TY - JOUR
T1 - A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes
AU - Breton, Marc D.
AU - Kanapka, Lauren G.
AU - Beck, Roy W.
AU - Ekhlaspour, Laya
AU - Forlenza, Gregory P.
AU - Cengiz, Eda
AU - Schoelwer, Melissa
AU - Ruedy, Katrina J.
AU - Jost, Emily
AU - Carria, Lori
AU - Emory, Emma
AU - Hsu, Liana J.
AU - Oliveri, Mary
AU - Kollman, Craig C.
AU - Dokken, Betsy B.
AU - Weinzimer, Stuart A.
AU - DeBoer, Mark D.
AU - Buckingham, Bruce A.
AU - Cherñavvsky, Daniel
AU - Wadwa, R. Paul
N1 - Funding Information:
Supported by Tandem Diabetes Care and the National Institute of Diabetes and Digestive and Kidney Diseases. Tandem Diabetes Care provided the experimental closed-loop systems used in the trial, system-related supplies including the Dexcom continuous glucose monitor and the Roche glucometer, and technical expertise.
Funding Information:
This multicenter, randomized, open-label, parallel-group trial was conducted at four pediatric diabetes centers in the United States. The protocol, available with the full text of this article at NEJM.org, was approved by a central institutional review board. Written informed consent was obtained from the parent or guardian of each patient, and assent was obtained from each patient when applicable. An investigational device exemption was approved by the FDA. An independent data and safety monitoring board established by the National Institute of Diabetes and Digestive and Kidney Diseases provided trial oversight. The first three authors and the last author wrote the first draft of the manuscript and vouch for the completeness and accuracy of the data and for the fidelity of the trial to the protocol. Funding was provided by Tandem Diabetes Care, which also provided the closed-loop systems and supplies used in the trial and provided technical expertise with respect to device issues. Representatives of Tandem Diabetes Care reviewed the manuscript before submission for publication, but the company was not otherwise involved in the design or conduct of the trial or in the analysis of the data. Additional funding was provided by the National Institute of Diabetes and Digestive and Kidney Diseases.
Publisher Copyright:
© 2020 Massachussetts Medical Society. All rights reserved.
PY - 2020/8/27
Y1 - 2020/8/27
N2 - BACKGROUND A closed-loop system of insulin delivery (also called an artificial pancreas) may improve glycemic outcomes in children with type 1 diabetes. METHODS In a 16-week, multicenter, randomized, open-label, parallel-group trial, we assigned, in a 3:1 ratio, children 6 to 13 years of age who had type 1 diabetes to receive treatment with the use of either a closed-loop system of insulin delivery (closed-loop group) or a sensor-augmented insulin pump (control group). The primary outcome was the percentage of time that the glucose level was in the target range of 70 to 180 mg per deciliter, as measured by continuous glucose monitoring. RESULTS A total of 101 children underwent randomization (78 to the closed-loop group and 23 to the control group); the glycated hemoglobin levels at baseline ranged from 5.7 to 10.1%. The mean (±SD) percentage of time that the glucose level was in the target range of 70 to 180 mg per deciliter increased from 53±17% at baseline to 67±10% (the mean over 16 weeks of treatment) in the closed-loop group and from 51±16% to 55±13% in the control group (mean adjusted difference, 11 percentage points [equivalent to 2.6 hours per day]; 95% confidence interval, 7 to 14; P<0.001). In both groups, the median percentage of time that the glucose level was below 70 mg per deciliter was low (1.6% in the closed-loop group and 1.8% in the control group). In the closed-loop group, the median percentage of time that the system was in the closed-loop mode was 93% (interquartile range, 91 to 95). No episodes of diabetic ketoacidosis or severe hypoglycemia occurred in either group. CONCLUSIONS In this 16-week trial involving children with type 1 diabetes, the glucose level was in the target range for a greater percentage of time with the use of a closed-loop system than with the use of a sensor-augmented insulin pump. (Funded by Tandem Diabetes Care and the National Institute of Diabetes and Digestive and Kidney Diseases; ClinicalTrials.gov number, NCT03844789.).
AB - BACKGROUND A closed-loop system of insulin delivery (also called an artificial pancreas) may improve glycemic outcomes in children with type 1 diabetes. METHODS In a 16-week, multicenter, randomized, open-label, parallel-group trial, we assigned, in a 3:1 ratio, children 6 to 13 years of age who had type 1 diabetes to receive treatment with the use of either a closed-loop system of insulin delivery (closed-loop group) or a sensor-augmented insulin pump (control group). The primary outcome was the percentage of time that the glucose level was in the target range of 70 to 180 mg per deciliter, as measured by continuous glucose monitoring. RESULTS A total of 101 children underwent randomization (78 to the closed-loop group and 23 to the control group); the glycated hemoglobin levels at baseline ranged from 5.7 to 10.1%. The mean (±SD) percentage of time that the glucose level was in the target range of 70 to 180 mg per deciliter increased from 53±17% at baseline to 67±10% (the mean over 16 weeks of treatment) in the closed-loop group and from 51±16% to 55±13% in the control group (mean adjusted difference, 11 percentage points [equivalent to 2.6 hours per day]; 95% confidence interval, 7 to 14; P<0.001). In both groups, the median percentage of time that the glucose level was below 70 mg per deciliter was low (1.6% in the closed-loop group and 1.8% in the control group). In the closed-loop group, the median percentage of time that the system was in the closed-loop mode was 93% (interquartile range, 91 to 95). No episodes of diabetic ketoacidosis or severe hypoglycemia occurred in either group. CONCLUSIONS In this 16-week trial involving children with type 1 diabetes, the glucose level was in the target range for a greater percentage of time with the use of a closed-loop system than with the use of a sensor-augmented insulin pump. (Funded by Tandem Diabetes Care and the National Institute of Diabetes and Digestive and Kidney Diseases; ClinicalTrials.gov number, NCT03844789.).
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U2 - 10.1056/NEJMoa2004736
DO - 10.1056/NEJMoa2004736
M3 - Article
C2 - 32846062
AN - SCOPUS:85089961333
SN - 0028-4793
VL - 383
SP - 836
EP - 845
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 9
ER -