<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/NCT04503239</url>
  </required_header>
  <id_info>
    <org_study_id>PTL-904050</org_study_id>
    <nct_id>NCT04503239</nct_id>
  </id_info>
  <brief_title>Prediabetes and Type 2 Diabetes Data Collection Study</brief_title>
  <acronym>T2Help</acronym>
  <official_title>Prediabetes and Type 2 Diabetes Data Collection Study: T2Help</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DexCom, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>DexCom, Inc.</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_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To collect data in an observational study from Prediabetes (PD) and Type 2 Diabetes (T2D)&#xD;
      patients including time correlated CGM, medication and food intake approximately 80% of the&#xD;
      time for each subject that completes the entire active phase.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In addition, lifestyle and treatment already established for prediabetes and Type 2 Diabetes&#xD;
      such as:&#xD;
&#xD;
        -  Sleep&#xD;
&#xD;
        -  Exercise/Physical activity/or lack of it&#xD;
&#xD;
        -  Heart rate&#xD;
&#xD;
        -  Five hours OGTT- 6 subjects in each group that have C-Peptide positive lab result at&#xD;
           screening and consent to the OGTT (Appendix 3) This data will address the sources and&#xD;
           nature of blood glucose variability across the progression of PD and T2D. The data&#xD;
           collected in this study will enable investigation into CGM-data artifacts that speak to&#xD;
           the state and management of PD and T2D. Possible applications enabled by these data sets&#xD;
           include: compliance with drug regimens and other lifestyle recommendations, drug&#xD;
           titration and/or escalation/de-escalation, and diagnosis and/or treatment throughout the&#xD;
           progression of the disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 22, 2020</start_date>
  <completion_date type="Anticipated">February 27, 2022</completion_date>
  <primary_completion_date type="Anticipated">February 27, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Collect Device Data - CGM</measure>
    <time_frame>up to 16 weeks</time_frame>
    <description>To collect data in an observational study from Prediabetes (PD) and Type 2 Diabetes (T2D) patients including time correlated CGM approximately 80% of the time for each subject that completes the entire active phase.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Collect Device Data - e-Diary</measure>
    <time_frame>up to 16 weeks</time_frame>
    <description>To collect data in an observational study from Prediabetes (PD) and Type 2 Diabetes (T2D) patients including logging diabetic medication taken or not taken 80% of the time for each subject that completes the entire active phase.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Collect Device Data - e-Diary</measure>
    <time_frame>up to 16 weeks</time_frame>
    <description>To collect data in an observational study from Prediabetes (PD) and Type 2 Diabetes (T2D) patients including logging food intake approximately 80% of the time for each subject that completes the entire active phase.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Collect Device Data - Activity Tracker</measure>
    <time_frame>up to 16 weeks</time_frame>
    <description>To collect data in an observational study from Prediabetes (PD) and Type 2 Diabetes (T2D) patients including logging lifestyle by activity tracker approximately 80% of the time for each subject that completes the entire active phase.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Collect Current Subject Lifestyle and Treatment Regimen</measure>
    <time_frame>up to 16 weeks</time_frame>
    <description>Collect subjects current treatment already established for Prediabetes and Type 2 Diabetes</description>
  </secondary_outcome>
  <number_of_groups>9</number_of_groups>
  <enrollment type="Actual">306</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Pre-diabetes</condition>
  <arm_group>
    <arm_group_label>Prediabetes (both IGT and IFG)</arm_group_label>
    <description>Device: G6 Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Type 2 Diabetes on 1 OAD</arm_group_label>
    <description>Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Type 2 Diabetes on 2 or more OAD</arm_group_label>
    <description>Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Type 2 Diabetes using Basal insulin with or without OAD</arm_group_label>
    <description>Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Type 2 Diabetes in GLP-1 with or without OAD</arm_group_label>
    <description>Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Type 2 Diabetes using intense insulin treatment-Multiple Dail</arm_group_label>
