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

Orbis

Status: Enrolling

Conditions: Diabetic Retinopathy (DR); Diabetes Mellitus

Treatments: Other: care recommendations

Study type: Interventional

Funder types: Other

Identifiers

NCT06968637

PIS-DR-SUPPLY-2025

Details and patient eligibility

About

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.

Enrollment: 336 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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336 participants in 2 patient groups

Control Group: Only DR results provided

No Intervention group

Description:

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 group

Description:

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)

Treatment:

Other: care recommendations