<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/NCT03028259</url>
  </required_header>
  <id_info>
    <org_study_id>24669</org_study_id>
    <nct_id>NCT03028259</nct_id>
  </id_info>
  <brief_title>Glucose Variability</brief_title>
  <official_title>Does Plasma Glucose Variability in Obese Diabetic Pregnancies Influence Maternal or Neonatal Outcomes?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Louis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Louis University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A retrospective data review of 243 pregnant women (≤32 wks gestational age), dtat collected&#xD;
      prior to 5/18/2014, with GDM, or T2DM, and their infants (until discharge from the hospital,&#xD;
      typically up to 1 week after deliver) will be conducted. These women are of any age and all&#xD;
      ethnic backgrounds delivering at St. Mary's Health Center.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Maternal glucose control is considered to be a major determinant of neonatal outcome in&#xD;
      pregnancies complicated by diabetes. Studies have examined the link between neonatal&#xD;
      mortality and morbidity using specific mean preprandial or postprandial plasma glucose&#xD;
      levels, however, have not taken into account the daily wide excursions that occur in maternal&#xD;
      glucose levels. Limited data are available on glucose variability (GV) in pregnancy and&#xD;
      affect on maternal or neonatal outcomes. A recent study amongst diabetics showed that glucose&#xD;
      variability between two data points, a morning fasting blood glucose and an afternoon blood&#xD;
      glucose, increased the rate of adverse neonatal outcomes1. Glycosylated hemoglobin (A1c),&#xD;
      which has been considered the &quot;gold standard&quot; for diabetes control since the Diabetes Control&#xD;
      and Complication Trial (DCCT)2, lacks the specificity to predict pregnancy outcomes. Through&#xD;
      review of data, we propose to examine other methods of evaluating daily maternal glucose&#xD;
      variations to determine the correlation to maternal and neonatal outcomes.&#xD;
&#xD;
      The objective of this study is to determine the effect of glucose variability and/ or other&#xD;
      elements on maternal and neonatal outcomes in the obese diabetic patient. We hypothesize that&#xD;
      glucose variability will be a stronger indicator of neonatal outcome than A1c or any single&#xD;
      given blood glucose value. Glucose variability, including the magnitude of hyperglycemia or&#xD;
      the incidence of acute maternal hypo- or hyperglycemic events, will be explored. We&#xD;
      hypothesise that obese pregnant women with higher magnitude of glucose fluctuations have more&#xD;
      maternal and fetal co morbidities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 5, 2014</start_date>
  <completion_date type="Actual">June 24, 2014</completion_date>
  <primary_completion_date type="Actual">June 24, 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>glucose levels</measure>
    <time_frame>1 year</time_frame>
    <description>the effect of glucose variability on maternal and neonatal outcomes in the obese diabetic patient.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">161</enrollment>
  <condition>Glucose Variability</condition>
  <arm_group>
    <arm_group_label>lab results</arm_group_label>
    <description>monitoring of</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>lab results</intervention_name>
    <description>Comparison of lab results</description>
    <arm_group_label>lab results</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women with diabetes in pregnancy of any age, any ethnic background&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women with diabetes in pregnancy of any age, any ethnic background who deliver at St.&#xD;
             Mary's Health Center, 1/1/2000 to 5/18/2014.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Data collected ager 5/18/2014&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laura Vricella, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Louis University</affiliation>
  </overall_official>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>May 14, 2018</last_update_submitted>
  <last_update_submitted_qc>May 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Louis University</investigator_affiliation>
    <investigator_full_name>Laura Vricella, MD</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <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/NCT03028259
org study id: 24669
nct id: NCT03028259
lead sponsor: 
has dmc: No
A retrospective data review of 243 pregnant women (≤32 wks gestational age), dtat collected
      prior to 5/18/2014, with GDM, or T2DM, and their infants (until discharge from the hospital,
      typically up to 1 week after deliver) will be conducted. These women are of any age and all
      ethnic backgrounds delivering at St. Mary's Health Center.
Maternal glucose control is considered to be a major determinant of neonatal outcome in
      pregnancies complicated by diabetes. Studies have examined the link between neonatal
      mortality and morbidity using specific mean preprandial or postprandial plasma glucose
      levels, however, have not taken into account the daily wide excursions that occur in maternal
      glucose levels. Limited data are available on glucose variability (GV) in pregnancy and
      affect on maternal or neonatal outcomes. A recent study amongst diabetics showed that glucose
      variability between two data points, a morning fasting blood glucose and an afternoon blood
      glucose, increased the rate of adverse neonatal outcomes1. Glycosylated hemoglobin (A1c),
      which has been considered the "gold standard" for diabetes control since the Diabetes Control
      and Complication Trial (DCCT)2, lacks the specificity to predict pregnancy outcomes. Through
      review of data, we propose to examine other methods of evaluating daily maternal glucose
      variations to determine the correlation to maternal and neonatal outcomes.

      The objective of this study is to determine the effect of glucose variability and/ or other
      elements on maternal and neonatal outcomes in the obese diabetic patient. We hypothesize that
      glucose variability will be a stronger indicator of neonatal outcome than A1c or any single
      given blood glucose value. Glucose variability, including the magnitude of hyperglycemia or
      the incidence of acute maternal hypo- or hyperglycemic events, will be explored. We
      hypothesise that obese pregnant women with higher magnitude of glucose fluctuations have more
      maternal and fetal co morbidities.
observational model: Cohort
time perspective: Retrospective
measure: glucose levels
time frame: 1 year
description: the effect of glucose variability on maternal and neonatal outcomes in the obese diabetic patient.
arm group label: lab results
description: monitoring of
intervention type: Other
intervention name: lab results
description: Comparison of lab results
arm group label: lab results
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 14 Years
maximum age: 55 Years
healthy volunteers: No
last name: Laura Vricella, MD
role: Principal Investigator
affiliation: St. Louis University
responsible party type: Principal Investigator
investigator affiliation: St. Louis University
investigator full name: Laura Vricella, MD
investigator title: PI
sharing ipd: No