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《MiniMed 780G 高级闭环系统在青少年 1 型糖尿病中的真实世界疗效:AWeSoMe 研究组多中心前瞻性试验》。

Real-Life Achievements of MiniMed 780G Advanced Closed-Loop System in Youth with Type 1 Diabetes: AWeSoMe Study Group Multicenter Prospective Trial.

机构信息

Pediatric Endocrine and Diabetes Unit, Edmond and Lily Safra Children's Hospital, Chaim Sheba Medical Center, Ramat-Gan, Israel.

School of Medicine, Faculty of Medical and Health Sciences, Tel Aviv University, Tel Aviv, Israel.

出版信息

Diabetes Technol Ther. 2024 Nov;26(11):869-880. doi: 10.1089/dia.2024.0148. Epub 2024 May 31.

Abstract

We assessed real-life glycemic outcomes and predictors of composite measures of optimal glycemic control in children and adolescents with type 1 diabetes (T1D) during their initial 12 months of the MiniMed™ 780G use. This prospective observational multicenter study collected demographic, clinical, and 2-week 780G system data at five time points. Optimal glycemic control was defined as a composite glycemic control (CGC) score requiring the attainment of four recommended continuous glucose monitoring (CGM) targets, as well as the glycemia risk index (GRI) of hypoglycemia and hyperglycemia and composite CGM index (COGI). Outcome measures included longitudinal changes in multiple glycemic parameters and CGC, GRI, and COGI scores, as well as predictors of these optimal measures. The cohort included 93 children, 43% girls, with a median age of 15.1 years (interquartile range [IQR] 12.9,17.0). A longitudinal analysis adjusted for age and socioeconomic index yielded a significant improvement in glycemic control for the entire cohort ( < 0.001) after the transition to 780G. The mean hemoglobin A1c (HbA1c) (SE) was 8.65% (0.12) at baseline and dropped by >1% after 1 year to 7.54% (0.14) ( < 0.001). Optimal glycemic control measures improved at 12 months post 780G; CGC improved by 5.6-fold ( < 0.001) and was attained by 24% of the participants, the GRI score improved by 10-fold ( = 0.009) and was achieved by 10% of them, and the COGI improved by 7.6-fold ( < 0.001) and was attained by 20% of them. Lower baseline HbA1c levels and increased adherence to Advanced Hybrid Closed-Loop (AHCL) usage were predictors of achieving optimal glycemic control. The AHCL 780G system enhances glycemic control in children and adolescents with T1D, demonstrating improvements in HbA1c and CGM metrics, albeit most participants did not achieve optimal glycemic control. This highlights yet ongoing challenges in diabetes management, emphasizing the need for continued proactive efforts on the part of health care professionals, youth, and caregivers.

摘要

我们评估了儿童和青少年在使用 MiniMed™ 780G 的最初 12 个月内的真实血糖结果和最佳血糖控制综合指标的预测因素。这项前瞻性观察性多中心研究在五个时间点收集了人口统计学、临床和 2 周 780G 系统数据。最佳血糖控制定义为需要达到四个推荐的连续血糖监测 (CGM) 目标的综合血糖控制 (CGC) 评分,以及低血糖和高血糖的血糖风险指数 (GRI) 和综合 CGM 指数 (COGI)。主要观察指标包括多个血糖参数和 CGC、GRI 和 COGI 评分的纵向变化,以及这些最佳措施的预测因素。该队列包括 93 名儿童,其中 43%为女孩,中位年龄为 15.1 岁(四分位距 [IQR] 12.9,17.0)。对年龄和社会经济指数进行调整的纵向分析显示,整个队列在过渡到 780G 后血糖控制有显著改善(<0.001)。平均血红蛋白 A1c(HbA1c)(SE)基线时为 8.65%(0.12),1 年后下降>1%至 7.54%(0.14)(<0.001)。使用 780G 后 12 个月时最佳血糖控制指标改善;CGC 提高了 5.6 倍(<0.001),24%的参与者达到,GRI 评分提高了 10 倍(=0.009),10%的参与者达到,COGI 提高了 7.6 倍(<0.001),20%的参与者达到。较低的基线 HbA1c 水平和增加对高级混合闭环 (AHCL) 使用的依从性是实现最佳血糖控制的预测因素。780G 系统增强了 T1D 儿童和青少年的血糖控制,HbA1c 和 CGM 指标有所改善,但大多数参与者并未达到最佳血糖控制。这突显了糖尿病管理方面仍存在挑战,强调了医疗保健专业人员、青少年及其照顾者需要继续积极努力。

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