Evaluation of Commonly Used Blood Glucose Meters in Vietnam

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Pregnancy in Diabetic

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.

• Study Type: Observational
• Enrollment (Actual): 135

Contacts and Locations

Study Locations

• Vietnam
  • Ho Chi Minh, Vietnam, 700000
    • Hung Vuong Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women at obstetrics clinics at Hung Vuong Hospital

Description

Inclusion Criteria:

• Pregnant women undergo 75g glucose tolerance test

Exclusion Criteria:

• Usage of anticoagulant drug
• History of bleeding disorders.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hematocrit	Hematocrit in percentage, measured on hematology analyzer alinity h	Each participant's blood samples are run immediately after phlebotomy
Reference Glucose concentration	Glucose concentration, measured on reference glucose analyzer cobas c 502	Each participant's blood samples are run immediately after phlebotomy
ACCU-CHEK Inform II glucose concentration	Glucose concentration, measured on assessed blood glucose monitoring device ACCU-CHEK Inform II, Serial number UU14463019	Each participant's blood samples are run immediately after phlebotomy
ACCU-CHEK performa glucose concentration	Glucose concentration, measured on assessed blood glucose monitoring device ACCU-CHEK performa, Serial number 68827245972	Each participant's blood samples are run immediately after phlebotomy
ONETOUCH VerioVue glucose concentration	Glucose concentration, measured on assessed blood glucose monitoring device ONETOUCH VerioVue, Serial number YEPMT06H	Each participant's blood samples are run immediately after phlebotomy
Contour Plus glucose concentration	Glucose concentration, measured on assessed blood glucose monitoring device Contour Plus, Serial number 6128289	Each participant's blood samples are run immediately after phlebotomy
EasyGlucose glucose concentration	Glucose concentration, measured on assessed blood glucose monitoring device EasyGlucose, Serial number G16D21I0700816	Each participant's blood samples are run immediately after phlebotomy
VivaChek Ino glucose concentration	Glucose concentration, measured on assessed blood glucose monitoring device VivaChek Ino, Serial number 311Z0021DFA	Each participant's blood samples are run immediately after phlebotomy

Collaborators and Investigators

• Sponsor: Hung Vuong Hospital
• Investigators: Principal Investigator: Huan N Pham, M.D., Hung Vuong Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): June 16, 2022
• Study Completion (Actual): October 20, 2022

Study Registration Dates

• First Submitted: January 18, 2024
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 29, 2024

Study Record Updates

• Last Update Posted (Actual): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy in Diabetics
• Other Study ID Numbers: CS/HV/21/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared upon reasonable request
• IPD Sharing Time Frame: 3 months after publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No