ESPEYB19 10. Type 1 Diabetes Clinical Trials (1 abstracts)
10.3. Randomized trial of closed-loop control in very young children with type 1 diabetes
Ware J , Allen JM , Boughton CK , Wilinska ME , Hartnell S , Thankamony A , de Beaufort C , Schierloh U , Fröhlich-Reiterer E , Mader JK , Kapellen TM , Rami-Merhar B , Tauschmann M , Nagl K , Hofer SE , Campbell FM , Yong J , Hood KK , Lawton J , Roze S , Sibayan J , Bocchino J , Kollman C , Hovorka R & KidsAP Consortium
N Engl J Med. 2022 Jan 20;386(3):209-219. https://pubmed.ncbi.nlm.nih.gov/35045227/
Brief Summary: This multicenter, randomized, crossover trial in 74 very young children (age: 1-7 years) with type 1 diabetes (T1D) tested the safety and efficacy of a hybrid closed-loop system for insulin delivery (CamAPS FX) compared with sensor-augmented pump therapy over 16 weeks. The hybrid closed-loop system showed better glycemic outcomes, without any difference in hypoglycemic episodes or adverse events.
Hybrid closed-loop systems, combining an insulin pump, a continuous glucose monitor (CGM) and a control algorithm, which automatically adjust basal insulin delivery based on glucose levels, are becoming progressively more available for the management of T1D. These systems have proven to improve glycemic control in older children and adults (1). However, there are limited data in younger children, a population where diabetes management can be challenging due to several factors, such as unpredictable eating and activity levels, variable insulin requirements and pronounced insulin sensitivity (2). This population is particularly vulnerable to the effect of hypoglycemia, due to lack of recognition of signs and symptoms. Greater frequency and severity of hypoglycemia in this age group is associated with parental emotional distress and burden. Both hypoglycemia and prolonged hyperglycemia can have negative neurocognitive effects in young children (3).
This study shows a clear benefit associated with the use of hybrid closed loop system in this young population, providing reduced hyperglycemia, better time spent within target, without increasing the time spent in hypoglycemia. This supports the longer-term use of this system in this age group to improve glycemic control and hopefully reduce parental burden related to diabetes management. However, there are still some barriers to address before a wider implementation of this system into clinical practice, including associated costs and equitable access. In addition, adequate resources need to be in place to fulfil the required training for staff and patients/families, which is essential to achieve the best outcomes with hybrid closed-loop therapy.
References: 1. Jiao X, Shen Y, Chen Y. Better TIR, HbA1c, and less hypoglycemia in closed-loop insulin system in patients with type 1 diabetes: a meta-analysis. BMJ Open Diabetes Res Care 2022;10:e002633. 2. Sundberg F, Barnard K, Cato A, de Beaufort C, DiMeglio LA, Dooley G, Hershey T, Hitchcock J, Jain V, Weissberg-Benchell J, Rami-Merhar B, Smart CE, Hanas R. ISPAD Guidelines. Managing diabetes in preschool children. Pediatr Diabetes. 2017;18:499–517. 3. Mauras N, Buckingham B, White NH, et al. Impact of type 1 diabetes in the developing brain in children: a longitudinal study. Diabetes Care 2021;44:983–92.
Volume 19
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ESPE Yearbook of Paediatric Endocrinology
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