Overnight Closed-Loop Control Improves Glycemic Control in a Multicenter Study of Adults With Type 1 Diabetes

Sue A. Brown, Marc D. Breton, Stacey M. Anderson, Laura Kollar, Patrick Keith-Hynes, Carol J. Levy, David W. Lam, Camilla Levister, Nihat Baysal, Yogish C Kudva, Ananda Basu, Vikash Dadlani, Ling Hinshaw, Shelly McCrady-Spitzer, Daniela Bruttomesso, Roberto Visentin, Silvia Galasso, Simone Del Favero, Yenny Leal, Federico BoscariAngelo Avogaro, Claudio Cobelli, Boris P. Kovatchev

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Context: Closed-loop control (CLC) for the management of type 1 diabetes (T1D) is a novel method for optimizing glucose control, and strategies for individualized implementation are being developed.

Objective: To analyze glycemic control in an overnight CLC system designed to "reset" the patient to near-normal glycemic targets every morning.

Design: Randomized, crossover, multicenter clinical trial.

Participants: Forty-four subjects with T1D requiring insulin pump therapy.

Intervention: Sensor-augmented pump therapy (SAP) at home vs 5 nights of CLC (active from 23:00 to 07:00) in a supervised outpatient setting (research house or hotel), with a substudy of 5 nights of CLC subsequently at home.

Main Outcome Measure: The percentage of time spent in the target range (70 to 180 mg/dL measured using a continuous glucose monitor).

Results: Forty subjects (age, 45.5 ± 9.5 years; hemoglobin A1c, 7.4% ± 0.8%) completed the study. The time in the target range (70 to 180 mg/dL) significantly improved in CLC vs SAP over 24 hours (78.3% vs 71.4%; P = 0.003) and overnight (85.7% vs 67.6%; P < 0.001). The time spent in a hypoglycemic range (<70 mg/dL) decreased significantly in the CLC vs SAP group over 24 hours (2.5% vs 4.3%; P = 0.002) and overnight (0.9% vs 3.2%; P < 0.001). The mean glucose level at 07:00 was lower with CLC than with SAP (123.7 vs 145.3 mg/dL; P < 0.001). The substudy at home, involving 10 T1D subjects, showed similar trends with an increased time in target (70 to 180 mg/dL) overnight (75.2% vs 62.2%; P = 0.07) and decreased time spent in the hypoglycemic range (<70 mg/dL) overnight in CLC vs SAP (0.6% vs 3.7%; P = 0.03).

Conclusion: Overnight-only CLC increased the time in the target range over 24 hours and decreased the time in hypoglycemic range over 24 hours in a supervised outpatient setting. A pilot extension study at home showed a similar nonsignificant trend.

Original languageEnglish (US)
Pages (from-to)3674-3682
Number of pages9
JournalThe Journal of clinical endocrinology and metabolism
Volume102
Issue number10
DOIs
StatePublished - Oct 1 2017

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Medical problems
Type 1 Diabetes Mellitus
Multicenter Studies
Pumps
Hypoglycemic Agents
Glucose
Sensors
Outpatients
Therapeutics
Group Psychotherapy
Cross-Over Studies
Closed loop control systems
Hemoglobins
Hotels
Outcome Assessment (Health Care)
Clinical Trials
Insulin
Research

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism
  • Biochemistry
  • Endocrinology
  • Clinical Biochemistry
  • Biochemistry, medical

Cite this

Brown, S. A., Breton, M. D., Anderson, S. M., Kollar, L., Keith-Hynes, P., Levy, C. J., ... Kovatchev, B. P. (2017). Overnight Closed-Loop Control Improves Glycemic Control in a Multicenter Study of Adults With Type 1 Diabetes. The Journal of clinical endocrinology and metabolism, 102(10), 3674-3682. https://doi.org/10.1210/jc.2017-00556

Overnight Closed-Loop Control Improves Glycemic Control in a Multicenter Study of Adults With Type 1 Diabetes. / Brown, Sue A.; Breton, Marc D.; Anderson, Stacey M.; Kollar, Laura; Keith-Hynes, Patrick; Levy, Carol J.; Lam, David W.; Levister, Camilla; Baysal, Nihat; Kudva, Yogish C; Basu, Ananda; Dadlani, Vikash; Hinshaw, Ling; McCrady-Spitzer, Shelly; Bruttomesso, Daniela; Visentin, Roberto; Galasso, Silvia; Del Favero, Simone; Leal, Yenny; Boscari, Federico; Avogaro, Angelo; Cobelli, Claudio; Kovatchev, Boris P.

In: The Journal of clinical endocrinology and metabolism, Vol. 102, No. 10, 01.10.2017, p. 3674-3682.

