EUCTR2016-002127-28-DK进行中（未招募）1 期
The impact of subcutaneous glucagon before, during and after exercise. A study in patients with type 1 diabetes mellitus - The impact of a glucagon injection before, during and after exercise
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age 18 - 70 years
- •- T1D = 2 year
- •- BMI 20-30 kg/m2
- •- Insulin pump = 1 year.
- •- HbA1c < 69 mmol/mol (8.5 %)
- •- Hypoglycemia awareness (reported by Gold et al.)
- •- Use of carbohydrate counting and the insulin pump bolus calculator for all meals
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 14
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Allergy or intolerance to lactose or GlucaGen® (Novo Nordisk, Bagsværd, DK)
- •- Impaired renal function (eGFR < 60 ml/min/1.73m2)
- •- Liver disease with ALAT > 2.5 times the upper limit of the reference interval
- •- Use of anti-diabetic medicine (other than insulin), per oral corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
- •- Known or suspected alcohol or drug abuse
- •- Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
- •- Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
- •- Inability to understand the patient information and to give informed consent
- •- Physical or mental incapacity to perform exercise
- •-People with vigorous intensity aerobic physical activity such as swimming, jogging, aerobics, football, tennis, gym, workout etc, more than 3 hours or more per week.
- •- Chronic use or unable to stop acetaminophen (paracetamol) use
- •-Allergy to the patch of CGM sensors
研究者
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