<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/NCT03032523</url>
  </required_header>
  <id_info>
    <org_study_id>36668</org_study_id>
    <nct_id>NCT03032523</nct_id>
  </id_info>
  <brief_title>Detecting Neonatal Hypoglycemia Using Real-Time Continuous Glucose Monitoring (CGM)</brief_title>
  <official_title>Detecting Neonatal Hypoglycemia Using Real-Time Continuous Glucose Monitoring (CGM)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypoglycemia is the most common metabolic problem faced after birth. The investigators will&#xD;
      be studying the utility of using a continuous glucose monitoring(CGM) system to more closely&#xD;
      monitor low blood sugars in newborns. The investigators will evaluate the number of&#xD;
      hypoglycemic events detected using CGM and compare it to those detected using current&#xD;
      standard of care screening methods.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A CGM will be subcutaneously inserted by trained staff on a healthy area of skin and will be&#xD;
      calibrated according to the manufacturer's instructions. Blood glucose measurements will be&#xD;
      taken using a blinded study glucometer to calibrate the device. Calibration by trained study&#xD;
      staff will take place about every 12 hours. Sensor insertion sites will be monitored for&#xD;
      infection throughout the course of the study by nursing and clinical staff or by trained&#xD;
      study staff on an as needed basis. At the conclusion of the study, the CGM will be removed&#xD;
      and assessed for signs of infection. Study duration will be up to 7 days while the patient is&#xD;
      admitted to the hospital.&#xD;
&#xD;
      Participants will be randomized into 2 groups. The control group will have a blinded CGM in&#xD;
      place for the duration of the study. The remote monitoring group will be blinded to clinical&#xD;
      staff. This group will have a CGM connected to an iPod that sends continuous glucose data to&#xD;
      the study phone and will be monitored 24/7 by study staff. If a blood sugar level of &lt;46&#xD;
      mg/dl is detected, the infant will first be evaluated for positioning that could be causing a&#xD;
      falsely low value. If the infant is re-positioned and CGM continues to show a blood sugar&#xD;
      level of &lt;46 mg/dl, study staff will prompt the nurse taking care of the patient to obtain a&#xD;
      capillary glucose value to verify the low blood sugar and treat it as deemed appropriate by&#xD;
      the clinical team.&#xD;
&#xD;
      The investigators will evaluate the number of hypoglycemic events that occur in the blinded&#xD;
      CGM group versus the number that occur in the remote monitoring group to assess if the CGM is&#xD;
      able to more sensitively detect low blood sugars in infants than current hospital standard of&#xD;
      care measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2016</start_date>
  <completion_date type="Actual">April 1, 2018</completion_date>
  <primary_completion_date type="Actual">April 1, 2018</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>Diagnostic</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sensor-detected Hypoglycemia</measure>
    <time_frame>up to 8 days</time_frame>
    <description>Reported values in the table represent the cumulative number of hypoglycemic events detected by the sensor that were not detected by the hospital standard of care measures across all participants.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of the CGM to Detect Hypoglycemia.</measure>
    <time_frame>up to 7 days</time_frame>
    <description>True positive rate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity of CGM to Detect Hypoglycemic Events</measure>
    <time_frame>up to 7 days</time_frame>
    <description>True negative rate</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Neonatal Hypoglycemia</condition>
  <arm_group>
    <arm_group_label>Remote Monitoring CGM Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants wear a CGM that is blinded at bedside (to participant and clinical staff) but remotely monitored by study staff. If a blood sugar less than 46 mg/dl occurs, the study staff receive a notification and ask the clinical staff to perform a confirmation standard of care glucose test.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Blinded CGM Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants wear a blinded CGM during the study period. Values are blinded to study staff, participant, and clinical staff.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Standard of care glucose test</intervention_name>
    <description>If the CGM in the remote monitoring group detects a blood sugar less than 46mg/dl, a confirmatory standard of care glucose test will be performed to confirm the low blood sugar.</description>
    <arm_group_label>Remote Monitoring CGM Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants who are at least 34 weeks gestation that are born to mothers with gestational&#xD;
             or pre-gestational diabetes and are admitted to LPCH are eligible for the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infants &lt;2,000 grams will be excluded from the study. Infants will also be excluded if&#xD;
             they have an anomaly of the skin or subcutaneous tissue that would prevent proper&#xD;
             adhesion, placement, and function of the sensor.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>7 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laura Nally, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <results_first_submitted>March 22, 2019</results_first_submitted>
  <results_first_submitted_qc>July 26, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 29, 2019</results_first_posted>
  <last_update_submitted>July 26, 2019</last_update_submitted>
