<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/NCT01680653</url>
  </required_header>
  <id_info>
    <org_study_id>2012PG-T1D001</org_study_id>
    <secondary_id>IRB 27428</secondary_id>
    <nct_id>NCT01680653</nct_id>
  </id_info>
  <brief_title>Testing State of the Art Remote Glucose Monitoring at Diabetes Camp</brief_title>
  <official_title>Pilot Study in Testing State of the Art Remote Glucose Monitoring at Diabetes Camp</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>DexCom, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Leona M. and Harry B. Helmsley Charitable Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The incidence of low blood sugar and hypoglycemic seizures at diabetes camp has been reduced&#xD;
      thanks to overnight blood glucose level testing. The timing of the overnight blood test is&#xD;
      often arbitrary and it is unclear when the highest frequency of nocturnal hypoglycemic events&#xD;
      at camp are occurring. It is also unclear what the most appropriate treatment for nocturnal&#xD;
      hypoglycemia is: simple carbohydrates, or mini-glucagon.&#xD;
&#xD;
      In this study, we will use Continuous Glucose Monitors (CGMs) that will send subject data&#xD;
      securely to a remote computer located in the medical cottage at camp throughout the night.&#xD;
      Study staff will monitor the computer and will intervene on low blood sugar as it occurs in&#xD;
      real time. On half of the nights, campers will receive mini-glucagon for low blood sugar, and&#xD;
      on the rest, they will receive standard carbohydrate treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will include approximately 20 subjects with Type 1 Diabetes per camp session. 10&#xD;
      will be linked to remote monitoring with the Diabetes Assistant Computational/Communication&#xD;
      platform (DIAs), and 10 will wear the Dexcom CGM with the same threshold alarm setting as&#xD;
      those wearing the DiAs (70 mg/dl), but without remote monitoring.&#xD;
&#xD;
      Study participants will be between the ages of 7-21 with type 1 diabetes. This would allow&#xD;
      for a counselor in training or a young counselor with a history of recent nocturnal&#xD;
      hypoglycemia to be included. It is these late adolescents and young adults who often have the&#xD;
      most severe hypoglycemic events during a camp session. We will preferentially recruit campers&#xD;
      into the study who: 1) have a history of nocturnal hypoglycemia requiring treatment within&#xD;
      the last 2 months, 2) have hypoglycemia unawareness confirmed with the Clark screening test,&#xD;
      3) have an A1c of &lt;8% while requiring &gt;0.7 units/kg/day of insulin and diabetes duration of &gt;&#xD;
      1year.&#xD;
&#xD;
      At the beginning of camp, a Dexcom G4 sensor will be inserted into each participating subject&#xD;
      and after the initial calibration, they will be calibrated with blood glucose levels in the&#xD;
      morning and before bed each day as well as when the Dexcom sensor requests a calibration. All&#xD;
      insulin doses and treatment decisions at camp will be based on capillary blood glucose levels&#xD;
      and they will not be based on sensor readings. Each night, 10 of the 20 campers will be&#xD;
      randomly assigned to remote monitoring. The randomization schedule will be computer generated&#xD;
      prior to camp. A hypoglycemia threshold will be set for 70 mg/dl. The Dexcom communicating&#xD;
      with the DiAs will not sound a local alarm, but an alarm will be generated at the remote&#xD;
      monitoring. Medical personnel on call at the remote monitoring station will come to the&#xD;
      camper's cabin and confirmatory capillary blood glucose (CBG) glucose will be obtained. If&#xD;
      the camper is &lt;70 hypoglycemia, treatment will be given (we will not use predictive alarms or&#xD;
      use the rate of change to determine treatment). Treatment will be randomized to mini-glucagon&#xD;
      or standard oral treatment if campers are &lt;70 mg/dl in a 1:1 ratio. All subjects less than 70&#xD;
      mg/dl will then be retested in 15 minutes with a CBG to confirm recovery from hypoglycemia.&#xD;
&#xD;
      If a sensor should fail or be dislodged during camp, it will be replaced. If a sensor needs&#xD;
      to be replaced more than 2 times, a subject may be dropped and a different subject enrolled.&#xD;
&#xD;
      There will be a designed medical staff person who will be monitoring subjects remotely each&#xD;
      night. A second staff person will be available to go to subjects cabins to provide treatment&#xD;
      for hypoglycemia. If a second event should occur at the same time, a third staff person will&#xD;
      be &quot;on call&quot; to attend the second camper.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</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>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of Nocturnal Hypoglycemia</measure>
    <time_frame>8 hours</time_frame>
    <description>Number of minutes with glucose reading &lt; 50 mg/dL. Each camper had Remote Monitoring nights and Control nights.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of Glucose Readings &lt;70 mg/dl</measure>
    <time_frame>8 Hours</time_frame>
    <description>Number of minutes with glucose reading &lt; 70 mg/dL. Each camper had Remote Monitoring nights and Control nights.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Prolonged Episodes of Hypoglycemic Events</measure>
