<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/NCT02190669</url>
  </required_header>
  <id_info>
    <org_study_id>08-67</org_study_id>
    <nct_id>NCT02190669</nct_id>
  </id_info>
  <brief_title>Exercise and Diabetes - an Observational Study of Exercise and Blood Glucose Control</brief_title>
  <official_title>Exercise and Diabetes - an Observational Study of Exercise and Blood Glucose Control</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sansum Diabetes Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sansum Diabetes Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This proposal seeks to gather continuous blood glucose and physical activity data from&#xD;
      individuals with and without diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This proposal seeks to gather continuous blood glucose and physical activity data from&#xD;
      individuals with and without diabetes who are physically active and exercising for health&#xD;
      benefits. The investigators hypothesize that insulin requirements will be inversely related&#xD;
      to intensity of activity and an algorithm will be able to detect physical activity and&#xD;
      automatically adjust insulin doses. Once such an algorithm has been determined for an&#xD;
      individual, it can be applied to future similar situations, but ideally the algorithm will be&#xD;
      dynamically refined based on closed-loop feedback information.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</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>Document the glycemic response of individuals without diabetes and with type 1 or type 2 diabetes</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">12</enrollment>
  <condition>Type 1 Diabetes</condition>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>exercise in individuals without diabetes</arm_group_label>
    <description>exercise in individuals without diabetes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>exercise in type 1 diabetes</arm_group_label>
    <description>exercise in type 1 diabetes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>exercise in type 2 diabetes</arm_group_label>
    <description>exercise in type 2 diabetes</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>exercise</intervention_name>
    <description>Sprinting, walking on a treadmill, and stationary bicycle riding</description>
    <arm_group_label>exercise in individuals without diabetes</arm_group_label>
    <arm_group_label>exercise in type 1 diabetes</arm_group_label>
    <arm_group_label>exercise in type 2 diabetes</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        individuals without diabetes and those with type 1 and type 2 diabetes&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion criteria for subjects with diabetes&#xD;
&#xD;
          -  Type 1 diabetes or insulin requiring type 2 diabetes for at least 1 year&#xD;
&#xD;
          -  Use insulin to control diabetes&#xD;
&#xD;
          -  Physically active (regularly work out, swim, run, walk, bike, etc.)&#xD;
&#xD;
          -  Free of major micro- and macrovascular complications of diabetes&#xD;
&#xD;
          -  18-75 years of age&#xD;
&#xD;
          -  A1C &lt; 9.0% Inclusion criteria for subjects without diabetes&#xD;
&#xD;
          -  No evidence of diabetes and physically active&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unwilling to perform repeated glucose checks or take insulin as instructed&#xD;
&#xD;
          -  abnormal thyroid function, kidney function, liver function&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristin Castorino, D.O.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sansum Diabetes Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sansum Diabetes Research Institute</name>
      <address>
        <city>Santa Barbara</city>
        <state>California</state>
        <zip>93105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>November 12, 2014</last_update_submitted>
  <last_update_submitted_qc>November 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 13, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_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/NCT02190669
org study id: 08-67
nct id: NCT02190669
lead sponsor: 
has dmc: No
This proposal seeks to gather continuous blood glucose and physical activity data from
      individuals with and without diabetes.
This proposal seeks to gather continuous blood glucose and physical activity data from
      individuals with and without diabetes who are physically active and exercising for health
      benefits. The investigators hypothesize that insulin requirements will be inversely related
      to intensity of activity and an algorithm will be able to detect physical activity and
      automatically adjust insulin doses. Once such an algorithm has been determined for an
      individual, it can be applied to future similar situations, but ideally the algorithm will be
      dynamically refined based on closed-loop feedback information.
observational model: Cohort
time perspective: Prospective
measure: Document the glycemic response of individuals without diabetes and with type 1 or type 2 diabetes
time frame: 7 days
arm group label: exercise in individuals without diabetes
description: exercise in individuals without diabetes
arm group label: exercise in type 1 diabetes
description: exercise in type 1 diabetes
arm group label: exercise in type 2 diabetes
description: exercise in type 2 diabetes
intervention type: Other
intervention name: exercise
description: Sprinting, walking on a treadmill, and stationary bicycle riding
arm group label: exercise in individuals without diabetes
arm group label: exercise in type 1 diabetes
arm group label: exercise in type 2 diabetes
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kristin Castorino, D.O.
role: Principal Investigator
affiliation: Sansum Diabetes Research Institute
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus