NCT01875783

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
385

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable diabetes

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2013

Completed
9 months until next milestone

Study Start

First participant enrolled

March 17, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2015

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2016

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

September 20, 2017

Completed
Last Updated

December 22, 2017

Status Verified

November 1, 2017

Enrollment Period

1.2 years

First QC Date

June 10, 2013

Results QC Date

August 24, 2017

Last Update Submit

November 22, 2017

Conditions

DiabetesDiabetic Macular EdemaDiabetic Retinopathy

Keywords

diabetesdiabetic macular edemadiabetic retinopathyoptical coherence tomography

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline visit

Secondary Outcomes (3)

  • Retinal Referral Rates for Patients With DME

    Baseline visit

  • Rates of Retinal Treatment for Patients With DME

    One month

  • Rates of Retinal Treatment Over 1 Year for Patients With DME

    9 months

Study Arms (1)

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.

Device: OCT imaging

Interventions

OCT imagingDEVICE

Optical coherence tomography (OCT) imaging is a noninvasive, rapid, and readily performed method for evaluating the anatomy of the central retina.

OCT imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

OuterCape Health Services, Inc

Wellfleet, Massachusetts, 02667, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

University of Endocrine Consultants

Chattanooga, Tennessee, 37411, United States

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetic Retinopathy

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes Complications

Results Point of Contact

Title
Dr. Jennifer Sun
Organization
Joslin Diabetes Center
jennifer.sun@joslin.harvard.edu
617-209-2554

Study Officials

  • Jennifer K Sun, MD

    Joslin Diabetes Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Masking Details
Primary diabetes care specialists masked to results of OCT intervention
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2013

First Posted

June 12, 2013

Study Start

March 17, 2014

Primary Completion

May 14, 2015

Study Completion

July 15, 2016

Last Updated

December 22, 2017

Results First Posted

September 20, 2017

Record last verified: 2017-11

Locations

US(4)