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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Type 2 Diabetes Mellitus (T2DM)
• Intervention / Treatment: Biological: Exposure to hyperglycemia (type 2 diabetes)

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.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• France
  • France
    • Corbeil-Essonnes, France, France, 91110
      • Centre hospitalier Sud Francilien

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient diagnosed with type 2 diabetes before or during pregnancy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients	Biological: Exposure to hyperglycemia (type 2 diabetes); Exposure to hyperglycemia, in the context of type 2 diabetes, as measured by continuous glucose monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean glucose (mmol/L)	Correlation between characteristics of pregnant patients with T2D and their newborns, including diabetes management and delivery details	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	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	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	up to delivery

Collaborators and Investigators

• Sponsor: Centre Hospitalier Sud Francilien
• Investigators: Principal Investigator: Coralie AMADOU, MD, Centre hospitalier Sud Francilien

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2025
• Primary Completion (Actual): November 26, 2025
• Study Completion (Actual): November 26, 2025

Study Registration Dates

• First Submitted: March 13, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Pregnancy; Type 2 diabetes mellitus; Continuous glucose monitoring; Retrospective cohort study
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2025/0006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No