Quality of Life and Treatment Satisfaction of People With Type 2 Diabetes: A European Survey
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 5,926
- 试验地点
- 1
- 主要终点
- Diabetes-related QoL and treatment satisfaction questionnaires: DTSQ, ADDQoL, HFSws and EQ5D
研究概览
简要总结
The present European survey seeks to assess quality of life and satisfaction with treatment in people with T2DM and to appreciate disease and treatment variables including hypoglycaemia and level of glycaemic control. It will also provide relevant information on other important aspects such as the level of correlation of objective measures such as HbA1c with health status, QoL and satisfaction with current treatment. Overall 5000 randomly selected patients will be invited to participate from a representative sample of clinical practices during a pre-specified period. The study will entail a single patient visit. Patients who agree to the study and give their informed consent will complete questionnaires which, combined with retrospective notes review & an HbA1c test, will allow patient, disease and treatment variables to be collected. An HbA1c test is a finger prick test to measure glycosylated haemoglobin in the blood indicating the level of blood glucose over the last 8-12 weeks.
研究设计
- 研究类型
- Observational
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With T2DM, diagnosed at least 1 year prior to entry in the study
- •Currently treated with diet, OAD(s) and/or insulin with no change in the type of OAD(s) or insulin in the previous three months
排除标准
- •Type 1 diabetes and/or history of diabetic ketoacidosis
- •Secondary diabetes (including disease of the exocrine pancreas, endocrinopathies or drug-induced)
- •Treatment with systemic glucocorticoids other than replacement therapy. Inhaled, local injected and topical use of glucocorticoids is allowed
结局指标
主要结局
Diabetes-related QoL and treatment satisfaction questionnaires: DTSQ, ADDQoL, HFSws and EQ5D
时间窗: Cross-sectional and retrospective
次要结局
- Disease-related variables: Years with diabetes, use of SMBG and frequency of monitoring, Hypoglycaemic episodes, Past Medical History, Macro and micro-vascular complications(Retrospective (previous 24 months))
- Health-economic variables: Use of healthcare resources Days off work (for either hypoglycaemias, acute or chronic complications)(Retrospective (previous 24 months))