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Sensitivities and specificities of screening tests for type 2 diabetes mellitus and prediabetes

Sensitivities and specificities of screening tests for type 2 diabetes mellitus and prediabetes
  Sensitivity %,
(95% CI)
Specificity %,
(95% CI)
Reference standard
Diabetes
Glycated hemoglobin (A1C)*
≥6.5% (≥48 mmol/mol)
68.4 (46.6 to 84.3) 95.9 (85.4 to 98.9) OGTT
Fasting plasma glucose (FPG)*
≥126 mg/dL (≥7 mmol/L)
56.0 (36.6 to 73.8) 97.9 (91.6 to 99.5) OGTT
Combined testing (A1C and FPG)Δ 54.9 (48.8 to 60.9) 98.1 (97.8 to 98.3) Clinical diabetes at 5-year follow-up
Combined testing (A1C and FPG)Δ 22.9 (20.7 to 25.2) 99.4 (99.3 to 99.6) Clinical diabetes at 10-year follow-up
Prediabetes
Glycated hemoglobin (A1C)§
5.7 to 6.4% (38.3 to 46.4 mmol/mol)
49 (40 to 58) 79 (73 to 84) OGTT¥
Fasting plasma glucose (FPG)§
100 to 125 mg/dL (5.6 to 6.9 mmol/L)
25 (19 to 32) 94 (92 to 96) OGTT¥
Comparisons of sensitivity and specificity for 3 screening strategies for type 2 diabetes mellitus: A1C, FPG, and combined testing with positive test results on both A1C and FPG tests from a simultaneous blood sample. Data and reference standards differ for combined testing (single cohort study) and A1C and FPG (meta-analysis of 9 studies directly comparing A1C and FPG testing with OGTT testing).

ADA: American Diabetes Association; OGTT: oral glucose tolerance test; WHO: World Health Organization.

* Sensitivities and specificities are pooled estimates derived from meta-analysis of 9 studies.[1]

¶ Abnormal OGTT defined as 2-hour plasma glucose ≥200 mg/dL (≥11.1 mmol/L).[1]

Δ Data from prospective cohort analysis of Atherosclerosis Risk in Communities (ARIC) study. Combined testing defined diabetes as abnormal results on A1C testing (≥6.5% [≥48 mmol/mol] and FPG ≥126 mg/dL [≥7 mmol/L]).[2]

◊ Clinical diabetes defined as self-reported use of glucose-lowering medication or clinician diagnosis of diabetes.[2]

§ Sensitivities and specificities are pooled estimates derived from meta-analysis of studies using both WHO and ADA diagnostic criteria for "at-risk" A1C and impaired fasting glucose.[3]

¥ Reference standard is an abnormal 2-hour OGTT.[3]

Prepared with data from:
  1. Hoyer A, Rathmann W, Kuss O. Utility of HbA1c and fasting plasma glucose for screening of type 2 diabetes: A meta-analysis of full ROC curves. Diabet Med 2018; 35:317.
  2. Selvin E, Wang D, Matsushita K, et al. Prognostic implications of single-sample confirmatory testing for undiagnosed diabetes: A prospective cohort study. Ann Intern Med 2018; 169:156.
  3. Barry E, Roberts S, Oke J, et al. Efficacy and effectiveness of screen and treat policies in prevention of type 2 diabetes: Systematic review and meta-analysis of screening tests and interventions. BMJ 2017; 356:i6538.
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