Gestational DiabetesLEMA_GDMNCT04451915
Early Gestational Diabetes Mellitus
A study testing late management strategy and early management strategy in people with Gestational Diabetes, run by University Hospital, Lille at 10 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- late management strategy and early management strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,010 participants
- Where
- 10 sitesFrance
- Study dates
- 30 Nov 2020to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
France10 sites, 10 recruiting
- Recruiting
CH ARRAS
Arras
- Recruiting
Hopital Estaing - Chu63 - Clermont Ferrand
Clermont-Ferrand
- Recruiting
Hop Claude Huriez Chu Lille
Lille, 59037
0320445962
- Recruiting
Hopital Saint Vincent - Saint Antoine - Lille
Lille, 59037
- Recruiting
Chu Nimes Caremeau - Nimes 9
Nîmes
- Recruiting
Hopital Haut-Leveque - Chu - Pessac
Pessac, 33604
- Recruiting
Ch Rene Dubos - Pontoise
Pontoise
- Recruiting
Chu Site Sud (Saint Pierre) - St Pierre
Saint-Pierre
- Recruiting
Csapa / Hus / Hopital Civil - Strasbourg
Strasbourg, 67091
- Recruiting
Hopital de Rangueil Chu Toulouse
Toulouse, 31300
About this study
Official title: 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
- Conditions
- Gestational Diabetes
- Being tested
- late management strategy, early management strategy
- Keywords
- Early gestational diabetes, pregnancy, fasting plasma glucose, diagnosis, prognosis
- Medical subject headings
- Diabetes, Gestational, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
late management strategyOther
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 strategyOther
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
| Study group | Role | What they receive |
|---|---|---|
| Early management GDM group | Experimental | 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 Receives: Other: early management strategy |
| Late management GDM group | Experimental | 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. Receives: Other: late management strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at delivery
Secondary outcomes (12)
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)
Measured: 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"
Measured: at each 10 days until delivery
Metabolic data: Fasting plasma glucose
Change of value of fasting plasma glucose
Measured: at inclusion (because <20 weeks') and an average at 24 28 weeks of gestation
Metabolic data: HbA1c
Change of value of HbA1c
Measured: at inclusion (because <20 weeks') and an average at 24 28 weeks of gestation
Oral Glucose Tolerance Test (OGTT)
Measured: 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
Measured: an average at 24 28 weeks of gestation
Number of complications in each subgroup of the late GDM management group
Maternal and neonatal complication
Measured: at delivery
Neonatal anthropometric parameters
Weight (kilograms), height in centimeters will be combined to report body mass index (kg/m2) at 6 weeks after delivery.
GDM+ children, body mass index (BMI) z score, , waist circumference, Height was measured to the nearest 0.1 centimeter using a stadiometer, weight was measured to the nearest 0.1 kilogram using a calibrated balance (Tanita BC-418) and BMI was calculated (kg/m2). Children's BMI z-score was calculated using World Health Organization Anthroplus software (version 1.0.4, WHO, Geneva, Switzerland, 2009) and compared between birth and 6 weeks after delivery.
Measured: 6 weeks after delivery
Maternal plasma metabolic parameters
Several biochemical parameters will be measured in maternal plasma both at inclusion and delivery such as (fasting) glucose (mM) using colorimetric detection kit, (fasting) plasma insulin (pM), and glycated hemoglobin (HbA1c) (%) using specific enzyme-linked immunosorbent assay (ELISA) kits. Glucose and insulin levels will be combined to report the HOMA-IR index, calculated as follows: Fasting insulin (pmol/L)/6.945) x fasting glucose (mmol/L))/22.5. Triglycerides (mM) and LDL- and HDL-cholesterol (mM) will be measured in maternal plasma between inclusion and delivery and determined simultaneously on Erba XL670 system. Exploratory analyses will be performed in maternal blood at inclusion and at delivery, using liquid-chromatography-high resolution combined with mass spectrometry in tandem in order to characterize the maternal metabolomic, lipidomic patterns as reflects of maternal metabolic status. Each variable will be expressed as %.
Measured: at 6 weeks after delivery
Cord blood metabolic parameters
Glucose (mM) will be measured in cord blood using colorimetric detection kit, and insulin (pM), and glycated hemoglobin (HbA1c) (%) using specific enzyme-linked immunosorbent assay (ELISA) kits.
