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

Centre Hospitalier Sud Francilien

Status: Completed

Conditions: Type 2 Diabetes Mellitus (T2DM); Pregnancy

Treatments: Biological: Exposure to hyperglycemia (type 2 diabetes)

Study type: Observational

Funder types: Other

Identifiers

NCT06892314

2025/0006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 1 patient group

Patients

Treatment:

Biological: Exposure to hyperglycemia (type 2 diabetes)