Closed-loop insulin delivery in suboptimally controlled type 1 diabetes: a multicentre, 12-week randomised trial.
Allen, Janet M
Beck, Roy W
Bergenstal, Richard M
Shah, Viral N
Lancet (London, England)
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Tauschmann, M., Thabit, H., Bally, L., Allen, J. M., Hartnell, S., Wilinska, M., Ruan, Y., et al. (2018). Closed-loop insulin delivery in suboptimally controlled type 1 diabetes: a multicentre, 12-week randomised trial.. Lancet (London, England), 392 (10155), 1321-1329. https://doi.org/10.1016/s0140-6736(18)31947-0
Background We assessed the effectiveness of day-and-night hybrid closed-loop insulin delivery compared with sensor-augmented pump therapy in youths and adults with sub-optimally controlled type 1 diabetes. Methods In an open-label, multi-centre, multi-national, single-period, parallel study, we randomly assigned subjects with type 1 diabetes aged six years and older treated with insulin pump and with sub-optimal glycaemic control (HbA1c 7·5% to 10%) to receive either hybrid closed-loop therapy (N=46) or sensor-augmented pump therapy (N=40; control) over 12 weeks of unrestricted living. Training on study insulin pump and continuous glucose monitoring took place over a 4-week run-in period. Findings In an intention to treat analysis, the proportion of time that glucose was in target range between 3·9 and 10·0mmol/l (primary endpoint, considered a normally distributed outcome) was significantly higher in closed-loop group (65±8%, mean±SD) compared to control group (54±9%) (mean difference in change: 10·8 percentage points, 95% CI 8·2 to 13·5 percentage points, p<0.0001). In the closed-loop group, HbA1c was reduced from a screening value of 8·3±0·6% to 8·0±0·6% post run-in and 7·4±0·6% post intervention. In control group these values were 8·2±0·5%, 7·8±0·6% and 7·7±0·5%; reductions in HbA1c levels were significantly greater in closed-loop group compared to control group (mean difference in change 0·36%, 95% CI 0·19% to 0·53%; p<0·0001). The time spent with glucose levels below 3·9mmol/l was lower in the closed-loop group (mean difference in change: 0·83 percentage points, 95% CI -1·40 to -0·16 percentage points; p=0·0013) and above 10·0mmol/L (mean difference in change: -10·3 percentage points, 95% CI -13·2 to 7·5 percentage points; p<0·0001). The coefficient of variation of sensor glucose was not different between interventions (mean difference in change: -0·4%, 95% CI -1·4% to +0·7%; p=0·50). Similarly, total daily insulin dose was not different (mean difference in change: +0·031 U/kg/day, 95% CI -0·005 to +0·067; p=0·09) and body weight did not differ (mean difference in change: +0·68 kg, 95% CI -0.34 to +1·69; p=0·19). No severe hypoglycaemia occurred. One diabetic ketoacidosis occurred in closed-loop group due to infusion set failure. Interpretation Hybrid closed-loop improves glucose control while reducing the risk of hypoglycaemia across a wide age range in sub-optimally controlled type 1 diabetes.
APCam11 Consortium, Humans, Diabetes Mellitus, Type 1, Hypoglycemia, Insulin, Hypoglycemic Agents, Blood Glucose Self-Monitoring, Insulin Infusion Systems, Infusion Pumps, Implantable, Adolescent, Adult, Child, Child, Preschool, Female, Male, Young Adult, Glycated Hemoglobin A
Cambridge University Hospitals NHS Foundation Trust (CUH) (146281)
Juvenile Diabetes Research Foundation Ltd (JDRF) (2-SRA-2014-256-M-R)
Wellcome Trust (100574/Z/12/Z)
External DOI: https://doi.org/10.1016/s0140-6736(18)31947-0
This record's URL: https://www.repository.cam.ac.uk/handle/1810/279927