Clinical trial NCT06892314: Association Between CGM Metrics in Type 2 Diabetes Pregnancy and Perinatal Morbidity
Official title: Association Between CGM Metrics in Type 2 Diabetes Pregnancy and Perinatal Morbidity
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Type 2 Diabetes Mellitus (T2DM)
Pregnancy
Keywords: Type 2 diabetes mellitus
Continuous glucose monitoring
Pregnancy
Retrospective cohort study
Lead sponsor: Centre Hospitalier Sud Francilien
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient diagnosed with type 2 diabetes before or during pregnancy

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: time in range (63-140 mg/dL) in pourcentage
timeFrame: up to delivery
measure: preterm birth : yes or no
timeFrame: at delivery
measure: birth weight in kilogramme
timeFrame: at delivery
measure: neonatal hypoglycemia : yes or no
timeFrame: at delivery
measure: shoulder dystocia : yes or no
timeFrame: at delivery
measure: neonatal resuscitation : yes or no
timeFrame: at delivery
measure: perinatal mortality : yes or no
timeFrame: at delivery
Secondary outcomes:
measure: mean glucose (mmol/L)
timeFrame: up to delivery
measure: time in range (less than 63 mg/dL) in pourcentage
timeFrame: up to delivery
measure: glucose management indicator in pourcentage
timeFrame: up to delivery
measure: glycemic coefficient of variation in pourcentage
timeFrame: up to delivery
Other outcomes:
Locations:
Study officials:
affiliation: Centre Hospitalier Sud Francilien
name: Coralie AMADOU, MD
role: PRINCIPAL_INVESTIGATOR
References: