Overnight closed-loop insulin delivery in young people with type 1 diabetes: a free-living, randomized clinical trial

Roman Hovorka; Daniela Elleri; Hood Thabit; Janet M Allen; Lalantha Leelarathna; Ranna El-Khairi; Kavita Kumareswaran; Karen Caldwell; Peter Calhoun; Craig Kollman; Helen R Murphy; Carlo L Acerini; Malgorzata E Wilinska; Marianna Nodale; David B Dunger

doi:10.2337/dc13-2644

Overnight closed-loop insulin delivery in young people with type 1 diabetes: a free-living, randomized clinical trial

Roman Hovorka, Daniela Elleri, Hood Thabit, Janet M Allen, Lalantha Leelarathna, Ranna El-Khairi, Kavita Kumareswaran, Karen Caldwell, Peter Calhoun, Craig Kollman, Helen R Murphy, Carlo L Acerini, Malgorzata E Wilinska, Marianna Nodale, David B Dunger

Research output: Contribution to journal › Article › peer-review

180 Citations (SciVal)

Abstract

OBJECTIVE: To evaluate feasibility, safety, and efficacy of overnight closed-loop insulin delivery in free-living youth with type 1 diabetes.

RESEARCH DESIGN AND METHODS: Overnight closed loop was evaluated at home by 16 pump-treated adolescents with type 1 diabetes aged 12-18 years. Over a 3-week period, overnight insulin delivery was directed by a closed-loop system, and on another 3-week period sensor-augmented therapy was applied. The order of interventions was random. The primary end point was time when adjusted sensor glucose was between 3.9 and 8.0 mmol/L from 2300 to 0700 h.

RESULTS: Closed loop was constantly applied over at least 4 h on 269 nights (80%); sensor data were collected over at least 4 h on 282 control nights (84%). Closed loop increased time spent with glucose in target by a median 15% (interquartile range -9 to 43; P < 0.001). Mean overnight glucose was reduced by a mean 14 (SD 58) mg/dL (P < 0.001). Time when glucose was <70 mg/dL was low in both groups, but nights with glucose <63 mg/dL for at least 20 min were less frequent during closed loop (10 vs. 17%; P = 0.01). Despite lower total daily insulin doses by a median 2.3 (interquartile range -4.7 to 9.3) units (P = 0.009), overall 24-h glucose was reduced by a mean 9 (SD 41) mg/dL (P = 0.006) during closed loop.

CONCLUSIONS: Unsupervised home use of overnight closed loop in adolescents with type 1 diabetes is safe and feasible. Glucose control was improved during the day and night with fewer episodes of nocturnal hypoglycemia.

Original language	English
Pages (from-to)	1204-1211
Number of pages	8
Journal	Diabetes Care
Volume	37
Issue number	5
DOIs	https://doi.org/10.2337/dc13-2644
Publication status	Published - May 2014

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.2337/dc13-2644Licence: CC BY-NC-ND

Cite this

Hovorka, R., Elleri, D., Thabit, H., Allen, J. M., Leelarathna, L., El-Khairi, R., Kumareswaran, K., Caldwell, K., Calhoun, P., Kollman, C., Murphy, H. R., Acerini, C. L., Wilinska, M. E., Nodale, M., & Dunger, D. B. (2014). Overnight closed-loop insulin delivery in young people with type 1 diabetes: a free-living, randomized clinical trial. Diabetes Care, 37(5), 1204-1211. https://doi.org/10.2337/dc13-2644

@article{0a117515cfd94425b4a027f1ed70c83e,

title = "Overnight closed-loop insulin delivery in young people with type 1 diabetes: a free-living, randomized clinical trial",

abstract = "OBJECTIVE: To evaluate feasibility, safety, and efficacy of overnight closed-loop insulin delivery in free-living youth with type 1 diabetes. RESEARCH DESIGN AND METHODS: Overnight closed loop was evaluated at home by 16 pump-treated adolescents with type 1 diabetes aged 12-18 years. Over a 3-week period, overnight insulin delivery was directed by a closed-loop system, and on another 3-week period sensor-augmented therapy was applied. The order of interventions was random. The primary end point was time when adjusted sensor glucose was between 3.9 and 8.0 mmol/L from 2300 to 0700 h. RESULTS: Closed loop was constantly applied over at least 4 h on 269 nights (80%); sensor data were collected over at least 4 h on 282 control nights (84%). Closed loop increased time spent with glucose in target by a median 15% (interquartile range -9 to 43; P < 0.001). Mean overnight glucose was reduced by a mean 14 (SD 58) mg/dL (P < 0.001). Time when glucose was <70 mg/dL was low in both groups, but nights with glucose <63 mg/dL for at least 20 min were less frequent during closed loop (10 vs. 17%; P = 0.01). Despite lower total daily insulin doses by a median 2.3 (interquartile range -4.7 to 9.3) units (P = 0.009), overall 24-h glucose was reduced by a mean 9 (SD 41) mg/dL (P = 0.006) during closed loop. CONCLUSIONS: Unsupervised home use of overnight closed loop in adolescents with type 1 diabetes is safe and feasible. Glucose control was improved during the day and night with fewer episodes of nocturnal hypoglycemia. ",

