Thekla Von dem Berge, Germany
Children’s Hospital AUF DER BULT PediatricsPresenter of 1 Presentation
ATTD CONSENSUS TARGETS ARE ACHIEVABLE FOR PRESCHOOLERS: HYBRID CLOSED LOOP USE IN CHILDREN FROM 2-14 YEARS
Abstract
Background and Aims
Currently, only one CE marked systems with a hybrid automated insulin delivery (H-AID) is available per prescription in Germany. It is not labelled for use in preschoolers. The only technical limitation of this system (Minimed670G) for small children is a daily use of 8 units of insulin. ATTD consensus targets recommend a Time in Range (TIR) of >70% and Time below Range <4% in all ages with T1D.
Methods
A two phase study of children aged 7-14 and <7 years was conducted at our center. All children received training for the system and used it for 8 weeks in manual mode or 8 weeks in auto mode, the order was randomly assigned. Primary outcome parameter was the TIR 70-180%.
Results
20 children from 2.5 to 6 years and 17 from 8-14 years completed the trial; younger group recruitment was stopped preliminary by Covid19 pandemic. After 8 weeks of HCL, TIR in 14day-profile was 70.7 % compared to 53.8% after PLGM in the older group, HCL 73.9 % vs. PLGM 68.2% in preschool kids. Details on achievement are shown in table.
Conclusions
As shown in other trials, 670G is safe even under the labelled age. TIR was higher in our study than published before. In both groups best results were achieved with the H-AID system. Prescoolers benefit from their parents performing the insulin therapy. To ensure safe use and modalities for children and prescribers, a label is also needed for small children.