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应用闭环系统控制1型糖尿病的6个月随机多中心试验
Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes


Sue A. Brown ... 糖尿病 • 2019.10.31
NEJM 动画解读

1型糖尿病的闭环控制系统
相关阅读
• 人工胰腺对1型糖尿病患儿有效 • 1型糖尿病患儿应用闭环系统控制血糖的随机试验 • 第二个胰岛素“闭环”输送系统 • 人工胰腺疗法改善1型糖尿病的血糖控制 • 对于1型糖尿病,胰岛素泵优于胰岛素注射

摘要


背景

自动输送胰岛素的闭环系统有可能改善1型糖尿病患者的血糖结局。

 

方法

在这项为期6个月的随机、多中心试验中,我们以2∶1的比例将1型糖尿病患者随机分组,分别接受闭环系统治疗(闭环组)或者传感器增强型胰岛素泵治疗(对照组)。主要结局是根据血糖连续监测结果,血糖水平在70~180 mg/dL(3.9~10.0 mmol/L)目标范围内的时间百分比。

 

结果

共有168例患者被随机分组;112例被分配至闭环组,56例被分配至对照组。患者年龄范围是14~71岁,糖化血红蛋白水平为5.4%~10.6%。全部168例患者均完成了本试验。在闭环组中,血糖水平在目标范围内的时间百分比平均值(±SD)从基线时的61%±17%增加至6个月期间的71%±12%,而对照组的百分比保持不变(59%±14%)(平均校正差异,11个百分点;95%置信区间[CI],9~14;P<0.001)。关键次要结局(血糖水平>180 mg/dL的时间百分比、平均血糖水平、糖化血红蛋白水平和血糖水平<70 mg/L或<54 mg/dL[3.0 mmol/L]的时间百分比)结果均达到预设的分级显著性标准,表明闭环系统效果较好。血糖水平低于70 mg/dL的时间百分比的平均差异(闭环组减去对照组)为-0.88个百分点(95% CI,-1.19~-0.57;P<0.001)。6个月后糖化血红蛋白水平的平均校正差异为-0.33个百分点(95% CI,-0.53~-0.13;P=0.001)。在闭环组中,6个月期间系统处于闭环模式的时间百分比中位数为90%。两组均未发生严重低血糖事件;闭环组发生了1起糖尿病酮症酸中毒事件。

 

结论

在对1型糖尿病患者进行的这项为期6个月的试验中,与使用传感器增强型胰岛素泵相比,使用闭环系统与血糖水平在目标范围内的时间百分比较高相关(由美国国立糖尿病、消化系统疾病和肾脏疾病研究所[National Institute of Diabetes and Digestive and Kidney Diseases]资助;iDCL在ClinicalTrials.gov注册号为NCT03563313)。





作者信息

Sue A. Brown, M.D., Boris P. Kovatchev, Ph.D., Dan Raghinaru, M.S., John W. Lum, M.S., Bruce A. Buckingham, M.D., Yogish C. Kudva, M.D., Lori M. Laffel, M.D., M.P.H., Carol J. Levy, M.D., Jordan E. Pinsker, M.D., R. Paul Wadwa, M.D., Eyal Dassau, Ph.D., Francis J. Doyle, III, Ph.D., Stacey M. Anderson, M.D., Mei Mei Church, N.P., M.S., Vikash Dadlani, M.B., B.S., Laya Ekhlaspour, M.D., Gregory P. Forlenza, M.D., Elvira Isganaitis, M.D., M.P.H., David W. Lam, M.D., Craig Kollman, Ph.D., and Roy W. Beck, M.D., Ph.D. for the iDCL Trial Research Group*
From the University of Virginia Center for Diabetes Technology, Charlottesville (S.A.B., B.P.K., S.M.A.); the Jaeb Center for Health Research, Tampa, FL (D.R., J.W.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B., L.E.), and the Sansum Diabetes Research Institute, Santa Barbara (J.E.P., M.C.) — both in California; the Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN (Y.C.K., V.D.); the Research Division, Joslin Diabetes Center and Department of Pediatrics, Harvard Medical School, Boston (L.M.L., E.I.), and the Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge (E.D., F.J.D.) — both in Massachusetts; the Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York (C.J.L., D.W.L.); and the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.). Address reprint requests to Dr. Kovatchev at the University of Virginia Center for Diabetes Technology, 560 Ray C. Hunt Dr., 2nd Flr., Charlottesville, VA 22903, or at boris@virginia.edu. *A list of the members of the iDCL Trial Research Group is provided in the Supplementary Appendix, available at NEJM.org.

