International Diabetes Center, Park Nicollet Internal Medicine, Minneapolis, Minnesota.
Jaeb Center for Health Research, Tampa, Florida.
JAMA. 2021 Jun 8;325(22):2262-2272. doi: 10.1001/jama.2021.7444.
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.
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 trial was 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.
Random assignment 2:1 to CGM (n = 116) or traditional blood glucose meter (BGM) monitoring (n = 59).
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 180 mg/dL, time with glucose level at greater than 250 mg/dL, and mean glucose level at 8 months.
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 180 mg/dL was 59% vs 43% (adjusted difference, 15% [95% CI, 8% to 23%]; P < .001), the mean percentage of time at greater than 250 mg/dL was 11% vs 27% (adjusted difference, -16% [95% CI, -21% to -11%]; P < .001), and the means of the mean glucose values were 179 mg/dL vs 206 mg/dL (adjusted difference, -26 mg/dL [95% CI, -41 to -12]; P < .001). Severe hypoglycemic events occurred in 1 participant (1%) in the CGM group and in 1 (2%) in the BGM group.
Among adults with poorly controlled type 2 diabetes treated with basal insulin without prandial insulin, continuous glucose monitoring, as compared with blood glucose meter monitoring, resulted in significantly lower HbA1c levels at 8 months.
ClinicalTrials.gov Identifier: NCT03566693.
连续血糖监测（CGM）已被证明对接受强化胰岛素治疗的 2 型糖尿病成人有益，但在接受基础胰岛素而不使用餐时胰岛素治疗的 2 型糖尿病患者中的应用尚未得到很好的研究。
确定 CGM 在接受基础胰岛素而不使用餐时胰岛素治疗的 2 型糖尿病成人中的有效性，这些患者在初级保健实践中接受治疗。
设计、地点和参与者：这是一项在美国 15 个中心进行的随机临床试验（招募时间为 2018 年 7 月 30 日至 2019 年 10 月 30 日；随访于 2020 年 7 月 7 日完成），纳入了从初级保健临床医生处接受糖尿病护理并接受 1 或 2 次每日注射长效或中效基础胰岛素而不使用餐时胰岛素治疗的 2 型糖尿病成人，无论是否使用非胰岛素降血糖药物。
随机分配 2:1 至 CGM（n=116）或传统血糖仪（BGM）监测（n=59）。
主要结局是 8 个月时的糖化血红蛋白（HbA1c）水平。关键次要结局是 CGM 测量的 70 至 180mg/dL 目标血糖范围内的时间、血糖水平大于 250mg/dL 的时间和 8 个月时的平均血糖水平。
在 175 名随机参与者中（平均[SD]年龄为 57[9]岁；88 名女性[50%]；92 名种族/民族少数个体[53%]；平均[SD]基线 HbA1c 水平为 9.1%[0.9%]），165 名（94%）完成了试验。CGM 组的平均 HbA1c 水平从基线时的 9.1%下降到 8 个月时的 8.0%，BGM 组从 9.0%下降到 8.4%（调整后的差异，-0.4%[95%CI，-0.8%至-0.1%]；P=0.02）。与 BGM 组相比，CGM 组的 CGM 测量时间中有 70 至 180mg/dL 的目标血糖范围内的平均百分比为 59%，而 BGM 组为 43%（调整后的差异，15%[95%CI，8%至 23%]；P<0.001），血糖水平大于 250mg/dL 的平均时间百分比为 11%，而 BGM 组为 27%（调整后的差异，-16%[95%CI，-21%至-11%]；P<0.001），平均血糖值的平均值为 179mg/dL，而 BGM 组为 206mg/dL（调整后的差异，-26mg/dL[95%CI，-41 至-12]；P<0.001）。1 名（1%）CGM 组和 1 名（2%）BGM 组发生严重低血糖事件。
在接受基础胰岛素而不使用餐时胰岛素治疗的血糖控制不佳的 2 型糖尿病成人中，与血糖监测相比，连续血糖监测可显著降低 8 个月时的 HbA1c 水平。
ClinicalTrials.gov 标识符：NCT03566693。
