Importance Adolescents and young adults with type 1 diabetes exhibit the worst glycemic control among individuals with type 1 diabetes across the lifespan. Although continuous glucose monitoring (CGM) has been shown to improve glycemic control in adults, its benefit in adolescents and young adults has not been demonstrated. Objective To determine the effect of CGM on glycemic control in adolescents and young adults with type 1 diabetes. Design, Setting, and Participants Randomized clinical trial conducted between January 2018 and May 2019 at 14 endocrinology practices in the US including 153 individuals aged 14 to 24 years with type 1 diabetes and screening hemoglobin A1c (HbA1c) of 7.5% to 10.9%. Interventions Participants were randomized 1:1 to undergo CGM (CGM group; n = 74) or usual care using a blood glucose meter for glucose monitoring (blood glucose monitoring [BGM] group; n = 79). Main Outcomes and Measures The primary outcome was change in HbA1c from baseline to 26 weeks. There were 20 secondary outcomes, including additional HbA1c outcomes, CGM glucose metrics, and patient-reported outcomes with adjustment for multiple comparisons to control for the false discovery rate. Results Among the 153 participants (mean [SD] age, 17 [3] years; 76 [50%] were female; mean [SD] diabetes duration, 9 [5] years), 142 (93%) completed the study. In the CGM group, 68% of participants used CGM at least 5 days per week in month 6. Mean HbA1c was 8.9% at baseline and 8.5% at 26 weeks in the CGM group and 8.9% at both baseline and 26 weeks in the BGM group (adjusted between-group difference, -0.37% [95% CI, -0.66% to -0.08%]; P = .01). Of 20 prespecified secondary outcomes, there were statistically significant differences in 3 of 7 binary HbA1c outcomes, 8 of 9 CGM metrics, and 1 of 4 patient-reported outcomes. The most commonly reported adverse events in the CGM and BGM groups were severe hypoglycemia (3 participants with an event in the CGM group and 2 in the BGM group), hyperglycemia/ketosis (1 participant with an event in CGM group and 4 in the BGM group), and diabetic ketoacidosis (3 participants with an event in the CGM group and 1 in the BGM group). Conclusions and Relevance Among adolescents and young adults with type 1 diabetes, continuous glucose monitoring compared with standard blood glucose monitoring resulted in a small but statistically significant improvement in glycemic control over 26 weeks. Further research is needed to understand the clinical importance of the findings. Trial Registration ClinicalTrials.gov Identifier: NCT03263494.

中文翻译：

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持续血糖监测对青少年和青年 1 型糖尿病患者血糖控制的影响

重要性 患有 1 型糖尿病的青少年和年轻人在 1 型糖尿病患者的一生中表现出最差的血糖控制。尽管连续血糖监测 (CGM) 已被证明可以改善成人的血糖控制，但其对青少年和年轻成人的益处尚未得到证实。目的 确定 CGM 对青少年和青年 1 型糖尿病患者血糖控制的影响。设计、设置和参与者 2018 年 1 月至 2019 年 5 月在美国 14 家内分泌诊所进行的随机临床试验，包括 153 名 14 至 24 岁的 1 型糖尿病患者，筛查血红蛋白 A1c (HbA1c) 为 7.5% 至 10.9%。干预 参与者以 1:1 的比例随机接受 CGM（CGM 组；n = 74) 或使用血糖仪进行血糖监测的常规护理（血糖监测 [BGM] 组；n = 79）。主要结果和措施 主要结果是 HbA1c 从基线到 26 周的变化。有 20 个次要结果，包括额外的 HbA1c 结果、CGM 血糖指标和患者报告的结果，并通过多重比较调整来控制错误发现率。结果 在 153 名参与者（平均 [SD] 年龄，17 [3] 岁；76 [50%] 为女性；平均 [SD] 糖尿病病程，9 [5] 年）中，142 (93%) 人完成了研究。在 CGM 组中，68% 的参与者在第 6 个月每周至少使用 5 天。平均 HbA1c 在基线时为 8.9%，在 CGM 组中为 8.5%，在 BGM 中为基线和 26 周时的 8.9%组（调整组间差异，-0.37% [95% CI，-0.66% 至 -0。08%]; P = .01）。在 20 个预先指定的次要结果中，7 个二元 HbA1c 结果中的 3 个、9 个 CGM 指标中的 8 个和 4 个患者报告的结果中的 1 个存在统计学显着差异。CGM 和 BGM 组中最常报告的不良事件是严重低血糖（3 名参与者在 CGM 组中发生事件，2 名在 BGM 组中发生）、高血糖/酮症（1 名参与者在 CGM 组中发生事件，4 名参与者发生在 BGM 组中）组）和糖尿病酮症酸中毒（CGM 组 3 名参与者和 BGM 组 1 名参与者）。结论和相关性 在患有 1 型糖尿病的青少年和年轻成人中，与标准血糖监测相比，连续血糖监测在 26 周内导致血糖控制的微小但具有统计学意义的改善。需要进一步研究以了解这些发现的临床重要性。试验注册 ClinicalTrials.gov 标识符：NCT03263494。