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1型糖尿病患儿应用闭环系统控制血糖的随机试验
A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes


Marc D. Breton ... 糖尿病 妇产科和儿科 • 2020.08.27
相关阅读
• 戈利木单抗与年轻新发1型糖尿病患者的β细胞功能 • 人工胰腺对1型糖尿病患儿有效 • 应用闭环系统控制1型糖尿病的6个月随机多中心试验 • 第二个胰岛素“闭环”输送系统 • 更多证据表明“人工胰腺”安全有效

摘要


背景

闭环胰岛素输送系统(也称为人工胰腺)可能改善1型糖尿病患儿的血糖结局。

 

方法

在一项为期16周的多中心、随机、开放标签、平行组试验中,我们以3∶1的比例将6~13岁的1型糖尿病患儿随机分组,两组分别接受闭环胰岛素输送系统(闭环组)或传感器增强型胰岛素泵(对照组)治疗。主要结局是血糖水平在70~180 mg/dL目标范围内的时间百分比,血糖水平通过连续血糖监测的方式测定。

 

结果

共计101例患儿被随机分组(闭环组78例和对照组23例);基线糖化血红蛋白水平范围为5.7%~10.1%。在闭环组和对照组中,血糖水平在70~180 mg/dL目标范围内的时间百分比平均值(±SD)分别从基线时的53%±17%增加至67%±10%(16周治疗期间的平均值),以及从51%±16%增加至55%±13%(平均校正差异,11个百分点[相当于每日2.6小时];95% CI,7~14;P<0.001)。在两组中,血糖水平低于70 mg/dL的时间百分比中位值均较低(闭环组1.6%和对照组1.8%)。在闭环组中,系统处于闭环模式的时间百分比中位值为93%(四分位距,91~95)。两组均未发生糖尿病酮症酸中毒或重度低血糖发作。

 

结论

在这项对1型糖尿病患儿开展的为期16周的试验中,闭环系统组的血糖水平在目标范围内的时间百分比高于传感器增强型胰岛素泵组(由Tandem Diabetes Care和美国国立糖尿病、消化系统疾病和肾脏疾病研究所[National Institute of Diabetes and Digestive and Kidney Diseases]等资助,在ClinicalTrials.gov注册号为NCT03844789)。





作者信息

Marc D. Breton, Ph.D., Lauren G. Kanapka, M.Sc., Roy W. Beck, M.D., Ph.D., Laya Ekhlaspour, M.D., Gregory P. Forlenza, M.D., Eda Cengiz, M.D., Melissa Schoelwer, M.D., Katrina J. Ruedy, M.S.P.H., Emily Jost, M.P.H., R.D., C.D.E., Lori Carria, M.S., Emma Emory, R.N., Liana J. Hsu, B.S., Mary Oliveri, C.C.R.C., Craig C. Kollman, Ph.D., Betsy B. Dokken, Ph.D., Stuart A. Weinzimer, M.D., Mark D. DeBoer, M.D., Bruce A. Buckingham, M.D., Daniel Cherñavvsky, M.D., and R. Paul Wadwa, M.D. for the iDCL Trial Research Group*
From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) — both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.). Address reprint requests to Dr. Wadwa at the Barbara Davis Center for Diabetes, 1775 Aurora Ct., Aurora, CO 80045, or at paul.wadwa@cuanschutz.edu. *A complete list of the members of the International Diabetes Closed Loop (iDCL) Trial Research Group is provided in the Supplementary Appendix, available at NEJM.org.

 

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