Effectiveness of continuous glucose monitoring during diabetic pregnancy

Completed

• Conditions: diabetes mellitus; gestational diabetes; 10018424; 10026908

• Registration Number: NL-OMON38017
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

- Pregnant women with pre-existing diabetes (type 1 or type 2) before 16 weeks of pregnancy or with gestational diabetes before 30 weeks of pregnancy;
- on insulin treatment regimen or use of insulinpump;
- who are 18 years or older.

Exclusion Criteria

- Severe medical or psychological comorbidity
- Multiple pregnancies

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome of the RCT will be macrosomia rate, defined as a birth weight<br /><br>above the 90th centile. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes will be birth weight, composite neonatal morbidity, maternal<br /><br>outcome and costs. The analyses will be according to the intention to treat<br /><br>principle.</p><br>