The Optimal Type of Bolus Following a High-protein Meal in Type 1 Diabetic Children Treated With Insulin Pumps
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 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
Patients receive a standardized high-protein test meal at breakfast time. Insulin is given as bolus (normal or dual-wave (normal plus square) and basal rate using an insulin pump. The 3h post-meal glucose excursions will be recorded by self-blood glucose measurements (SMBG) (every 1 hour) and continuous glucose monitoring system (CGMS). The intervention is taking part under in-patient clinical conditions.
详细描述
The dual-wave bolus delivers an immediate normal pre-meal insulin bolus followed by square-wave bolus that is evenly delivered over several hours as programmed by the patient. The aim of this study is to compare post-prandial glycaemic excursions following a high-protein meal after administration of insulin by normal vs dual-wave bolus. During this prospective, cross-over, repeated measures study, pediatric patients with type 1 diabetes, treated with insulin pump therapy will be evaluated using the self-blood glucose measurements following standardized high-protein meal and two types of boluses (normal or dual-wave). The required insulin dose will be calculated based on patient's insulin-exchange ratio. A high-protein meal will be given on two subsequent breakfasts and comparisons will be made between normal and dual-wave insulin bolus delivery. Prolonged post-prandial glycaemic excursions will be identified using the CGMS.
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
- Single (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
- •patients must be willing to wear a glucose sensor for two days
- •insulin requirement more than 0,5 units/kg/day
排除标准
- •concomitant dietary restrictions (e.g. celiac disease or food allergy)
- •diabetes related complications (e.g. nephropathy)
- •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
Normal/ Dual-wave
On the first study day, pre-breakfast insulin was given as a normal bolus 15 minutes before a standardized high-protein meal. On the second day, pre-breakfast insulin was given as a dual-wave bolus before the same high-protein meal.
The carbo-insulin and 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)
Normal/ Dual-wave
On the first study day, pre-breakfast insulin was given as a normal bolus 15 minutes before a standardized high-protein meal. On the second day, pre-breakfast insulin was given as a dual-wave bolus before the same high-protein meal.
The carbo-insulin and 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)
Normal/ Dual-wave
On the first study day, pre-breakfast insulin was given as a normal bolus 15 minutes before a standardized high-protein meal. On the second day, pre-breakfast insulin was given as a dual-wave bolus before the same high-protein meal.
The carbo-insulin and 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)
Dual-wave/Normal
On the first study day, pre-breakfast insulin was given as a dual-wave bolus 15 minutes before a standardized high-protein meal. On the second day, pre-breakfast insulin was given as a normal bolus before the same high-protein meal.
The carbo-insulin and 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)
Dual-wave/Normal
On the first study day, pre-breakfast insulin was given as a dual-wave bolus 15 minutes before a standardized high-protein meal. On the second day, pre-breakfast insulin was given as a normal bolus before the same high-protein meal.
The carbo-insulin and 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)
Dual-wave/Normal
On the first study day, pre-breakfast insulin was given as a dual-wave bolus 15 minutes before a standardized high-protein meal. On the second day, pre-breakfast insulin was given as a normal bolus before the same high-protein meal.
The carbo-insulin and 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)
结局指标
主要结局
Postprandial glycemia
时间窗: 180 minutes after the meal
Post-prandial blood glucose excursions measured by self monitoring of blood glucose
次要结局
- Hypoglycemia episodes(3-hour study period)
- Glucose Area Under the Curve (AUC)(3-hour study period)
- Mean amplitude of glycemic excursion(3-hour study period)