Comparison of Glycemic Control With Smartphone Application (Vivovitals) - Based Glucose Monitoring to Routine Home Glucose Monitoring in Poorly Controlled T2DM Patients Treated With Insulin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- HbA1c
研究概览
简要总结
The study is aimed to determine if a smartphone application based weekly glucose monitoring by a care provider is superior to the routine home glucose monitoring by patients in poorly controlled type 2 diabetes mellitus who are on insulin.
详细描述
The study is a randomized, prospective cohort study. Subjects will be enrolled randomly after fulfilling the meeting criteria into two groups. Group 1 (intervention group) will used mobile application to enter their glucose level and group 2 (control group) will record their glucose level on daily diary. Data collection will be standardized in order to eliminate bias. In addition, all statistical analyses will be performed by a departmental statistician and not the study investigators. Patients in each arm of the study will be selected form the same population in order to avoid selection bias.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult type 2 diabetes mellitus patients (≥ 18years of age) whose HbA1c is ≥8% on insulin.
- •At least three months of daily home glucose monitoring before including in the study
- •Willing to provide consent to participate in the study
- •Uses a smartphone with cellular network and willing to and has ability to learn and use the Vivo vitals application on it.
排除标准
- •Patients who have Gestational diabetes or type 1 diabetes
- •Patients who have been admitted to the hospital in the last month for more than 3 days.
- •Patients who have adrenal disorders or taking exogenous glucocorticoids.
- •Patients who are mentally incompetent, having uncontrolled psychiatric conditions, inmates.
- •Patients with active malignancies including those on treatment
结局指标
主要结局
HbA1c
时间窗: at the end of 3 months follow-up
A1C is a lab test that shows the average level of blood sugar (glucose) over the previous 3 months. It shows how well a person is controlling their blood sugar to help prevent complications from diabetes.
次要结局
- Change in weight(baseline and 3 month)
- Change in Body Mass Index (BMI)(baseline and 3 month)
- Change in blood pressure(baseline and 3 month)
研究者
Issac Sachmechi
Director of Diabetes Center of Excellence
Icahn School of Medicine at Mount Sinai