xml: <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/NCT06031987</url>
    </required_header>
    <id_info>
      <org_study_id>GDMLIBRE</org_study_id>
      <nct_id>NCT06031987</nct_id>
    </id_info>
    <brief_title>Long-term Effects of Flash Glucose Monitoring System in Patients With Gestational Diabetes</brief_title>
    <acronym>GDMLIBRE</acronym>
    <official_title>Long-term Effects of Flash Glucose Monitoring System in Patients With Gestational Diabetes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kangbuk Samsung Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Daewoong Pharmaceutical Co. LTD.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Kangbuk Samsung Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to report the glycemic control effect and clinical safety and&#xD;
        effectiveness of mother and fetus when using a continuous glucose monitoring system (CGM)&#xD;
        [Freestyle Libre] for a long period of time compared to self monitoring blood glucose(SMBG)&#xD;
        in gestational diabetes patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The investigators plan to conduct a randomized clinical trial among patients with Gestational&#xD;
        Diabetes Mellitus (GDM). The intervention group will use Continuous Glucose Monitoring (CGM)&#xD;
        throughout the study period, scanning four or more times per day. The control group will be&#xD;
        instructed to perform Self-Monitoring Blood Glucose (SMBG), also four or more times per day.&#xD;
  &#xD;
        Eligible participants are those within 24 to 30 weeks of gestation (Visit 0). These subjects&#xD;
        will undergo a 1-week run-in period, during which they will wear a retrospective CGM device&#xD;
        and perform SMBG four or more times daily as a part of the screening process (Visit 1).&#xD;
  &#xD;
        Following the run-in period, subjects will be randomly assigned to either the CGM group&#xD;
        (using the Freestyle Libre device) or the Control group (using SMBG). Members of the control&#xD;
        group will be asked to perform SMBG four or more times daily, while those in the CGM group&#xD;
        will be instructed to scan their CGM four or more times per day.&#xD;
  &#xD;
        Participants will have clinic visits at intervals ranging from 2 to 4 weeks, the frequency of&#xD;
        which will be determined at the discretion of the attending physician (Visits 2, 2', 2'',&#xD;
        2''', 2''').&#xD;
  &#xD;
        Upon reaching gestational age 34-35 weeks (Visit 3), members of the control group will begin&#xD;
        to wear a retrospective CGM device until they reach gestational age 36 weeks (Visit 4).&#xD;
  &#xD;
        After 6-12 weeks from delivery, subjects will be asked to visit the clinic again and undergo&#xD;
        a 75g Oral Glucose Tolerance Test (OGTT) (Visit 5).&#xD;
  &#xD;
        For the purposes of data analysis and outcome determination, the most recent 1-week CGM data&#xD;
        collected at Visit 4 will be used for both groups.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 26, 2022</start_date>
    <completion_date type="Anticipated">December 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 26, 2024</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>
      <intervention_model_description>randomized, parallel, open labeled study</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>Open label</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>63-140 mg/dL Time in Range</measure>
      <time_frame>at visit 4(gestational age 36weeks)</time_frame>
      <description>63-140 mg/dL Time in Range evaluated for 1 week before Visit4 visit</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>AbA1C (%)</measure>
      <time_frame>at visit 4(gestational age 36weeks)</time_frame>
      <description>HbA1C evaluated at visit 4</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Glycated Albumin(g/dL)</measure>
      <time_frame>at visit 4(gestational age 36weeks)</time_frame>
      <description>Glycated Albumin evaluated at visit 4</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>&gt;180 mg/dL Time in Range</measure>
      <time_frame>1 week before Visit4 (gestational age 36weeks)</time_frame>
      <description>&gt;180 mg/dL Time in Range evaluated for 1 week before Visit4</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>&gt;140 mg/dL Time in Range</measure>
      <time_frame>1 week before Visit4 (gestational age 36weeks)</time_frame>
      <description>&gt;140 mg/dL Time in Range evaluated for 1 week before Visit4</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>&gt;120 mg/dL Time in Range</measure>
      <time_frame>1 week before Visit4 (gestational age 36weeks)</time_frame>
      <description>&gt;120 mg/dL Time in Range evaluated for 1 week before Visit4</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>&lt;63mg/dL Time in Range</measure>
      <time_frame>1 week before Visit4 (gestational age 36weeks)</time_frame>
      <description>&lt;63mg/dL Time in Range evaluated for 1 week before Visit4</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>&lt;54mg/dL Time in Range</measure>
