دورية أكاديمية
Closed-loop insulin delivery in suboptimally controlled type 1 diabetes: a multicentre, 12-week randomised trial.
| العنوان: | Closed-loop insulin delivery in suboptimally controlled type 1 diabetes: a multicentre, 12-week randomised trial. |
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| المؤلفون: | Tauschmann, Martin, Thabit, Hood, Bally, Lia, Allen, Janet M, Hartnell, Sara, Wilinska, Malgorzata E, Ruan, Yue, Sibayan, Judy, Kollman, Craig, Cheng, Peiyao, Beck, Roy W, Acerini, Carlo L, Evans, Mark L, Dunger, David B, Elleri, Daniela, Campbell, Fiona, Bergenstal, Richard M, Criego, Amy, Shah, Viral N, Leelarathna, Lalantha, Hovorka, Roman, APCam11 Consortium |
| بيانات النشر: | Elsevier BV //dx.doi.org/10.1016/s0140-6736(18)31947-0 Lancet |
| سنة النشر: | 2018 |
| المجموعة: | Apollo - University of Cambridge Repository |
| مصطلحات موضوعية: | Adolescent, Adult, Blood Glucose Self-Monitoring, Child, Preschool, Diabetes Mellitus, Type 1, Female, Glycated Hemoglobin, Humans, Hypoglycemia, Hypoglycemic Agents, Infusion Pumps, Implantable, Insulin, Insulin Infusion Systems, Male, Young Adult |
| الوصف: | BACKGROUND: The achievement of glycaemic control remains challenging for patients with type 1 diabetes. We assessed the effectiveness of day-and-night hybrid closed-loop insulin delivery compared with sensor-augmented pump therapy in people with suboptimally controlled type 1 diabetes aged 6 years and older. METHODS: In this open-label, multicentre, multinational, single-period, parallel randomised controlled trial, participants were recruited from diabetes outpatient clinics at four hospitals in the UK and two centres in the USA. We randomly assigned participants with type 1 diabetes aged 6 years and older treated with insulin pump and with suboptimal glycaemic control (glycated haemoglobin [HbA1c] 7·5-10·0%) to receive either hybrid closed-loop therapy or sensor-augmented pump therapy over 12 weeks of free living. Training on study insulin pump and continuous glucose monitoring took place over a 4-week run-in period. Eligible subjects were randomly assigned using central randomisation software. Allocation to the two study groups was unblinded, and randomisation was stratified within centre by low (<8·5%) or high (≥8·5%) HbA1c. The primary endpoint was the proportion of time that glucose concentration was within the target range of 3·9-10·0 mmol/L at 12 weeks post randomisation. Analyses of primary outcome and safety measures were done in all randomised patients. The trial is registered with ClinicalTrials.gov, number NCT02523131, and is closed to accrual. FINDINGS: From May 12, 2016, to Nov 17, 2017, 114 individuals 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). The proportion of time that glucose concentration was within the target range was significantly higher in the closed-loop group (65%, SD 8) compared with the control group (54%, SD 9; mean difference in change 10·8 percentage points, 95% CI 8·2 to 13·5; p<0·0001). In the closed-loop group, HbA1c was reduced from a screening value ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | Print-Electronic; application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| اللغة: | English |
| العلاقة: | https://www.repository.cam.ac.uk/handle/1810/279927Test |
| DOI: | 10.17863/CAM.27295 |
| الإتاحة: | https://doi.org/10.17863/CAM.27295Test https://www.repository.cam.ac.uk/handle/1810/279927Test |
| رقم الانضمام: | edsbas.7CCE35F8 |
| قاعدة البيانات: | BASE |
| DOI: | 10.17863/CAM.27295 |
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