Glucose Self-monitoring in Non-Insulin-Treated Patients With Type 2 Diabetes in Primary Care Settings A Randomized Trial
Glucose Self-monitoring in Non-Insulin-Treated Patients With Type 2 Diabetes in Primary Care Settings A Randomized Trial
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DOI：
10.1001/jamainternmed.2017.1233
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发表时间：
2017-07-01
影响因子：
39
通讯作者：
Donahue, Katrina E.
中科院分区：
文献类型：
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作者：
Young, Laura A.;Buse, John B.;Donahue, Katrina E.
重要性自我监测血糖（SMBG）水平在非胰岛素治疗的2型糖尿病患者中的价值一直存在争议。目的比较3种SMBG方法对初级保健实践中非胰岛素治疗的2型糖尿病患者血红蛋白A（1c）水平和健康相关生活质量（HRQOL）的影响。在北卡罗来纳州中部的15个初级保健实践中进行的开放标签随机试验。参与者在2014年1月至2015年7月期间随机分组。符合条件的2型非胰岛素治疗糖尿病患者为：年龄大于30岁，在参与实践中由初级保健医生确定，在筛选前6个月内血糖控制（血红蛋白A（1c））水平高于6.5%但低于9.5%（从电子病历中获得），并愿意遵守随机分配到研究组的结果。干预无SMBG，每日一次SMBG，和每日一次SMBG，增强患者反馈，包括通过血糖仪提供的自动定制信息。主要结局和指标共同主要结局包括52周时的血红蛋白A（1c）水平和HRQOL。（92.9%）完成最终访视。所有3组的血红蛋白A（1c）水平均无显著差异（P = 0.74;估计的校正平均血红蛋白A（1c）差异，有消息的SMBG vs无SMBG，-0.09%; 95% CI，-0.31%至0.14%; SMBG vs无SMBG，-0.05%; 95% CI，-0.27%至0.17%）。在HRQOL方面也没有发现显著差异。有没有显着的差异，包括低血糖的频率，医疗保健利用，或胰岛素initiation.Conclusions和相关性在非胰岛素治疗的2型糖尿病患者，我们观察到没有临床或统计学显着差异，在1年血糖控制或HRQOL之间的患者谁进行SMBG与那些谁没有进行SMBG。通过血糖仪的消息传递提供的这种定制反馈的添加在血糖控制方面没有提供任何优势。
IMPORTANCE The value of self-monitoring of blood glucose (SMBG) levels in patients with non-insulin-treated type 2 diabetes has been debated.OBJECTIVE To compare 3 approaches of SMBG for effects on hemoglobin A(1c) levels and health-related quality of life (HRQOL) among people with non-insulin-treated type 2 diabetes in primary care practice.DESIGN, SETTING, AND PARTICIPANTS The Monitor Trial study was a pragmatic, open-label randomized trial conducted in 15 primary care practices in central North Carolina. Participants were randomized between January 2014 and July 2015. Eligible patients with type 2 non-insulin-treated diabetes were: older than 30 years, established with a primary care physician at a participating practice, had glycemic control (hemoglobin A(1c)) levels higher than 6.5% but lower than 9.5% within the 6 months preceding screening, as obtained from the electronic medical record, and willing to comply with the results of random assignment into a study group. Of the 1032 assessed for eligibility, 450 were randomized.INTERVENTIONS No SMBG, once-daily SMBG, and once-daily SMBG with enhanced patient feedback including automatic tailored messages delivered via the meter.MAIN OUTCOMES AND MEASURES Coprimary outcomes included hemoglobin A(1c) levels and HRQOL at 52 weeks.RESULTS A total of 450 patients were randomized and 418 (92.9%) completed the final visit. There were no significant differences in hemoglobin A(1c) levels across all 3 groups (P =.74; estimated adjusted mean hemoglobin A(1c) difference, SMBG with messaging vs no SMBG, -0.09%; 95% CI, -0.31% to 0.14%; SMBG vs no SMBG, -0.05%; 95% CI, -0.27% to 0.17%). There were also no significant differences found in HRQOL. There were no notable differences in key adverse events including hypoglycemia frequency, health care utilization, or insulin initiation.CONCLUSIONS AND RELEVANCE In patients with non-insulin-treated type 2 diabetes, we observed no clinically or statistically significant differences at 1 year in glycemic control or HRQOL between patients who performed SMBG compared with those who did not perform SMBG. The addition of this type of tailored feedback provided through messaging via a meter did not provide any advantage in glycemic control.