      <time_frame>1 week before Visit4 (gestational age 36weeks)</time_frame>
      <description>&lt;54mg/dL Time in Range evaluated for 1 week before Visit4</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>63-120mg/dL Time in Range</measure>
      <time_frame>1 week before Visit4 (gestational age 36weeks)</time_frame>
      <description>63-120mg/dL Time in Range evaluated for 1 week before Visit4</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Night time Blood glucose (0AM-6AM) 63-94 mg/dL Time in Range</measure>
      <time_frame>1 week before Visit4 (gestational age 36weeks)</time_frame>
      <description>Night time Blood glucose (0AM-6AM) 63-94 mg/dL Time in Range evaluated for 1 week before Visit4</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Night time Blood glucose (0AM-6AM) ≥95 mg/dL Time in Range</measure>
      <time_frame>1 week before Visit4 (gestational age 36weeks)</time_frame>
      <description>Night time Blood glucose (0AM-6AM) ≥95 mg/dL Time in Range evaluated for 1 week before Visit4</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Night time Blood glucose (0AM-6AM) &lt;63 mg/dL Time in Range</measure>
      <time_frame>1 week before Visit4 (gestational age 36weeks)</time_frame>
      <description>Night time Blood glucose (0AM-6AM) &lt;63 mg/dL Time in Range evaluated for 1 week before Visit4</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Night time Blood glucose (0AM-6AM) &lt;54 mg/dL Time in Range</measure>
      <time_frame>1 week before Visit4 (gestational age 36weeks)</time_frame>
      <description>Night time Blood glucose (0AM-6AM) &lt;54 mg/dL Time in Range evaluated for 1 week before Visit4</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall average blood glucose level</measure>
      <time_frame>1 week before Visit4 (gestational age 36weeks)</time_frame>
      <description>Overall average blood glucose level evaluated for 1week before visit4</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall average Night time Blood glucose (0AM-6AM) level</measure>
      <time_frame>1 week before Visit4 (gestational age 36weeks)</time_frame>
      <description>Overall average Night time Blood glucose (0AM-6AM) level evaluated for 1week before visit4</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall average During the day time blood glucose (6AM-12PM) level</measure>
      <time_frame>1 week before Visit4 (gestational age 36weeks)</time_frame>
      <description>Overall average During the day time blood glucose (6AM-12PM) level evaluated for 1week before visit4</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Frequency of severe hypoglycemia(Hypoglycemia requiring help from others)</measure>
      <time_frame>From visit 1 to visit 4(Gestational age 25-31 weeks to Gestational age 36 week)</time_frame>
      <description>Frequency of severe hypoglycemia during the study period hyperglycemia requiring help from others)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>glucose variability</measure>
      <time_frame>1 week before Visit4(gestational age 36weeks)</time_frame>
      <description>glucose variability evaluated for 1week before visit4 (MAGE,SD,CV)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>rate of insulin treatment</measure>
      <time_frame>From visit 1 to visit 4 (Gestational age 25-31 weeks to Gestational age 36 week)</time_frame>
      <description>rate of insulin treatment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Estimation A1c of continuous blood glucose measurement for 1 week before Visit4 visit</measure>
      <time_frame>1 week before Visit4(Gestational age 36 week)</time_frame>
      <description>Estimation A1c of continuous blood glucose measurement for 1 week before Visit4 visit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total daily insulin requirements (evaluated at every visit)</measure>
      <time_frame>From visit 1 to visit 4(Gestational age 25-31 weeks to Gestational age 36 week)</time_frame>
      <description>Total daily insulin requirements (evaluated at every visit)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Satisfaction Questionnaire</measure>
      <time_frame>Visit 1 (Gestational age 25-31 weeks) , Visit 4 (Gestational age 36 week)</time_frame>
      <description>Satisfaction Questionnaire(DTSQ) ,Score: min0 ~max 48, higher scores mean a better outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>C-section rate</measure>
      <time_frame>during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)</time_frame>
      <description>C-section rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>preeclampsia rate</measure>
      <time_frame>during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)</time_frame>
      <description>preeclampsia rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>preeclampsia or gestational hypertension rate</measure>
      <time_frame>during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)</time_frame>
      <description>preeclampsia or gestational hypertension rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the rate of preterm birth</measure>
