<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/NCT02974816</url>
  </required_header>
  <id_info>
    <org_study_id>GL1</org_study_id>
    <nct_id>NCT02974816</nct_id>
  </id_info>
  <brief_title>Glooko mHealth Advantage Study</brief_title>
  <official_title>The Glooko Diabetes Mobile Monitoring and Management Advantage Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Glooko</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Glooko</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>
      The purpose of this study is to compare HbA1c of insulin-treated subjects with type 2&#xD;
      diabetes managed via usual care alone and usual care augmented with remote monitoring using&#xD;
      Glooko&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, the investigator wants to evaluate if diabetes self-management supported by a&#xD;
      mobile application, which captures a subject's blood glucose readings, lifestyle and&#xD;
      medication information and shares it with the subject's certified diabetes educator (CDE) to&#xD;
      enable remote monitoring, improves their glycemic control compared to standard of care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2017</start_date>
  <completion_date type="Actual">April 17, 2020</completion_date>
  <primary_completion_date type="Actual">April 17, 2020</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in HbA1c from baseline</measure>
    <time_frame>24 weeks</time_frame>
    <description>Change in HbA1c from baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1c from baseline</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change in HbA1c from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients achieving &lt;/=7%</measure>
    <time_frame>12 and 24 weeks</time_frame>
    <description>Percentage of patients achieving &lt;/=7%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Basal insulin dose(Change from baseline)</measure>
    <time_frame>12 and 24 weeks</time_frame>
    <description>Basal insulin dose(Change from baseline)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bolus insulin dose(Change from baseline)</measure>
    <time_frame>12 and 24 weeks</time_frame>
    <description>Bolus insulin dose(Change from baseline)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Total insulin dose(Change from baseline)</measure>
    <time_frame>12 and 24 weeks</time_frame>
    <description>Change in Total insulin dose(Change from baseline)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight(Change from baseline)</measure>
    <time_frame>12 and 24 weeks</time_frame>
    <description>Weight(Change from baseline)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Problem Areas in Diabetes score(Change from baseline)</measure>
    <time_frame>12 and 24 weeks</time_frame>
    <description>Problem Areas in Diabetes score(Change from baseline)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of hypoglycemic events (blood glucose level &lt;70mg/dL)</measure>
    <time_frame>12 and 24 weeks</time_frame>
    <description>Rate of hypoglycemic events (blood glucose level &lt;70mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-monitoring blood glucose frequency</measure>
    <time_frame>12 and 24 weeks</time_frame>
    <description>Self-monitoring blood glucose frequency</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean blood glucose concentration(Change from baseline)</measure>
    <time_frame>12 and 24 weeks</time_frame>
    <description>Mean blood glucose concentration(Change from baseline)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of ER visits(Change from baseline)</measure>
    <time_frame>12 and 24 weeks</time_frame>
    <description>Number of ER visits(Change from baseline)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hospitalizations(Change from baseline)</measure>
    <time_frame>12 and 24 weeks</time_frame>
    <description>Number of hospitalizations(Change from baseline)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">197</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects in this arm will visit their physician once every 3 months and will receive usual care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Remote Monitoring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this arm will visit their physician once every 3 months and will receive usual care. In addition, in between clinic visits, subjects will measure their blood glucose (BG) readings at least once a day and share their BG readings with their CDE using Glooko's mobile application. Once a week, the CDE will review the subject's BG readings on Glooko's population tracker and reach out to the subjects if he/she experienced clinical incident(s). During the conversation, the CDE will either recommend medication or lifestyle modification to address the clinical incident.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Glooko's mobile application</intervention_name>
