Association Between CGM Metrics in Type 2 Diabetes Pregnancy and Perinatal Morbidity
NCT ID: NCT06892314
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
80 participants
OBSERVATIONAL
2025-05-15
2025-11-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients
Exposure to hyperglycemia (type 2 diabetes)
Exposure to hyperglycemia, in the context of type 2 diabetes, as measured by continuous glucose monitoring
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Exposure to hyperglycemia (type 2 diabetes)
Exposure to hyperglycemia, in the context of type 2 diabetes, as measured by continuous glucose monitoring
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre Hospitalier Sud Francilien
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Coralie AMADOU, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Sud Francilien
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France, France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2025/0006
Identifier Type: -
Identifier Source: org_study_id