Bihormonal Bionic Pancreas Is Shown to Be Effective in Patients Ranging From 6 to 75 Years and 21 to 128 kg
June 7, 2015–Boston, Massachusetts–The bihormonal artificial pancreas is effective in patients ranging from 6 to 75 years of age and weighing between 21 and 128 kg, according to findings presented at the American Diabetes Association’s 75th Scientific Sessions, from June 5–9. Results of a comparative trial in children with type 1 diabetes attending a diabetes summer camp were consolidated with past data to arrive at this conclusion.
Firas H. El-Khatib, PhD, of Boston University explained that, until now, automated glycemic management had not been studied in multiday outpatient evaluations in preadolescents.
Glucose regulation by automated bihormonal (insulin and glucagon) bionic pancreas was compared with insulin pump therapy under medical supervision for 5 days each, in random order, in 19 preadolescents (aged 6–11 years) with type 1 diabetes mellitus at the diabetes summer camp. The children chose their own meals and participated in all camp activities. Both groups of preadolescents were monitored remotely for severe hypoglycemia.
“This preadolescent study was very significant,” said Dr. El-Khatib, “because it allowed us to validate the performance of our bionic pancreas and its adaptation in younger kids for the first time. These children are significantly smaller in body weight and their dosing requirements differ significantly from those of older kids and adults. Type 1 diabetes commonly afflicts preadolescent kids, so it was important to include this young population in our studies sooner rather than later.”
The bionic pancreas was initialized using participant weight only. After 24 hours of autonomous adaptation, the bionic pancreas produced a lower mean continuous glucose level compared with the insulin pump (138 ± 11 vs 168 ± 30 mg/dL; P < .001); less time <60 mg/dL (1.2% vs 2.8%; P < .001); more time 70 to 180 mg/dL (80.6% vs 57.6%; P < .001); and less time >180 mg/dL (16.5% vs 36.3%; P < .001).
Hypoglycemia requiring oral carbohydrates was observed less frequently in children with the bionic pancreas compared with children with the insulin pump (once per 1.1 vs 1.8 days; P = .04). The amount of insulin used was similar between groups (0.68 ± 0.15 vs 0.68 ± 0.13 units/kg daily).
Dr. El-Khatib concluded that the same bionic pancreas previously studied in adolescents and adults achieved similar results in preadolescents when initialized using body weight only. Overall, the device now has demonstrated safety and efficacy in patients ranging in age from age 6 to 75 years and weighing from 21 to 128 kg.
“The system showed great success and analogous efficacy to that demonstrated in the adult population,” said Dr. El-Khatib. “Now we can enroll this young age group in our planned pivotal studies. Ultimately the device, when approved, will be indicated in this young population as well as in older patients.”
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