Flash Glucose Monitoring: an alternative screening method for Gestational Diabetes Mellitus?

Recruiting

• Conditions: GDM; gestational diabetes; 10018424; 10026908

• Registration Number: NL-OMON55968
• Lead Sponsor: Gelre Ziekenhuizen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

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

Diabetes mellitus in history
Pregnant women in 2nd and 3rd line obstetric/gynaecological care.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Outcomes:<br /><br>- Gestational age at start FGM in weeks + days<br /><br>- Time above target range (>7.8 mmol/l) in percent. Where >1% is abnormal.<br /><br>- Active sensor in percent minimum 80% active sensor needed for reliable image<br /><br>- FGM diagnosis GDM yes/no<br /><br><br /><br>- Gestational age at taking OGTT, in weeks + days<br /><br>- OGTT result fasting capillary glucose in mmol/l<br /><br>- Result OGTT two-hour capillary glucose value in mmol/l<br /><br>- OGTT diagnosis GDM yes/no</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Patient characteristics<br /><br>- Age in years at first antenatal check-up<br /><br>- BMI at first antenatal check-up in kg/m2<br /><br>- How many pregnancy<br /><br>- À terme date<br /><br>- Indication OGTT<br /><br>- Evidencio score in percent rounded to one decimal point. This is a prediction<br /><br>model which calculates the pregnant person's risk of developing GDM and is<br /><br>calculated in the first trimester of pregnancy</p><br>