Effect of Diabetes Education During Retinal Ophthalmology Visits on Diabetes Control

Completed · Phase 3

Conditions studied: Diabetes, Diabetic Retinopathy

In brief

The purpose of this study is to assess whether glycemic control (assessed with HbA1c measurement) in individuals with type 1 or type 2 diabetes can be improved with a point-of-care measurement of HbA1c in the ophthalmologist's office combined with a personalized risk assessment for diabetic retinopathy and other complications of diabetes.

Key facts

Study ID

NCT01323348

Run by

Jaeb Center for Health Research

People needed

1875

Starts

2011-10-01

Expected to finish

2015-01-01

Last updated by the study team

2016-08-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >18 years
• Diagnosis of type 1 or type 2 diabetes mellitus
• Any one of the following will be considered to be sufficient evidence that diabetes is present:
• Current regular use of insulin for the treatment of diabetes
• Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes
• Documented diabetes by American Diabetes Associate and/or World Health Organization criteria
• Routine care follow-up is yearly or more frequent
• English or Spanish speaking
• Able and willing to provide informed consent
• Willing to complete 24 months of study follow up

You may not qualify if…

• Known HbA1c (patient report or available records at time of enrollment) <7.5% within prior 6 months
• Active participation in any type of intervention study
• Initiation of insulin treatment within 3 months from date of enrollment
• Prior complete panretinal photocoagulation or prior diabetes-related vitrectomy in both eyes
• Advanced visual acuity loss in both eyes which prohibits ability to read study materials (tested as needed with reading test using materials in appropriate size script)
• Significant renal disease including use of erythropoietin (Procrit, Epogen, Eprex) or a history of chronic renal failure requiring dialysis or kidney transplant

Where it is running

• Loma Linda University Health Care, Dept. of Ophthalmology — Loma Linda, California, United States
• California Retina Consultants — Santa Barbara, California, United States
• Retina Vitreous Consultants — Fort Lauderdale, Florida, United States
• University of Florida College of Med., Department of Ophthalmology — Jacksonville, Florida, United States
• Central Florida Retina Institute — Lakeland, Florida, United States
• University of Illinois at Chicago Medical Center — Chicago, Illinois, United States
• Raj K. Maturi, M.D., P.C. — Indianapolis, Indiana, United States
• John-Kenyon American Eye Institute — New Albany, Indiana, United States
• Retina and Vitreous Associates of Kentucky — Lexington, Kentucky, United States
• Paducah Retinal Center — Paducah, Kentucky, United States
• Elman Retina Group, P.A. — Baltimore, Maryland, United States
• Wilmer Ophthalmological Institute at Johns Hopkins — Baltimore, Maryland, United States
• Joslin Diabetes Center — Boston, Massachusetts, United States
• Henry Ford Health System, Dept of Ophthalmology and Eye Care Services — Detroit, Michigan, United States
• Retina Center, PA — Minneapolis, Minnesota, United States
• Barnes Retina Institute — St Louis, Missouri, United States
• The New York Eye and Ear Infirmary/Faculty Eye Practice — New York, New York, United States
• University of North Carolina, Dept of Ophthalmology — Chapel Hill, North Carolina, United States
• Charlotte Eye, Ear, Nose and Throat Assoc., PA — Charlotte, North Carolina, United States
• Wake Forest University Eye Center — Winston-Salem, North Carolina, United States
• Retina Associates of Cleveland, Inc. — Beachwood, Ohio, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• Casey Eye Institute — Portland, Oregon, United States
• Penn State College of Medicine — Hershey, Pennsylvania, United States
• University of Pennsylvania Scheie Eye Institute — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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