Improving Patient-centered Care for Diabetes in Bangladesh Through "Dynamic Integration" of Vision Care on the Supply Side

Not Applicable

Not yet recruiting

• Conditions: Diabetes Mellitus; Diabetic Retinopathy (DR)

• Registration Number: NCT06968637
• Lead Sponsor: Orbis

Brief Summary

The goal of this clinical trial is to determine whether integration of vision care into the DM treatment system, by providing specific recommendations to doctors for management of diabetes alongside feedback on positive eye exams for DR can improve diabetes care outcomes.

The main questions it aims to answer are:

1. Does delivery of specific diabetes management recommendations to diabetes doctors for patients of theirs found to have DR lead to significantly improved blood glucose control as indicated by % reaching WHO targets of HbA1c (or targets for blood sugar if HbA1c data are unavailable)?

2. What is the cost-effectiveness of the intervention, measured as total intervention cost per additional participant reaching the WHO target?

Researchers will compare participant adherence with international guidelines when DR results are provided by a PIS without specific care recommendations to when the PIS provides DR results with specific care recommendations for DM management.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-05
• Study First Submitted QC: 2025-05-12
• Study First Posted: 2025-05-13
• Status Verified: 2025-07
• Study Start: 2025-07-01
• Last Update Submitted: 2025-07-17
• Last Update Posted: 2025-07-22
• Primary Completion: 2026-12
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 336

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The proportion of participants reaching WHO target HbA1c levels of <= 7.0% (or WHO blood sugar targets if HbA1c data are unavailable) among participants with any DR, upon chart review by a masked clinician observer, compared between study groups.	From enrollment to chart review (3 months after enrollment)	According to the World Health Organization (WHO), the specific HgA1c target is \<= 7.0%

Secondary Outcome Measures

Name	Time	Method
Cost-effectiveness, measured as total intervention cost per additional patient meeting the WHO blood sugar target.	Enrollment to chart review (3 months after enrollment)

Trial Locations

Locations (2)

Dinajpur Diabetes & Swasthoseba Hospital; 🇧🇩 Dinajpur Sadar, Dinajpur, Bangladesh

Gausul Azam BNSB Eye Hospital; 🇧🇩 Dinajpur district, Bangladesh

Dinajpur Diabetes & Swasthoseba Hospital

🇧🇩Dinajpur Sadar, Dinajpur, Bangladesh

Diabetic Association, Dinajpur

Contact

+8802588817827

dinajpur.diabetes@gmail.com