Recruitment

Recruitment Status
Completed
Estimated Enrollment
380

Inclusion Criterias

Current regular use of insulin or oral anti-hyperglycemia agents for the treatment of diabetes OR
Type 1 or type 2 diabetes mellitus as evidenced by:
Not moving out of the study area during the 1 year follow-up period
...
Current regular use of insulin or oral anti-hyperglycemia agents for the treatment of diabetes OR
Type 1 or type 2 diabetes mellitus as evidenced by:
Not moving out of the study area during the 1 year follow-up period
Able to give informed consent for study participation
Diabetes duration of 10 more years OR last measured HbA1c of 10% or more
Age greater than or equal to 18 years old
Documented diabetes by American Diabetes Association and/or World Health Organization criteria
Able and willing to participate in study procedures and comply with study follow-up visits

Exclusion Criterias

Unable or unwilling to sign form for release of retinal medical records
Unable or unwilling to comply with the study follow-up visits
Unable to cooperate with the OCT image acquisition procedure or other study procedures
Unable or unwilling to sign form for release of retinal medical records
Unable or unwilling to comply with the study follow-up visits
Unable to cooperate with the OCT image acquisition procedure or other study procedures

Summary

Conditions
  • Diabetes
  • Diabetic Macular Edema
  • Diabetic Retinopathy
Type
Interventional
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: Double (Care Provider, Investigator)
  • Masking Description: Primary diabetes care specialists masked to results of OCT interventionPrimary Purpose: Diagnostic

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Inclusion Criterias

Current regular use of insulin or oral anti-hyperglycemia agents for the treatment of diabetes OR
Type 1 or type 2 diabetes mellitus as evidenced by:
Not moving out of the study area during the 1 year follow-up period
...
Current regular use of insulin or oral anti-hyperglycemia agents for the treatment of diabetes OR
Type 1 or type 2 diabetes mellitus as evidenced by:
Not moving out of the study area during the 1 year follow-up period
Able to give informed consent for study participation
Diabetes duration of 10 more years OR last measured HbA1c of 10% or more
Age greater than or equal to 18 years old
Documented diabetes by American Diabetes Association and/or World Health Organization criteria
Able and willing to participate in study procedures and comply with study follow-up visits

Exclusion Criterias

Unable or unwilling to sign form for release of retinal medical records
Unable or unwilling to comply with the study follow-up visits
Unable to cooperate with the OCT image acquisition procedure or other study procedures
Unable or unwilling to sign form for release of retinal medical records
Unable or unwilling to comply with the study follow-up visits
Unable to cooperate with the OCT image acquisition procedure or other study procedures

Locations

Syracuse, New York, 13210
Wellfleet, Massachusetts, 02667
Chattanooga, Tennessee, 37411
Boston, Massachusetts, 02215
...
Syracuse, New York, 13210
Wellfleet, Massachusetts, 02667
Chattanooga, Tennessee, 37411
Boston, Massachusetts, 02215

Tracking Information

NCT #
NCT01875783
Collaborators
  • Genentech, Inc.
  • Juvenile Diabetes Research Foundation
  • Optovue
Investigators
  • Principal Investigator: Jennifer K Sun, MD Joslin Diabetes Center
  • Jennifer K Sun, MD Joslin Diabetes Center