      <time_frame>during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)</time_frame>
      <description>the rate of preterm birth</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Weight gain during the study period</measure>
      <time_frame>during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)</time_frame>
      <description>Weight gain during the study period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Average daily blood glucose measurements during the study period</measure>
      <time_frame>during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)</time_frame>
      <description>Freestyle Libre scans, SMBG</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in Microbiome</measure>
      <time_frame>during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)</time_frame>
      <description>Changes in Microbiome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of transition to type 2 diabetes</measure>
      <time_frame>at post partum (6-12 weeks after delivery)</time_frame>
      <description>Rate of transition to type 2 diabetes</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of transition to Glucose intolerance (prediabetes and/or diabetes)</measure>
      <time_frame>at post partum (6-12 weeks after delivery)</time_frame>
      <description>Rate of transition to Glucose intolerance (prediabetes and/or diabetes)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of transition to Impaired fasting glucose (IFG) and/or diabetes</measure>
      <time_frame>at post partum (6-12 weeks after delivery)</time_frame>
      <description>Rate of transition to Impaired fasting glucose (IFG) and/or diabetes</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of transition to Impaired fasting glucose (IGT) and/or diabetes</measure>
      <time_frame>at post partum (6-12 weeks after delivery)</time_frame>
      <description>Rate of transition to Impaired fasting glucose (IGT) and/or diabetes</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>75g OGTT hourly blood glucose</measure>
      <time_frame>at post partum (6-12 weeks after delivery)</time_frame>
      <description>75g OGTT hourly blood glucose</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>hemoglobinA1C</measure>
      <time_frame>at post partum (6-12 weeks after delivery)</time_frame>
      <description>hemoglobinA1C</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>glycated albumin</measure>
      <time_frame>at post partum (6-12 weeks after delivery)</time_frame>
      <description>glycated albumin</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Insulin resistance index (HOMA-IR)</measure>
      <time_frame>at post partum (6-12 weeks after delivery)</time_frame>
      <description>HOMA-IR (no unit, higher score means a worse outcome)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Insulin resistance index (Matsuda index)</measure>
      <time_frame>at post partum (6-12 weeks after delivery)</time_frame>
      <description>Matsuda index (no unit, higher score means a better outcome)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Insulin secretion ability index (HOMA-beta)</measure>
      <time_frame>at post partum (6-12 weeks after delivery)</time_frame>
      <description>HOMA-beta(no unit, higher score means a better outcome)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Insulin secretion ability index (Insulinogenic index)</measure>
      <time_frame>at post partum (6-12 weeks after delivery)</time_frame>
      <description>Insulinogenic index(no unit, higher score means a better outcome)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Insulin Composite index(Oral disposition index)</measure>
      <time_frame>at post partum (6-12 weeks after delivery)</time_frame>
      <description>Oral disposition index(no unit, higher score means a better outcome)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Insulin Composite index(disposition index)</measure>
      <time_frame>at post partum (6-12 weeks after delivery)</time_frame>
      <description>disposition index(no unit, higher score means a better outcome)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>weight change</measure>
      <time_frame>at post partum (6-12 weeks after delivery)</time_frame>
      <description>weight change</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Bioelectric impedance analysis (BIA)</measure>
      <time_frame>at post partum (6-12 weeks after delivery)</time_frame>
      <description>Change in Bioelectric impedance analysis (BIA)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>fetal: childbirth weight</measure>
      <time_frame>at Delivery</time_frame>
      <description>fetal: childbirth weight</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>fetal: Macrosomia ( &gt; 4000 g)</measure>
      <time_frame>at Delivery</time_frame>
      <description>fetal: Macrosomia ( &gt; 4000 g)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>fetal:Large for gestational age ( &gt; 90th percentile for age)</measure>