  <last_update_submitted_qc>July 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Laura Nally</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypoglycemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 6, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/23/NCT03032523/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Mothers attending obstetrics clinics at Stanford University were approached if they met inclusion criteria. 119 mothers were approached, 66 declined to participate, 23 were lost to follow up after initially discussing the study, 6 were unable to participate because research staff were not available at the time of birth, and 3 were ineligible.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Remote Monitoring CGM Group</title>
          <description>Participants wear a CGM that is blinded at bedside (to participant and clinical staff) but remotely monitored by study staff. If a blood sugar less than 46 mg/dl occurs, the study staff receive a notification and ask the clinical staff to perform a confirmation standard of care glucose test.&#xD;
Standard of care glucose test: If the CGM in the remote monitoring group detects a blood sugar less than 45 mg/dl, a confirmatory standard of care glucose test will be performed to confirm the low blood sugar.</description>
        </group>
        <group group_id="P2">
          <title>Blinded CGM Group</title>
          <description>Participants wear a blinded CGM during the study period. Values are blinded to study staff, participant, and clinical staff.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All infants enrolled in the study.</population>
      <group_list>
        <group group_id="B1">
          <title>Remote Monitoring CGM Group</title>
          <description>Participants wear a CGM that is blinded at bedside (to participant and clinical staff) but remotely monitored by study staff. If a blood sugar less than 46 mg/dl occurs, the study staff receive a notification and ask the clinical staff to perform a confirmation standard of care glucose test.&#xD;
Standard of care glucose test: If the CGM in the remote monitoring group detects a blood sugar less than 45 mg/dL, a confirmatory standard of care glucose test will be performed to confirm the low blood sugar.</description>
        </group>
        <group group_id="B2">
          <title>Blinded CGM Group</title>
          <description>Participants wear a blinded CGM during the study period. Values are blinded to study staff, participant, and clinical staff.</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="15"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="21"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Less than 24 hours of life</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24-48 hours of life</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </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="10"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </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>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Sensor-detected Hypoglycemia</title>
        <description>Reported values in the table represent the cumulative number of hypoglycemic events detected by the sensor that were not detected by the hospital standard of care measures across all participants.</description>
        <time_frame>up to 8 days</time_frame>
        <population>Participants in the remote monitoring group were eligible for analysis. 3 were excluded from the remote monitoring group for the analysis. Blinded CGM participants did not have a verification glucose check, thus sensor-detected hypoglycemia was not verified, and thus were not reported in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Remote Monitoring CGM Group</title>
            <description>Participants wear a CGM that is blinded at bedside (to participant and clinical staff) but remotely monitored by study staff. If a blood sugar less than 46 mg/dl occurs, the study staff receive a notification and ask the clinical staff to perform a confirmation standard of care glucose test.&#xD;
Standard of care glucose test: If the CGM in the remote monitoring group detects a blood sugar less than 45mg/dl, a confirmatory standard of care glucose test will be performed to confirm the low blood sugar.</description>
          </group>
          <group group_id="O2">
            <title>Blinded CGM Group</title>
            <description>Participants wear a blinded CGM during the study period. Values are blinded to study staff, participant, and clinical staff.</description>
          </group>
        </group_list>
        <measure>
          <title>Sensor-detected Hypoglycemia</title>
          <description>Reported values in the table represent the cumulative number of hypoglycemic events detected by the sensor that were not detected by the hospital standard of care measures across all participants.</description>
          <population>Participants in the remote monitoring group were eligible for analysis. 3 were excluded from the remote monitoring group for the analysis. Blinded CGM participants did not have a verification glucose check, thus sensor-detected hypoglycemia was not verified, and thus were not reported in the analysis.</population>
          <units>events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hypo Events Detected by Sensor (not SOC)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypo Events Detected by SOC and not sensor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sensitivity of the CGM to Detect Hypoglycemia.</title>
        <description>True positive rate.</description>
        <time_frame>up to 7 days</time_frame>
        <population>Participants in the Remote Monitoring CGM Group were analyzed. 3 were excluded from the remote monitoring group for the analysis. Those in the blinded group were unable to be analyzed because the CGM was blinded and did not prompt a BG check.</population>
