Evaluation of Commonly Used Blood Glucose Meters in Vietnam

NCT06228313 | Completed DMC

• 1 other identifier: CS/HV/21/18
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy in Diabetic; Diabetes

Outcome Measures

Primary Outcomes (8)

• 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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women at obstetrics clinics at Hung Vuong Hospital

You may qualify if:

• Pregnant women undergo 75g glucose tolerance test

You may not qualify if:

• Usage of anticoagulant drug
• History of bleeding disorders.

Sponsors & Collaborators

• Hung Vuong Hospital: lead

Study Sites (1)

Hung Vuong Hospital

Ho Chi Minh City, 700000, Vietnam

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood sample in EDTA-NaF tube

MeSH Terms

Conditions

Pregnancy in Diabetics; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Huan N Pham, M.D.

  Hung Vuong Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Technical supervisor

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 29, 2024
• Study Start: June 1, 2022
• Primary Completion: June 16, 2022
• Study Completion: October 20, 2022
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 3 months after publication

Locations

VN (1)