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NCT03769948 Clinical Trial

Clinical Decision Support Algorithm to Predict Diabetic Retinopathy

Diabetic Retinopathy Clinical Trial

Official title:
Validating a Clinical Decision Support Algorithm Developed With Demographic, Co-morbidity, and Lab Data to Diagnose, Stage, Prevent, and Monitor a Patient's Diabetic Retinopathy

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03769948
Other study ID # HR-18-087
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 2022
Est. completion date July 2023

Study information
Verified date September 2020
Source Oklahoma State University Center for Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 500
Est. completion date July 2023
Est. primary completion date August 2022
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• 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

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
Oklahoma State University Center for Health Sciences Oklahoma State University, University of Oklahoma

Outcome
Type Measure Description Time frame Safety issue
Primary Diabetic retinopathy indicator (yes/no) Diabetic patients with 362.0x ICD-9 codes are classified as DR patient March, 2019
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