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临床试验/EUCTR2020-005836-31-DK
EUCTR2020-005836-31-DK进行中(未招募)1 期

Dual-Hormone Closed-Loop Glucose Control in Adolescents with Type 1 Diabetes - Dual-Hormone Closed-Loop 2021

Steno Diabetes Center Copenhagen0 个研究点目标入组 20 人开始时间: 2021年2月23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)
入组人数
20

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 = 13-17 years
  • -T1D duration = 2 years
  • -Insulin pump therapy = 1 year
  • -Using CGM or isCGM (Flash Libre)
  • -HbA1c = 9.0% (75 mmol/mol)
  • -Using carbohydrate counting
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • -Allergy to glucagon or lactose
  • -Allergy to faster insulin aspart (FiAsp)
  • -Pheochromocytoma
  • -Self-reported lack of hypoglycemia symptoms when blood glucose is < 3.0 mmol/l
  • -Inability to follow study procedures, e.g. exercise, sleeping, blood sampling, and meal intake
  • -Pregnancy, nursing, plan to become pregnant or sexually active and not using adequate contraceptive methods (intrauterine device, contraceptive pill, patch or injection)
  • -Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during or within 30 days prior to study participation
  • -Other concomitant medical or psychological condition that according to the investigator's assessment makes the participant unsuitable for study participation

研究者

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