Diabetes Obes Metab. 2022 Apr 4. doi: 10.1111/dom.14706. Online ahead of print.
ABSTRACT
BACKGROUND: In Europe regulatory approval of the Medtronic MinimedTM 670G is limited to those above 7 years. Thus, additional information on the incremental differences between using a sensor-augmented pump (SAP) without automated insulin delivery (AID), using it with predictive low-glucose suspension (PLGM) or as hybrid closed loop (HCL) in preschool and school children is needed.
METHODS: We conducted a monocentric, randomized, controlled, two-phase cross-over study in 38 children 2-6 and 7-14 years of age. Primary endpoint was percentage of time in range (TIR) of 70-180 mg/dl. Other CGM metrics, HbA1c, patient related outcomes (DISABKIDS questionnaire, Fear of Hypoglycemia Survey) and safety events were also assessed. Results from 2 weeks SAP, 8 weeks PLGM and 8 weeks 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=0.0002). Diabetes burden and worries and fear of hypoglycemia remained on low levels without significant changes vs. PLGM. No events of severe hypoglycemia or diabetic ketoacidosis occurred.
CONCLUSIONS: Preschool children profit from AID at least as much as those age 7 and above. To ensure safe use and prescribing modalities, regulatory approval is required also for young children. This article is protected by copyright. All rights reserved.
PMID:35373894 | DOI:10.1111/dom.14706
