Benefit of a digital diabetes care program in patients with type 2 diabetes mellitus
Not Applicable
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2022/09/045748
- Lead Sponsor
- Wellwork Technologies Private Limited India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Adults with Type 2 Diabetes Mellitus, aged 18-70 years
2. Must have a smartphone to access the diabetes educator/health coach
Exclusion Criteria
1. Acute cardiac event within 3 months
2. Stroke within 3 months
3. Cardiac intervention within 3 months
4. Patient reported history of chronic kidney disease (CKD) and /or Chronic liver disease (CLD).
5. H/o severe hypoglycemia in last 3 months
6. Pregnancy
7. On steroids/drugs altering the glycemic status
8. Uncontrolled hypothyroidism or hyperthyroidism
9. Diabetes duration >10 years
10. Patients on premixed insulin, regular and NPH Insulins
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method I. Change in CGM summary measures from the first wear period versus the final wear period: <br/ ><br>A. Glycemic variability (GV) <br/ ><br>B. TIR <br/ ><br>C. MAGE <br/ ><br>II. Change in DDS score at 3 months <br/ ><br>Timepoint: 1. Baseline <br/ ><br>2. 3 months
- Secondary Outcome Measures
Name Time Method Change in HbA1c at 3 months <br/ ><br>Timepoint: 1. Baseline <br/ ><br>2. 3 months;Change in systolic and diastolic blood pressure from enrollment to 3 monthsTimepoint: 1. Baseline <br/ ><br>2. 3 months;Change in weight from enrollment to 3 monthsTimepoint: 1. Baseline <br/ ><br>2. 3 months