    <time_frame>8 hours at night</time_frame>
    <description>Prolonged hypoglycemia is defined as glucose readings of either &lt;70 mg/dL for greater than one hour on and off the device, &lt;70 mg/dL for greater than 2 hours on and off the device, &lt;50 mg/dL that lasted longer than 30 minutes on and off the device and readings of &lt;50 mg/dL for longer than an hour, again for both the control and the subjects that were remotely monitored with the device. Each camper had Remote Monitoring nights and Control nights.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Type 1 Diabetes</condition>
  <arm_group>
    <arm_group_label>Mini-Glucagon and Remote Monitoring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects glucose data are remotely monitored at night using the University of Virginia (UVA) Diabetes Assistant (DiAs) Android Platform. Study staff intervenes with a fingerstick blood glucose measurement when sensor value falls below 70mg/dL. If fingerstick value is less than 70 mg/dL, hypoglycemic treatment is administered as below.&#xD;
Administer mini-glucagon as treatment for nocturnal hypoglycemia. Administer 0.01 cc per number of years in age via insulin syringe, subcutaneously. This amounts to 1 unit per age, for example: an 8 year old gets 8 &quot;units&quot; glucagon.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Carbohydrates and Remote Monitoring</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects glucose data are remotely monitored at night using the University of Virginia (UVA) Diabetes Assistant (DiAs) Android Platform. Study staff intervenes with a fingerstick blood glucose measurement when sensor value falls below 70mg/dL. If fingerstick value is less than 70 mg/dL, hypoglycemic treatment is administered as below.&#xD;
Administration of carbohydrate per camp protocol to treat nocturnal hypoglycemia. Expected treatment is 15-45g.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Carbohydrates No Remote Monitoring</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects wear a continuous glucose monitor for their own use, but they are not remotely monitored.&#xD;
If hypoglycemia occurs and is acknowledged through standard camp protocol it will be treated with standard camp protocol administration of carbohydrates. Expected treatment is 15g-45g.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mini-Glucagon and No Remote Monitoring</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects wear a continuous glucose monitor for their own use, but they are not remotely monitored.&#xD;
If hypoglycemia occurs and is acknowledged through standard camp protocol it will be treated with mini-glucagon.&#xD;
Administer mini-glucagon as treatment for nocturnal hypoglycemia. Administer 0.01 cc per number of years in age via insulin syringe, subcutaneously. This amounts to 1 unit per age, for example: an 8 year old gets 8 &quot;units&quot; glucagon.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mini-glucagon</intervention_name>
    <description>Mini dose glucagon given for glucose &lt;70 mg/dl at a dose of 1unit/year of age</description>
    <arm_group_label>Mini-Glucagon and No Remote Monitoring</arm_group_label>
    <arm_group_label>Mini-Glucagon and Remote Monitoring</arm_group_label>
    <other_name>glucagon</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Remote monitoring</intervention_name>
    <description>Provides real-time continuous glucose monitoring</description>
    <arm_group_label>Carbohydrates and Remote Monitoring</arm_group_label>
    <arm_group_label>Mini-Glucagon and Remote Monitoring</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Carbohydrates</intervention_name>
    <description>16 grams of carbohydrate</description>
    <arm_group_label>Carbohydrates No Remote Monitoring</arm_group_label>
    <arm_group_label>Carbohydrates and Remote Monitoring</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one&#xD;
             year&#xD;
&#xD;
          -  Age 7-21 years&#xD;
&#xD;
          -  Attendee of Camp De Los Ninos or Conrad Chinnock&#xD;
&#xD;
          -  Come to camp with a consent already signed after having talked to study staff about&#xD;
             the study, or at the onset of the camp meet with study staff and sign the consent&#xD;
             before the first night at camp.&#xD;
&#xD;
          -  Using multiple daily insulin injections (Lantus) or on an insulin pump (any brand)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cystic fibrosis&#xD;
&#xD;
          -  Medications such as current use of oral steroids or other medications, which in the&#xD;
             judgment of the investigator would be a contraindication to participation in the&#xD;
             study.&#xD;
&#xD;
          -  History of adhesive allergies which would interfere with sensor wear.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bruce Buckingham, 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>
  <results_reference>
    <citation>DeSalvo DJ, Keith-Hynes P, Peyser T, Place J, Caswell K, Wilson DM, Harris B, Clinton P, Kovatchev B, Buckingham BA. Remote glucose monitoring in cAMP setting reduces the risk of prolonged nocturnal hypoglycemia. Diabetes Technol Ther. 2014 Jan;16(1):1-7. doi: 10.1089/dia.2013.0139. Epub 2013 Oct 29.</citation>
    <PMID>24168317</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>September 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <results_first_submitted>October 29, 2015</results_first_submitted>
