Type I diabetes mellitus (T1DM) affects about 0.1-0.2% of all pregnancies. T1DM in pregnancy increases the risk of maternal and neonatal complications. Continuous glucose monitoring systems (CGM) provide a continuous display of measured glucose. Studies have shown improved pregnancy outcomes for patients with T1DM using CGM when compared to capillary blood glucose measurements. This prospective observational study analyses impact of glycemic variability on development of large-for-gestational-age neonates and effects of hypoglycemia during pregnancy on pregnancy outcomes. Furthermore, overall glycemic regulation, different insulin metrics and C-peptide concentration during pregnancy will also be assesed.
Up to 200 patients with type one diabetes will be enrolled in the study during first trimester of pregnancy. Medical history, clinical examination, anthropometric measurements and laboratory work-up will be obtained at first visit. Glucose metrics are provided from continuous glucose monitoring systems and blood glucose measurements . Following the initial evaluation, patients will be regularly examined in the hospital setting once a month during pregnancy. Following evaluations will include the same procedures as the first one. Pregnancy outcomes that will be analysed: spontaneous abortion, preterm birth, large-for-gestational-age neonates, macrosomia, small-for-gestational-age neonates, birth weight, congenital anomalies, APGAR score, neonatal hypoglycemia, intensive care unit admission for mother and/or infant.
Study Type
OBSERVATIONAL
Enrollment
200
University hospital centre Zagreb
Zagreb, Croatia
RECRUITINGIncidence of large-for-gestational-age neonates
Incidence of large-for-gestational-age neonates will be determined in group of patients with increased glycemic variability (%CV\> 36%) and in the group of patients with normal glycemic variability (%CV \< 36%) during different pregnancy trimesters. Glycemic variability parameters are available from continuous glucose monitoring system:percent coefficient of variation (%CV), interquartile range (IQR), standard deviation (SD).
Time frame: 9 months
Correlation of glycated hemoglobin and glycemic variability
Correlation of glycemic variability parameters (%CV, IQR, SD) and glycated hemoglobin in different pregnancy trimesters will be performed.Both parameters are available from continuos glucose monitoring systems.
Time frame: 9 months
Pregnancy outcomes - maternal and fetal
Effects of hypoglycemia on pregnancy outcomes will be analysed. Pregnancy outcomes included in the analysis: spontaneous abortion, preterm birth, large-for-gestational-age neonates, macrosomia, small-for-gestational-age neonates, birth weight, congenital anomalies, APGAR score, neonatal hypoglycemia, intensive care unit admission for mother and/or infant. Hypoglycemia will be assesed through parameters available from continuos glucose monitoring systems (low glucose events, time spent below target).
Time frame: 9 months
Correlation of hypoglycemia and glycemic variability
Correlation between hypoglycemia parameters (time below target, low glucose events) and glycemic variability parameters (%CV, SD, IQR) will be performed. Both parameters are available from continuous glucose monitoring systems.
Time frame: 9 months
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