Laboratory Tests for Patients with Diabetes
For patients with diabetes, hemoglobin A1c (HbA1c) should be measured routinely every 3 months until acceptable targets are reached, then at least every 6 months, along with regular assessment of fasting plasma glucose and urine albumin-to-creatinine ratio to monitor glycemic control and screen for complications. 1
Core Laboratory Tests
- HbA1c should be measured routinely to document the degree of glycemic control, reflecting average glucose levels over the past 60-90 days 2, 3
- Fasting plasma glucose (FPG) should be measured after at least 8 hours of fasting, with samples collected in tubes containing citrate buffer or placed immediately in ice-water slurry to minimize glycolysis 1
- Urine albumin-to-creatinine ratio (uACR) should be measured annually in all adults with diabetes using morning spot urine samples to screen for diabetic kidney disease 1
- More frequent uACR testing (every 6 months) is needed if estimated glomerular filtration rate is <60 mL/min/1.73 m² and/or albuminuria is >30 mg/g creatinine 1
Frequency of Testing
- HbA1c should be measured at least twice a year in patients meeting glycemic goals, and quarterly in patients not meeting goals or with recent treatment changes 2
- Patients with prediabetes (A1C ≥5.7% [39 mmol/mol], impaired glucose tolerance, or impaired fasting glucose) should be tested yearly 2
- Women with a history of gestational diabetes should have lifelong testing at least every 3 years 2
Special Considerations for HbA1c Testing
- Only NGSP-certified methods should be used in accredited laboratories 2, 3
- HbA1c may not be reliable in conditions affecting red blood cell turnover, such as:
- Sickle cell disease
- Pregnancy (second and third trimesters)
- Hemodialysis
- Recent blood loss or transfusion
- Erythropoietin therapy 2
- In these cases, only plasma blood glucose criteria should be used for diagnosis and monitoring 2
- Marked discrepancies between measured A1C and plasma glucose levels should prompt consideration that the A1C assay may not be reliable for that individual 2
Additional Testing Based on Clinical Situation
- Lipid profile should be measured to assess cardiovascular risk factors, particularly in patients with hypertension, HDL cholesterol <35 mg/dL, or triglycerides >250 mg/dL 2
- C-peptide measurement may help distinguish type 1 from type 2 diabetes in ambiguous cases 1
- Blood ketone determinations (specifically β-hydroxybutyrate) should be used for diagnosis of diabetic ketoacidosis and may be used for monitoring during treatment 2
- Blood ketone testing is recommended for individuals prone to ketosis (those with type 1 diabetes, history of diabetic ketoacidosis, or treated with sodium-glucose transport protein 2 inhibitors) when they have unexplained hyperglycemia or symptoms of ketosis 2
Diagnostic Criteria for Diabetes
- Diabetes can be diagnosed by any of the following criteria:
- In the absence of unequivocal hyperglycemia, results should be confirmed by repeat testing 2
Common Pitfalls and Caveats
- Point-of-care A1C testing for diabetes screening and diagnosis should be restricted to FDA-approved devices at CLIA-certified laboratories that perform testing of moderate complexity or higher 2
- A1C does not provide a measure of glycemic variability or hypoglycemia, which are important factors in diabetes management 2
- For patients with conditions that interfere with A1C interpretation, alternative approaches such as self-monitoring of blood glucose, continuous glucose monitoring, or glycated serum protein assays should be used 2
- Patients should be informed about the importance of frequent blood glucose monitoring to achieve effective glycemic control and avoid both hyperglycemia and hypoglycemia 4
By following these laboratory testing guidelines, clinicians can effectively monitor glycemic control and screen for complications in patients with diabetes, ultimately improving morbidity, mortality, and quality of life outcomes.