Diabetes, Diabetic Retinopathy
Conditions
Keywords
Diabetes, Diabetes Education, Diabetic Retinopathy, HbA1c
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALDiabetes Education
The intervention will consist of the following at enrollment and at each follow-up visit (but no more frequently than once every 12 weeks): * Measurement of HbA1c in office with immediate feedback * Measurement of blood pressure with immediate feedback * Assessment of retinopathy risk with immediate feedback * Personalized risk assessment reports based on current HbA1c * Brief assessment of patient understanding of key issues with immediate feedback * Supplemental diabetes management educational materials (provided at baseline only) * Feedback to primary care provider * Email reminder to study participants with email access of individualized risk assessment findings
Sponsors
National Eye Institute (NEI)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Jaeb Center for Health Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | 12 Months | Mean change in HbA1c from baseline to 12 months in intervention versus control for study participants being seen for standard care more frequently than every 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Care Knowledge | 12 Months/24 Months | At baseline and at annual visits, study participants in all treatment groups will complete self-assessment questionnaires in order to assess perception of emotional problems frequently reported in type 1 and type 2 diabetes and to measure perceived adherence to diabetes self-care recommendations. At the annual visits, summary statistics will be presented on the responses as appropriate to the distribution and the treatment groups will be compared controlling for baseline responses. |
| Blood Pressure | 12 Months/24 Months | For analyses, systolic and diastolic blood pressure will be converted to an overall mean blood pressure according to the following calculation: diastolic blood pressure + 1/3 (systolic blood pressure - diastolic blood pressure). Blood pressure will be analyzed as the change in the weighted mean blood pressure from baseline to 12 months adjusted for the baseline weighted mean blood pressure. Treatment group comparisons will be made using ANCOVA to adjust for the baseline blood pressure, with GEE to adjust for the correlation within subjects of the same cluster. |
| Body Mass Index | 12 Months/24 Months | Treatment group comparisons will be made using analysis of covariance (ANCOVA) to adjust for the baseline HbA1c, with generalized estimating equations (GEE) to adjust for the correlation within subjects of the same randomization cluster. |
Countries
United States
Outcome results
None listed