Department of Pediatric Endocrinology, Diabetes and Metabolic Diseases, University Children's Hospital, Ljubljana, Slovenia.
Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
JAMA Netw Open. 2023 Feb 1;6(2):e230077. doi: 10.1001/jamanetworkopen.2023.0077.
Continuous glucose monitoring (CGM) devices have demonstrated efficacy in adults and more recently in youths and older adults with type 1 diabetes. In adults with type 1 diabetes, the use of real-time CGM compared with intermittently scanned CGM was associated with improved glycemic control, but there are limited data available for youths.
To assess real-world data on achievement of time in range clinical targets associated with different treatment modalities in youths with type 1 diabetes.
DESIGN, SETTING, AND PARTICIPANTS: This multinational cohort study included children, adolescents, and young adults younger than 21 years (hereinafter referred to collectively as youths) with type 1 diabetes for a duration of at least 6 months who provided CGM data between January 1, 2016, and December 31, 2021. Participants were enrolled from the international Better Control in Pediatric and Adolescent Diabetes: Working to Create Centers of Reference (SWEET) registry. Data from 21 countries were included. Participants were divided into 4 treatment modalities: intermittently scanned CGM with or without insulin pump use and real-time CGM with or without insulin pump use.
Type 1 diabetes and the use of CGM with or without an insulin pump.
Proportion of individuals in each treatment modality group achieving recommended CGM clinical targets.
Among the 5219 participants (2714 [52.0%] male; median age, 14.4 [IQR, 11.2-17.1] years), median duration of diabetes was 5.2 (IQR, 2.7-8.7) years and median hemoglobin A1c level was 7.4% (IQR, 6.8%-8.0%). Treatment modality was associated with the proportion of individuals achieving recommended clinical targets. Adjusted for sex, age, diabetes duration, and body mass index standard deviation score, the proportion achieving the recommended greater than 70% time in range target was highest with real-time CGM plus insulin pump use (36.2% [95% CI, 33.9%-38.4%]), followed by real-time CGM plus injection use (20.9% [95% CI, 18.0%-24.1%]), intermittently scanned CGM plus injection use (12.5% [95% CI, 10.7%-14.4%]), and intermittently scanned CGM plus insulin pump use (11.3% [95% CI, 9.2%-13.8%]) (P < .001). Similar trends were observed for less than 25% time above (real-time CGM plus insulin pump, 32.5% [95% CI, 30.4%-34.7%]; intermittently scanned CGM plus insulin pump, 12.8% [95% CI, 10.6%-15.4%]; P < .001) and less than 4% time below range target (real-time CGM plus insulin pump, 73.1% [95% CI, 71.1%-75.0%]; intermittently scanned CGM plus insulin pump, 47.6% [95% CI, 44.1%-51.1%]; P < .001). Adjusted time in range was highest among real-time CGM plus insulin pump users (64.7% [95% CI, 62.6%-66.7%]). Treatment modality was associated with the proportion of participants experiencing severe hypoglycemia and diabetic ketoacidosis events.
In this multinational cohort study of youths with type 1 diabetes, concurrent use of real-time CGM and an insulin pump was associated with increased probability of achieving recommended clinical targets and time in range target as well as lower probability of severe adverse events compared with other treatment modalities.
连续血糖监测（CGM）设备在成年人中已经证明了其疗效，最近在 1 型糖尿病的青少年和老年人中也得到了证实。在 1 型糖尿病的成年人中，与间歇性扫描 CGM 相比，实时 CGM 与改善血糖控制相关，但针对青少年的数据有限。
评估不同治疗模式下与不同治疗模式相关的实时范围内临床目标在 1 型糖尿病青少年中的真实数据。
设计、地点和参与者：这项多国队列研究包括至少有 6 个月病史的 1 型糖尿病儿童、青少年和年龄在 21 岁以下的年轻人（以下统称为青少年）。参与者来自国际更好地控制儿科和青少年糖尿病：努力建立参考中心（SWEET）登记处。研究纳入了来自 21 个国家的数据。参与者被分为 4 种治疗模式：间歇性扫描 CGM 加或不加胰岛素泵使用，以及实时 CGM 加或不加胰岛素泵使用。
1 型糖尿病和 CGM 与胰岛素泵的使用。
在每个治疗模式组中，达到推荐 CGM 临床目标的个体比例。
在 5219 名参与者中（2714 名[52.0%]为男性；中位年龄，14.4[四分位距，11.2-17.1]岁），糖尿病病程中位数为 5.2（四分位距，2.7-8.7）年，血红蛋白 A1c 水平中位数为 7.4%（四分位距，6.8%-8.0%）。治疗模式与达到推荐临床目标的个体比例有关。调整性别、年龄、糖尿病病程和体重指数标准差评分后，实时 CGM 加胰岛素泵使用的推荐的大于 70%时间在范围内的目标比例最高（36.2%[95%置信区间，33.9%-38.4%]），其次是实时 CGM 加注射使用（20.9%[95%置信区间，18.0%-24.1%]），间歇性扫描 CGM 加注射使用（12.5%[95%置信区间，10.7%-14.4%]），以及间歇性扫描 CGM 加胰岛素泵使用（11.3%[95%置信区间，9.2%-13.8%]）（P < .001）。对于小于 25%的时间超过范围目标（实时 CGM 加胰岛素泵，32.5%[95%置信区间，30.4%-34.7%]；间歇性扫描 CGM 加胰岛素泵，12.8%[95%置信区间，10.6%-15.4%]）和小于 4%的时间低于范围目标（实时 CGM 加胰岛素泵，73.1%[95%置信区间，71.1%-75.0%]；间歇性扫描 CGM 加胰岛素泵，47.6%[95%置信区间，44.1%-51.1%]），也观察到类似的趋势（P < .001）。调整后的范围内时间在实时 CGM 加胰岛素泵使用者中最高（64.7%[95%置信区间，62.6%-66.7%]）。治疗模式与严重低血糖和糖尿病酮症酸中毒事件的发生率有关。
在这项针对 1 型糖尿病青少年的多国队列研究中，与其他治疗模式相比，实时 CGM 和胰岛素泵的联合使用与更高的推荐临床目标和范围内时间目标的达成概率以及严重不良事件的发生率降低相关。
