xml: <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/NCT05992350</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00002582</org_study_id>
      <nct_id>NCT05992350</nct_id>
    </id_info>
    <brief_title>Garmin PACT (Physical Activity Tracking in Type 1 Diabetes Using Garmin Vivosmart)</brief_title>
    <official_title>Garmin PACT (Physical Activity Tracking)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Children's Mercy Hospital Kansas City</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Children's Mercy Hospital Kansas City</source>
    <brief_summary>
      <textblock>
        The goal of this observational study is to test the Garmin Vivosmart in children and youth&#xD;
        (8-21) with Type 1 Diabetes (T1D) and their parents. The main questions it aims to answer&#xD;
        are:&#xD;
  &#xD;
          -  Does the Garmin Vivosmart increase physical activity (PA)?&#xD;
  &#xD;
          -  Does the Garmin Vivosmart improve T1D status&#xD;
  &#xD;
        Participants will:&#xD;
  &#xD;
          -  Wear the Garmin Vivosmart (4 or higher) for a year&#xD;
  &#xD;
          -  Complete surveys at the beginning, middle and end of participation asking about your&#xD;
             T1D, T1D management, and PA&#xD;
  &#xD;
          -  Parents of children will also complete similar surveys about T1D&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">August 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Moderate to Vigorous Physical Activity (MVPA) Amount</measure>
      <time_frame>Up to 365 days +- 30 days</time_frame>
      <description>Minutes per Day of MVPA</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Diabetic Ketoacidosis (DKA) Admission</measure>
      <time_frame>90 days +- 30 days</time_frame>
      <description>Rate of hospitalization for diabetic ketoacidosis</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Diabetic Ketoacidosis (DKA) Admission</measure>
      <time_frame>180 days +- 30 days</time_frame>
      <description>Rate of hospitalization for diabetic ketoacidosis</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Diabetic Ketoacidosis (DKA) Admission</measure>
      <time_frame>365 +-30 days</time_frame>
      <description>Rate of hospitalization for diabetic ketoacidosis</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Time in Range</measure>
      <time_frame>Over 90, 180, and 365 +- 30 days</time_frame>
      <description>Time where blood glucose is in an appropriate range (and other glucose measurements)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Predicted Change</measure>
      <time_frame>90 +- 30 days</time_frame>
      <description>machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Predicted Change</measure>
      <time_frame>180 +- 30 days</time_frame>
      <description>machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Predicted Change</measure>
      <time_frame>365 +- 30 days</time_frame>
      <description>machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Minutes of Sleep per Day</measure>
      <time_frame>Up to 365 days +- 30 days</time_frame>
      <description>Minutes of Sleep per Day</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Self Reported Physical Activity</measure>
      <time_frame>0 months</time_frame>
      <description>Self-reported physical activity via the International Physical Activity Questionnaire Short Form (IPAQ-SF), no min or max, recording the amount of time spent in MVPA in the past week, higher amounts are better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self Reported Physical Activity</measure>
      <time_frame>6 months</time_frame>
      <description>Self-reported physical activity via the International Physical Activity Questionnaire Short Form (IPAQ- SF), no min or max, recording the amount of time spent in MVPA in the past week, higher amounts are better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self Reported Physical Activity</measure>
      <time_frame>12 months</time_frame>
      <description>Self-reported physical activity via the International Physical Activity Questionnaire Short Form (IPAQ-SF), no min or max, recording the amount of time spent in MVPA in the past week higher amounts are better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self Reported T1D Management</measure>
      <time_frame>0 months</time_frame>
      <description>Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self Reported T1D Management</measure>
      <time_frame>6 months</time_frame>
      <description>Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self Reported T1D Management</measure>
      <time_frame>12 months</time_frame>
      <description>Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self Reported T1D Management</measure>
      <time_frame>0 months</time_frame>
      <description>Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self Reported T1D Management</measure>
      <time_frame>6 months</time_frame>
