Mild Nonproliferative Diabetic RetinopathyDIVERNCT01790945
Diabetic Macular Edema and Diabetic Retinopathy Screening (TeleMed) With Automated Retinal Photography
An observational study of Mild Nonproliferative Diabetic Retinopathy and Moderate Nonproliferative Diabetic Retinopathy, run by Retina Institute of Hawaii at 1 site in United States.
Trial summary
The purpose of this study is explore if a partnership and screening program put in place between a busy retina practice and their referring diabetes care offices can improve diabetic retinopathy and diabetic macular edema diagnosis, care and overall diabetes control in patients with diabetic eye disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Nonproliferative Diabetic Retinopathy, Moderate Nonproliferative Diabetic Retinopathy, Severe Nonproliferative Diabetic Retinopathy
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Aug 2013
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: (n=500) A large population will need to be screened to find 100-150 patients with diabetic eye disease
Who may be able to join
- Patients diagnosed with diabetes that have not seen an Ophthalmologist in the past 1 year
Who cannot join
- Patients with diabetes already under the care of an Ophthalmologist.
- Patient not willing to give Consent for participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Craig Kadooka, MD
Hilo, Hawaii, 96720
Debra L Shimabukuro, RN, 808-348-9247, deb@retinahawaii.com
Anovale Semisi, 808-955-0255, anovale@retinahawaii.com
About this study
Official title: Diabetic Macular Edema and Diabetic Retinopathy Identification by Screening (Telemed) With Verified Automated Retinal Photography
The purpose of this study is explore if a partnership and screening program put in place between a busy retina practice and their referring diabetes care offices can improve diabetic retinopathy and diabetic macular edema diagnosis, care and overall diabetes control in patients with diabetic eye disease.
Read the detailed description
Retina Institute of Hawaii will place an infrastructure to screen for diabetic retinopathy/diabetic macular edema in 5 of the states largest Primary Care Clinics, General Medical and or Endocrine practices which re our primary referrals for diabetes patients. Each Sub-site will receive a DRS Automated Retinal Camera and our staff will train the sub-site's staff on taking images. The submission of these images to our practice will be administered by an automated job scheduler in the DRS Automated Retinal Camera removing the requirement of the locations to send images. Images will be electronically uploaded and sent to the Retina Institute of Hawaii for detailed interpretation and report sent back to the patients, their diabetes care MD's and their nurse practitioners/diabetic educators.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No treatment Study | Population of subjects will have been diagnosed with mild NPDR, Moderate NPDR, Severe NPDR, PDR and DME |
What is being measured
The primary outcome is the main question the study is designed to answer.
% change in Diabetic Retinopahy/Diabetic Macular Edema diagnosis with pre-screening system compared to post-screening system
Measured: 6 months
Secondary outcomes (1)
Change in HgA1C from Primary Care Physician referral to post retinal specialist visit
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Nonproliferative 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Retina Institute of Hawaii
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael D Bennett, MD, Principal investigator, Retina Institute of Hawaii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790945
- Sponsor's protocol ID
- DIVER Study
- Acronym
- DIVER
- Status last verified
- Feb 2013
- First submitted
- 11 Feb 2013
- Last updated
- 13 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetic Macular Edema and Diabetic Retinopathy Identification by Screening (Telemed) With Verified Automated Retinal Photography
- ClinicalTrials.gov ID
- NCT01790945
- Acronym / sponsor ID
- DIVER / DIVER Study
- Conditions
- Mild Nonproliferative Diabetic Retinopathy, Moderate Nonproliferative Diabetic Retinopathy, Severe Nonproliferative Diabetic Retinopathy, Proliferative Diabetic Retinopathy, Diabetic Macular Edema
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Retina Institute of HawaiiUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 13 Feb 2013 (estimated)
- 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.
The purpose of this study is explore if a partnership and screening program put in place between a busy retina practice and their referring diabetes care offices can improve diabetic retinopathy and diabetic macular edema diagnosis, care and overall diabetes control in patients with diabetic eye disease.
Detailed description
Retina Institute of Hawaii will place an infrastructure to screen for diabetic retinopathy/diabetic macular edema in 5 of the states largest Primary Care Clinics, General Medical and or Endocrine practices which re our primary referrals for diabetes patients. Each Sub-site will receive a DRS Automated Retinal Camera and our staff will train the sub-site's staff on taking images. The submission of these images to our practice will be administered by an automated job scheduler in the DRS Automated Retinal Camera removing the requirement of the locations to send images. Images will be electronically uploaded and sent to the Retina Institute of Hawaii for detailed interpretation and report sent back to the patients, their diabetes care MD's and their nurse practitioners/diabetic educators.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment Study | – | –Population of subjects will have been diagnosed with mild NPDR, Moderate NPDR, Severe NPDR, PDR and DME |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- (n=500) A large population will need to be screened to find 100-150 patients with diabetic eye disease
Key inclusion criteria (1 listed)
- Patients diagnosed with diabetes that have not seen an Ophthalmologist in the past 1 year
Key exclusion criteria (2 listed)
- Patients with diabetes already under the care of an Ophthalmologist.
- Patient not willing to give Consent for participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
% change in Diabetic Retinopahy/Diabetic Macular Edema diagnosis with pre-screening system compared to post-screening system
Time frame: 6 months
1 secondary outcome
Change in HgA1C from Primary Care Physician referral to post retinal specialist visit
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2013.
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.
Michael D Bennett, MD principal investigator
Retina Institute of Hawaii
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Nonproliferative Diabetic Retinopathy and Moderate Nonproliferative Diabetic Retinopathy, run by Retina Institute of Hawaii at 1 site in United States.
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 1 inclusion and 2 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 13 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% change in Diabetic Retinopahy/Diabetic Macular Edema diagnosis with pre-screening system compared to post-screening system (time frame: 6 months). 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 13 Feb 2013; AzTrials last refreshed its copy on 8 Nov 2026.