<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/NCT02204657</url>
  </required_header>
  <id_info>
    <org_study_id>961.7</org_study_id>
    <secondary_id>PPUM/QSU/300-04/11</secondary_id>
    <nct_id>NCT02204657</nct_id>
  </id_info>
  <brief_title>The Effect of Continuous Glucose Monitoring on Glycemic Control in Insulin-requiring Gestational Diabetes Mellitus</brief_title>
  <official_title>The Effect of Professional Continuous Glucose Monitoring on Diabetes Management,Hypoglycemia and Glycemic Control in Insulin-requiring Gestational Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Malaya</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Malaya</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if professional Continuous glucose monitoring&#xD;
      improves glycemic control with less hypoglycaemia in insulin-requiring Gestational Diabetes&#xD;
      Mellitus&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. OBJECTIVES&#xD;
&#xD;
             1. To determine if professional CGM improves glycemic control with less hypoglycaemia&#xD;
                in insulin- requiring GDM&#xD;
&#xD;
             2. To determine if professional CGM use alters management of insulin-requiring GDM&#xD;
&#xD;
             3. To determine if professional CGM improves pregnancy outcomes in insulin-requiring&#xD;
                GDM.&#xD;
&#xD;
             4. To determine patient attitudes toward CGMS.&#xD;
&#xD;
        2. HYPOTHESES&#xD;
&#xD;
             1. Professional CGMS improves glycaemic control in women with insulin-requiring GDM&#xD;
                with less hypoglycaemia&#xD;
&#xD;
             2. Professional CGM use will alter management of insulin-requiring GDM&#xD;
&#xD;
             3. Professional CGMS will reduce perinatal morbidity and mortality in patients with&#xD;
                insulin- requiring GDM&#xD;
&#xD;
             4. Third trimester CGMS parameters will correlate better with perinatal outcomes&#xD;
                compared with conventional measures of glycaemic control in pregnancy i.e.&#xD;
                fructosamine/ A1c/ FBS/ 2hrs PP glucose&#xD;
&#xD;
      STUDY DESIGN&#xD;
&#xD;
        -  This is a prospective, open-label, randomized controlled trial. We plan to recruit 80&#xD;
           women with gestational diabetes at 28 weeks gestation or less from the UMMC antenatal&#xD;
           clinic. These women should be insulin-naïve but require insulin therapy. 40 subjects&#xD;
           (Group 1) will be selected to undergo professional CGM at weeks 28, 32, and week 36 and&#xD;
           another 40 subjects individually matched with regards, to age, baseline A1c, BMI will be&#xD;
           recruited to undergo usual antenatal care without CGMS (Group 2). The CGMS data will be&#xD;
           uploaded and reviewed at weeks 29, 33, and 37 and changes made to the therapeutic&#xD;
           regimen as required by the endocrinologist. All mothers will be required to measure&#xD;
           their glucose levels at 7 standardized points in a day daily. These glucose readings&#xD;
           will be recorded in a diary together with a food log. All subjects will also be required&#xD;
           to keep a hypoglycaemia diary.&#xD;
&#xD;
        -  The primary outcomes will be glycaemic control in the third trimester and maternal&#xD;
           hypoglycaemia. We also plan to assess changes to management made by the endocrinologist&#xD;
           based on the additional information on glycemic control obtained from professional CGM&#xD;
           use. We also plan to compare hypoglycaemia and hyperglycaemia detection rates using the&#xD;
           CGMS and fingerstick methods of glucose evaluation. Patient satisfaction in both groups&#xD;
           will also be assessed. Written and informed consent will be obtained in accordance with&#xD;
           the principles of the Helsinki Declaration&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glycemic Control by Measurement of HbA1c</measure>
    <time_frame>From 28 weeks until delivery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hypoglycemia</measure>
    <time_frame>28 weeks until delivery</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Gestational Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Continuous Glucose Monitoring System</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Continuous Glucose Monitoring System</intervention_name>
    <description>Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings</description>
    <arm_group_label>Continuous Glucose Monitoring System</arm_group_label>
    <other_name>iPro, Medtronic</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women with gestational diabetes&#xD;
&#xD;
          -  aged &gt;18 years&#xD;
&#xD;
          -  less than or equal to 28 weeks gestation of pregnancy&#xD;
&#xD;
          -  singleton pregnancy&#xD;
&#xD;
          -  insulin naive , but requiring insulin therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregestational type 1 or 2 diabetes mellitus&#xD;
&#xD;
          -  newly diagnosed overt diabetes in pregnancy ( HbA1c &gt; 6.5)&#xD;
&#xD;
          -  hypothyroidism&#xD;
&#xD;
          -  Cushing's syndrome/ using exogenous steroids&#xD;
&#xD;
          -  chronic infection ( HIV, Hepatitis B/C, Tuberculosis)&#xD;
&#xD;
          -  any active chronic systemic disease ( except essential hypertension)&#xD;
&#xD;
          -  assisted conception&#xD;
&#xD;
          -  pregnancies with fetal anomalies / where imminent or preterm delivery is likely&#xD;
             because of maternal disease ( besides gestational diabetes)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shireene R Vethakkan, MBBS,MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Malaya</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Malaya Medical Centre</name>
      <address>
        <city>Kuala Lumpur</city>
        <state>Federal Territory</state>
        <zip>59100</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <reference>
    <citation>Murphy HR, Rayman G, Lewis K, Kelly S, Johal B, Duffield K, Fowler D, Campbell PJ, Temple RC. Effectiveness of continuous glucose monitoring in pregnant women with diabetes: randomised clinical trial. BMJ. 2008 Sep 25;337:a1680. doi: 10.1136/bmj.a1680.</citation>
    <PMID>18818254</PMID>
  </reference>
  <reference>
    <citation>Chen R, Yogev Y, Ben-Haroush A, Jovanovic L, Hod M, Phillip M. Continuous glucose monitoring for the evaluation and improved control of gestational diabetes mellitus. J Matern Fetal Neonatal Med. 2003 Oct;14(4):256-60. doi: 10.1080/jmf.14.4.256.260.</citation>
    <PMID>14738172</PMID>
