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Randomized Controlled Trial
. 2017 Oct 1;102(10):3674-3682.
doi: 10.1210/jc.2017-00556.

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

Sue A Brown  1 , Marc D Breton  1 , Stacey M Anderson  1 , Laura Kollar  1 , Patrick Keith-Hynes  2 , Carol J Levy  3 , David W Lam  3 , Camilla Levister  3 , Nihat Baysal  4 , Yogish C Kudva  5 , Ananda Basu  5 , Vikash Dadlani  5 , Ling Hinshaw  5 , Shelly McCrady-Spitzer  5 , Daniela Bruttomesso  6 , Roberto Visentin  7 , Silvia Galasso  6 , Simone Del Favero  7 , Yenny Leal  7 , Federico Boscari  6 , Angelo Avogaro  6 , Claudio Cobelli  7 , Boris P Kovatchev  1
Affiliations
Randomized Controlled Trial

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

Sue A Brown et al. J Clin Endocrinol Metab. .

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.

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Figures

Figure 1.
Figure 1.
Time spent in target range of 70 to 180 mg/dL (median and interquartile range) measured by CGM for 24 hours and overnight only (11 pm to 7 am). Double dagger indicates outlier.
Figure 2.
Figure 2.
Time spent in hypoglycemia range (<70 mg/dL; median and interquartile range) measured by CGM for 24 hours and overnight only (11 pm to 7 am). Plus signs indicate outliers.
Figure 3.
Figure 3.
CGM glucose levels overnight (11 pm to 7 am) in SAP therapy compared with CLC (mean and interquartile range).
See this image and copyright information in PMC

References

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