      <description>Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self Reported T1D Management</measure>
      <time_frame>12 months</time_frame>
      <description>Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in self reported physical activity levels</measure>
      <time_frame>Between 0, 6, and 12 months</time_frame>
      <description>Change in self reported physical activity levels via self-report with the IPAQ survey no min or max, recording the amount of time spent in MVPA in the past week, higher amounts are better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in how participants feel about episodes of hypoglycemia</measure>
      <time_frame>Between 0, 6, and 12 months</time_frame>
      <description>Change in how participants feel about episodes of hypoglycemia measured via the Hypoglycemic Fear Scale II (HFS-II) min 0 max 132, higher scores are a worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in how parents feel about episodes of hypoglycemia in their children</measure>
      <time_frame>Between 0, 6, and 12 months</time_frame>
      <description>Change in how parents feel about episodes of hypoglycemia in their children wearing the Garmin physical activity tracker via the Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome</description>
    </secondary_outcome>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Type 1 Diabetes</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Garmin physical activity tracker</intervention_name>
      <description>The Garmin physical activity tracker is worn like a watch on the user. The tracker assesses several physical states, indicates when the body is at optimal time for activity or when the body needs to rest. The tracker also monitors stress levels and prompts relaxation when appropriate. The tracker sets goals with participants based on previously completed activity. The tracker alerts participants after a period of inactivity, encourages regular movement throughout the day, and decreases the amount of time spent sedentary.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Youth (8-21 YO) diagnosed with T1D and parents of youth (8-17 YO)&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants aged 8-21 years of age and/or parent of participant aged 8-17 years of&#xD;
               age&#xD;
  &#xD;
            -  Participants diagnosed with T1D greater than 6 months ago&#xD;
  &#xD;
            -  Participants must be patients at the Children's Mercy Kansas City network&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participants who do not meet age criteria above&#xD;
  &#xD;
            -  Participants who do not have T1D&#xD;
  &#xD;
            -  Participants who are unwilling to wear the device for at least 6 months&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>8 Years</minimum_age>
      <maximum_age>21 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Mark Clements, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Children's Mercy</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Priscilla Connell, MPH</last_name>
      <phone>816-601-4543</phone>
      <email>pcconnell@cmh.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Emily DeWit</last_name>
      <phone>913 5155173</phone>
      <email>eldewit@cmh.edu</email>
    </overall_contact_backup>
    <reference>
      <citation>Cescon M, Choudhary D, Pinsker JE, Dadlani V, Church MM, Kudva YC, Doyle Iii FJ, Dassau E. Activity detection and classification from wristband accelerometer data collected on people with type 1 diabetes in free-living conditions. Comput Biol Med. 2021 Aug;135:104633. doi: 10.1016/j.compbiomed.2021.104633. Epub 2021 Jul 12.</citation>
      <PMID>34346318</PMID>
    </reference>
    <reference>
      <citation>Grimes A, Lightner JS, Eighmy K, Steel C, Shook RP, Carlson J. Decreased Physical Activity Among Youth Resulting From COVID-19 Pandemic-Related School Closures: Natural Experimental Study. JMIR Form Res. 2022 Apr 15;6(4):e35854. doi: 10.2196/35854.</citation>
      <PMID>35297778</PMID>
    </reference>
    <reference>
      <citation>Jaggers JR, McKay T, King KM, Thrasher BJ, Wintergerst KA. Integration of Consumer-Based Activity Monitors into Clinical Practice for Children with Type 1 Diabetes: A Feasibility Study. Int J Environ Res Public Health. 2021 Oct 10;18(20):10611. doi: 10.3390/ijerph182010611.</citation>
      <PMID>34682355</PMID>
    </reference>
    <reference>
      <citation>Ozaslan B, Patek SD, Breton MD. Impact of Daily Physical Activity as Measured by Commonly Available Wearables on Mealtime Glucose Control in Type 1 Diabetes. Diabetes Technol Ther. 2020 Oct;22(10):742-748. doi: 10.1089/dia.2019.0517.</citation>
      <PMID>32105515</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Children's Mercy Hospital Kansas City</investigator_affiliation>
      <investigator_full_name>Mark Clements</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <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>
  
