Insulin Requirement for Pure- Protein Meal in Children With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion - a Cross-over, Randomized Trial.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Postprandial glycemia
研究概览
简要总结
This is a randomized, cross-over study. The aim of this study is to compare the post-prandial glycaemic variability after pure protein meal following with an administration of square-wave bolus of meal-insulin or without any meal-insulin bolus on the other day.
Prolonged post-prandial glycaemic variability will be identified using the self-monitoring of blood glucose (10-point curve) and CGMS.
详细描述
The square-wave bolus (for meals rich in fat and/or protein) is evenly delivered over several hours as programmed by the patient. The required insulin dose will be calculated based on patient's insulin-exchange ratio. Pure protein meal will be given 3 hours after a first breakfast.
To provide the minimal impact of the previous breakfast, all patients will receive up to 120 kcal of carbohydrates and <100 kcal from protein and fat for the first breakfast (without any extended bolus) Patients receive a standardized pure protein meal at a second breakfast time. Meal insulin will be given as a square bolus or no meal -insulin will be given at all. The 5h post-meal glucose excursions will be recorded by self-blood glucose measurements (SMBG) (every 30 minutes) and continuous glucose monitoring system (CGMS). The intervention is taking part under in-patient clinical conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •duration of type 1 diabetes longer than 12 months
- •insulin pump therapy longer than 3 months
- •written informed consent by patients and parents
- •insulin requirement more than 0,5 units/kg/day
排除标准
- •diabetes related complications (e.g. nephropathy)
- •chronic kidney diseases
- •any disease judged by the investigator to affect the trial
- •withdrawal of consent to participate in the study
研究组 & 干预措施
group A
On the first study day, insulin bolus was not given before a standardized pure protein meal. On the second day, pre-breakfast insulin was given as a square-wave bolus before the same standardized pure protein meal.
The fat-protein-insulin ratio on both study days were identical to the patient's ratio when entering trial.
Kind of study bolus insulin will be a rapid-acting insulin analog same as previously used by the participant (before entering the trial) - insulin aspart, insulin lispro or insulin glulisine
干预措施: Insulin glulisine (Drug)
group A
On the first study day, insulin bolus was not given before a standardized pure protein meal. On the second day, pre-breakfast insulin was given as a square-wave bolus before the same standardized pure protein meal.
The fat-protein-insulin ratio on both study days were identical to the patient's ratio when entering trial.
Kind of study bolus insulin will be a rapid-acting insulin analog same as previously used by the participant (before entering the trial) - insulin aspart, insulin lispro or insulin glulisine
干预措施: Insulin aspart (Drug)
group A
On the first study day, insulin bolus was not given before a standardized pure protein meal. On the second day, pre-breakfast insulin was given as a square-wave bolus before the same standardized pure protein meal.
The fat-protein-insulin ratio on both study days were identical to the patient's ratio when entering trial.
Kind of study bolus insulin will be a rapid-acting insulin analog same as previously used by the participant (before entering the trial) - insulin aspart, insulin lispro or insulin glulisine
干预措施: Insulin lispro (Drug)
group B
On the first study day, pre-breakfast insulin was given as a square-wave bolus before a standardized pure protein meal. On the second day, insulin bolus was not given before the same standardized pure protein meal.
The fat-protein-insulin ratio on both study days were identical to the patient's ratio when entering trial.
Kind of study bolus insulin will be a rapid-acting insulin analog same as previously used by the participant (before entering the trial) - insulin aspart, insulin lispro or insulin glulisine
干预措施: Insulin glulisine (Drug)
group B
On the first study day, pre-breakfast insulin was given as a square-wave bolus before a standardized pure protein meal. On the second day, insulin bolus was not given before the same standardized pure protein meal.
The fat-protein-insulin ratio on both study days were identical to the patient's ratio when entering trial.
Kind of study bolus insulin will be a rapid-acting insulin analog same as previously used by the participant (before entering the trial) - insulin aspart, insulin lispro or insulin glulisine
干预措施: Insulin aspart (Drug)
group B
On the first study day, pre-breakfast insulin was given as a square-wave bolus before a standardized pure protein meal. On the second day, insulin bolus was not given before the same standardized pure protein meal.
The fat-protein-insulin ratio on both study days were identical to the patient's ratio when entering trial.
Kind of study bolus insulin will be a rapid-acting insulin analog same as previously used by the participant (before entering the trial) - insulin aspart, insulin lispro or insulin glulisine
干预措施: Insulin lispro (Drug)
结局指标
主要结局
Postprandial glycemia
时间窗: 300 minutes after the meal
Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)
次要结局
- Hypoglycemia episodes(5-hour study period)
- Glucose Area Under the Curve (AUC)(5-hour study period)
- Mean amplitude of glycemic excursion(5-hour study period)
- The difference between the maximum and baseline glucose level(5-hour study period)