Source:

Breton
M
,
Kanapka
LG
,
Beck
RW
, et al
A randomized trial of closed-loop control in children with type 1 diabetes
.
N Engl J Med.
2020
;
383
(
9
):
836
-
845
; doi:
https://doi.org/10.1056/NEJMoa2004736

Investigators from multiple institutions conducted a randomized controlled trial comparing the effectiveness of a closed-loop system of insulin delivery (eg, artificial pancreas) to that of a standard insulin pump in maintaining target glucose levels in children with type 1 diabetes over a 16-week treatment period. Children 6-13 years old with type 1 diabetes requiring at least 10 units of insulin daily were randomized in a 3:1 manner to either the closed-loop system or the control group. For those in the closed-loop system, data transmitted from a continuous glucose monitor (CGM) to the pump were used to automatically adjust insulin delivery. Patients randomized to the control group used an insulin pump, with CGM to help determine insulin dosing. The primary study outcome was percent of time that the glucose level (as measured by the CGM) was within the target range of 70 to 180 mg/dL. Secondary outcomes included percent of time with glucose levels >180 mg/dL, percent of time <70 mg/dL, glycated hemoglobin level at 16 weeks, and adverse events. Regression models were used to compare outcomes between groups; baseline values were included in the analyses.

A total of 101 patients were enrolled in the study, with 78 assigned to the closed-loop system and 23 to the control group. The mean age of study patients was 11.3 ±2.0 years for those in the closed-loop group and 10.8 ±2.4 years for controls, and mean glycated hemoglobin levels at randomization were 7.7% ±1.1% and 8.0% ±1.1%, respectively. The mean percent time that glucose levels were in the target range was 67% ±10% for the closed loop group vs 55% ±13% for controls (difference 11 percentage points; 95% CI, 7, 14; P <0.001). The mean percent time that glucose levels were >180 mg/dL were significantly less for those in the control loop group than control patients (31% ±10% and 43% ±14%, respectively; P <0.001); percent time that glucose levels were <70 mg/dL were low in both groups (mean values 1.6% and 1.8%, respectively). After the 16-week treatment period, mean glycated hemoglobin levels were 7.0% and 7.6%, respectively, for children assigned to the closed loop and control groups (P = 0.08). There were no episodes of diabetic ketoacidosis or severe hypoglycemia in any study participant, but there were 12 episodes of hyperglycemia and/or hyperketosis in patients randomized to the closed-loop group vs 1 among controls.

The authors conclude that use of a closed-loop system for automated insulin delivery was more effective than a standard insulin pump in maintaining target glucose levels in children with type 1 diabetes.

Dr Fechner has disclosed no financial relationship relevant to this commentary. This commentary does not contain a discussion of an unapproved/investigative use of a commercial product/device.

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