      <time_frame>at Delivery</time_frame>
      <description>fetal:Large for gestational age ( &gt; 90th percentile for age)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>fetal:Small for gestational age ( &lt; 10th percentile for age)</measure>
      <time_frame>at Delivery</time_frame>
      <description>fetal:Small for gestational age ( &lt; 10th percentile for age)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>fetal:Neonatal glucose level</measure>
      <time_frame>at Delivery</time_frame>
      <description>fetal:Neonatal glucose level</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>fetal:NICU admission</measure>
      <time_frame>at Delivery</time_frame>
      <description>fetal:NICU admission</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>fetal:birth trauma (including shoulderdystocia, clavicle fracture or Erb's palsy)</measure>
      <time_frame>at Delivery</time_frame>
      <description>fetal:birth trauma (including shoulderdystocia, clavicle fracture or Erb's palsy)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>fetal:Pre-term birth</measure>
      <time_frame>at Delivery</time_frame>
      <description>fetal:Pre-term birth</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>fetal:Apgar score</measure>
      <time_frame>at Delivery</time_frame>
      <description>score: min 0 ~ max 10, higher scores mean a better outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>fetal:Meconium aspiration</measure>
      <time_frame>at Delivery</time_frame>
      <description>fetal:Meconium aspiration</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Gestational Diabetes Mellitus in Pregnancy</condition>
    <arm_group>
      <arm_group_label>SMBG arm</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Self Monitoring of Blood Glucose group</description>
    </arm_group>
    <arm_group>
      <arm_group_label>CGMS arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Continuous glucose monitoring system, CGM</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>CareSens N (iSENS)</intervention_name>
      <description>Control group is asked to perform SMBG (4 times or more per day).</description>
      <arm_group_label>SMBG arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Freestyle Libre (Abbott)</intervention_name>
      <description>CGM group is asked to scan CGM (4 times or more per day).</description>
      <arm_group_label>CGMS arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          [Inclusion Criteria]&#xD;
  &#xD;
            1. 19-40 aged female&#xD;
  &#xD;
            2. Gestational diabetes diagnosed at 24 to 28 weeks of pregnancy screening (stage 1 or&#xD;
               stage 2 approach)&#xD;
  &#xD;
                 -  2-1.Screening one-step approach (75g oral glucose tolerance test, diagnosed when&#xD;
                    one or more of the following)&#xD;
  &#xD;
                      -  Fasting blood glucose 92 mg/dL or higher&#xD;
  &#xD;
                      -  Blood glucose 180 mg/dL or higher 1 hour after glucose loading&#xD;
  &#xD;
                      -  Blood glucose of 153 mg/dL or higher 2 hours after glucose loading&#xD;
  &#xD;
                 -  2-2. Screening two-step approach (50 g oral glucose tolerance test then,100g oral&#xD;
                    glucose tolerance test)&#xD;
  &#xD;
                      -  If the blood glucose level is 140 mg/dL or higher for 1 hour after the 50g&#xD;
                         oral glucose tolerance test,&#xD;
  &#xD;
                      -  100g oral glucose tolerance test 2 or more of the following&#xD;
  &#xD;
                           1. Fasting blood glucose 95mg/dL or higher&#xD;
  &#xD;
                           2. Blood glucose 180mg/dL or higher 1 hour after glucose loading&#xD;
  &#xD;
                           3. Blood glucose of 155 mg/dL or higher 2 hours after glucose loading&#xD;
  &#xD;
                           4. Blood glucose of 140 mg/dL or higher 3 hours after glucose loading&#xD;
  &#xD;
            3. Singleton Pregnancy&#xD;
  &#xD;
          [Exclusion Criteria]&#xD;
  &#xD;
          - pregestational diabetes (Overt diabetes)&#xD;
  &#xD;
            1. Diabetes Before Pregnancy&#xD;
  &#xD;
            2. At least one of the following at the first prenatal visit&#xD;
  &#xD;
                 -  Fasting blood glucose 126mg/dL or higher&#xD;
  &#xD;
                 -  Random blood glucose 200mg/dL or higher&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Gestational Diabetes</gender_description>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Cheol-Young Park, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>KangbukSamsung Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Cheol-Young Park, MD</last_name>
      <phone>82-010-3397-6107</phone>
      <email>cydoctor68@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>SunJoon Moon, MD</last_name>
      <email>ipleat.m@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Kangbuk Samsung hospital</name>
        <address>
          <city>Seoul</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Cheol-Young Park, MD</last_name>
