An observational study in Type 2 Diabetes Mellitus (T2DM) and Pregnancy, sponsored by Centre Hospitalier Sud Francilien. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-30.
Sponsored by Centre Hospitalier Sud Francilien · Observational
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 80 is below the median of 300 across 1,588 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Centre Hospitalier Sud Francilien is the lead sponsor of 57 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient diagnosed with type 2 diabetes before or during pregnancy
Exclusion Criteria:
Biological: Exposure to hyperglycemia (type 2 diabetes)
Exposure to hyperglycemia, in the context of type 2 diabetes, as measured by continuous glucose monitoring
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
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
Plan to share: No
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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Sud Francilien