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 language | English (US) |
|---|---|
| Pages (from-to) | 3674-3682 |
| Number of pages | 9 |
| Journal | The Journal of clinical endocrinology and metabolism |
| Volume | 102 |
| Issue number | 10 |
| DOIs | |
| State | Published - Oct 1 2017 |
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ASJC Scopus subject areas
- Endocrinology, Diabetes and Metabolism
- Biochemistry
- Endocrinology
- Clinical Biochemistry
- Biochemistry, medical
Cite this
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 journal › Article
}
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.
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 -