EUCTR2008-002336-15-GB进行中（未招募）1 期
The effect of prednisolone versus hydrocortisone as glucocorticoid replacement therapy on hypoglycaemia frequency in people with Type 1 diabetes and adrenal insufficiency: a pilot study. - Hypoglycaemia frequency in people with Type 1 diabetes and adrenal insufficiency.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 3
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
入选标准
- •1. Able to provide informed consent to participate in the study
- •2. Age 18 or over
- •3. Type 1 diabetes.
- •4. On current insulin regimen for at least 4 weeks.
- •5. Understanding of the principles of self-adjustment of insulin regimen on the basis of self blood glucose monitoring results.
- •6. Adrenal insufficiency
- •7. On current hydrocortisone regimen for at least 2 months.
- •8. Normal thyroid function or on appropriate thyroxine replacement.
- •9. With or without problematic hypoglycaemia.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 16
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •1. Inability to give informed consent
- •2. Age less than 18 years
- •3. Pregnancy or breastfeeding
- •4. Currently enrolled in other clinical study
- •5. Islet transplant / pancreatic transplant
- •6. Other steroid treatment (except inhalers and topical steroids)
- •7. Unstable angina, myocardial infarction, uncontrolled congestive cardiac failure in the previous year
- •8. Recent history of cancer (<5years)
- •9. Chronic kidney disease ( stage 3-5)
- •10. Liver function tests more than 3 times the upper limit of normal.
- •11. Coagulopathy (INR>1.5 or platelets less than 50x109/L)
- •12. Anaemia (Hb less than 10g/dL, except stable haemoglobinopathy)
研究者
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