Pregnancy, Type 2 Diabetes Mellitus (T2DM)
Conditions
Keywords
Type 2 diabetes mellitus, Continuous glucose monitoring, Pregnancy, Retrospective cohort study
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.
Interventions
BIOLOGICALExposure to hyperglycemia (type 2 diabetes)
Exposure to hyperglycemia, in the context of type 2 diabetes, as measured by continuous glucose monitoring
Sponsors
Centre Hospitalier Sud Francilien
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| mean glucose (mmol/L) | up to delivery | Correlation between characteristics of pregnant patients with T2D and their newborns, including diabetes management and delivery details |
Countries
France
Outcome results
None listed