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Diabetes Care:控制良好的1型糖尿病患者连续血糖监测时还需要常规血糖监测吗?

2017-02-17 xing.T MedSci原创

使用无验证性BGM的CGM与有BGM的CGM在控制良好的严重低血糖低风险的成年I型糖尿病患者中是安全和有效的。

近日,糖尿病领域权威杂志Diabetes Care上发表了一篇研究文章。研究人员旨在确定使用没有验证性血糖监测(BGM)的连续血糖监测(CGM)测量在控制良好的1型糖尿病(T1D)患者是否安全有效,相比于使用带有BGM的CGM。

该研究采用随机非劣效性临床试验,并且在14个T1D交流临床网络中心进行。参与者年龄≥18岁(平均年龄为44±14岁),T1D超过 1年(平均时间为24±12年),使用胰岛素泵,并有糖化血红蛋白≤9%(≤75mmol/ml)(平均为7±0.7% [53±7.7mmol/mol]);研究之前,47%的患者为CGM用户。参与者按2:1比例被随机分配为接受单纯的CGM(n=149)或CGM+BGM(n=77)治疗。该研究主要结果是在26周的试验期间血糖在(70-180mg/dL)这一范围的时间,预先设定的非劣效性限制为7.5%。

在26周的试验期间,单纯CGM和CGM+BGM组患者使用CGM的平均天数分别为6.7±0.5和6.8±0.4天/周。两组BGM检测每天(包括两每日所需的CGM校准)平均分别为2.8±0.9和5.4±1.4(P<0.001)。两组基础的在70-180mg/dL范围内的平均时间均为63±13%,在26周。单纯CGM和CGM+BGM组分别为65±13%和65±11%(调整差异为0%;单侧95%可信区间为−2%)。在单纯CGM组未发生严重低血糖事件,CGM+BGM组有一例发生严重低血糖事件。

使用无验证性BGM的CGM与有BGM的CGM在控制良好的严重低血糖低风险的成年I型糖尿病患者中是安全和有效的。

原始出处:

Grazia Aleppo, et al. REPLACE-BG: A Randomized Trial Comparing Continuous Glucose Monitoring With and Without Routine Blood Glucose Monitoring in Well-Controlled Adults With Type 1 Diabetes. Diabetes Care 2017 Feb. https://doi.org/10.2337/dc16-2482

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