NCT01285076已完成不适用
Naturalistic Evaluation of Hypoglycemic Events in Diabetic Subjects (NEEDS Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 834
- 试验地点
- 1
- 主要终点
- Number of Participants With Hypoglycemic Episodes
研究概览
简要总结
This is a multi-center, observational, retrospective and cross-sectional study to be conducted in a cohort of consecutively selected participants with Type 2 diabetes mellitus (DM) who have been treated with sulphonylurea (SU) monotherapy or SU + metformin (MF) combination therapy by their cardiologist, nephrologist, neurologist, or family practice doctor for at least 6 months prior to Study Enrollment.
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
- •Participants diagnosed with Type 2 DM.
- •Participants at least 30 years of age at time of Type 2 DM diagnosis.
- •Participants treated with SU monotherapy or SU + MF combination therapy for at least 6 months prior to enrollment.
- •Participants receiving diabetes care from a cardiologist, nephrologist, neurologist, or family practice doctor for at least 6 months.
- •Participants with a clinical record in the health care center.
- •Participants in whose medical records a minimum core data set can be found; core data defined as: age, gender, duration of diabetes/age at diagnosis, all glucose-lowering medications (branded and generic names, dosage, dosing frequency, starting and stopping dates) since the start of all antihyperglycemic medications.
排除标准
- •Participants with Type 1 DM.
- •Participants who are pregnant or with gestational DM.
- •Participants receiving any anti-diabetic treatment from an endocrinologist/diabetologist in the previous 6 months.
- •Participants requiring daily concomitant usage of insulin.
- •Participants receiving any oral diabetes medications other than SU or SU + MF.
- •Participants who are already participating in a clinical trial or other clinical study.
- •Participants for whom it would be impossible to complete the questionnaire.
结局指标
主要结局
Number of Participants With Hypoglycemic Episodes
时间窗: 6 months
Participants self-reported hypoglycemic (low blood sugar) episodes.
Number of Participants Achieving Hemoglobin A1C (HbA1C) <7%
时间窗: 6 months
HbA1c is measured as a percent.
次要结局
- Fear of Weight Gain Questionnaire(1 year (during the 12-month period prior to the encounter visit))
- Score on the Treatment Satisfaction Questionnaire for Medication (TSQM)(1 day (the day of the encounter visit))
- Number of Adherence Days on the Self-reported Adherence Questionnaire(7 days (during the 7-day period prior to the encounter visit))
- Score on the Worry Scale of Hypoglycemia Fear Survey (HFS) II(6 months (during the 6-month period prior to the encounter visit))
- Experience of Weight Gain Questionnaire(1 year (during the 12-month period prior to the encounter visit))
- Score on the Quality of Life (EQ-5D) Questionnaire(1 day (the day of the encounter visit))
- Experience of Low Blood Sugar (Hypoglycemia) Questionnaire(6 months (during the 6-month period prior to the encounter visit))
- Self-reported Barrier Questionnaire(30 days (during the 30-day period prior to the encounter visit))
研究者
研究点 (1)
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