<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/NCT02218268</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201400553</org_study_id>
    <secondary_id>00093792</secondary_id>
    <nct_id>NCT02218268</nct_id>
  </id_info>
  <brief_title>Arterial Stiffness in Type I Diabetes Mellitus</brief_title>
  <official_title>Acute Effect of a Mixed Meal With and Without Extra Insulin on Arterial Stiffness, a Prospective Randomized Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Diabetes Action Research and Education Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Using radial artery tonometry to study arterial stiffness, the plan is to study a cohort of&#xD;
      65 children with Type I diabetes mellitus. This prospective, crossover study will help&#xD;
      determine if there is an acute increase in arterial stiffness in children with Type I&#xD;
      diabetes mellitus who do not give extra insulin to cover a meal. This will give more support&#xD;
      to show why it is so critical to bolus every time they eat and to bolus on time to decrease&#xD;
      cardiovascular consequences of poorly controlled diabetes. The hypothesis is that giving&#xD;
      insulin before a meal compared to not giving insulin before a meal will be associated with&#xD;
      lower arterial stiffness in children with type I diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The subject will fast overnight (nothing to eat or drink for at least 8 hours). The subject&#xD;
      will be asked to drink a mixed meal replacement drink (Boost) and will be randomized (like&#xD;
      flipping a coin) to bolus insulin for the &quot;meal&quot; or to not bolus insulin using their standard&#xD;
      insulin dose. Glucose will be monitored with a finger prick before they drink the meal&#xD;
      replacement, 1 hour later and finally 2 hours after drinking the meal replacement.&#xD;
&#xD;
      Stiffness of the blood vessel of the wrist will be determined using radial tonometry. Radial&#xD;
      tonometry is safe and does not hurt. A pen like probe is placed on the blood vessel of the&#xD;
      wrist. When the machine reads a good wave form the computer will calculate the stiffness of&#xD;
      the blood vessel. This test will be done along with the glucose checks; before drinking the&#xD;
      meal replacement drink, and 1 and 2 hours after drinking the meal replacement drink.&#xD;
&#xD;
      During the next study visit, the subject will repeat the exact same study described above.&#xD;
      However, this time they will receive the other insulin assignment they were assigned during&#xD;
      the first study (either bolus or no bolus).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Determine the Difference Between Acute Effect of a Mixed Meal on Radial Artery Stiffness in Subjects With Type I Diabetes Mellitus Who do and Who do Not Take an Additional Bolus of Insulin.</measure>
    <time_frame>From baseline to one hour then 2 hours</time_frame>
    <description>Determine the difference between acute effect of a mixed meal on radial artery stiffness in subjects with type I diabetes mellitus who do and who do not take an additional bolus of insulin. Radial tonometry is used to calculate the augmentation index (AI). AI is expressed as a percentage of the pulse pressure and represents the difference between the first and second peaks of the central arterial waveform. The stiffer the artery the more positive elevation of the AI and the machine will indicate stiffness using a color indicator (green less stiff and red being stiff). AI is measured using the SphygmoCor VX version 7.01 (AtCor Medical, Syndey, Australia). AI will be corrected to a heart rate of 75 to eliminate differences related to heart rate variation.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Arterial Stiffness in Youth With Type 1 Diabetes</condition>
  <arm_group>
    <arm_group_label>Pre-meal bolus then No meal bolus</arm_group_label>
    <description>A meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.&#xD;
Then 3 months later A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No meal bolus then Pre-meal bolus</arm_group_label>
    <description>A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.&#xD;
Then 3 months later meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pre-meal bolus</intervention_name>
    <description>Long acting insulin as scheduled per usual routine PLUS rapid/ short acting (bolus) prior to Boost</description>
    <arm_group_label>No meal bolus then Pre-meal bolus</arm_group_label>
    <arm_group_label>Pre-meal bolus then No meal bolus</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>No meal bolus</intervention_name>
    <description>Long Acting insulin as scheduled per usual routine (given once daily)</description>
    <arm_group_label>No meal bolus then Pre-meal bolus</arm_group_label>
    <arm_group_label>Pre-meal bolus then No meal bolus</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        University of Florida diabetes clinic and the Florida Camp for Children and Youth with&#xD;
        Diabetes. Subjects had type 1 diabetes for at least one year, were using a basal-bolus&#xD;
        insulin regimen, and were not taking oral hypoglycemic agents or antihypertensive drugs.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 1 diabetes based on clinical history&#xD;
&#xD;
          -  Basal-bolus insulin regimen&#xD;
&#xD;
          -  Duration of diabetes greater than 1 year&#xD;
&#xD;
          -  Blood glucose 65-200 mg/dL fasting&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of metformin or any other hypoglycemic agents besides insulin&#xD;
