<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/NCT03769701</url>
  </required_header>
  <id_info>
    <org_study_id>2017-1-53</org_study_id>
    <nct_id>NCT03769701</nct_id>
  </id_info>
  <brief_title>Efficacy of Two Schemes of Self-monitoring Capillary Glucose in Gestational Diabetes</brief_title>
  <official_title>Efficacy of Two Schemes of Self-monitoring Capillary Glucose to Monitor Glycemic Control in Mexican Women With GDM</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Gestational diabetes mellitus (GDM) affects 10 % of women who receive prenatal care at&#xD;
      Instituto Nacional de Perinatología (Mexico, City). Currently, there is clear evidence on the&#xD;
      utility of self- monitoring of capillary glucose (SMGC) to evaluate the efficacy of&#xD;
      medical-nutrition therapy on glycemic control. However, the reports regarding the best&#xD;
      pattern of SMGC in terms of frequency and number of determinations per day are limited. The&#xD;
      objective of this study is to evaluate the efficacy of two SMGC schemes for monitoring&#xD;
      glycemic control in Mexican women with GDM.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Currently, the evidence from randomized clinical trials about the most appropriate scheme of&#xD;
      SMGC for monitoring the glycemic control among women with GDM is limited. This study was&#xD;
      designed to evaluate the efficacy of two different schemes of SMGC in GDM Mexican population,&#xD;
      it is an open-label randomized clinical trial including 2 groups: group 1 (SMGC 4 times/day)&#xD;
      measured in fasting and 1 hour postprandial of breakfast, lunch and dinner; group 2 (SMGC 2&#xD;
      times/day), measured preprandial and 1 hour postprandial, of breakfast, lunch or dinner,&#xD;
      alternating the meal each day, from GDM diagnosis until the resolution of pregnancy.&#xD;
      Additionally, determinations of insulin, lipids and glycosylated hemoglobin (HbA1c) will be&#xD;
      determinate at enrollment, and between the 30-32 and 36-38 of gestation week. The primary&#xD;
      outcome: To compare the proportion of women who achieve glycemic control using SMGC 4&#xD;
      times/day versus SMGC 2 times/day.&#xD;
&#xD;
      Secondary outcome: To compare the risk of new-born large for gestational age, gestational&#xD;
      hypertension, preeclampsia, preterm birth, cesarean section, new-born weight, neonatal&#xD;
      hypoglycemia, neonatal hyperbilirubinemia and entry to neonatal intensive care between&#xD;
      groups. An analysis for intention of treatment will be made according to the recommendations&#xD;
      of the CONSORT guidelines.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 7, 2018</start_date>
  <completion_date type="Anticipated">July 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2022</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>Proportion of women who achieve glycemic control.</measure>
    <time_frame>from GDM diagnosis to delivery.</time_frame>
    <description>Proportion of women with more than 80% of capillary glucose determination into the following goals: preprandial; 70 to 95 mg/dl and 1 hour post-prandial ≤ 140 mg/dl.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Gestational Diabetes</condition>
  <arm_group>
    <arm_group_label>Group 1, SMGC four times/day</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Women with GDM and SMGC 4 times/day; fasting and 1-hour post-prandial of breakfast, lunch and dinner</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SMGC two times/day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women with GDM and SMGC 2 times/day; pre-prandial and 1-hour post-prandial of breakfast, lunch or dinner alternating the meal each day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>self-monitoring capillary glucose (SMCG)</intervention_name>
    <description>To measure the capillary glucose with a glucometer according to the assigned group.</description>
    <arm_group_label>Group 1, SMGC four times/day</arm_group_label>
    <arm_group_label>SMGC two times/day</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  GDM diagnosis, defined by 2 or more altered values during oral glucose tolerance test&#xD;
             (75g-2h): Fasting ≥ 95 mg/dl, 1 hour ≥ 180 mg/dl and 2 hours ≥ 155 mg/dl.&#xD;
&#xD;
          -  Singleton pregnancy between 12-32 weeks of gestation at GDM diagnosis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Multiple pregnancy.&#xD;
&#xD;
          2. Pregestational diabetes.&#xD;
&#xD;
          3. Fasting glucose &gt; 126 mg/dl or random glucose &gt; 200 mg/dl before 12 weeks of&#xD;
             gestation.&#xD;
&#xD;
          4. Active pathology: systemic lupus erythematosus, rheumatoid arthritis, congenital or&#xD;
             acquired cardiopathy, uterine leiomyoma &gt; 10cm, renal insufficiency and chronic&#xD;