    <description>Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Type 2 Diabetes in MDI or basal insulin plus GLP-1</arm_group_label>
    <description>Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Type 2 Diabetes on 0 OAD</arm_group_label>
    <description>Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High Risk to Develop Prediabetes / Type 2 Diabetes</arm_group_label>
    <description>Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>G6</intervention_name>
    <description>Wear 9 wear periods of the 10-day CGM</description>
    <arm_group_label>High Risk to Develop Prediabetes / Type 2 Diabetes</arm_group_label>
    <arm_group_label>Prediabetes (both IGT and IFG)</arm_group_label>
    <arm_group_label>Type 2 Diabetes in GLP-1 with or without OAD</arm_group_label>
    <arm_group_label>Type 2 Diabetes in MDI or basal insulin plus GLP-1</arm_group_label>
    <arm_group_label>Type 2 Diabetes on 0 OAD</arm_group_label>
    <arm_group_label>Type 2 Diabetes on 1 OAD</arm_group_label>
    <arm_group_label>Type 2 Diabetes on 2 or more OAD</arm_group_label>
    <arm_group_label>Type 2 Diabetes using Basal insulin with or without OAD</arm_group_label>
    <arm_group_label>Type 2 Diabetes using intense insulin treatment-Multiple Dail</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pre-diabetics and Type 2 Diabetics 18 and over willing to wear 2 study devices and enter in&#xD;
        the daily medication and food intake.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects ages ≥18 years of age at the time of screening&#xD;
&#xD;
          -  High Risk of developing PD or T2D with HbA1c ≤5.6%&#xD;
&#xD;
        With one or more of the following:&#xD;
&#xD;
          -  Strong family history of T2D&#xD;
&#xD;
          -  BMI ≥35 kg/m2&#xD;
&#xD;
          -  History of gestational diabetes mellitus (GDM)&#xD;
&#xD;
          -  Age and Race, Ethnicity&#xD;
&#xD;
          -  Polycistic Ovarian Syndrome&#xD;
&#xD;
          -  High Blood Pressure&#xD;
&#xD;
          -  Abnormal cholesterol and triglyceride levels&#xD;
&#xD;
               -  Clinical Diagnosis of Prediabetes (PD) as defined by ADA to have an HbA1c&#xD;
                  ≥5.7%-6.4%. or clinical diagnosis of Type 2 Diabetes (T2D) with HbA1c between&#xD;
                  ≥6.5 % and ≤12.0%. Determined via medical record or source documentation by an&#xD;
                  individual qualified to make a medical diagnosis.&#xD;
&#xD;
               -  Having no treatment, one or more of the combination of treatments for the disease&#xD;
                  in every spectrum such as exercise and diet for PD and no treatment, 1 or more&#xD;
                  methods of treatment for T2D and combination of treatments for the disease MDI or&#xD;
                  CSII alone, MDI or CSII plus OAD and MDI or CSII with or without GLP-1 with or&#xD;
                  without OAD.&#xD;
&#xD;
               -  No change in diabetic medication in the last three months for patients in&#xD;
                  treatment.&#xD;
&#xD;
               -  Willingness to use a study provided CGM, use of an activity tracker, and agree to&#xD;
                  record data related to food and medication intake in an e-diary (e.g. mobile&#xD;
                  app).&#xD;
&#xD;
               -  For a subset of subjects who agree to provide consent, an OGTT will be performed&#xD;
                  as explained on Appendix 3. OGTT will be performed on 6 subjects per group that&#xD;
                  have a lab result with positive c-peptide. Having a smartphone compatible with&#xD;
                  Dexcom G6 CGM, activity tracker &amp; e-Diary. (This could be provided by the study&#xD;
                  team if the qualified subject does not have smartphone compatible with apps. For&#xD;
                  users that do not use their personal smartphones for data collection purposes,&#xD;
                  the T2Help study will provide a commercially available smartphone. The&#xD;
                  smartphones will be modified so they are only capable of hosting and running the&#xD;
                  study applications required for data collection (Fitbit, Welldoc, G6). The&#xD;
                  modified smartphones will not be able to execute standard smartphone&#xD;
                  functionality such as internet browsing, texting, or making phone calls.&#xD;
                  Bluetooth functionality will remain intact as it is required for the approved&#xD;
                  applications to collect data.)&#xD;
&#xD;
               -  If using additional medication, such as thyroid, hypertension, and cholesterol&#xD;
