Association Between CGM Metrics in Type 2 Diabetes Pregnancy and Perinatal Morbidity
- Conditions
- Type 2 Diabetes Mellitus (T2DM)Pregnancy
- Interventions
- Biological: Exposure to hyperglycemia (type 2 diabetes)
- Registration Number
- NCT06892314
- Lead Sponsor
- Centre Hospitalier Sud Francilien
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 120
- Adult patient
- Patient diagnosed with type 2 diabetes before or during pregnancy (fasting blood glucose > 126 mg/dL, blood glucose > 200 mg/dL after an oral glucose tolerance test, or HbA1c > 6.5%)
- Patient who has undergone continuous glucose monitoring at least once during pregnancy
- Multiple pregnancy
- Pregnancy terminated before 20 weeks of amenorrhea
- Delivery outside CHSF
- Patient and/or legal guardians of the newborn who objected to the use of data
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients Exposure to hyperglycemia (type 2 diabetes) -
- Primary Outcome Measures
Name Time Method time in range (63-140 mg/dL) in pourcentage up to delivery 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.
preterm birth : yes or no at delivery 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.
birth weight in kilogramme at delivery 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.
neonatal hypoglycemia : yes or no at delivery 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.
shoulder dystocia : yes or no at delivery 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.
neonatal resuscitation : yes or no at delivery 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.
perinatal mortality : yes or no at delivery 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.
- Secondary Outcome Measures
Name Time Method mean glucose (mmol/L) up to delivery Correlation between characteristics of pregnant patients with T2D and their newborns, including diabetes management and delivery details
time in range (less than 63 mg/dL) in pourcentage up to delivery Correlation between characteristics of pregnant patients with T2D and their newborns, including diabetes management and delivery details
glucose management indicator in pourcentage up to delivery Correlation between distribution of characteristics of pregnant patients with T2D and their newborns, including diabetes management and delivery details
glycemic coefficient of variation in pourcentage up to delivery Correlation between distribution of characteristics of pregnant patients with T2D and their newborns, including diabetes management and delivery details
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