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 review if improved patient-centered diabetes mellitus (DM) care, through the integration of vision services utilizing a patient information system (PIS), can promote cooperation between diabetic retinopathy (DR) and DM care providers for participants that are diagnosed with DM and identified with high-risk DR.

The main questions it aims to answer are:

1. What proportion of participants' care meets international guidelines upon chart review by a masked clinician observer, compared between study groups.

2. What is the cost-effectiveness, measured as total intervention cost per additional participant complying with the suggested exam, to improve diabetic care.

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

• Status Verified: 2025-05
• Study First Submitted: 2025-05-05
• Study First Submitted QC: 2025-05-12
• Study First Posted: 2025-05-13
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Study Start: 2025-07
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Diagnosed with DM
• Diagnosed with high-risk DR
• Over 30 years of age
• Currently treated at the Dinajpur Diabetes Hospital in Bangladesh
• willingness to participate in the study

Exclusion Criteria

• Other significant causes of vision loss
• Medical conditions that could impair compliance with follow-up (such as stroke, dementia, etc.)
• Not willing to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The proportion of participants reaching recommended HgA1c levels among participants with 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
The proportion of participants reaching recommended HgA1c levels among all participants with DM, 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%
Cost-effectiveness, measured as total intervention cost per additional patient complying with the suggested exam to improve diabetic care.	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