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Home use of closed-loop insulin delivery for overnight glucose control in adults with type 1 diabetes: a 4-week, multicentre, randomised crossover study.
| Content Provider | World Health Organization (WHO)-Global Index Medicus |
|---|---|
| Author | Thabit, Hood Lubina-Solomon, Alexandra Stadler, Marietta Leelarathna, Lalantha Walkinshaw, Emma Pernet, Andrew Allen, Janet M. Iqbal, Ahmed Choudhary, Pratik Kumareswaran, Kavita Nodale, Marianna Nisbet, Chloe Wilinska, Malgorzata E. Barnard, Katharine D. Dunger, David B. Heller, Simon R. Amiel, Stephanie A. Evans, Mark L. Hovorka, Roman |
| Description | Country affiliation: United kingdom Author Affiliation: Thabit H ( Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.); Lubina-Solomon A ( Academic Unit of Diabetes, Endocrinology and Metabolism, Department of Human Metabolism, University of Sheffield, Sheffield, UK.); Stadler M ( Diabetes Research Group, King's College London, London, UK.); Leelarathna L ( Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.); Walkinshaw E ( Academic Unit of Diabetes, Endocrinology and Metabolism, Department of Human Metabolism, University of Sheffield, Sheffield, UK.); Pernet A ( Diabetes Research Group, King's College London, London, UK.); Allen JM ( Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.); Iqbal A ( Academic Unit of Diabetes, Endocrinology and Metabolism, Department of Human Metabolism, University of Sheffield, Sheffield, UK.); Choudhary P ( Diabetes Research Group, King's College London, London, UK.); Kumareswaran K ( Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.); Nodale M ( Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.); Nisbet C ( Academic Unit of Diabetes, Endocrinology and Metabolism, Department of Human Metabolism, University of Sheffield, Sheffield, UK.); Wilinska ME ( Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.); Barnard KD ( Human Development and Health Academic Unit, Faculty of Medicine, University of Southampton, Southampton, UK.); Dunger DB ( Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.); Heller SR ( Academic Unit of Diabetes, Endocrinology and Metabolism, Department of Human Metabolism, University of Sheffield, Sheffield, UK.); Amiel SA ( Diabetes Research Group, King's College London, London, UK.); Evans ML ( Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.); Hovorka R ( Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK. Electronic address: rh347@cam.ac.uk.) |
| 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. |
| File Format | HTM / HTML |
| ISSN | 22138587 |
| e-ISSN | 22138595 |
| DOI | 10.1016/S2213-8587(14)70114-7 |
| Journal | The Lancet Diabetes & Endocrinology |
| Issue Number | 9 |
| Volume Number | 2 |
| Language | English |
| Publisher | Elsevier |
| Publisher Date | 2014-09-01 |
| Publisher Place | Great Britain (UK) |
| Access Restriction | Open |
| Subject Keyword | Discipline Endocrinology Blood Glucose Drug Effects Diabetes Mellitus, Type 1 Drug Therapy Hemoglobin A, Glycosylated Hypoglycemia Prevention & Control Hypoglycemic Agents Administration & Dosage Insulin Pancreas, Artificial Algorithms Metabolism Cross-over Studies Blood Epidemiology Insulin Infusion Systems Multicenter Study Randomized Controlled Trial Research Support, N.i.h., Extramural Research Support, Non-u.s. Gov't |
| Content Type | Text |
| Resource Type | Article |
| Subject | Endocrinology, Diabetes and Metabolism Internal Medicine Endocrinology |
