Home Use of Day-and-Night Hybrid Closed-Loop Insulin Delivery in Very Young Children: A Multicenter, 3-Week, Randomized Trial.

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Tauschmann, Martin 
Allen, Janet M 
Nagl, Katrin 
Fritsch, Maria 
Yong, James 

OBJECTIVE: 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 ± SD HbA1c 7.4 ± 0.7% [57 ± 8 mmol/mol] and total insulin 13.2 ± 4.8 units/day) underwent two 21-day periods of unrestricted living and we compared hybrid closed-loop with diluted insulin (U20) and hybrid closed-loop 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 ± SD 72 ± 8% vs. 70 ± 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 ± 0.8 vs. 8.2 ± 0.6 mmol/L; P = 0.14), glucose variability (SD of sensor glucose 3.1 ± 0.5 vs. 3.2 ± 0.4 mmol/L; P = 0.16), or the proportion of time spent with sensor glucose <3.9 mmol/L (4.5 ± 1.7% vs. 4.7 ± 1.4%; P = 0.47) or <2.8 mmol/L (0.6 ± 0.5% vs. 0.6 ± 0.4%; P > 0.99). Total daily insulin delivery did not differ (17.3 ± 5.6 vs. 18.9 ± 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.

Algorithms, Blood Glucose, Child, Child, Preschool, Cross-Over Studies, Diabetes Mellitus, Type 1, Female, Humans, Hypoglycemia, Hypoglycemic Agents, Infant, Insulin, Insulin Infusion Systems, Male, Treatment Outcome
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Diabetes Care
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American Diabetes Association
European Commission Horizon 2020 (H2020) Societal Challenges (731560)
Cambridge University Hospitals NHS Foundation Trust (CUH) (146281)
Wellcome Trust (100574/Z/12/Z)
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under the grant agreement No 731560. This material reflects only the author’s views and the Commission is not liable for any use that may be made of the information contained therein. The Jaeb Center for Health Research is funded by JDRF under the grant 3-SRA-2016-297-M-N. Additional support for the artificial pancreas work was from National Institute for Health Research Cambridge Biomedical Research Centre, and Wellcome Trust Strategic Award (100574/Z/12/Z).