Effectiveness of continuous glucose monitoring during diabetic pregnancy

Effectiveness of continuous glucose monitoring during diabetic pregnancy - Continuous glucose monitoring in diabetic pregnancies

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38017

Enrollment

300

Registered

2011-04-19

Start date

2011-07-12

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

diabetes mellitus gestational diabetes

Interventions

Participating women will get either addtional use of CGMS or care as usual. All women will check their blood glucose by daily monitoring and HBA1c-values. For the women in the CGMS group monthly use

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - Severe medical or psychological comorbidity - Multiple pregnancies

Design outcomes

Primary

Measure	Time frame
Primary outcome of the RCT will be macrosomia rate, defined as a birth weight above the 90th centile.	—

Secondary

Measure	Time frame
Secondary outcomes will be birth weight, composite neonatal morbidity, maternal outcome and costs. The analyses will be according to the intention to treat principle.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)