Pregnancy in DiabeticNCT06228313
Evaluation of Commonly Used Blood Glucose Meters in Vietnam
An observational study of Pregnancy in Diabetic and Diabetes, run by Hung Vuong Hospital at 1 site in Vietnam.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy in Diabetic, Diabetes
- How many people
- 135 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jun 2022to 20 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women at obstetrics clinics at Hung Vuong Hospital
Who may be able to join
- Pregnant women undergo 75g glucose tolerance test
Who cannot join
- Usage of anticoagulant drug
- History of bleeding disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy in Diabetic, Diabetes
- Medical subject headings
- Pregnancy in Diabetics, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematocrit
Hematocrit in percentage, measured on hematology analyzer alinity h
Measured: Each participant's blood samples are run immediately after phlebotomy
Reference Glucose concentration
Glucose concentration, measured on reference glucose analyzer cobas c 502
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Each participant's blood samples are run immediately after phlebotomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start1 Jun 2022
- Primary completion16 Jun 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy in DiabeticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hung Vuong Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huan Nguyen Pham, Hung Vuong Hospital
- Investigators
- Huan N Pham, M.D., Principal investigator, Hung Vuong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228313
- Sponsor's protocol ID
- CS/HV/21/18
- Status last verified
- Jan 2024
- First submitted
- 18 Jan 2024
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Commonly Used Blood Glucose Meters in Vietnam and Effect of Hematocrit on Device's Accuracy
- ClinicalTrials.gov ID
- NCT06228313
- Acronym / sponsor ID
- CS/HV/21/18
- Conditions
- Pregnancy in Diabetic, Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Hung Vuong HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 16 Jun 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women at obstetrics clinics at Hung Vuong Hospital
Key inclusion criteria (1 listed)
- Pregnant women undergo 75g glucose tolerance test
Key exclusion criteria (2 listed)
- Usage of anticoagulant drug
- History of bleeding disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hematocrit
Time frame: Each participant's blood samples are run immediately after phlebotomy
Hematocrit in percentage, measured on hematology analyzer alinity h
Reference Glucose concentration
Time frame: Each participant's blood samples are run immediately after phlebotomy
Glucose concentration, measured on reference glucose analyzer cobas c 502
ACCU-CHEK Inform II glucose concentration
Time frame: Each participant's blood samples are run immediately after phlebotomy
Glucose concentration, measured on assessed blood glucose monitoring device ACCU-CHEK Inform II, Serial number UU14463019
ACCU-CHEK performa glucose concentration
Time frame: Each participant's blood samples are run immediately after phlebotomy
Glucose concentration, measured on assessed blood glucose monitoring device ACCU-CHEK performa, Serial number 68827245972
ONETOUCH VerioVue glucose concentration
Time frame: Each participant's blood samples are run immediately after phlebotomy
Glucose concentration, measured on assessed blood glucose monitoring device ONETOUCH VerioVue, Serial number YEPMT06H
Contour Plus glucose concentration
Time frame: Each participant's blood samples are run immediately after phlebotomy
Glucose concentration, measured on assessed blood glucose monitoring device Contour Plus, Serial number 6128289
EasyGlucose glucose concentration
Time frame: Each participant's blood samples are run immediately after phlebotomy
Glucose concentration, measured on assessed blood glucose monitoring device EasyGlucose, Serial number G16D21I0700816
VivaChek Ino glucose concentration
Time frame: Each participant's blood samples are run immediately after phlebotomy
Glucose concentration, measured on assessed blood glucose monitoring device VivaChek Ino, Serial number 311Z0021DFA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Individual participant dataSharing planned: Yes. Data will be shared upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huan N Pham, M.D. principal investigator
Hung Vuong Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy in Diabetic and Diabetes, run by Hung Vuong Hospital at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematocrit (time frame: Each participant's blood samples are run immediately after phlebotomy). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024.