Clinical Decision Support Algorithm to Predict Diabetic Retinopathy

September 17, 2020 updated by: William Paiva, Oklahoma State University Center for Health Sciences

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The cohort will be selected from diabetic patients that have Electronic Medical Records in Harold Hamm Diabetes Center.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oklahoma State University Center for Health Sciences

Collaborators

University of Oklahoma
Oklahoma State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2022

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

December 6, 2018

First Submitted That Met QC Criteria

December 6, 2018

First Posted (Actual)

December 10, 2018

Study Record Updates

Last Update Posted (Actual)

September 18, 2020

Last Update Submitted That Met QC Criteria

September 17, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HR-18-087

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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