Clinical Decision Support Algorithm to Predict Diabetic Retinopathy

NCT ID: NCT03769948

Last Updated: 2020-09-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-28
• Study Completion Date: 2023-07-31

Brief Summary

Diabetic retinopathy (DR), a complication of diabetes, is a leading cause of blindness among working-aged adults globally. In its early stages, DR is symptomless, and can only be detected by an annual eye exam. Once the disease has progressed to the point where vision loss has occurred, the damage is irreversible. Consequently, early detection is quintessential in treating DR. Two barriers to early detection are poor patient compliance with the annual exam and lack of access to specialists in rural areas. This research is focused on developing and validating new, cost-effective predictive technologies that can improve early screening of DR. Our overall objective is to develop and implement an entire suite of tools to detect diabetes complications in order to augment care for underserved rural populations in the US and internationally.

Conditions

Diabetic Retinopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

risk factors for diabetic retinopathy

Demographic variables: gender, race, marital status, urban rural status. Co-morbidity variable: neuropathy, nephropathy, peripheral circulatory, ketoacidosis, hyperosmolarity Lab tests variables: alanine aminotransferase (ALT), albumin serum, anion gap, aspartate aminotransferase, blood urea nitrogen, calcium serum, chloride serum, creatinine serum, glucose serum plasma, hematocrit, hemoglobin, mean corpuscular hemoglobin concentration (MCHC), mean platelet volume (MPV), potassium serum, protein total serum, red blood cell (RBC) count, sodium serum, white blood cell (WBC) count

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

For diabetic patients with DR:

• With 250.xx diabetes and 362.0x DR ICD-9 codes
• All variables are complete within the observation window

For diabetic patients without DR:

• With 250.xx diabetes ICD-9 codes
• Without 362.0x DR ICD-9 codes
• All variables are complete within the observation window

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oklahoma State University

OTHER

Sponsor Role: collaborator

University of Oklahoma

OTHER

Sponsor Role: collaborator

Oklahoma State University Center for Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

William Paiva

Executive Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

HR-18-087

Identifier Type: -

Identifier Source: org_study_id