CompletedNot Applicable

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

France80 participantsStarted 2025-05-15

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

time in range (63-140 mg/dL) in pourcentage

Timeframe: up to delivery

preterm birth : yes or no

Timeframe: at delivery

birth weight in kilogramme

Timeframe: at delivery

neonatal hypoglycemia : yes or no

Timeframe: at delivery

shoulder dystocia : yes or no

Timeframe: at delivery

neonatal resuscitation : yes or no

Timeframe: at delivery

perinatal mortality : yes or no

Timeframe: at delivery

Trial details

NCT IDNCT06892314

SponsorCentre Hospitalier Sud Francilien

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-11-26

View on ClinicalTrials.gov More Type 2 Diabetes Mellitus (T2DM) trials