    <description>Standard of care and Remote monitoring</description>
    <arm_group_label>Remote Monitoring</arm_group_label>
    <other_name>Glooko's Population Tracker, Meter Sync Blue</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject has voluntarily signed and dated an informed consent form, approved by an&#xD;
             Institutional Review Board/Independent Ethics Committee, and provided Health Insurance&#xD;
             Portability and Accountability Act (HIPAA) or other privacy authorization prior to any&#xD;
             participation in study.&#xD;
&#xD;
          2. Subject has self-reported type 2 diabetes.&#xD;
&#xD;
          3. Subject has HbA1c ≥ 7.5% and ≤ 12.5% measured within 30 days of screening visit.&#xD;
&#xD;
          4. Subject is on a stable diabetes therapeutic regimen of two or more diabetic&#xD;
             medications (e.g., metformin plus one other antihyperglycemic agent) and/or insulin&#xD;
             therapy for at least 2 months before screening visit. Dose changes or adjustments made&#xD;
             within 2 months is acceptable as long as the patient has been on the medication&#xD;
             regimen for 2 months or longer.&#xD;
&#xD;
          5. Subject is ≥ 18 and ≤ 75 years of age.&#xD;
&#xD;
          6. Subject is a male or non-pregnant, non-lactating female, at least 6 weeks postpartum&#xD;
             prior to screening visit. A urine pregnancy test is required for all female subjects&#xD;
             unless she is not of childbearing potential, defined as postmenopausal for at least&#xD;
             one year prior to screening visit or surgically sterile (bilateral tubal ligation,&#xD;
             bilateral oophorectomy, or hysterectomy).&#xD;
&#xD;
          7. If female is of childbearing potential, is practicing one of the following methods of&#xD;
             birth control (and will continue through the duration of the study):&#xD;
&#xD;
               1. Condoms, sponge, diaphragm, or intrauterine device;&#xD;
&#xD;
               2. Oral or parenteral contraceptives for 3 months prior to screening visit;&#xD;
&#xD;
               3. Vasectomized partner;&#xD;
&#xD;
               4. Total abstinence from sexual intercourse&#xD;
&#xD;
          8. Subject is able to speak, read and write in English&#xD;
&#xD;
          9. Subject has a Glooko compatible smartphone/device with an active data plan or access&#xD;
             to Wi-Fi and downloaded at least one mobile application on their phone on their own.&#xD;
&#xD;
         10. Subject has performed self-monitoring of blood glucose at least five (5) times within&#xD;
             two (2) weeks prior to screening visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has type 1 diabetes.&#xD;
&#xD;
          2. Subject has advanced disease (physical or psychological) that would prevent them from&#xD;
             being able to comply with study tasks and considered exclusionary by the study&#xD;
             physicians.&#xD;
&#xD;
          3. Subject has been on medication or therapy within the last 2 months that severely&#xD;
             affects blood glucose levels (e.g. corticosteroids).&#xD;
&#xD;
          4. Subject has visual impairment which severely limits his/her ability to see or use the&#xD;
             mobile application.&#xD;
&#xD;
          5. Subject is a participant in another clinical study that has not been approved as a&#xD;
             concomitant study by Glooko.&#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>Michael Greenfield, MD</last_name>
    <role>Study Director</role>
    <affiliation>Glooko</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>John Muir Physician Network Clinical Research Center</name>
      <address>
        <city>Concord</city>
        <state>California</state>
        <zip>94520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sutter Health</name>
      <address>
        <city>Elk Grove</city>
        <state>California</state>
        <zip>95758</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scripps Whittier Diabetes Institute</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Billings Clinic</name>
      <address>
        <city>Billings</city>
        <state>Montana</state>
        <zip>59101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Huang ES, Basu A, O'Grady M, Capretta JC. Projecting the future diabetes population size and related costs for the U.S. Diabetes Care. 2009 Dec;32(12):2225-9. doi: 10.2337/dc09-0459.</citation>
    <PMID>19940225</PMID>
  </reference>
  <reference>
    <citation>Cowie CC, Rust KF, Ford ES, Eberhardt MS, Byrd-Holt DD, Li C, Williams DE, Gregg EW, Bainbridge KE, Saydah SH, Geiss LS. Full accounting of diabetes and pre-diabetes in the U.S. population in 1988-1994 and 2005-2006. Diabetes Care. 2009 Feb;32(2):287-94. doi: 10.2337/dc08-1296. Epub 2008 Nov 18. Erratum In: Diabetes Care. 2011 Oct;34(10):2338.</citation>
