DiabetesDME FOUNDNCT01875783
OCT Screening for Diabetic Macular Edema at Primary Diabetes Care Visits
A study testing OCT imaging in people with Diabetes and Diabetic Macular Edema, run by Joslin Diabetes Center at 4 sites in United States.
Trial summary
The purpose of this protocol is to determine whether point of care optical coherence tomography (OCT) imaging combined with an OCT-guided retinal referral algorithm at primary diabetes care visits increases rates of retina specialist eye care for patients with diabetic macular edema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetic Macular Edema, Diabetic Retinopathy
- What is being tested?
- OCT imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- 4 sitesUnited States
- Study dates
- 17 Mar 2014to 15 Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 or type 2 diabetes mellitus as evidenced by:
- Current regular use of insulin or oral anti-hyperglycemia agents for the treatment of diabetes OR
- Documented diabetes by American Diabetes Association and/or World Health Organization criteria
- Age greater than or equal to 18 years old
- Diabetes duration of 10 more years OR last measured HbA1c of 10% or more
- Able and willing to participate in study procedures and comply with study follow-up visits
- Able to give informed consent for study participation
- Not moving out of the study area during the 1 year follow-up period
Who cannot join
- Unable to cooperate with the OCT image acquisition procedure or other study procedures
- Unable or unwilling to comply with the study follow-up visits
- Unable or unwilling to sign form for release of retinal medical records
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Joslin Diabetes Center
Boston, Massachusetts, 02215
University of Endocrine Consultants
Chattanooga, Tennessee, 37411
SUNY Upstate Medical University
Syracuse, New York, 13210
OuterCape Health Services, Inc
Wellfleet, Massachusetts, 02667
About this study
Official title: Diabetic Macular Edema Found by OCT Utilization at Non-ophthalmic Diabetes Care Visits
The purpose of this protocol is to determine whether point of care optical coherence tomography (OCT) imaging combined with an OCT-guided retinal referral algorithm at primary diabetes care visits increases rates of retina specialist eye care for patients with diabetic macular edema. The hypothesis is that OCT imaging with an automated OCT-guided referral algorithm will enable identification of patients at risk for vision loss from diabetic macular edema and facilitate direct referral to retina specialists for more timely evaluation and treatment.
- Conditions
- Diabetes, Diabetic Macular Edema, Diabetic Retinopathy
- Being tested
- OCT imaging
- Keywords
- diabetes, diabetic macular edema, diabetic retinopathy, optical coherence tomography
- Medical subject headings
- Diabetes Mellitus, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT imagingDevice
Optical coherence tomography (OCT) imaging is a noninvasive, rapid, and readily performed method for evaluating the anatomy of the central retina.
| Study group | Role | What they receive |
|---|---|---|
| OCT imaging | Experimental | All study participants will undergo optical coherence tomography imaging and will be referred to a retina specialist for further standard care evaluation and management if they are identified as having diabetic macular edema or the scan quality is not sufficient to evaluate macular status. Receives: Device: OCT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of Retina Care Referral for Patients With Diabetic Macular Edema
Percentage of participants who are referred to a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm
Measured: Baseline visit
Secondary outcomes (3)
Retinal Referral Rates for Patients With DME
Count of eyes that are referred to a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm
Measured: Baseline visit
Rates of Retinal Treatment for Patients With DME
Percentage of participants are referred by OCT-guided algorithm who are confirmed to have vision threatening retinopathy at first visit with retina specialist after study enrollment
Measured: One month
Rates of Retinal Treatment Over 1 Year for Patients With DME
Percentage of participants who are referred by OCT guided algorithm to a retina specialist who receive treatment for DME over the course of 9 months follow-up by retina specialist
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study start17 Mar 2014
- Primary completion14 May 2015
- Study completion15 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., Juvenile Diabetes Research Foundation, Optovue
- Responsible party
- Sponsor
- Investigators
- Jennifer K Sun, MD, Principal investigator, Joslin Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875783
- Sponsor's protocol ID
- 2011-17
- Acronym
- DME FOUND
- Status last verified
- Nov 2017
- First submitted
- 10 Jun 2013
- Last updated
- 22 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetic Macular Edema Found by OCT Utilization at Non-ophthalmic Diabetes Care Visits
- ClinicalTrials.gov ID
- NCT01875783
- Acronym / sponsor ID
- DME FOUND / 2011-17
- Conditions
- Diabetes, Diabetic Macular Edema, Diabetic Retinopathy
- Keywords
- diabetes, diabetic macular edema, diabetic retinopathy, optical coherence tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc., Juvenile Diabetes Research Foundation, Optovue
- Study start
- 17 Mar 2014 (actual)
- Primary completion
- 14 May 2015 (actual)
- Study completion
- 15 Jul 2016 (actual)
- First posted
- 12 Jun 2013 (estimated)
- Results
- Posted 20 Sep 2017
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 protocol is to determine whether point of care optical coherence tomography (OCT) imaging combined with an OCT-guided retinal referral algorithm at primary diabetes care visits increases rates of retina specialist eye care for patients with diabetic macular edema. The hypothesis is that OCT imaging with an automated OCT-guided referral algorithm will enable identification of patients at risk for vision loss from diabetic macular edema and facilitate direct referral to retina specialists for more timely evaluation and treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OCT imaging | Experimental | Device: OCT imagingAll study participants will undergo optical coherence tomography imaging and will be referred to a retina specialist for further standard care evaluation and management if they are identified as having diabetic macular edema or the scan quality is not sufficient to evaluate macular status. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Type 1 or type 2 diabetes mellitus as evidenced by:
- Current regular use of insulin or oral anti-hyperglycemia agents for the treatment of diabetes OR
- Documented diabetes by American Diabetes Association and/or World Health Organization criteria
- Age greater than or equal to 18 years old
- Diabetes duration of 10 more years OR last measured HbA1c of 10% or more
Key exclusion criteria (3 listed)
- Unable to cooperate with the OCT image acquisition procedure or other study procedures
- Unable or unwilling to comply with the study follow-up visits
- Unable or unwilling to sign form for release of retinal medical records
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 |
|---|---|---|
| OCT imagingOptical coherence tomography (OCT) imaging is a noninvasive, rapid, and readily performed method for evaluating the anatomy of the central retina. | Device | OCT imaging |
Primary outcome
Rates of Retina Care Referral for Patients With Diabetic Macular Edema
Time frame: Baseline visit
Percentage of participants who are referred to a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm
3 secondary outcomes
Retinal Referral Rates for Patients With DME
Time frame: Baseline visit
Rates of Retinal Treatment for Patients With DME
Time frame: One month
Rates of Retinal Treatment Over 1 Year for Patients With DME
Time frame: 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jennifer K Sun, MD principal investigator
Joslin Diabetes Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCT imaging in people with Diabetes and Diabetic Macular Edema, run by Joslin Diabetes Center at 4 sites 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 8 inclusion and 3 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: finished, as of the sponsor's last update on 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 20 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rates of Retina Care Referral for Patients With Diabetic Macular Edema (time frame: Baseline visit). 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 22 Dec 2017.