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临床试验/NCT03481530
NCT03481530已完成不适用

Development of Novel Predictors of Hypoglycemia for Type 2 Diabetes: Role of CGMS Usage in Predicting Risk for Hypoglycemia

University of Minnesota1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2018年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
1
主要终点
Hypoglycemia rate

研究概览

简要总结

This is a clinical study to examine rates hypoglycemia (self-report, EHR review, and review of values from a FDA approved continuous glucose monitoring system (CGMS)). Subjects will wear either blinded or unblinded CGMS. This is a 1:1 assignment with one group (50%) wearing 1 unblinded/1 blinded CGMS and the other group 50% wearing 2 blinded CGMS. The assignment will be computer based in a random fashion. Participants will continue with their usual diabetes management and glycemic monitoring profile as per usual. Those assigned to an unblinded CGMS can use the CGMS to manage their glucose levels at their own discretion. Individuals recruited will be those Type 2 diabetes who are deemed to be at high risk for hypoglycemia or low risk for hypoglycemia from a point score system established in an affiliated study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Type 2 Diabetes
  • 18 years or older

排除标准

  • Type 1 diabetes
  • Current pregnancy or anticipation of pregnancy during study period
  • At screening visit, HR> 130 or SBP>160 or DBP>100 which remains present on recheck

结局指标

主要结局

Hypoglycemia rate

时间窗: Week 16

Overall rate

次要结局

  • Comparison hypoglycemia rate(Week 16)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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