search
Back to results

OCT Screening for Diabetic Macular Edema at Primary Diabetes Care Visits (DME FOUND)

Primary Purpose

Diabetes, Diabetic Macular Edema, Diabetic Retinopathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OCT imaging
Sponsored by
Joslin Diabetes Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetes focused on measuring diabetes, diabetic macular edema, diabetic retinopathy, optical coherence tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Joslin Diabetes Center
  • OuterCape Health Services, Inc
  • SUNY Upstate Medical University
  • University of Endocrine Consultants

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OCT imaging

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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

Full Information

First Posted
June 10, 2013
Last Updated
November 22, 2017
Sponsor
Joslin Diabetes Center
Collaborators
Genentech, Inc., Juvenile Diabetes Research Foundation, Optovue
search

1. Study Identification

Unique Protocol Identification Number
NCT01875783
Brief Title
OCT Screening for Diabetic Macular Edema at Primary Diabetes Care Visits
Acronym
DME FOUND
Official Title
Diabetic Macular Edema Found by OCT Utilization at Non-ophthalmic Diabetes Care Visits
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
March 17, 2014 (Actual)
Primary Completion Date
May 14, 2015 (Actual)
Study Completion Date
July 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Joslin Diabetes Center
Collaborators
Genentech, Inc., Juvenile Diabetes Research Foundation, Optovue

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetic Macular Edema, Diabetic Retinopathy
Keywords
diabetes, diabetic macular edema, diabetic retinopathy, optical coherence tomography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Care ProviderInvestigator
Masking Description
Primary diabetes care specialists masked to results of OCT intervention
Allocation
N/A
Enrollment
385 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OCT imaging
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
OCT imaging
Intervention Description
Optical coherence tomography (OCT) imaging is a noninvasive, rapid, and readily performed method for evaluating the anatomy of the central retina.
Primary Outcome Measure Information:
Title
Rates of Retina Care Referral for Patients With Diabetic Macular Edema
Description
Percentage of participants who are referred to a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm
Time Frame
Baseline visit
Secondary Outcome Measure Information:
Title
Retinal Referral Rates for Patients With DME
Description
Count of eyes that are referred to a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm
Time Frame
Baseline visit
Title
Rates of Retinal Treatment for Patients With DME
Description
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
Time Frame
One month
Title
Rates of Retinal Treatment Over 1 Year for Patients With DME
Description
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
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer K Sun, MD
Organizational Affiliation
Joslin Diabetes Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joslin Diabetes Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
OuterCape Health Services, Inc
City
Wellfleet
State/Province
Massachusetts
ZIP/Postal Code
02667
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
University of Endocrine Consultants
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37411
Country
United States

12. IPD Sharing Statement

Learn more about this trial

OCT Screening for Diabetic Macular Edema at Primary Diabetes Care Visits

We'll reach out to this number within 24 hrs