Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06968637

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Diabetes Mellitus Cardiovascular Diseases Diabetes Complications Diabetic Angiopathies Diabetic Retinopathy Diabetic Retinopathy (DR) Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Retinal Diseases Vascular Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dinajpur Diabetes & Swasthoseba Hospital, Dinajpur Sadar, Dinajpur, Bangladesh

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

care recommendations

Other

Provision of specific care recommendations for diabetes management. Based on existing guidelines, when any DR is present, the PIS will prompt diabetologists to check, and if necessary, change medicines to optimize, blood sugar, blood pressure and lipids.

Other names: Specific DM care recommendations

Primary outcomes

  1. 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.

    Time frame: From enrollment to chart review (3 months after enrollment)

    According to the World Health Organization (WHO), the specific HgA1c target is <= 7.0%

Secondary outcomes

  1. Cost-effectiveness, measured as total intervention cost per additional patient meeting the WHO blood sugar target.

    Time frame: Enrollment to chart review (3 months after enrollment)

Study contacts

Contact information is provided by the study sponsor or research team.

Lutful Husain

CONTACT

[email protected]

+8801711626852

Nathan Congdon

CONTACT

[email protected]

+44 7748 751393

Sponsors and collaborators

Lead sponsor

Orbis

Other

Collaborators

  • District Diabetes Hospital, Dinajpur district of Bangladesh
  • Gausul Azam BNSB Eye Hospital in the Dinajpur district of Bangladesh

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 13, 2025
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.