        <phone>82-010-3397-6107</phone>
        <email>cydoctor68@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <link>
      <url>https://www.frontiersin.org/articles/10.3389/fcimb.2020.00188/full</url>
      <description>Hasain Z, Mokhtar NM , Kamaruddin NA, Mohamed Ismail NA, Razalli NH, Gnanou JV, et al. Gut Microbiota and Gestational Diabetes Mellitus: A Review of Host Gut Microbiota Interactions and Their Therapeutic Potential. Front Cell Infect Microbiol [Internet].</description>
    </link>
    <results_reference>
      <citation>Cespedes EM, Hu FB, Tinker L, Rosner B, Redline S, Garcia L, Hingle M, Van Horn L, Howard BV, Levitan EB, Li W, Manson JE, Phillips LS, Rhee JJ, Waring ME, Neuhouser ML. Multiple Healthful Dietary Patterns and Type 2 Diabetes in the Women's Health Initiative. Am J Epidemiol. 2016 Apr 1;183(7):622-33. doi: 10.1093/aje/kwv241. Epub 2016 Mar 2.</citation>
      <PMID>26940115</PMID>
    </results_reference>
    <results_reference>
      <citation>Guariguata L, Linnenkamp U, Beagley J, Whiting DR, Cho NH. Global estimates of the prevalence of hyperglycaemia in pregnancy. Diabetes Res Clin Pract. 2014 Feb;103(2):176-85. doi: 10.1016/j.diabres.2013.11.003. Epub 2013 Dec 1.</citation>
      <PMID>24300020</PMID>
    </results_reference>
    <results_reference>
      <citation>Kim KS. The importance of treating mild hyperglycemia in pregnant women with diabetes. Korean J Intern Med. 2018 Nov;33(6):1079-1080. doi: 10.3904/kjim.2018.351. Epub 2018 Oct 30. No abstract available.</citation>
      <PMID>30396252</PMID>
    </results_reference>
    <results_reference>
      <citation>Koo BK, Lee JH, Kim J, Jang EJ, Lee CH. Prevalence of Gestational Diabetes Mellitus in Korea: A National Health Insurance Database Study. PLoS One. 2016 Apr 5;11(4):e0153107. doi: 10.1371/journal.pone.0153107. eCollection 2016. Erratum In: PLoS One. 2016 Oct 20;11(10 ):e0165445.</citation>
      <PMID>27046149</PMID>
    </results_reference>
    <results_reference>
      <citation>DeSisto CL, Kim SY, Sharma AJ. Prevalence estimates of gestational diabetes mellitus in the United States, Pregnancy Risk Assessment Monitoring System (PRAMS), 2007-2010. Prev Chronic Dis. 2014 Jun 19;11:E104. doi: 10.5888/pcd11.130415.</citation>
      <PMID>24945238</PMID>
    </results_reference>
    <results_reference>
      <citation>McIntyre HD, Catalano P, Zhang C, Desoye G, Mathiesen ER, Damm P. Gestational diabetes mellitus. Nat Rev Dis Primers. 2019 Jul 11;5(1):47. doi: 10.1038/s41572-019-0098-8.</citation>
      <PMID>31296866</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>October 21, 2022</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Kangbuk Samsung Hospital</investigator_affiliation>
      <investigator_full_name>Cheol-Young Park</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetes, Gestational</mesh_term>
      <mesh_term>Pregnancy in Diabetics</mesh_term>
      <mesh_term>Diabetes Mellitus</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06031987
  org study id: GDMLIBRE
  nct id: NCT06031987
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  The purpose of this study is to report the glycemic control effect and clinical safety and
        effectiveness of mother and fetus when using a continuous glucose monitoring system (CGM)
        [Freestyle Libre] for a long period of time compared to self monitoring blood glucose(SMBG)
        in gestational diabetes patients.
  The investigators plan to conduct a randomized clinical trial among patients with Gestational
        Diabetes Mellitus (GDM). The intervention group will use Continuous Glucose Monitoring (CGM)
        throughout the study period, scanning four or more times per day. The control group will be
        instructed to perform Self-Monitoring Blood Glucose (SMBG), also four or more times per day.
  
        Eligible participants are those within 24 to 30 weeks of gestation (Visit 0). These subjects
        will undergo a 1-week run-in period, during which they will wear a retrospective CGM device
        and perform SMBG four or more times daily as a part of the screening process (Visit 1).
  
        Following the run-in period, subjects will be randomly assigned to either the CGM group
        (using the Freestyle Libre device) or the Control group (using SMBG). Members of the control
        group will be asked to perform SMBG four or more times daily, while those in the CGM group
        will be instructed to scan their CGM four or more times per day.
  
        Participants will have clinic visits at intervals ranging from 2 to 4 weeks, the frequency of
        which will be determined at the discretion of the attending physician (Visits 2, 2', 2'',
        2''', 2''').
  
        Upon reaching gestational age 34-35 weeks (Visit 3), members of the control group will begin
        to wear a retrospective CGM device until they reach gestational age 36 weeks (Visit 4).
  
        After 6-12 weeks from delivery, subjects will be asked to visit the clinic again and undergo
        a 75g Oral Glucose Tolerance Test (OGTT) (Visit 5).
