The Impact of Daily CarboHydrate Intake on Glycemic Control in Children and Adolescents With Type 1 Diabetes Using an Advanced Hybrid Closed-loop System (Medtronic MiniMed 780G): a Multi-center Real-world Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 347
- 试验地点
- 2
- 主要终点
- Time below range level 1 (%)
研究概览
简要总结
Lifestyle factors, including diet, play an important role in the achievement of glycemic targets in patients with diabetes, even with the use of automated insulin delivery (AID) systems. Advanced hybrid closed-loop systems (AHCL), by implementing innovative and powerful control algorithms, have been shown to improve the post-meal glycemic control in their users through the delivery of automatic correction boluses. However, data about the influence of the daily amount of carbohydrate intake on glycemic outcomes in youth with type 1 diabetes using AHCL are missing. Therefore, this study will evaluate the association between daily carbohydrate intakes and meal patterns on glycemic control of young people living with type 1 diabetes using an AHCL system (Medtronic MiniMed 780G; Medtronic, Northridge, California) under real-life conditions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 1 diabetes
- •Patients aged 7-18 years
- •Patients using Medtronic MiniMed 780G with SmartGuard activated
- •Patients whose informed consent has been obtained
- •>70% CGM data during observational period
排除标准
- •Patients with partial clinical remission according to the Hvidovre Study Group definition
- •Concomitant treatment with steroids or other drugs known to interfere with blood glucose levels
- •Previous diagnosis of psychological or eating disorders
结局指标
主要结局
Time below range level 1 (%)
时间窗: 6 months
Time spent with sensor glucose between 54 and 70 mg/dl (3.0 and 3.8 mmol/L)
Time above range level 2 (%)
时间窗: 6 months
Time spent with sensor glucose \> 250 mg/dl (13.9 mmol/L)
Time above range level 1 (%)
时间窗: 6 months
Time spent with sensor glucose between 180 and 250 mg/dl (10.1 and 13.9 mmol/L)
Time below range level 2 (%)
时间窗: 6 months
Time spent with sensor glucose \< 54 mg/dl (3.0 mmol/L)
Mean sensor glucose (mg/dl or mmol/L)
时间窗: 6 months
Coefficient of variation (%)
时间窗: 6 months
Time in range (%)
时间窗: 6 months
Time spent with sensor glucose between 70 and 180 mg/dl (3.9 and 10 mmol/L)
次要结局
- BMI Z-score(Baseline, 3 months, 6 months)
- Weight Z-score(Baseline, 3 months, 6 months)
- Height Z-score(Baseline, 3 months, 6 months)