Early Gestational Diabetes Mellitus

  • End date
    Dec 28, 2023
  • participants needed
  • sponsor
    University Hospital, Lille
Updated on 28 April 2021


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

Condition Gestational Diabetes, Diabetes Mellitus, Diabetes Mellitus Types I and II, Diabetes Prevention, Diabetes (Pediatric), Pregnancy Complications, Pregnancy Complications, Diabetes Prevention, Diabetes Mellitus Types I and II, Diabetes (Pediatric)
Treatment late management strategy, early management strategy
Clinical Study IdentifierNCT04451915
SponsorUniversity Hospital, Lille
Last Modified on28 April 2021


Yes No Not Sure

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

Multiple Pregnancy
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
Refusal to participate in research
Person in emergency situation
Person under the protection of justice (tutelage/ curatorship)
Persons deprived of their liberty
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note