FindTrial
Sign In

Benefit of a digital diabetes care program in patients with type 2 diabetes mellitus

Effectiveness of a digital diabetes care program in patients with type 2 diabetes mellitus: an open label randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045748
Enrollment
120
Registered
2022-09-21
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: OneCare IMPACT Program: OneCare IMPACT program includes: 1. Qualified health coach 2. Yoga / Physical training Sessions: 3. Emotional Wellness Coach- 4. Mobile App - The mobile app

Sponsors

Wellwork Technologies Private Limited India
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
I. Change in CGM summary measures from the first wear period versus the final wear period: A. Glycemic variability (GV) B. TIR C. MAGE II. Change in DDS score at 3 months Timepoint: 1. Baseline 2. 3 months—

Secondary

MeasureTime frame
Change in HbA1c at 3 months Timepoint: 1. Baseline 2. 3 months;Change in systolic and diastolic blood pressure from enrollment to 3 monthsTimepoint: 1. Baseline 2. 3 months;Change in weight from enrollment to 3 monthsTimepoint: 1. Baseline 2. 3 months—

Countries

India

Contacts

Public ContactDr Shalini Rajesh

Narayana Health, Department of Clinical Research

shalini.rajesh.dr@narayanahealth.org9980009761

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026