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