Introduction As an upgrade of a semi-automatic insulin dosing system (AID), Tandem Control IQ is the second system with automatic basal insulin modulation and correction boluses that can be prescribed in Germany for children and adolescents at the expense of the statutory health insurance. It is a further development of a predictive insulin suspension for hypoglycemia protection (Basal-IQ). In this study, the iterative switch from initially predictive suspension only to immediate initiation of AID with insulin modulation to reduce hypo- and hyperglycemia was compared. Methodology Children and adolescents on intensified insulin therapy ( MDI or CSII) with health insurance approval for Tandem Basal IQ, were offered treatment with the Control IQ AID system before the new system was launched. Participants and parents received system training. One group was not previously using any other AID system(START group). Another group already using Tandem Basal IQ was offered a pump upgrade (SWITCH group) to the Control IQ AID system prior to the launch of the new system. Therapy data and well-being questionnaires were compared before starting the new form of therapy and after 3 months. Results In total 49 children and adolescents (mean age 12 +/- 3.4 years, 38 % female, BMI-SDS 0.28 +/- 1.0, diabetes duration 4.7 +/- 4.1 Jahre) completed the study, one adolescent had to stop due to allergic skin reaction. Primary endpoint Time in Range (TIR) was significantly higher after 3 months 68.8 +/- 12.0 vs. 64.1 +/- 16.2 %, p = 0.003; Time in Hypoglycemia was reduced from 2.7 +/- 2.0 to 1.7 +/- 1.6 % (p = 0.02) Improved glycemic parameters at 3 months were evident in both START ( TIR 66.6 +/- 17.5 vs. 69.8 +/- 13.9 %, TBR (5470mg/dl) 2.7 +/- 2.2 vs. 4 +/- 1.6%, TBR (< 54mg/dl) 1.3 +/- 1.6 vs. 0.5 +/- 0.9; HbA1c 7.1 +/- 1.1 vs. 6.9 +/- 0.8%), as well as SWITCH ( TIR 61.9 +/- 14.9 vs. 67.7 +/- 10.1 %, TBR (54- 70 mg/ dl) 2.6 +/- 1.8 vs. 1.9 +/- 1.6 %, HbA1c 6.9 +/- 0.6 vs. 6.9 +/- 0.6 %) were present. Significant improvements in parental hypoglycemic anxiety were found in 2 and 8 items, respectively, in both groups. Conclusion After switching therapy to an AID system, an improvement in glycemic parameters was achieved in both the START and SWITCH groups with already good baseline values of the collective and in the overall cohort. Parental anxiety of hypoglycema was significantly reduced.