  </reference>
  <reference>
    <citation>Yogev Y, Visser GH. Obesity, gestational diabetes and pregnancy outcome. Semin Fetal Neonatal Med. 2009 Apr;14(2):77-84. doi: 10.1016/j.siny.2008.09.002. Epub 2008 Oct 15.</citation>
    <PMID>18926784</PMID>
  </reference>
  <reference>
    <citation>Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS; Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) Trial Group. Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. N Engl J Med. 2005 Jun 16;352(24):2477-86. doi: 10.1056/NEJMoa042973. Epub 2005 Jun 12.</citation>
    <PMID>15951574</PMID>
  </reference>
  <reference>
    <citation>Tan PC, Ling LP, Omar SZ. The 50-g glucose challenge test and pregnancy outcome in a multiethnic Asian population at high risk for gestational diabetes. Int J Gynaecol Obstet. 2009 Apr;105(1):50-5. doi: 10.1016/j.ijgo.2008.11.038. Epub 2009 Jan 19.</citation>
    <PMID>19154997</PMID>
  </reference>
  <reference>
    <citation>Balaji V, Balaji M, Anjalakshi C, Cynthia A, Arthi T, Seshiah V. Inadequacy of fasting plasma glucose to diagnose gestational diabetes mellitus in Asian Indian women. Diabetes Res Clin Pract. 2011 Oct;94(1):e21-3. doi: 10.1016/j.diabres.2011.07.008. Epub 2011 Aug 10.</citation>
    <PMID>21831468</PMID>
  </reference>
  <reference>
    <citation>Klonoff DC, Buckingham B, Christiansen JS, Montori VM, Tamborlane WV, Vigersky RA, Wolpert H; Endocrine Society. Continuous glucose monitoring: an Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2011 Oct;96(10):2968-79. doi: 10.1210/jc.2010-2756. Erratum In: J Clin Endocrinol Metab. 2021 May 13;106(6):e2460. J Clin Endocrinol Metab. 2022 Apr 19;107(5):e2220.</citation>
    <PMID>21976745</PMID>
  </reference>
  <reference>
    <citation>Klonoff DC. Continuous glucose monitoring: roadmap for 21st century diabetes therapy. Diabetes Care. 2005 May;28(5):1231-9. doi: 10.2337/diacare.28.5.1231. No abstract available.</citation>
    <PMID>15855600</PMID>
  </reference>
  <reference>
    <citation>Landon MB, Spong CY, Thom E, Carpenter MW, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Lain KY, Sorokin Y, Peaceman AM, Tolosa JE, Anderson GB; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. A multicenter, randomized trial of treatment for mild gestational diabetes. N Engl J Med. 2009 Oct 1;361(14):1339-48. doi: 10.1056/NEJMoa0902430.</citation>
    <PMID>19797280</PMID>
  </reference>
  <reference>
    <citation>Sathyapalan T, Mellor D, Atkin SL. Obesity and gestational diabetes. Semin Fetal Neonatal Med. 2010 Apr;15(2):89-93. doi: 10.1016/j.siny.2009.09.002. Epub 2009 Oct 28.</citation>
    <PMID>19875346</PMID>
  </reference>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <results_first_submitted>June 23, 2016</results_first_submitted>
  <results_first_submitted_qc>June 23, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">August 5, 2016</results_first_posted>
  <last_update_submitted>June 23, 2016</last_update_submitted>
  <last_update_submitted_qc>June 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Malaya</investigator_affiliation>
    <investigator_full_name>Shireene Vethakkan</investigator_full_name>
    <investigator_title>Associate Professor and Consultant Endocrinologist</investigator_title>
  </responsible_party>
  <keyword>Continuous glucose monitoring in GDM</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>50 women with insulin-requiring gestational diabetes enrolled from the University of Malaya Medical CentreAntenatal Clinic between April 2013 to April 2015.&#xD;
Women with overt diabetes or pregestational diabetes were excluded.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Continuous Glucose Monitoring System</title>
          <description>Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.&#xD;
Continuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Continuous Glucose Monitoring System</title>
          <description>Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.&#xD;
Continuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="25"/>
            <count group_id="B2" value="25"/>
            <count group_id="B3" value="50"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.80" spread="4.53"/>
                    <measurement group_id="B2" value="32.6" spread="4.93"/>
                    <measurement group_id="B3" value="32.7" spread="4.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Malaysia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Glycemic Control by Measurement of HbA1c</title>
        <time_frame>From 28 weeks until delivery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Continuous Glucose Monitoring System</title>
            <description>Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.&#xD;
Continuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.</description>
          </group>
        </group_list>
        <measure>
          <title>Glycemic Control by Measurement of HbA1c</title>
          <units>mean percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.17" spread="0.41"/>
                    <measurement group_id="O2" value="5.57" spread="0.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hypoglycemia</title>
        <time_frame>28 weeks until delivery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Continuous Glucose Monitoring System</title>
            <description>Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.&#xD;
Continuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.</description>
          </group>
        </group_list>
        <measure>
          <title>Hypoglycemia</title>
          <units>episodes per patient</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0" lower_limit="3" upper_limit="14"/>
                    <measurement group_id="O2" value="4.0" lower_limit="1" upper_limit="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Continuous Glucose Monitoring System</title>
          <description>Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.&#xD;
Continuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>small sample size</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr Sharmila SP</name_or_title>
      <organization>University Malaya Medical Centre</organization>
      <phone>60379492299</phone>
      <email>sharmsp13@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02204657
org study id: 961.7
secondary id: PPUM/QSU/300-04/11
nct id: NCT02204657
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine if professional Continuous glucose monitoring
      improves glycemic control with less hypoglycaemia in insulin-requiring Gestational Diabetes
      Mellitus
1. OBJECTIVES

