NCT01315808终止不适用
Rate of Change of HbA1c (dx/dt) May Predict Progression to Type 2 DM: Comparing the Concept of dx/dt With QD Diabetes Prediction Model. D.E.R.M.S Initiative (Doctor Enabled Risk Management System)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 542
- 试验地点
- 1
- 主要终点
- Study the rate of change of HbA1c in normal population with known risk factors of diabetes
研究概览
简要总结
The investigators hypothesize that the HbA1c shows a rising trend in pre-diabetics and normal population with risk factors of developing type 2 DM. There is no known diabetes model for predicting incident diabetes in an individual which takes into account the rate of change of HbA1c (dx/dt). In such cases, the rate of change of HbA1c may give the physicians lead time needed to implement the Diabetes Prevention Program measures.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No self-reported history of diabetes or pre-diabetes defined as per ADA criteria
- •Age greater than 18 years
- •Scheduled to receive HbA1c in participating clinic
- •Able and willing to give legally effective consent
- •Able and willing to participate in patient questionnaires(attached)
排除标准
- •Previously or currently taking medications for lowering glucose (i.e., exenatide, pramlintide, metformin, rosiglitazone, pioglitazone, or future diabetes drugs) based on self-report and/or prescreening. Patients on drugs causing hyperglycemia like Oral Steroids will be excluded.
- •Baseline HbA1c level above 5.7
- •Severe Anemia (defined as Hb less than 8gm/dL)
- •Patients with hemoglobinopathies
- •Pregnancy
- •Polycystic ovarian disease
结局指标
主要结局
Study the rate of change of HbA1c in normal population with known risk factors of diabetes
时间窗: one year
次要结局
- Diabetes prediction model based on the rate of change in HbA1c(one year)
研究者
研究点 (1)
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