<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/NCT04413578</url>
  </required_header>
  <id_info>
    <org_study_id>1050955</org_study_id>
    <nct_id>NCT04413578</nct_id>
  </id_info>
  <brief_title>CGM - Reimagine Primary Care</brief_title>
  <official_title>Assessing the Feasibility of Continuous Glucose Monitoring in Reimagine Primary Care Clinics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Intermountain Health Care, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Intermountain Health Care, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess the impact of continuous glucose monitoring versus standard of care (e.g. a&#xD;
      finger-prick protocol using a glucometer) on clinical outcomes, healthcare utilization, and&#xD;
      cost in patients with type I or II diabetes treated within the Reimagine Primary Care&#xD;
      clinics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a parallel randomized controlled trial. Eligible patients who consent will be&#xD;
      randomized to one of two groups: (1) the intervention group who will be given a Dexcom G6 for&#xD;
      CGM, or (2) the control group who will follow their current standard finger-prick protocol&#xD;
      via a provided Contour Next ONE glucometer. The CGM group must download the Dexcom G6 and&#xD;
      Clarity mobile apps for data capture, whereas the standard of care group will use the Contour&#xD;
      Next mobile app for their respective readings.&#xD;
&#xD;
      The Dexcom G6 captures real-time, dynamic glucose data every five minutes. Devices used in&#xD;
      this study are FDA approved and commercially available.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">November 28, 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Parallel Randomized Control Trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Patients were either randomized to the Dexcom G6 Device or the Contour NextOne a Standard of Care glucometer. Both subjects knew what they received after they were randomized.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>HbA1c Variation</measure>
    <time_frame>6 months</time_frame>
    <description>Coefficient of variation in HbA1c levels before, during and end of study completion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HbA1c Range</measure>
    <time_frame>6 months</time_frame>
    <description>Variation of range in HbA1c levels before, during and end of study completion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Current Diabetes Standards</measure>
    <time_frame>6 months</time_frame>
    <description>Current HEDIS performance on diabetes and behavioral health measures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral Changes</measure>
    <time_frame>6 months</time_frame>
    <description>Subjects will complete a self reported survey related to behavioral changes at end of study to assess self empowered behavioral changes after using the devices (e.g. feeling more empowered to self-manage care, engaged with changing healthcare behaviors, and patient perceptions of the technology).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypoglycemic Events</measure>
    <time_frame>6 months</time_frame>
    <description>Frequency of hypoglycemic events during the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare Utilization</measure>
    <time_frame>6 months</time_frame>
    <description>Healthcare utilization per count of inpatient/outpatient visits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic Variability</measure>
    <time_frame>6 months</time_frame>
    <description>Glycemic variability per mean amplitude of glycemic excursion (MAGE)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emergency Room Visits</measure>
    <time_frame>6 months</time_frame>
    <description>Emergency department visits per 1000 rate, overall and for patients with diabetes, and hospitalization per 1000 rate related to.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare Cost</measure>
    <time_frame>6 months</time_frame>
    <description>Cost per patient of healthcare for Emergency Room visits, blood draws, inpatient/outpatient services, medications etc.