                  lowering medication these have to be stable for at least 3 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hospital admissions for diabetes ketoacidosis (DKA) or Hyperglycemic Hyperosmolar&#xD;
             Nonketotic Syndrome (HHNS) in the last 6 months.&#xD;
&#xD;
          -  History of 2 or more episodes of severe hypoglycemia, which resulted in any of the&#xD;
             following during the 6 months prior to screening:&#xD;
&#xD;
        Medical assistance by a third party (Caregiver needed to inject glucagon, ER visit,&#xD;
        hospitalization) Coma Seizures&#xD;
&#xD;
          -  Subject has a skin condition for which he/she is unable to tolerate tape adhesive in&#xD;
             the area of sensor placement.&#xD;
&#xD;
          -  Pregnancy (as demonstrated by a positive test at study entry) at time of screening or&#xD;
             are planning to become pregnant during the study.&#xD;
&#xD;
          -  Subject has had any of the following cardiovascular events within 3 months of&#xD;
             screening: myocardial infarction, unstable angina, coronary artery bypass surgery,&#xD;
             coronary artery stenting, recent transient ischemic attack, cerebrovascular accident&#xD;
             with sequelae, unstable angina, unstable congestive heart failure, unstable&#xD;
             ventricular rhythm disturbances or thromboembolic disease.&#xD;
&#xD;
          -  Unstable thyroid disease. (changes in Thyroid medication in the last 90 days)&#xD;
&#xD;
          -  Subject has taken any oral, injectable, or intravenous (IV) steroids within 8 weeks&#xD;
             from the time of screening visit, or plans to take any oral, injectable, or IV&#xD;
             steroids during the course of the study.&#xD;
&#xD;
          -  Subject is actively participating in an investigational study (drug or device) wherein&#xD;
             he/she has received treatment from an investigational study drug or investigational&#xD;
             study device in the last 2 weeks.&#xD;
&#xD;
          -  Subject is currently using illicit drugs.&#xD;
&#xD;
          -  Subject is currently abusing prescription drugs.&#xD;
&#xD;
          -  Subject is currently abusing alcohol.&#xD;
&#xD;
          -  Subject has a history of visual impairment which would not allow him/her to&#xD;
             participate in the study and perform all study procedures safely, as determined by the&#xD;
             investigator.&#xD;
&#xD;
          -  Subject has elective surgery planned that requires general anesthesia during the&#xD;
             course of the study.&#xD;
&#xD;
          -  Subject has a sickle cell disease, hemoglobinopathy, or has received red blood cell&#xD;
             transfusion or erythropoietin within 3 months prior to time of screening.&#xD;
&#xD;
          -  Subject plans to receive red blood cell transfusion or erythropoietin over the course&#xD;
             of study participation.&#xD;
&#xD;
          -  Subject diagnosed with current eating disorder such as anorexia or bulimia.&#xD;
&#xD;
          -  Subject is on dialysis.&#xD;
&#xD;
          -  Subject has eGFR &lt;45 confirmed by medical record.&#xD;
&#xD;
          -  Recent Pancreatitis. (&lt; 30 days)&#xD;
&#xD;
          -  Cancer/malignancy in treatment.&#xD;
&#xD;
          -  Cystic fibrosis.&#xD;
&#xD;
          -  Any other problem for which the investigator or the sponsor may believe that the&#xD;
             subject will not be able to comply with the study. (e.g. use of hydroxyurea)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>not pregnant or planning on becoming pregnant during study</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Danny Chernavvsky, MD</last_name>
    <role>Study Director</role>
    <affiliation>DexCom, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Synergy San Diego</name>
      <address>
        <city>Lemon Grove</city>
        <state>California</state>
        <zip>91945</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palm Research Center</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diabetes and Glandular Disease</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>October 4, 2021</last_update_submitted>
  <last_update_submitted_qc>October 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2021</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>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Prediabetic State</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/NCT04503239
org study id: PTL-904050
nct id: NCT04503239
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
To collect data in an observational study from Prediabetes (PD) and Type 2 Diabetes (T2D)
      patients including time correlated CGM, medication and food intake approximately 80% of the
      time for each subject that completes the entire active phase.
