xml: <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/NCT06035367</url>
    </required_header>
    <id_info>
      <org_study_id>2022-A02789-34</org_study_id>
      <nct_id>NCT06035367</nct_id>
    </id_info>
    <brief_title>SKAMo-2: the Real-life Test of Continuous Photoacoustic Signal by Neogly in Patients With Type I Diabetes</brief_title>
    <official_title>SKAMo-2: the Real-life Test of Continuous Photoacoustic Signal by Neogly in Patients With Type I Diabetes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Eclypia</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Eclypia</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>
        Diabetes is one of the very common and chronic diseases in the present world, which affects&#xD;
        children and adults. Diabetes is characterized by hyperglycemia. Hence, diabetic patients&#xD;
        need to precisely monitor their blood sugar level regularly a few times a day. Currently, the&#xD;
        solutions for self-monitoring blood glucose are invasive (finger prick method, continuous&#xD;
        glucose monitoring (CGM) using microneedle).The fully non-invasive CGM approaches still are&#xD;
        in high demand.&#xD;
  &#xD;
        The medical device is developed, ultimately, to continuously measure the blood glucose level&#xD;
        from continuous in-vivo photoacoustic signal.&#xD;
  &#xD;
        For this study, the goal is to check if the signal collected by the investigational device is&#xD;
        relevant and exploitable in patients with type I diabetes.&#xD;
  &#xD;
        The main task of participants is to wear the investigational device during one week.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 6, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2023</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>Value of absolute photoacoustic signal on the participant arm</measure>
      <time_frame>around one week (7 to 9 days)</time_frame>
      <description>The first endpoint is evaluated by the value of photoacoustic signal on the participant arm. To check if if the photoacoustic data of the investigational device are relevant and exploitable. This signal should be above a given threshold, corresponding to an absolute photoacoustic value at least three times higher than this measured when the device is not worn.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>assess the safety by the general clinical evaluation (normal, abnormal, abnormal not clinically significant)</measure>
      <time_frame>around one week (7 to 9 days)</time_frame>
      <description>baseline (V1) and after the device wearing (V2)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>assess the safety by number/class of adverse events</measure>
      <time_frame>during one week (7 to 9 days)</time_frame>
      <description>definitions of AE from European Medical Device Regulation 2017/745</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>assess the tolerability of the investigational device by a usability questionnaire</measure>
      <time_frame>around one week (7 to 9 days)</time_frame>
      <description>some questions with scales from 1 to 10 (no total score) and other questions with a free field to collect the user feedback about the size, appearance, comfort, operation of the device and the suggestions for device improvement</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Diabetes</condition>
    <arm_group>
      <arm_group_label>Wearing the non-invasive continous monitoring device during one week to record photoacoustic signal</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Wearing the non-invasive continous monitoring device during one week to record photoacoustic signal</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Non-invasive continuous monitoring device to record photoacoustic signal</intervention_name>
      <description>Neogly is in two parts, the measurement head, to be worn on the wrist and the power box, to be worn on the forearm or upper arm. The ribbon cable makes the connection between the two parts.&#xD;
  A handset is used to start/stop the device. The medical device record a continuous photoacoustic signal.</description>
      <arm_group_label>Wearing the non-invasive continous monitoring device during one week to record photoacoustic signal</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients with type I diabetes&#xD;
  &#xD;
            -  male and female patients aged 18 to 50 years&#xD;
  &#xD;
            -  wearing a FreeStyle Libre CGM and giving the access of collected data&#xD;
  &#xD;
            -  using insulin pump or insulin pen and giving the access of collected data&#xD;
  &#xD;
            -  willing to wear the investigational device continuously throughout the study (24h/24h)&#xD;
  &#xD;
            -  affiliated with French Social Security&#xD;
  &#xD;
            -  having signed the informed consent form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  any skin disease (inflammatory diseases of skin, cancer of skin, infectious diseases&#xD;
               of skin, change in skin color...)&#xD;
  &#xD;
            -  any serious disease that could interfere with the study&#xD;
  &#xD;
            -  body mass index (BMI) &gt; 30kg/m2&#xD;
  &#xD;
            -  scars or tattoos on the upper side of the wrist wearing the investigational device&#xD;
  &#xD;
            -  who may have an allergy to one of the material used in the device&#xD;
  &#xD;
            -  who have magnetic resonance imagery (MRI), computed tomography (CT) scan or high&#xD;
               frequency electrical heat (diathermy) treatment during the study&#xD;
  &#xD;
            -  persons mentioned in articles L1121-5 to L1121-9 of the public health code (Pregnancy&#xD;
               or Lactation ; Females with childbearing potential, defined as a premenopausal female&#xD;
               and not using an effective form of birth control*; Person deprived of liberty by&#xD;
               judicial order ; Person under guardianship or curatorship ; Minors ; Adults who are&#xD;
               incapable or unable to give their consent ; Cross-over situations)&#xD;
  &#xD;
            -  who would receive more than 4500 euros in compensation due to his or her participation&#xD;
               in other research involving the human person in the 12 months preceding this study&#xD;
  &#xD;
            -  who, in the judgment of the investigator, are likely to be non-compliant or&#xD;
               uncooperative during the study, or unable to cooperate because of language problem,&#xD;
               poor mental development&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Eclypia</last_name>
      <phone>33476767383</phone>
      <email>contact@eclypia.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>CHU Grenoble Alpes</name>
        <address>
          <city>Grenoble</city>
          <zip>38043</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Centre d'investigation clinique Centre d'investigation clinique</last_name>
        <phone>334.76.767.575</phone>
        <email>CIC@chu-grenoble.fr</email>
      </contact>
      <investigator>
        <last_name>Pierre-Yves Pr BENHAMOU, principal investigator</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06035367
  org study id: 2022-A02789-34
  nct id: NCT06035367
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Diabetes is one of the very common and chronic diseases in the present world, which affects
        children and adults. Diabetes is characterized by hyperglycemia. Hence, diabetic patients
        need to precisely monitor their blood sugar level regularly a few times a day. Currently, the
        solutions for self-monitoring blood glucose are invasive (finger prick method, continuous
        glucose monitoring (CGM) using microneedle).The fully non-invasive CGM approaches still are
        in high demand.
  
