<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/NCT04443153</url>
  </required_header>
  <id_info>
    <org_study_id>200007</org_study_id>
    <secondary_id>2R01DK051562-19A1</secondary_id>
    <nct_id>NCT04443153</nct_id>
  </id_info>
  <brief_title>Adapting Diabetes Treatment Expert Systems to Patient in Type 1 Diabetes</brief_title>
  <acronym>DSS-2</acronym>
  <official_title>Adapting Diabetes Treatment Expert Systems to Patient's Expectations and Psychobehavioral Characteristics in Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Virginia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is evaluate the superior efficacy of a Continuous Glucose Monitor (CGM)-based&#xD;
      advisory system in Type 1 Diabetes Mellitus (T1DM), as compared to Sensor Augmented Mode&#xD;
      (SAM) therapy, and with characterizing the impact of psycho-behavioral factors on system&#xD;
      performance, which will enable system individualization and lead to automated adaptation of&#xD;
      advice delivery to optimize glycemic control and reduce the system's psychological impact.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Four cohorts of about 25 participants each (expected retention 20 per cohort). Each cohort&#xD;
      will continue for ~7 months. Following recruitment, screening, and a run-in period of SAM,&#xD;
      participants will be randomized into one of two groups: escalation vs. de-escalation of&#xD;
      devices and function. Each treatment modality (SAM - Sensor-Augmented Mode, PF - Personalized&#xD;
      Feedback, DSS - Decision Support Systems) will continue for about 8 weeks, with the last 4&#xD;
      weeks used to assess glucose variability (GV) from CGM data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 4, 2020</start_date>
  <completion_date type="Anticipated">July 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2024</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glycemic Outcomes</measure>
    <time_frame>7 Months</time_frame>
    <description>Glucose Variability (GV) as measured by CGM-based Coefficient of Variation (CV), as recommended by the International Consensus on Use of Continuous Glucose Monitoring.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>percent time in clinical hypoglycemia</measure>
    <time_frame>7 months</time_frame>
    <description>percent time spent below 54mg/dL as per CGM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>percent time below recommended threshold</measure>
    <time_frame>7 months</time_frame>
    <description>percent time spent below 70mg/dL as per CGM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>percent time in target range</measure>
    <time_frame>7 months</time_frame>
    <description>percent time spent between 70mg/dL and 180mg/dL as per CGM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>percent time above range</measure>
    <time_frame>7 months</time_frame>
    <description>percent time spent above 180mg/dL as per CGM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>percent time above 250 mg/dL</measure>
    <time_frame>7 months</time_frame>
    <description>percent time spent above 250mg/dL as per CGM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>average glycemia</measure>
    <time_frame>7 months</time_frame>
    <description>average of CGM values</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Low Blood Glucose Index</measure>
    <time_frame>7 months</time_frame>
    <description>average of hypoglycemia risk value per Kovatchev et al 1998 as per CGM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>High Blood Glucose Index</measure>
    <time_frame>7 months</time_frame>
    <description>average of hyperglycemia risk value per Kovatchev et al 1998 as per CGM</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Diabetes Mellitus, Type 1</condition>
  <arm_group>
    <arm_group_label>De-escalation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects randomized to this arm will proceed from DSS to PF to SAM</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Escalation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects randomized to this arm will proceed from SAM to PF to DSS</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Personalized Feedback</intervention_name>
    <description>Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user.</description>
    <arm_group_label>De-escalation</arm_group_label>
    <arm_group_label>Escalation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Decision Support System</intervention_name>
    <description>CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges</description>
    <arm_group_label>De-escalation</arm_group_label>
    <arm_group_label>Escalation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sensor Augmented Mode</intervention_name>
    <description>A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.</description>
    <arm_group_label>De-escalation</arm_group_label>
