Early Gestational Diabetes Mellitus

Gestational Diabetes Clinical Trial

— LEMA_GDM  

Official title:

Late Versus Early Management of Gestational Diabetes Mellitus: a Non Inferiority Randomized Multicenter Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04451915
• Other study ID #: 2017_76
• Secondary ID: 2018-A00794-51PH
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2020
• Est. completion date: December 2023

Study information

• Verified date: January 2023
• Source: University Hospital, Lille
• Contact: Anne VAMBERGUE, MD,PhD
• Phone: 0320445962
• Email: anne.vambergue[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2010
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Other:
• late management strategy
late management strategy of GDM defined as no intervention until GDM screening at 24-28 weeks. Between 24-28 weeks gestation, a 75-g OGTT will be done
• early management strategy
early management of GDM defined as intensive metabolic treatment. Intensive treatment involved the following multidisciplinary approach: lifestyle defined by diet and exercise intervention according to the French guidelines

Locations

Country	Name	City	State
France	CH ARRAS	Arras
France	Hopital Estaing - Chu63 - Clermont Ferrand	Clermont-Ferrand
France	Hop Claude Huriez Chu Lille	Lille
France	Hopital Saint Vincent - Saint Antoine - Lille	Lille
France	Chu Nimes Caremeau - Nimes 9	Nîmes
France	Hopital Haut-Leveque - Chu - Pessac	Pessac
France	Ch Rene Dubos - Pontoise	Pontoise
France	Chu Site Sud (Saint Pierre) - St Pierre	Saint-Pierre
France	Csapa / Hus / Hopital Civil - Strasbourg	Strasbourg
France	Hopital de Rangueil Chu Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The occurrence of materno-fetal complications	Composite endpoint defined by Large for Gestational Age (LGA) (defined by birth weight =90th percentile, adjusted for gestational age, sex, maternal BMI, parity, ethnicity) and/or neonatal hypoglycemia and/or shoulder dystocia and/or birth traumatisms	at delivery
Secondary	Correlation between composite endpoint (defined in the outcome 1) and the 5 risk factors of GDM	Correlation between composite endpoint (defined in the outcome 1) and the 5 risk factors of GDM (age more or equal to 35 years, BMI more or equal to 25 kg/m2, familial history of diabetes, personal history of GDM, personal history of macrosomia)	at delivery
Secondary	Need for insulin during pregnancy	After at least 10 days of dietary and lifestyles measures, if the target are not achieved, women will receive insulin therapy. fastin glucose target <5.1 mmol/ and/or a 2 hour post prandial capillary glucose < 6.6 mmol/l; at each 10 days a contact with the diabetologist or the nurses for the transmission of the capillary glycaemia either by phone or by the platform 'myDiabby"	at each 10 days until delivery
Secondary	Metabolic data: Fasting plasma glucose	Change of value of fasting plasma glucose	at inclusion (because <20 weeks') and an average at 24 28 weeks of gestation
Secondary	Metabolic data: HbA1c	Change of value of HbA1c	at inclusion (because <20 weeks') and an average at 24 28 weeks of gestation
Secondary	Oral Glucose Tolerance Test (OGTT)		an average at 24 28 weeks of gestation
Secondary	Percent of GDM women in the late GDM management group according to the IADPSG criteria.	IADPSG criteria(fasting glucose more or equal to 5.1 mmol/l and/or 1h more or equal to 10.0 mmol/l and /or 2h more or equal to 8.5 mmol/l	an average at 24 28 weeks of gestation
Secondary	Number of complications in each subgroup of the late GDM management group	Maternal and neonatal complication	at delivery