Research output: Contribution to journalArticle

Brown, SA, Breton, MD, Anderson, SM, Kollar, L, Keith-Hynes, P, Levy, CJ, Lam, DW, Levister, C, Baysal, N, Kudva, YC, Basu, A, Dadlani, V, Hinshaw, L, McCrady-Spitzer, S, Bruttomesso, D, Visentin, R, Galasso, S, Del Favero, S, Leal, Y, Boscari, F, Avogaro, A, Cobelli, C & Kovatchev, BP 2017, 'Overnight Closed-Loop Control Improves Glycemic Control in a Multicenter Study of Adults With Type 1 Diabetes', The Journal of clinical endocrinology and metabolism, vol. 102, no. 10, pp. 3674-3682. https://doi.org/10.1210/jc.2017-00556
Brown, Sue A. ; Breton, Marc D. ; Anderson, Stacey M. ; Kollar, Laura ; Keith-Hynes, Patrick ; Levy, Carol J. ; Lam, David W. ; Levister, Camilla ; Baysal, Nihat ; Kudva, Yogish C ; Basu, Ananda ; Dadlani, Vikash ; Hinshaw, Ling ; McCrady-Spitzer, Shelly ; Bruttomesso, Daniela ; Visentin, Roberto ; Galasso, Silvia ; Del Favero, Simone ; Leal, Yenny ; Boscari, Federico ; Avogaro, Angelo ; Cobelli, Claudio ; Kovatchev, Boris P. / Overnight Closed-Loop Control Improves Glycemic Control in a Multicenter Study of Adults With Type 1 Diabetes. In: The Journal of clinical endocrinology and metabolism. 2017 ; Vol. 102, No. 10. pp. 3674-3682.
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abstract = "Context: Closed-loop control (CLC) for the management of type 1 diabetes (T1D) is a novel method for optimizing glucose control, and strategies for individualized implementation are being developed.Objective: To analyze glycemic control in an overnight CLC system designed to {"}reset{"} the patient to near-normal glycemic targets every morning.Design: Randomized, crossover, multicenter clinical trial.Participants: Forty-four subjects with T1D requiring insulin pump therapy.Intervention: Sensor-augmented pump therapy (SAP) at home vs 5 nights of CLC (active from 23:00 to 07:00) in a supervised outpatient setting (research house or hotel), with a substudy of 5 nights of CLC subsequently at home.Main Outcome Measure: The percentage of time spent in the target range (70 to 180 mg/dL measured using a continuous glucose monitor).Results: Forty subjects (age, 45.5 ± 9.5 years; hemoglobin A1c, 7.4{\%} ± 0.8{\%}) completed the study. The time in the target range (70 to 180 mg/dL) significantly improved in CLC vs SAP over 24 hours (78.3{\%} vs 71.4{\%}; P = 0.003) and overnight (85.7{\%} vs 67.6{\%}; P < 0.001). The time spent in a hypoglycemic range (<70 mg/dL) decreased significantly in the CLC vs SAP group over 24 hours (2.5{\%} vs 4.3{\%}; P = 0.002) and overnight (0.9{\%} vs 3.2{\%}; P < 0.001). The mean glucose level at 07:00 was lower with CLC than with SAP (123.7 vs 145.3 mg/dL; P < 0.001). The substudy at home, involving 10 T1D subjects, showed similar trends with an increased time in target (70 to 180 mg/dL) overnight (75.2{\%} vs 62.2{\%}; P = 0.07) and decreased time spent in the hypoglycemic range (<70 mg/dL) overnight in CLC vs SAP (0.6{\%} vs 3.7{\%}; P = 0.03).Conclusion: Overnight-only CLC increased the time in the target range over 24 hours and decreased the time in hypoglycemic range over 24 hours in a supervised outpatient setting. A pilot extension study at home showed a similar nonsignificant trend.",
author = "Brown, {Sue A.} and Breton, {Marc D.} and Anderson, {Stacey M.} and Laura Kollar and Patrick Keith-Hynes and Levy, {Carol J.} and Lam, {David W.} and Camilla Levister and Nihat Baysal and Kudva, {Yogish C} and Ananda Basu and Vikash Dadlani and Ling Hinshaw and Shelly McCrady-Spitzer and Daniela Bruttomesso and Roberto Visentin and Silvia Galasso and {Del Favero}, Simone and Yenny Leal and Federico Boscari and Angelo Avogaro and Claudio Cobelli and Kovatchev, {Boris P.}",
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TY - JOUR

T1 - Overnight Closed-Loop Control Improves Glycemic Control in a Multicenter Study of Adults With Type 1 Diabetes

AU - Brown, Sue A.

AU - Breton, Marc D.

AU - Anderson, Stacey M.

