The safety and effectiveness of automated glycemic management have not been tested in multiday studies under unrestricted outpatient conditions.
In two random-order, crossover studies with similar but distinct designs, Dr Steven Russell and colleagues compared glycemic control with a wearable, bihormonal, automated, “bionic” pancreas (bionic-pancreas period) with glycemic control with an insulin pump (control period) for 5 days in 20 adults and 32 adolescents with type 1 diabetes mellitus.
The automatically adaptive algorithm of the bionic pancreas received data from a continuous glucose monitor to control subcutaneous delivery of insulin and glucagon.
|The mean percentage of time with a low glucose level over the 5-day bionic-pancreas period was about 5%|
|New England Journal of Medicine|
Among the adults, the mean plasma glucose level over the 5-day bionic-pancreas period was 138 mg per deciliter, and the mean percentage of time with a low glucose level was about 5%.
The team observed that after 1 day of automatic adaptation by the bionic pancreas, the mean glucose level on continuous monitoring was lower than the mean level during the control period, and the percentage of time with a low glucose reading was lower.
The research team noted that among the adolescents, the mean plasma glucose level was also lower during the bionic-pancreas period than during the control period, but the percentage of time with a low plasma glucose reading was similar during the two periods.
The team found that the mean frequency of interventions for hypoglycemia among the adolescents was lower during the bionic-pancreas period than during the control period.
Dr Russell's team concludes, "As compared with an insulin pump, a wearable, automated, bihormonal, bionic pancreas improved mean glycemic levels, with less frequent hypoglycemic episodes, among both adults and adolescents with type 1 diabetes mellitus."