             1. To determine if professional CGM improves glycemic control with less hypoglycaemia
                in insulin- requiring GDM

             2. To determine if professional CGM use alters management of insulin-requiring GDM

             3. To determine if professional CGM improves pregnancy outcomes in insulin-requiring
                GDM.

             4. To determine patient attitudes toward CGMS.

        2. HYPOTHESES

             1. Professional CGMS improves glycaemic control in women with insulin-requiring GDM
                with less hypoglycaemia

             2. Professional CGM use will alter management of insulin-requiring GDM

             3. Professional CGMS will reduce perinatal morbidity and mortality in patients with
                insulin- requiring GDM

             4. Third trimester CGMS parameters will correlate better with perinatal outcomes
                compared with conventional measures of glycaemic control in pregnancy i.e.
                fructosamine/ A1c/ FBS/ 2hrs PP glucose

      STUDY DESIGN

        -  This is a prospective, open-label, randomized controlled trial. We plan to recruit 80
           women with gestational diabetes at 28 weeks gestation or less from the UMMC antenatal
           clinic. These women should be insulin-naïve but require insulin therapy. 40 subjects
           (Group 1) will be selected to undergo professional CGM at weeks 28, 32, and week 36 and
           another 40 subjects individually matched with regards, to age, baseline A1c, BMI will be
           recruited to undergo usual antenatal care without CGMS (Group 2). The CGMS data will be
           uploaded and reviewed at weeks 29, 33, and 37 and changes made to the therapeutic
           regimen as required by the endocrinologist. All mothers will be required to measure
           their glucose levels at 7 standardized points in a day daily. These glucose readings
           will be recorded in a diary together with a food log. All subjects will also be required
           to keep a hypoglycaemia diary.

