Type 1 Diabetics Who Are Pregnant or Planning Pregnancy Clinical Trial
Official title:
Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial
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.
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.
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