Control:Diabetes - a Mobile App to Improve Glycemic Control in Patients With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- The mean change in blood glucose.
研究概览
简要总结
This is a single arm open label pilot clinical trial that will assess patient-reported blood glucose levels before and after using the Control:Diabetes mobile app, while collecting user feedback and recommendations for further improvements to the app functionality and user interface. This study will enroll approximately 70 individuals with insulin-treated diabetes mellitus. The study will include two online surveys (baseline and exit), one study initiation phone call, and will also collect data entered by the users into the mobile app.
详细描述
The objectives of this study are to:
- Test the hypothesis that patients with diabetes mellitus treated with insulin and elevated blood glucose will achieve better glycemic control after using the Control:Diabetes mobile app.
- Test the hypothesis that patients with diabetes mellitus treated with insulin and frequent hypoglycemia will achieve lower frequency of hypoglycemia after using the Control:Diabetes mobile app.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Diagnosis of Type 1 Diabetes or Type 2 Diabetes
- •Treatment with multiple daily insulin injections (MDII) or continuous subcutaneous insulin infusion (CSII)
- •Baseline HbA1c between 7% and 10.5% (as reported by the participant) and/or self- reported frequency of symptomatic hypoglycemia ≥ 3 times / week
- •Ownership of a smartphone running either Android or iOS operating system with an active data plan
排除标准
- •Using a closed loop insulin delivery system (Medtronic 670G or OpenAPS)
结局指标
主要结局
The mean change in blood glucose.
时间窗: Measured between the first two weeks and the last two weeks of the study.
As recorded by the patient in the app.
次要结局
- The change in the number of hypoglycemic episodes.(Measured every week between the two weeks prior to the study entry and the last two weeks of study follow-up.)
研究者
Alexander Turchin
Associate Professor of Medicine
Brigham and Women's Hospital