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Dexcom G6 (Intervention Group)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>• Intervention group: CGM using a Dexcom G6 to measure glycosylated hemoglobin levels every five minutes. Patients will be asked to download the Dexcom G6 and Clarity applications (to have access to their real-time data) and be given a link to complete an exit survey in REDCap near the end of their study participation. Data will be sent via Bluetooth and then exported by the Intermountain research team into a Tableau (or similar) dashboard for data analysis/comparison</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Contour NextOne (Standard of Care) Glucometer</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>• Control group: A standard finger-prick protocol that will require patients to continue with their daily fingerprick regimen established by their physician. This group will be given a Contour Next One meter to ensure that each patient is receiving the same level of accuracy by the same device. A review by Ekhlaspour et al of 17 glucose meters demonstrated wide variability, with only two devices achieving the 2013 ISO standard (with the most accurate being the Contour Next). Patients in the control group will be asked to download the Contour Next application which will send data via Bluetooth similar to above. Data will be aggregated, and protected health information removed prior to analysis (by Intermountain Healthcare and Savvysherpa). At the end of the study, patients will be asked to complete a short survey in REDCap about their willingness to participate in future studies.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dexcom G6</intervention_name>
    <description>Continuous Glucose Monitor that, after applied, sends continuous glucose readings to to the patient's smartphone every 5 minutes. This allows the patients to receive more readings over a 24 hour period versus standard of care glucometer finger sticks.</description>
    <arm_group_label>Dexcom G6 (Intervention Group)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Contour NextOne</intervention_name>
    <description>A Standard of Care Glucometer with Bluetooth capability. The patient inserts a test strip into the device, takes a finger stick and collects a small blood sample on the tip of the strip to initiate the device to detect a glucose reading.</description>
    <arm_group_label>Contour NextOne (Standard of Care) Glucometer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 1 or type 2 diabetes mellitus with a HbA1c ≥6.5%&#xD;
&#xD;
          -  Patients that are currently managing their glucose levels for diabetes with a glucose&#xD;
             meter (or will be prescribed one by their healthcare provider)&#xD;
&#xD;
          -  Patients that are treated within the four Reimagine Primary Care clinics (Cottonwood&#xD;
             Family Medicine, Cottonwood Senior, Avenues Internal Medicine, and Holladay Internal&#xD;
             Medicine). • Patients 18-80 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients that are not managing their glucose levels for diabetes (and not advised to&#xD;
             use a glucose monitor by their physician)&#xD;
&#xD;
          -  Patients that are not treated within the four Reimagine Primary Care clinics&#xD;
&#xD;
          -  Patients less than 18 years of age, and 81 years of age and older&#xD;
&#xD;
          -  Patients with a diagnosis of dementia&#xD;
&#xD;
          -  If the patient is currently using a Continuous Glucose Monitor&#xD;
&#xD;
          -  Patients with previous hospitalization for hypoglycemia within the last 18 months&#xD;
&#xD;
          -  No access to a mobile phone to download the Dexcom or Contour Next applications&#xD;
&#xD;
          -  Patients who are pregnant or planning to become pregnant over the course of their&#xD;
             six-month participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Holladay Internal Medicine</name>
      <address>
        <city>Holladay</city>
        <state>Utah</state>
        <zip>84121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Intermountain Cottonwood Family Practice</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Intermountain Senior Clinic</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Avenues Internal Medicine</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.niddk.nih.gov/health-information/diabetes/overview/what-is-diabetes</url>
    <description>What is Diabetes</description>
  </link>
  <link>
    <url>https://www.cdc.gov/diabetes/basics/prediabetes.html</url>
    <description>Preventing prediabetes</description>
  </link>
  <link>
    <url>http://professional.diabetes.org/diapro/glucose_calc</url>
    <description>Diabetes and glucose information</description>
  </link>
  <results_reference>
    <citation>Lee PA, Greenfield G, Pappas Y. The impact of telehealth remote patient monitoring on glycemic control in type 2 diabetes: a systematic review and meta-analysis of systematic reviews of randomised controlled trials. BMC Health Serv Res. 2018 Jun 26;18(1):495. doi: 10.1186/s12913-018-3274-8.</citation>
    <PMID>29940936</PMID>
  </results_reference>
  <results_reference>
    <citation>Medical Advisory Secretariat. Home telemonitoring for type 2 diabetes: an evidence-based analysis. Ont Health Technol Assess Ser. 2009;9(24):1-38. Epub 2009 Oct 1.</citation>
