NCT01788527

Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 325 (actual)
• Sponsor: Mount Sinai Hospital, Canada · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to determine if RT CGM (Real Time-Continuous Glucose Monitoring) can improve glycemic control in women with T1D who are pregnant or planning pregnancy.

Detailed description

In women with diabetes, hyperglycemia is associated with increased rates of numerous maternal and fetal adverse outcomes. Mothers are at increased risk of preeclampsia, polyhydramnios, and caesarean sections. Infants of mothers with diabetes have increased rates of congenital anomalies, premature delivery, macrosomia, stillbirth and NICU admissions. Macrosomia itself is associated with numerous adverse fetal outcomes including shoulder dystocia, birth injury, neonatal hypoglycemia, hyperbilirubinemia, respiratory distress syndrome and NICU admissions, asphyxia and death. Postprandial blood sugars in particular have been associated with increased macrosomia rates. Numerous studies have shown that pregnancy outcomes can be reduced with improved glycemic control. In particular, pre-pregnancy care has been shown to assist women improve glucose control during the crucial period of organogenesis, and is associated with reduced rates of adverse pregnancy outcome including major congenital malformation, stillbirth and neonatal death. Technological advances aimed at reducing glycemic excursions and improving glucose control in patients with diabetes include the continuous glucose monitoring (CGM) system. We hypothesize that real-time CGM will assist women with type 1 diabetes to improve their glycemic control before and during pregnancy.

Conditions

• Type 1 Diabetics Who Are Pregnant or Planning Pregnancy

Interventions

Type	Name	Description
DEVICE	CGM	Real Time Continuous Glucose Monitoring

Timeline

• Start date: 2013-03-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2013-02-11
• Last updated: 2017-07-19

Locations

31 sites across 6 countries: United States, Canada, Ireland, Italy, Spain, United Kingdom