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临床试验/EUCTR2022-000427-20-NL
EUCTR2022-000427-20-NL进行中(未招募)1 期

A stable glucagon analog administered by a bihormonal closed loop system; a feasibility study - STABLE1

Inreda Diabetic0 个研究点目标入组 12 人开始时间: 2022年2月16日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
12

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

  • Diagnosed with diabetes mellitus type 1;
  • Treated with the Inreda AP system for a minimum of 1 month;
  • Age between 18 and 75 years;
  • Adequate contraception is required (only applicable for female participants);
  • 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 9
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 3

排除标准

  • Impaired awareness of hypoglycemia
  • Pregnancy and/or breastfeeding;
  • Use of oral antidiabetic agents;
  • Pheochromocytoma;
  • Insulinoma;
  • Severe liver/heart/renal failure;
  • Alcohol abuse;
  • Hypersensitivity reactions to dasiglucagon.

研究者

发起方
Inreda Diabetic

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