A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes

Marc D. Breton; Lauren G. Kanapka; Roy W. Beck; Laya Ekhlaspour; Gregory P. Forlenza; Eda Cengiz; Melissa Schoelwer; Katrina J. Ruedy; Emily Jost; Lori Carria; Emma Emory; Liana J. Hsu; Mary Oliveri; Craig C. Kollman; Betsy B. Dokken; Stuart A. Weinzimer; Mark D. DeBoer; Bruce A. Buckingham; Daniel Cherñavvsky; R. Paul Wadwa

doi:10.1056/NEJMoa2004736

A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes

Marc D. Breton, Lauren G. Kanapka, Roy W. Beck, Laya Ekhlaspour, Gregory P. Forlenza, Eda Cengiz, Melissa Schoelwer, Katrina J. Ruedy, Emily Jost, Lori Carria, Emma Emory, Liana J. Hsu, Mary Oliveri, Craig C. Kollman, Betsy B. Dokken, Stuart A. Weinzimer, Mark D. DeBoer, Bruce A. Buckingham, Daniel Cherñavvsky, R. Paul Wadwa

Medicine

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Abstract

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.).

Original language	English (US)
Pages (from-to)	836-845
Number of pages	10
Journal	New England Journal of Medicine
Volume	383
Issue number	9
DOIs	https://doi.org/10.1056/NEJMoa2004736
State	Published - Aug 27 2020

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General Medicine

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10.1056/NEJMoa2004736

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Breton, M. D., Kanapka, L. G., Beck, R. W., Ekhlaspour, L., Forlenza, G. P., Cengiz, E., Schoelwer, M., Ruedy, K. J., Jost, E., Carria, L., Emory, E., Hsu, L. J., Oliveri, M., Kollman, C. C., Dokken, B. B., Weinzimer, S. A., DeBoer, M. D., Buckingham, B. A., Cherñavvsky, D., & Wadwa, R. P. (2020). A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes. New England Journal of Medicine, 383(9), 836-845. https://doi.org/10.1056/NEJMoa2004736

Breton, MD, Kanapka, LG, Beck, RW, Ekhlaspour, L, Forlenza, GP, Cengiz, E, Schoelwer, M, Ruedy, KJ, Jost, E, Carria, L, Emory, E, Hsu, LJ, Oliveri, M, Kollman, CC, Dokken, BB, Weinzimer, SA, DeBoer, MD, Buckingham, BA, Cherñavvsky, D & Wadwa, RP 2020, 'A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes', New England Journal of Medicine, vol. 383, no. 9, pp. 836-845. https://doi.org/10.1056/NEJMoa2004736

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title = "A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes",

abstract = "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.).",

author = "Breton, {Marc D.} and Kanapka, {Lauren G.} and Beck, {Roy W.} and Laya Ekhlaspour and Forlenza, {Gregory P.} and Eda Cengiz and Melissa Schoelwer and Ruedy, {Katrina J.} and Emily Jost and Lori Carria and Emma Emory and Hsu, {Liana J.} and Mary Oliveri and Kollman, {Craig C.} and Dokken, {Betsy B.} and Weinzimer, {Stuart A.} and DeBoer, {Mark D.} and Buckingham, {Bruce A.} and Daniel Cher{\~n}avvsky and Wadwa, {R. Paul}",

year = "2020",

month = aug,

day = "27",

doi = "10.1056/NEJMoa2004736",

language = "English (US)",

volume = "383",

pages = "836--845",

journal = "New England Journal of Medicine",

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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

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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A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes

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