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NCT Number: NCT06892314

Association Between CGM Metrics in Type 2 Diabetes Pregnancy and Perinatal Morbidity

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.

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France, 91110

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exposure to hyperglycemia (type 2 diabetes)

Biological

Exposure to hyperglycemia, in the context of type 2 diabetes, as measured by continuous glucose monitoring

Primary outcomes

  1. time in range (63-140 mg/dL) in pourcentage

    Time frame: 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.

  2. preterm birth : yes or no

    Time frame: 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.

  3. birth weight in kilogramme

    Time frame: 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.

  4. neonatal hypoglycemia : yes or no

    Time frame: 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.

  5. shoulder dystocia : yes or no

    Time frame: 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.

  6. neonatal resuscitation : yes or no

    Time frame: 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.

  7. perinatal mortality : yes or no

    Time frame: 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 outcomes

  1. mean glucose (mmol/L)

    Time frame: up to delivery

    Correlation between characteristics of pregnant patients with T2D and their newborns, including diabetes management and delivery details

  2. time in range (less than 63 mg/dL) in pourcentage

    Time frame: up to delivery

    Correlation between characteristics of pregnant patients with T2D and their newborns, including diabetes management and delivery details

  3. glucose management indicator in pourcentage

    Time frame: up to delivery

    Correlation between distribution of characteristics of pregnant patients with T2D and their newborns, including diabetes management and delivery details

  4. glycemic coefficient of variation in pourcentage

    Time frame: up to delivery

    Correlation between distribution of characteristics of pregnant patients with T2D and their newborns, including diabetes management and delivery details

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Sud Francilien

Other

Registry information

Acronym: PREG CGM

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 24, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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