    <arm_group_label>Escalation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years and older&#xD;
&#xD;
          -  Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least&#xD;
             one year and using insulin for at least one year&#xD;
&#xD;
          -  HbA1c 6.0-11.0%, inclusive&#xD;
&#xD;
          -  Demonstration of proper mental status and cognition for the study&#xD;
&#xD;
          -  If on a non-insulin hyperglycemic therapy, stability on that therapy for the prior 3&#xD;
             months and willingness not to alter the therapy for the study duration.&#xD;
&#xD;
          -  For females, not currently known to be pregnant&#xD;
&#xD;
          -  If female and sexually active, must agree to use a highly effective form of&#xD;
             contraception to prevent pregnancy while a participant in the study. A negative serum&#xD;
             or urine pregnancy test will be required for all premenopausal women who are not&#xD;
             surgically sterile. Subjects who become pregnant will be discontinued from the study.&#xD;
             Also, subjects who during the study develop and express the intention to become&#xD;
             pregnant within the timespan of the study will be discontinued.&#xD;
&#xD;
          -  Subjects must have Internet access and a computer system that meets the requirements&#xD;
             for uploading the study equipment and ability to participate in video conferencing.&#xD;
&#xD;
          -  Investigator has confidence that the subject can successfully operate all study&#xD;
             devices and is capable of adhering to the protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  NPH (neutral protamine hagedorn) insulin&#xD;
&#xD;
          -  Use of any medication that at the discretion of the investigator is deemed to&#xD;
             interfere with the trial.&#xD;
&#xD;
          -  Current treatment of a primary seizure disorder&#xD;
&#xD;
          -  Coronary artery disease or heart failure, unless written clearance is received from a&#xD;
             cardiologist.&#xD;
&#xD;
          -  Hemophilia or any other bleeding disorder&#xD;
&#xD;
          -  A known medical condition, which in the opinion of the investigator or designee, would&#xD;
             put the participant or study at risk such as the following examples:&#xD;
&#xD;
               -  Inpatient psychiatric treatment in the past 6 months&#xD;
&#xD;
               -  Presence of a known adrenal disorder&#xD;
&#xD;
               -  Abnormal liver function test results (Transaminase &gt;3 times the upper limit of&#xD;
                  normal)&#xD;
&#xD;
               -  Abnormal renal function test results (calculated GFR &lt;60 mL/min/1.73m2).&#xD;
&#xD;
               -  Active gastroparesis requiring medical therapy&#xD;
&#xD;
               -  Uncontrolled thyroid disease (TSH undetectable or &gt;10 mlU/L).&#xD;
&#xD;
               -  Abuse of alcohol or recreational drugs&#xD;
&#xD;
               -  Infectious process not anticipated to be resolved prior to study procedures (e.g.&#xD;
                  meningitis, pneumonia, osteomyelitis, deep tissue infection).&#xD;
&#xD;
               -  Uncontrolled arterial hypertension (Resting diastolic blood pressure &gt;100 mmHg&#xD;
                  and/or systolic blood pressure &gt;180 mmHg).&#xD;
&#xD;
               -  Uncontrolled microvascular complications such as current active proliferative&#xD;
                  diabetic retinopathy defined as proliferative retinopathy requiring treatment&#xD;
                  (e.g. laser therapy or VEGF inhibitor injections) 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;
&#xD;
          -  Not familiar with smart phone technology&#xD;
&#xD;
          -  Current use of the following drugs and supplements:&#xD;
&#xD;
               -  Oral steroids&#xD;
&#xD;
               -  Any other medication that the investigator believes is a contraindication to the&#xD;
                  subject's participation&#xD;
&#xD;
          -  Participation in another pharmaceutical or device trial at the time of enrollment or&#xD;
             during the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marc Breton, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Virginia Center for Diabetes Technology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marc Breton, PhD</last_name>
    <phone>434-982-6484</phone>
    <email>mb6nt@virginia.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Emma Emory, RN</last_name>
    <phone>434-327-0725</phone>
    <email>ee9m@virginia.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Virginia Center for Diabetes Technology</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marc Breton, PhD</last_name>
      <phone>434-982-6484</phone>
      <email>mb6nt@virginia.edu</email>
    </contact>
    <investigator>