    <PMID>23074529</PMID>
  </results_reference>
  <results_reference>
    <citation>Ekhlaspour L, Mondesir D, Lautsch N, Balliro C, Hillard M, Magyar K, Radocchia LG, Esmaeili A, Sinha M, Russell SJ. Comparative Accuracy of 17 Point-of-Care Glucose Meters. J Diabetes Sci Technol. 2017 May;11(3):558-566. doi: 10.1177/1932296816672237. Epub 2016 Oct 3.</citation>
    <PMID>27697848</PMID>
  </results_reference>
  <results_reference>
    <citation>Verkuilen J. Explanatory Item Response Models: A Generalized Linear and Nonlinear Approach by P. de Boeck and M. Wilson and Generalized Latent Variable Modeling: Multilevel, Longitudinal and Structural Equation Models by A. Skrondal and S. Rabe-Hesketh. Psychometrika. 2006 Jun;71(2):415-418. doi: 10.1007/s11336-005-1333-7. No abstract available.</citation>
    <PMID>28197954</PMID>
  </results_reference>
  <results_reference>
    <citation>Fong Y, Rue H, Wakefield J. Bayesian inference for generalized linear mixed models. Biostatistics. 2010 Jul;11(3):397-412. doi: 10.1093/biostatistics/kxp053. Epub 2009 Dec 4.</citation>
    <PMID>19966070</PMID>
  </results_reference>
  <results_reference>
    <citation>Musio M, Sauleau EA, Augustin NH. Resources allocation in healthcare for cancer: a case study using generalised additive mixed models. Geospat Health. 2012 Nov;7(1):83-9. doi: 10.4081/gh.2012.107.</citation>
    <PMID>23242683</PMID>
  </results_reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Continuous Glucose Monitor (CGM)</keyword>
  <keyword>Dexcom G6</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 12, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT04413578/ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 8, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT04413578/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04413578
org study id: 1050955
nct id: NCT04413578
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
To assess the impact of continuous glucose monitoring versus standard of care (e.g. a
      finger-prick protocol using a glucometer) on clinical outcomes, healthcare utilization, and
      cost in patients with type I or II diabetes treated within the Reimagine Primary Care
      clinics.
This is a parallel randomized controlled trial. Eligible patients who consent will be
      randomized to one of two groups: (1) the intervention group who will be given a Dexcom G6 for
      CGM, or (2) the control group who will follow their current standard finger-prick protocol
      via a provided Contour Next ONE glucometer. The CGM group must download the Dexcom G6 and
      Clarity mobile apps for data capture, whereas the standard of care group will use the Contour
      Next mobile app for their respective readings.

      The Dexcom G6 captures real-time, dynamic glucose data every five minutes. Devices used in
      this study are FDA approved and commercially available.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel Randomized Control Trial
primary purpose: Treatment
masking: None (Open Label)
masking description: Patients were either randomized to the Dexcom G6 Device or the Contour NextOne a Standard of Care glucometer. Both subjects knew what they received after they were randomized.
measure: HbA1c Variation
time frame: 6 months
description: Coefficient of variation in HbA1c levels before, during and end of study completion.
measure: HbA1c Range
time frame: 6 months
description: Variation of range in HbA1c levels before, during and end of study completion.
measure: Current Diabetes Standards
time frame: 6 months
description: Current HEDIS performance on diabetes and behavioral health measures.
measure: Behavioral Changes
time frame: 6 months
description: Subjects will complete a self reported survey related to behavioral changes at end of study to assess self empowered behavioral changes after using the devices (e.g. feeling more empowered to self-manage care, engaged with changing healthcare behaviors, and patient perceptions of the technology).
measure: Hypoglycemic Events
time frame: 6 months
description: Frequency of hypoglycemic events during the study.
measure: Healthcare Utilization
time frame: 6 months
description: Healthcare utilization per count of inpatient/outpatient visits.
measure: Glycemic Variability
time frame: 6 months
description: Glycemic variability per mean amplitude of glycemic excursion (MAGE)
measure: Emergency Room Visits
time frame: 6 months
description: Emergency department visits per 1000 rate, overall and for patients with diabetes, and hospitalization per 1000 rate related to.
measure: Healthcare Cost
time frame: 6 months
description: Cost per patient of healthcare for Emergency Room visits, blood draws, inpatient/outpatient services, medications etc.
arm group label: Dexcom G6 (Intervention Group)
arm group type: Experimental
description: • Intervention group: CGM using a Dexcom G6 to measure glycosylated hemoglobin levels every five minutes. Patients will be asked to download the Dexcom G6 and Clarity applications (to have access to their real-time data) and be given a link to complete an exit survey in REDCap near the end of their study participation. Data will be sent via Bluetooth and then exported by the Intermountain research team into a Tableau (or similar) dashboard for data analysis/comparison
arm group label: Contour NextOne (Standard of Care) Glucometer
arm group type: Placebo Comparator
description: • Control group: A standard finger-prick protocol that will require patients to continue with their daily fingerprick regimen established by their physician. This group will be given a Contour Next One meter to ensure that each patient is receiving the same level of accuracy by the same device. A review by Ekhlaspour et al of 17 glucose meters demonstrated wide variability, with only two devices achieving the 2013 ISO standard (with the most accurate being the Contour Next). Patients in the control group will be asked to download the Contour Next application which will send data via Bluetooth similar to above. Data will be aggregated, and protected health information removed prior to analysis (by Intermountain Healthcare and Savvysherpa). At the end of the study, patients will be asked to complete a short survey in REDCap about their willingness to participate in future studies.
intervention type: Device
intervention name: Dexcom G6
description: Continuous Glucose Monitor that, after applied, sends continuous glucose readings to to the patient's smartphone every 5 minutes. This allows the patients to receive more readings over a 24 hour period versus standard of care glucometer finger sticks.
arm group label: Dexcom G6 (Intervention Group)
intervention type: Device
intervention name: Contour NextOne
description: A Standard of Care Glucometer with Bluetooth capability. The patient inserts a test strip into the device, takes a finger stick and collects a small blood sample on the tip of the strip to initiate the device to detect a glucose reading.
arm group label: Contour NextOne (Standard of Care) Glucometer
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://www.niddk.nih.gov/health-information/diabetes/overview/what-is-diabetes
description: What is Diabetes
url: https://www.cdc.gov/diabetes/basics/prediabetes.html
description: Preventing prediabetes
url: http://professional.diabetes.org/diapro/glucose_calc
description: Diabetes and glucose information
citation: Lee PA, Greenfield G, Pappas Y. The impact of telehealth remote patient monitoring on glycemic control in type 2 diabetes: a systematic review and meta-analysis of systematic reviews of randomised controlled trials. BMC Health Serv Res. 2018 Jun 26;18(1):495. doi: 10.1186/s12913-018-3274-8.
PMID: 29940936
citation: Medical Advisory Secretariat. Home telemonitoring for type 2 diabetes: an evidence-based analysis. Ont Health Technol Assess Ser. 2009;9(24):1-38. Epub 2009 Oct 1.
PMID: 23074529
citation: Ekhlaspour L, Mondesir D, Lautsch N, Balliro C, Hillard M, Magyar K, Radocchia LG, Esmaeili A, Sinha M, Russell SJ. Comparative Accuracy of 17 Point-of-Care Glucose Meters. J Diabetes Sci Technol. 2017 May;11(3):558-566. doi: 10.1177/1932296816672237. Epub 2016 Oct 3.
PMID: 27697848
citation: Verkuilen J. Explanatory Item Response Models: A Generalized Linear and Nonlinear Approach by P. de Boeck and M. Wilson and Generalized Latent Variable Modeling: Multilevel, Longitudinal and Structural Equation Models by A. Skrondal and S. Rabe-Hesketh. Psychometrika. 2006 Jun;71(2):415-418. doi: 10.1007/s11336-005-1333-7. No abstract available.
PMID: 28197954
citation: Fong Y, Rue H, Wakefield J. Bayesian inference for generalized linear mixed models. Biostatistics. 2010 Jul;11(3):397-412. doi: 10.1093/biostatistics/kxp053. Epub 2009 Dec 4.
PMID: 19966070
citation: Musio M, Sauleau EA, Augustin NH. Resources allocation in healthcare for cancer: a case study using generalised additive mixed models. Geospat Health. 2012 Nov;7(1):83-9. doi: 10.4081/gh.2012.107.
PMID: 23242683
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No
provided document: 
provided document: 