&#xD;
          -  Use of anti-hypertensives&#xD;
&#xD;
          -  Caffeine or smoking within the past 24 hours&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Haller, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <results_first_submitted>August 4, 2016</results_first_submitted>
  <results_first_submitted_qc>December 12, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 6, 2017</results_first_posted>
  <last_update_submitted>December 12, 2016</last_update_submitted>
  <last_update_submitted_qc>December 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>type I diabetes</keyword>
  <keyword>healthy</keyword>
  <keyword>children</keyword>
  <keyword>adolescents</keyword>
  <keyword>young adults</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Pre-meal Bolus Then No Meal Bolus</title>
          <description>A meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.&#xD;
Then 3 months later A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.</description>
        </group>
        <group group_id="P2">
          <title>No Meal Bolus Then Pre-meal Bolus</title>
          <description>A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.&#xD;
Then 3 months later meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Phase (2 Hours)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>24 Hour Washout</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Final Phase (2 Hours)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Participants</title>
          <description>This is a crossover study of youth with Diabetes on a stable basal bolus insulin regimen. They will be randomized either receive a pre-meal insulin bolus in conjunction with their Basal insulin bolus or receive their standard of care basal insulin bolus only. A mixed meal replacement (Boost) will be consumed. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring. This is a crossover study and all participants will take place in this arm after 3 months of their visit.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="60"/>
          </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="12.5" spread="2.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</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="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </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="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HbA1c</title>
          <units>percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.86" spread="0.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Determine the Difference Between Acute Effect of a Mixed Meal on Radial Artery Stiffness in Subjects With Type I Diabetes Mellitus Who do and Who do Not Take an Additional Bolus of Insulin.</title>
        <description>Determine the difference between acute effect of a mixed meal on radial artery stiffness in subjects with type I diabetes mellitus who do and who do not take an additional bolus of insulin. Radial tonometry is used to calculate the augmentation index (AI). AI is expressed as a percentage of the pulse pressure and represents the difference between the first and second peaks of the central arterial waveform. The stiffer the artery the more positive elevation of the AI and the machine will indicate stiffness using a color indicator (green less stiff and red being stiff). AI is measured using the SphygmoCor VX version 7.01 (AtCor Medical, Syndey, Australia). AI will be corrected to a heart rate of 75 to eliminate differences related to heart rate variation.</description>
        <time_frame>From baseline to one hour then 2 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pre-meal Bolus Then No Meal Bolus</title>
            <description>A meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.&#xD;
Then 3 months later A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.</description>
          </group>
          <group group_id="O2">
            <title>No Meal Bolus Then Pre-meal Bolus</title>
            <description>A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.&#xD;
Then 3 months later meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.</description>
          </group>
        </group_list>
        <measure>
          <title>Determine the Difference Between Acute Effect of a Mixed Meal on Radial Artery Stiffness in Subjects With Type I Diabetes Mellitus Who do and Who do Not Take an Additional Bolus of Insulin.</title>
          <description>Determine the difference between acute effect of a mixed meal on radial artery stiffness in subjects with type I diabetes mellitus who do and who do not take an additional bolus of insulin. Radial tonometry is used to calculate the augmentation index (AI). AI is expressed as a percentage of the pulse pressure and represents the difference between the first and second peaks of the central arterial waveform. The stiffer the artery the more positive elevation of the AI and the machine will indicate stiffness using a color indicator (green less stiff and red being stiff). AI is measured using the SphygmoCor VX version 7.01 (AtCor Medical, Syndey, Australia). AI will be corrected to a heart rate of 75 to eliminate differences related to heart rate variation.</description>
          <units>Percent of Pulse Pressure</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Difference of mean AI75 1 hour after</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.5" lower_limit="-7.97" upper_limit="-1.1"/>