  <results_first_submitted_qc>January 30, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">March 5, 2018</results_first_posted>
  <last_update_submitted>January 30, 2018</last_update_submitted>
  <last_update_submitted_qc>January 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Bruce A. Buckingham</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glucagon</mesh_term>
    <mesh_term>Glucagon-Like Peptide 1</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Potential subjects were recruited from clinic; if more than 20 subjects were interested in participating in a given session, we preferentially enrolled those with a history of nocturnal awareness confirmed within the previous 2 months, (hypoglycemia unawareness confirmed with the Clarke screening test), or A1c &lt;8% needing &gt;0.7 units/kg day insulin.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>All Participants</title>
          <description>The subjects participated in three camps; each camp had approximately 20 subjects. There were two locations, one hosting two sessions. Each camp was approximately 5-6 days in length. Campers wore the device on alternating days, and hypoglycemia was treated with either mini glucagon or carbohydrates.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Participants</title>
          <description>The subjects were enrolled at three camps for diabetes; from each camp approximately 20 subjects were enrolled. There were two locations, one hosting two sessions. Each camp was approximately 5-6 days in length. Campers wore a continuous glucose sensor every day they were in the study. On alternate nights they had remote monitoring, this defined the primary treatment arms: remote monitoring or no remote monitoring. On alternating days of remote monitoring hypoglycemia was treated with either mini glucagon or carbohydrates, this was a secondary randomization.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="57"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="13.9" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>7-11 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-16 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>17-21 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </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="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </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="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Duration of Nocturnal Hypoglycemia</title>
        <description>Number of minutes with glucose reading &lt; 50 mg/dL. Each camper had Remote Monitoring nights and Control nights.</description>
        <time_frame>8 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Remote Monitoring</title>
            <description>Subjects glucose data are remotely monitored at night using the University of Virginia (UVA) Diabetes Assistant (DiAs) Android Platform. Study staff intervenes with a fingerstick blood glucose measurement when sensor value falls below 70mg/dL. If fingerstick value is less than 70 mg/dL, hypoglycemic treatment is administered as below.&#xD;
Administer mini-glucagon as treatment for nocturnal hypoglycemia. Administer 0.01 cc per number of years in age via insulin syringe, subcutaneously. This amounts to 1 unit per age, for example: an 8 year old gets 8 &quot;units&quot; glucagon.&#xD;
Mini-glucagon: Mini dose glucagon given for glucose &lt;70 mg/dl at a dose of 1unit/year of age&#xD;
Remote monitoring: Provides real-time continuous glucose monitoring</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Subjects glucose data are remotely monitored at night using the University of Virginia (UVA) Diabetes Assistant (DiAs) Android Platform. Study staff intervenes with a fingerstick blood glucose measurement when sensor value falls below 70mg/dL. If fingerstick value is less than 70 mg/dL, hypoglycemic treatment is administered as below.&#xD;
Administration of carbohydrate per camp protocol to treat nocturnal hypoglycemia. Expected treatment is 15-45g.&#xD;
Remote monitoring: Provides real-time continuous glucose monitoring&#xD;
Carbohydrates and remote monitoring: 16 grams of carbohydrate with remote monitoring</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Nocturnal Hypoglycemia</title>
          <description>Number of minutes with glucose reading &lt; 50 mg/dL. Each camper had Remote Monitoring nights and Control nights.</description>
          <units>minutes</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <units_analyzed>Hypoglycemic events</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Hypoglycemic events</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5" lower_limit="10" upper_limit="20"/>
                    <measurement group_id="O2" value="15" lower_limit="10" upper_limit="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The study was a feasibility and preliminary safety study. As such, the sample size was not statistically derived and the protocol was not powered to provide for definitive conclusions. The study was limited to 20 participants at each camp session. A hypoglycemic event was defined as at least two consecutive CGM readings (10 mins) below the hypoglycemic threshold of &lt;70 mg/dL. Recovery from a hypoglycemic event required readings above threshold for &gt; or = 25 minutes.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.106</p_value>
