Qatar Diabetes Mobile Application Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Difference in mean HbA1c
研究概览
简要总结
Diabetes mobile technology is an emerging and rapidly expanding field that seeks to combine cutting edge behavioral insights with best practice in diabetes self management education to improve patient empowerment and deliver better patient outcomes.The question that arises is whether or not, diabetes mobile applications are effective in improving glycemic control, clinical outcomes, quality of life and overall patient satisfaction, in diabetic patients in Qatar. To answer this, we plan to enroll 90 diabetic patients into a custom-made diabetes app for Qatar (Droobi) (as intervention group) in comparison with 90 diabetic patients followed in the current standard care, matched in characteristics (as control group). We have the hypothesis that with utilization of the mobile application, patients will have improved glycemic control, improved self management and patient empowerment; together with improved patient-educator/doctor interaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Adults with T2DM (more than 18 yrs of age and younger than 60) who are able to provide consent
- •Arabic speaking and non-arabic speaking T2DM patients, who can communicate in Arabic and or English language.
- •Uncontrolled diabetes with HbA1c more than or equal to 8.5%
- •T2DM on insulin with or without any other oral medication
- •Subject must have a smart phone (must be an iOS (Apple) phone user) and must be interested in using a smart phone app.
- •Subject must have no visual impairment.
- •Minimal level of literacy (able to read and write in english or arabic).
- •To be able to communicate via chat with the mobile app team through the app as evidenced by at least weekly use of any of the social media such as WhatsApp, Viber, Facebook Messenger etc
- •Subject must be willing to utilize a mobile application for diabetes control
排除标准
- •• Recent history (3 months) of stroke or Myocardial infarction.
- •Patients with proliferating retinopathy
- •Patients with an acute illness during the past 2 weeks.
- •Patients who plan to be away for more than 3 months.
- •Patients with CKD requiring dialysis.
- •Hypoglycemia unawareness.
- •More than one episode of severe hypoglycemia in the previous 6 months.
- •Female patients who are planning for pregnancy in the coming 6 months.
结局指标
主要结局
Difference in mean HbA1c
时间窗: 3 months
Difference in mean HbA1C between the intervention arm and the standard care
次要结局
- Lipids(6 months)
- Blood Pressure(6 months)
- Change in subjects attitudes towards disease(6 months)
- Time to achieve normoglycemia(6 months)
- Subject perceptions of diabetes self management(6 months)
- Changes in insulin doses(6 months)
- Changes in reported hypoglycemia(6 months)
- Number of clinical interactions(6 months)
- Missed clinical appointments(6 months)
- Weight(6 months)