Home use of closed-loop insulin delivery for overnight glucose control in adults with type 1 diabetes: a 4-week, multicentre, randomised crossover study

Hood Thabit; Alexandra Lubina-Solomon; Marietta Stadler; Lalantha Leelarathna; Emma Walkinshaw; Andrew Pernet; Janet M Allen; Ahmed Iqbal; Pratik Choudhary; Kavita Kumareswaran; Marianna Nodale; Chloe Nisbet; Malgorzata E Wilinska; Katharine D Barnard; David B Dunger; Simon R Heller; Stephanie A Amiel; Mark L Evans; Roman Hovorka

doi:10.1016/S2213-8587(14)70114-7

Home use of closed-loop insulin delivery for overnight glucose control in adults with type 1 diabetes: a 4-week, multicentre, randomised crossover study

Hood Thabit
, Alexandra Lubina-Solomon
, Marietta Stadler
, Lalantha Leelarathna
, Emma Walkinshaw
, Andrew Pernet
, Janet M Allen
, Ahmed Iqbal
, Pratik Choudhary
, Kavita Kumareswaran
, Marianna Nodale
, Chloe Nisbet
, Malgorzata E Wilinska
, Katharine D Barnard
, David B Dunger
, Simon R Heller
, Stephanie A Amiel
, Mark L Evans
, Roman Hovorka

King's College London
The University of Sheffield
Chancellor, Masters and Scholars of the University of Cambridge
Southampton Solent University

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

Abstract

BACKGROUND: Closed-loop insulin delivery is a promising option to improve glycaemic control and reduce the risk of hypoglycaemia. We aimed to assess whether overnight home use of automated closed-loop insulin delivery would improve glucose control.

METHODS: We did this open-label, multicentre, randomised controlled, crossover study between Dec 1, 2012, and Dec 23, 2014, recruiting patients from three centres in the UK. Patients aged 18 years or older with type 1 diabetes were randomly assigned to receive 4 weeks of overnight closed-loop insulin delivery (using a model-predictive control algorithm to direct insulin delivery), then 4 weeks of insulin pump therapy (in which participants used real-time display of continuous glucose monitoring independent of their pumps as control), or vice versa. Allocation to initial treatment group was by computer-generated permuted block randomisation. Each treatment period was separated by a 3-4 week washout period. The primary outcome was time spent in the target glucose range of 3·9-8·0 mmol/L between 0000 h and 0700 h. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01440140.

FINDINGS: We randomly assigned 25 participants to initial treatment in either the closed-loop group or the control group, patients were later crossed over into the other group; one patient from the closed-loop group withdrew consent after randomisation, and data for 24 patients were analysed. Closed loop was used over a median of 8·3 h (IQR 6·0-9·6) on 555 (86%) of 644 nights. The proportion of time when overnight glucose was in target range was significantly higher during the closed-loop period compared to during the control period (mean difference between groups 13·5%, 95% CI 7·3-19·7; p=0·0002). We noted no severe hypoglycaemic episodes during the control period compared with two episodes during the closed-loop period; these episodes were not related to closed-loop algorithm instructions.

INTERPRETATION: Unsupervised overnight closed-loop insulin delivery at home is feasible and could improve glucose control in adults with type 1 diabetes.

FUNDING: Diabetes UK.

Original language	English
Pages (from-to)	701-9
Number of pages	9
Journal	The Lancet Diabetes and Endocrinology
Volume	2
Issue number	9
DOIs	https://doi.org/10.1016/S2213-8587(14)70114-7
Publication status	Published - Sept 2014

UN SDGs

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

SDG 3 Good Health and Well-being

Keywords

Adult
Algorithms
Blood Glucose/drug effects
Cross-Over Studies
Diabetes Mellitus, Type 1/blood
Female
Glycated Hemoglobin A/drug effects
Humans
Hypoglycemia/prevention & control
Hypoglycemic Agents/administration & dosage
Insulin/administration & dosage
Insulin Infusion Systems
Male
Middle Aged
Pancreas, Artificial
Treatment Outcome
United Kingdom/epidemiology

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10.1016/S2213-8587(14)70114-7

Cite this

Thabit, H., Lubina-Solomon, A., Stadler, M., Leelarathna, L., Walkinshaw, E., Pernet, A., Allen, J. M., Iqbal, A., Choudhary, P., Kumareswaran, K., Nodale, M., Nisbet, C., Wilinska, M. E., Barnard, K. D., Dunger, D. B., Heller, S. R., Amiel, S. A., Evans, M. L., & Hovorka, R. (2014). Home use of closed-loop insulin delivery for overnight glucose control in adults with type 1 diabetes: a 4-week, multicentre, randomised crossover study. The Lancet Diabetes and Endocrinology, 2(9), 701-9. https://doi.org/10.1016/S2213-8587(14)70114-7

