<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/NCT03034798</url>
  </required_header>
  <id_info>
    <org_study_id>1DP3DK101075</org_study_id>
    <nct_id>NCT03034798</nct_id>
  </id_info>
  <brief_title>Suspending Basal Insulin Levels for Exercise in Adults With Type 1 Diabetes</brief_title>
  <official_title>The Effects of Basal Insulin Suspension at the Start of Exercise on Blood Glucose Levels During Continuous vs. Circuit-based Exercise in Individuals With Type 1 Diabetes on CSII</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>York University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Illinois Institute of Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>York University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to determine the effects of insulin suspension at start of&#xD;
      exercise in individuals with type 1 diabetes. A total of 3 sessions will be required for this&#xD;
      project. The first will be a familiarization session that requires completed informed&#xD;
      consent, anthropometric measurements (height, weight, body fat percentage), questionnaires,&#xD;
      and a test of maximal aerobic fitness. The remaining 2 sessions will be steady-state aerobic&#xD;
      exercise as well as circuit exercise.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Written informed consent will be collected on the first day during the familiarization&#xD;
      session from all individuals that wish to participate. A researcher will provide a brief&#xD;
      explanation on how the continuous glucose monitor (CGM) works (Medtronic Inc., Canada) during&#xD;
      the first visit to the laboratory. They will also describe how the CGM sensor insertion&#xD;
      process will occur for those participants who have not worn one in the past. The participant&#xD;
      will clean and sanitize the area and insert the CGM superficially in the skin themselves and&#xD;
      connect the transmitter device to the sensor. The CGM will be worn for a total of 7 days and&#xD;
      then removed by the participant and returned to the researcher to be downloaded. The sports&#xD;
      armband will also be placed on the left upper arm and be worn continuously for 7 days. The&#xD;
      principal student investigator (PSI) or principal investigator (PI) will provide all&#xD;
      participants with information about the sports armband and place it on the skin immediately&#xD;
      following. This device simply sits on the surface of the skin, but has a specific placement&#xD;
      and activation and must be applied by the PSI or PI. Finally, during exercise visits, the&#xD;
      Zephyr bioharness will be connected just below chest level and around the rib cage. This&#xD;
      device is sits on top of the skin simply like an elastic band around the rib cage. The&#xD;
      bioharness will only be worn during exercise visits and disconnected at the end of each&#xD;
      activity.&#xD;
&#xD;
      Blood glucose levels will be monitored frequently during exercise using a Contour Link&#xD;
      glucometer (Bayer, Canada). Participants will use personal lancing device for finger pokes,&#xD;
      but the investigators will provide the glucometer and test strips. Each blood sugar check&#xD;
      will be recorded in the data binder along with carbohydrate intake, any changes in basal rate&#xD;
      or pump settings, and food intake. If blood glucose levels reach 3.9 mmol/L or less,&#xD;
      participants will be asked to stop activity immediately and consume fast-acting carbohydrates&#xD;
      (i.e. Dextrose tablets (Dex4, USA)). 15-minutes after ingestion of carbohydrates, blood&#xD;
      glucose will be tested again before allowing the individual to return to activity safely. On&#xD;
      the last day of testing, participants will be asked to return the CGM, sports armband, and&#xD;
      bioharness to the research team. The data will later be uploaded and analyzed.&#xD;
&#xD;
      Patients will undergo a fitness assessment (maximal aerobic capacity) during visit 1 and&#xD;
      perform 40-minutes of continuous (treadmill jogging) and 40-minutes of intermittent&#xD;
      (calisthenics) high-intensity type exercises (visit 2 and 3). Upon entry to the laboratory,&#xD;
      participants will be asked to check blood glucose levels using the glucometer provided. The&#xD;
      first exercise session will consist of a 40-minute treadmill walk/jog at ~40-50% of VO2max.&#xD;
      The second exercise session will include various aerobic and anaerobic activities including&#xD;
      push-ups, plank, jumping jacks, high knees, etc. Regular finger capillary blood samples will&#xD;
      be collected every 10-minutes during exercise. Once the exercise session is complete,&#xD;
      participants will be asked to remain in the laboratory for 30-minutes for additional blood&#xD;
      glucose measurements and to ensure hypoglycemic episodes do not occur post-exercise.&#xD;
      Participants will be given the contour link glucometer to monitor glucose levels throughout&#xD;