        <group_list>
          <group group_id="O1">
            <title>Remote Monitoring CGM Group</title>
            <description>Participants wear a CGM that is blinded at bedside (to participant and clinical staff) but remotely monitored by study staff. If a blood sugar less than 46 mg/dl occurs, the study staff receive a notification and ask the clinical staff to perform a confirmation standard of care glucose test.&#xD;
Standard of care glucose test: If the CGM in the remote monitoring group detects a blood sugar less than 45 mg/dl, a confirmatory standard of care glucose test will be performed to confirm the low blood sugar.</description>
          </group>
          <group group_id="O2">
            <title>Blinded CGM Group</title>
            <description>Participants wear a blinded CGM during the study period. Values are blinded to study staff, participant, and clinical staff.</description>
          </group>
        </group_list>
        <measure>
          <title>Sensitivity of the CGM to Detect Hypoglycemia.</title>
          <description>True positive rate.</description>
          <population>Participants in the Remote Monitoring CGM Group were analyzed. 3 were excluded from the remote monitoring group for the analysis. Those in the blinded group were unable to be analyzed because the CGM was blinded and did not prompt a BG check.</population>
          <units>% of true hypoglycemic events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Specificity of CGM to Detect Hypoglycemic Events</title>
        <description>True negative rate</description>
        <time_frame>up to 7 days</time_frame>
        <population>12 participants had sensor data for analysis. 3 were excluded from the remote monitoring group for the analysis. Blinded CGM participants did not have a verification glucose check, thus specificity could not be calculated on these participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Remote Monitoring CGM Group</title>
            <description>Participants wear a CGM that is blinded at bedside (to participant and clinical staff) but remotely monitored by study staff. If a blood sugar less than 46 mg/dl occurs, the study staff receive a notification and ask the clinical staff to perform a confirmation standard of care glucose test.&#xD;
Standard of care glucose test: If the CGM in the remote monitoring group detects a blood sugar less than 45mg/dl, a confirmatory standard of care glucose test will be performed to confirm the low blood sugar.</description>
          </group>
          <group group_id="O2">
            <title>Blinded CGM Group</title>
            <description>Participants wear a blinded CGM during the study period. Values are blinded to study staff, participant, and clinical staff.</description>
          </group>
        </group_list>
        <measure>
          <title>Specificity of CGM to Detect Hypoglycemic Events</title>
          <description>True negative rate</description>
          <population>12 participants had sensor data for analysis. 3 were excluded from the remote monitoring group for the analysis. Blinded CGM participants did not have a verification glucose check, thus specificity could not be calculated on these participants.</population>
          <units>% of true negative events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 7 days of life</time_frame>
      <desc>Sensor sites on infants examined twice daily by research staff and daily chart reviews were performed.</desc>
      <group_list>
        <group group_id="E1">
          <title>Remote Monitoring CGM Group</title>
          <description>Participants wear a CGM that is blinded at bedside (to participant and clinical staff) but remotely monitored by study staff. If a blood sugar less than 45 mg/dl occurs, the study staff receive a notification and ask the clinical staff to perform a confirmation standard of care glucose test.&#xD;
Standard of care glucose test: If the CGM in the remote monitoring group detects a blood sugar less than 46mg/dl, a confirmatory standard of care glucose test will be performed to confirm the low blood sugar.</description>
        </group>
        <group group_id="E2">
          <title>Blinded CGM Group</title>
          <description>Participants wear a blinded CGM during the study period. Values are blinded to study staff, participant, and clinical staff.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Retained sensor wire</sub_title>
                <description>One infant retained the sensor wire upon removal of the sensor, which is a very rare, but known risk. No medical intervention related to the retained sensor wire was required.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </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>Because we were unable to recruit 40 infants during the time frame of the randomized trial, we modified the study design to test the additional benefit of using CGM monitoring to detect hypoglycemia.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Laura Nally, MD, Instructor in Pediatrici Endocrinology</name_or_title>
      <organization>Yale University</organization>
      <phone>9728324734</phone>
      <email>laura.nally@yale.edu</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/NCT03032523
org study id: 36668
nct id: NCT03032523
lead sponsor: 
has dmc: No
Hypoglycemia is the most common metabolic problem faced after birth. The investigators will
      be studying the utility of using a continuous glucose monitoring(CGM) system to more closely
      monitor low blood sugars in newborns. The investigators will evaluate the number of
      hypoglycemic events detected using CGM and compare it to those detected using current
      standard of care screening methods.