Exploratory analyses will be performed in cord blood plasma, using liquid-chromatography-high resolution combined with mass spectrometry in tandem in order to characterize the umbilical cord blood metabolomic, lipidomic patterns as reflects of neonatal metabolic status in order to characterize the new-born metabolic status. Each variable will be expressed as %.
Measured: 6 weeks after delivery
Fecal microbiota composition and diversity in early and late GDM management group compared to euglycaemic group and, for the early and late GDM groups, analyzed according to GDM management of their own mothers and in regard of colostrum microbiota
Fecal microbiota in infant feces collected will be analyzed following the French Gut workflow pipeline (https://hal.inrae.fr/hal-04707112v1) combining a large-scale longitudinal dataset of fecal microbiota limited to taxonomic composition of bacteria from 16S rRNA gene sequencing and high-throughput shotgun metagenomics with MetaGenoPolis facilities (https://mgps.eu/) that describe the microbiome at the functional level. A similar workflow will be used for analyze microbiota from colostrum.
The shotgun sequencing data (expressed in % relative abundance and alpha-diversity using Shannon and Simpson indexes) together with the metadata provided (maternal GDM management, colostrum composition) using innovative statistical tools as path modelling approaches (tools specifically developed in the ANR GDM-MILK program a funder of this ancillary study GDM-MILK) will enable to evaluate both early and late GDM-management and colostrum microbiota impact on infant fecal microbiota.
Measured: at 6 weeks after delivery
Breast milk composition (nutrients and bacterial community) in early and late GDM management group compared to euglycaemic group
Measured: at 6 weeks after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start30 Nov 2020
- Primary completion15 Feb 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,010 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne VAMBERGUE, Study director, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451915
- Sponsor's protocol ID
- 2017_76
- Other IDs
- 2018-A00794-51, PHRC-17-008
- Acronym
- LEMA_GDM
- Status last verified
- May 2026
- First submitted
- 22 Jun 2020
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late Versus Early Management of Gestational Diabetes Mellitus: a Non Inferiority Randomized Multicenter Trial
- ClinicalTrials.gov ID
- NCT04451915
- Acronym / sponsor ID
- LEMA_GDM / 2017_76
- Conditions
- Gestational Diabetes
- Keywords
- Early gestational diabetes, pregnancy, fasting plasma glucose, diagnosis, prognosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,010 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early management GDM group | Experimental | Other: early management strategydefined 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 |
| Late management GDM group | Experimental | Other: late management strategyearly 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- Diabetic follow-up started at time of inclusion
- Pre-existing diabetes in pregnancy
- Renal impairment
- Hepatic insufficiency
- History of bariatric surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| late management strategylate 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 | Other | Late management GDM group |
| early management strategyearly 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 | Other | Early management GDM group |
Primary outcome
The occurrence of materno-fetal complications
Time frame: at delivery
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
12 secondary outcomes
Correlation between composite endpoint (defined in the outcome 1) and the 5 risk factors of GDM
Time frame: at delivery
Need for insulin during pregnancy
Time frame: at each 10 days until delivery
Metabolic data: Fasting plasma glucose
Time frame: at inclusion (because <20 weeks') and an average at 24 28 weeks of gestation
Metabolic data: HbA1c
Time frame: at inclusion (because <20 weeks') and an average at 24 28 weeks of gestation
Oral Glucose Tolerance Test (OGTT)
Time frame: an average at 24 28 weeks of gestation
Percent of GDM women in the late GDM management group according to the IADPSG criteria.
Time frame: an average at 24 28 weeks of gestation
Number of complications in each subgroup of the late GDM management group
Time frame: at delivery
Neonatal anthropometric parameters
Time frame: 6 weeks after delivery
Maternal plasma metabolic parameters
Time frame: at 6 weeks after delivery
Cord blood metabolic parameters
Time frame: 6 weeks after delivery
Fecal microbiota composition and diversity in early and late GDM management group compared to euglycaemic group and, for the early and late GDM groups, analyzed according to GDM management of their own mothers and in regard of colostrum microbiota
Time frame: at 6 weeks after delivery
Breast milk composition (nutrients and bacterial community) in early and late GDM management group compared to euglycaemic group
Time frame: at 6 weeks after delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne VAMBERGUE study director
University Hospital, Lille
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing late management strategy and early management strategy in people with Gestational Diabetes, run by University Hospital, Lille at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne VAMBERGUE, MD,PhD (0320445962, anne.vambergue@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of materno-fetal complications (time frame: at delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.