  
text: 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/NCT05992350
  org study id: STUDY00002582
  nct id: NCT05992350
  lead sponsor: 
  The goal of this observational study is to test the Garmin Vivosmart in children and youth
        (8-21) with Type 1 Diabetes (T1D) and their parents. The main questions it aims to answer
        are:
  
          -  Does the Garmin Vivosmart increase physical activity (PA)?
  
          -  Does the Garmin Vivosmart improve T1D status
  
        Participants will:
  
          -  Wear the Garmin Vivosmart (4 or higher) for a year
  
          -  Complete surveys at the beginning, middle and end of participation asking about your
             T1D, T1D management, and PA
  
          -  Parents of children will also complete similar surveys about T1D
  observational model: Other
  time perspective: Prospective
  measure: Moderate to Vigorous Physical Activity (MVPA) Amount
  time frame: Up to 365 days +- 30 days
  description: Minutes per Day of MVPA
  measure: Diabetic Ketoacidosis (DKA) Admission
  time frame: 90 days +- 30 days
  description: Rate of hospitalization for diabetic ketoacidosis
  measure: Diabetic Ketoacidosis (DKA) Admission
  time frame: 180 days +- 30 days
  description: Rate of hospitalization for diabetic ketoacidosis
  measure: Diabetic Ketoacidosis (DKA) Admission
  time frame: 365 +-30 days
  description: Rate of hospitalization for diabetic ketoacidosis
  measure: Change in Time in Range
  time frame: Over 90, 180, and 365 +- 30 days
  description: Time where blood glucose is in an appropriate range (and other glucose measurements)
  measure: Predicted Change
  time frame: 90 +- 30 days
  description: machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range
  measure: Predicted Change
  time frame: 180 +- 30 days
  description: machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range
  measure: Predicted Change
  time frame: 365 +- 30 days
  description: machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range
  measure: Minutes of Sleep per Day
  time frame: Up to 365 days +- 30 days
  description: Minutes of Sleep per Day
  measure: Self Reported Physical Activity
  time frame: 0 months
  description: Self-reported physical activity via the International Physical Activity Questionnaire Short Form (IPAQ-SF), no min or max, recording the amount of time spent in MVPA in the past week, higher amounts are better.
  measure: Self Reported Physical Activity
  time frame: 6 months
  description: Self-reported physical activity via the International Physical Activity Questionnaire Short Form (IPAQ- SF), no min or max, recording the amount of time spent in MVPA in the past week, higher amounts are better.
  measure: Self Reported Physical Activity
  time frame: 12 months
  description: Self-reported physical activity via the International Physical Activity Questionnaire Short Form (IPAQ-SF), no min or max, recording the amount of time spent in MVPA in the past week higher amounts are better.
  measure: Self Reported T1D Management
  time frame: 0 months
  description: Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome
  measure: Self Reported T1D Management
  time frame: 6 months
  description: Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome
  measure: Self Reported T1D Management
  time frame: 12 months
  description: Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome
  measure: Self Reported T1D Management
  time frame: 0 months
  description: Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome
  measure: Self Reported T1D Management
  time frame: 6 months
  description: Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome
  measure: Self Reported T1D Management
  time frame: 12 months
  description: Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome
  measure: Change in self reported physical activity levels
  time frame: Between 0, 6, and 12 months
  description: Change in self reported physical activity levels via self-report with the IPAQ survey no min or max, recording the amount of time spent in MVPA in the past week, higher amounts are better.
  measure: Change in how participants feel about episodes of hypoglycemia
  time frame: Between 0, 6, and 12 months
  description: Change in how participants feel about episodes of hypoglycemia measured via the Hypoglycemic Fear Scale II (HFS-II) min 0 max 132, higher scores are a worse outcome
  measure: Change in how parents feel about episodes of hypoglycemia in their children
  time frame: Between 0, 6, and 12 months
  description: Change in how parents feel about episodes of hypoglycemia in their children wearing the Garmin physical activity tracker via the Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome
  intervention type: Other
  intervention name: Garmin physical activity tracker
  description: The Garmin physical activity tracker is worn like a watch on the user. The tracker assesses several physical states, indicates when the body is at optimal time for activity or when the body needs to rest. The tracker also monitors stress levels and prompts relaxation when appropriate. The tracker sets goals with participants based on previously completed activity. The tracker alerts participants after a period of inactivity, encourages regular movement throughout the day, and decreases the amount of time spent sedentary.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 8 Years
  maximum age: 21 Years
  last name: Mark Clements, MD
  role: Principal Investigator
  affiliation: Children's Mercy
  last name: Priscilla Connell, MPH
  phone: 816-601-4543
  email: pcconnell@cmh.edu
  last name: Emily DeWit
  phone: 913 5155173
  email: eldewit@cmh.edu
  citation: Cescon M, Choudhary D, Pinsker JE, Dadlani V, Church MM, Kudva YC, Doyle Iii FJ, Dassau E. Activity detection and classification from wristband accelerometer data collected on people with type 1 diabetes in free-living conditions. Comput Biol Med. 2021 Aug;135:104633. doi: 10.1016/j.compbiomed.2021.104633. Epub 2021 Jul 12.
  PMID: 34346318
  citation: Grimes A, Lightner JS, Eighmy K, Steel C, Shook RP, Carlson J. Decreased Physical Activity Among Youth Resulting From COVID-19 Pandemic-Related School Closures: Natural Experimental Study. JMIR Form Res. 2022 Apr 15;6(4):e35854. doi: 10.2196/35854.
  PMID: 35297778
  citation: Jaggers JR, McKay T, King KM, Thrasher BJ, Wintergerst KA. Integration of Consumer-Based Activity Monitors into Clinical Practice for Children with Type 1 Diabetes: A Feasibility Study. Int J Environ Res Public Health. 2021 Oct 10;18(20):10611. doi: 10.3390/ijerph182010611.
  PMID: 34682355
  citation: Ozaslan B, Patek SD, Breton MD. Impact of Daily Physical Activity as Measured by Commonly Available Wearables on Mealtime Glucose Control in Type 1 Diabetes. Diabetes Technol Ther. 2020 Oct;22(10):742-748. doi: 10.1089/dia.2019.0517.
  PMID: 32105515
  responsible party type: Principal Investigator
  investigator affiliation: Children's Mercy Hospital Kansas City
  investigator full name: Mark Clements
  investigator title: Principal Investigator
  mesh term: Diabetes Mellitus, Type 1
  sharing ipd: No