<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/NCT03781232</url>
  </required_header>
  <id_info>
    <org_study_id>RSP-09</org_study_id>
    <nct_id>NCT03781232</nct_id>
  </id_info>
  <brief_title>Non-invasive Glucose Measurement With Raman Technology in Patients With Type 1 and Type 2 Diabetes</brief_title>
  <official_title>Non-invasive Glucose Measurement With Raman Technology. Calibration of Newly Developed Devices in Patients With Type 1 and Type 2 Diabetes - Glucobrunn Study</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>
      The study was established to collect data and reference measurements in order to establish&#xD;
      calibration models for the Prototype 0.3&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects are recruited at two different sites.&#xD;
&#xD;
      Site 1: In group 1 subjects will on their regular stay in the clinic perform four measurement&#xD;
      sessions a day. A measurement session consist of a reference capillary blood sample and two&#xD;
      measures on the IMD.&#xD;
&#xD;
      Site 2: The study in group 2 consists of 26 home-based measurements and two in-clinic days.&#xD;
      During the home measurements, 6 measurement sessions will be performed by the subjects a day.&#xD;
      A measurement session consists of two reference BGMs, two reference CGMs and two measurements&#xD;
      on the device. On in-clinic visits, subjects will be administered high glucose breakfast and&#xD;
      the following 6-7 hours, measurement sessions are performed every 15 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 22, 2018</start_date>
  <completion_date type="Actual">August 5, 2019</completion_date>
  <primary_completion_date type="Actual">August 5, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Generation and validation of predictive models by Inter Subject Unified Performance (ISUP).</measure>
    <time_frame>2 years</time_frame>
    <description>Spectral Raman data will be collected together with paired reference measurements. Collected data will be used to generate calibration models capable of predicting tissue glucose levels.&#xD;
Models will be validated on independent data sets using the ISUP measure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Generation and validation of predictive models by Mean Absolute Relative Difference (MARD) measures</measure>
    <time_frame>2 years</time_frame>
    <description>Spectral Raman data will be collected together with paired reference measurements. Collected data will be used to generate calibration models capable of predicting tissue glucose levels.&#xD;
Models will be validated on independent data sets using the MARD measure.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Diabete Mellitus</condition>
  <condition>Medical Device</condition>
  <arm_group>
    <arm_group_label>RSP-09-01</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enrolled subjects will perform 4 daily measurement session during their regular stay at the clinic. A measurement session consists of a reference capillary blood sample and two measurements on the Prototype 0.3.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RSP-09-02</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enrolled subjects will measure at home for 26 six days and visit the clinic two times. During home measurements, 6 measurement sessions will be performed by the subject a day. A measurement session consists of two BGMs, two CGMs and two measurements on the Prototype 0.3. On in-clinic visits the subject will be administered a high glucose breakfast and the following 6-7 hours, measurement sessions will be performed every 15 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Prototype 0.3</intervention_name>
    <description>Prototype 0.3 is a non-invasive glucose monitoring device using Raman spectroscopy</description>
    <arm_group_label>RSP-09-01</arm_group_label>
    <arm_group_label>RSP-09-02</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years of age&#xD;
&#xD;
          -  Have a diagnosis of type 1 or type 2 diabetes mellitus (for RSP-09-02, only patients&#xD;
             with type 1 diabetes)&#xD;
&#xD;
          -  Skin phototype 1-4&#xD;
&#xD;
          -  Be willing to perform a minimum of 6 / 12 (31 during excursion days) finger sticks per&#xD;
             day during the study&#xD;
&#xD;
          -  Be able to follow the instructions provided to him/her by the study site and perform&#xD;
             all study tasks as specified by the protocol&#xD;
&#xD;
          -  Be willing to provide written signed and dated informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to comply with the study procedures as described by the study protocol,&#xD;
             according to the opinion of the investigator, due to e.g. known psychiatric diagnoses,&#xD;
             lack of cognitive ability, alcohol dependency, drug use, psychosocial overload&#xD;
&#xD;
          -  Have known severe allergy to medical grade adhesive or isopropyl alcohol used to clean&#xD;
             the skin&#xD;
&#xD;
          -  Be breastfeeding, pregnant, attempting to conceive or not willing and able to practice&#xD;
             birth control during the study execution (applicable to female subjects only)&#xD;
&#xD;
