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

ConditionsDiabetes Mellitus Diabetic Retinopathy (DR)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age30+

SponsorOrbis

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

care recommendations
Other intervention
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.

Treatment groups

336 Participants

are divided into 2 treatment groups

Group A: Control Group: Only DR results providedNo intervention 0 interventions

Group B: Intervention Group: DR results + care recommendations for DM management providedExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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%

Time frame

From enrollment to chart review (3 months after enrollment)

Secondary outcomes

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)

Locations

Map coordinates are unavailable for these locations. Locations are shown below instead.

Dinajpur Diabetes & Swasthoseba HospitalRecruiting5200, Dinajpur Sadar, Dinajpur

Bangladesh

Gausul Azam BNSB Eye HospitalRecruiting Dinajpur District

Bangladesh

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Orbis

Lead sponsor

District Diabetes Hospital, Dinajpur district of Bangladesh

Collaborator

Gausul Azam BNSB Eye Hospital in the Dinajpur district of Bangladesh