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Evaluation of Commonly Used Blood Glucose Meters in Vietnam

NCT06228313 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 135

Last updated 2024-01-29

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Hung Vuong Hospital

    lead OTHER

Principal Investigators

  • Huan N Pham, M.D. · Hung Vuong Hospital

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2022-06-16
Completion
2022-10-20

Countries

  • Vietnam

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06228313 on ClinicalTrials.gov