        The medical device is developed, ultimately, to continuously measure the blood glucose level
        from continuous in-vivo photoacoustic signal.
  
        For this study, the goal is to check if the signal collected by the investigational device is
        relevant and exploitable in patients with type I diabetes.
  
        The main task of participants is to wear the investigational device during one week.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Device Feasibility
  masking: None (Open Label)
  measure: Value of absolute photoacoustic signal on the participant arm
  time frame: around one week (7 to 9 days)
  description: The first endpoint is evaluated by the value of photoacoustic signal on the participant arm. To check if if the photoacoustic data of the investigational device are relevant and exploitable. This signal should be above a given threshold, corresponding to an absolute photoacoustic value at least three times higher than this measured when the device is not worn.
  measure: assess the safety by the general clinical evaluation (normal, abnormal, abnormal not clinically significant)
  time frame: around one week (7 to 9 days)
  description: baseline (V1) and after the device wearing (V2)
  measure: assess the safety by number/class of adverse events
  time frame: during one week (7 to 9 days)
  description: definitions of AE from European Medical Device Regulation 2017/745
  measure: assess the tolerability of the investigational device by a usability questionnaire
  time frame: around one week (7 to 9 days)
  description: some questions with scales from 1 to 10 (no total score) and other questions with a free field to collect the user feedback about the size, appearance, comfort, operation of the device and the suggestions for device improvement
  arm group label: Wearing the non-invasive continous monitoring device during one week to record photoacoustic signal
  arm group type: Experimental
  description: Wearing the non-invasive continous monitoring device during one week to record photoacoustic signal
  intervention type: Device
  intervention name: Non-invasive continuous monitoring device to record photoacoustic signal
  description: Neogly is in two parts, the measurement head, to be worn on the wrist and the power box, to be worn on the forearm or upper arm. The ribbon cable makes the connection between the two parts.
  A handset is used to start/stop the device. The medical device record a continuous photoacoustic signal.
  arm group label: Wearing the non-invasive continous monitoring device during one week to record photoacoustic signal
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: No
  last name: Eclypia
  phone: 33476767383
  email: contact@eclypia.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 1