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

NCT06892314 | Completed

• 1 other identifier: 2025/0006
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus (T2DM); Pregnancy

Keywords

Type 2 diabetes mellitus; Continuous glucose monitoring; Pregnancy; Retrospective cohort study

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  at delivery

Secondary Outcomes (4)

• mean glucose (mmol/L)

  up to delivery

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

  up to delivery

• glucose management indicator in pourcentage

  up to delivery

• glycemic coefficient of variation in pourcentage

  up to delivery

Study Arms (1)

Patients

Biological: Exposure to hyperglycemia (type 2 diabetes)

Interventions

Exposure to hyperglycemia (type 2 diabetes) BIOLOGICAL

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

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient diagnosed with type 2 diabetes before or during pregnancy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Sud Francilien: lead

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France, 91110, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Coralie AMADOU, MD

  Centre Hospitalier Sud Francilien

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 24, 2025
• Study Start: May 15, 2025
• Primary Completion: November 26, 2025
• Study Completion: November 26, 2025
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)