            <p_value_desc>In analyzing prolonged events on remote monitoring versus control, we used x squared analysis or Fisher's exact test to analyze data on 2 x 2 contingency tables. Significance was defined as P&lt;0.05.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Glucose Readings &lt;70 mg/dl</title>
        <description>Number of minutes with glucose reading &lt; 70 mg/dL. Each camper had Remote Monitoring nights and Control nights.</description>
        <time_frame>8 Hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Remote Monitoring</title>
            <description>Subjects glucose data are remotely monitored at night using the University of Virginia (UVA) Diabetes Assistant (DiAs) Android Platform. Study staff intervenes with a fingerstick blood glucose measurement when sensor value falls below 70mg/dL. If fingerstick value is less than 70 mg/dL, hypoglycemic treatment is administered as below.&#xD;
Remote monitoring: Provides real-time continuous glucose monitoring</description>
          </group>
          <group group_id="O2">
            <title>Control (no Remote Monitoring)</title>
            <description>Subjects glucose data are remotely monitored at night using the University of Virginia (UVA) Diabetes Assistant (DiAs) Android Platform. Study staff intervenes with a fingerstick blood glucose measurement when sensor value falls below 70mg/dL. If fingerstick value is less than 70 mg/dL, hypoglycemic treatment is administered as below.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Glucose Readings &lt;70 mg/dl</title>
          <description>Number of minutes with glucose reading &lt; 70 mg/dL. Each camper had Remote Monitoring nights and Control nights.</description>
          <units>minutes</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <units_analyzed>Hypoglycemic events</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Hypoglycemic events</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
                <count group_id="O2" value="119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30" lower_limit="20" upper_limit="45"/>
                    <measurement group_id="O2" value="35" lower_limit="25" upper_limit="72.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.078</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Prolonged Episodes of Hypoglycemic Events</title>
        <description>Prolonged hypoglycemia is defined as glucose readings of either &lt;70 mg/dL for greater than one hour on and off the device, &lt;70 mg/dL for greater than 2 hours on and off the device, &lt;50 mg/dL that lasted longer than 30 minutes on and off the device and readings of &lt;50 mg/dL for longer than an hour, again for both the control and the subjects that were remotely monitored with the device. Each camper had Remote Monitoring nights and Control nights.</description>
        <time_frame>8 hours at night</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Remote Monitoring</title>
            <description>Subjects who were on the device during the night (remotely monitored)</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Subjects who were not being remotely monitored (not on the device)</description>
          </group>
        </group_list>
        <measure>
          <title>Prolonged Episodes of Hypoglycemic Events</title>
          <description>Prolonged hypoglycemia is defined as glucose readings of either &lt;70 mg/dL for greater than one hour on and off the device, &lt;70 mg/dL for greater than 2 hours on and off the device, &lt;50 mg/dL that lasted longer than 30 minutes on and off the device and readings of &lt;50 mg/dL for longer than an hour, again for both the control and the subjects that were remotely monitored with the device. Each camper had Remote Monitoring nights and Control nights.</description>
          <units>events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Events &lt;70 mg/dL &gt;1 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Events &lt;70 mg/dL &gt;2hr</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Events &lt;50 mg/dL &gt;30 mins</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Events &lt;50 mg/dL &gt;1hr</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>This is the P value for the number of events &lt;70 mg/dL longer than one hour</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.003</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>This is the p value for the number of events &lt;70 mg/dL that were greater than 2 hours</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.010</p_value>
            <method>Fisher's exact test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>This is the p value for the number of events that were &lt;50 mg/dL for &gt; 30 minutes</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.021</p_value>
            <method>Fisher's exact test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>This is the P value for the number of events &lt;50 mg/dL that were &gt;1 hr</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.077</p_value>
            <method>Fisher's exact</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AE data was collected during the camp study periods (from 5-6 days for each of the 3 camps).</time_frame>
      <desc>Serious hypoglycemic events are recorded as AEs if the event required assistance due to altered consciousness and required another person to actively administer treatment. Hyperglycemic events are AEs if the event involved DKA, polyuria, polydipsia, nausea, vomiting, serum ketones, blood pH &lt;7.3, venous pH &lt;7.24, or serum bicarbonate &lt;15</desc>
