Cambridge Hybrid Closed-Loop System in Very Young Children With Type 1 Diabetes Reduces Caregivers’ Fear of Hypoglycemia and Improves Their Well-being

Abstract

OBJECTIVE To evaluate the impact of CamAPS FX hybrid closed-loop (HCL) automated insulin delivery in very young children with type 1 diabetes (T1D) on caregivers’ well-being, fear of hypoglycemia, and sleepiness. RESEARCH DESIGN AND METHODS We conducted a multinational, open-label, randomized crossover study. Children (age 1–7 years) with T1D received treatment for two 4-month periods in random order, comparing HCL with sensor augmented pump (control). At baseline and after each treatment period, caregivers were invited to complete World Health Organization–Five Well-Being Index, Hypoglycemia Fear Survey, and Epworth Sleepiness Scale questionnaires. RESULTS Caregivers of 74 children (mean ± SD age 5 ± 2 years and baseline HbA1c 7.3 ± 0.7%; 42% female) participated. Results revealed significantly lower scores for hypoglycemia fear (P < 0.001) and higher scores for well-being (P < 0.001) after HCL treatment. A trend toward a reduction in sleepiness score was observed (P = 0.09). CONCLUSIONS Our results suggest better well-being and less hypoglycemia fear in caregivers of very young children with T1D on CamAPS FX HCL.

A Systematic Review of Commercial Hybrid Closed-Loop Automated Insulin Delivery Systems

“…A total of 23 studies were identified in the literature search as having psychosocial endpoints (Table 8 in the Supplementary Information) [23,29,38,41,44,66,67,76,83,[88][89][90][91][92][93][94][95][96][97][98][99][100][101]. These were analysed separately to the 59 papers included in the systematic review, although eight of the 23 studies were also featured in the systematic review with a focus on their glycaemic endpoints.…”

During an 18‐month course of automated insulin delivery treatment, children aged 2 to 6 years achieve and maintain a higher time in tight range

“…1 Previous studies have shown that parental sleep and well-being improved while using AID systems in young children. 31,32 We hypothesize that better parental sleep quality could be one explanation for the decreased treatment-related stress observed in parents of children in our study.…”

ISPAD Clinical Practice Consensus Guidelines 2022: Managing diabetes in preschoolers

“… 41 HCL with AID can reduce parental burden for managing diabetes‐related care and reduce perceptions of parenting stress. 42 , 43 Making certified systems with this technology available for children younger than 7 years, tailoring the algorithms to the age‐specific needs of this patient group, and further developing clinical and research experience using this treatment modality in preschool children will be important. Age‐specific challenges to address in automated systems include the small insulin doses needed, often well below 10 U per day, 44 the large differences in physiological insulin needs during different parts of the day, significant day‐to‐day variation in insulin needs, and safety concerns to avoid accidental insulin dosing.…”