It's all too common to suppose that studies with negative results (that is, failure to meet the study's primary endpoint) will never see the light of day. But there's a recent publication that disproves that supposition. The publication was titled
Assessing the Effect of Personalized Diabetes Risk Assessments During Ophthalmologic Visits on Glycemic Control A Randomized Clinical Trial and is published in JAMA Ophthalmology.
The authors commented that "Although vision loss is among the greatest fears of individuals with diabetes, comprehensive personalized diabetes education and risk assessments are not consistently used in ophthalmologic settings." So they set up a study to see if such education and risk assessments did anything to lower A1C.
The study included 42 office-based ophthalmology sites, which enrolled 1746 adults with type 1 or 2 diabetes, who were randomized to either augmented diabetes assessment and education or usual care. The augmented care included the following, done 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 A1C
- 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
The patients getting what the study called "No Intervention: Standard Care / Usual care" presumably got no advice on their diabetes management during their eye doctor appointment.
The primary outcome that was assessed in the study was the change in A1C from baseline to 12 months in intervention versus control patients who were being seen more frequently than every 12 months. Secondary outcomes that were assessed included body mass index, blood pressure, and responses to surveys of diabetes self-management practices and attitudes.
The results were clear: "The addition of personalized education and risk assessment during retinal ophthalmologic visits did not result in a reduction in HbA1c [A1C] level compared with usual care over 1 year." Or, in other words, PWD [people with diabetes] who are getting eye exams are not going to get better diabetes control due to admonishments by their eye docs.
However, let me make one point very clear: this study's results should in no way discourage PWD from getting annual eye exams. My annual eye exam is scheduled for later this month. When's yours?
