title: Assessing the Effect of Personalized Diabetes Risk Assessments During Ophthalmologic Visits on Glycemic Control: A Randomized Clinical Trial.
abstract: OBJECTIVE
  Optimization of glycemic control is critical to reduce the number of diabetes mellitus-related complications, but long-term success is challenging. 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.
  
  
  OBJECTIVE
  To determine whether the point-of-care measurement of hemoglobin A(1c) (HbA(1c)) and personalized diabetes risk assessments performed during retinal ophthalmologic visits improve glycemic control as assessed by HbA(1c) level.
  
  
  METHODS
  Ophthalmologist office-based randomized, multicenter clinical trial in which investigators from 42 sites were randomly assigned to provide either a study-prescribed augmented diabetes assessment and education or the usual care. Adults with type 1 or 2 diabetes enrolled into 2 cohorts: those with a more-frequent-than-annual follow-up (502 control participants and 488 intervention participants) and those with an annual follow-up (368 control participants and 388 intervention participants). Enrollment was from April 2011 through January 2013.
  
  
  METHODS
  Point-of-care measurements of HbA1c, blood pressure, and retinopathy severity; an individualized estimate of the risk of retinopathy progression derived from the findings from ophthalmologic visits; structured comparison and review of past and current clinical findings; and structured education with immediate assessment and feedback regarding participant's understanding. These interventions were performed at enrollment and at routine ophthalmic follow-up visits scheduled at least 12 weeks apart.
  
  
  METHODS
  Mean change in HbA(1c) level from baseline to 1-year follow-up. Secondary outcomes included body mass index, blood pressure, and responses to diabetes self-management practices and attitudes surveys.
  
  
  RESULTS
  In the cohort with more-frequent-than-annual follow-ups, the mean (SD) change in HbA(1c) level at 1 year was -0.1% (1.5%) in the control group and -0.3% (1.4%) in the intervention group (adjusted mean difference, -0.09% [95% CI, -0.29% to 0.12%]; P = .35). In the cohort with annual follow-ups, the mean (SD) change in HbA(1c) level was 0.0% (1.1%) in the control group and -0.1% (1.6%) in the intervention group (mean difference, -0.05% [95% CI, -0.27% to 0.18%]; P = .63). Results were similar for all secondary outcomes.
  
  
  CONCLUSIONS
  Long-term optimization of glycemic control is not achieved by a majority of individuals with diabetes. The addition of personalized education and risk assessment during retinal ophthalmologic visits did not result in a reduction in HbA(1c) level compared with usual care over 1 year. These data suggest that optimizing glycemic control remains a substantive challenge requiring interventional paradigms other than those examined in our study.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier:NCT01323348.
authors.affiliation: Beetham Eye Institute, Joslin Diabetes Center, Department of Ophthalmology, Harvard Medical School, Boston, Massachusetts.
authors.forename: Lloyd Paul
authors.initials: LP
authors.lastname: Aiello
authors.affiliation: Jaeb Center for Health Research, Tampa, Florida.
authors.forename: Allison R
authors.initials: AR
authors.lastname: Ayala
authors.affiliation: Charlotte Eye, Ear, Nose, and Throat Associates, Charlotte, North Carolina.
authors.forename: Andrew N
authors.initials: AN
authors.lastname: Antoszyk
authors.affiliation: Jaeb Center for Health Research, Tampa, Florida.
authors.forename: Bambi
authors.initials: B
authors.lastname: Arnold-Bush
authors.affiliation: Paducah Retinal Center, Paducah, Kentucky.
authors.forename: Carl
authors.initials: C
authors.lastname: Baker
authors.affiliation: Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland6Editor, JAMA Ophthalmology.
authors.forename: Neil M
authors.initials: NM
authors.lastname: Bressler
authors.affiliation: Elman Retina Group, Baltimore, Maryland.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Elman
authors.affiliation: Jaeb Center for Health Research, Tampa, Florida.
authors.forename: Adam R
authors.initials: AR
authors.lastname: Glassman
authors.affiliation: Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
authors.forename: Lee M
authors.initials: LM
authors.lastname: Jampol
authors.affiliation: Jaeb Center for Health Research, Tampa, Florida.
authors.forename: Michele
authors.initials: M
authors.lastname: Melia
authors.affiliation: Wolfe Eye Clinic, West Des Moines, Iowa.
authors.forename: Jared
authors.initials: J
authors.lastname: Nielsen
authors.affiliation: Section of Adult Diabetes, Joslin Diabetes Center, Department of Medicine, Harvard Medical School, Boston, Massachusetts.
authors.forename: Howard A
authors.initials: HA
authors.lastname: Wolpert
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000032:analysis*; D001794:Blood Pressure; D003922:Diabetes Mellitus, Type 1 / Q000150:complications; D003924:Diabetes Mellitus, Type 2 / Q000150:complications; D003930:Diabetic Retinopathy / Q000097:blood / Q000175:diagnosis*; D018450:Disease Progression; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009819:Office Visits; D009885:Ophthalmology; D010353:Patient Education as Topic; D019095:Point-of-Care Systems; D057285:Precision Medicine; D018570:Risk Assessment; D012648:Self Care; D014792:Visual Acuity
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; C517652:hemoglobin A1c protein, human