author = "Roman Hovorka and Daniela Elleri and Hood Thabit and Allen, {Janet M} and Lalantha Leelarathna and Ranna El-Khairi and Kavita Kumareswaran and Karen Caldwell and Peter Calhoun and Craig Kollman and Murphy, {Helen R} and Acerini, {Carlo L} and Wilinska, {Malgorzata E} and Marianna Nodale and Dunger, {David B}",

note = "Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/licenses/by-nc-nd/3.0/ for details.",

year = "2014",

month = may,

doi = "10.2337/dc13-2644",

language = "English",

volume = "37",

pages = "1204--1211",

journal = "Diabetes Care",

issn = "0149-5992",

publisher = "American Diabetes Association Inc.",

number = "5",

}

Hovorka, R, Elleri, D, Thabit, H, Allen, JM, Leelarathna, L, El-Khairi, R, Kumareswaran, K, Caldwell, K, Calhoun, P, Kollman, C, Murphy, HR, Acerini, CL, Wilinska, ME, Nodale, M & Dunger, DB 2014, 'Overnight closed-loop insulin delivery in young people with type 1 diabetes: a free-living, randomized clinical trial', Diabetes Care, vol. 37, no. 5, pp. 1204-1211. https://doi.org/10.2337/dc13-2644

TY - JOUR

T1 - Overnight closed-loop insulin delivery in young people with type 1 diabetes

T2 - a free-living, randomized clinical trial

AU - Hovorka, Roman

AU - Elleri, Daniela

AU - Thabit, Hood

AU - Allen, Janet M

AU - Leelarathna, Lalantha

AU - El-Khairi, Ranna

AU - Kumareswaran, Kavita

AU - Caldwell, Karen

AU - Calhoun, Peter

AU - Kollman, Craig

AU - Murphy, Helen R

AU - Acerini, Carlo L

AU - Wilinska, Malgorzata E

AU - Nodale, Marianna

AU - Dunger, David B

N1 - Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/licenses/by-nc-nd/3.0/ for details.

PY - 2014/5

Y1 - 2014/5

N2 - OBJECTIVE: To evaluate feasibility, safety, and efficacy of overnight closed-loop insulin delivery in free-living youth with type 1 diabetes. RESEARCH DESIGN AND METHODS: Overnight closed loop was evaluated at home by 16 pump-treated adolescents with type 1 diabetes aged 12-18 years. Over a 3-week period, overnight insulin delivery was directed by a closed-loop system, and on another 3-week period sensor-augmented therapy was applied. The order of interventions was random. The primary end point was time when adjusted sensor glucose was between 3.9 and 8.0 mmol/L from 2300 to 0700 h. RESULTS: Closed loop was constantly applied over at least 4 h on 269 nights (80%); sensor data were collected over at least 4 h on 282 control nights (84%). Closed loop increased time spent with glucose in target by a median 15% (interquartile range -9 to 43; P < 0.001). Mean overnight glucose was reduced by a mean 14 (SD 58) mg/dL (P < 0.001). Time when glucose was <70 mg/dL was low in both groups, but nights with glucose <63 mg/dL for at least 20 min were less frequent during closed loop (10 vs. 17%; P = 0.01). Despite lower total daily insulin doses by a median 2.3 (interquartile range -4.7 to 9.3) units (P = 0.009), overall 24-h glucose was reduced by a mean 9 (SD 41) mg/dL (P = 0.006) during closed loop. CONCLUSIONS: Unsupervised home use of overnight closed loop in adolescents with type 1 diabetes is safe and feasible. Glucose control was improved during the day and night with fewer episodes of nocturnal hypoglycemia.

AB - OBJECTIVE: To evaluate feasibility, safety, and efficacy of overnight closed-loop insulin delivery in free-living youth with type 1 diabetes. RESEARCH DESIGN AND METHODS: Overnight closed loop was evaluated at home by 16 pump-treated adolescents with type 1 diabetes aged 12-18 years. Over a 3-week period, overnight insulin delivery was directed by a closed-loop system, and on another 3-week period sensor-augmented therapy was applied. The order of interventions was random. The primary end point was time when adjusted sensor glucose was between 3.9 and 8.0 mmol/L from 2300 to 0700 h. RESULTS: Closed loop was constantly applied over at least 4 h on 269 nights (80%); sensor data were collected over at least 4 h on 282 control nights (84%). Closed loop increased time spent with glucose in target by a median 15% (interquartile range -9 to 43; P < 0.001). Mean overnight glucose was reduced by a mean 14 (SD 58) mg/dL (P < 0.001). Time when glucose was <70 mg/dL was low in both groups, but nights with glucose <63 mg/dL for at least 20 min were less frequent during closed loop (10 vs. 17%; P = 0.01). Despite lower total daily insulin doses by a median 2.3 (interquartile range -4.7 to 9.3) units (P = 0.009), overall 24-h glucose was reduced by a mean 9 (SD 41) mg/dL (P = 0.006) during closed loop. CONCLUSIONS: Unsupervised home use of overnight closed loop in adolescents with type 1 diabetes is safe and feasible. Glucose control was improved during the day and night with fewer episodes of nocturnal hypoglycemia.

U2 - 10.2337/dc13-2644

DO - 10.2337/dc13-2644

M3 - Article

C2 - 24757227

SN - 0149-5992

VL - 37

SP - 1204

EP - 1211

JO - Diabetes Care

JF - Diabetes Care

IS - 5

ER -