Evaluation of Glycemic Changes and Optimization of Glycemic Control During Exercise in Children With Type 1 Diabetes Under Continuous Subcutaneous Insulin Infusion (CSII) or Multiple Daily Injection Regimen (MDI) (TREAD-DIAB Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Subcutaneous glucose evolution
研究概览
简要总结
The objectives of the study are: 1) to evaluate the effects of moderate exercise on SG evolution without insulin dose modification in patients with T1D under continuous subcutaneous insulin infusion (CSII) and multiple daily injection (MDI) therapy, and compare differences between these 2 groups; 2) to evaluate the impact of insulin dose modification (bolus, basal, reduction or increase, based on SG evolution profile obtained after first exercise) before and/or during moderate exercise on T1D children under CSII and MDI regimen, and compare differences between these 2 groups.
详细描述
Intervention and procedures:
a) The patients will first be assigned to standardized moderate-to-vigorous exercise for SG determination; b) similar exercise will then be repeated with preemptive adaptation of insulin dose (tailored on SG evolution during first exercise) for determination of potential influences on SG evolution.
Intervention Plan:
- At first visit (day [>18h] before exercise): setting of a Continuous Glucose Monitoring System
- At second visit: moderate-to-vigorous exercise with treadmill.
- At third visit (2 days after exercise): removal of CGMS
- At fourth visit (day [>18h] before fifth visit): setting of a Continuous Glucose Monitoring System
- At fifth visit: moderate exercise with treadmill, and insulin dose modification (basal rate, bolus, reduction, increase)
- At sixth visit (2 days after exercise): removal of CGMS
- Total number of visits: 6
- The exercises will be performed between 1 and 2 hours after breakfast or after lunch; the second exercise will be performed ≥2 weeks after the first exercise.
Controls:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosis of T1D (according to the ISPAD 2011 guidelines)
- •T1D outside of partial remission phase (defined according to the IDAA1C definition [Diabetes Care 2007], being equal to A1C (%) + [4 x insulin dose (units per kilogram per 24 h)] and at least > 2 years after T1D diagnosis (defined as the first day of insulin therapy)
排除标准
- •Non-type 1 diabetes
- •Severe neonatal asphyxia (defined as Apgar score 3 or less after 5 min), children born small for gestational age, chronic systemic disease, active malignancy, hypothyroidism, hypopituitarism, developmental delay, bladder dysfunction, obesity, carnitine deficiency, β-oxidation defect, cardiac malformations, dysrhythmia
- •Intake of drugs interfering with insulin sensitivity (e.g. corticosteroids, GH).
- •HbA1C >9.5% at the time of enrollment in the study.
研究组 & 干预措施
Patients under MDI.
Patients under multiple daily injection regimen. Intervention= 2 treadmill exercises to evaluate the efficacy of algorithmic changes in insulin therapy (insulin aspart and glargine or detemir).
干预措施: Algorithmic changes in insulin therapy. (Other)
Patients under insulin pump therapy.
Patients under insulin pump therapy. Intervention= 2 treadmill exercises to evaluate the efficacy of algorithmic changes in insulin therapy (insulin aspart).
干预措施: Algorithmic changes in insulin therapy. (Other)
Patients under insulin pump therapy.
Patients under insulin pump therapy. Intervention= 2 treadmill exercises to evaluate the efficacy of algorithmic changes in insulin therapy (insulin aspart).
干预措施: Treadmill exercises (Other)
Patients under insulin pump therapy.
Patients under insulin pump therapy. Intervention= 2 treadmill exercises to evaluate the efficacy of algorithmic changes in insulin therapy (insulin aspart).
干预措施: Insulin aspart, glargine and detemir (Drug)
Patients under MDI.
Patients under multiple daily injection regimen. Intervention= 2 treadmill exercises to evaluate the efficacy of algorithmic changes in insulin therapy (insulin aspart and glargine or detemir).
干预措施: Treadmill exercises (Other)
结局指标
主要结局
Subcutaneous glucose evolution
时间窗: 12 months
Subcutaneous glucose evolution after completion of 2 exercise tests
次要结局
未报告次要终点