Comparison of Point-Of-Care Testing and venous blood glucose samples at the oral glucose tolerance test in pregnancy: a prospective observational cohort study

Comparison of Point-Of-Care Testing and venous blood glucose samples at the oral glucose tolerance test in pregnancy: a prospective observational cohort study - POCT-SUGAR trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51068

Enrollment

322

Registered

2021-04-23

Start date

2021-08-19

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational diabetes mellitus

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Pregnant patients 12-40 weeks of gestation Indication for OGTT: - Based on the outcome of the EXPECT calculator. The calculator is a tool we use in our regional midwifery collaboration to draft a risk profile for pregnant women. The calculator is used to counsel patients and develop a personal plan for obstetric care. This calculator uses a cut-off value of * 3.5% on the risk of GDM. - Based on risk factors: - GDM in previous pregnancy - BMI > 30 (kg/m2) at the first prenatal check-up - An earlier child with a birthweight > P95 or > 4500 grams - First-degree family member with diabetes - Certain ethnic groups in which diabetes is common (South Asians, including Hindus, Afro- Caribbean, Middle Eastern women, Morocco and Egypt) - Unexplained intrauterine fetal death in de past - Polycystic ovary syndrome (PCOS) - Based on symptoms in the pregnancy, such as macrosomia and/or polyhydramnios

Exclusion criteria

Exclusion criteria: - Unable to read informed consent in Dutch or English - Pre-gestational diabetes mellitus (type I or II) - Using glucose lowering medication (for example Metformin or Glyburide) - History of bariatric surgery with dumping in the past

Design outcomes

Primary

Measure	Time frame
The difference in clinical decision between capillary glucose samples and venous glucose samples in diagnosing patients with gestational diabetes mellitus. The utility and diagnostic accuracy of capillary glucose samples (POCT; Roche Accu-Chek Inform II) will be compared to venous glucose samples with laboratory determinations as the gold standard. To determine the diagnostic accuracy the sensitivity, specificity, positive predictive value and negative predictive value of POCT will be compared to the laboratory determination.	—

Measure

Time frame

The difference in clinical decision between capillary glucose samples and venous glucose samples in diagnosing patients with gestational diabetes mellitus. The utility and diagnostic accuracy of capillary glucose samples (POCT; Roche Accu-Chek Inform II) will be compared to venous glucose samples with laboratory determinations as the gold standard. To determine the diagnostic accuracy the sensitivity, specificity, positive predictive value and negative predictive value of POCT will be compared to the laboratory determination.

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Secondary

Measure	Time frame
* The difference between capillary and venous glucose values will be compared, for both fasting and one- and two-hour glucose values. * Investigate whether adjusted cut-offs can be found for the diagnosis of GDM based on POCT without compromising the diagnostic accuracy. Sensitivity, specificity, positive predictive value, negative predictive value and area under the curve will be measured for different cut-off values.	—

Measure

Time frame

* The difference between capillary and venous glucose values will be compared, for both fasting and one- and two-hour glucose values. * Investigate whether adjusted cut-offs can be found for the diagnosis of GDM based on POCT without compromising the diagnostic accuracy. Sensitivity, specificity, positive predictive value, negative predictive value and area under the curve will be measured for different cut-off values.

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Countries

Netherlands

Outcome results