In the present proposal, we aim to assess the cost-effectiveness of the use of CGMS in diabetic pregnancies.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Maternal complications of pregnancy
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome of the RCT will be macrosomia rate, defined as a birth weight
above the 90th centile.
Secondary outcome
Secondary outcomes will be birth weight, composite neonatal morbidity, maternal
outcome and costs. The analyses will be according to the intention to treat
principle.
Background summary
Hyperglycemia in pregnancy is associated with poor perinatal outcome. Even if
pregnant women with diabetes are monitored according to current guidelines,
they do much worse than their normoglycemic counterparts. The Continuous
Glucose Monitoring System (CGMS) is an efficacious new method to optimize
glucose control in pregnant women with diabetes.
Study objective
In the present proposal, we aim to assess the cost-effectiveness of the use of
CGMS in diabetic pregnancies.
Study design
Multicenter open label randomized clinical trial (RCT) with a decision and
cost-effectiveness study alongside it.
Intervention
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 of the CGMS will be added. Their
inulinescheme will be adjusted according to the CGMS-profiles.
Study burden and risks
The risks of participation in this trial are considered to be negligible.
Participants who are randomised for use of the CGMS might benefit from it.
Participants who are randomised for standard care might not benefit from this
trial in this pregnancy, but their participation is indispensable for the well
being of future diabetic pregnant women and their children. All participants
fill out three questionnaires, which will take them approximately 30 minutes
per questionnaire. Furthermore, participants who are randomised for the CGMS
will have the device placed and removed during regular visits with their doctor
and wear the sensor and the monitor during 5-7 days each time, with a maximum
of 5 times.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
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
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 | NL33801.018.10 |