In addition, lifestyle and treatment already established for prediabetes and Type 2 Diabetes
      such as:

        -  Sleep

        -  Exercise/Physical activity/or lack of it

        -  Heart rate

        -  Five hours OGTT- 6 subjects in each group that have C-Peptide positive lab result at
           screening and consent to the OGTT (Appendix 3) This data will address the sources and
           nature of blood glucose variability across the progression of PD and T2D. The data
           collected in this study will enable investigation into CGM-data artifacts that speak to
           the state and management of PD and T2D. Possible applications enabled by these data sets
           include: compliance with drug regimens and other lifestyle recommendations, drug
           titration and/or escalation/de-escalation, and diagnosis and/or treatment throughout the
           progression of the disease.
observational model: Case-Control
time perspective: Prospective
measure: Collect Device Data - CGM
time frame: up to 16 weeks
description: To collect data in an observational study from Prediabetes (PD) and Type 2 Diabetes (T2D) patients including time correlated CGM approximately 80% of the time for each subject that completes the entire active phase.
measure: Collect Device Data - e-Diary
time frame: up to 16 weeks
description: To collect data in an observational study from Prediabetes (PD) and Type 2 Diabetes (T2D) patients including logging diabetic medication taken or not taken 80% of the time for each subject that completes the entire active phase.
measure: Collect Device Data - e-Diary
time frame: up to 16 weeks
description: To collect data in an observational study from Prediabetes (PD) and Type 2 Diabetes (T2D) patients including logging food intake approximately 80% of the time for each subject that completes the entire active phase.
measure: Collect Device Data - Activity Tracker
time frame: up to 16 weeks
description: To collect data in an observational study from Prediabetes (PD) and Type 2 Diabetes (T2D) patients including logging lifestyle by activity tracker approximately 80% of the time for each subject that completes the entire active phase.
measure: Collect Current Subject Lifestyle and Treatment Regimen
time frame: up to 16 weeks
description: Collect subjects current treatment already established for Prediabetes and Type 2 Diabetes
arm group label: Prediabetes (both IGT and IFG)
description: Device: G6 Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily
arm group label: Type 2 Diabetes on 1 OAD
description: Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily
arm group label: Type 2 Diabetes on 2 or more OAD
description: Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily
arm group label: Type 2 Diabetes using Basal insulin with or without OAD
description: Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily
arm group label: Type 2 Diabetes in GLP-1 with or without OAD
description: Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily
arm group label: Type 2 Diabetes using intense insulin treatment-Multiple Dail
description: Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily
arm group label: Type 2 Diabetes in MDI or basal insulin plus GLP-1
description: Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily
arm group label: Type 2 Diabetes on 0 OAD
description: Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily
arm group label: High Risk to Develop Prediabetes / Type 2 Diabetes
description: Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily
intervention type: Device
intervention name: G6
description: Wear 9 wear periods of the 10-day CGM
arm group label: High Risk to Develop Prediabetes / Type 2 Diabetes
arm group label: Prediabetes (both IGT and IFG)
arm group label: Type 2 Diabetes in GLP-1 with or without OAD
arm group label: Type 2 Diabetes in MDI or basal insulin plus GLP-1
arm group label: Type 2 Diabetes on 0 OAD
arm group label: Type 2 Diabetes on 1 OAD
arm group label: Type 2 Diabetes on 2 or more OAD
arm group label: Type 2 Diabetes using Basal insulin with or without OAD
arm group label: Type 2 Diabetes using intense insulin treatment-Multiple Dail
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
gender based: Yes
gender description: not pregnant or planning on becoming pregnant during study
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Danny Chernavvsky, MD
role: Study Director
affiliation: DexCom, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Prediabetic State
sharing ipd: No