A Real World evidence study to evaluate the Impact of MyTatva Application in the Management of Type II Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- • The percentage of patients with improvement in Time in Range (TIR) from the baseline (first 2 weeks) to the end of 12 weeks (last 2 weeks)
研究概览
简要总结
Trial Synopsis: MyTatva Application in the Management of Type II Diabetes Mellitus
Design: A prospective, open-labeled, single-arm, Real-world Evidence study to evaluate the impact of MyTatva application in Type II Diabetes Mellitus patient management.
Duration: 12 weeks per patient.
Sample Size: 20 patients
Population: Patients diagnosed with Type II Diabetes Mellitus
Regimen: Patients will receive MyTatva Diabetes Care Plan access via the patients’ smartphone using MyTatva app. The patients will receive personalized diet plans, exercise plans, and cognitive behaviour therapy (CBT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female aged at least 18 years with confirmed diagnosis of Type II Diabetes Mellitus.
- •Subject diagnosed with Type II Diabetes Mellitus with HbA1c 7.5% to 9.5%.
- •Patients with access to a smartphone with internet access/data plan.
- •Patients who understand and speak English sufficiently to be able to use the MyTatva Patient application.
- •Patient is willing to comply with all study procedures and is available for the duration of the study.
排除标准
- 未提供
结局指标
主要结局
• The percentage of patients with improvement in Time in Range (TIR) from the baseline (first 2 weeks) to the end of 12 weeks (last 2 weeks)
时间窗: From baseline to the end of 12 weeks
• The percentage of patients with reduction in Time above Range (TAR) from the baseline (first 2 weeks) to the end of 12 weeks (last 2 weeks)
时间窗: From baseline to the end of 12 weeks
• The percentage of patients with improvement in Time below Range (TBR) from the baseline (first 2 weeks) to the end of 12 weeks (last 2 weeks)
时间窗: From baseline to the end of 12 weeks
• The percentage of patients with improvement in FBG (mg/dL) from baseline to the end of 12 weeks.
时间窗: From baseline to the end of 12 weeks
• The percentage of patients with improvement in PPBG (mg/dL) from baseline to the end of 12 weeks.
时间窗: From baseline to the end of 12 weeks
• The percentage of patients with reduction in HbA1c (%) from baseline to the end of 12 weeks.
时间窗: From baseline to the end of 12 weeks
次要结局
- • Change in the BMI (kg/m2) from baseline to the end of 12 weeks.(• Change in the waist circumference (cm) from baseline to the end of 12 weeks.)
研究者
Dr Saboo Banshi Damodarlal
Diabetes Care and Hormone Clinic