A Prospective, Non-safety Observational Study in Japanese Type 2 Diabetes Patients(INSIGHTS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 677
- 试验地点
- 1
- 主要终点
- Changes in Health Related Quality of Life (ITR-QOL) in insulin treated type 2 diabetes at baseline and 12 weeks after a significant change in insulin treatment regimen
研究概览
简要总结
This study is designed to address the gap in the literature related to changing treatment regimen or formulation between different types of insulin, and how this change impacts quality of life, adherence, individual patient treatment satisfaction and glycemic control.
详细描述
To measure changes in Health Related Quality of Life (as measured by the Insulin Therapy Related-Quality of Life: ITR-QOL) in insulin treated type 2 diabetes over a 12 weeks period following a significant change in insulin treatment regimen. Definition of significant change is a) increase or decrease the in number of injections per day, or/and b) change in formulation of insulin (human or analog insulin, basal or bolus, rapid or mix insulin), and/or c) change in administration method (syringe or pen, disposal or re-usable).
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatients or outpatients with type 2 diabetes, aged 20 years or older, on insulin therapy who have planned to change insulin therapy during the registration period of the study
- •Patients who have provided written informed consent to participation in the study after receiving explanations about the objective and other details of the study
- •Patients who have received the same insulin therapy for 3 months or longer before informed consent. (i.e. receiving the same type of insulin preparation at the same dosing frequency regardless of insulin dose)
排除标准
- •Patients who have planned to discontinue insulin therapy
- •Patients incapable of completing the ITR-QOL, DTSQ and patient's questionnaire based on their self-ratings
- •Patients with type 1 diabetes
- •Patients who have used CSII or have planned to switch to CSII(continuous subcutaneous insulin infusion )
- •Patients with poor treatment compliance as determined by their investigators based on the treatment history
研究组 & 干预措施
Type 2 diabetes treated with insulin
干预措施: Insulins (Drug)
结局指标
主要结局
Changes in Health Related Quality of Life (ITR-QOL) in insulin treated type 2 diabetes at baseline and 12 weeks after a significant change in insulin treatment regimen
时间窗: Baseline, 12 weeks
次要结局
- Summarize by occurrence the reason for insulin treatment change at study entry(Baseline)
- Change in HbA1c at baseline and 12 weeks after a significant change in insulin treatment regimen(Baseline, 12 weeks)
- Change in treatment adherence at baseline and 12 weeks after a significant change in insulin treatment regimen(Baseline, 12 weeks)
- Change in DTSQ (Diabetes treatment satisfaction questionnaire) at baseline and 12 weeks after a significant change in insulin treatment regimen(Baseline, 12 weeks)
- Total daily dose of insulin(Baseline, over 12 weeks)
- Change in type of insulin product(Baseline, 12 weeks)
- Change from baseline in use of concomitant oral hypoglycemic drugs(Baseline, 12 weeks)