To assess the utility and diagnostic accuracy of capillary glucose samples (using the Roche Accu-Chek Inform II point-of-care testing device) compared with venous glucose samples with laboratory determination as the gold standard. To determine the…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
* 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.
Background summary
Gestational diabetes mellitus is defined as any degree of glucose intolerance
with onset or first recognition during pregnancy and is associated with a
higher incidence of maternal and neonatal morbidity. Worldwide there is an
increasing prevalence of gestational diabetes mellitus. Point-of-care testing
of glucose is currently used to monitor diabetes gravidarum. Point-of-care
testing is a good alternative to gestational diabetes mellitus screening at the
time of the oral glucose tolerance test, considering lower laboratory costs,
convenience for patients and the immediate availability of test-results. To use
point-of-care testing equipment to diagnose gestational diabetes mellitus,
reliability and validity must match the laboratory analysis. In previous
studies, there is still controversy about the reliability and validity of
point-of-care glucose testing for the diagnosis of gestational diabetes
mellitus, due to the heterogeneity in used glucose meters. The study examines
the analytical quality and usefulness of the Roche Accu-Chek Inform II for
diagnosing gestational diabetes. The Roche Accu-Chek Inform II is used in the
daily clinical practice of the Zuyderland Medical Center to measure capillary
glucose samples in clinical patients.
Study objective
To assess the utility and diagnostic accuracy of capillary glucose samples
(using the Roche Accu-Chek Inform II point-of-care testing device) compared
with venous glucose samples with laboratory determination as the gold standard.
To determine the diagnostic accuracy the sensitivity, specificity, positive
predictive value, negative predictive value and area under the curve of
different cut-off values from capillary glucose samples will be compared to
venous glucose samples.
Study design
Prospective observational cohort study. Three capillary blood samples are taken
in addition to regular care (three venous blood samples) in 322 pregnant
patients during the OGTT, both fasting and one and two hours after ingesting
the glucose-contained drink the blood samples will be taken. The research is
carried out at the Zuyderland Medical Center.
Study burden and risks
The burden on the subjects are the three capillary blood samples. These blood
draws are fast, the duration of the blood draws will be a maximum of 5 minutes.
The risks of these capillary blood draws are blood loss and pain / discomfort
at the site of the blood draw. The risks are less compared to standard care
(venous blood sampling).
It's possible that a patient participates more than once in the study, this may
occur when an OGTT is performed more than once during the pregnancy or when a
patient in a subsequent pregnancy also participate in the study.
Henri Dunantstraat 5
Heerlen 6419 PC
NL
Henri Dunantstraat 5
Heerlen 6419 PC
NL
Listed location countries
Age
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
- 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL77188.096.21 |
| Other | NL9308 |