Clinical trial NCT06228313: Evaluation of Commonly Used Blood Glucose Meters in Vietnam
Official title: Evaluation of Commonly Used Blood Glucose Meters in Vietnam and Effect of Hematocrit on Device's Accuracy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy in Diabetic
Diabetes
Lead sponsor: Hung Vuong Hospital
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 135
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women at obstetrics clinics at Hung Vuong Hospital

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Pregnant women undergo 75g glucose tolerance test

Exclusion Criteria:

* Usage of anticoagulant drug
* History of bleeding disorders.

Primary outcomes:
measure: Hematocrit
timeFrame: Each participant's blood samples are run immediately after phlebotomy
measure: Reference Glucose concentration
timeFrame: Each participant's blood samples are run immediately after phlebotomy
measure: ACCU-CHEK Inform II glucose concentration
timeFrame: Each participant's blood samples are run immediately after phlebotomy
measure: ACCU-CHEK performa glucose concentration
timeFrame: Each participant's blood samples are run immediately after phlebotomy
measure: ONETOUCH VerioVue glucose concentration
timeFrame: Each participant's blood samples are run immediately after phlebotomy
measure: Contour Plus glucose concentration
timeFrame: Each participant's blood samples are run immediately after phlebotomy
measure: EasyGlucose glucose concentration
timeFrame: Each participant's blood samples are run immediately after phlebotomy
measure: VivaChek Ino glucose concentration
timeFrame: Each participant's blood samples are run immediately after phlebotomy
Secondary outcomes:
Other outcomes:
Locations:
city: Ho Chi Minh
country: Vietnam
facility: Hung Vuong Hospital
Study officials:
affiliation: Hung Vuong Hospital
name: Huan N Pham, M.D.
role: PRINCIPAL_INVESTIGATOR
References: