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.
N1 - Funding Information:
The authors thank the study participants without whom this workwasnotpossible.Inaddition,theauthorsthankthemultiple teammemberswhocontributedtothesuccessfulexecutionofour study, including Molly McElwee-Malloy, Christian Wakeman, Elaine Schertz, Jill Greiner, Benton Mize, Antoine Robert, and Mary Oliveri. This study was supported by National Institutes of Health Grants DK 085623, DK 101055 to the University of Virginia and Grant DK85516 the Mayo Clinic; the Urdang Family Fund (to Y.C.K.); and JDRF to Mt. Sinai/ University of Virginia (Grant 1-SRA-2014-239-M-R). Material support was provided by Roche Diagnostics (Indianapolis, IN).
Funding Information:
Disclosure Summary: S.A.B. reports materials support from Roche Diagnostics, Inc. and materials support from DexCom during the course of the study, grants and materials support from Animas Corp., and grants from Medtronic outside the submitted work. B.P.K. reports grants from BD Medical Technology, grants from Sanofi-Aventis, personal fees from Sanofi-Aventis, nonfinancial support from Roche Diagnostics, Inc., and nonfinancial support from Tandem Diabetes Care, outside the submitted work. B.P.K. has patent no. 8,562,587, October 22, 2013, with royalties paid by Animas Corp., patent no. PCT/US12/43883, July 2012, licensed to TypeZero Technologies, and patent no. PCT/US12/43910, June 2012, licensed to TypeZero Technologies, and is a shareholder in TypeZero Technologies. M.D.B. holds patents or patent applications related to the study technology; is a consultant for Animas Corp., DexCom, Roche Diagnostics, Inc., Bayer, and Sanofi and has received research grants or study materials support from Animas Corp., BD Biosciences, DexCom, Insulet Corp., LifeScan, Inc., Sanofi, and Tandem Diabetes Care, Inc.; is a founder and equity holder of TypeZero Technologies LLC, and holds equity
Funding Information:
Financial Support: This study was supported by National Institutes of Health Grants DK 085623, DK 101055 to the University of Virginia and Grant DK85516 the Mayo Clinic; the Urdang Family Fund (to Y.C.K.); and JDRF to Mt. Sinai/ University of Virginia (Grant 1-SRA-2014-239-M-R). Material support was provided by Roche Diagnostics (Indianapolis, IN).
Publisher Copyright:
Copyright © 2017 Endocrine Society.
PY - 2017/10
Y1 - 2017/10
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 6 9.5 years; hemoglobin A1c, 7.4% 6 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 6 9.5 years; hemoglobin A1c, 7.4% 6 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.
UR - http://www.scopus.com/inward/record.url?scp=85029889798&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85029889798&partnerID=8YFLogxK
U2 - 10.1210/jc.2017-00556
DO - 10.1210/jc.2017-00556
M3 - Article
C2 - 28666360
AN - SCOPUS:85029889798
VL - 102
SP - 3674
EP - 3682
JO - Journal of Clinical Endocrinology and Metabolism
JF - Journal of Clinical Endocrinology and Metabolism
SN - 0021-972X
IS - 10
ER -