Improving Patient-centered Care for Diabetes in Bangladesh Through "Dynamic Integration" of Vision Care on the Supply Side
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: care recommendations.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Diabetic Retinopathy (DR). Basic parameters: from 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Bangladesh
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other care recommendations
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.
Primary outcome measures
- 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)]
Secondary outcome measures (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)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Health services research
Study locations
Bangladesh · 2 centers
- Dinajpur Diabetes & Swasthoseba Hospital — Dinajpur Sadar
- Gausul Azam BNSB Eye Hospital — Dinajpur District
Identifiers
NCT: NCT06968637 · PIS-DR-SUPPLY-2025