The purpose of this observational study is to measure the association between continuous glucose monitoring (CGM) parameters and perinatal morbidity in offspring of women with type 2 diabetes. Specifically, the study will assess whether gestational age interacts with metabolic control in influencing perinatal morbidity, as well as the impact of the timing of CGM initiation during pregnancy.
Continuous glucose monitoring (CGM) data in pregnant women living with type 2 diabetes (T2D) and its association with perinatal morbidity are very recent and remain scarce. Moreover, perinatal morbidity appears to differ in these patients compared to pregnancies affected by type 1 diabetes or gestational diabetes. As a result, a deeper understanding is needed to identify the most relevant glycemic parameters and, in particular, the gestational age most critical for metabolic control. Furthermore, uncertainty remains regarding the benefits of early CGM use in this population, which is characterized by early-onset T2D. A description of this population in the French context is therefore of particular interest. This single-centre observational study will consist of a retrospective cohort of patients with type 2 diabetes and pregnancy with pregnancy follow-up and delivery at the Centre Hospitalier Sud-Francilien between 1 January 2020 and 31 January 2025.
Study Type
OBSERVATIONAL
Enrollment
80
Exposure to hyperglycemia, in the context of type 2 diabetes, as measured by continuous glucose monitoring
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France, France
time in range (63-140 mg/dL) in pourcentage
Correlation between time in range (63-140 mg/dL) during pregnancy and perinatal risk, assessed using a composite outcome including preterm birth, birth weight \> 90th percentile for gestational age, neonatal hypoglycemia, shoulder dystocia, neonatal resuscitation, neonatal hyperbilirubinemia, and perinatal mortality.
Time frame: up to delivery
preterm birth : yes or no
Correlation between time in range (63-140 mg/dL) during pregnancy and perinatal risk, assessed using a composite outcome including preterm birth, birth weight \> 90th percentile for gestational age, neonatal hypoglycemia, shoulder dystocia, neonatal resuscitation, neonatal hyperbilirubinemia, and perinatal mortality.
Time frame: at delivery
birth weight in kilogramme
Correlation between time in range (63-140 mg/dL) during pregnancy and perinatal risk, assessed using a composite outcome including preterm birth, birth weight \> 90th percentile for gestational age, neonatal hypoglycemia, shoulder dystocia, neonatal resuscitation, neonatal hyperbilirubinemia, and perinatal mortality.
Time frame: at delivery
neonatal hypoglycemia : yes or no
Correlation between time in range (63-140 mg/dL) during pregnancy and perinatal risk, assessed using a composite outcome including preterm birth, birth weight \> 90th percentile for gestational age, neonatal hypoglycemia, shoulder dystocia, neonatal resuscitation, neonatal hyperbilirubinemia, and perinatal mortality.
Time frame: at delivery
shoulder dystocia : yes or no
Correlation between time in range (63-140 mg/dL) during pregnancy and perinatal risk, assessed using a composite outcome including preterm birth, birth weight \> 90th percentile for gestational age, neonatal hypoglycemia, shoulder dystocia, neonatal resuscitation, neonatal hyperbilirubinemia, and perinatal mortality.
Time frame: at delivery
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neonatal resuscitation : yes or no
Correlation between time in range (63-140 mg/dL) during pregnancy and perinatal risk, assessed using a composite outcome including preterm birth, birth weight \> 90th percentile for gestational age, neonatal hypoglycemia, shoulder dystocia, neonatal resuscitation, neonatal hyperbilirubinemia, and perinatal mortality.
Time frame: at delivery
perinatal mortality : yes or no
Correlation between time in range (63-140 mg/dL) during pregnancy and perinatal risk, assessed using a composite outcome including preterm birth, birth weight \> 90th percentile for gestational age, neonatal hypoglycemia, shoulder dystocia, neonatal resuscitation, neonatal hyperbilirubinemia, and perinatal mortality.
Time frame: at delivery
mean glucose (mmol/L)
Correlation between characteristics of pregnant patients with T2D and their newborns, including diabetes management and delivery details
Time frame: up to delivery
time in range (less than 63 mg/dL) in pourcentage
Correlation between characteristics of pregnant patients with T2D and their newborns, including diabetes management and delivery details
Time frame: up to delivery
glucose management indicator in pourcentage
Correlation between distribution of characteristics of pregnant patients with T2D and their newborns, including diabetes management and delivery details
Time frame: up to delivery
glycemic coefficient of variation in pourcentage
Correlation between distribution of characteristics of pregnant patients with T2D and their newborns, including diabetes management and delivery details
Time frame: up to delivery