Ware, J. et al | 2022 | Randomized Trial of Closed-Loop Control in Very Young Children with Type 1 Diabetes | N Engl J Med 2022| 386| P. 209-219 | DOI: 10.1056/NEJMoa2111673
This paper outlines the findings of a trial, at the outset the researchers hypothesized that use of the Cambridge closed-loop algorithm for 16 weeks in children 1 to 7 years of age with type 1 diabetes would improve glycemic control, as compared with sensor-augmented pump therapy, and have an acceptable safety profile.
The possible advantage of hybrid closed-loop therapy (i.e., artificial pancreas) over sensor-augmented pump therapy in very young children with type 1 diabetes is unclear.
In this multicenter, randomized, crossover trial, we recruited children 1 to 7 years of age with type 1 diabetes who were receiving insulin-pump therapy at seven centers across Austria, Germany, Luxembourg, and the United Kingdom. Participants received treatment in two 16-week periods, in random order, in which the closed-loop system was compared with sensor-augmented pump therapy (control). The primary end point was the between-treatment difference in the percentage of time that the sensor glucose measurement was in the target range (70 to 180 mg per deciliter) during each 16-week period. The analysis was conducted according to the intention-to-treat principle. Key secondary end points included the percentage of time spent in a hyperglycemic state (glucose level, more than180 mg per deciliter), the glycated hemoglobin level, the mean sensor glucose level, and the percentage of time spent in a hypoglycemic state (glucose level, less than 70 mg per deciliter). Safety was assessed.
A total of 74 participants underwent randomization. The mean (±SD) age of the participants was 5.6±1.6 years, and the baseline glycated hemoglobin level was 7.3±0.7 per cent. The percentage of time with the glucose level in the target range was 8.7 percentage points (95 per cent confidence interval [CI], 7.4 to 9.9) higher during the closed-loop period than during the control period (P less than 0.001). The mean adjusted difference (closed-loop minus control) in the percentage of time spent in a hyperglycemic state was −8.5 percentage points (95 per cent CI, −9.9 to −7.1), the difference in the glycated hemoglobin level was −0.4 percentage points (95 per cent CI, −0.5 to −0.3), and the difference in the mean sensor glucose level was −12.3 mg per deciliter (95 per cent CI, −14.8 to −9.8) (P less than0.001 for all comparisons). The time spent in a hypoglycemic state was similar with the two treatments (P equal to0.74). The median time spent in the closed-loop mode was 95 per cent (interquartile range, 92 to 97) over the 16-week closed-loop period. One serious adverse event of severe hypoglycemia occurred during the closed-loop period. One serious adverse event that was deemed to be unrelated to treatment occurred.
A hybrid closed-loop system significantly improved glycemic control in very young children with type 1 diabetes, without increasing the time spent in hypoglycemia.
Research summary is available from the NEJM
Full article available from NEJM