<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/NCT03840161</url>
  </required_header>
  <id_info>
    <org_study_id>CNG-NGM-003</org_study_id>
    <nct_id>NCT03840161</nct_id>
  </id_info>
  <brief_title>Use of CoG by Patients With Diabetes Mellitus</brief_title>
  <official_title>Evaluation of the CNOGA TensorTip COMBO GLUCOMETER (CoG) During Standardized Meal Test and Consecutive Home Use by Patients With Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sciema UG</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cnoga Medical Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Sciema UG</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_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The CNOGA Combo Glucometer (CoG) employs an invasive glucose meter using blood glucose&#xD;
      teststrips and requiering a capillary blood sample obtained from a fingerstick and in&#xD;
      addition, a non-invasive optical component for prediction of tissue glucose at the fingertip.&#xD;
      In this study, participants will use both devices during meal tests and also at home during&#xD;
      routine care. The results from the device will be compared to a standard reference method and&#xD;
      will be used to determine the accuracy of the two device components.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The trial starts with a screening and training visit (V1). This is followed by an individual&#xD;
      calibration period for the non-invasive device component by means of multiple parallel&#xD;
      measurements with the invasive and the noninvasive device component. This will be done by the&#xD;
      participants at home. Thereafter, the participants will come to the study site and will&#xD;
      ingest a standardized meal (V2). Blood will be drawn for assessment of HbA1c and biochemical&#xD;
      safety parameters. During the next 3 hours, 11 fingersticks will be made to obtain capillary&#xD;
      blood samples for comparator readings with the two CoG components and with a laboratory&#xD;
      reference method (YSI gucose analyzer). The patients will now continue to use the devices at&#xD;
      home for three months, but are not allowed to use any CoG result for treatment decisions. In&#xD;
      an interim visit after 6 weeks (V3), blood will be drawrn for HbA1c and biochemical safety&#xD;
      parameters and three comparison measurements will be made with the CoG device components and&#xD;
      the laboratory reference method. At the final visit after 12 weeks (V4), the procedures of&#xD;
      the first meal test visit (V2) will be repeated, which conludes that study. In addition, the&#xD;
      participants will be asked to complete a device satisfaction questionnaire at V2, V3, and V4.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 16, 2018</start_date>
  <completion_date type="Actual">March 31, 2019</completion_date>
  <primary_completion_date type="Actual">February 28, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>CoG accuracy in measuring glucose levels (non-invasively) during a standardized meal experiment.</measure>
    <time_frame>Experiment will be performed twice within 3 months</time_frame>
    <description>Comparison of non-invasive CoG device measurements (tissue glucose in mg/dL) with the results of a standard laboratory reference method (YSI glucose analyzer, blood glucose in mg/dL) by consensus-error grid analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CoG accuracy in monitoring glucose levels (invasively) during a standardized meal experiment.</measure>
    <time_frame>Experiment will be performed twice within 3 months</time_frame>
    <description>Comparison of CoG invasive device readings (blood glucose in mg/dL) with the results of a standard laboratory reference method (YSI glucose analyzer, blood glucose in mg/dL) by consensus-error grid analysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact of the CoG on long-term (three month) glycemic control (HbA1c using standard laboratory procedures) in patients with type 1 and 2 diabetes</measure>
    <time_frame>3 months</time_frame>
    <description>Change in HbA1c from baseline after 6 weeks and 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment satisfaction questionnaire</measure>
    <time_frame>3 months</time_frame>
    <description>Change in device satisfaction questionnaire score after 6 weeks and 12 weeks</description>
  </secondary_outcome>
  <enrollment type="Actual">40</enrollment>
  <condition>Diabetes Mellitus</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>non-invasive tissue glucose prediction</intervention_name>
    <description>Generation of non-invasive and invasive glucose readings for comparison with a standard laboratory reference glucose determination method (YSI glucose analyzer)</description>
    <other_name>invasive blood glucose measurement</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with diabetes mellitus (type 1 or type 2, any treatment) of other than caucasian&#xD;
        origin, who are experienced with performing blood glucose self-testing.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with Type 1 or Type 2 diabetes of Afro-American, Hispanic, or Asian-American&#xD;
             origin&#xD;
&#xD;
          -  Subjects who are able to provide informed consent (by him/herself or by his/her&#xD;
             guardian);&#xD;
&#xD;
          -  18 years old and above;&#xD;
&#xD;
          -  HbA1c &lt; 10 %&#xD;
