<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/NCT01693302</url>
  </required_header>
  <id_info>
    <org_study_id>06-0994</org_study_id>
    <nct_id>NCT01693302</nct_id>
  </id_info>
  <brief_title>Timing of Meal Insulin Boluses for Optimal Postprandial Glycemic Control in Type 1 Diabetes</brief_title>
  <official_title>Timing of Meal Insulin Boluses to Achieve Optimal Postprandial Glycemic Control in Patients With Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Blood glucose levels in patients with type 1 diabetes tend to peak after eating a meal due to&#xD;
      the delayed action of insulin when compared to carbohydrate absorption from food. It is the&#xD;
      hypothesis of the investigator that administering the insulin for a meal 20 minutes before&#xD;
      the meal will result in lower blood glucose peaks compared to administration of insulin&#xD;
      immediately before or 20 minutes after starting to eat.&#xD;
&#xD;
      All subjects will eat the same meal on three different occasions. Insulin will be&#xD;
      administered at one of the three times at each visit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects enrolled in this study will be between the ages of 12 and 30 years inclusive. All&#xD;
      subjects will be on an insulin pump and use carbohydrate counting as their method for insulin&#xD;
      dosing at a meal.&#xD;
&#xD;
      Subjects in this study will complete three study visits lasting from approximately 8:30am&#xD;
      until 1:30pm. At each visit, the subject will eat the same frozen breakfast meal. Subjects&#xD;
      will be supplied with the same insulin to maintain consistency between visits and between&#xD;
      subjects.&#xD;
&#xD;
      Insulin will be administered at different times, depending upon the randomization group&#xD;
      assigned to the participant. The three different times the insulin will be given is either 20&#xD;
      minutes before the meal, immediately before the meal and 20 minutes after the meal. All&#xD;
      subjects will complete all three insulin bolus times. Blood glucose will be measured by&#xD;
      fingerstick every 30 minutes until the completion of the visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2007</start_date>
  <completion_date type="Actual">May 2009</completion_date>
  <primary_completion_date type="Actual">May 2009</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood glucose area under the curve</measure>
    <time_frame>9:00am until 1:30pm</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glucose values one hour after the meal</measure>
    <time_frame>10:30am</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose values two hours after the beginning of the meal</measure>
    <time_frame>11:30am</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Type 1 Diabetes</condition>
  <arm_group>
    <arm_group_label>-20 minute insulin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Insulin for the meal is given 20 minutes prior to starting the meal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0 minute insulin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Insulin for the meal is given immediately before starting to eat.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>+20 minute insulin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Insulin is given 20 minutes after the start of the meal.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Insulin</intervention_name>
    <description>The timing of insulin delivery varies with each study visit. The dose is given based on carbohydrate content and blood glucose level. The insulin is given either 20 minutes before the meal, immediately before the meal, or 20 minutes after the meal.</description>
    <arm_group_label>+20 minute insulin</arm_group_label>
    <arm_group_label>-20 minute insulin</arm_group_label>
    <arm_group_label>0 minute insulin</arm_group_label>
    <other_name>Insulin time</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  12 to 30 years of age, inclusive&#xD;
&#xD;
          -  Clinical diagnosis of T1D and using daily insulin therapy for at least 1 year&#xD;
&#xD;
          -  Using carbohydrate counting to dose meal time insulin&#xD;
&#xD;
          -  HbA1c value upon enrollment greater than 6.0% and less than 12.0%&#xD;
&#xD;
          -  Using CSII therapy for diabetes management for at least three months&#xD;
&#xD;
          -  Able and willing to give informed consent/assent to participate&#xD;
&#xD;
          -  No expectation that the subject will be moving out of the area of the clinical center&#xD;
             during the study&#xD;
&#xD;
          -  Willing to consume the same standard frozen meal on all three visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The presence of a significant medical disorder that in the judgment of the&#xD;
             investigator will affect the wearing of the CGMS sensors or the completion of any&#xD;
             aspect of the protocol&#xD;
&#xD;
          -  Being unable or unwilling to give informed consent&#xD;
&#xD;
          -  Having documented hypoglycemia unawareness&#xD;
&#xD;
          -  An episode of severe hypoglycemia (seizure or loss of consciousness) or of&#xD;
             ketoacidosis in the past six months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Chase, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Barbara Davis Center</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 9, 2009</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>September 21, 2012</last_update_submitted>
  <last_update_submitted_qc>September 21, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Blood Glucose</keyword>
  <keyword>Meal insulin</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin</mesh_term>
    <mesh_term>Insulin, Globin Zinc</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01693302
org study id: 06-0994
nct id: NCT01693302
lead sponsor: 
collaborator: 
has dmc: No
Blood glucose levels in patients with type 1 diabetes tend to peak after eating a meal due to
      the delayed action of insulin when compared to carbohydrate absorption from food. It is the
      hypothesis of the investigator that administering the insulin for a meal 20 minutes before
      the meal will result in lower blood glucose peaks compared to administration of insulin
      immediately before or 20 minutes after starting to eat.

      All subjects will eat the same meal on three different occasions. Insulin will be
      administered at one of the three times at each visit.
Subjects enrolled in this study will be between the ages of 12 and 30 years inclusive. All
      subjects will be on an insulin pump and use carbohydrate counting as their method for insulin
      dosing at a meal.

      Subjects in this study will complete three study visits lasting from approximately 8:30am
      until 1:30pm. At each visit, the subject will eat the same frozen breakfast meal. Subjects
      will be supplied with the same insulin to maintain consistency between visits and between
      subjects.

      Insulin will be administered at different times, depending upon the randomization group
      assigned to the participant. The three different times the insulin will be given is either 20
      minutes before the meal, immediately before the meal and 20 minutes after the meal. All
      subjects will complete all three insulin bolus times. Blood glucose will be measured by
      fingerstick every 30 minutes until the completion of the visit.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Blood glucose area under the curve
time frame: 9:00am until 1:30pm
measure: Glucose values one hour after the meal
time frame: 10:30am
measure: Glucose values two hours after the beginning of the meal
time frame: 11:30am
arm group label: -20 minute insulin
arm group type: Experimental
description: Insulin for the meal is given 20 minutes prior to starting the meal.
arm group label: 0 minute insulin
arm group type: Experimental
description: Insulin for the meal is given immediately before starting to eat.
arm group label: +20 minute insulin
arm group type: Experimental
description: Insulin is given 20 minutes after the start of the meal.
intervention type: Other
intervention name: Insulin
description: The timing of insulin delivery varies with each study visit. The dose is given based on carbohydrate content and blood glucose level. The insulin is given either 20 minutes before the meal, immediately before the meal, or 20 minutes after the meal.
arm group label: +20 minute insulin
arm group label: -20 minute insulin
arm group label: 0 minute insulin
other name: Insulin time
criteria: 
gender: All
minimum age: 12 Years
maximum age: 30 Years
healthy volunteers: No
last name: Peter Chase, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Insulin
mesh term: Insulin, Globin Zinc