    <PMID>19017771</PMID>
  </reference>
  <reference>
    <citation>Quinn CC, Shardell MD, Terrin ML, Barr EA, Ballew SH, Gruber-Baldini AL. Cluster-randomized trial of a mobile phone personalized behavioral intervention for blood glucose control. Diabetes Care. 2011 Sep;34(9):1934-42. doi: 10.2337/dc11-0366. Epub 2011 Jul 25. Erratum In: Diabetes Care. 2013 Nov;36(11):3850.</citation>
    <PMID>21788632</PMID>
  </reference>
  <reference>
    <citation>Standards of medical care in diabetes--2015: summary of revisions. Diabetes Care. 2015 Jan;38 Suppl:S4. doi: 10.2337/dc15-S003. No abstract available.</citation>
    <PMID>25537706</PMID>
  </reference>
  <reference>
    <citation>Fisher L, Glasgow RE, Mullan JT, Skaff MM, Polonsky WH. Development of a brief diabetes distress screening instrument. Ann Fam Med. 2008 May-Jun;6(3):246-52. doi: 10.1370/afm.842.</citation>
    <PMID>18474888</PMID>
  </reference>
  <reference>
    <citation>Welch GW, Jacobson AM, Polonsky WH. The Problem Areas in Diabetes Scale. An evaluation of its clinical utility. Diabetes Care. 1997 May;20(5):760-6. doi: 10.2337/diacare.20.5.760.</citation>
    <PMID>9135939</PMID>
  </reference>
  <reference>
    <citation>UK Prospective Diabetes Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. UK Prospective Diabetes Study Group. BMJ. 1998 Sep 12;317(7160):703-13. Erratum In: BMJ 1999 Jan 2;318(7175):29.</citation>
    <PMID>9732337</PMID>
  </reference>
  <reference>
    <citation>American Diabetes Association. Economic costs of diabetes in the U.S. in 2012. Diabetes Care. 2013 Apr;36(4):1033-46. doi: 10.2337/dc12-2625. Epub 2013 Mar 6.</citation>
    <PMID>23468086</PMID>
  </reference>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>June 2, 2021</last_update_submitted>
  <last_update_submitted_qc>June 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Glooko</keyword>
  <keyword>Mobile health application</keyword>
  <keyword>Insulin treated</keyword>
  <keyword>Type 2 Diabetes</keyword>
  <keyword>Remote patient monitoring</keyword>
  <keyword>Certified diabetes educator</keyword>
  <keyword>mHealth Advantage</keyword>
  <keyword>Population health</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>
  <!-- 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/NCT02974816
org study id: GL1
nct id: NCT02974816
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to compare HbA1c of insulin-treated subjects with type 2
      diabetes managed via usual care alone and usual care augmented with remote monitoring using
      Glooko
In this study, the investigator wants to evaluate if diabetes self-management supported by a
      mobile application, which captures a subject's blood glucose readings, lifestyle and
      medication information and shares it with the subject's certified diabetes educator (CDE) to
      enable remote monitoring, improves their glycemic control compared to standard of care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in HbA1c from baseline
time frame: 24 weeks
description: Change in HbA1c from baseline
measure: Change in HbA1c from baseline
time frame: 12 weeks
description: Change in HbA1c from baseline
measure: Percentage of patients achieving </=7%
time frame: 12 and 24 weeks
description: Percentage of patients achieving </=7%
measure: Basal insulin dose(Change from baseline)
time frame: 12 and 24 weeks
description: Basal insulin dose(Change from baseline)
measure: Bolus insulin dose(Change from baseline)
time frame: 12 and 24 weeks
description: Bolus insulin dose(Change from baseline)
measure: Change in Total insulin dose(Change from baseline)
time frame: 12 and 24 weeks
description: Change in Total insulin dose(Change from baseline)
measure: Weight(Change from baseline)
time frame: 12 and 24 weeks
description: Weight(Change from baseline)
measure: Problem Areas in Diabetes score(Change from baseline)
time frame: 12 and 24 weeks
description: Problem Areas in Diabetes score(Change from baseline)
measure: Rate of hypoglycemic events (blood glucose level <70mg/dL)
time frame: 12 and 24 weeks
description: Rate of hypoglycemic events (blood glucose level <70mg/dL)
measure: Self-monitoring blood glucose frequency
time frame: 12 and 24 weeks
description: Self-monitoring blood glucose frequency
measure: Mean blood glucose concentration(Change from baseline)
time frame: 12 and 24 weeks
description: Mean blood glucose concentration(Change from baseline)
measure: Number of ER visits(Change from baseline)
time frame: 12 and 24 weeks
description: Number of ER visits(Change from baseline)
measure: Number of hospitalizations(Change from baseline)
time frame: 12 and 24 weeks
description: Number of hospitalizations(Change from baseline)
arm group label: Standard of Care
arm group type: No Intervention
description: Subjects in this arm will visit their physician once every 3 months and will receive usual care.
arm group label: Remote Monitoring
arm group type: Experimental
description: Subjects in this arm will visit their physician once every 3 months and will receive usual care. In addition, in between clinic visits, subjects will measure their blood glucose (BG) readings at least once a day and share their BG readings with their CDE using Glooko's mobile application. Once a week, the CDE will review the subject's BG readings on Glooko's population tracker and reach out to the subjects if he/she experienced clinical incident(s). During the conversation, the CDE will either recommend medication or lifestyle modification to address the clinical incident.
intervention type: Device
intervention name: Glooko's mobile application
description: Standard of care and Remote monitoring
arm group label: Remote Monitoring
other name: Glooko's Population Tracker, Meter Sync Blue
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Michael Greenfield, MD
role: Study Director
affiliation: Glooko
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Huang ES, Basu A, O'Grady M, Capretta JC. Projecting the future diabetes population size and related costs for the U.S. Diabetes Care. 2009 Dec;32(12):2225-9. doi: 10.2337/dc09-0459.
PMID: 19940225
citation: Cowie CC, Rust KF, Ford ES, Eberhardt MS, Byrd-Holt DD, Li C, Williams DE, Gregg EW, Bainbridge KE, Saydah SH, Geiss LS. Full accounting of diabetes and pre-diabetes in the U.S. population in 1988-1994 and 2005-2006. Diabetes Care. 2009 Feb;32(2):287-94. doi: 10.2337/dc08-1296. Epub 2008 Nov 18. Erratum In: Diabetes Care. 2011 Oct;34(10):2338.
PMID: 19017771
citation: Quinn CC, Shardell MD, Terrin ML, Barr EA, Ballew SH, Gruber-Baldini AL. Cluster-randomized trial of a mobile phone personalized behavioral intervention for blood glucose control. Diabetes Care. 2011 Sep;34(9):1934-42. doi: 10.2337/dc11-0366. Epub 2011 Jul 25. Erratum In: Diabetes Care. 2013 Nov;36(11):3850.
PMID: 21788632
citation: Standards of medical care in diabetes--2015: summary of revisions. Diabetes Care. 2015 Jan;38 Suppl:S4. doi: 10.2337/dc15-S003. No abstract available.
PMID: 25537706
citation: Fisher L, Glasgow RE, Mullan JT, Skaff MM, Polonsky WH. Development of a brief diabetes distress screening instrument. Ann Fam Med. 2008 May-Jun;6(3):246-52. doi: 10.1370/afm.842.
PMID: 18474888
citation: Welch GW, Jacobson AM, Polonsky WH. The Problem Areas in Diabetes Scale. An evaluation of its clinical utility. Diabetes Care. 1997 May;20(5):760-6. doi: 10.2337/diacare.20.5.760.
PMID: 9135939
citation: UK Prospective Diabetes Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. UK Prospective Diabetes Study Group. BMJ. 1998 Sep 12;317(7160):703-13. Erratum In: BMJ 1999 Jan 2;318(7175):29.
PMID: 9732337
citation: American Diabetes Association. Economic costs of diabetes in the U.S. in 2012. Diabetes Care. 2013 Apr;36(4):1033-46. doi: 10.2337/dc12-2625. Epub 2013 Mar 6.
PMID: 23468086
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No