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

Last updated: August 13, 2025
Sponsor: Centre Hospitalier Sud Francilien
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy

Diabetes Mellitus, Type 2

Diabetes And Hypertension

Treatment

Exposure to hyperglycemia (type 2 diabetes)

Clinical Study ID

NCT06892314
2025/0006
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patient

  • Patient diagnosed with type 2 diabetes before or during pregnancy (fasting bloodglucose > 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 duringpregnancy

Exclusion

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 Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Exposure to hyperglycemia (type 2 diabetes)
Phase:
Study Start date:
April 15, 2025
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes, 91110
    France

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.