GDM gestational diabetes
Conditions
Interventions
As part of diagnostic research, an FGM will be placed in addition to the
standard OGTT (placement is an act). The subject will then scan the sensor
every 8 hours for 7 days (there may be more than 8
Sponsors
Gelre Ziekenhuizen
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Adult woman between 24 and 28 weeks of pregnancy who is eligible for an OGTT in primary obstetric care according to the guideline of the Dutch Society of Obstetrics & Gynaecology
Exclusion criteria
Exclusion criteria: Diabetes mellitus in history Pregnant women in 2nd and 3rd line obstetric/gynaecological care.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcomes: - Gestational age at start FGM in weeks + days - Time above target range (>7.8 mmol/l) in percent. Where >1% is abnormal. - Active sensor in percent minimum 80% active sensor needed for reliable image - FGM diagnosis GDM yes/no - Gestational age at taking OGTT, in weeks + days - OGTT result fasting capillary glucose in mmol/l - Result OGTT two-hour capillary glucose value in mmol/l - OGTT diagnosis GDM yes/no | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient characteristics - Age in years at first antenatal check-up - BMI at first antenatal check-up in kg/m2 - How many pregnancy - À terme date - Indication OGTT - Evidencio score in percent rounded to one decimal point. This is a prediction model which calculates the pregnant person's risk of developing GDM and is calculated in the first trimester of pregnancy | — |
Countries
Netherlands
Outcome results
None listed