一个前性的,多中心的,平行组的,开放的随机对照试验的协议,比较标准护理与封闭的LOOP 在患有1型糖尿病和高风险血糖控制的儿童和青少年中:CO-PILOT试验
Alisa Boucsein1, Yongwen Zhou1,2, Jillian J Haszard3
1Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.
Journal of diabetes and metabolic disorders
|June 27, 2024
概括
在CO-PILOT试验中,研究了针对儿童和青少年1型糖尿病 (T1D) 的先进混合闭环 (AHCL) 系统. 这项研究旨在改善血糖控制,并减少这种脆弱人群中T1D的负担.
科学领域:
- 内分泌学 在内分泌学.
- 糖尿病学 糖尿病学
- 儿科内分泌学 儿科内分泌学
背景情况:
- 儿童和青少年的1型糖尿病 (T1D) 管理具有独特的挑战,具有超标血糖控制的高风险.
- 先进的混合闭环 (AHCL) 系统在改善血糖和减少糖尿病管理的日常负担方面提供了潜在的好处.
- 之前没有任何随机对照试验 (RCT) 专门评估了这一年龄组的AHCL,该年龄组的HbA1c水平明显升高.
研究的目的:
- 评估MiniMedTM 780G AHCL系统在儿童和青少年 (7-25岁) 患有T1D和高HbA1c (≥8.5%) 的疗效和安全性.
- 评估AHCL对血糖控制,心理社会因素,睡眠和用户体验的影响.
- 建立AHCL作为管理T1D的潜在黄金标准,在小儿和青少年群体中,低于最佳的血糖控制.
主要方法:
- 一个前性的,多中心的,平行组的,开放标签的RCT,将AHCL与标准糖尿病护理进行比较.
- 80名患有T1D,HbA1c≥8.5%且之前没有自动胰岛素输送经验的参与者被随机分类.
- 主要结果是HbA1c从基线到13周的变化,次要结果包括持续血糖监测指标和心理社会评估.
主要成果:
- 主要结局是基线和13周之间HbA1c的变化.
- 二次结果包括持续的葡萄糖监测血糖指标,心理社会因素,睡眠,平台性能,安全性和用户体验.
- 39周的延续阶段将评估对照组的交叉对长期结果.
结论:
- 预计CO-PILOT试验将在患有T1D和高HbA1c的儿童和青少年中证明AHCL的疗效和安全性.
- AHCL有可能显著改善血糖控制,并降低这一群体的糖尿病负担.
- 这项研究可能将AHCL定位为儿童和青少年T1D患者的首选治疗方式,这些患者具有具有挑战性的血糖控制.
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