Diabetes Mellitus, Diabetic Retinopathy (DR)
Conditions
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. 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
OTHERcare 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.
Sponsors
District Diabetes Hospital, Dinajpur district of Bangladesh
Gausul Azam BNSB Eye Hospital in the Dinajpur district of Bangladesh
Orbis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | From enrollment to chart review (3 months after enrollment) | According to the World Health Organization (WHO), the specific HgA1c target is \<= 7.0% |
Secondary
| Measure | Time frame |
|---|---|
| Cost-effectiveness, measured as total intervention cost per additional patient meeting the WHO blood sugar target. | Enrollment to chart review (3 months after enrollment) |
Countries
Bangladesh
Contacts
Primary ContactLutful Husain
Backup ContactNathan Congdon
Outcome results
None listed