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

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.

• Authors: 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
• Journal: The lancet. Diabetes & endocrinology (Lancet Diabetes Endocrinol) Vol. 2 Issue 9 Pg. 701-9 (Sep 2014) ISSN: 2213-8595 [Electronic] England
• PMID: 24943065 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2014 Elsevier Ltd. All rights reserved.

Chemical References

• Blood Glucose
• Glycated Hemoglobin A
• Hypoglycemic Agents
• Insulin
• hemoglobin A1c protein, human

Topics

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