ESPEYB16 10. Type 1 Diabetes Mellitus (1) (20 abstracts)
10.2. Closed-loop insulin delivery in suboptimally controlled type 1 diabetes: a multicentre, 12-week randomised trial
Martin Tauschmann , Hood Thabit Lia Bally , Janet M Allen , Sara Hartnell , Malgorzata E Wilinska , Yue Ruan , Judy Sibayan , Craig Kollman , Peiyao Cheng , Roy W Beck , Carlo L Acerini , Mark L Evans , David B Dunger , Daniela Elleri , Fiona Campbell , Richard M Bergenstal , Amy Criego , Viral N Shah , Lalantha Leelarathna , Roman Hovork & Roman APCam Consortium
Wellcome Trust-MRC Institute of Metabolic Science, and Department of Paediatrics, University of Cambridge, Cambridge, UK
To read the full abstract: Lancet. 2018 Oct 13; 392(10155): 1321–1329
The appearance of new technologies and treatment modalities are changing the fate of patients with diabetes. While until recently the global epidemic of type 1 diabetes (T1D) has been largely neglected (1), much data are being published on the impact of new technologies on metabolic control, quality of life and microvascular complications. As it is still difficult for patients with T1D to achieve good metabolic control and reduce disease burden in daily life, indeed new insight into the usefulness of new devices is urgently needed.
This large multinational randomized controlled trial compared the effectiveness of day-and-night hybrid closed-loop insulin delivery systems versus sensor-augmented pump therapy over 12 weeks of free-living in patients with poorly controlled T1D. Patients aged 6 years or older with HbA1c 7.5–10.0% on insulin pump therapy were recruited from four hospital outpatient clinics in the UK and two centers in the USA. The primary outcome was the proportion of time that glucose concentration was within the target range of 3.9–10.0 mmol/l at 12 weeks post randomization. 114 patients were screened, and 86 eligible patients were randomly assigned to receive hybrid closed-loop therapy (n=46) or sensor-augmented pump therapy (n=40; control group).
Duration of target range glucose concentrations was significantly higher in the closed-loop group (65%, S.D. 8) compared with the control group (54%, S.D. 9; mean difference 10.8%, 95% CI 8.2–13.5; P<0.0001). Importantly, in the closed-loop group HbA1c reduced from 8.3% (S.D. 0.6) at screening to 8.0% (S.D. 0.6) after the 4-week run-in, to 7.4% (S.D. 0.6) after the 12-week intervention period. In the control group, HbA1c was 8.2% (S.D. 0.5) at screening, 7.8% (S.D. 0.6) after run-in, and 7.7% (S.D. 0.5) after intervention; reductions in HbA1c were significantly greater in the closed-loop group compared with the control group (mean difference in change 0.36%, 95% CI 0.19–0.53; P<0.0001). However, it is interesting to note, that metabolic control also improved in the control group! Compared to controls, the closed-loop intervention also reduced time spent in hypoglycaemia (glucose <3.9 mmol/l: mean difference in change −0.83%, −1.40 to −0.16; P=0.0013) and in hyperglycaemic (glucose >10.0 mmol/l: −10.3%, −13.2 to −7.5; P<0.0001). No difference between groups was seen in: variability in sensor-measured glucose (mean difference in coefficient of variation −0.4%; P=0.50); total daily insulin dose (mean difference 0.031 U/kg per day; P=0.09) or body weight (mean difference 0.68 kg; P=0.19). No severe hypoglycaemia event occurred in either group. One diabetic ketoacidosis event occurred in the closed-loop group, due to infusion set failure, which shows the potential risk of any new technology namely technical error. Two participants in each group had significant hyperglycaemia, and there were 13 other adverse events in the closed-loop group and three in the control group.
The authors conclude that hybrid closed-loop insulin delivery improves glucose control while reducing the risk of hypoglycaemia across a wide age range in patients with suboptimally controlled T1D. However, it might be hypothesized that intensifying diabetes education and increasing attention and care for the patient alone can improve metabolic outcomes and reduce acute complications. It is technologies applied wisely and with care that will improve life for patients with T1D.
Reference: 1. Kiess W, Gorski T, Penke M, Klamt S, Kapellen TM. Diabetes mellitus in children and adolescents - a global epidemic which has become neglected. J Pediatr Endocrinol Metab. 2015;28:247–50.
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ESPE Yearbook of Paediatric Endocrinology
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