title: Effects of Prior Intensive Insulin Therapy and Risk Factors on Patient-Reported Visual Function Outcomes in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Cohort.
abstract: OBJECTIVE
  Preservation of vision in patients with diabetes mellitus is critical. Interventions to improve glycemic control through early intensive treatment of diabetes reduce rates of severe retinopathy and preserve visual acuity.
  
  
  OBJECTIVE
  To assess the effects of prior intensive insulin treatment and risk factors on patient-reported visual function in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) cohort.
  
  
  METHODS
  Cohort study of 1184 participants with type 1 diabetes from the DCCT/EDIC study (randomized clinical trial followed by an observational follow-up study) who completed the 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) during EDIC years 17 through 20 (September 1, 2009, through April 30, 2014) in 28 institutions across the United States and Canada.
  
  
  METHODS
  The primary outcome was the composite NEI-VFQ-25 score. Secondary outcomes were visual acuity (measured by the Early Treatment Diabetic Retinopathy Study protocol), retinopathy level (determined by masked grading of stereoscopic color fundus photographs), and NEI-VFQ-25 subscale scores. The composite NEI-VFQ-25 scale and its subscales were scored 0 to 100, corresponding to poor to excellent function, respectively.
  
  
  RESULTS
  The overall average NEI-VFQ-25 score for 1184 DCCT/EDIC participants (mean [SD] age, 52.3 [6.9] years; 48% female) with a 30-year duration of diabetes was high (all participants: median, 91.7; interquartile range [IQR], 89.7-96.9; intensive treatment [n = 605]: median, 94.7; IQR, 91.0-97.2; conventional treatment [n = 579]: median, 94.0; IQR, 88.4-96.1; P = .006 for intensive vs conventional). After adjustment for sex, age, hemoglobin A1c level, and retinopathy level at DCCT baseline, the former intensive treatment group had a significant, albeit modest, improvement in overall NEI-VFQ-25 score compared with the former conventional diabetes treatment group (median difference, -1.0; 95% CI, -1.7 to -0.3; P = .006). This beneficial treatment effect was fully attributed to the prior glycemic control in DCCT (explained treatment effect: 100%). Those with visual acuity worse than 20/100 reported the largest decline in visual function (median difference, -21.0; 95% CI, -40.5 to -1.6; P = .03).
  
  
  CONCLUSIONS
  In the DCCT/EDIC cohort, patient-reported visual function remains high in both treatment groups, comparable to previous reports of overall health-related quality of life. Intensive diabetes therapy modestly improved NEI-VFQ-25 score 30 years after the start of the DCCT, the benefit underestimated owing to more nonparticipants from the conventional treatment group. Visual acuity had the greatest effect on patient-reported visual function from among all risk factors.
  
  
  BACKGROUND
  clinicaltrials.gov Identifiers: NCT00360815 and NCT00360893.
authors.affiliation: University Hospitals Case Medical Center, Cleveland, Ohio.
authors.forename: Rose A
authors.initials: RA
authors.lastname: Gubitosi-Klug
authors.affiliation: Biostatistics Center, George Washington University, Rockville, Maryland.
authors.forename: Wanjie
authors.initials: W
authors.lastname: Sun
authors.affiliation: Biostatistics Center, George Washington University, Rockville, Maryland.
authors.forename: Patricia A
authors.initials: PA
authors.lastname: Cleary
authors.affiliation: Biostatistics Center, George Washington University, Rockville, Maryland.
authors.forename: Barbara H
authors.initials: BH
authors.lastname: Braffett
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: University of New Mexico, Albuquerque.
authors.forename: Arup
authors.initials: A
authors.lastname: Das
authors.affiliation: Yale University School of Medicine, New Haven, Connecticut.
authors.forename: William
authors.initials: W
authors.lastname: Tamborlane
authors.affiliation: Department of Ophthalmology and Visual Sciences, University of Wisconsin School of Medicine and Public Health, Madison.
authors.forename: Ronald
authors.initials: R
authors.lastname: Klein
mesh_terms: D000293:Adolescent; D000328:Adult; D001786:Blood Glucose / Q000378:metabolism; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D003930:Diabetic Retinopathy / Q000175:diagnosis / Q000453:epidemiology / Q000503:physiopathology*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012307:Risk Factors; D018434:Sickness Impact Profile; D011795:Surveys and Questionnaires; D014792:Visual Acuity / Q000502:physiology*; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; C517652:hemoglobin A1c protein, human