PDF(Pubmed)
Abstract：
UNASSIGNED: Advanced hybrid closed loop (AHCL) systems have the potential to improve glycemia and reduce burden for people with type 1 diabetes (T1D). Children and youth, who are at particular risk for out-of-target glycemia, may have the most to gain from AHCL. However, no randomized controlled trial (RCT) specifically targeting this age group with very high HbA1c has previously been attempted. Therefore, the CO-PILOT trial (Closed lOoP In chiLdren and yOuth with Type 1 diabetes and high-risk glycemic control) aims to evaluate the efficacy and safety of AHCL in this group.
UNASSIGNED: A prospective, multicenter, parallel-group, open-label RCT, comparing MiniMed™ 780G AHCL to standard care (multiple daily injections or continuous subcutaneous insulin infusion). Eighty participants aged 7-25 years with T1D, a current HbA1c ≥ 8.5% (69 mmol/mol), and naïve to automated insulin delivery will be randomly allocated to AHCL or control (standard care) for 13 weeks. The primary outcome is change in HbA1c between baseline and 13 weeks. Secondary outcomes include standard continuous glucose monitor glycemic metrics, psychosocial factors, sleep, platform performance, safety, and user experience. This RCT will be followed by a continuation phase where the control arm crosses over to AHCL and all participants use AHCL for a further 39 weeks to assess longer term outcomes.
UNASSIGNED: This study will evaluate the efficacy and safety of AHCL in this population and has the potential to demonstrate that AHCL is the gold standard for children and youth with T1D experiencing out-of-target glucose control and considerable diabetes burden.
UNASSIGNED: This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry on 14 November 2022 (ACTRN12622001454763) and the World Health Organization International Clinical Trials Registry Platform (Universal Trial Number U1111-1284-8452).
UNASSIGNED: The online version contains supplementary material available at 10.1007/s40200-024-01397-4.
UNASSIGNED: A prospective, multicenter, parallel-group, open-label RCT, comparing MiniMed™ 780G AHCL to standard care (multiple daily injections or continuous subcutaneous insulin infusion). Eighty participants aged 7-25 years with T1D, a current HbA1c ≥ 8.5% (69 mmol/mol), and naïve to automated insulin delivery will be randomly allocated to AHCL or control (standard care) for 13 weeks. The primary outcome is change in HbA1c between baseline and 13 weeks. Secondary outcomes include standard continuous glucose monitor glycemic metrics, psychosocial factors, sleep, platform performance, safety, and user experience. This RCT will be followed by a continuation phase where the control arm crosses over to AHCL and all participants use AHCL for a further 39 weeks to assess longer term outcomes.
UNASSIGNED: This study will evaluate the efficacy and safety of AHCL in this population and has the potential to demonstrate that AHCL is the gold standard for children and youth with T1D experiencing out-of-target glucose control and considerable diabetes burden.
UNASSIGNED: This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry on 14 November 2022 (ACTRN12622001454763) and the World Health Organization International Clinical Trials Registry Platform (Universal Trial Number U1111-1284-8452).
UNASSIGNED: The online version contains supplementary material available at 10.1007/s40200-024-01397-4.
摘要：
■先进的混合闭环（AHCL）系统具有改善血糖并减轻1型糖尿病（T1D）患者负担的潜力。儿童和青年，特别容易发生血糖脱靶的人，可能会从AHCL中获得最大收益。然而,以前没有尝试专门针对HbA1c非常高的这一年龄组的随机对照试验(RCT).因此,CO-PILOT试验(在1型糖尿病和高风险血糖控制的儿童和青少年中的封闭式lOoP)旨在评估AHCL在该组中的疗效和安全性.
■预期，多中心，平行组，开放标签RCT,将MiniMed™780GAHCL与标准护理（每日多次注射或持续皮下胰岛素输注）进行比较。80名年龄在7-25岁的T1D参与者，a当前HbA1c≥8.5%(69mmol/mol)，和幼稚的自动胰岛素输送将随机分配给AHCL或对照（标准护理）13周。主要结果是基线和13周之间的HbA1c变化。次要结果包括标准连续血糖监测血糖指标，社会心理因素,睡眠,平台性能,安全,和用户体验。此RCT之后将是一个持续阶段，控制臂交叉到AHCL，所有参与者再使用AHCL39周以评估长期结果。
这项研究将评估AHCL在该人群中的疗效和安全性，并有可能证明AHCL是T1D患者血糖控制不达标和糖尿病负担相当大的儿童和青少年的金标准。
该试验于2022年11月14日在澳大利亚新西兰临床试验注册中心（ACTRN12622001454763）和世界卫生组织国际临床试验注册平台（通用试验编号U1111-1284-8452）进行了前瞻性注册。
■在线版本包含补充材料，可在10.1007/s40200-024-01397-4获得。
■预期，多中心，平行组，开放标签RCT,将MiniMed™780GAHCL与标准护理（每日多次注射或持续皮下胰岛素输注）进行比较。80名年龄在7-25岁的T1D参与者，a当前HbA1c≥8.5%(69mmol/mol)，和幼稚的自动胰岛素输送将随机分配给AHCL或对照（标准护理）13周。主要结果是基线和13周之间的HbA1c变化。次要结果包括标准连续血糖监测血糖指标，社会心理因素,睡眠,平台性能,安全,和用户体验。此RCT之后将是一个持续阶段，控制臂交叉到AHCL，所有参与者再使用AHCL39周以评估长期结果。
这项研究将评估AHCL在该人群中的疗效和安全性，并有可能证明AHCL是T1D患者血糖控制不达标和糖尿病负担相当大的儿童和青少年的金标准。
该试验于2022年11月14日在澳大利亚新西兰临床试验注册中心（ACTRN12622001454763）和世界卫生组织国际临床试验注册平台（通用试验编号U1111-1284-8452）进行了前瞻性注册。
■在线版本包含补充材料，可在10.1007/s40200-024-01397-4获得。
