<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/NCT03307850</url>
  </required_header>
  <id_info>
    <org_study_id>JDRFSignals1</org_study_id>
    <nct_id>NCT03307850</nct_id>
  </id_info>
  <brief_title>Impact of Non-glucose Signals on Glycemic Control in Patients With Type 1 Diabetes</brief_title>
  <official_title>Feasibility Study to Assess the Impact of Non-glucose Signals on Glycemic Control in Patients With Type 1 Diabetes on Sensor Augmented Insulin Pump</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sansum Diabetes Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Harvard University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sansum Diabetes Research Institute</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>
      This clinical trial will identify exercise-related and emotional stress related effects on&#xD;
      glycemic control in patients with type 1 diabetes using sensor-augmented pump (SAP) therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with type 1 diabetes (T1D) on an insulin pump will be studied for 5 weeks in the&#xD;
      outpatient setting performing their normal activities, to include their normal diet and&#xD;
      exercise, while assessing the amount of type of exercise performed, and emotional stress&#xD;
      levels, using stress sensor, questionnaires and salivary cortisol levels.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Actual">August 31, 2018</completion_date>
  <primary_completion_date type="Actual">August 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Impact of Stress and Exercise on CGM Glucose Levels, determining how these factors affect time within target glucose range 70-180 mg/dl</measure>
    <time_frame>5 Weeks</time_frame>
    <description>Examine the impact of Stress and Exercise on CGM Glucose Levels, determining how these factors affect time within target glucose range 70-180 mg/dl. Correlate these factors that influence glycemic control to inform future algorithm development for an artificial pancreas (AP) device to better handle exercise and stress related events to be used in a future study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CGM Glucose Levels 70-180 mg/dl</measure>
    <time_frame>5 Weeks</time_frame>
    <description>CGM Glucose Levels, within target range 70-180 mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CGM Glucose Levels less than 70 mg/dl</measure>
    <time_frame>5 Weeks</time_frame>
    <description>CGM Glucose Levels, less than 70 mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CGM Glucose Levels greater than 180 mg/dl</measure>
    <time_frame>5 Weeks</time_frame>
    <description>CGM Glucose Levels, greater than 180 mg/dl</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Observation of Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Observation During Exercise and Stress</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observation During Exercise and Stress</intervention_name>
    <description>Patients with type 1 diabetes (T1D) on an insulin pump will be studied for 5 weeks in the outpatient setting performing their normal activities, to include their normal diet and exercise, while assessing the amount of type of exercise performed, and emotional stress levels, using stress sensor, questionnaires and salivary cortisol levels.&#xD;
Subjects at the William Sansum Diabetes Center will perform graded exercise on a treadmill for up to 45 minutes with all activity and stress monitors running, achieving 30 and 60% calculated heart rate reserve, once during the study. Subjects at Mayo Clinic will perform a graded exercise test on a treadmill to determine V02max and ensure stable cardiac status, once during the study.</description>
    <arm_group_label>Observation of Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-75 years&#xD;
&#xD;
          -  Clinical diagnosis, based on investigator assessment, of T1D for at least one year and&#xD;
             using insulin for at least 1 year.&#xD;
&#xD;
          -  Using an insulin pump for diabetes therapy for at least 3 months&#xD;
&#xD;
          -  Demonstration of proper mental status and cognition for the study&#xD;
&#xD;
          -  Non-smoker&#xD;
&#xD;
          -  If not currently using CGM, willing to use CGM during the study&#xD;
&#xD;
          -  An understanding of and willingness to follow the protocol and sign the informed&#xD;
             consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Admission for diabetic ketoacidosis in the 6 months prior to enrollment unless study&#xD;
             team feels the subject is appropriate for study given complete clinical context for&#xD;
             subject&#xD;
&#xD;
          -  Severe hypoglycemia resulting in seizure or loss of consciousness &gt; once in the 6&#xD;
             months prior to enrollment&#xD;
&#xD;
          -  History of a seizure disorder (except hypoglycemic seizure), unless written clearance&#xD;
             is received from a neurologist and not currently on a seizure medication&#xD;
&#xD;
          -  Cystic fibrosis&#xD;
&#xD;
          -  Unstable coronary artery disease or heart failure, unless written clearance is&#xD;
             received from a cardiologist or primary care provider&#xD;
&#xD;
          -  A known medical condition that in the judgment of the investigator might interfere&#xD;
             with the completion of the protocol such as the following examples:&#xD;
&#xD;
               1. Inpatient psychiatric treatment in the past 6 months&#xD;
&#xD;
               2. Presence of a known adrenal disorder or chronic oral steroid therapy&#xD;
&#xD;
               3. Abnormal liver function test results (Transaminase &gt;3 times the upper limit of&#xD;
                  normal); testing required for subjects taking medications known to affect liver&#xD;
                  function or with diseases known to affect liver function&#xD;
&#xD;
               4. Abnormal renal function test results (calculated GFR &lt;60 mL/min/1.73m2);&#xD;
&#xD;
               5. Active gastroparesis (defined actively being treated with medications)&#xD;
&#xD;
          -  If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of&#xD;
             stability on the medication for the past 2 months prior to enrollment in the study&#xD;
&#xD;
          -  Abuse of alcohol or recreational drugs&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Infectious process not anticipated to resolve prior to study procedures (e.g.&#xD;
             meningitis, pneumonia, osteomyelitis).&#xD;
&#xD;
          -  Uncontrolled arterial hypertension (Resting diastolic blood pressure &gt;90 mmHg and/or&#xD;
             systolic blood pressure &gt;160 mmHg) at the time of screening&#xD;
&#xD;
          -  Uncontrolled microvascular complications such as current active proliferative diabetic&#xD;
             retinopathy defined as proliferative retinopathy requiring treatment (e.g. laser&#xD;
             therapy) in the past 12 months.&#xD;
&#xD;
          -  A recent injury to body or limb, muscular disorder, use of any medication, any&#xD;
             carcinogenic disease, or other significant medical disorder if that injury, medication&#xD;
             or disease in the judgment of the investigator will affect the completion of the&#xD;
             protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yogish C Kudva, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eyal Dassau, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Harvard University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jordan E Pinsker, MD</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>93111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>October 3, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>September 4, 2018</last_update_submitted>
  <last_update_submitted_qc>September 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>type 1 diabetes</keyword>
  <keyword>hypoglycemia</keyword>
  <keyword>exercise</keyword>
  <keyword>stress</keyword>
  <keyword>artificial pancreas</keyword>
  <keyword>cortisol</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>
  <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/NCT03307850
org study id: JDRFSignals1
nct id: NCT03307850
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This clinical trial will identify exercise-related and emotional stress related effects on
      glycemic control in patients with type 1 diabetes using sensor-augmented pump (SAP) therapy.
Patients with type 1 diabetes (T1D) on an insulin pump will be studied for 5 weeks in the
      outpatient setting performing their normal activities, to include their normal diet and
      exercise, while assessing the amount of type of exercise performed, and emotional stress
      levels, using stress sensor, questionnaires and salivary cortisol levels.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Impact of Stress and Exercise on CGM Glucose Levels, determining how these factors affect time within target glucose range 70-180 mg/dl
time frame: 5 Weeks
description: Examine the impact of Stress and Exercise on CGM Glucose Levels, determining how these factors affect time within target glucose range 70-180 mg/dl. Correlate these factors that influence glycemic control to inform future algorithm development for an artificial pancreas (AP) device to better handle exercise and stress related events to be used in a future study.
measure: CGM Glucose Levels 70-180 mg/dl
time frame: 5 Weeks
description: CGM Glucose Levels, within target range 70-180 mg/dl
measure: CGM Glucose Levels less than 70 mg/dl
time frame: 5 Weeks
description: CGM Glucose Levels, less than 70 mg/dl
measure: CGM Glucose Levels greater than 180 mg/dl
time frame: 5 Weeks
description: CGM Glucose Levels, greater than 180 mg/dl
arm group label: Observation of Exercise
arm group type: Experimental
description: Observation During Exercise and Stress
intervention type: Other
intervention name: Observation During Exercise and Stress
description: Patients with type 1 diabetes (T1D) on an insulin pump will be studied for 5 weeks in the outpatient setting performing their normal activities, to include their normal diet and exercise, while assessing the amount of type of exercise performed, and emotional stress levels, using stress sensor, questionnaires and salivary cortisol levels.
Subjects at the William Sansum Diabetes Center will perform graded exercise on a treadmill for up to 45 minutes with all activity and stress monitors running, achieving 30 and 60% calculated heart rate reserve, once during the study. Subjects at Mayo Clinic will perform a graded exercise test on a treadmill to determine V02max and ensure stable cardiac status, once during the study.
arm group label: Observation of Exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yogish C Kudva, MD
role: Principal Investigator
affiliation: Mayo Clinic
last name: Eyal Dassau, PhD
role: Principal Investigator
affiliation: Harvard University
last name: Jordan E Pinsker, MD
role: Principal Investigator
affiliation: Sansum Diabetes Research Institute
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No