Evaluation of Commonly Used Blood Glucose Meters in Vietnam
Condition: Pregnancy in Diabetic; Diabetes
MeSH terms: Pregnancy in Diabetics
Study type: Observational

Summary: 
      Rationale: Most BGM (blood glucose monitoring) devices in Vietnam are manufactured for home
      use only. However, they are commonly used in healthcare facility, primarily at point of care.
      We want to assess the validity of these devices by using CLSI (Clinical and Laboratory
      Standards Institute) POCT12-A3 to assess the accuracy.

      Objective: To validate the accuracy and effect of hematocrit on these devices, along with the
      precision profile using CLSI EP15A3

      Study design: This is a cross-sectional study.

      Study population: Because we need a wide range of blood glucose level. We chose pregnant
      women who underwent 75g glucose tolerance test.
    

Detailed description: 
      Most blood glucose monitors circulating the market are manufactured after ISO 15197:2013
      standard, which is intended for self-measurement. Medical organizations need to verify blood
      glucose monitors if they are designed for prescription point-of-care use or validate blood
      glucose monitors if they are designed for over-the-counter use.

      Pregnant women are selected after consent, their blood are then drawn by phlebotomist into an
      EDTA (ethylenediamine tetraacetic acid) with NaF (sodium flouride) blood tube. Samples are
      run on alinity h hematology analyzer, manufactured by Abbott, to measure hematocrit. The
      analyzers are verified by laboratory procedure, recommended by CLSI (Clinical and Laboratory
      Standards Institute) method and quality control is checked before in accordance to the
      laboratory procedure. After that, blood tube is mixed thoroughly before being pipetted. Each
      BGM device will measure blood glucose level of the pipetted whole blood. Finally, samples
      will be run on a cobas c 502 analyzer to measure plasma glucose level, which is a reference
      method for determining the accuracy of the BGM devices.

      Statistical analysis: Meter performance is acceptable for use in hospitals when 95% of the
      individual results from the POC glucose meter system agree within 0.67 mmol/L (12 mg/dL) of
      the laboratory analyzer values at glucose concentrations below 5.55 mmol/L (100 mg/dL) and
      within 12.5% of the laboratory analyzer values at glucose concentrations at or above 5.55
      mmol/L (100 mg/dL). In addition, the sum of the number of individual results with 1) errors
      that exceed 0.83 mmol/L (15 mg/dL) at glucose concentrations below 4.2 mmol/L (75 mg/dL) and
      2) errors that exceed 20% at glucose concentrations at or above 4.2 mmol/L (75 mg/dL) should
      not exceed 2% of all results. An ordinary linear regression is performed to see how well the
      glucose level of BGM devices correlates with the reference method. Bland-Altman difference
      plots are used to describe the difference along with the hematocrit of each sample.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women at obstetrics clinics at Hung Vuong Hospital
      
Biospecimen description: 
      Whole blood sample in EDTA-NaF tube