Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts.
Jaeb Center for Health Research, Tampa, Florida.
JAMA. 2020 Jun 16;323(23):2388-2396. doi: 10.1001/jama.2020.6940.
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.
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%.
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).
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.
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).
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.
ClinicalTrials.gov Identifier: NCT03263494.
在整个生命周期中，1 型糖尿病青少年和年轻人的血糖控制是所有 1 型糖尿病患者中最差的。虽然连续血糖监测（CGM）已被证明可以改善成年人的血糖控制，但尚未证明其对青少年和年轻人的益处。
确定 CGM 对 1 型糖尿病青少年和年轻人血糖控制的影响。
设计、地点和参与者：在美国 14 个内分泌科进行的随机临床试验，时间为 2018 年 1 月至 2019 年 5 月，参与者包括 153 名年龄在 14 至 24 岁之间、1 型糖尿病且糖化血红蛋白（HbA1c）筛查值为 7.5%至 10.9%的患者。
参与者被随机分为 1:1 接受 CGM（CGM 组；n = 74）或使用血糖仪进行常规血糖监测（血糖监测[BGM]组；n = 79）。
主要结局是从基线到 26 周时 HbA1c 的变化。共有 20 个次要结局，包括额外的 HbA1c 结局、CGM 血糖指标以及经过多次比较调整以控制假发现率的患者报告结局。
在 153 名参与者中（平均[标准差]年龄，17[3]岁；76[50%]为女性；平均[标准差]糖尿病病程，9[5]年），142 名（93%）完成了研究。在 CGM 组中，68%的参与者在第 6 个月至少每周使用 CGM 5 天。CGM 组的基线 HbA1c 为 8.9%，26 周时为 8.5%，BGM 组的基线和 26 周时均为 8.9%（调整后的组间差异，-0.37%[95%CI，-0.66%至-0.08%]；P = .01）。在 20 个预先指定的次要结局中，有 7 个二进制 HbA1c 结局中的 3 个、9 个 CGM 指标中的 8 个和 4 个患者报告结局中的 1 个存在统计学差异。CGM 组和 BGM 组最常报告的不良事件是严重低血糖（CGM 组 3 名参与者，BGM 组 2 名参与者）、高血糖/酮症（CGM 组 1 名参与者，BGM 组 4 名参与者）和糖尿病酮症酸中毒（CGM 组 3 名参与者，BGM 组 1 名参与者）。
在 1 型糖尿病青少年和年轻人中，与标准血糖监测相比，连续血糖监测在 26 周内使血糖控制有了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意义。
ClinicalTrials.gov 标识符：NCT03263494。
