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临床试验/ACTRN12622000828729
ACTRN12622000828729已完成未知

Effect of exercise on hypoglycaemia awareness in individuals with type 1 diabetes and IAH under free-living conditions: A pilot study

Telethon Kids Institute0 个研究点目标入组 7 人开始时间: 2022年6月14日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
7

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
14 Years 至 35 Years(—)
性别
All

入选标准

  • Participant inclusion criteria.
  • 1. Type 1 diabetes
  • 2. Age 14 to 35 years
  • 3. Impaired awareness of hypoglycaemia (Clarke score greater than or equal to 4 OR Gold Score greater than or equal to 4)
  • 4. No clinical contraindication to exercise
  • 5. HIE naïve or not participating in competitive team sports/sprints less than or equal to 1 /week
  • 6. No expected participation in high intensity exercise other than the study-prescribed exercise for
  • the duration of the study
  • 7. Willing to follow study instructions and attend visits
  • 8. Willing to wear real-time CGM
  • 9. Willing to wear a wrist-warn physical activity monitor (Garmin Forerunner)
  • 10. Able to carry out exercise tasks

排除标准

  • 1. Any clinical evidence of microvascular, macrovascular or neurological complications associated with T1D
  • 2. Any clinical evidence of cardiovascular disease
  • 3. Individuals not able to perform high-intensity exercise
  • 4. Individuals with severe hypoglycaemia (coma, convulsion or requiring third-party assistance for treatment) in the last six months
  • 5. Pregnancy or planned pregnancy within the study period
  • 6. Another serious chronic illness or concomitant medication impacting one’s ability to perform the
  • exercise testing or study participation
  • 7. Commenced new treatment (insulin pump or sensor) during or in the three months preceding the study

研究者

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