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临床试验/NCT04262700
NCT04262700Unknown不适用

Customer Outcomes & Value Experiencing A New Monitoring Technology

LifeScan Scotland Ltd4 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2020年2月7日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
170
试验地点
4
主要终点
A1c change from baseline after 12 weeks

研究概览

简要总结

To investigate whether novel insight features in new Blood Glucose Monitoring System (BGMs) can improve glycemic control.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with Type 1 diabetes mellitus or Type 2 diabetes mellitus for ≥ 3 month prior to screening
  • Currently performing self-monitoring of blood glucose (SMBG) at home for diabetes management decisions
  • Willingness to notify the study staff if they become pregnant during the study
  • Willing to sign an informed consent

排除标准

  • Currently using a continuous or flash glucose monitoring
  • Currently pregnant or planning pregnancy within duration of study or breast feeding; subjects who become pregnant during the study will be withdrawn.
  • Conflict of Interest

结局指标

主要结局

A1c change from baseline after 12 weeks

时间窗: 12 weeks

A1c change from baseline after 12 weeks in subjects using new BGMS compared to subjects' pre-study glycemic control

次要结局

未报告次要终点

研究者

发起方
LifeScan Scotland Ltd
申办方类型
Industry
责任方
Sponsor

研究点 (4)

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