Unrestricted home use of day and night hybrid closed-loop insulin is safe and feasible for very young children, according to study results published in Diabetes Care.

Researchers conducted an open-label, multicenter crossover study to determine whether day and night hybrid closed-loop insulin can be safely used at home by children age 1 to 7 years with type 1 diabetes. They also compared the effects of diluted and standard strength insulin on glucose control and risk for hypoglycemia.

In total, 24 children on insulin pump therapy for at least 3 months (median age, 5 years; mean glycated hemoglobin, 7.4%; mean total daily insulin, 13.2 units)underwent 2 treatment periods of 21 days of unrestricted living. Each participant was randomly assigned to receive standard strength insulin (U100) for 1 period and diluted insulin (U20) for the other.

The researchers discovered no significant difference between diluted and standard insulin regarding average proportion of time that sensor glucose was in the target range between 3.9 and 10 mmol/L (72% vs 70%, respectively; P =.16). There was also no significant difference in mean glucose levels (8.0 vs 8.2 mmol/L; P =.14), mean glucose variability (standard deviation of sensor glucose 3.1 vs 3.2 mmol/L; P =.16),or average proportion of time spent with sensor glucose <3.9 mmol/L (4.5% vs 4.7%; P =.47) or <2.8 mmol/L (0.6%vs 0.6%; P >.99).

Furthermore,there was no significant between-group difference in average total insulin delivery (17.3 units/day for diluted vs 18.9 units/day for standard strength; P =.07).

The researchers reported no cases of severe hypoglycemia or ketoacidosis related to closed-loop insulin delivery.

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Limitations to this study included its short follow-up duration, small sample size, and lack of a control group.

“Our findings document that hybrid [closed-loop] insulin delivery in a relatively well-controlled population is feasible and safe in managing glucose control,”the researchers said, adding, “No benefits associated with the use of diluted insulin were observed.”

Medtronic supplied discounted monitoring devices for the purpose of this study, and several researchers reported associations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.

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Reference

Tauschmann M, Allen JM, Nagl K, et al. Home use of day and night hybrid closed loop insulin delivery in very young children: a multicenter 3-week, randomized trial [published online January 28, 2019]. Diabetes Care.doi:10.2337/dc18-1881