Effect of Continuous Glucose Monitoring on Glycemic Control in Patients With Type 2 Diabetes Treated With Basal Insulin A Randomized Clinical Trial
Effect of Continuous Glucose Monitoring on Glycemic Control in Patients With Type 2 Diabetes Treated With Basal Insulin A Randomized Clinical Trial
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DOI：
10.1001/jama.2021.7444
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发表时间：
2021-06-02
影响因子：
120.7
通讯作者：
Group, Mobile Study
中科院分区：
文献类型：
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作者：
Martens, Thomas;Beck, Roy W.;Group, Mobile Study
重要性连续血糖监测(CGM)已被证明对接受强化胰岛素治疗的成人2型糖尿病患者是有益的，但其在基础胰岛素治疗的2型糖尿病患者中的应用尚未得到很好的研究。目的在初级保健实践中确定CGM在基础胰岛素治疗的成人2型糖尿病患者中的有效性。设计、设置和参与者这项随机临床试验在美国的15个中心进行(注册时间为2018年7月30日至2019年10月30日；随访结束于2020年7月7日)，包括从初级保健临床医生那里接受糖尿病护理的成年2型糖尿病患者，每天注射1到2次长效或中效基础胰岛素，不含餐前胰岛素，使用或不使用非胰岛素降血糖药物。干预措施随机分配2：1给CGM(n=116)或传统血糖仪(BGM)监测(n=59)。主要结果和衡量主要结果是8个月时的血红蛋白A1c(HbA1c)水平。关键的次要结果是CGM测量的目标血糖范围为70至180 mg/dL的时间，血糖水平大于250 mg/dL的时间，以及8个月的平均血糖水平。结果在175名随机受试者中(平均年龄57[9]岁；女性88名[50%]；92名种族/少数民族个体[53%]；平均[SD]基线HbA1c水平9.1%[0.9%])，165名(94%)完成试验。CGM组的平均HbA1c水平从基线时的9.1%降至8个月时的8.0%，BGM组从9.0%降至8.4%(调整后差异为-0.4%[95%CI，-0.8%至-0.1%]；P=0.02)。在CGM组，与BGM组相比，CGM在70~180 mg/dL目标血糖范围内测量时间的平均百分比分别为59%和43%(调整后差异，15%[95%CI，8%~23%]；P
IMPORTANCE Continuous glucose monitoring (CGM) has been shown to be beneficial for adults with type 2 diabetes using intensive insulin therapy, but its use in type 2 diabetes treated with basal insulin without prandial insulin has not been well studied.OBJECTIVE To determine the effectiveness of CGM in adults with type 2 diabetes treated with basal insulin without prandial insulin in primary care practices.DESIGN, SETTING, AND PARTICIPANTS This randomized clinical trialwas conducted at 15 centers in the US (enrollment from July 30, 2018, to October 30, 2019; follow-up completed July 7, 2020) and included adults with type 2 diabetes receiving their diabetes care from a primary care clinician and treated with 1 or 2 daily injections of long- or intermediate-acting basal insulin without prandial insulin, with or without noninsulin glucose-lowering medications.INTERVENTIONS Random assignment 2:1 to CGM (n = 116) or traditional blood glucose meter (BGM) monitoring (n = 59).MAIN OUTCOMES AND MEASURES The primary outcome was hemoglobin A1c (HbA1c) level at 8 months. Key secondary outcomes were CGM-measured time in target glucose range of 70 to 180mg/dL, time with glucose level at greater than 250mg/dL, and mean glucose level at 8 months. RESULTS Among 175 randomized participants (mean [SD] age, 57 [9] years; 88 women [50%]; 92 racial/ethnic minority individuals [53%]; mean [SD] baseline HbA1c level, 9.1% [0.9%]), 165 (94%) completed the trial. Mean HbA1c level decreased from 9.1% at baseline to 8.0% at 8 months in the CGM group and from 9.0% to 8.4% in the BGM group (adjusted difference, -0.4%[95% CI, -0.8% to -0.1%]; P =.02). In the CGM group, compared with the BGM group, the mean percentage of CGM-measured time in the target glucose range of 70 to 180mg/dL was 59% vs 43%(adjusted difference, 15%[95% CI, 8% to 23%]; P