Skip to main content
OpenTrials
Completed

NCT Number: NCT06228313

Evaluation of Commonly Used Blood Glucose Meters in Vietnam

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy in Diabetic Diabetes Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Pregnancy in Diabetics Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Hung Vuong Hospital

Ho Chi Minh City, 700000, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women undergo 75g glucose tolerance test

Exclusion criteria

  • Usage of anticoagulant drug
  • History of bleeding disorders.

Treatment and study plan

Primary outcomes

  1. Hematocrit

    Time frame: Each participant's blood samples are run immediately after phlebotomy

    Hematocrit in percentage, measured on hematology analyzer alinity h

  2. Reference Glucose concentration

    Time frame: Each participant's blood samples are run immediately after phlebotomy

    Glucose concentration, measured on reference glucose analyzer cobas c 502

  3. ACCU-CHEK Inform II glucose concentration

    Time frame: Each participant's blood samples are run immediately after phlebotomy

    Glucose concentration, measured on assessed blood glucose monitoring device ACCU-CHEK Inform II, Serial number UU14463019

  4. ACCU-CHEK performa glucose concentration

    Time frame: Each participant's blood samples are run immediately after phlebotomy

    Glucose concentration, measured on assessed blood glucose monitoring device ACCU-CHEK performa, Serial number 68827245972

  5. ONETOUCH VerioVue glucose concentration

    Time frame: Each participant's blood samples are run immediately after phlebotomy

    Glucose concentration, measured on assessed blood glucose monitoring device ONETOUCH VerioVue, Serial number YEPMT06H

  6. Contour Plus glucose concentration

    Time frame: Each participant's blood samples are run immediately after phlebotomy

    Glucose concentration, measured on assessed blood glucose monitoring device Contour Plus, Serial number 6128289

  7. EasyGlucose glucose concentration

    Time frame: Each participant's blood samples are run immediately after phlebotomy

    Glucose concentration, measured on assessed blood glucose monitoring device EasyGlucose, Serial number G16D21I0700816

  8. VivaChek Ino glucose concentration

    Time frame: Each participant's blood samples are run immediately after phlebotomy

    Glucose concentration, measured on assessed blood glucose monitoring device VivaChek Ino, Serial number 311Z0021DFA

Sponsors and collaborators

Lead sponsor

Hung Vuong Hospital

Other

Registry information

Official study title

Evaluation of Commonly Used Blood Glucose Meters in Vietnam and Effect of Hematocrit on Device's Accuracy

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 29, 2024
Registry last updated
Jan 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.