  
        For the purposes of data analysis and outcome determination, the most recent 1-week CGM data
        collected at Visit 4 will be used for both groups.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: randomized, parallel, open labeled study
  primary purpose: Supportive Care
  masking: None (Open Label)
  masking description: Open label
  measure: 63-140 mg/dL Time in Range
  time frame: at visit 4(gestational age 36weeks)
  description: 63-140 mg/dL Time in Range evaluated for 1 week before Visit4 visit
  measure: AbA1C (%)
  time frame: at visit 4(gestational age 36weeks)
  description: HbA1C evaluated at visit 4
  measure: Glycated Albumin(g/dL)
  time frame: at visit 4(gestational age 36weeks)
  description: Glycated Albumin evaluated at visit 4
  measure: >180 mg/dL Time in Range
  time frame: 1 week before Visit4 (gestational age 36weeks)
  description: >180 mg/dL Time in Range evaluated for 1 week before Visit4
  measure: >140 mg/dL Time in Range
  time frame: 1 week before Visit4 (gestational age 36weeks)
  description: >140 mg/dL Time in Range evaluated for 1 week before Visit4
  measure: >120 mg/dL Time in Range
  time frame: 1 week before Visit4 (gestational age 36weeks)
  description: >120 mg/dL Time in Range evaluated for 1 week before Visit4
  measure: <63mg/dL Time in Range
  time frame: 1 week before Visit4 (gestational age 36weeks)
  description: <63mg/dL Time in Range evaluated for 1 week before Visit4
  measure: <54mg/dL Time in Range
  time frame: 1 week before Visit4 (gestational age 36weeks)
  description: <54mg/dL Time in Range evaluated for 1 week before Visit4
  measure: 63-120mg/dL Time in Range
  time frame: 1 week before Visit4 (gestational age 36weeks)
  description: 63-120mg/dL Time in Range evaluated for 1 week before Visit4
  measure: Night time Blood glucose (0AM-6AM) 63-94 mg/dL Time in Range
  time frame: 1 week before Visit4 (gestational age 36weeks)
  description: Night time Blood glucose (0AM-6AM) 63-94 mg/dL Time in Range evaluated for 1 week before Visit4
  measure: Night time Blood glucose (0AM-6AM) ≥95 mg/dL Time in Range
  time frame: 1 week before Visit4 (gestational age 36weeks)
  description: Night time Blood glucose (0AM-6AM) ≥95 mg/dL Time in Range evaluated for 1 week before Visit4
  measure: Night time Blood glucose (0AM-6AM) <63 mg/dL Time in Range
  time frame: 1 week before Visit4 (gestational age 36weeks)
  description: Night time Blood glucose (0AM-6AM) <63 mg/dL Time in Range evaluated for 1 week before Visit4
  measure: Night time Blood glucose (0AM-6AM) <54 mg/dL Time in Range
  time frame: 1 week before Visit4 (gestational age 36weeks)
  description: Night time Blood glucose (0AM-6AM) <54 mg/dL Time in Range evaluated for 1 week before Visit4
  measure: Overall average blood glucose level
  time frame: 1 week before Visit4 (gestational age 36weeks)
  description: Overall average blood glucose level evaluated for 1week before visit4
  measure: Overall average Night time Blood glucose (0AM-6AM) level
  time frame: 1 week before Visit4 (gestational age 36weeks)
  description: Overall average Night time Blood glucose (0AM-6AM) level evaluated for 1week before visit4
  measure: Overall average During the day time blood glucose (6AM-12PM) level
  time frame: 1 week before Visit4 (gestational age 36weeks)
  description: Overall average During the day time blood glucose (6AM-12PM) level evaluated for 1week before visit4
  measure: Frequency of severe hypoglycemia(Hypoglycemia requiring help from others)
  time frame: From visit 1 to visit 4(Gestational age 25-31 weeks to Gestational age 36 week)
  description: Frequency of severe hypoglycemia during the study period hyperglycemia requiring help from others)
  measure: glucose variability
  time frame: 1 week before Visit4(gestational age 36weeks)
  description: glucose variability evaluated for 1week before visit4 (MAGE,SD,CV)
  measure: rate of insulin treatment
  time frame: From visit 1 to visit 4 (Gestational age 25-31 weeks to Gestational age 36 week)
  description: rate of insulin treatment
  measure: Estimation A1c of continuous blood glucose measurement for 1 week before Visit4 visit
  time frame: 1 week before Visit4(Gestational age 36 week)
  description: Estimation A1c of continuous blood glucose measurement for 1 week before Visit4 visit
  measure: Total daily insulin requirements (evaluated at every visit)
  time frame: From visit 1 to visit 4(Gestational age 25-31 weeks to Gestational age 36 week)
  description: Total daily insulin requirements (evaluated at every visit)
  measure: Satisfaction Questionnaire
  time frame: Visit 1 (Gestational age 25-31 weeks) , Visit 4 (Gestational age 36 week)
  description: Satisfaction Questionnaire(DTSQ) ,Score: min0 ~max 48, higher scores mean a better outcome
  measure: C-section rate
  time frame: during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)
  description: C-section rate
  measure: preeclampsia rate
  time frame: during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)
  description: preeclampsia rate
  measure: preeclampsia or gestational hypertension rate
