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临床试验/ACTRN12622000472774
ACTRN12622000472774撤回未知

Assessment of the efficacy of closed loop technology for glucose control in young children with Type 1 Diabetes

Telethon Kids Institute0 个研究点目标入组 70 人开始时间: 2022年3月25日最近更新:
适应症

试验速览

阶段
未知
状态
撤回
入组人数
70

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
2 Years 至 7 Years(—)
性别
All

入选标准

  • 1.Type 1 diabetes (diagnosis consistent with American Diabetes Association Classification of Diabetes Mellitus, diagnosed at least 1 year ago)
  • 2.CSII therapy for at least 3 months
  • 3.Age 2 to 7 years (inclusive)
  • 4.Total daily insulin of greater or equal 8 units/day in last 2 weeks
  • 5.Participant and parent willing to follow study instructions
  • 6.Living in an area with internet and cellular coverage

排除标准

  • 1. Commenced CGM in the 3 months prior to screening visit
  • 2. Using advanced hybrid closed loop system: Control IQ
  • 3. Uncontrolled coeliac disease
  • 4. Uncontrolled thyroid disease
  • 5. Inability or unwillingness to meet protocol requirements
  • 6. Unwilling to perform 3 to 4 finger stick blood glucose measurements daily
  • 7. Use of Hydroxyurea medication
  • 8. Poor vision (of primary caregiver) precluding the use of investigational technology

研究者

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