<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/NCT03017287</url>
  </required_header>
  <id_info>
    <org_study_id>Clin-002-00</org_study_id>
    <nct_id>NCT03017287</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of the GlucoMe APP in Patients With Uncontrolled Diabetes Treated With MDI</brief_title>
  <official_title>Safety and Efficacy of the GlucoMe APP in Patients With Uncontrolled Diabetes Treated With MDI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlucoMe</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlucoMe</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will evaluate the safety and efficacy of computerized GlucoMe App in patients with&#xD;
      uncontrolled diabetes treated with MDI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      GlucoMe is an interactive system, which provides glucose management tools to both the patient&#xD;
      and health care team (HCT). The system includes a decision support system to be used by the&#xD;
      HCT aiming to aid clinical decision making with mathematical models. The system does not&#xD;
      intend to replace clinical judgement and all recommendations are to be approved by the HCT.&#xD;
&#xD;
      Forty (40) diabetic patients on multiple daily insulin injection (MDI) with abnormal HbA1c&#xD;
      and identified as potential end users of the device will be recruited to the study and&#xD;
      screened according to the study inclusion and exclusion criteria. Patient's daily blood&#xD;
      glucose will be measured and the GlucoMe App will give its recommendations for change in&#xD;
      insulin dose, as well as recommendations for pre and post-meal carbohydrate and exercise.&#xD;
      Patient's daily blood glucose levels will be followed by the HCT biweekly for 12 weeks and&#xD;
      patients will be instructed to change their insulin doses according to the decision of the&#xD;
      treating physician. At the end of the study, the HCT's recommendations for treatment&#xD;
      adjustment will be compared to those of the system for both safety and efficacy. Study&#xD;
      subjects and the HCT will be asked to complete a questionnaire regarding the GlucoMe system&#xD;
      usability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Poor accrual&#xD;
  </why_stopped>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hypoglycemic and Hyperglycemic Events</measure>
    <time_frame>At 12 weeks of the study</time_frame>
    <description>Number and severity of hypoglycemic and severe hyperglycemic events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation between GlucoMe and HCT recommendations</measure>
    <time_frame>At 12 weeks of the study</time_frame>
    <description>Correlation between GlucoMe and HCT recommendations for changing insulin dose and the treating physician/HCT advice.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Target HbA1C/glucose achievement</measure>
    <time_frame>At 12 weeks of the study</time_frame>
    <description>Percent of patients that achieve HbA1C/glucose targets</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Diabetes Mellitus, Type 1 or 2</condition>
  <arm_group>
    <arm_group_label>GlucoMe App</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Self monitoring of glucose blood measurements using the GlucoMe glucose monitoring glucose device and App</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GlucoMe App</intervention_name>
    <description>Assessment of the the GlucoMe App</description>
    <arm_group_label>GlucoMe App</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Both type 1 and type 2 diabetes&#xD;
&#xD;
          2. HbA1c 7-11%&#xD;
&#xD;
          3. Treated with MDI for at least 3 months&#xD;
&#xD;
          4. Ability to use the system at home, mobile phone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Active CAD, CVA during last 6 months&#xD;
&#xD;
          2. Treatment with steroids or other glucose modifying drugs&#xD;
&#xD;
          3. Chronic infection/cancer/other severe disease&#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>Diabitic Unit of the Wolfson Medical Center</name>
      <address>
        <city>Holon</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>September 21, 2020</last_update_submitted>
  <last_update_submitted_qc>September 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Glucose blood measurements, glucometer, BGM, Diabetes App</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>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/NCT03017287
org study id: Clin-002-00
nct id: NCT03017287
lead sponsor: 
has dmc: No
The study will evaluate the safety and efficacy of computerized GlucoMe App in patients with
      uncontrolled diabetes treated with MDI.
GlucoMe is an interactive system, which provides glucose management tools to both the patient
      and health care team (HCT). The system includes a decision support system to be used by the
      HCT aiming to aid clinical decision making with mathematical models. The system does not
      intend to replace clinical judgement and all recommendations are to be approved by the HCT.

      Forty (40) diabetic patients on multiple daily insulin injection (MDI) with abnormal HbA1c
      and identified as potential end users of the device will be recruited to the study and
      screened according to the study inclusion and exclusion criteria. Patient's daily blood
      glucose will be measured and the GlucoMe App will give its recommendations for change in
      insulin dose, as well as recommendations for pre and post-meal carbohydrate and exercise.
      Patient's daily blood glucose levels will be followed by the HCT biweekly for 12 weeks and
      patients will be instructed to change their insulin doses according to the decision of the
      treating physician. At the end of the study, the HCT's recommendations for treatment
      adjustment will be compared to those of the system for both safety and efficacy. Study
      subjects and the HCT will be asked to complete a questionnaire regarding the GlucoMe system
      usability.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Hypoglycemic and Hyperglycemic Events
time frame: At 12 weeks of the study
description: Number and severity of hypoglycemic and severe hyperglycemic events
measure: Correlation between GlucoMe and HCT recommendations
time frame: At 12 weeks of the study
description: Correlation between GlucoMe and HCT recommendations for changing insulin dose and the treating physician/HCT advice.
measure: Target HbA1C/glucose achievement
time frame: At 12 weeks of the study
description: Percent of patients that achieve HbA1C/glucose targets
arm group label: GlucoMe App
arm group type: Experimental
description: Self monitoring of glucose blood measurements using the GlucoMe glucose monitoring glucose device and App
intervention type: Device
intervention name: GlucoMe App
description: Assessment of the the GlucoMe App
arm group label: GlucoMe App
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No