      the evening and night.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 14, 2015</start_date>
  <completion_date type="Actual">July 28, 2016</completion_date>
  <primary_completion_date type="Actual">July 28, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Blood glucose concentrations</measure>
    <time_frame>Approximately 2 hours</time_frame>
    <description>Whole blood glucose concentrations were measured using a handheld glucometer every 10-minutes before, during, and after both exercise conditions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Participants estimated blood glucose concentration</measure>
    <time_frame>40-minutes during exercise and 10-minutes post-exercise</time_frame>
    <description>Whole blood glucose concentrations were measured using a handheld glucometer and the values were blinded from participants during exercise. Participants were asked to estimate the change in glycemia every 10-minutes and actual measured blood glucose was revealed to participants post-exercise.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">12</enrollment>
  <condition>Type1 Diabetes Mellitus</condition>
  <condition>Physical Activity</condition>
  <condition>Hypoglycemia</condition>
  <arm_group>
    <arm_group_label>Type 1 Diabetes Exercisers</arm_group_label>
    <description>Participants performed 2 different forms of exercise of identical duration and similar total energy expenditure. One form was purely aerobic in nature and the other was intermittent, high-intensity exercise.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Participants were recruited by random sampling as well as an email blast using previous&#xD;
        studies that involved individuals with type 1 diabetes on insulin pump therapy and&#xD;
        regularly active. The previous research project at York University had the same inclusion&#xD;
        criteria, so that email list will be used to contact those individuals for this study as&#xD;
        well.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have had diabetes for &gt; 1 year&#xD;
&#xD;
          -  Currently treated with continuous subcutaneous insulin infusion (CSII)/insulin pump&#xD;
             therapy for at least 6 months&#xD;
&#xD;
          -  Fair-to-good glycemic control (last HbA1c ≤ 9.0%)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Frequent and unpredictable hypoglycemia&#xD;
&#xD;
          -  Unable to exercise on a regular basis due to an injury or other restriction&#xD;
&#xD;
          -  Using an insulin pump and switch to injections (or vice versa) in the last two months&#xD;
&#xD;
          -  Have conditions that would make exercise unsafe (e.g. high blood pressure)&#xD;
&#xD;
          -  Take medications in the class of drugs called 'beta-blockers'&#xD;
&#xD;
          -  A woman who is pregnant, planning pregnancy, or breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael C Riddell, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>York University</affiliation>
  </overall_official>
  <results_reference>
    <citation>Iscoe KE, Riddell MC. Continuous moderate-intensity exercise with or without intermittent high-intensity work: effects on acute and late glycaemia in athletes with Type 1 diabetes mellitus. Diabet Med. 2011 Jul;28(7):824-32. doi: 10.1111/j.1464-5491.2011.03274.x.</citation>
    <PMID>21388440</PMID>
  </results_reference>
  <results_reference>
    <citation>Guelfi KJ, Ratnam N, Smythe GA, Jones TW, Fournier PA. Effect of intermittent high-intensity compared with continuous moderate exercise on glucose production and utilization in individuals with type 1 diabetes. Am J Physiol Endocrinol Metab. 2007 Mar;292(3):E865-70. doi: 10.1152/ajpendo.00533.2006.</citation>
    <PMID>17339500</PMID>
  </results_reference>
  <results_reference>
    <citation>Yardley JE, Sigal RJ. Exercise strategies for hypoglycemia prevention in individuals with type 1 diabetes. Diabetes Spectr. 2015 Jan;28(1):32-8. doi: 10.2337/diaspect.28.1.32.</citation>
    <PMID>25717276</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>January 26, 2017</last_update_submitted>
  <last_update_submitted_qc>January 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>York University</investigator_affiliation>
    <investigator_full_name>Michael Riddell</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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>
    <mesh_term>Hypoglycemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03034798
org study id: 1DP3DK101075
nct id: NCT03034798
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to determine the effects of insulin suspension at start of
      exercise in individuals with type 1 diabetes. A total of 3 sessions will be required for this
      project. The first will be a familiarization session that requires completed informed
      consent, anthropometric measurements (height, weight, body fat percentage), questionnaires,
      and a test of maximal aerobic fitness. The remaining 2 sessions will be steady-state aerobic
      exercise as well as circuit exercise.