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abstract = "BACKGROUND: Closed-loop insulin delivery is a promising option to improve glycaemic control and reduce the risk of hypoglycaemia. We aimed to assess whether overnight home use of automated closed-loop insulin delivery would improve glucose control.METHODS: We did this open-label, multicentre, randomised controlled, crossover study between Dec 1, 2012, and Dec 23, 2014, recruiting patients from three centres in the UK. Patients aged 18 years or older with type 1 diabetes were randomly assigned to receive 4 weeks of overnight closed-loop insulin delivery (using a model-predictive control algorithm to direct insulin delivery), then 4 weeks of insulin pump therapy (in which participants used real-time display of continuous glucose monitoring independent of their pumps as control), or vice versa. Allocation to initial treatment group was by computer-generated permuted block randomisation. Each treatment period was separated by a 3-4 week washout period. The primary outcome was time spent in the target glucose range of 3·9-8·0 mmol/L between 0000 h and 0700 h. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01440140.FINDINGS: We randomly assigned 25 participants to initial treatment in either the closed-loop group or the control group, patients were later crossed over into the other group; one patient from the closed-loop group withdrew consent after randomisation, and data for 24 patients were analysed. Closed loop was used over a median of 8·3 h (IQR 6·0-9·6) on 555 (86\%) of 644 nights. The proportion of time when overnight glucose was in target range was significantly higher during the closed-loop period compared to during the control period (mean difference between groups 13·5\%, 95\% CI 7·3-19·7; p=0·0002). We noted no severe hypoglycaemic episodes during the control period compared with two episodes during the closed-loop period; these episodes were not related to closed-loop algorithm instructions.INTERPRETATION: Unsupervised overnight closed-loop insulin delivery at home is feasible and could improve glucose control in adults with type 1 diabetes.FUNDING: Diabetes UK.",

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author = "Hood Thabit and Alexandra Lubina-Solomon and Marietta Stadler and Lalantha Leelarathna and Emma Walkinshaw and Andrew Pernet and Allen, \{Janet M\} and Ahmed Iqbal and Pratik Choudhary and Kavita Kumareswaran and Marianna Nodale and Chloe Nisbet and Wilinska, \{Malgorzata E\} and Barnard, \{Katharine D\} and Dunger, \{David B\} and Heller, \{Simon R\} and Amiel, \{Stephanie A\} and Evans, \{Mark L\} and Roman Hovorka",

year = "2014",

month = sep,

doi = "10.1016/S2213-8587(14)70114-7",

language = "English",

volume = "2",

pages = "701--9",

journal = "The Lancet Diabetes and Endocrinology",

issn = "2213-8587",

publisher = "Elsevier BV",

number = "9",

}

Thabit, H, Lubina-Solomon, A, Stadler, M, Leelarathna, L, Walkinshaw, E, Pernet, A, Allen, JM, Iqbal, A, Choudhary, P, Kumareswaran, K, Nodale, M, Nisbet, C, Wilinska, ME, Barnard, KD, Dunger, DB, Heller, SR, Amiel, SA, Evans, ML & Hovorka, R 2014, 'Home use of closed-loop insulin delivery for overnight glucose control in adults with type 1 diabetes: a 4-week, multicentre, randomised crossover study', The Lancet Diabetes and Endocrinology, vol. 2, no. 9, pp. 701-9. https://doi.org/10.1016/S2213-8587(14)70114-7

TY - JOUR

T1 - Home use of closed-loop insulin delivery for overnight glucose control in adults with type 1 diabetes

