Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female aged at least 18 years with confirmed diagnosis of Type II Diabetes Mellitus. 2. Subject diagnosed with Type II Diabetes Mellitus with HbA1c 7.5% to 9.5%. 3. Patients with access to a smartphone with internet access/data plan. 4. Patients who understand and speak English sufficiently to be able to use the MyTatva Patient application. 5. Patient is willing to comply with all study procedures and is available for the duration of the study
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •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) •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) •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) •The percentage of patients with improvement in FBG (mg/dL) 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. •The percentage of patients with reduction in HbA1c (%) from baseline to the end of 12 weeks. Timepoint: From baseline to the end of 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| • 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. • Change in Serum LDL, Serum HDL, Serum VLDL, Serum Triglyceride and Total Cholesterol (mg/dL) from baseline to the end of 12 weeks. • Change in BCA Parameters like Skeletal Muscle Mass(kg) and Body Fat Mass (kg) from baseline to the end of 12 weeks. Timepoint: From baseline to the end of 12 weeks | — |
Countries
India
Contacts
Diabetes Care and Hormone Clinic