非胰岛素治疗的2型糖尿病中的持续葡萄糖监测。
完整摘要 · 中文译文
背景：持续葡萄糖监测（CGM）已被证明对1型糖尿病患者以及其他接受胰岛素治疗的2型糖尿病患者有益，但其在未接受胰岛素治疗的2型糖尿病患者治疗中的作用仍需进一步研究。 方法：在美国22家基层医疗诊所开展的一项为期26周的试验中，我们将未使用胰岛素的成年2型糖尿病患者随机分配至CGM组或常规护理组（对照组）。主要结局为第26周时的糖化血红蛋白水平。关键的CGM测量的次要结局按层次顺序检验，以控制I类错误率。 结果：共有145名参与者被分配至CGM组，138名分配至常规护理组。参与者年龄范围为21至84岁。CGM组的平均（±SD）糖化血红蛋白水平从基线的8.8±1.3%降至第26周的7.2±1.1%，常规护理组从8.7±1.2%降至8.0±1.4%（校正平均差，-0.9个百分点；95%置信区间[CI]，-1.1至-0.6；P<0.001）。CGM测量的葡萄糖水平处于70至180 mg/dL范围内的平均时间百分比，CGM组比常规护理组高21个百分点（95% CI，16至26）（P<0.001）。两组间葡萄糖水平低于54 mg/dL的时间百分比差异为-0.17个百分点（95% CI，-0.27至-0.11；非劣效性P<0.001）；葡萄糖水平低于70 mg/dL的时间百分比差异为-0.20个百分 tage 点（95% CI，-0.43 至 -0.09；非劣效性 P<0.001；优效性 P = 0.004）。未报告严重低血糖事件。 结论：在未接受胰岛素治疗、且在初级保健机构中管理的2型糖尿病成人患者中，使用持续葡萄糖监测（CGM）较常规护理使糖化血红蛋白水平降低幅度更大，且高血糖风险更低。（由 Dexcom 资助；CONNECT ClinicalTrials.gov 编号，NCT06601166。）
完整摘要 · 英文原文
BACKGROUND: Continuous glucose monitoring (CGM) has been shown to be beneficial in persons with type 1 diabetes and others with insulin-treated type 2 diabetes, but its role in the treatment of persons with type 2 diabetes not being treated with insulin has needed further study. METHODS: In a 26-week trial conducted at 22 primary care practices in the United States, we randomly assigned adults with type 2 diabetes who were not using insulin to either CGM or routine care (control). The primary outcome was the glycated hemoglobin level at 26 weeks. Key CGM-measured secondary outcomes were tested hierarchically to control the type I error rate. RESULTS: A total of 145 participants were assigned to the CGM group, and 138 to the routine-care group. Participants ranged in age from 21 to 84 years. The mean (±SD) glycated hemoglobin level decreased from 8.8±1.3% at baseline to 7.2±1.1% at 26 weeks in the CGM group and from 8.7±1.2% to 8.0±1.4% in the routine-care group (adjusted mean difference, -0.9 percentage points; 95% confidence interval [CI], -1.1 to -0.6; P<0.001). The mean percentage of time that the CGM-measured glucose level was in the glucose-level range of 70 to 180 mg per deciliter was 21 percentage points higher (95% CI, 16 to 26) with CGM than with routine care (P<0.001). The between-group difference in the percentage of time that the glucose level was below 54 mg per deciliter was -0.17 percentage points (95% CI, -0.27 to -0.11; P<0.001 for noninferiority); the difference in the percentage of time that the glucose level was below 70 mg per deciliter was -0.20 percentage points (95% CI, -0.43 to -0.09; P<0.001 for noninferiority; P = 0.004 for superiority). No severe hypoglycemia events were reported. CONCLUSIONS: Among adults with type 2 diabetes that was not being treated with insulin and was being managed in a primary care setting, the use of CGM led to a greater reduction in the glycated hemoglobin level and to a lower risk of hyperglycemia than routine care. (Funded by Dexcom; CONNECT ClinicalTrials.gov number, NCT06601166.).