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Randomized Controlled Trial
. 2014 Sep;2(9):701-9.
doi: 10.1016/S2213-8587(14)70114-7. Epub 2014 Jun 16.

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  1 , Alexandra Lubina-Solomon  2 , Marietta Stadler  3 , Lalantha Leelarathna  1 , Emma Walkinshaw  2 , Andrew Pernet  3 , Janet M Allen  1 , Ahmed Iqbal  2 , Pratik Choudhary  3 , Kavita Kumareswaran  1 , Marianna Nodale  1 , Chloe Nisbet  2 , Malgorzata E Wilinska  1 , Katharine D Barnard  4 , David B Dunger  1 , Simon R Heller  2 , Stephanie A Amiel  3 , Mark L Evans  1 , Roman Hovorka  5
Affiliations
Randomized Controlled Trial

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 et al. Lancet Diabetes Endocrinol. 2014 Sep.

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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Conflict of interest statement

Conflict of interest disclosures: RH reports having received speaker honoraria from Minimed Medtronic, Lifescan, Eli Lilly, BBraun, and Novo Nordisk, serving on advisory panel for Animas, Minimed Medtronic, and Eli Lilly, receiving license fees from BBraun and Beckton Dickinson; and having served as a consultant to Beckton Dickinson, BBraun, Sanofi-Aventis, and Profil. SRH has undertaken consultancy for Novo Nordisk, Eli Lilly for which his institution has received payment. He has spoken at meetings for which he has received payment from NovoNordisk, Eli Lilly, BD. Medtronic has provided research support for some of his work. MLE has received speaker honorariums from Eli Lilly, Animas and Abbott Diabetes Care and served on advisory panels for Medtronic, Roche, Sanofi-Aventis and Cellnovo. PC declares speaker honoraria and travel support from Medtronic, Roche and Lifescan, and has undertaken consultancy for Novo Nordisk, Eli Lilly for which his institution has received payment. He has spoken at meetings for which he has received payment from NovoNordisk, Eli Lilly, and Beckton Dickinson. Medtronic has provided research support for some of his work. KK has spoken at meetings for which she received personal fees from Eli Lilly, Merck Sharpe & Dohme and Sanofi. MEW reports receiving licensing fees from Beckton Dickinson. RH, DBD and MEW report patent applications. HT, ALS, MS, LL, EW, AP, JMA, AI, MN, CN, KDB and SAA declare no competing financial interests exist.

Figures

Figure 1
Figure 1
Study design comparing overnight closed loop insulin delivery with control. The outline shows when continuous glucose monitoring data were collected, efficacy assessed, and adverse events monitored.
Figure 2
Figure 2
Flow of participants through the trial.
Figure 3
Figure 3
Median (interquartile range) of sensor glucose (top panel) and insulin delivery (bottom panel) during closed loop (solid red line and red shaded area) and control (dashed black line and gray shaded area) period for the 24-hour duration. The glucose range 3·9 to 8·0 mmol/l is denoted in the top panel by horizontal dashed lines.
Figure 4
Figure 4
Individual values of time when glucose was in target glucose range from 3·9 to 8·0 mmol/l (left panel) and mean overnight glucose (right panel) (n=24).
See this image and copyright information in PMC

Comment in

References

    1. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Trial Research Group. N Engl J Med. 1993;329(14):977–86. - PubMed
    1. Epidemiology of severe hypoglycemia in the diabetes control and complications trial. The DCCT Research Group. Am J Med. 1991;90(4):450–9. - PubMed
    1. McCoy RG, Van Houten HK, Ziegenfuss JY, Shah ND, Wermers RA, Smith SA. Self-report of hypoglycemia and health-related quality of life in patients with type 1 and type 2 diabetes. Endocr Pract. 2013;19(5):792–9. - PubMed
    1. Monami M, Marchionni N, Mannucci E. Long-acting insulin analogues vs. NPH human insulin in type 1 diabetes. A meta-analysis. Diabetes Obes Metab. 2009;11(4):372–8. - PubMed
    1. Rankin D, Cooke DD, Clark M, et al. How and why do patients with Type 1 diabetes sustain their use of flexible intensive insulin therapy? A qualitative longitudinal investigation of patients’ self-management practices following attendance at a Dose Adjustment for Normal Eating (DAFNE) course. Diabet Med. 2011;28(5):532–8. - PubMed

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