Diagnosis of Diabetes: A1C and FBS Testing Requirements
For diagnosing diabetes, two abnormal test results are required, either from the same sample or from two separate test samples, with A1C ≥6.5% or fasting blood sugar ≥126 mg/dL on two occasions being diagnostic. 1
Diagnostic Criteria for Diabetes
A1C Testing
- Threshold: A1C ≥6.5% (48 mmol/mol)
- Requirements:
- Must be performed in a laboratory using NGSP-certified method standardized to DCCT assay
- Two separate abnormal results required for diagnosis
- No specific time interval mandated between tests, but should be performed without delay 1
Fasting Blood Sugar (FBS) Testing
- Threshold: FBS ≥126 mg/dL (7.0 mmol/L)
- Requirements:
- Fasting defined as no caloric intake for at least 8 hours
- Two separate abnormal results required for diagnosis
- Samples must be spun and separated immediately after collection to prevent preanalytic variability 1
Alternative Diagnostic Methods
- 2-hour plasma glucose: ≥200 mg/dL (11.1 mmol/L) during OGTT using 75g glucose load
- Random plasma glucose: ≥200 mg/dL (11.1 mmol/L) with classic symptoms of hyperglycemia (only requires one measurement in this scenario) 1
Confirmation Process
- Two tests of the same type: If initial A1C is 7.0% and repeat A1C is 6.8%, diabetes is confirmed
- Two different test types: If both A1C and FBS are above diagnostic thresholds from same sample or separate samples, diabetes is confirmed
- Discordant results: If results from two different tests are discordant, repeat the test that was above diagnostic threshold 1
Special Considerations
When A1C is Unreliable
- In conditions with increased red blood cell turnover:
- Pregnancy (second and third trimesters)
- Sickle cell disease
- Hemodialysis
- Recent blood loss or transfusion
- Erythropoietin therapy
- HIV treated with certain drugs
- Iron-deficient anemia 1
Timing Between Tests
- If initial test is abnormal but near diagnostic threshold, repeat testing in 3-6 months is recommended 1
- For patients with normal results and no risk factors, repeat testing at minimum 3-year intervals 1
- For patients with prediabetes (A1C 5.7-6.4%), yearly testing is recommended 1
Common Pitfalls to Avoid
- Preanalytic variability: FBS samples must be spun and separated immediately after collection to prevent falsely low results 1
- Point-of-care A1C testing: Not standardized for diagnostic purposes; clinical laboratory testing required 1
- Single test diagnosis: Except in cases of unequivocal hyperglycemia with classic symptoms, a single abnormal test result is insufficient for diagnosis 1
- Ignoring hemoglobinopathies: Can interfere with A1C measurement; use glucose-based criteria in affected individuals 1
Algorithm for Diabetes Diagnosis
- Initial screening: Perform either A1C or FBS test
- If result abnormal:
- A1C ≥6.5% or FBS ≥126 mg/dL: Perform second test (same type or different)
- If second test confirms: Diagnose diabetes
- If second test discordant: Repeat the test that was above threshold
- If initial result normal but patient has risk factors:
- Retest at appropriate interval (yearly for prediabetes, every 3 years otherwise)
By following this evidence-based approach to diabetes diagnosis, clinicians can ensure accurate identification of patients with diabetes, allowing for timely intervention to reduce morbidity and mortality associated with this chronic disease.