&#xD;
          -  Anatomically suitable finger as determined by the clinical investigator and detailed&#xD;
             in section 4&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Does not meet inclusion criteria;&#xD;
&#xD;
          -  Subjects requiring dialysis;&#xD;
&#xD;
          -  Any conditions that may hamper good visual contact between the finger and sensor, such&#xD;
             as raised birthmarks, scars and/or tattoos;&#xD;
&#xD;
          -  Pregnancy;&#xD;
&#xD;
          -  Nursing mothers;&#xD;
&#xD;
          -  Any skin injuries on the measured finger;&#xD;
&#xD;
          -  Severe disease conditions (cancer etc.)&#xD;
&#xD;
          -  Any condition that may prevent patients from successful participation in the trial (in&#xD;
             discretion of the investigator)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Filiz Demircik, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Sciema UG</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mills-Penisnsula Medical Center</name>
      <address>
        <city>San Mateo</city>
        <state>California</state>
        <zip>94596</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>July 21, 2018</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>January 14, 2020</last_update_submitted>
  <last_update_submitted_qc>January 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetes mellitus Type 1</keyword>
  <keyword>Diabetes mellitus Type 2</keyword>
  <keyword>blood glucose self-testing</keyword>
  <keyword>non-invasive tissue glucose prediction</keyword>
  <keyword>optical pain-free glucose testing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</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/NCT03840161
org study id: CNG-NGM-003
nct id: NCT03840161
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
The CNOGA Combo Glucometer (CoG) employs an invasive glucose meter using blood glucose
      teststrips and requiering a capillary blood sample obtained from a fingerstick and in
      addition, a non-invasive optical component for prediction of tissue glucose at the fingertip.
      In this study, participants will use both devices during meal tests and also at home during
      routine care. The results from the device will be compared to a standard reference method and
      will be used to determine the accuracy of the two device components.
The trial starts with a screening and training visit (V1). This is followed by an individual
      calibration period for the non-invasive device component by means of multiple parallel
      measurements with the invasive and the noninvasive device component. This will be done by the
      participants at home. Thereafter, the participants will come to the study site and will
      ingest a standardized meal (V2). Blood will be drawn for assessment of HbA1c and biochemical
      safety parameters. During the next 3 hours, 11 fingersticks will be made to obtain capillary
      blood samples for comparator readings with the two CoG components and with a laboratory
      reference method (YSI gucose analyzer). The patients will now continue to use the devices at
      home for three months, but are not allowed to use any CoG result for treatment decisions. In
      an interim visit after 6 weeks (V3), blood will be drawrn for HbA1c and biochemical safety
      parameters and three comparison measurements will be made with the CoG device components and
      the laboratory reference method. At the final visit after 12 weeks (V4), the procedures of
      the first meal test visit (V2) will be repeated, which conludes that study. In addition, the
      participants will be asked to complete a device satisfaction questionnaire at V2, V3, and V4.
observational model: Cohort
time perspective: Prospective
measure: CoG accuracy in measuring glucose levels (non-invasively) during a standardized meal experiment.
time frame: Experiment will be performed twice within 3 months
description: Comparison of non-invasive CoG device measurements (tissue glucose in mg/dL) with the results of a standard laboratory reference method (YSI glucose analyzer, blood glucose in mg/dL) by consensus-error grid analysis
measure: CoG accuracy in monitoring glucose levels (invasively) during a standardized meal experiment.
time frame: Experiment will be performed twice within 3 months
description: Comparison of CoG invasive device readings (blood glucose in mg/dL) with the results of a standard laboratory reference method (YSI glucose analyzer, blood glucose in mg/dL) by consensus-error grid analysis
measure: Impact of the CoG on long-term (three month) glycemic control (HbA1c using standard laboratory procedures) in patients with type 1 and 2 diabetes
time frame: 3 months
description: Change in HbA1c from baseline after 6 weeks and 12 weeks
measure: Treatment satisfaction questionnaire
time frame: 3 months
description: Change in device satisfaction questionnaire score after 6 weeks and 12 weeks
intervention type: Device
intervention name: non-invasive tissue glucose prediction
description: Generation of non-invasive and invasive glucose readings for comparison with a standard laboratory reference glucose determination method (YSI glucose analyzer)
other name: invasive blood glucose measurement
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Filiz Demircik, PhD
role: Study Director
affiliation: Sciema UG
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
sharing ipd: No