 

参考文献

1. American Diabetes Association. Glycemic targets: Standards of Medical Care in Diabetes — 2019. Diabetes Care 2019;42:Suppl 1:S61-S70.

2. Foster NC, Beck RW, Miller KM, et al. State of type 1 diabetes management and outcomes from the T1D Exchange in 2016-2018. Diabetes Technol Ther 2019;21:66-72.

3. Kovatchev B. The artificial pancreas in 2017: the year of transition from research to clinical practice. Nat Rev Endocrinol 2018;14:74-76.

4. Kovatchev B. A century of diabetes technology: signals, models, and artificial pancreas control.Trends Endocrinol Metab 2019;30:432-444.

5. Bekiari E, Kitsios K, Thabit H, et al. Artificial pancreas treatment for outpatients with type 1 diabetes: systematic review and meta-analysis. BMJ 2018;361:k1310-k1310.

6. Karageorgiou V, Papaioannou TG, Bellos I, et al. Effectiveness of artificial pancreas in the non-adult population: a systematic review and network meta-analysis. Metabolism 2019;90:20-30.

7. Weisman A, Bai JW, Cardinez M, Kramer CK, Perkins BA. Effect of artificial pancreas systems on glycaemic control in patients with type 1 diabetes: a systematic review and meta-analysis of outpatient randomised controlled trials. Lancet Diabetes Endocrinol 2017;5:501-512.

8. Bergenstal RM, Garg S, Weinzimer SA, et al. Safety of a hybrid closed-loop insulin delivery system in patients with type 1 diabetes. JAMA 2016;316:1407-1408.

9. Brown S, Raghinaru D, Emory E, Kovatchev B. First look at Control-IQ: a new-generation automated insulin delivery system. Diabetes Care 2018;41:2634-2636.

10. Keith-Hynes P, Guerlain S, Mize B, et al. DiAs user interface: a patient-centric interface for mobile artificial pancreas systems. J Diabetes Sci Technol 2013;7:1416-1426.

11. Nathan DM, Genuth S, Lachin J, et al. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993;329:977-986.

12. Anderson SM. The International Diabetes Closed Loop Trial. Presented at the 18th Annual Diabetes Technology Meeting, Bethseda, MD, November 8–10, 2018.

13. Tauschmann M, Thabit H, Bally L, et al. Closed-loop insulin delivery in suboptimally controlled type 1 diabetes: a multicentre, 12-week randomised trial. Lancet 2018;392:1321-1329.

14. Benhamou P-Y, Franc S, Reznik Y, et al. Closed-loop insulin delivery in adults with type 1 diabetes in real-life conditions: a 12-week multicentre, open-label randomised controlled crossover trial. Lancet Digital Health 2019;1(1):e17-e25.

15. Battelino T, Nimri R, Dovc K, Phillip M, Bratina N. Prevention of hypoglycemia with predictive low glucose insulin suspension in children with type 1 diabetes: a randomized controlled trial. Diabetes Care 2017;40:764-770.

16. Abraham MB, Nicholas JA, Smith GJ, et al. Reduction in hypoglycemia with the predictive low-glucose management system: a long-term randomized controlled trial in adolescents with type 1 diabetes. Diabetes Care 2018;41:303-310.

17. Forlenza GP, Li Z, Buckingham BA, et al. Predictive low-glucose suspend reduces hypoglycemia in adults, adolescents, and children with type 1 diabetes in an at-home randomized crossover study: results of the PROLOG Trial. Diabetes Care 2018;41:2155-2161.

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