In‐home use of a hybrid closed loop achieves time‐in‐range targets in preschoolers and school children: Results from a randomized, controlled, crossover trial

• Published in: Diabetes, obesity & metabolism Vol. 24; no. 7; pp. 1319 - 1327
• Main Authors: Berge, Thekla, Remus, Kerstin, Biester, Sarah, Reschke, Felix, Klusmeier, Britta, Adolph, Kerstin, Holtdirk, Anette, Thomas, Andreas, Kordonouri, Olga, Danne, Thomas, Biester, Torben
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01-07-2022; Wiley Subscription Services, Inc
• Subjects: automated insulin delivery; CGM; Children; Childrens health; Closed loop systems; CSII; Diabetes; Diabetes mellitus; Diabetic ketoacidosis; Disease management; Drug delivery systems; Fear; glucose; Glucose monitoring; Hypoglycemia; Insulin; Ketoacidosis; paediatric type 1; Pediatrics; Preschool children; Sensors; Students; treatment goals; CGM; glucose; paediatric type 1; treatment goals; automated insulin delivery; CSII
• ISSN: 1462-8902; 1463-1326
• DOI: 10.1111/dom.14706

Aim
To obtain additional information on the incremental differences between using a sensor‐augmented pump (SAP) without automated insulin delivery (AID), using it with predictive low‐glucose management (PLGM) or as hybrid closed loop (HCL), in preschool and school children.
Methods
We conducted a monocentric, randomized, controlled, two‐phase crossover study in 38 children aged 2‐6 and 7‐14 years. The primary endpoint was the percentage of time in range (TIR) of 70‐180 mg/dl. Other continuous glucose sensor metrics, HbA1c, patient‐related outcomes (DISABKIDS questionnaire, Fear of Hypoglycaemia Survey) and safety events were also assessed. Results from 2 weeks of SAP, 8 weeks of PLGM and 8 weeks of HCL were compared using a paired t‐test or Wilcoxon signed‐rank test.
Results
Overall, we found a high rate of TIR target (>70%) achievement with HCL in preschool (88%) and school children (50%), with average times in Auto Mode of 93% and 87%, respectively. Preschool children achieved a mean TIR of 73% ± 6% (+8% vs. SAP, +6% vs. PLGM) and school children 69% ± 8% (+15% vs. SAP and + 14% vs. PLGM). Overall, HbA1c improved from 7.4% ± 0.9% to 6.9% ± 0.5% (P = .0002). Diabetes burden and worries and fear of hypoglycaemia remained at low levels, without significant changes versus PLGM. No events of severe hypoglycaemia or diabetic ketoacidosis occurred.
Conclusions
Preschool children profit from AID at least as much as those aged 7 years and older. To ensure safe use and prescribing modalities, regulatory approval is also required for young children.