      <group_list>
        <group group_id="E1">
          <title>Remote Monitoring</title>
          <description>All participants; during the study, each subject was randomized to either the control or the remote monitoring group, and then alternated on subsequent nights.</description>
        </group>
        <group group_id="E2">
          <title>Control (no Remote Monitoring)</title>
          <description>All participants; during the study, each subject was randomized to either the control or the remote monitoring group, and then alternated on subsequent nights.</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="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
              </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="3" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="57"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>mild erythema from the adhesive</sub_title>
                <description>5% of the campers had mild erythema from the adhesive, and there was no significant edema or induction at the sensor insertion sites.</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="57"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="57"/>
              </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>Limitations revolved around sensor failure. There was one subject removed because of improper use of the device (turning it off at improper times and failing to calibrate as instructed).</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Bruce Buckingham</name_or_title>
      <organization>Stanford University</organization>
      <phone>650-725-6549</phone>
      <email>bbendo@stanford.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/NCT01680653
org study id: 2012PG-T1D001
secondary id: IRB 27428
nct id: NCT01680653
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The incidence of low blood sugar and hypoglycemic seizures at diabetes camp has been reduced
      thanks to overnight blood glucose level testing. The timing of the overnight blood test is
      often arbitrary and it is unclear when the highest frequency of nocturnal hypoglycemic events
      at camp are occurring. It is also unclear what the most appropriate treatment for nocturnal
      hypoglycemia is: simple carbohydrates, or mini-glucagon.

      In this study, we will use Continuous Glucose Monitors (CGMs) that will send subject data
      securely to a remote computer located in the medical cottage at camp throughout the night.
      Study staff will monitor the computer and will intervene on low blood sugar as it occurs in
      real time. On half of the nights, campers will receive mini-glucagon for low blood sugar, and
      on the rest, they will receive standard carbohydrate treatment.
The study will include approximately 20 subjects with Type 1 Diabetes per camp session. 10
      will be linked to remote monitoring with the Diabetes Assistant Computational/Communication
      platform (DIAs), and 10 will wear the Dexcom CGM with the same threshold alarm setting as
      those wearing the DiAs (70 mg/dl), but without remote monitoring.

      Study participants will be between the ages of 7-21 with type 1 diabetes. This would allow
      for a counselor in training or a young counselor with a history of recent nocturnal
      hypoglycemia to be included. It is these late adolescents and young adults who often have the
      most severe hypoglycemic events during a camp session. We will preferentially recruit campers
      into the study who: 1) have a history of nocturnal hypoglycemia requiring treatment within
      the last 2 months, 2) have hypoglycemia unawareness confirmed with the Clark screening test,
      3) have an A1c of <8% while requiring >0.7 units/kg/day of insulin and diabetes duration of >
      1year.

      At the beginning of camp, a Dexcom G4 sensor will be inserted into each participating subject
      and after the initial calibration, they will be calibrated with blood glucose levels in the
      morning and before bed each day as well as when the Dexcom sensor requests a calibration. All
      insulin doses and treatment decisions at camp will be based on capillary blood glucose levels
      and they will not be based on sensor readings. Each night, 10 of the 20 campers will be
      randomly assigned to remote monitoring. The randomization schedule will be computer generated
      prior to camp. A hypoglycemia threshold will be set for 70 mg/dl. The Dexcom communicating
      with the DiAs will not sound a local alarm, but an alarm will be generated at the remote
      monitoring. Medical personnel on call at the remote monitoring station will come to the
      camper's cabin and confirmatory capillary blood glucose (CBG) glucose will be obtained. If
      the camper is <70 hypoglycemia, treatment will be given (we will not use predictive alarms or
      use the rate of change to determine treatment). Treatment will be randomized to mini-glucagon
      or standard oral treatment if campers are <70 mg/dl in a 1:1 ratio. All subjects less than 70
      mg/dl will then be retested in 15 minutes with a CBG to confirm recovery from hypoglycemia.

      If a sensor should fail or be dislodged during camp, it will be replaced. If a sensor needs
      to be replaced more than 2 times, a subject may be dropped and a different subject enrolled.

