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N Engl J Med. 2019 Oct 31;381(18):1707-1717. doi: 10.1056/NEJMoa1907863. Epub 2019 Oct 16.

Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes.

Author information

1
From the University of Virginia Center for Diabetes Technology, Charlottesville (S.A.B., B.P.K., S.M.A.); the Jaeb Center for Health Research, Tampa, FL (D.R., J.W.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B., L.E.), and the Sansum Diabetes Research Institute, Santa Barbara (J.E.P., M.C.) - both in California; the Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN (Y.C.K., V.D.); the Research Division, Joslin Diabetes Center and Department of Pediatrics, Harvard Medical School, Boston (L.M.L., E.I.), and the Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge (E.D., F.J.D.) - both in Massachusetts; the Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York (C.J.L., D.W.L.); and the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.).

Abstract

BACKGROUND:

Closed-loop systems that automate insulin delivery may improve glycemic outcomes in patients with type 1 diabetes.

METHODS:

In this 6-month randomized, multicenter trial, patients with type 1 diabetes were assigned in a 2:1 ratio to receive treatment with a closed-loop system (closed-loop group) or a sensor-augmented pump (control group). The primary outcome was the percentage of time that the blood glucose level was within the target range of 70 to 180 mg per deciliter (3.9 to 10.0 mmol per liter), as measured by continuous glucose monitoring.

RESULTS:

A total of 168 patients underwent randomization; 112 were assigned to the closed-loop group, and 56 were assigned to the control group. The age range of the patients was 14 to 71 years, and the glycated hemoglobin level ranged from 5.4 to 10.6%. All 168 patients completed the trial. The mean (±SD) percentage of time that the glucose level was within the target range increased in the closed-loop group from 61±17% at baseline to 71±12% during the 6 months and remained unchanged at 59±14% in the control group (mean adjusted difference, 11 percentage points; 95% confidence interval [CI], 9 to 14; P<0.001). The results with regard to the main secondary outcomes (percentage of time that the glucose level was >180 mg per deciliter, mean glucose level, glycated hemoglobin level, and percentage of time that the glucose level was <70 mg per deciliter or <54 mg per deciliter [3.0 mmol per liter]) all met the prespecified hierarchical criterion for significance, favoring the closed-loop system. The mean difference (closed loop minus control) in the percentage of time that the blood glucose level was lower than 70 mg per deciliter was -0.88 percentage points (95% CI, -1.19 to -0.57; P<0.001). The mean adjusted difference in glycated hemoglobin level after 6 months was -0.33 percentage points (95% CI, -0.53 to -0.13; P = 0.001). In the closed-loop group, the median percentage of time that the system was in closed-loop mode was 90% over 6 months. No serious hypoglycemic events occurred in either group; one episode of diabetic ketoacidosis occurred in the closed-loop group.

CONCLUSIONS:

In this 6-month trial involving patients with type 1 diabetes, the use of a closed-loop system was associated with a greater percentage of time spent in a target glycemic range than the use of a sensor-augmented insulin pump. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases; iDCL ClinicalTrials.gov number, NCT03563313.).

PMID:
31618560
PMCID:
PMC7076915
DOI:
10.1056/NEJMoa1907863
[Indexed for MEDLINE]
Free PMC Article

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