Evaluation of Commonly Used Blood Glucose Meters in Vietnam

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06228313
• Other study ID #: CS/HV/21/18
• Status: Completed
• Start date: June 1, 2022
• Est. completion date: October 20, 2022

Study information

• Verified date: January 2024
• Source: Hung Vuong Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: October 20, 2022
• Est. primary completion date: June 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Pregnant women undergo 75g glucose tolerance test

Exclusion Criteria:

• Usage of anticoagulant drug

• History of bleeding disorders.

Related Conditions & MeSH terms

• Diabetes
• Pregnancy in Diabetic
• Pregnancy in Diabetics

Locations

Country	Name	City	State
Vietnam	Hung Vuong Hospital	Ho Chi Minh

Sponsors (1)

Lead Sponsor	Collaborator
Hung Vuong Hospital

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematocrit	Hematocrit in percentage, measured on hematology analyzer alinity h	Each participant's blood samples are run immediately after phlebotomy
Primary	Reference Glucose concentration	Glucose concentration, measured on reference glucose analyzer cobas c 502	Each participant's blood samples are run immediately after phlebotomy
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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