  time frame: during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)
  description: preeclampsia or gestational hypertension rate
  measure: the rate of preterm birth
  time frame: during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)
  description: the rate of preterm birth
  measure: Weight gain during the study period
  time frame: during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)
  description: Weight gain during the study period
  measure: Average daily blood glucose measurements during the study period
  time frame: during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)
  description: Freestyle Libre scans, SMBG
  measure: Changes in Microbiome
  time frame: during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)
  description: Changes in Microbiome
  measure: Rate of transition to type 2 diabetes
  time frame: at post partum (6-12 weeks after delivery)
  description: Rate of transition to type 2 diabetes
  measure: Rate of transition to Glucose intolerance (prediabetes and/or diabetes)
  time frame: at post partum (6-12 weeks after delivery)
  description: Rate of transition to Glucose intolerance (prediabetes and/or diabetes)
  measure: Rate of transition to Impaired fasting glucose (IFG) and/or diabetes
  time frame: at post partum (6-12 weeks after delivery)
  description: Rate of transition to Impaired fasting glucose (IFG) and/or diabetes
  measure: Rate of transition to Impaired fasting glucose (IGT) and/or diabetes
  time frame: at post partum (6-12 weeks after delivery)
  description: Rate of transition to Impaired fasting glucose (IGT) and/or diabetes
  measure: 75g OGTT hourly blood glucose
  time frame: at post partum (6-12 weeks after delivery)
  description: 75g OGTT hourly blood glucose
  measure: hemoglobinA1C
  time frame: at post partum (6-12 weeks after delivery)
  description: hemoglobinA1C
  measure: glycated albumin
  time frame: at post partum (6-12 weeks after delivery)
  description: glycated albumin
  measure: Insulin resistance index (HOMA-IR)
  time frame: at post partum (6-12 weeks after delivery)
  description: HOMA-IR (no unit, higher score means a worse outcome)
  measure: Insulin resistance index (Matsuda index)
  time frame: at post partum (6-12 weeks after delivery)
  description: Matsuda index (no unit, higher score means a better outcome)
  measure: Insulin secretion ability index (HOMA-beta)
  time frame: at post partum (6-12 weeks after delivery)
  description: HOMA-beta(no unit, higher score means a better outcome)
  measure: Insulin secretion ability index (Insulinogenic index)
  time frame: at post partum (6-12 weeks after delivery)
  description: Insulinogenic index(no unit, higher score means a better outcome)
  measure: Insulin Composite index(Oral disposition index)
  time frame: at post partum (6-12 weeks after delivery)
  description: Oral disposition index(no unit, higher score means a better outcome)
  measure: Insulin Composite index(disposition index)
  time frame: at post partum (6-12 weeks after delivery)
  description: disposition index(no unit, higher score means a better outcome)
  measure: weight change
  time frame: at post partum (6-12 weeks after delivery)
  description: weight change
  measure: Change in Bioelectric impedance analysis (BIA)
  time frame: at post partum (6-12 weeks after delivery)
  description: Change in Bioelectric impedance analysis (BIA)
  measure: fetal: childbirth weight
  time frame: at Delivery
  description: fetal: childbirth weight
  measure: fetal: Macrosomia ( > 4000 g)
  time frame: at Delivery
  description: fetal: Macrosomia ( > 4000 g)
  measure: fetal:Large for gestational age ( > 90th percentile for age)
  time frame: at Delivery
  description: fetal:Large for gestational age ( > 90th percentile for age)
  measure: fetal:Small for gestational age ( < 10th percentile for age)
  time frame: at Delivery
  description: fetal:Small for gestational age ( < 10th percentile for age)
  measure: fetal:Neonatal glucose level
  time frame: at Delivery
  description: fetal:Neonatal glucose level
  measure: fetal:NICU admission
  time frame: at Delivery
  description: fetal:NICU admission
  measure: fetal:birth trauma (including shoulderdystocia, clavicle fracture or Erb's palsy)
  time frame: at Delivery
  description: fetal:birth trauma (including shoulderdystocia, clavicle fracture or Erb's palsy)
  measure: fetal:Pre-term birth
  time frame: at Delivery
  description: fetal:Pre-term birth
  measure: fetal:Apgar score
  time frame: at Delivery
  description: score: min 0 ~ max 10, higher scores mean a better outcome
  measure: fetal:Meconium aspiration
  time frame: at Delivery
  description: fetal:Meconium aspiration
  arm group label: SMBG arm
  arm group type: Active Comparator
  description: Self Monitoring of Blood Glucose group
  arm group label: CGMS arm
  arm group type: Experimental
  description: Continuous glucose monitoring system, CGM
  intervention type: Device
  intervention name: CareSens N (iSENS)
  description: Control group is asked to perform SMBG (4 times or more per day).
