<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04451915</url>
  </required_header>
  <id_info>
    <org_study_id>2017_76</org_study_id>
    <secondary_id>2018-A00794-51</secondary_id>
    <secondary_id>PHRC-17-008</secondary_id>
    <nct_id>NCT04451915</nct_id>
  </id_info>
  <brief_title>Early Gestational Diabetes Mellitus</brief_title>
  <acronym>LEMA_GDM</acronym>
  <official_title>Late Versus Early Management of Gestational Diabetes Mellitus: a Non Inferiority Randomized Multicenter Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In 2010, the International Association of the Diabetes and Pregnancy Study Groups (IADPSG)&#xD;
      panel published consensus-based recommendations on the diagnosis and classification of&#xD;
      hyperglycemia in pregnancy. Cognizant that milder degrees of hyperglycemia would also be&#xD;
      detected by early pregnancy testing, the IADPSG recommended that fasting plasma glucose (FPG)&#xD;
      in the range of 5.1-6.9 mmol/l should be considered diagnostic of early Gestational Diabetes&#xD;
      Mellitus (GDM) even if the level of proof for this recommendation is very low regarding to&#xD;
      prognosis. This threshold was extrapolated from the FPG value used between 24 and 28 weeks.&#xD;
&#xD;
      In France, a FPG is proposed at the first prenatal visit for women with risk factors of GDM.&#xD;
      Early GDM is diagnosed if FPG is ≥ 5.1 mmol/l, leading to an intensive metabolic management.&#xD;
      Data have shown that GDM prevalence increased rapidly from 5.9% in 2009 to 9.3% in 2014.&#xD;
      26.9% of women with hyperglycemia during their pregnancy but without known diabetes are&#xD;
      treated before 22 weeks' gestation (WG). More recent data from Italy and China, where IADPSG&#xD;
      diagnosis criteria were applied, have strongly challenged this recommendation, and showed&#xD;
      that early FPG ≥ 5.1mmo/L is poorly predictive of later GDM. No prior studies have&#xD;
      demonstrated benefits to early screening and management. In 2016, the IADPSG members have&#xD;
      suggested that the use of the FPG threshold ≥5.1 mmol/l for the identification of GDM in&#xD;
      early pregnancy is not justified by current evidence&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 30, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The occurrence of materno-fetal complications</measure>
    <time_frame>at delivery</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between composite endpoint (defined in the outcome 1) and the 5 risk factors of GDM</measure>
    <time_frame>at delivery</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for insulin during pregnancy</measure>
    <time_frame>at each 10 days until delivery</time_frame>
    <description>After at least 10 days of dietary and lifestyles measures, if the target are not achieved, women will receive insulin therapy. fastin glucose target &lt;5.1 mmol/ and/or a 2 hour post prandial capillary glucose &lt; 6.6 mmol/l&#xD;
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&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolic data: Fasting plasma glucose</measure>
    <time_frame>at inclusion (because &lt;20 weeks') and an average at 24 28 weeks of gestation</time_frame>
    <description>Change of value of fasting plasma glucose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolic data: HbA1c</measure>
    <time_frame>at inclusion (because &lt;20 weeks') and an average at 24 28 weeks of gestation</time_frame>
    <description>Change of value of HbA1c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oral Glucose Tolerance Test (OGTT)</measure>
    <time_frame>an average at 24 28 weeks of gestation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of GDM women in the late GDM management group according to the IADPSG criteria.</measure>
    <time_frame>an average at 24 28 weeks of gestation</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of complications in each subgroup of the late GDM management group</measure>
    <time_frame>at delivery</time_frame>
    <description>Maternal and neonatal complication</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">2010</enrollment>
  <condition>Gestational Diabetes</condition>
  <arm_group>
    <arm_group_label>Early management GDM group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Late management GDM group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>late management strategy</intervention_name>
    <description>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</description>
    <arm_group_label>Late management GDM group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>early management strategy</intervention_name>
    <description>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</description>
    <arm_group_label>Early management GDM group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant woman&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
          -  Early GDM defined by a fasting plasma glucose between 5.1 mmol/l and 6.1 mmol/ with at&#xD;
             least one risk factor (age ≥35 years and/or BMI ≥ 25 kg/m2 and/or familial history of&#xD;
             diabetes and/or personal history of GDM and/or personal history of macrosomia).&#xD;
&#xD;
