We aimed to assess the feasibility and safety of hybrid closed-loop insulin delivery in children with type 1 diabetes aged 1-7 years as well as evaluate the role of diluted insulin on glucose control. RESEARCH DESIGN AND METHODS In an open-label, multicenter, multinational, randomized crossover study, 24 children with type 1 diabetes on insulin pump therapy (median age 5 years [interquartile range 3-6] and mean 6 SD HbA 1c 7.4 6 0.7% [57 6 8 mmol/mol] and total insulin 13.2 6 4.8 units/day) underwent two 21-day periods of unrestricted living and we compared hybrid closed-loop with diluted insulin (U20) and hybrid closedloop with standard strength insulin (U100) in random order. During both interventions, the Cambridge model predictive control algorithm was used. RESULTS The proportion of time that sensor glucose was in the target range between 3.9 and 10 mmol/L (primary end point) was not different between interventions (mean 6 SD 72 6 8% vs. 70 6 7% for closed-loop with diluted insulin vs. closed-loop with standard insulin, respectively; P = 0.16). There was no difference in mean glucose levels (8.0 6 0.8 vs. 8.2 6 0.6 mmol/L; P = 0.14), glucose variability (SD of sensor glucose 3.1 6 0.5 vs. 3.2 6 0.4 mmol/L; P = 0.16), or the proportion of time spent with sensor glucose <3.9 mmol/L (4.5 6 1.7% vs. 4.7 6 1.4%; P = 0.47) or <2.8 mmol/L (0.6 6 0.5% vs. 0.6 6 0.4%; P > 0.99). Total daily insulin delivery did not differ (17.3 6 5.6 vs. 18.9 6 6.9 units/day; P = 0.07). No closed-loop-related severe hypoglycemia or ketoacidosis occurred. CONCLUSIONS Unrestricted home use of day-and-night closed-loop in very young children with type 1 diabetes is feasible and safe. The use of diluted insulin during closed-loop does not provide additional benefits compared with standard strength insulin. Despite advances in the management of type 1 diabetes and supporting technologies, the majority of children with type 1 diabetes are unable to achieve recommended treatment targets (1,2). Closed-loop systems (3) delivering insulin in glucose-responsive fashion may provide benefits compared with existing treatment modalities including

Objective To evaluate the experiences of families with very young children aged 1 to 7 years (inclusive) with type 1 diabetes using day‐and‐night hybrid closed‐loop insulin delivery. Methods Parents/caregivers of 20 children aged 1 to 7 years with type 1 diabetes completed a closed‐loop experience survey following two 3‐week periods of unrestricted day‐and‐night hybrid closed‐loop insulin therapy using Cambridge FlorenceM system at home. Benefits, limitations, and improvements of closed‐loop technology were explored. Results Responders reported reduced burden of diabetes management, less time spent managing diabetes, and improved quality of sleep with closed‐loop. Ninety percent of the responders felt less worried about their child's glucose control using closed‐loop. Size of study devices, battery performance and connectivity issues were identified as areas for improvement. Parents/caregivers wished for more options to input information to the system such as temporary glucose targets. Conclusions Parents/caregivers of very young children reported important quality of life benefits associated with using closed‐loop, supporting adoption of this technology in this population.

To quantify age-related variability of insulin needs during day and night closed-loop insulin delivery. RESEARCH DESIGN AND METHODS We retrospectively analyzed data from hybrid closed-loop studies involving young children (1-6 years old, n 5 20), children (7-12 years, n 5 21), adolescents (13-17 years, n 5 15), and adults (>18 years, n 5 58) with type 1 diabetes. The coefficient of variation quantified variability of insulin needs during 3 weeks of unrestrictedliving hybrid closed-loop use. RESULTS Data from 2,365 nights and 2,367 days in 114 participants were analyzed. The coefficient of variation of insulin delivery was higher in young children compared with adults (mean difference at nighttime 10.7 percentage points [95% CI 2.9-18.4], P 5 0.003; daytime 6.4 percentage points [95% CI 2.0-10.9], P 5 0.002) and compared with adolescents (mean difference at nighttime 10.2 percentage points [95% CI 0.0-20.4], P 5 0.049; daytime 7.0 percentage points [95% CI 1.1-12.8], P 5 0.014). CONCLUSIONS Diabetes management in young children is complicated by higher variability in insulin requirements, supporting fast-track clinical practice adoption of closed-loop in this vulnerable population. With increasing application of insulin pump therapy and continuous glucose monitors, hybrid closed-loop has become a feasible treatment modality for people with type 1 diabetes (1,2). Apart from manual mealtime boluses, insulin delivery is autonomously modulated by a control algorithm based on real-time sensor glucose values. Insulin delivery may vary considerably from day to day and night to night due to varying activity levels, insulin set-changes, meal timings and composition, and other factors (3,4). To date, the association between age and insulin variability has not been assessed. In the present analysis, we investigate whether insulin requirements may be more variable in younger age.

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