  arm group label: SMBG arm
  intervention type: Device
  intervention name: Freestyle Libre (Abbott)
  description: CGM group is asked to scan CGM (4 times or more per day).
  arm group label: CGMS arm
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Gestational Diabetes
  minimum age: 19 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Cheol-Young Park, MD
  role: Principal Investigator
  affiliation: KangbukSamsung Hospital
  last name: Cheol-Young Park, MD
  phone: 82-010-3397-6107
  email: cydoctor68@gmail.com
  last name: SunJoon Moon, MD
  email: ipleat.m@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Korea, Republic of
  url: https://www.frontiersin.org/articles/10.3389/fcimb.2020.00188/full
  description: Hasain Z, Mokhtar NM , Kamaruddin NA, Mohamed Ismail NA, Razalli NH, Gnanou JV, et al. Gut Microbiota and Gestational Diabetes Mellitus: A Review of Host Gut Microbiota Interactions and Their Therapeutic Potential. Front Cell Infect Microbiol [Internet].
  citation: Cespedes EM, Hu FB, Tinker L, Rosner B, Redline S, Garcia L, Hingle M, Van Horn L, Howard BV, Levitan EB, Li W, Manson JE, Phillips LS, Rhee JJ, Waring ME, Neuhouser ML. Multiple Healthful Dietary Patterns and Type 2 Diabetes in the Women's Health Initiative. Am J Epidemiol. 2016 Apr 1;183(7):622-33. doi: 10.1093/aje/kwv241. Epub 2016 Mar 2.
  PMID: 26940115
  citation: Guariguata L, Linnenkamp U, Beagley J, Whiting DR, Cho NH. Global estimates of the prevalence of hyperglycaemia in pregnancy. Diabetes Res Clin Pract. 2014 Feb;103(2):176-85. doi: 10.1016/j.diabres.2013.11.003. Epub 2013 Dec 1.
  PMID: 24300020
  citation: Kim KS. The importance of treating mild hyperglycemia in pregnant women with diabetes. Korean J Intern Med. 2018 Nov;33(6):1079-1080. doi: 10.3904/kjim.2018.351. Epub 2018 Oct 30. No abstract available.
  PMID: 30396252
  citation: Koo BK, Lee JH, Kim J, Jang EJ, Lee CH. Prevalence of Gestational Diabetes Mellitus in Korea: A National Health Insurance Database Study. PLoS One. 2016 Apr 5;11(4):e0153107. doi: 10.1371/journal.pone.0153107. eCollection 2016. Erratum In: PLoS One. 2016 Oct 20;11(10 ):e0165445.
  PMID: 27046149
  citation: DeSisto CL, Kim SY, Sharma AJ. Prevalence estimates of gestational diabetes mellitus in the United States, Pregnancy Risk Assessment Monitoring System (PRAMS), 2007-2010. Prev Chronic Dis. 2014 Jun 19;11:E104. doi: 10.5888/pcd11.130415.
  PMID: 24945238
  citation: McIntyre HD, Catalano P, Zhang C, Desoye G, Mathiesen ER, Damm P. Gestational diabetes mellitus. Nat Rev Dis Primers. 2019 Jul 11;5(1):47. doi: 10.1038/s41572-019-0098-8.
  PMID: 31296866
  responsible party type: Principal Investigator
  investigator affiliation: Kangbuk Samsung Hospital
  investigator full name: Cheol-Young Park
  investigator title: Professor
  mesh term: Diabetes, Gestational
  mesh term: Pregnancy in Diabetics
  mesh term: Diabetes Mellitus