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

NCT06968637 | Recruiting

• 1 other identifier: PIS-DR-SUPPLY-2025
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 2

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

Conditions

Diabetes Mellitus; Diabetic Retinopathy (DR)

Outcome Measures

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.

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

  From enrollment to chart review (3 months after enrollment)

Secondary Outcomes (1)

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

  Enrollment to chart review (3 months after enrollment)

Study Arms (2)

Control Group: Only DR results provided

NO INTERVENTION

For these participants, the patient information system (PIS) will send only diabetic retinopathy (DR) results to the Diabetologist at the diabetic hospital without specific care recommendations

Intervention Group: DR results + care recommendations for DM management provided

EXPERIMENTAL

For these participants, the patient information system (PIS) will send DR results to the Diabetologist at the diabetic hospital along with specific care recommendations for diabetes management (only for those patients with ANY DR)

Other: care recommendations

Interventions

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.

Also known as: Specific DM care recommendations

Intervention Group: DR results + care recommendations for DM management provided

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Orbis: lead
• District Diabetes Hospital, Dinajpur district of Bangladesh: collaborator
• Gausul Azam BNSB Eye Hospital in the Dinajpur district of Bangladesh: collaborator

Study Sites (2)

Dinajpur Diabetes & Swasthoseba Hospital

Dinajpur Sadar, Dinajpur, 5200, Bangladesh

RECRUITING

Gausul Azam BNSB Eye Hospital

Dinajpur District, Bangladesh

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications

Study Officials

• Munir Ahmed

  Orbis Bangladesh

  PRINCIPAL INVESTIGATOR

• Nathan Congdon

  Orbis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lutful Husain

CONTACT

+8801711626852; lutful.husain@orbis.org

Nathan Congdon

CONTACT

+44 7748 751393; ncongdon1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster-randomised design, with diabetologist as the cluster. In the intervention group, a Patient Information System (PIS) database will be used, both at the diabetic hospital and eye hospital in Dinajpur. The PIS will be used for referral tracking, to deliver the results of the eye exam to the diabetologist, and, most importantly, based on the result of the DR exam, to provide specific care recommendations for diabetes management. Based on existing guidelines, when DR is present, the PIS will prompt diabetologists to check, and if necessary, change medicines to optimize, blood sugar, blood pressure and lipids. Therefore, through the doctors of the diabetic hospital tracking eye results, the PIS will reinforce the need for the patient to visit both the eye hospital and diabetic hospital for DM/DR management and will improve overall DM care. In the Control group, information on the DR exam will be conveyed through the PIS without specific care recommendations.

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

BA (2)