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临床试验/ACTRN12615000137594
ACTRN12615000137594已完成未知

Evaluation of the Impact of Exercise on the Performance of an Artificial Pancreas in Adults with Type 1 Diabetes.

St Vincents Hospital0 个研究点目标入组 12 人开始时间: 2015年2月12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
12

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
18 Years 至 o limit(—)
性别
All

入选标准

  • Age > 18 years
  • -Type 1 Diabetes (confirmed by fasting C-peptide level < 50 pmol/L)
  • -Insulin pump therapy for at least 6 months
  • -HbA1c < 9.0%
  • -Experience with a glucose sensor
  • -Established insulin pump therapy parameters
  • -Ability to insert/change sensor
  • -Ability to undertake exercise as per protocol

排除标准

  • -Requiring > 150 units of insulin/day
  • -Diabetic ketoacidosis within the past 4 weeks
  • -Hypoglycaemic unawareness (Gold score >4) while on Sensor Augmented Pump Therapy (SAPT) or > 2 severe hypoglycaemic episodes within the last 12 months
  • -Pregnancy
  • -Renal impairment (eGFR < 60ml/min/1.73m2)
  • -Current or recent (<4 weeks) oral or inhaled steroid therapy
  • -Dermatological conditions involving the region of device insertion
  • -Ischaemic heart disease or peripheral vascular disease precluding exercise
  • -Physical limitations (e.g. impaired vision) that would compromise operation of the Closed Loop system

研究者

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