T2 - a 4-week, multicentre, randomised crossover study

AU - Thabit, Hood

AU - Lubina-Solomon, Alexandra

AU - Stadler, Marietta

AU - Leelarathna, Lalantha

AU - Walkinshaw, Emma

AU - Pernet, Andrew

AU - Allen, Janet M

AU - Iqbal, Ahmed

AU - Choudhary, Pratik

AU - Kumareswaran, Kavita

AU - Nodale, Marianna

AU - Nisbet, Chloe

AU - Wilinska, Malgorzata E

AU - Barnard, Katharine D

AU - Dunger, David B

AU - Heller, Simon R

AU - Amiel, Stephanie A

AU - Evans, Mark L

AU - Hovorka, Roman

PY - 2014/9

Y1 - 2014/9

N2 - BACKGROUND: Closed-loop insulin delivery is a promising option to improve glycaemic control and reduce the risk of hypoglycaemia. We aimed to assess whether overnight home use of automated closed-loop insulin delivery would improve glucose control.METHODS: We did this open-label, multicentre, randomised controlled, crossover study between Dec 1, 2012, and Dec 23, 2014, recruiting patients from three centres in the UK. Patients aged 18 years or older with type 1 diabetes were randomly assigned to receive 4 weeks of overnight closed-loop insulin delivery (using a model-predictive control algorithm to direct insulin delivery), then 4 weeks of insulin pump therapy (in which participants used real-time display of continuous glucose monitoring independent of their pumps as control), or vice versa. Allocation to initial treatment group was by computer-generated permuted block randomisation. Each treatment period was separated by a 3-4 week washout period. The primary outcome was time spent in the target glucose range of 3·9-8·0 mmol/L between 0000 h and 0700 h. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01440140.FINDINGS: We randomly assigned 25 participants to initial treatment in either the closed-loop group or the control group, patients were later crossed over into the other group; one patient from the closed-loop group withdrew consent after randomisation, and data for 24 patients were analysed. Closed loop was used over a median of 8·3 h (IQR 6·0-9·6) on 555 (86%) of 644 nights. The proportion of time when overnight glucose was in target range was significantly higher during the closed-loop period compared to during the control period (mean difference between groups 13·5%, 95% CI 7·3-19·7; p=0·0002). We noted no severe hypoglycaemic episodes during the control period compared with two episodes during the closed-loop period; these episodes were not related to closed-loop algorithm instructions.INTERPRETATION: Unsupervised overnight closed-loop insulin delivery at home is feasible and could improve glucose control in adults with type 1 diabetes.FUNDING: Diabetes UK.

AB - BACKGROUND: Closed-loop insulin delivery is a promising option to improve glycaemic control and reduce the risk of hypoglycaemia. We aimed to assess whether overnight home use of automated closed-loop insulin delivery would improve glucose control.METHODS: We did this open-label, multicentre, randomised controlled, crossover study between Dec 1, 2012, and Dec 23, 2014, recruiting patients from three centres in the UK. Patients aged 18 years or older with type 1 diabetes were randomly assigned to receive 4 weeks of overnight closed-loop insulin delivery (using a model-predictive control algorithm to direct insulin delivery), then 4 weeks of insulin pump therapy (in which participants used real-time display of continuous glucose monitoring independent of their pumps as control), or vice versa. Allocation to initial treatment group was by computer-generated permuted block randomisation. Each treatment period was separated by a 3-4 week washout period. The primary outcome was time spent in the target glucose range of 3·9-8·0 mmol/L between 0000 h and 0700 h. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01440140.FINDINGS: We randomly assigned 25 participants to initial treatment in either the closed-loop group or the control group, patients were later crossed over into the other group; one patient from the closed-loop group withdrew consent after randomisation, and data for 24 patients were analysed. Closed loop was used over a median of 8·3 h (IQR 6·0-9·6) on 555 (86%) of 644 nights. The proportion of time when overnight glucose was in target range was significantly higher during the closed-loop period compared to during the control period (mean difference between groups 13·5%, 95% CI 7·3-19·7; p=0·0002). We noted no severe hypoglycaemic episodes during the control period compared with two episodes during the closed-loop period; these episodes were not related to closed-loop algorithm instructions.INTERPRETATION: Unsupervised overnight closed-loop insulin delivery at home is feasible and could improve glucose control in adults with type 1 diabetes.FUNDING: Diabetes UK.

KW - Adult

KW - Algorithms

KW - Blood Glucose/drug effects

KW - Cross-Over Studies

KW - Diabetes Mellitus, Type 1/blood

KW - Female

KW - Glycated Hemoglobin A/drug effects

KW - Humans

KW - Hypoglycemia/prevention & control

KW - Hypoglycemic Agents/administration & dosage

KW - Insulin/administration & dosage

KW - Insulin Infusion Systems

KW - Male

KW - Middle Aged

KW - Pancreas, Artificial

KW - Treatment Outcome

KW - United Kingdom/epidemiology

U2 - 10.1016/S2213-8587(14)70114-7

DO - 10.1016/S2213-8587(14)70114-7

M3 - Article

C2 - 24943065

SN - 2213-8587

VL - 2

SP - 701

EP - 709

JO - The Lancet Diabetes and Endocrinology

JF - The Lancet Diabetes and Endocrinology

IS - 9

ER -

Home use of closed-loop insulin delivery for overnight glucose control in adults with type 1 diabetes: a 4-week, multicentre, randomised crossover study

Abstract

UN SDGs

Keywords

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