<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/NCT03782649</url>
  </required_header>
  <id_info>
    <org_study_id>RSP-08</org_study_id>
    <nct_id>NCT03782649</nct_id>
  </id_info>
  <brief_title>Performance Evaluation of a Novel Non-invasive Glucometer, Calibrated Against Validated Interstitial Glucose References</brief_title>
  <official_title>Performance Evaluation of a Novel Non-invasive Glucometer, Calibrated Against Validated Interstitial Glucose References</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 clinical study has been launched to collect spectral Raman data on the Investigational&#xD;
      Medical Device (IMD) compared with reference methods in terms of interstitial fluid samples&#xD;
      and capillary and venous references.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will visit the clinic for a baseline visit and two in-clinic visits. On in-clinic&#xD;
      days, subjects will attend the clinic in a fasting state. They will have inserted a Dexcom&#xD;
      and Freestyle Libre and a microdialysis catheter. At time = 0, subjects will be administered&#xD;
      a glucose rich drink and every 6. minut measurements will be performed. These include a&#xD;
      measurement on the IMD, microdialysate, FreeStyle Libre and Dexcom readings. Every 18. minut&#xD;
      a venous blood sample will be included and every 36. minut a capillary blood sample will be&#xD;
      collected. This continues until time = 180 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 29, 2018</start_date>
  <completion_date type="Actual">June 19, 2019</completion_date>
  <primary_completion_date type="Actual">June 19, 2019</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>Generation and validation of prediction models - MARD</measure>
    <time_frame>One year</time_frame>
    <description>Two in-clinic visits each of a duration of 5-6 hours are scheduled for each subject. Subjects will enter clinic in fasting state and will receive an oral glucose bolus. Glucose excursion is followed with frequent capillary and venous blood samples along with FGM and CGM readings and microdialysis. In parallel, optical glucose data from the investigational medical device will be collected.&#xD;
Optical glucose readings will be masked to the subjects.&#xD;
Collected data will be used to generate individual calibration models capable of predicting tissue glucose. Models will be validated on independent data sets using Mean Absolute Relative Difference (MARD) endpoint measure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Generation and validation of prediction models - ISUP</measure>
    <time_frame>One year</time_frame>
    <description>Two in-clinic visits each of a duration of 5-6 hours are scheduled for each subject. Subjects will enter clinic in fasting state and will receive an oral glucose bolus. Glucose excursion is followed with frequent capillary and venous blood samples along with FGM and CGM readings and microdialysis. In parallel, optical glucose data from the investigational medical device will be collected.&#xD;
Optical glucose readings will be masked to the subjects.&#xD;
Collected data will be used to generate individual calibration models capable of predicting tissue glucose. Models will be validated on independent data sets using Inter Subject Unified Performance (ISUP) measure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Generation and validation of prediction models - Consensus Error Grid</measure>
    <time_frame>One year</time_frame>
    <description>Two in-clinic visits each of a duration of 5-6 hours are scheduled for each subject. Subjects will enter clinic in fasting state and will receive an oral glucose bolus. Glucose excursion is followed with frequent capillary and venous blood samples along with FGM and CGM readings and microdialysis. In parallel, optical glucose data from the investigational medical device will be collected.&#xD;
Optical glucose readings will be masked to the subjects.&#xD;
Collected data will be used to generate individual calibration models capable of predicting tissue glucose. Models will be validated on independent data sets using Consensus Error Grid Analysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of dynamics between arterial and venous glucose profiles in relation to interstitial glucose levels</measure>
    <time_frame>One year</time_frame>
    <description>Two in-clinic visits each of a duration of 5-6 hours are scheduled for each subject. Subjects will enter clinic in fasting state and will receive an oral glucose bolus. Glucose excursion is followed with frequent capillary and venous blood samples along with FGM and CGM readings and microdialysis. In parallel, optical glucose data from the investigational medical device will be collected.&#xD;
Optical glucose readings will be masked to the subjects.&#xD;
A modeling-based evaluation of the dynamics between blood glucose and tissue glucose will be conducted and serve as a secondary endpoint of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety evaluation: paucity of adverse events</measure>
    <time_frame>One year</time_frame>
    <description>Safety will be evaluated in a descriptive manner by the paucity of adverse events</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>RSP-08</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects undergo the same procedures. Subjects will be subjected to measurements on the IMD (Working Model 3.4NR), FreeStyle Libre, Dexcom, microdialysis, venous and capillary blood collection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Working Model 3.4NR</intervention_name>
    <description>Investigational Medical Device collecting spectral Raman data from tissue</description>
    <arm_group_label>RSP-08</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects 18-70 years old&#xD;
&#xD;
          -  Patients diagnosed with type 1 or type 2 diabetes (T1D or T2D) (insulin requiring T2D&#xD;
             patients)&#xD;
&#xD;
          -  Diabetes management strategy: lifestyle regimen + insulin ± oral hypoglycemic agents&#xD;
&#xD;
          -  Skin phototype 1-4&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  For female participants: Pregnancy or subject is attempting to conceive or not willing&#xD;
             and able to practice birth control during the study duration&#xD;
&#xD;
          -  &gt; 10 cigarettes pr. day&#xD;
&#xD;
          -  Participants not able to understand and read Swedish&#xD;
&#xD;
          -  In investigator's opinion, participant is not able to follow instructions as specified&#xD;
             in the protocol&#xD;
&#xD;
