Effect of Diabetes Education During Retinal Ophthalmology Visits on Diabetes Control



Status:Completed
Conditions:Ocular, Diabetes
Therapuetic Areas:Endocrinology, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:5/21/2016
Start Date:October 2011
End Date:January 2015

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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.

Although each patient with diabetes should be receiving diabetic education as part of their
on-going routine medical care, it is likely that such education is delivered with different
details and intensity. Motivating a patient with diabetes to become involved in his or her
care is of primary importance in achieving better systemic control.

Ocular complications from diabetes remain the most common cause of blindness among American
adults 20-74 years of age. A recent survey reported that loss of vision is the most feared
of all diabetic complications. Thus, it is possible that an educational intervention at an
ophthalmology office may have additional impact beyond the current standard of diabetes
education at a primary care or diabetologist/endocrinologist office alone. This study will
determine whether diabetes education in the ophthalmology office (which includes same-visit
feedback of HbA1c levels, combined with standardized education regarding same-visit blood
pressure, retinopathy status and overall diabetes education) can improve subsequent HbA1c as
compared with current standard care in an ophthalmology office.

Materials used in this research setting must be applicable for use in ophthalmology
practices. Therefore, the materials and procedures for this study have been developed with
the goal of easy translation to this audience.

Inclusion Criteria:

1. Age >18 years

2. 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

3. Routine care follow-up is yearly or more frequent

4. English or Spanish speaking

5. Able and willing to provide informed consent

6. Willing to complete 24 months of study follow up

Exclusion Criteria:

1. Known HbA1c (patient report or available records at time of enrollment) <7.5% within
prior 6 months

2. Active participation in any type of intervention study

3. Initiation of insulin treatment within 3 months from date of enrollment

4. Prior complete panretinal photocoagulation or prior diabetes-related vitrectomy in
both eyes

5. 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)

6. Significant renal disease including use of erythropoietin (Procrit, Epogen, Eprex) or
a history of chronic renal failure requiring dialysis or kidney transplant
We found this trial at
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Chapel Hill, North Carolina 27599
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Austin, Texas 78705
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Baltimore, Maryland 21237
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Beachwood, Ohio 44122
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One Joslin Place
Boston, Massachusetts 02215
617-309-2400
Joslin Diabetes Center Joslin Diabetes Center, located in Boston, Massachusetts, is the world's largest diabetes...
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Charlotte, North Carolina 28210
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Chicago, IL
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10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
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Columbia, South Carolina 29223
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Columbia, South Carolina 29204
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1966
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Detroit, MI
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Ft. Lauderdale, Florida 33334
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Hershey, Pennsylvania 17033
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Houston, Texas 77025
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Indianapolis, Indiana 46290
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Jacksonville, FL
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Lakeland, Florida 33805
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Lexington, Kentucky 40509
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Loma Linda, CA
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Madison, WI
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McAllen, Texas 78503
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Minneapolis, Minnesota 55404
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New Albany, Indiana 47150
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Paducah, Kentucky 42001
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Philadelphia, Pennsylvania 19104
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Portland, Oregon 97239
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San Antonio, Texas 78240
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Santa Barbara, California 93103
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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St. Louis, Missouri 63110
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Winston-Salem, North Carolina 27157
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