A Monocentric, Controlled, Randomized, Open-label Cross-over Study to Explore the Possible Insulin Treatment of Beverages Containing Alcohol and Carbohydrates in Adolescents and Young Adults With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- • Number of hypoglycaemic events <70 mg/dl per arm from begin of consumption until lunch next day (12:00 am)
研究概览
简要总结
The purpose of this study is to show that during and after drinking beer a treatment strategy by insulin bolus and reduction of basal rate reduces the rate of hyperglycaemia without an increase of hypoglycaemic events compared to a treatment strategy according to the standard recommendation without insulin Bolus.
详细描述
Participants will get two times a height, weight an gender based amount of beer.
One time (Standard) there will be no Insulin given for the beer. Second time (Intervention) half of the carbohydrates containing in the beer will be covered with Insulin, additionally the basal rate will be set to 50% for 12 hours.
All the time, Glucose will be monitored by continuous subcutaneous Glucose Monitoring.
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
- None
入排标准
- 年龄范围
- 16 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent by participants
- •Signed informed consent by parent or legal guardian of adolescent participants <18 years of age
- •Age between16-21 years (both including)
- •>1 year Type 1 Diabetes
- •continuous subcutaneous insulin infusion for at least 3 months
- •HbA1c 7-10 % (both including)
- •BMI between10-95th percentile for gender and age (both including) for adolescents, <95th percentile for adults
- •Ability to wear glucose sensor
- •Normal liver enzymes (alanine aminotransferase , aspartate transaminase , Gamma-Glutamyl-Transferase, bilirubin) in age appropriate range by local lab
排除标准
- •Severe hypoglycaemia or diabetic ketoacidosis in the past 6 month
- •Alcohol or drug abuse
- •Psychiatric disorder
- •Unstable other metabolic disease as judged by investigator
- •Intake of glucocorticoids or growth hormone
- •Allergy to adhesive
- •Coeliac disease
- •Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study
研究组 & 干预措施
Intervention
For carbohydrates in beer, subjects will get covering by Insulin (1/2 of calculated amount). As well Insulin basal rate will set to half for 12 hours
干预措施: Insulin (Drug)
结局指标
主要结局
• Number of hypoglycaemic events <70 mg/dl per arm from begin of consumption until lunch next day (12:00 am)
时间窗: 18 hours
次要结局
- • Total Area under the curve(18 hours)
- • average Sensor Glucose from begin of drinking to 12 hours past and to lunch next day(18 hours)
- • Time from end of consumption to nadir of serum glucose
- • Number of hypoglycaemic events <70 mg/dl per treatment arm until lunch(18 hours)
- • Number of hyperglycaemic events > 180 mg/dl per treatment arm until lunch(18 hours)
- • Time in Hypoglycaemia <70 mg/dl per treatment arm(18 hours)
- • Max. alcohol in expiratory breath(3 hours)
- • Area under the curve Glucose Sensor >120 mg/dl from begin of drinking to lunch next day(18 hours)