A CGM will be subcutaneously inserted by trained staff on a healthy area of skin and will be
      calibrated according to the manufacturer's instructions. Blood glucose measurements will be
      taken using a blinded study glucometer to calibrate the device. Calibration by trained study
      staff will take place about every 12 hours. Sensor insertion sites will be monitored for
      infection throughout the course of the study by nursing and clinical staff or by trained
      study staff on an as needed basis. At the conclusion of the study, the CGM will be removed
      and assessed for signs of infection. Study duration will be up to 7 days while the patient is
      admitted to the hospital.

      Participants will be randomized into 2 groups. The control group will have a blinded CGM in
      place for the duration of the study. The remote monitoring group will be blinded to clinical
      staff. This group will have a CGM connected to an iPod that sends continuous glucose data to
      the study phone and will be monitored 24/7 by study staff. If a blood sugar level of <46
      mg/dl is detected, the infant will first be evaluated for positioning that could be causing a
      falsely low value. If the infant is re-positioned and CGM continues to show a blood sugar
      level of <46 mg/dl, study staff will prompt the nurse taking care of the patient to obtain a
      capillary glucose value to verify the low blood sugar and treat it as deemed appropriate by
      the clinical team.

      The investigators will evaluate the number of hypoglycemic events that occur in the blinded
      CGM group versus the number that occur in the remote monitoring group to assess if the CGM is
      able to more sensitively detect low blood sugars in infants than current hospital standard of
      care measures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Sensor-detected Hypoglycemia
time frame: up to 8 days
description: Reported values in the table represent the cumulative number of hypoglycemic events detected by the sensor that were not detected by the hospital standard of care measures across all participants.
measure: Sensitivity of the CGM to Detect Hypoglycemia.
time frame: up to 7 days
description: True positive rate.
measure: Specificity of CGM to Detect Hypoglycemic Events
time frame: up to 7 days
description: True negative rate
arm group label: Remote Monitoring CGM Group
arm group type: Experimental
description: Participants wear a CGM that is blinded at bedside (to participant and clinical staff) but remotely monitored by study staff. If a blood sugar less than 46 mg/dl occurs, the study staff receive a notification and ask the clinical staff to perform a confirmation standard of care glucose test.
arm group label: Blinded CGM Group
arm group type: No Intervention
description: Participants wear a blinded CGM during the study period. Values are blinded to study staff, participant, and clinical staff.
intervention type: Diagnostic Test
intervention name: Standard of care glucose test
description: If the CGM in the remote monitoring group detects a blood sugar less than 46mg/dl, a confirmatory standard of care glucose test will be performed to confirm the low blood sugar.
arm group label: Remote Monitoring CGM Group
criteria: 
gender: All
minimum age: N/A
maximum age: 7 Days
healthy volunteers: No
last name: Laura Nally, MD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Laura Nally
investigator title: Principal Investigator
mesh term: Hypoglycemia
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Because we were unable to recruit 40 infants during the time frame of the randomized trial, we modified the study design to test the additional benefit of using CGM monitoring to detect hypoglycemia.
point of contact: 