          -  Participants not able to hold hand/arm steadily (including tremors and Parkinson's&#xD;
             Disease)&#xD;
&#xD;
          -  Diagnosed with reduced circulation&#xD;
&#xD;
          -  Extensive skin changes, tattoos or diseases on probe application site&#xD;
&#xD;
          -  Rejection by screening optical measurements&#xD;
&#xD;
          -  Known allergy to medical grade alcohol&#xD;
&#xD;
          -  Known allergy to adhesives&#xD;
&#xD;
          -  Systemic or topical administration of glucocorticoids for the past 7 days&#xD;
&#xD;
          -  Participants undergoing dialysis treatment&#xD;
&#xD;
          -  Anti-coagulation or anti-platelet therapy&#xD;
&#xD;
          -  Use of beta-blockers&#xD;
&#xD;
          -  Medical conditions causing bleeding tendency&#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;
          -  Concomitant medical condition which could present a risk to the safety or welfare of&#xD;
             the subject or study staff. Such conditions include but are not limited to HIV and&#xD;
             Hepatitis B or C.&#xD;
&#xD;
          -  Participants currently enrolled in another study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Per-Anders Jansson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sahlgrenska Universitetssjukhuset, Gothenburg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gothia Forum för Klinisk Forskning, Sahlgrenska Universitetssjukhuset</name>
      <address>
        <city>Gothenburg</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>December 11, 2019</last_update_submitted>
  <last_update_submitted_qc>December 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2019</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/NCT03782649
org study id: RSP-08
nct id: NCT03782649
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This clinical study has been launched to collect spectral Raman data on the Investigational
      Medical Device (IMD) compared with reference methods in terms of interstitial fluid samples
      and capillary and venous references.
Subjects will visit the clinic for a baseline visit and two in-clinic visits. On in-clinic
      days, subjects will attend the clinic in a fasting state. They will have inserted a Dexcom
      and Freestyle Libre and a microdialysis catheter. At time = 0, subjects will be administered
      a glucose rich drink and every 6. minut measurements will be performed. These include a
      measurement on the IMD, microdialysate, FreeStyle Libre and Dexcom readings. Every 18. minut
      a venous blood sample will be included and every 36. minut a capillary blood sample will be
      collected. This continues until time = 180 minutes.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Generation and validation of prediction models - MARD
time frame: One year
description: Two in-clinic visits each of a duration of 5-6 hours are scheduled for each subject. Subjects will enter clinic in fasting state and will receive an oral glucose bolus. Glucose excursion is followed with frequent capillary and venous blood samples along with FGM and CGM readings and microdialysis. In parallel, optical glucose data from the investigational medical device will be collected.
Optical glucose readings will be masked to the subjects.
Collected data will be used to generate individual calibration models capable of predicting tissue glucose. Models will be validated on independent data sets using Mean Absolute Relative Difference (MARD) endpoint measure.
measure: Generation and validation of prediction models - ISUP
time frame: One year
description: Two in-clinic visits each of a duration of 5-6 hours are scheduled for each subject. Subjects will enter clinic in fasting state and will receive an oral glucose bolus. Glucose excursion is followed with frequent capillary and venous blood samples along with FGM and CGM readings and microdialysis. In parallel, optical glucose data from the investigational medical device will be collected.
Optical glucose readings will be masked to the subjects.
Collected data will be used to generate individual calibration models capable of predicting tissue glucose. Models will be validated on independent data sets using Inter Subject Unified Performance (ISUP) measure.
measure: Generation and validation of prediction models - Consensus Error Grid
time frame: One year
description: Two in-clinic visits each of a duration of 5-6 hours are scheduled for each subject. Subjects will enter clinic in fasting state and will receive an oral glucose bolus. Glucose excursion is followed with frequent capillary and venous blood samples along with FGM and CGM readings and microdialysis. In parallel, optical glucose data from the investigational medical device will be collected.
Optical glucose readings will be masked to the subjects.
Collected data will be used to generate individual calibration models capable of predicting tissue glucose. Models will be validated on independent data sets using Consensus Error Grid Analysis
measure: Evaluation of dynamics between arterial and venous glucose profiles in relation to interstitial glucose levels
time frame: One year
description: Two in-clinic visits each of a duration of 5-6 hours are scheduled for each subject. Subjects will enter clinic in fasting state and will receive an oral glucose bolus. Glucose excursion is followed with frequent capillary and venous blood samples along with FGM and CGM readings and microdialysis. In parallel, optical glucose data from the investigational medical device will be collected.
Optical glucose readings will be masked to the subjects.
A modeling-based evaluation of the dynamics between blood glucose and tissue glucose will be conducted and serve as a secondary endpoint of the study.
measure: Safety evaluation: paucity of adverse events
time frame: One year
description: Safety will be evaluated in a descriptive manner by the paucity of adverse events
arm group label: RSP-08
arm group type: Experimental
description: All subjects undergo the same procedures. Subjects will be subjected to measurements on the IMD (Working Model 3.4NR), FreeStyle Libre, Dexcom, microdialysis, venous and capillary blood collection.
intervention type: Device
intervention name: Working Model 3.4NR
description: Investigational Medical Device collecting spectral Raman data from tissue
arm group label: RSP-08
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Per-Anders Jansson, MD
role: Principal Investigator
affiliation: Sahlgrenska Universitetssjukhuset, Gothenburg
facility: 
country: Sweden
responsible party type: Sponsor
sharing ipd: No