Abstract

History

The feasible gain of hybrid closed-loop remedy (i.e., synthetic pancreas) about sensor-augmented pump treatment in very young small children with kind 1 diabetes is unclear.

Solutions

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In this multicenter, randomized, crossover trial, we recruited little ones 1 to 7 yrs of age with form 1 diabetic issues who were being obtaining insulin-pump remedy at seven facilities throughout Austria, Germany, Luxembourg, and the United Kingdom. Individuals gained cure in two 16-7 days periods, in random purchase, in which the shut-loop system was in contrast with sensor-augmented pump treatment (command). The most important conclude point was the concerning-therapy variation in the percentage of time that the sensor glucose measurement was in the concentrate on range (70 to 180 mg per deciliter) in the course of just about every 16-7 days time period. The analysis was done according to the intention-to-take care of basic principle. Vital secondary end details incorporated the share of time spent in a hyperglycemic condition (glucose level, >180 mg per deciliter), the glycated hemoglobin stage, the imply sensor glucose stage, and the proportion of time put in in a hypoglycemic point out (glucose level, <70 mg per deciliter). Safety was assessed.

Results

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%. The percentage of time with the glucose level in the target range was 8.7 percentage points (95% confidence interval [CI], 7.4 to 9.9) higher during the closed-loop period than during the control period (P<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% CI, −9.9 to −7.1), the difference in the glycated hemoglobin level was −0.4 percentage points (95% CI, −0.5 to −0.3), and the difference in the mean sensor glucose level was −12.3 mg per deciliter (95% CI, −14.8 to −9.8) (P<0.001 for all comparisons). The time spent in a hypoglycemic state was similar with the two treatments (P=0.74). The median time spent in the closed-loop mode was 95% (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.

Conclusions

A hybrid closed-loop system significantly improved glycemic control in very young children with type 1 diabetes, without increasing the time spent in hypoglycemia. (Funded by the European Commission and others ClinicalTrials.gov number, NCT03784027.)

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Closed-Loop Therapy in Young Children with Type 1 Diabetes
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