In a nutshell
This study looked at using a closed-loop system, which connects glucose tests automatically to an insulin pump, for children with type 1 diabetes (T1D). It found that a closed-loop system improved glucose control in these patients.
T1D is a condition in which the pancreas is unable to create the hormone insulin, which controls levels of glucose (sugar) in the blood. T1D is a lifelong condition that typically starts in childhood or young adulthood. Patients with T1D require injections of artificial insulin to prevent harmful high glucose levels. Managing insulin therapy can require multiple daily injections, and the timing and dose can vary depending on meals and exercise. This regimen is particularly challenging for children.
A closed-loop system can simplify diabetes management. Closed-loop systems include a patch on the skin that continuously measures glucose. This information is automatically connected to an insulin pump, which dispenses insulin based on the current blood glucose. Closed-loop systems improve blood glucose control in adults. However, there is not enough research on children.
Methods & findings
This study included 101 children with T1D between the ages of 6 and 13. 78 children received a closed-loop system. A control (comparison) group of 23 children received both a continuous glucose monitor (CGM) and an insulin pump, which were not automatically connected. The CGM tells the patient the blood glucose level and the patient must decide what dose of insulin to administer. All patients were followed for 16 weeks.
Both groups measured the percentage of time that blood glucose was well controlled (between 70 and 180 mg/dL). Patients using a closed-loop system improved from 53% to 67% the percentage of time in range. The control group improved from 51% to 55%. There was significantly more improvement for patients using the closed-loop system. Patients on the closed-loop system had an improvement equal to 2.6 hours more a day of blood glucose in range compared to the control group.
Glycated hemoglobin (HbA1c) is a measure of blood glucose control over the past 3 months. HbA1c below 7% indicates good glucose control. Significantly more of the patients using the closed-loop system achieved the HbA1c target (51% vs. 18%) after 16 weeks.
The bottom line
This study found that a closed-loop system leads to better glucose control for children with T1D than continuous monitoring and an insulin pump.
The fine print
This study and its authors have financial ties to Dexcom and Tandem Diabetes Care, which manufacture the continuous glucose monitor and insulin pump used in the closed-loop system.
Published By :
The New England Journal of Medicine
Original Title :
A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes.
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