Importance Continuous glucose monitoring (CGM) provides real-time assessment of glucose levels and may be beneficial in reducing hypoglycemia in older adults with type 1 diabetes. Objective To determine whether CGM is effective in reducing hypoglycemia compared with standard blood glucose monitoring (BGM) in older adults with type 1 diabetes. Design, Setting, and Participants Randomized clinical trial conducted at 22 endocrinology practices in the United States among 203 adults at least 60 years of age with type 1 diabetes. Interventions Participants were randomly assigned in a 1:1 ratio to use CGM (n = 103) or standard BGM (n = 100). Main Outcomes and Measures The primary outcome was CGM-measured percentage of time that sensor glucose values were less than 70 mg/dL during 6 months of follow-up. There were 31 prespecified secondary outcomes, including additional CGM metrics for hypoglycemia, hyperglycemia, and glucose control; hemoglobin A1c (HbA1c); and cognition and patient-reported outcomes, with adjustment for multiple comparisons to control for false-discovery rate. Results Of the 203 participants (median age, 68 [interquartile range {IQR}, 65-71] years; median type 1 diabetes duration, 36 [IQR, 25-48] years; 52% female; 53% insulin pump use; mean HbA1c, 7.5% [SD, 0.9%]), 83% used CGM at least 6 days per week during month 6. Median time with glucose levels less than 70 mg/dL was 5.1% (73 minutes per day) at baseline and 2.7% (39 minutes per day) during follow-up in the CGM group vs 4.7% (68 minutes per day) and 4.9% (70 minutes per day), respectively, in the standard BGM group (adjusted treatment difference, -1.9% (-27 minutes per day); 95% CI, -2.8% to -1.1% [-40 to -16 minutes per day]; P <.001). Of the 31 prespecified secondary end points, there were statistically significant differences for all 9 CGM metrics, 6 of 7 HbA1c outcomes, and none of the 15 cognitive and patient-reported outcomes. Mean HbA1c decreased in the CGM group compared with the standard BGM group (adjusted group difference, -0.3%; 95% CI, -0.4% to -0.1%; P <.001). The most commonly reported adverse events using CGM and standard BGM, respectively, were severe hypoglycemia (1 and 10), fractures (5 and 1), falls (4 and 3), and emergency department visits (6 and 8). Conclusions and Relevance Among adults aged 60 years or older with type 1 diabetes, continuous glucose monitoring compared with standard blood glucose monitoring resulted in a small but statistically significant improvement in hypoglycemia over 6 months. Further research is needed to understand the long-term clinical benefit. Trial Registration ClinicalTrials.gov Identifier: NCT03240432.

中文翻译：

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连续血糖监测对老年 1 型糖尿病患者低血糖的影响

重要性 连续血糖监测 (CGM) 可实时评估血糖水平，可能有助于减少患有 1 型糖尿病的老年人的低血糖。目的 确定与标准血糖监测 (BGM) 相比，CGM 是否能有效减少 1 型糖尿病老年人的低血糖。设计、设置和参与者 在美国 22 家内分泌诊所进行的随机临床试验，涉及 203 名至少 60 岁的 1 型糖尿病成人。干预 参与者以 1:1 的比例随机分配使用 CGM (n = 103) 或标准 BGM (n = 100)。主要结果和测量 主要结果是 CGM 测量的 6 个月随访期间传感器葡萄糖值低于 70 mg/dL 的时间百分比。有 31 个预先指定的次要结果，包括用于低血糖、高血糖和血糖控制的其他 CGM 指标；血红蛋白 A1c (HbA1c); 以及认知和患者报告的结果，调整多重比较以控制错误发现率。结果 在 203 名参与者中（中位年龄，68 [四分位距 {IQR}，65-71] 岁；中位 1 型糖尿病病程，36 [IQR，25-48] 岁；52% 女性；53% 使用胰岛素泵；平均HbA1c，7.5% [SD，0.9%])，83% 在第 6 个月每周至少使用 CGM 6 天。血糖水平低于 70 mg/dL 的中位时间为 5.1%（每天 73 分钟）在基线和 2.7 CGM 组随访期间的 %（每天 39 分钟）与标准 BGM 组分别为 4.7%（每天 68 分钟）和 4.9%（每天 70 分钟）（调整后的治疗差异，-1.9%） -27 分钟/天）；95% CI，-2.8% 到 -1。1% [-40 到 -16 分钟/天]；P <.001）。在 31 个预设的次要终点中，所有 9 个 CGM 指标、7 个 HbA1c 结果中的 6 个以及 15 个认知和患者报告的结果均无统计学差异。与标准 BGM 组相比，CGM 组的平均 HbA1c 降低（调整后的组差异，-0.3%；95% CI，-0.4% 至 -0.1%；P <.001）。分别使用 CGM 和标准 BGM 报告的最常见的不良事件是严重低血糖（1 和 10）、骨折（5 和 1）、跌倒（4 和 3）和急诊就诊（6 和 8）。结论和相关性 在 60 岁或以上的 1 型糖尿病成人中，与标准血糖监测相比，连续血糖监测导致 6 个月内低血糖的改善幅度很小但具有统计学意义。需要进一步研究以了解长期临床益处。试验注册 ClinicalTrials.gov 标识符：NCT03240432。