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临床试验/EUCTR2014-003261-20-DK
EUCTR2014-003261-20-DK进行中(未招募)1 期

Dual-Hormone Closed-Loop Glucose Control in Type 1 Diabetes - Dual-Hormone Closed-Loop

Hvidovre University Hospital0 个研究点开始时间: 2014年10月2日最近更新:
适应症
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 years
  • -T1D = 2 years
  • -Insulin pump therapy with rapid-acting analog insulin = 1 year
  • -HbA1c = 8.5% (69 mmol/mol)
  • -Ability and willingness to comply with all protocol procedures
  • 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 13
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • -Pregnancy or nursing
  • -Plan to become pregnant or sexually active and not using adequate contraceptive methods (sterilization, intrauterine device, contraceptive pill, patch or injection)
  • -Hypoglycemia unawareness (self-reported lack of hypoglycemia symptoms when blood glucose is < 3.0 mmol/l)
  • -Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during or within 30 days prior to study participation
  • -History of coronary artery disease or congestive heart failure
  • -Abnormal ECG suggestive of coronary artery disease and increased risk of malignant arrhythmia
  • -Allergy to glucagon or lactose
  • -Pheochromocytoma
  • -Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation

研究者

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