          -  First prenatal visit prior 20 weeks of gestation at the time of randomization.&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Diabetic follow-up started at time of inclusion&#xD;
&#xD;
          -  Pre-existing diabetes in pregnancy&#xD;
&#xD;
          -  Renal impairment&#xD;
&#xD;
          -  Hepatic insufficiency&#xD;
&#xD;
          -  History of bariatric surgery&#xD;
&#xD;
          -  Long time corticosteroids treatment&#xD;
&#xD;
          -  Insufficient understanding&#xD;
&#xD;
          -  Language difficulties&#xD;
&#xD;
          -  Lack of social Insurance&#xD;
&#xD;
          -  Person in emergency situation&#xD;
&#xD;
          -  Person under the protection of justice (tutelage/ curatorship)&#xD;
&#xD;
          -  Persons deprived of their liberty&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Pregnant women with at least one GDM risk factor and a fasting plasma glucose between 5.1 mmol/l and 6.1 mmol/l prior 20 weeks' gestation.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anne VAMBERGUE</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anne VAMBERGUE, MD,PhD</last_name>
    <phone>0320445962</phone>
    <email>anne.vambergue@chru-lille.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CH ARRAS</name>
      <address>
        <city>Arras</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hopital Estaing - Chu63 - Clermont Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hop Claude Huriez Chu Lille</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>0320445962</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopital Saint Vincent - Saint Antoine - Lille</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chu Nimes Caremeau - Nimes 9</name>
      <address>
        <city>Nîmes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hopital Haut-Leveque - Chu - Pessac</name>
      <address>
        <city>Pessac</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ch Rene Dubos - Pontoise</name>
      <address>
        <city>Pontoise</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chu Site Sud (Saint Pierre) - St Pierre</name>
      <address>
        <city>Saint-Pierre</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Csapa / Hus / Hopital Civil - Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hopital de Rangueil Chu Toulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31300</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>January 26, 2023</last_update_submitted>
  <last_update_submitted_qc>January 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Early gestational diabetes</keyword>
  <keyword>pregnancy</keyword>
  <keyword>fasting plasma glucose</keyword>
  <keyword>diagnosis</keyword>
  <keyword>prognosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04451915
org study id: 2017_76
secondary id: 2018-A00794-51
secondary id: PHRC-17-008
nct id: NCT04451915
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: The occurrence of materno-fetal complications
time frame: at delivery
description: 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
measure: Correlation between composite endpoint (defined in the outcome 1) and the 5 risk factors of GDM
time frame: at delivery
description: 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)
measure: Need for insulin during pregnancy
time frame: at each 10 days until delivery
description: 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"
measure: Metabolic data: Fasting plasma glucose
time frame: at inclusion (because <20 weeks') and an average at 24 28 weeks of gestation
description: Change of value of fasting plasma glucose
measure: Metabolic data: HbA1c
time frame: at inclusion (because <20 weeks') and an average at 24 28 weeks of gestation
description: Change of value of HbA1c
measure: Oral Glucose Tolerance Test (OGTT)
time frame: an average at 24 28 weeks of gestation
measure: 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
description: 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
measure: Number of complications in each subgroup of the late GDM management group
time frame: at delivery
description: Maternal and neonatal complication
arm group label: Early management GDM group
arm group type: Experimental
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
arm group label: Late management GDM group
arm group type: Experimental
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.
intervention type: Other
intervention name: late management strategy
description: 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
arm group label: Late management GDM group
intervention type: Other
intervention name: early management strategy
description: 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
arm group label: Early management GDM group
criteria: 
gender: Female
gender based: Yes
gender description: Pregnant women with at least one GDM risk factor and a fasting plasma glucose between 5.1 mmol/l and 6.1 mmol/l prior 20 weeks' gestation.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anne VAMBERGUE
role: Study Director
affiliation: University Hospital, Lille
last name: Anne VAMBERGUE, MD,PhD
phone: 0320445962
email: anne.vambergue@chru-lille.fr
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: France
responsible party type: Sponsor
mesh term: Diabetes, Gestational
mesh term: Diabetes Mellitus