A closed-loop insulin offer design produces seriously better blood glucose time in differ than a sensor-augmented pump in teens used 6 to 13 years, fresh learn finds.
Outcomes from a 16-week, multicenter, randomized, originate-stamp trial were published on-line August 26 in the New England Journal of Medicine. The learn about became as soon as conducted by Marc D. Breton, PhD, of the University of Virginia Heart for Diabetes Technology, Charlottesville, and colleagues.
“Closed-loop” or “artificial pancreas” methods comprise an insulin pump, a proper glucose note, and instrument that enables the two devices to keep up a correspondence in assert to automate insulin offer to preserve watch over blood glucose stages. One such commercially readily available design, the MiniMed 670G (Medtronic), is a hybrid closed-loop design since the customers must composed manually enter meal data. The 670G became as soon as popular for teenagers used 6 to 13 years with form 1 diabetes, but no randomized trial data were published.
One other hybrid design, the t:slim X2 insulin pump with Control-IQ Technology (Tandem Diabetes Care), became as soon as popular for sufferers used 14 years and older with form 1 diabetes. The present learn about investigated the efficacy and security of the Tandem design in teens used 6 to 13 years.
The learn about incorporated 101 sufferers who had had diabetes for a length of 1 to 12 years. The sufferers’ A1c level became as soon as 5.7% to 10.1%. They were randomly assigned both to a neighborhood that received the closed-loop design (n = 78), consisting of the t:slim insulin pump with Control-IQ Technology (a instrument algorithm originate on the University of Virginia) with a Dexcom G6 proper glucose note, or to a preserve watch over neighborhood (n = 23), wherein the Dexcom G6 and stand-on my own pumps were passe. Of the sufferers in the preserve watch over neighborhood, 15 passe the t:slim pump with a predictive low-glucose suspend feature, which stops the insulin offer when the glucose stages are trending downward to a predicted hypoglycemia cutoff. The diversified sufferers in the preserve watch over neighborhood passe their very bag pumps.
The principle end result, percentage of time spent with glucose in the procedure 70 –180 mg/dL differ, increased from 53% at baseline to 67% at 16 weeks in the closed-loop neighborhood, when put next with 51% to 55% in the preserve watch over neighborhood. The principal between-neighborhood difference became as soon as 11 percentage components (P < .001). The tag grew to turn into evident all around the major month and remained consistent over 4 months.
Daylight hours (6: 00 AM to tiring evening) time in differ at 16 weeks became as soon as 63% for sufferers in the closed-loop neighborhood when put next with 56% for the preserve watch over neighborhood. Hour of darkness (tiring evening to 6: 00 AM) values were 80% vs 54%. Equal patterns were seen for mean glucose level.
The 11 percentage point difference works out to 2.6 hours less per day spent in hyperglycemia with the closed-loop design, which is virtually much like the tag seen in randomized trials of teens and adults, Breton and colleagues say.
The quantity of alternate in A1c from baseline at 16 weeks did now not differ seriously between the two groups (7.6% to 7.0% with closed loop vs 7.9% to 7.6% for preserve watch over sufferers; P = .08 for between-neighborhood difference). Nonetheless, more sufferers in the closed-loop neighborhood met the American Diabetes Affiliation’s procedure A1c ticket of <7% (51% vs 18%).
Adversarial events were reported in 19% in the closed-loop neighborhood and 9% of the preserve watch over sufferers, a nonsignificant difference (P = .50). There were no circumstances of severe hypoglycemia or diabetic ketoacidosis in both neighborhood. Time spent in hypoglycemia at stages <70 mg/dL became as soon as now not up to 2% in both groups; time spent in hypoglycemia at stages <54 mg/dL became as soon as now not up to 1% overall. This became as soon as seemingly attributable to the utilization of pumps with a predictive low-glucose suspend feature, the authors roar.
The learn about became as soon as supported by Tandem Diabetes Care and the National Institute of Diabetes and Digestive and Kidney Diseases. Breton has received consulting charges from Air Liquide; grant reinforce, paid to the University of Virginia; consulting charges; and convention attendance charges from Dexcom; grant reinforce, paid to the University of Virginia; and convention attendance charges from Tandem Diabetes Care. He also holds several patents or pending patents associated to automated insulin offer methods.
N Engl J Med. Published August 26, 2020. Abstract
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