Early Gestational Diabetes Mellitus

Last updated: January 26, 2023
Sponsor: University Hospital, Lille
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Prevention

Diabetes (Pediatric)

Pregnancy Complications

Treatment

N/A

Clinical Study ID

NCT04451915
2017_76
2018-A00794-51
PHRC-17-008
  • Ages > 18
  • Female

Study Summary

In 2010, the International Association of the Diabetes and Pregnancy Study Groups (IADPSG) panel published consensus-based recommendations on the diagnosis and classification of hyperglycemia in pregnancy. Cognizant that milder degrees of hyperglycemia would also be detected by early pregnancy testing, the IADPSG recommended that fasting plasma glucose (FPG) in the range of 5.1-6.9 mmol/l should be considered diagnostic of early Gestational Diabetes Mellitus (GDM) even if the level of proof for this recommendation is very low regarding to prognosis. This threshold was extrapolated from the FPG value used between 24 and 28 weeks.

In France, a FPG is proposed at the first prenatal visit for women with risk factors of GDM. Early GDM is diagnosed if FPG is ≥ 5.1 mmol/l, leading to an intensive metabolic management. Data have shown that GDM prevalence increased rapidly from 5.9% in 2009 to 9.3% in 2014. 26.9% of women with hyperglycemia during their pregnancy but without known diabetes are treated before 22 weeks' gestation (WG). More recent data from Italy and China, where IADPSG diagnosis criteria were applied, have strongly challenged this recommendation, and showed that early FPG ≥ 5.1mmo/L is poorly predictive of later GDM. No prior studies have demonstrated benefits to early screening and management. In 2016, the IADPSG members have suggested that the use of the FPG threshold ≥5.1 mmol/l for the identification of GDM in early pregnancy is not justified by current evidence

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pregnant woman
  • Singleton pregnancy
  • Early GDM defined by a fasting plasma glucose between 5.1 mmol/l and 6.1 mmol/ with atleast one risk factor (age ≥35 years and/or BMI ≥ 25 kg/m2 and/or familial history ofdiabetes 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

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

Study Design

Total Participants: 2010
Study Start date:
November 30, 2020
Estimated Completion Date:
December 31, 2023

Connect with a study center

  • CH ARRAS

    Arras,
    France

    Active - Recruiting

  • Hopital Estaing - Chu63 - Clermont Ferrand

    Clermont-Ferrand,
    France

    Active - Recruiting

  • Hop Claude Huriez Chu Lille

    Lille, 59037
    France

    Active - Recruiting

  • Hopital Saint Vincent - Saint Antoine - Lille

    Lille, 59037
    France

    Active - Recruiting

  • Chu Nimes Caremeau - Nimes 9

    Nîmes,
    France

    Active - Recruiting

  • Hopital Haut-Leveque - Chu - Pessac

    Pessac, 33604
    France

    Active - Recruiting

  • Ch Rene Dubos - Pontoise

    Pontoise,
    France

    Active - Recruiting

  • Chu Site Sud (Saint Pierre) - St Pierre

    Saint-Pierre,
    France

    Active - Recruiting

  • Csapa / Hus / Hopital Civil - Strasbourg

    Strasbourg, 67091
    France

    Active - Recruiting

  • Hopital de Rangueil Chu Toulouse

    Toulouse, 31300
    France

    Active - Recruiting

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.