Diabetic RetinopathyNCT03769948
Clinical Decision Support Algorithm to Predict Diabetic Retinopathy
An observational study of Diabetic Retinopathy, run by Oklahoma State University Center for Health Sciences.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- risk factors for diabetic retinopathy
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Feb 2022to Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: The cohort will be selected from diabetic patients that have Electronic Medical Records in Harold Hamm Diabetes Center.
Who may be able to join
- 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
Who cannot join
None listed.
About this study
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
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
- Being tested
- risk factors for diabetic retinopathy
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risk factors for diabetic retinopathyOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetic retinopathy indicator (yes/no)
Diabetic patients with 362.0x ICD-9 codes are classified as DR patient
Measured: March, 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study startFeb 2022 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University Center for Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Oklahoma State University, University of Oklahoma
- Responsible party
- Principal investigator, William Paiva, Oklahoma State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03769948
- Sponsor's protocol ID
- HR-18-087
- Status last verified
- Sep 2020
- First submitted
- 6 Dec 2018
- Last updated
- 18 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03769948
- Acronym / sponsor ID
- HR-18-087
- Conditions
- Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Oklahoma State University Center for Health SciencesUniversity, hospital or other
- Collaborators
- Oklahoma State University, University of Oklahoma
- Study start
- Feb 2022 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 10 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The cohort will be selected from diabetic patients that have Electronic Medical Records in Harold Hamm Diabetes Center.
Key inclusion criteria (7 listed)
- With 250.xx diabetes and 362.0x DR ICD-9 codes
- All variables are complete within the observation window
- With 250.xx diabetes ICD-9 codes
- Without 362.0x DR ICD-9 codes
- All variables are complete within the observation window
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| risk factors for diabetic retinopathyDemographic 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 | Other | – |
Primary outcome
Diabetic retinopathy indicator (yes/no)
Time frame: March, 2019
Diabetic patients with 362.0x ICD-9 codes are classified as DR patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy, run by Oklahoma State University Center for Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetic retinopathy indicator (yes/no) (time frame: March, 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.