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Background  Studies have shown that overnight closed-loop insulin delivery can improve glucose control and reduce the risk of hypoglycemia and hence may improve metabolic outcomes and reduce burden for children with type 1 diabetes and their families. However, research so far has not reported insulin levels while comparing closed-loop to open-loop insulin delivery in children. Therefore, in this study we obtained glucose levels as well as plasma insulin levels in children with type 1 diabetes to evaluate the efficacy of a model—based closed-loop algorithm compared to an open-loop administration.    Methods  Fifteen children with type 1 diabetes, 6–12 years, participated in this open-label single center study. We used a randomized cross over design in which we compared overnight closed-loop insulin delivery with sensor augmented pump therapy for two nights in both the hospital and at home (i.e., 1 night in-patient stay and at home per treatment condition). Only during the in-patient stay, hourly plasma insulin and blood glucose levels were assessed and are reported in this paper.    Results  Results of paired sample  t -tests revealed that although plasma insulin levels were significantly lower during the closed-loop than in the open-loop (Mean difference 36.51 pmol/l;  t (13) = 2.13,  p  = .03, effect size  d  = 0.57), blood glucose levels did not vary between conditions (mean difference 0.76 mmol/l;  t (13) = 1.24,  p  = .12,  d  = 0.37). The administered dose of insulin was significantly lower during the closed-loop compared with the open-loop  ( mean difference 0.10 UI;  t (12) = 2.45,  p  = .02,  d  = 0.68).    Conclusions  Lower insulin doses were delivered in the closed-loop, resulting in lower plasma insulin levels, whereby glucose levels were not affected negatively. This suggests that the closed-loop administration is better targeted and hence could be more effective.

Lower plasma insulin levels during overnight closed-loop in school children with type 1 diabetes: Potential advantage? A randomized cross-over trial