Abstract
BackgroundHyperglycemia 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 normoglycaemic counterparts, marked by increased risks of pre-eclampsia, macrosomia, and caesarean section amongst others. Continuous Glucose Monitoring (CGM) is a new method providing detailed information on daily fluctuations, used to optimize glucose control. Whether this tool improves pregnancy outcome remains unclear. In the present protocol, we aim to assess the effect of CGM use in diabetic pregnancies on pregnancy outcome.Methods/designThe GlucoMOMS trial is a multicenter open label randomized clinical trial with a decision and cost-effectiveness study alongside. Pregnant women aged 18 and over with either diabetes mellitus type 1 or 2 on insulin therapy or with gestational diabetes requiring insulin therapy before 30 weeks of gestation will be asked to participate. Consenting women will be randomly allocated to either usual care or complementary CGM. All women will determine their glycaemic control by self-monitoring of blood glucose levels and HbA1c. In addition, women allocated to CGM will use it for 5–7 days every six weeks. Based on their CGM profiles they receive dietary advice and insulin therapy adjustments if necessary. The primary outcome measure is rate of macrosomia, defined as a birth weight above the 90th centile. Secondary outcome measures will be birth weight, composite neonatal morbidity, maternal outcome and costs. The analyses will be according to the intention to treat principle.DiscussionWith this trial we aim at clarifying whether the CGM improves pregnancy outcome when used during diabetic pregnancies.Trial registrationNederlands Trial Register: NTR2996
Highlights
Hyperglycemia in pregnancy is associated with poor perinatal outcome
With this trial we aim at clarifying whether the Continuous Glucose Monitoring (CGM) improves pregnancy outcome when used during diabetic pregnancies
Even if pregnant women with diabetes are monitored according to current guidelines, they do much worse than their normoglycaemic counterparts
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 normoglycaemic counterparts, marked by increased risks of pre-eclampsia, macrosomia, and caesarean section amongst others. Continuous Glucose Monitoring (CGM) is a new method providing detailed information on daily fluctuations, used to optimize glucose control Whether this tool improves pregnancy outcome remains unclear. A recent RCT showed that intermittent CGMS use during pregnancy in 71 women with pre-existing diabetes resulted in a significant reduction in HbA1c at 32–36 weeks gestation. 11 (4%) of the children in the intervention group were small for gestational age (≤10 centile) as opposed to none in the control group This difference did not reach statistical significance either but may point to an adverse effect of CGMS. Another recent RCT by Secher et al investigated the effect of intermittent real time CGMS use during pregnancy in 154 women with pre-existing diabetes on pregnancy outcome [9]. Further evaluation in larger studies is urgently needed before wide implementation of CGMS during pregnancy
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
