Using eye exam results to guide diabetes care for people with diabetic retinopathy in Dinajpur
Improving Patient-centered Care for Diabetes in Bangladesh Through "Dynamic Integration" of Vision Care on the Supply Side
This project will try sending specific diabetes management recommendations based on patients' eye exams to diabetes doctors to see if people with diabetes and diabetic retinopathy reach WHO blood sugar targets more often.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 336 (estimated) |
| Ages | 30 Years and up |
| Sex | All |
| Sponsor | Orbis Academic / other |
| Locations | 2 sites (Dinajpur Sadar, Dinajpur and 1 other locations) |
| Trial ID | NCT06968637 on ClinicalTrials.gov |
What this trial studies
Adults with diabetes and confirmed diabetic retinopathy at two hospitals in Dinajpur will have retinal photographs and their results communicated to their diabetes doctors. The trial compares routine reporting of diabetic retinopathy versus reporting that also includes tailored recommendations for diabetes management. The main outcome is the proportion of participants who reach WHO HbA1c (or equivalent blood glucose) targets, and the study will also calculate the cost per additional person reaching that target. Routine clinic visits and record review will be used to measure glycemic control and guideline adherence over the follow-up period.
Who should consider this trial
Good fit: Adults over 30 with diagnosed diabetes and diabetic retinopathy who receive care at the listed Dinajpur hospitals and agree to participate.
Not a fit: People without diabetic retinopathy, those unable to obtain gradable retinal images, or those with medical or cognitive conditions preventing follow-up are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could help more people with diabetes and retinopathy achieve recommended blood sugar control and receive more coordinated care.
How similar studies have performed: Integrated care programs linking eye screening and diabetes services have improved care processes in prior work, but direct evidence that this linkage consistently lowers HbA1c is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with DM * Diagnosed with DR in at least one eye * Over 30 years of age * Currently treated at the Dinajpur Diabetes Hospital and Gausul Azam BNSB Eye Hospital in Bangladesh * willingness to participate in the study Exclusion Criteria: * Any ocular condition impairing the view of the fundus sufficiently to preclude grading of the image for DR. * Inability to comply with retinal photography to the extent that a gradable image cannot be captured, or any other factor leading to absence of sufficient images to grade at least one eye of a participant. * Medical conditions that could impair compliance with follow-up (such as stroke, dementia, etc.) * Unwilling to participate in the study, or incapable of giving informed consent.
Where this trial is running
Dinajpur Sadar, Dinajpur and 1 other locations
- Dinajpur Diabetes & Swasthoseba Hospital — Dinajpur Sadar, Dinajpur, Bangladesh (Recruiting)
- Gausul Azam BNSB Eye Hospital — Dinajpur District, Bangladesh (Recruiting)
Study contacts
- Principal investigator: Munir Ahmed — Orbis Bangladesh
- Study coordinator: Lutful Husain
- Email: lutful.husain@orbis.org
- Phone: +8801711626852
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.