Six-month randomized, multicenter trial of closed-loop control in type 1 diabetes

Autor: 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
Přispěvatelé: 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)
Rok vydání: 2020
Předmět:
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
Zdroj: New England Journal of Medicine
New England Journal of Medicine, Massachusetts Medical Society, 2019, 381 (18), pp.1707-1717. ⟨10.1056/NEJMoa1907863⟩
ISSN: 1662-4009
0028-4793
1533-4406
DOI: 10.1530/ey.17.10.13
Popis: 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.).
Databáze: OpenAIRE
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