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临床试验/EUCTR2016-002127-28-DK
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

Hvidovre University Hospital0 个研究点开始时间: 2016年5月31日最近更新:
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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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