Early gestational diabetes management strategy compared to late management

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study investigates management strategies for early gestational diabetes diagnosed by first-trimester fasting glucose. Eligible participants are pregnant women with singleton pregnancies and early GDM (FPG 5.1–6.1 mmol/L) plus at least one risk factor, randomized before 20 weeks’ gestation. The trial compares an early intensive management approach to a later, standard strategy to see if earlier control of blood sugar affects pregnancy outcomes. It is conducted at multiple French sites led by University Hospital, Lille. Common exclusion criteria include pre-existing diabetes in pregnancy and significant comorbidities.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Pregnant woman
* Singleton pregnancy
* Early GDM defined by a fasting plasma glucose between 5.1 mmol/l and 6.1 mmol/ with at least one risk factor (age ≥35 years and/or BMI ≥ 25 kg/m2 and/or familial history of diabetes and/or personal history of GDM and/or personal history of macrosomia).
* First prenatal visit prior 20 weeks of gestation at the time of randomization.
* Signed informed consent

Exclusion Criteria:

Diabetic follow-up started at time of inclusion

* Pre-existing diabetes in pregnancy
* Renal impairment
* Hepatic insufficiency
* History of bariatric surgery
* Long time corticosteroids treatment
* Insufficient understanding
* Language difficulties
* Lack of social Insurance
* Person in emergency situation
* Person under the protection of justice (tutelage/ curatorship)
* Persons deprived of their liberty

Where it's running

• Ch Arras
  Arras, France Recruiting
• Hopital Estaing - Chu63 - Clermont Ferrand
  Clermont-Ferrand, France Recruiting
• Hop Claude Huriez Chu Lille
  Lille, France Recruiting
• Hopital Saint Vincent - Saint Antoine - Lille
  Lille, France Recruiting
• Chu Nimes Caremeau - Nimes 9
  Nîmes, France Recruiting
• Hopital Haut-Leveque - Chu - Pessac
  Pessac, France Recruiting

Study contacts

• Study coordinator: Anne VAMBERGUE, MD,PhD
• Email: anne.vambergue@chru-lille.fr
• Phone: 0320445962

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.