      There will be a designed medical staff person who will be monitoring subjects remotely each
      night. A second staff person will be available to go to subjects cabins to provide treatment
      for hypoglycemia. If a second event should occur at the same time, a third staff person will
      be "on call" to attend the second camper.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Duration of Nocturnal Hypoglycemia
time frame: 8 hours
description: Number of minutes with glucose reading < 50 mg/dL. Each camper had Remote Monitoring nights and Control nights.
measure: Duration of Glucose Readings <70 mg/dl
time frame: 8 Hours
description: Number of minutes with glucose reading < 70 mg/dL. Each camper had Remote Monitoring nights and Control nights.
measure: Prolonged Episodes of Hypoglycemic Events
time frame: 8 hours at night
description: Prolonged hypoglycemia is defined as glucose readings of either <70 mg/dL for greater than one hour on and off the device, <70 mg/dL for greater than 2 hours on and off the device, <50 mg/dL that lasted longer than 30 minutes on and off the device and readings of <50 mg/dL for longer than an hour, again for both the control and the subjects that were remotely monitored with the device. Each camper had Remote Monitoring nights and Control nights.
arm group label: Mini-Glucagon and Remote Monitoring
arm group type: Experimental
description: Subjects glucose data are remotely monitored at night using the University of Virginia (UVA) Diabetes Assistant (DiAs) Android Platform. Study staff intervenes with a fingerstick blood glucose measurement when sensor value falls below 70mg/dL. If fingerstick value is less than 70 mg/dL, hypoglycemic treatment is administered as below.
Administer mini-glucagon as treatment for nocturnal hypoglycemia. Administer 0.01 cc per number of years in age via insulin syringe, subcutaneously. This amounts to 1 unit per age, for example: an 8 year old gets 8 "units" glucagon.
arm group label: Carbohydrates and Remote Monitoring
arm group type: Other
description: Subjects glucose data are remotely monitored at night using the University of Virginia (UVA) Diabetes Assistant (DiAs) Android Platform. Study staff intervenes with a fingerstick blood glucose measurement when sensor value falls below 70mg/dL. If fingerstick value is less than 70 mg/dL, hypoglycemic treatment is administered as below.
Administration of carbohydrate per camp protocol to treat nocturnal hypoglycemia. Expected treatment is 15-45g.
arm group label: Carbohydrates No Remote Monitoring
arm group type: Other
description: Subjects wear a continuous glucose monitor for their own use, but they are not remotely monitored.
If hypoglycemia occurs and is acknowledged through standard camp protocol it will be treated with standard camp protocol administration of carbohydrates. Expected treatment is 15g-45g.
arm group label: Mini-Glucagon and No Remote Monitoring
arm group type: Other
description: Subjects wear a continuous glucose monitor for their own use, but they are not remotely monitored.
If hypoglycemia occurs and is acknowledged through standard camp protocol it will be treated with mini-glucagon.
Administer mini-glucagon as treatment for nocturnal hypoglycemia. Administer 0.01 cc per number of years in age via insulin syringe, subcutaneously. This amounts to 1 unit per age, for example: an 8 year old gets 8 "units" glucagon.
intervention type: Drug
intervention name: Mini-glucagon
description: Mini dose glucagon given for glucose <70 mg/dl at a dose of 1unit/year of age
arm group label: Mini-Glucagon and No Remote Monitoring
arm group label: Mini-Glucagon and Remote Monitoring
other name: glucagon
intervention type: Device
intervention name: Remote monitoring
description: Provides real-time continuous glucose monitoring
arm group label: Carbohydrates and Remote Monitoring
arm group label: Mini-Glucagon and Remote Monitoring
intervention type: Dietary Supplement
intervention name: Carbohydrates
description: 16 grams of carbohydrate
arm group label: Carbohydrates No Remote Monitoring
arm group label: Carbohydrates and Remote Monitoring
criteria: 
gender: All
minimum age: 7 Years
maximum age: 21 Years
healthy volunteers: No
last name: Bruce Buckingham, MD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
citation: DeSalvo DJ, Keith-Hynes P, Peyser T, Place J, Caswell K, Wilson DM, Harris B, Clinton P, Kovatchev B, Buckingham BA. Remote glucose monitoring in cAMP setting reduces the risk of prolonged nocturnal hypoglycemia. Diabetes Technol Ther. 2014 Jan;16(1):1-7. doi: 10.1089/dia.2013.0139. Epub 2013 Oct 29.
PMID: 24168317
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Bruce A. Buckingham
investigator title: Principle Investigator
mesh term: Diabetes Mellitus
mesh term: Glucagon
mesh term: Glucagon-Like Peptide 1
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Limitations revolved around sensor failure. There was one subject removed because of improper use of the device (turning it off at improper times and failing to calibrate as instructed).
point of contact: 