<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/NCT03782441</url>
  </required_header>
  <id_info>
    <org_study_id>RSP-19</org_study_id>
    <nct_id>NCT03782441</nct_id>
  </id_info>
  <brief_title>Study of a Novel Non-invasive Glucose Monitoring Device</brief_title>
  <official_title>A Pilot Study of a Novel Non-invasive Glucose Monitoring Device</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RSP Systems A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RSP Systems A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This explorative clinical study has been launched to collect spectral Raman data paired with&#xD;
      validated glucose reference values in diabetic patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Investigational Medical Device (IMD) for this investigation is the Prototype 0.5 (P0.5)&#xD;
      developed and manufactured by RSP Systems (RSP). The device is intended for non-invasive&#xD;
      interstitial intermittent glucose monitoring in persons (age 18 and older) with diabetes. The&#xD;
      technology relies on the well-established capacities of Raman spectroscopy for directly&#xD;
      detecting glucose subcutaneously. The Raman spectroscopy physical principle relies on the&#xD;
      fact that when laser light of a given wavelength interferes with a molecule, a small fraction&#xD;
      of the incident light will interact with the vibrational states of the molecule, causing the&#xD;
      photons to lose a portion of their energy which will change the wavelength of the light. The&#xD;
      scattered light will be collected by the optical probe head and analyzed with advanced&#xD;
      algorithms to correlate the signal to glucose concentrations. Data collected from the IMD&#xD;
      will be paired with validated glucose reference values collected by the finger sticking&#xD;
      method.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 5, 2019</start_date>
  <completion_date type="Actual">December 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 1, 2020</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>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement accuracy of IMD</measure>
    <time_frame>4 months</time_frame>
    <description>Accuracy of measurements performed on the IMD will be evaluated by data from subjects. Data will be analyzed by Mean Absolute Relative Difference (MARD) and Inter Subject Unified Performance (ISUP)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety evaluation: paucity of adverse events</measure>
    <time_frame>4 months</time_frame>
    <description>Safety of the IMD will be evaluated in a descriptive manner by the paucity of adverse events reported during the clinical study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Device deficiency</measure>
    <time_frame>4 months</time_frame>
    <description>Description of device deficiencies will be listed. Deficiencies will be reported during the clinical study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device usability</measure>
    <time_frame>4 months</time_frame>
    <description>The use of the device by the subjects will be evaluated by means of questionnaires</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>RSP-19</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will perform daily measurements on the IMD (Prototype 0.5) for 42 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Prototype 0.5</intervention_name>
    <description>Investigational Medical Device collecting spectral Raman data from tissue</description>
    <arm_group_label>RSP-19</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects ≥18 years of age&#xD;
&#xD;
          -  Diagnosed with diabetes, all types except gestational diabetes&#xD;
&#xD;
          -  HbA1c distribution &gt; 60 mmol/mol at baseline visit&#xD;
&#xD;
          -  Skin phototype 1-4&#xD;
&#xD;
          -  Willing to perform a minimum of 8 finger sticks during each day of home-based&#xD;
             measurements and 30 finger sticks at the two in-clinic study days&#xD;
&#xD;
          -  Subject has a wireless internet connection at home to be used in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  For female subjects: Pregnancy or subject is attempting to conceive or not willing and&#xD;
             able to practice birth control during the study duration&#xD;
&#xD;
          -  For female subjects: Breastfeeding&#xD;
&#xD;
          -  Subject currently participating in another study&#xD;
&#xD;
          -  Subject not able to understand and read Danish&#xD;
&#xD;
          -  In investigator's opinion, subject is not able to follow instructions provided and as&#xD;
             specified in the protocol&#xD;
&#xD;
          -  Subject not able to hold hand/arm steady (including tremors and Parkinson's Disease)&#xD;
&#xD;
          -  Reduced circulation in right hand evaluated by Allen's test&#xD;
&#xD;
          -  Extensive skin changes, tattoos or diseases on right hand thenar (probe application&#xD;
             site)&#xD;
&#xD;
          -  Known allergy to medical grade alcohol used to clean the skin&#xD;
&#xD;
          -  Medical history or any condition that may, in the opinion of the investigator&#xD;
             compromise the subject's ability to participate&#xD;
&#xD;
          -  Comorbidity or concomitant medical condition which, in the opinion of the&#xD;
             Investigator, could interfere with the study or present a risk to the safety or&#xD;
             welfare of the subject or study staff&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sanne Fisker</last_name>
    <role>Principal Investigator</role>
    <affiliation>Steno Diabetes Center, Aarhus University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Steno Diabetes Center Aarhus</name>
      <address>
        <city>Aarhus</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>December 2, 2020</last_update_submitted>
  <last_update_submitted_qc>December 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Non-invasive glucose monitoring</keyword>
  <keyword>Raman spectroscopy</keyword>
  <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/NCT03782441
org study id: RSP-19
nct id: NCT03782441
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This explorative clinical study has been launched to collect spectral Raman data paired with
      validated glucose reference values in diabetic patients.
The Investigational Medical Device (IMD) for this investigation is the Prototype 0.5 (P0.5)
      developed and manufactured by RSP Systems (RSP). The device is intended for non-invasive
      interstitial intermittent glucose monitoring in persons (age 18 and older) with diabetes. The
      technology relies on the well-established capacities of Raman spectroscopy for directly
      detecting glucose subcutaneously. The Raman spectroscopy physical principle relies on the
      fact that when laser light of a given wavelength interferes with a molecule, a small fraction
      of the incident light will interact with the vibrational states of the molecule, causing the
      photons to lose a portion of their energy which will change the wavelength of the light. The
      scattered light will be collected by the optical probe head and analyzed with advanced
      algorithms to correlate the signal to glucose concentrations. Data collected from the IMD
      will be paired with validated glucose reference values collected by the finger sticking
      method.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Measurement accuracy of IMD
time frame: 4 months
description: Accuracy of measurements performed on the IMD will be evaluated by data from subjects. Data will be analyzed by Mean Absolute Relative Difference (MARD) and Inter Subject Unified Performance (ISUP)
measure: Safety evaluation: paucity of adverse events
time frame: 4 months
description: Safety of the IMD will be evaluated in a descriptive manner by the paucity of adverse events reported during the clinical study
measure: Device deficiency
time frame: 4 months
description: Description of device deficiencies will be listed. Deficiencies will be reported during the clinical study.
measure: Device usability
time frame: 4 months
description: The use of the device by the subjects will be evaluated by means of questionnaires
arm group label: RSP-19
arm group type: Experimental
description: Subjects will perform daily measurements on the IMD (Prototype 0.5) for 42 days.
intervention type: Device
intervention name: Prototype 0.5
description: Investigational Medical Device collecting spectral Raman data from tissue
arm group label: RSP-19
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sanne Fisker
role: Principal Investigator
affiliation: Steno Diabetes Center, Aarhus University Hospital
facility: 
country: Denmark
responsible party type: Sponsor
sharing ipd: No