Erste pädiatrische Nutzung eines AID-Systems mit automatischem Korrekturbolus in Deutschland

Zusammenfassung

Einleitung Als Upgrade eines teilautomatischen Insulindosierungssystems (AID) ist die Weiterentwicklung einer prädiktiven Insulinabschaltung vom Hypoglykämieschutz (Basal-IQ) zu Tandem Control IQ das zweite in Deutschland für Kinder und Jugendliche zu Lasten der gesetzlichen Krankenversicherung rezeptierbare System mit automatischer Basalratenmodulation und Korrekturbolusgaben erhältlich. In dieser Studie wurden der iterative Umstieg von zunächst nur prädiktiver Abschaltung mit dem sofortigen Beginn von AID mit Insulinmodulation zur Reduktion von Hypo- und Hyperglykämie verglichen.

Methodik Kindern und Jugendlichen mit intensivierter Insulintherapie (ICT oder CSII) mit Krankenkassengenehmigung für Tandem Basal IQ wurde vor Markteinführung des neuen Systems eine Behandlung mit dem AID-System Control IQ angeboten. Teilnehmende und Eltern erhielten eine Systemschulung. Eine Gruppe nutzte zuvor kein anderes AID-System (START-Gruppe). Eine andere Gruppe, die bereits Tandem Basal IQ nutzte, wurde vor Markteinführung des neuen Systems ein Pumpenupgrade (SWITCH-Gruppe) auf das AID-System Control IQ angeboten. Es wurden die Therapiedaten und Fragebögen zum Wohlbefinden vor Beginn der neuen Therapieform und nach 3 Monaten miteinander verglichen.

Resultate Insgesamt konnten 49 Kinder und Jugendliche (mittleres Alter 12±3,4 Jahre, 38% weiblich, BMI-SDS 0,28±1,0, Diabetesdauer 4,7±4,1 Jahre) ausgewertet werden, eine Jugendliche musste aufgrund eines allergischen Kontaktekzems abbrechen. Der primäre Endpunkt Time in Range (TIR) zeigte sich nach der Intervention signifikant erhöht mit 68,8±12,0 vs. zuvor 64,1±16,2 %, p=0.003; die Zeit in der Unterzuckerung sank von 2,7±2,0 auf 1,7±1,6 % (p=0.02)

Verbesserte glykämische Parameter nach drei Monaten lagen sowohl bei START (HbA1c 7,1±1,1 vs. 6,9±0,8 %, TIR 66,6±17,5 vs. 69,8±13,9 %, TBR (54–70 mg/dl) 2,7±2,2 vs. 1,4±1,6 %, TBR (<54 mg/dl) 1,3±1,6 vs. 0,5±0,9 %) wie auch SWITCH (HbA1c 6,9±0,6 vs. 6,9±0,6 %, TIR 6,.9±14,9 vs. 67,7±10,1 %, TBR (54–70 mg/dl) 2,6±1,8 vs. 1,9±1,6 %) vor. Signifikante Verbesserungen elterlicher Hypoglykämieangst waren bei 2 bzw. 8 Items in beiden Gruppen zu finden.

Schlussfolgerung Nach Therapieumstellung auf ein AID-System konnte bei bereits guten Ausgangswerten des Kollektivs sowohl in der START- wie auch der SWITCH-Gruppe trotzdem eine Verbesserung der glykämischen Parameter erzielt werden, auch über das Gesamtkollektiv bestand eine Verbesserung. Die elterliche Hypoglykämieangst konnte signifikant reduziert werden.

Abstract

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 (54–70 mg/dl) 2.7±2.2 vs. 4±1.6 %, TBR (<54 mg/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.

Schlüsselwörter

Insulinpumpe - Glukosesensor - automatische Insulindosierung - Zeit im Zielbereich - Hypoglykämie - AID - insulin pump - glucose sensor - automated insulin delivery - AID - time in range - hypoglycemia

Publikationsverlauf

Eingereicht: 14. April 2023

Angenommen nach Revision: 13. Juli 2023

Artikel online veröffentlicht:
16. August 2023

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