      <last_name>Marc Breton, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ralf Nass, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Chiara Fabris, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Leela Krishna Chaitanya Koravi, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Linda Gonder-Fredrick, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mary Clancy-Oliveri, MS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Katharine Barnard-Kelly, Ph.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>May 3, 2023</last_update_submitted>
  <last_update_submitted_qc>May 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Virginia</investigator_affiliation>
    <investigator_full_name>Marc Breton</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Behavior</keyword>
  <keyword>Continuous Glucose Monitor (CGM)</keyword>
  <keyword>Insulin Pump</keyword>
  <keyword>Decision Support System (DSS)</keyword>
  <keyword>Personalized Feedback (PF)</keyword>
  <keyword>Sensor Augmented Pump therapy (SAP)</keyword>
  <keyword>Multiple Daily Injections (MDI)</keyword>
  <keyword>Sensor Augmented Mode (SAM)</keyword>
  <keyword>Continuous Subcutaneous Insulin Infusion (CSII)</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>Yes</sharing_ipd>
    <ipd_description>Pending</ipd_description>
  </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/NCT04443153
org study id: 200007
secondary id: 2R01DK051562-19A1
nct id: NCT04443153
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
This study is evaluate the superior efficacy of a Continuous Glucose Monitor (CGM)-based
      advisory system in Type 1 Diabetes Mellitus (T1DM), as compared to Sensor Augmented Mode
      (SAM) therapy, and with characterizing the impact of psycho-behavioral factors on system
      performance, which will enable system individualization and lead to automated adaptation of
      advice delivery to optimize glycemic control and reduce the system's psychological impact.
Four cohorts of about 25 participants each (expected retention 20 per cohort). Each cohort
      will continue for ~7 months. Following recruitment, screening, and a run-in period of SAM,
      participants will be randomized into one of two groups: escalation vs. de-escalation of
      devices and function. Each treatment modality (SAM - Sensor-Augmented Mode, PF - Personalized
      Feedback, DSS - Decision Support Systems) will continue for about 8 weeks, with the last 4
      weeks used to assess glucose variability (GV) from CGM data.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Glycemic Outcomes
time frame: 7 Months
description: Glucose Variability (GV) as measured by CGM-based Coefficient of Variation (CV), as recommended by the International Consensus on Use of Continuous Glucose Monitoring.
measure: percent time in clinical hypoglycemia
time frame: 7 months
description: percent time spent below 54mg/dL as per CGM
measure: percent time below recommended threshold
time frame: 7 months
description: percent time spent below 70mg/dL as per CGM
measure: percent time in target range
time frame: 7 months
description: percent time spent between 70mg/dL and 180mg/dL as per CGM
measure: percent time above range
time frame: 7 months
description: percent time spent above 180mg/dL as per CGM
measure: percent time above 250 mg/dL
time frame: 7 months
description: percent time spent above 250mg/dL as per CGM
measure: average glycemia
time frame: 7 months
description: average of CGM values
measure: Low Blood Glucose Index
time frame: 7 months
description: average of hypoglycemia risk value per Kovatchev et al 1998 as per CGM
measure: High Blood Glucose Index
time frame: 7 months
description: average of hyperglycemia risk value per Kovatchev et al 1998 as per CGM
arm group label: De-escalation
arm group type: Experimental
description: Subjects randomized to this arm will proceed from DSS to PF to SAM
arm group label: Escalation
arm group type: Experimental
description: Subjects randomized to this arm will proceed from SAM to PF to DSS
intervention type: Device
intervention name: Personalized Feedback
description: Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user.
arm group label: De-escalation
arm group label: Escalation
intervention type: Device
intervention name: Decision Support System
description: CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges
arm group label: De-escalation
arm group label: Escalation
intervention type: Device
intervention name: Sensor Augmented Mode
description: A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.
arm group label: De-escalation
arm group label: Escalation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marc Breton, PhD
role: Principal Investigator
affiliation: University of Virginia Center for Diabetes Technology
last name: Marc Breton, PhD
phone: 434-982-6484
email: mb6nt@virginia.edu
last name: Emma Emory, RN
phone: 434-327-0725
email: ee9m@virginia.edu
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Virginia
investigator full name: Marc Breton
investigator title: Associate Professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: Yes
ipd description: Pending