Early Gestational Diabetes Mellitus (LEMA_GDM)

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

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

Study Overview

• Status: Recruiting
• Conditions: Gestational Diabetes
• Intervention / Treatment: Other: early management strategy; Other: late management strategy

• Study Type: Interventional
• Enrollment (Anticipated): 2010
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne VAMBERGUE, MD,PhD; Phone Number: 0320445962; Email: anne.vambergue@chru-lille.fr

Study Locations

• France
  • Arras, France
    • Recruiting
    • CH Arras
  • Clermont-Ferrand, France
    • Recruiting
    • Hopital Estaing - Chu63 - Clermont Ferrand
  • Lille, France, 59037
    • Recruiting
    • Hop Claude Huriez Chu Lille
  • Lille, France, 59037
    • Recruiting
    • Hopital Saint Vincent - Saint Antoine - Lille
  • Nîmes, France
    • Recruiting
    • Chu Nimes Caremeau - Nimes 9
  • Pessac, France, 33604
    • Recruiting
    • Hopital Haut-Leveque - Chu - Pessac
  • Pontoise, France
    • Recruiting
    • CH René Dubos - Pontoise
  • Saint-Pierre, France
    • Recruiting
    • Chu Site Sud (Saint Pierre) - St Pierre
  • Strasbourg, France, 67091
    • Recruiting
    • Csapa / Hus / Hopital Civil - Strasbourg
  • Toulouse, France, 31300
    • Recruiting
    • Hopital de Rangueil CHU Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early management GDM group; 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	Other: 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
Experimental: Late management GDM group; 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Metabolic data: HbA1c	Change of value of HbA1c	at inclusion (because <20 weeks') and an average at 24 28 weeks of gestation
Oral Glucose Tolerance Test (OGTT)		an average at 24 28 weeks of gestation
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
Number of complications in each subgroup of the late GDM management group	Maternal and neonatal complication	at delivery

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Study Director: Anne VAMBERGUE, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2020
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: June 25, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): January 27, 2023
• Last Update Submitted That Met QC Criteria: January 26, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: prognosis; pregnancy; diagnosis; fasting plasma glucose; Early gestational diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: 2017_76; 2018-A00794-51 (Other Identifier: ID-RCB number, ANSM); PHRC-17-008 (Other Identifier: PHRC number, DGOS)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No