Naturalistic Evaluation of Hypoglycemic Events in Diabetic Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 726
- 主要终点
- Number of Participants Experiencing Mild, Moderate, Severe, or Very Severe Hypoglycemic Episodes in the 6 Months Prior to Enrollment
研究概览
简要总结
This is a multicenter, observational, retrospective and cross-sectional study to be conducted in a cohort of consecutively selected participants with type 2 diabetes mellitus (T2DM) who have been treated with sulphonylurea (SU) monotherapy or SU + metformin (MF) combination therapy by their cardiologist, nephrologist, or family practice doctor for at least 6 months prior to study enrollment.
The purpose of the study is to assess treatment patterns, goal attainment rates, long-term diabetes complication rates, and frequency and severity of hypoglycemic episodes among T2DM participants treated in cardiology, nephrology and family practice settings.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sulphonylurea (SU) Monotherapy or SU + Metformin
Participants with Type 2 diabetes that have been treated with SU monotherapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
干预措施: Metformn (Drug)
Sulphonylurea (SU) Monotherapy or SU + Metformin
Participants with Type 2 diabetes that have been treated with SU monotherapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
干预措施: Sulphonylurea (Drug)
结局指标
主要结局
Number of Participants Experiencing Mild, Moderate, Severe, or Very Severe Hypoglycemic Episodes in the 6 Months Prior to Enrollment
时间窗: Up to 6 Months Prior to Enrollment
At the time of enrollment, participants were asked to rate their hypoglycemic episodes in the last 6 months as mild, moderate, severe, or very severe. Participants were able to select more than one category.
Number of Participants Experiencing Hypoglycemic Episodes in the 6 Months Prior to Enrollment
时间窗: Up to 6 Months Prior to Enrollment
The participant experience of low blood sugar (hypoglycemia) questionnaire was used to evaluate participants' experience of hypoglycemia during the previous 6 months. Participants were asked to record whether they experienced hypoglycemia symptoms (yes/no) and to record the severity of those symptoms as mild, moderate, severe, or very severe.
Number of Participants With Hemoglobin A1c <7.0% at the Time of Enrollment
时间窗: Day of Enrollment
Participant serum samples were collected after an overnight fast to determine the hemoglobin A1c level. Hemoglobin A1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation.
次要结局
- Number of Participants Experiencing a Change in Body Weight in the 12 Months Prior to Enrollment(Up to 12 Months Prior to Enrollment)
- Participant Mean Score on the EuroQol Visual Analog Scale (EQ-VAS) Quality-of-Life Questionnaire At the Time of Enrollment(Day of Enrollment)
- Participant Mean Score on the EuroQol-5 Dimension (EQ-5D) Quality-of-Life Questionnaire At the Time of Enrollment(Day of Enrollment)
- Participant Mean Score on the Worry Scale of Hypoglycemia Fear Survey (HFS II) At the Time of Enrollment(Day of Enrollment)
- Participant Mean Score on the Self-Reported Adherence and Barriers Questionnaire At the Time of Enrollment(Day of Enrollment)
- Number of Participants Reporting Body Weight Fears in the 12 Months Prior to Enrollment(Up to 12 Months Prior to Enrollment)
- Participant Mean Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) At the Time of Enrollment(Day of Enrollment)