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A 16-week, multi-center, randomized trial of over 100 children aged 6 to 13 at sites around the U.S. showed improved control and time in range for those using closed-loop systems, the New England Journal of Medicine reported on Wednesday.
The study, which was jointly funded by Tandem Diabetes Care and the National Institute of Diabetes and Digestive and Kidney Diseases, separated the children into a test group on a closed-loop insulin delivery system and a control group using ‘conventional’ sensor-augmented insulin pumps. The researchers primarily looked at whether or not the children remained within the target blood glucose range of 70 to 180 mg/dL, measured in both cases by continuous glucose monitoring.
Study results showed marked improvement for closed loop/artificial pancreas
Of the 101 children in the study, 78 were assigned to the closed-loop testing group and 23 to the control group. The children tested at a broad range of HbA1c levels prior to the study, from 5.7% at the low end to 10.1% at the top.
Over the 16 weeks, the mean percentage of time in which the testing group on the closed-loop pumps remained in range from 53±17% at baseline to 67±10% at baseline. Meanwhile, the group using insulin pumps with a separate glucose sensor rose from 51±16% to 55±13% at baseline – an improvement about 1/3 as great as the closed-loop cohort.
Both groups maintained relatively good blood glucose control on the low end – with median percentage of time below 70 mg/dL at 1.6% in the closed-loop group and 1.8% in the control group.
The study also showed promising results in terms of remaining in the closed-loop mode, with the patients keeping that 93% of the time. Finally, none of the participants experienced episodes of diabetic ketoacidosis or severe hypoglycemia.
Closed-loop systems move closer to wide adoption
Closed-loop insulin delivery systems, sometimes referred to as an “artificial pancreas,” represent one of the fastest-growing and most-promising technology-based interventions for people living with type 1 diabetes. Already, many adults are using or testing out these types of devices, and this new research expands the available evidence that they are also safe to use with children.
The main concerns around the safety and efficacy of the closed-loop type systems center on the possibility of erroneous sensor reading pushing the device to give too much insulin in a short period of time, inducing hypoglycemia. However, the increasing sensitivity and accuracy of sensor technology, combined with an increase in FDA-approved interoperable systems (those which allow different brands and models of diabetes devices to work together) have dramatically mitigated that risk.
Many challenges still remain, not least the question of how to improve access to the necessary devices, educate the broader T1D population, and increase affordability and insurance coverage.
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