AU - Kollar, Laura

AU - Keith-Hynes, Patrick

AU - Levy, Carol J.

AU - Lam, David W.

AU - Levister, Camilla

AU - Baysal, Nihat

AU - Kudva, Yogish C

AU - Basu, Ananda

AU - Dadlani, Vikash

AU - Hinshaw, Ling

AU - McCrady-Spitzer, Shelly

AU - Bruttomesso, Daniela

AU - Visentin, Roberto

AU - Galasso, Silvia

AU - Del Favero, Simone

AU - Leal, Yenny

AU - Boscari, Federico

AU - Avogaro, Angelo

AU - Cobelli, Claudio

AU - Kovatchev, Boris P.

PY - 2017/10/1

Y1 - 2017/10/1

N2 - Context: Closed-loop control (CLC) for the management of type 1 diabetes (T1D) is a novel method for optimizing glucose control, and strategies for individualized implementation are being developed.Objective: To analyze glycemic control in an overnight CLC system designed to "reset" the patient to near-normal glycemic targets every morning.Design: Randomized, crossover, multicenter clinical trial.Participants: Forty-four subjects with T1D requiring insulin pump therapy.Intervention: Sensor-augmented pump therapy (SAP) at home vs 5 nights of CLC (active from 23:00 to 07:00) in a supervised outpatient setting (research house or hotel), with a substudy of 5 nights of CLC subsequently at home.Main Outcome Measure: The percentage of time spent in the target range (70 to 180 mg/dL measured using a continuous glucose monitor).Results: Forty subjects (age, 45.5 ± 9.5 years; hemoglobin A1c, 7.4% ± 0.8%) completed the study. The time in the target range (70 to 180 mg/dL) significantly improved in CLC vs SAP over 24 hours (78.3% vs 71.4%; P = 0.003) and overnight (85.7% vs 67.6%; P < 0.001). The time spent in a hypoglycemic range (<70 mg/dL) decreased significantly in the CLC vs SAP group over 24 hours (2.5% vs 4.3%; P = 0.002) and overnight (0.9% vs 3.2%; P < 0.001). The mean glucose level at 07:00 was lower with CLC than with SAP (123.7 vs 145.3 mg/dL; P < 0.001). The substudy at home, involving 10 T1D subjects, showed similar trends with an increased time in target (70 to 180 mg/dL) overnight (75.2% vs 62.2%; P = 0.07) and decreased time spent in the hypoglycemic range (<70 mg/dL) overnight in CLC vs SAP (0.6% vs 3.7%; P = 0.03).Conclusion: Overnight-only CLC increased the time in the target range over 24 hours and decreased the time in hypoglycemic range over 24 hours in a supervised outpatient setting. A pilot extension study at home showed a similar nonsignificant trend.

AB - Context: Closed-loop control (CLC) for the management of type 1 diabetes (T1D) is a novel method for optimizing glucose control, and strategies for individualized implementation are being developed.Objective: To analyze glycemic control in an overnight CLC system designed to "reset" the patient to near-normal glycemic targets every morning.Design: Randomized, crossover, multicenter clinical trial.Participants: Forty-four subjects with T1D requiring insulin pump therapy.Intervention: Sensor-augmented pump therapy (SAP) at home vs 5 nights of CLC (active from 23:00 to 07:00) in a supervised outpatient setting (research house or hotel), with a substudy of 5 nights of CLC subsequently at home.Main Outcome Measure: The percentage of time spent in the target range (70 to 180 mg/dL measured using a continuous glucose monitor).Results: Forty subjects (age, 45.5 ± 9.5 years; hemoglobin A1c, 7.4% ± 0.8%) completed the study. The time in the target range (70 to 180 mg/dL) significantly improved in CLC vs SAP over 24 hours (78.3% vs 71.4%; P = 0.003) and overnight (85.7% vs 67.6%; P < 0.001). The time spent in a hypoglycemic range (<70 mg/dL) decreased significantly in the CLC vs SAP group over 24 hours (2.5% vs 4.3%; P = 0.002) and overnight (0.9% vs 3.2%; P < 0.001). The mean glucose level at 07:00 was lower with CLC than with SAP (123.7 vs 145.3 mg/dL; P < 0.001). The substudy at home, involving 10 T1D subjects, showed similar trends with an increased time in target (70 to 180 mg/dL) overnight (75.2% vs 62.2%; P = 0.07) and decreased time spent in the hypoglycemic range (<70 mg/dL) overnight in CLC vs SAP (0.6% vs 3.7%; P = 0.03).Conclusion: Overnight-only CLC increased the time in the target range over 24 hours and decreased the time in hypoglycemic range over 24 hours in a supervised outpatient setting. A pilot extension study at home showed a similar nonsignificant trend.

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