        -  The primary outcomes will be glycaemic control in the third trimester and maternal
           hypoglycaemia. We also plan to assess changes to management made by the endocrinologist
           based on the additional information on glycemic control obtained from professional CGM
           use. We also plan to compare hypoglycaemia and hyperglycaemia detection rates using the
           CGMS and fingerstick methods of glucose evaluation. Patient satisfaction in both groups
           will also be assessed. Written and informed consent will be obtained in accordance with
           the principles of the Helsinki Declaration
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Glycemic Control by Measurement of HbA1c
time frame: From 28 weeks until delivery
measure: Hypoglycemia
time frame: 28 weeks until delivery
arm group label: Continuous Glucose Monitoring System
arm group type: Active Comparator
description: Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.
arm group label: Control
arm group type: No Intervention
description: Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.
intervention type: Device
intervention name: Continuous Glucose Monitoring System
description: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings
arm group label: Continuous Glucose Monitoring System
other name: iPro, Medtronic
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shireene R Vethakkan, MBBS,MD
role: Principal Investigator
affiliation: University of Malaya
facility: 
country: Malaysia
citation: Murphy HR, Rayman G, Lewis K, Kelly S, Johal B, Duffield K, Fowler D, Campbell PJ, Temple RC. Effectiveness of continuous glucose monitoring in pregnant women with diabetes: randomised clinical trial. BMJ. 2008 Sep 25;337:a1680. doi: 10.1136/bmj.a1680.
PMID: 18818254
citation: Chen R, Yogev Y, Ben-Haroush A, Jovanovic L, Hod M, Phillip M. Continuous glucose monitoring for the evaluation and improved control of gestational diabetes mellitus. J Matern Fetal Neonatal Med. 2003 Oct;14(4):256-60. doi: 10.1080/jmf.14.4.256.260.
PMID: 14738172
citation: Yogev Y, Visser GH. Obesity, gestational diabetes and pregnancy outcome. Semin Fetal Neonatal Med. 2009 Apr;14(2):77-84. doi: 10.1016/j.siny.2008.09.002. Epub 2008 Oct 15.
PMID: 18926784
citation: Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS; Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) Trial Group. Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. N Engl J Med. 2005 Jun 16;352(24):2477-86. doi: 10.1056/NEJMoa042973. Epub 2005 Jun 12.
PMID: 15951574
citation: Tan PC, Ling LP, Omar SZ. The 50-g glucose challenge test and pregnancy outcome in a multiethnic Asian population at high risk for gestational diabetes. Int J Gynaecol Obstet. 2009 Apr;105(1):50-5. doi: 10.1016/j.ijgo.2008.11.038. Epub 2009 Jan 19.
PMID: 19154997
citation: Balaji V, Balaji M, Anjalakshi C, Cynthia A, Arthi T, Seshiah V. Inadequacy of fasting plasma glucose to diagnose gestational diabetes mellitus in Asian Indian women. Diabetes Res Clin Pract. 2011 Oct;94(1):e21-3. doi: 10.1016/j.diabres.2011.07.008. Epub 2011 Aug 10.
PMID: 21831468
citation: Klonoff DC, Buckingham B, Christiansen JS, Montori VM, Tamborlane WV, Vigersky RA, Wolpert H; Endocrine Society. Continuous glucose monitoring: an Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2011 Oct;96(10):2968-79. doi: 10.1210/jc.2010-2756. Erratum In: J Clin Endocrinol Metab. 2021 May 13;106(6):e2460. J Clin Endocrinol Metab. 2022 Apr 19;107(5):e2220.
PMID: 21976745
citation: Klonoff DC. Continuous glucose monitoring: roadmap for 21st century diabetes therapy. Diabetes Care. 2005 May;28(5):1231-9. doi: 10.2337/diacare.28.5.1231. No abstract available.
PMID: 15855600
citation: Landon MB, Spong CY, Thom E, Carpenter MW, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Lain KY, Sorokin Y, Peaceman AM, Tolosa JE, Anderson GB; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. A multicenter, randomized trial of treatment for mild gestational diabetes. N Engl J Med. 2009 Oct 1;361(14):1339-48. doi: 10.1056/NEJMoa0902430.
PMID: 19797280
citation: Sathyapalan T, Mellor D, Atkin SL. Obesity and gestational diabetes. Semin Fetal Neonatal Med. 2010 Apr;15(2):89-93. doi: 10.1016/j.siny.2009.09.002. Epub 2009 Oct 28.
PMID: 19875346
responsible party type: Principal Investigator
investigator affiliation: University of Malaya
investigator full name: Shireene Vethakkan
investigator title: Associate Professor and Consultant Endocrinologist
mesh term: Diabetes, Gestational
mesh term: Diabetes Mellitus
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: small sample size
point of contact: 