Written informed consent will be collected on the first day during the familiarization
      session from all individuals that wish to participate. A researcher will provide a brief
      explanation on how the continuous glucose monitor (CGM) works (Medtronic Inc., Canada) during
      the first visit to the laboratory. They will also describe how the CGM sensor insertion
      process will occur for those participants who have not worn one in the past. The participant
      will clean and sanitize the area and insert the CGM superficially in the skin themselves and
      connect the transmitter device to the sensor. The CGM will be worn for a total of 7 days and
      then removed by the participant and returned to the researcher to be downloaded. The sports
      armband will also be placed on the left upper arm and be worn continuously for 7 days. The
      principal student investigator (PSI) or principal investigator (PI) will provide all
      participants with information about the sports armband and place it on the skin immediately
      following. This device simply sits on the surface of the skin, but has a specific placement
      and activation and must be applied by the PSI or PI. Finally, during exercise visits, the
      Zephyr bioharness will be connected just below chest level and around the rib cage. This
      device is sits on top of the skin simply like an elastic band around the rib cage. The
      bioharness will only be worn during exercise visits and disconnected at the end of each
      activity.

      Blood glucose levels will be monitored frequently during exercise using a Contour Link
      glucometer (Bayer, Canada). Participants will use personal lancing device for finger pokes,
      but the investigators will provide the glucometer and test strips. Each blood sugar check
      will be recorded in the data binder along with carbohydrate intake, any changes in basal rate
      or pump settings, and food intake. If blood glucose levels reach 3.9 mmol/L or less,
      participants will be asked to stop activity immediately and consume fast-acting carbohydrates
      (i.e. Dextrose tablets (Dex4, USA)). 15-minutes after ingestion of carbohydrates, blood
      glucose will be tested again before allowing the individual to return to activity safely. On
      the last day of testing, participants will be asked to return the CGM, sports armband, and
      bioharness to the research team. The data will later be uploaded and analyzed.

      Patients will undergo a fitness assessment (maximal aerobic capacity) during visit 1 and
      perform 40-minutes of continuous (treadmill jogging) and 40-minutes of intermittent
      (calisthenics) high-intensity type exercises (visit 2 and 3). Upon entry to the laboratory,
      participants will be asked to check blood glucose levels using the glucometer provided. The
      first exercise session will consist of a 40-minute treadmill walk/jog at ~40-50% of VO2max.
      The second exercise session will include various aerobic and anaerobic activities including
      push-ups, plank, jumping jacks, high knees, etc. Regular finger capillary blood samples will
      be collected every 10-minutes during exercise. Once the exercise session is complete,
      participants will be asked to remain in the laboratory for 30-minutes for additional blood
      glucose measurements and to ensure hypoglycemic episodes do not occur post-exercise.
      Participants will be given the contour link glucometer to monitor glucose levels throughout
      the evening and night.
observational model: Case-Crossover
time perspective: Prospective
measure: Blood glucose concentrations
time frame: Approximately 2 hours
description: Whole blood glucose concentrations were measured using a handheld glucometer every 10-minutes before, during, and after both exercise conditions.
measure: Participants estimated blood glucose concentration
time frame: 40-minutes during exercise and 10-minutes post-exercise
description: Whole blood glucose concentrations were measured using a handheld glucometer and the values were blinded from participants during exercise. Participants were asked to estimate the change in glycemia every 10-minutes and actual measured blood glucose was revealed to participants post-exercise.
arm group label: Type 1 Diabetes Exercisers
description: Participants performed 2 different forms of exercise of identical duration and similar total energy expenditure. One form was purely aerobic in nature and the other was intermittent, high-intensity exercise.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Michael C Riddell, PhD
role: Principal Investigator
affiliation: York University
citation: Iscoe KE, Riddell MC. Continuous moderate-intensity exercise with or without intermittent high-intensity work: effects on acute and late glycaemia in athletes with Type 1 diabetes mellitus. Diabet Med. 2011 Jul;28(7):824-32. doi: 10.1111/j.1464-5491.2011.03274.x.
PMID: 21388440
citation: Guelfi KJ, Ratnam N, Smythe GA, Jones TW, Fournier PA. Effect of intermittent high-intensity compared with continuous moderate exercise on glucose production and utilization in individuals with type 1 diabetes. Am J Physiol Endocrinol Metab. 2007 Mar;292(3):E865-70. doi: 10.1152/ajpendo.00533.2006.
PMID: 17339500
citation: Yardley JE, Sigal RJ. Exercise strategies for hypoglycemia prevention in individuals with type 1 diabetes. Diabetes Spectr. 2015 Jan;28(1):32-8. doi: 10.2337/diaspect.28.1.32.
PMID: 25717276
responsible party type: Principal Investigator
investigator affiliation: York University
investigator full name: Michael Riddell
investigator title: Professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Hypoglycemia
sharing ipd: No