             hypertension.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Enrique Reyes-Muñoz, PhD</last_name>
    <phone>+521 5555209900</phone>
    <phone_ext>307</phone_ext>
    <email>dr.enriquereyes@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lidia Arce-Sánchez, MD</last_name>
    <phone>+521 5555209900</phone>
    <phone_ext>299</phone_ext>
    <email>li_arce@yahoo.com.mx</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Institute of Perinatology</name>
      <address>
        <city>Mexico</city>
        <zip>11000</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Enrique Reyes-Muñoz, MD</last_name>
      <phone>52 (55)55209900</phone>
      <phone_ext>299</phone_ext>
      <email>dr.enriquereyes@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Carlos Orega-Gonzalez, MD</last_name>
      <phone>52 (55) 55209900</phone>
      <phone_ext>307</phone_ext>
      <email>ortegagonzalez@hotmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>December 24, 2021</last_update_submitted>
  <last_update_submitted_qc>December 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes</investigator_affiliation>
    <investigator_full_name>ENRIQUE REYES-Munoz MD</investigator_full_name>
    <investigator_title>Medical Science Researcher</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03769701
org study id: 2017-1-53
nct id: NCT03769701
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Gestational diabetes mellitus (GDM) affects 10 % of women who receive prenatal care at
      Instituto Nacional de Perinatología (Mexico, City). Currently, there is clear evidence on the
      utility of self- monitoring of capillary glucose (SMGC) to evaluate the efficacy of
      medical-nutrition therapy on glycemic control. However, the reports regarding the best
      pattern of SMGC in terms of frequency and number of determinations per day are limited. The
      objective of this study is to evaluate the efficacy of two SMGC schemes for monitoring
      glycemic control in Mexican women with GDM.
Currently, the evidence from randomized clinical trials about the most appropriate scheme of
      SMGC for monitoring the glycemic control among women with GDM is limited. This study was
      designed to evaluate the efficacy of two different schemes of SMGC in GDM Mexican population,
      it is an open-label randomized clinical trial including 2 groups: group 1 (SMGC 4 times/day)
      measured in fasting and 1 hour postprandial of breakfast, lunch and dinner; group 2 (SMGC 2
      times/day), measured preprandial and 1 hour postprandial, of breakfast, lunch or dinner,
      alternating the meal each day, from GDM diagnosis until the resolution of pregnancy.
      Additionally, determinations of insulin, lipids and glycosylated hemoglobin (HbA1c) will be
      determinate at enrollment, and between the 30-32 and 36-38 of gestation week. The primary
      outcome: To compare the proportion of women who achieve glycemic control using SMGC 4
      times/day versus SMGC 2 times/day.

      Secondary outcome: To compare the risk of new-born large for gestational age, gestational
      hypertension, preeclampsia, preterm birth, cesarean section, new-born weight, neonatal
      hypoglycemia, neonatal hyperbilirubinemia and entry to neonatal intensive care between
      groups. An analysis for intention of treatment will be made according to the recommendations
      of the CONSORT guidelines.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Proportion of women who achieve glycemic control.
time frame: from GDM diagnosis to delivery.
description: Proportion of women with more than 80% of capillary glucose determination into the following goals: preprandial; 70 to 95 mg/dl and 1 hour post-prandial ≤ 140 mg/dl.
arm group label: Group 1, SMGC four times/day
arm group type: Active Comparator
description: Women with GDM and SMGC 4 times/day; fasting and 1-hour post-prandial of breakfast, lunch and dinner
arm group label: SMGC two times/day
arm group type: Experimental
description: Women with GDM and SMGC 2 times/day; pre-prandial and 1-hour post-prandial of breakfast, lunch or dinner alternating the meal each day.
intervention type: Procedure
intervention name: self-monitoring capillary glucose (SMCG)
description: To measure the capillary glucose with a glucometer according to the assigned group.
arm group label: Group 1, SMGC four times/day
arm group label: SMGC two times/day
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Enrique Reyes-Muñoz, PhD
phone: +521 5555209900
phone ext: 307
email: dr.enriquereyes@gmail.com
last name: Lidia Arce-Sánchez, MD
phone: +521 5555209900
phone ext: 299
email: li_arce@yahoo.com.mx
facility: 
status: Recruiting
contact: 
contact backup: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
investigator full name: ENRIQUE REYES-Munoz MD
investigator title: Medical Science Researcher
mesh term: Diabetes, Gestational
sharing ipd: No