NCT06892314

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: Centre Hospitalier Sud Francilien · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus (T2DM)
• Pregnancy

Interventions

Type	Name	Description
BIOLOGICAL	Exposure to hyperglycemia (type 2 diabetes)	Exposure to hyperglycemia, in the context of type 2 diabetes, as measured by continuous glucose monitoring

Timeline

• Start date: 2025-05-15
• Primary completion: 2025-11-26
• Completion: 2025-11-26
• First posted: 2025-03-24
• Last updated: 2025-12-30

Locations

1 site across 1 country: France