Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
Intervention1: PhableCare Digital Therapeutic Tool: Duration: 3 months
Control Intervention1: Standard of care: Duration: 3 months
Sponsors
Terrals Technologies Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients between the ages of 18 to 65 years, both ages inclusive, who have provided written informed consent for participation in the study and willing to comply with study procedures. 2. Patients with an established diagnosis of hypertension [office systolic blood pressure (SBP) ââ?°Â¥ 140 mmHg] and T2DM (HbA1c ââ?°Â¥ 6.5%) with a duration of at least 3 months at study entry. 3. Current treatment with oral antidiabetic, antihypertensive and/or antilipidemic medications and expected to remain on the stable dose of these medications during the study period. 4. Functional English literacy. 5. Mobile phone capable of running the protocol-specific applications. 6. Willingness and ability to follow physicianââ?¬•s instructions as per protocol schedule of events, and keep records of the same.
Exclusion criteria
Exclusion criteria: 1. BMI ââ?°Â¥ 40 kg/m2. 2. Patients showing COVID symptoms or tested COVID positive within 72 hours prior to study entry. 3. Unable to operate or use the protocol-specified devices and applications or to comply with the study-specified procedures. 4. Diagnosis of gestational diabetes or secondary causes of hypertension. 5. Associated with any other chronic disease intervention program via digital therapeutic channels. 6. Pregnant or lactating women. 7. Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days prior to the day of screening. 8. Patients with any other clinically significant disease (CKD, HIV, cancer, post-surgery, etc.) which, in the opinion of the Investigator could compromise the patientââ?¬•s safety, the patientââ?¬•s involvement in the study or overall interpretation of the study data. 9. Cardiovascular disease such as stroke, unstable angina pectoris, myocardial infarction, coronary arterial bypass graft or angioplasty, congestive heart failure class III or IV as per New York Heart Association, within 6 months prior to screening. 10. Handicapped persons with restricted physical movements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Impact of digital therapeutic tools on mean change in the SBP from baseline to end of 3 months.Timepoint: Baseline to end of 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Impact of digital therapeutic tools on mean change in HbA1c from baseline to end of 3 months.Timepoint: Baseline to end of 3 months.;Impact of digital therapeutic tools on mean change in lipid profile from baseline to end of 3 monthsTimepoint: Baseline to end of 3 months.;Impact of digital therapeutic tools on mean change in the distress levels with regards to disease management from baseline to end of 3 months.Timepoint: Baseline to end of 3 months.;Impact of digital therapeutic tools on mean change in the fasting blood glucose from baseline to end of 3 monthsTimepoint: From baseline to end of 3 months;Impact of reminders and nudges in improving the medication adherence at the end of 3 months.Timepoint: Baseline to end of 3 months. | — |
Countries
India
Contacts
Public ContactDr Suhas Patil
Terrals Technologies Private Limited
Outcome results
None listed