Six-month randomized, multicenter trial of closed-loop control in type 1 diabetes
| العنوان: | Six-month randomized, multicenter trial of closed-loop control in type 1 diabetes |
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| المؤلفون: | Brown SA, Kovatchev BP, Raghinaru D, Lum JW, Buckingham BA, Kudva YC, Laffel LM, Levy CJ, Pinsker JE, Wadwa RP, Dassau E, Doyle FJ, Anderson SM, Church MM, Dadlani V, Ekhlaspour L, Forlenza GP, Isganaitis E, Lam DW, Kollman C, Beck RW, Trial Research Group. iDCL |
| المساهمون: | University of Virginia [Charlottesville], Department of Molecular Medicine [Tampa], University of South Florida [Tampa] (USF), Stanford School of Medicine [Stanford], Stanford Medicine, Stanford University-Stanford University, Mayo Clinic [Rochester], Harvard Medical School [Boston] (HMS), Université de Lorraine (UL) |
| المصدر: | New England Journal of Medicine New England Journal of Medicine, Massachusetts Medical Society, 2019, 381 (18), pp.1707-1717. ⟨10.1056/NEJMoa1907863⟩ |
| بيانات النشر: | Bioscientifica, 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | Adult, Blood Glucose, Male, Pancreas, Artificial, Pediatrics, medicine.medical_specialty, Adolescent, Insulin delivery, 030204 cardiovascular system & hematology, law.invention, Young Adult, 03 medical and health sciences, Insulin Infusion Systems, 0302 clinical medicine, Randomized controlled trial, law, Diabetes mellitus, Multicenter trial, medicine, Humans, Hypoglycemic Agents, Insulin, MESH: Diabetes Mellitus, Type 1/drug therapy, Hypoglycemic Agents/administration & dosage, Insulin/administration & dosage, Pancreas, Artificial/adverse effects, In patient, 030212 general & internal medicine, Aged, Glycemic, Glycated Hemoglobin, Type 1 diabetes, business.industry, Equipment Design, General Medicine, Middle Aged, [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences, medicine.disease, 3. Good health, Diabetes Mellitus, Type 1, Multicenter study, Female, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology |
| الوصف: | Closed-loop systems that automate insulin delivery may improve glycemic outcomes in patients with type 1 diabetes.In this 6-month randomized, multicenter trial, patients with type 1 diabetes were assigned in a 2:1 ratio to receive treatment with a closed-loop system (closed-loop group) or a sensor-augmented pump (control group). The primary outcome was the percentage of time that the blood glucose level was within the target range of 70 to 180 mg per deciliter (3.9 to 10.0 mmol per liter), as measured by continuous glucose monitoring.A total of 168 patients underwent randomization; 112 were assigned to the closed-loop group, and 56 were assigned to the control group. The age range of the patients was 14 to 71 years, and the glycated hemoglobin level ranged from 5.4 to 10.6%. All 168 patients completed the trial. The mean (±SD) percentage of time that the glucose level was within the target range increased in the closed-loop group from 61±17% at baseline to 71±12% during the 6 months and remained unchanged at 59±14% in the control group (mean adjusted difference, 11 percentage points; 95% confidence interval [CI], 9 to 14; P0.001). The results with regard to the main secondary outcomes (percentage of time that the glucose level was180 mg per deciliter, mean glucose level, glycated hemoglobin level, and percentage of time that the glucose level was70 mg per deciliter or54 mg per deciliter [3.0 mmol per liter]) all met the prespecified hierarchical criterion for significance, favoring the closed-loop system. The mean difference (closed loop minus control) in the percentage of time that the blood glucose level was lower than 70 mg per deciliter was -0.88 percentage points (95% CI, -1.19 to -0.57; P0.001). The mean adjusted difference in glycated hemoglobin level after 6 months was -0.33 percentage points (95% CI, -0.53 to -0.13; P = 0.001). In the closed-loop group, the median percentage of time that the system was in closed-loop mode was 90% over 6 months. No serious hypoglycemic events occurred in either group; one episode of diabetic ketoacidosis occurred in the closed-loop group.In this 6-month trial involving patients with type 1 diabetes, the use of a closed-loop system was associated with a greater percentage of time spent in a target glycemic range than the use of a sensor-augmented insulin pump. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases; iDCL ClinicalTrials.gov number, NCT03563313.). |
| تدمد: | 1662-4009 0028-4793 1533-4406 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::84267546ab801b96b04bdc2b2278ee67Test https://doi.org/10.1530/ey.17.10.13Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....84267546ab801b96b04bdc2b2278ee67 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 16624009 00284793 15334406 |
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