Early Gestational Diabetes Mellitus (LEMA_GDM)

University Hospital, Lille

Status: Enrolling

Conditions: Gestational Diabetes

Treatments: Other: early management strategy; Other: late management strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT04451915

2017_76

PHRC-17-008 (Other Identifier)

2018-A00794-51 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 2,010 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,010 participants in 2 patient groups

Early management GDM group

Experimental group

Description:

defined as no intervention until GDM screening at 24-28 weeks' gestation. If there is a diagnosis of GDM at 24-28 according to the IADPSG criteria), intensive metabolic treatment until delivery

Treatment:

Other: early management strategy

Late management GDM group

Experimental group

Description:

early management of GDM defined as intensive metabolic treatment (diet, physical activity self-blood glucose monitoring according and/or insulin therapy according to the French guidelines). This intensive treatment will begin after the randomization until delivery.

Treatment:

Other: late management strategy