                    <measurement group_id="O2" value="-4.5" lower_limit="-7.97" upper_limit="-1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Difference of mean AI75 2 hours after</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.3" lower_limit="-8.9" upper_limit="0.2"/>
                    <measurement group_id="O2" value="-4.3" lower_limit="-8.9" upper_limit="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Pre-meal Bolus Then No Meal Bolus</title>
          <description>A meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring. This is a crossover study and all participants will take place in this arm after 3 months of their visit.</description>
        </group>
        <group group_id="E2">
          <title>No Meal Bolus Then Pre-meal Bolus</title>
          <description>A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring, This is a crossover study and all participants will take place in this arm after 3 months of their visit.</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="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </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="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </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>
    <point_of_contact>
      <name_or_title>Michael Haller</name_or_title>
      <organization>University of Florida</organization>
      <phone>352-265-0111</phone>
      <email>hallemj@peds.ufl.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/NCT02218268
org study id: IRB201400553
secondary id: 00093792
nct id: NCT02218268
lead sponsor: 
collaborator: 
has dmc: No
Using radial artery tonometry to study arterial stiffness, the plan is to study a cohort of
      65 children with Type I diabetes mellitus. This prospective, crossover study will help
      determine if there is an acute increase in arterial stiffness in children with Type I
      diabetes mellitus who do not give extra insulin to cover a meal. This will give more support
      to show why it is so critical to bolus every time they eat and to bolus on time to decrease
      cardiovascular consequences of poorly controlled diabetes. The hypothesis is that giving
      insulin before a meal compared to not giving insulin before a meal will be associated with
      lower arterial stiffness in children with type I diabetes.
The subject will fast overnight (nothing to eat or drink for at least 8 hours). The subject
      will be asked to drink a mixed meal replacement drink (Boost) and will be randomized (like
      flipping a coin) to bolus insulin for the "meal" or to not bolus insulin using their standard
      insulin dose. Glucose will be monitored with a finger prick before they drink the meal
      replacement, 1 hour later and finally 2 hours after drinking the meal replacement.

      Stiffness of the blood vessel of the wrist will be determined using radial tonometry. Radial
      tonometry is safe and does not hurt. A pen like probe is placed on the blood vessel of the
      wrist. When the machine reads a good wave form the computer will calculate the stiffness of
      the blood vessel. This test will be done along with the glucose checks; before drinking the
      meal replacement drink, and 1 and 2 hours after drinking the meal replacement drink.

      During the next study visit, the subject will repeat the exact same study described above.
      However, this time they will receive the other insulin assignment they were assigned during
      the first study (either bolus or no bolus).
observational model: Cohort
time perspective: Prospective
measure: Determine the Difference Between Acute Effect of a Mixed Meal on Radial Artery Stiffness in Subjects With Type I Diabetes Mellitus Who do and Who do Not Take an Additional Bolus of Insulin.
time frame: From baseline to one hour then 2 hours
description: Determine the difference between acute effect of a mixed meal on radial artery stiffness in subjects with type I diabetes mellitus who do and who do not take an additional bolus of insulin. Radial tonometry is used to calculate the augmentation index (AI). AI is expressed as a percentage of the pulse pressure and represents the difference between the first and second peaks of the central arterial waveform. The stiffer the artery the more positive elevation of the AI and the machine will indicate stiffness using a color indicator (green less stiff and red being stiff). AI is measured using the SphygmoCor VX version 7.01 (AtCor Medical, Syndey, Australia). AI will be corrected to a heart rate of 75 to eliminate differences related to heart rate variation.
arm group label: Pre-meal bolus then No meal bolus
description: A meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.
Then 3 months later A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring
arm group label: No meal bolus then Pre-meal bolus
description: A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.
Then 3 months later meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring
intervention type: Drug
intervention name: Pre-meal bolus
description: Long acting insulin as scheduled per usual routine PLUS rapid/ short acting (bolus) prior to Boost
arm group label: No meal bolus then Pre-meal bolus
arm group label: Pre-meal bolus then No meal bolus
intervention type: Drug
intervention name: No meal bolus
description: Long Acting insulin as scheduled per usual routine (given once daily)
arm group label: No meal bolus then Pre-meal bolus
arm group label: Pre-meal bolus then No meal bolus
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 8 Years
maximum age: 21 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Haller, MD
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 