          -  Unable to hold hand/arm steadily (including tremors and Parkinson's Disease)&#xD;
&#xD;
          -  Severe diabetes related complications such as advanced autonomic neuropathy, kidney&#xD;
             disease, foot ulcers, legal blindness, or symptomatic cardiovascular disease as&#xD;
             evidenced by a history of cardiovascular episode(s)&#xD;
&#xD;
          -  Systemic or topical administration of glucocorticoids for the past 7 days&#xD;
&#xD;
          -  Undergoing dialysis treatment&#xD;
&#xD;
          -  Have extensive skin changes/diseases at the proposed measurement site (thenar) that&#xD;
             could interfere with the accuracy of interstitial glucose measurements&#xD;
&#xD;
          -  Have a concomitant medical condition which could interfere with the study devices&#xD;
             (study arm 1: intake of acetaminophen study arm 2: intake of salicylic acid or higher&#xD;
             doses of ascorbic acid)&#xD;
&#xD;
          -  Unsuitable for participation due to any other cause as determined by the Investigator.&#xD;
             Mental incapacity, unwillingness or language barriers precluding adequate&#xD;
             understanding or co-operation e.g. with required documentation&#xD;
&#xD;
          -  Dependency from the sponsor or the clinical investigator (e.g. co-workers of the&#xD;
             sponsor, the study site, and/ or their families)&#xD;
&#xD;
        Additional exclusion criteria for study arm 2:&#xD;
&#xD;
          -  Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months&#xD;
             prior to enrollment&#xD;
&#xD;
          -  Hypoglycemia unawareness&#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>Guido Freckmann, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>m&amp;i-Fachklinik Bad Heilbrunn - Zentrum für Diabetes und Stoffwechselerkrankungen</name>
      <address>
        <city>Bad Heilbrunn</city>
        <zip>83670</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm</name>
      <address>
        <city>Ulm</city>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 3, 2019</last_update_submitted>
  <last_update_submitted_qc>December 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 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>
  <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/NCT03781232
org study id: RSP-09
nct id: NCT03781232
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study was established to collect data and reference measurements in order to establish
      calibration models for the Prototype 0.3
Subjects are recruited at two different sites.

      Site 1: In group 1 subjects will on their regular stay in the clinic perform four measurement
      sessions a day. A measurement session consist of a reference capillary blood sample and two
      measures on the IMD.

      Site 2: The study in group 2 consists of 26 home-based measurements and two in-clinic days.
      During the home measurements, 6 measurement sessions will be performed by the subjects a day.
      A measurement session consists of two reference BGMs, two reference CGMs and two measurements
      on the device. On in-clinic visits, subjects will be administered high glucose breakfast and
      the following 6-7 hours, measurement sessions are performed every 15 minutes.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Generation and validation of predictive models by Inter Subject Unified Performance (ISUP).
time frame: 2 years
description: Spectral Raman data will be collected together with paired reference measurements. Collected data will be used to generate calibration models capable of predicting tissue glucose levels.
Models will be validated on independent data sets using the ISUP measure.
measure: Generation and validation of predictive models by Mean Absolute Relative Difference (MARD) measures
time frame: 2 years
description: Spectral Raman data will be collected together with paired reference measurements. Collected data will be used to generate calibration models capable of predicting tissue glucose levels.
Models will be validated on independent data sets using the MARD measure.
arm group label: RSP-09-01
arm group type: Experimental
description: Enrolled subjects will perform 4 daily measurement session during their regular stay at the clinic. A measurement session consists of a reference capillary blood sample and two measurements on the Prototype 0.3.
arm group label: RSP-09-02
arm group type: Experimental
description: Enrolled subjects will measure at home for 26 six days and visit the clinic two times. During home measurements, 6 measurement sessions will be performed by the subject a day. A measurement session consists of two BGMs, two CGMs and two measurements on the Prototype 0.3. On in-clinic visits the subject will be administered a high glucose breakfast and the following 6-7 hours, measurement sessions will be performed every 15 minutes.
intervention type: Device
intervention name: Prototype 0.3
description: Prototype 0.3 is a non-invasive glucose monitoring device using Raman spectroscopy
arm group label: RSP-09-01
arm group label: RSP-09-02
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Guido Freckmann, Dr.
role: Principal Investigator
affiliation: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Diabetes Mellitus
sharing ipd: No