دورية أكاديمية
Multicenter, randomized trial of a bionic pancreas in type 1 diabetes
| العنوان: | Multicenter, randomized trial of a bionic pancreas in type 1 diabetes |
|---|---|
| المؤلفون: | Russell, Steven J, McGill, Janet B, Salam, Maamoun, Silverstein, Julie M, Adamson, Samantha, Cedeno, Andrea |
| المصدر: | 2020-Current year OA Pubs |
| بيانات النشر: | Digital Commons@Becker |
| سنة النشر: | 2022 |
| المجموعة: | Washington University School of Medicine: Digital Commons@Becker |
| مصطلحات موضوعية: | Adolescent, Adult, Aged, Bionics, Blood Glucose, Blood Glucose Self-Monitoring, Child, Diabetes Mellitus, Type 1, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Insulin, Insulin Aspart, Insulin Infusion Systems, Insulin Lispro, Middle Aged, Young Adult, ICTS (Institute of Clinical and Translational Sciences), Medicine and Health Sciences |
| الوصف: | BACKGROUND: Currently available semiautomated insulin-delivery systems require individualized insulin regimens for the initialization of therapy and meal doses based on carbohydrate counting for routine operation. In contrast, the bionic pancreas is initialized only on the basis of body weight, makes all dose decisions and delivers insulin autonomously, and uses meal announcements without carbohydrate counting. METHODS: In this 13-week, multicenter, randomized trial, we randomly assigned in a 2:1 ratio persons at least 6 years of age with type 1 diabetes either to receive bionic pancreas treatment with insulin aspart or insulin lispro or to receive standard care (defined as any insulin-delivery method with unblinded, real-time continuous glucose monitoring). The primary outcome was the glycated hemoglobin level at 13 weeks. The key secondary outcome was the percentage of time that the glucose level as assessed by continuous glucose monitoring was below 54 mg per deciliter; the prespecified noninferiority limit for this outcome was 1 percentage point. Safety was also assessed. RESULTS: A total of 219 participants 6 to 79 years of age were assigned to the bionic-pancreas group, and 107 to the standard-care group. The glycated hemoglobin level decreased from 7.9% to 7.3% in the bionic-pancreas group and did not change (was at 7.7% at both time points) in the standard-care group (mean adjusted difference at 13 weeks, -0.5 percentage points; 95% confidence interval [CI], -0.6 to -0.3; P<0.001). The percentage of time that the glucose level as assessed by continuous glucose monitoring was below 54 mg per deciliter did not differ significantly between the two groups (13-week adjusted difference, 0.0 percentage points; 95% CI, -0.1 to 0.04; P<0.001 for noninferiority). The rate of severe hypoglycemia was 17.7 events per 100 participant-years in the bionic-pancreas group and 10.8 events per 100 participant-years in the standard-care group (P = 0.39). No episodes of diabetic ketoacidosis occurred in either group. ... |
| نوع الوثيقة: | text |
| وصف الملف: | application/pdf |
| اللغة: | unknown |
| العلاقة: | https://digitalcommons.wustl.edu/oa_4/1994Test; https://digitalcommons.wustl.edu/context/oa_4/article/3000/viewcontent/nejmoa2205225.pdfTest |
| DOI: | 10.1056/NEJMoa2205225 |
| الإتاحة: | https://doi.org/10.1056/NEJMoa2205225Test https://digitalcommons.wustl.edu/oa_4/1994Test https://digitalcommons.wustl.edu/context/oa_4/article/3000/viewcontent/nejmoa2205225.pdfTest |
| رقم الانضمام: | edsbas.52BA50D6 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1056/NEJMoa2205225 |
|---|