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Prognostic implications of single-sample confirmatory testing for undiagnosed diabetes: A prospective cohort study

Annals of Internal Medicine Jun 29, 2018

Selvin E, et al. - The prognostic performance of a single-sample confirmatory definition of undiagnosed diabetes was investigated in this prospective cohort study. The data presented in this work showed a single-sample confirmatory definition of diabetes had a high positive predictive value for subsequent diagnosis and was strongly connected with clinical end points. The clinical utility of using a combination of elevated fasting glucose and hemoglobin A1c (HbA1c) levels from a single blood sample to identify undiagnosed diabetes in the population was supported.

Methods
  • Participants in the study were 13,346 ARIC (Atherosclerosis Risk in Communities) members (12,268 without diagnosed diabetes) with 25 years of follow-up for incident diabetes, cardiovascular outcomes, kidney disease, and mortality.
  • Confirmed undiagnosed diabetes was characterized as elevated levels of fasting glucose (≥7.0 mmol/L [≥126 mg/dL]) and HbA1c (≥6.5%) from a single blood sample.

Results
  • The study results showed that among 12,268 participants without diagnosed diabetes, 978 had elevated levels of fasting glucose or HbA1c at baseline (1990 to 1992).
  • It was observed that 39% had both (confirmed undiagnosed diabetes), whereas 61% had only 1 elevated measure (unconfirmed undiagnosed diabetes).
  • Findings revealed that the confirmatory definition had moderate sensitivity (54.9%) but high specificity (98.1%) for identification of diabetes cases diagnosed during the first 5 years of follow-up, with specificity increasing to 99.6% by 15 years.
  • It was noted that the 15-year positive predictive value was 88.7% compared with 71.1% for unconfirmed cases.
  • According to the findings obtained, confirmed undiagnosed diabetes was significantly correlated with cardiovascular and kidney disease and mortality, with stronger associations than unconfirmed diabetes.
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