<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/NCT02225379</url>
  </required_header>
  <id_info>
    <org_study_id>029514ctil</org_study_id>
    <nct_id>NCT02225379</nct_id>
  </id_info>
  <brief_title>Development and Assessment of Feasibility of Non-invasive Multiple Sensor Hypo-Sense as a Tool for Detection of Hypoglycemia</brief_title>
  <acronym>Hypo-Sense</acronym>
  <official_title>Development and Assessment of Feasibility of Non-invasive Multiple Sensor Hypo-Sense Sensor as a Tool for Detection of Hypoglycemia - Exploratory Study for Prototype Rev 1</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rabin Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Night Sense Ltd</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rabin Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypo Sense is a non- invasive method for detection of hypoglycemia. The Hypo Sense combines&#xD;
      an array of non-invasive sensors which monitors the patient's physiological parameters (heart&#xD;
      &amp; respiration rate, perspiration, skin temperature and arm motion) designed as a wrist watch&#xD;
      device.&#xD;
&#xD;
      The Hypo sense is intended for monitoring symptoms of hypoglycemia in diabetic patients in&#xD;
      hospital environment among type 1 and type 2 diabetes adults as an adjunctive device to&#xD;
      reference methods&#xD;
&#xD;
      The proposed study will be consisting of two main segments:&#xD;
&#xD;
      The primary aim of segment 1 of the study is data collection and calibration of the Hypo&#xD;
      Sense sensor prototype compared to standard invasive reference glucometer.&#xD;
&#xD;
      The primary aim of segment 2 of the study is to validate the Hypo Sense prototype performance&#xD;
      in detecting hypoglycemic events.&#xD;
&#xD;
      During the first segment of the study we intend to collect in parallel measurements of blood&#xD;
      glucose using reference method (capillary glucometer) and continuous data generated by the&#xD;
      non- invasive study device during approximately 4 hours, in which a hypoglycemic event will&#xD;
      be induced.&#xD;
&#xD;
      The reference and study device data will be analyzed using multivariate regression model to&#xD;
      formulate a calibration algorithm model. This model will translate the set of the&#xD;
      physiological recorded parameters into detection of hypoglycemic events.&#xD;
&#xD;
      During the second segment of the study we intend to evaluate the validity of the Hypo Sense&#xD;
      sensor ability to detect hypoglycemic events compared to standard invasive reference method&#xD;
      (capillary glucometer).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity</measure>
    <time_frame>At final visit ( week 4 for participants at segment 1 of the study and week 6 for participants at segment 2 of the study)</time_frame>
    <description>Sensitivity of the Hypo Sense-the proportion of hypoglycemia events detected by the Hypo Sense sensor from total number of hypoglycemic events detected by reference capillary glucometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive Predictive Value of the hypo-Sense</measure>
    <time_frame>At final visit ( week 4 for participants at segment 1 of the study and week 6 for participants at segment 2 of the study)</time_frame>
    <description>Positive Predictive Value of the hypo sense- the proportion of validated (&quot;true&quot;) hypoglycemia events detected by the hypo sense sensor from total alerts detected by the Hypo-Sense sensor</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Type 1 Diabetes</condition>
  <condition>Nocturnal Hypoglycemia</condition>
  <arm_group>
    <arm_group_label>Hypo-Sense (non invasive sensor)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Parallel measurements of capillary blood glucose using reference method and data generated by the non- invasive study device (Hypo Sense) during approximately 4 hours, in which a hypoglycemic event will be induced.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hypo-Sense (non invasive sensor)</intervention_name>
    <description>Parallel measurements of capillary blood glucose using reference methods (both capillary glucometer and continuous sensor) and data generated by the non- invasive study device during approximately 4 hours, in which a hypoglycemic event will be induced.</description>
    <arm_group_label>Hypo-Sense (non invasive sensor)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signing an inform consent form prior to any trial related procedure&#xD;
&#xD;
          -  Type 1 diabetes diagnosed at least 12 months prior to study inclusion&#xD;
&#xD;
          -  Age &gt; 18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participating in other device or drug study&#xD;
&#xD;
          -  Any significant disease or condition, including psychiatric disorders that in the&#xD;
             opinion of the investigator is likely to affect patient's compliance or ability to&#xD;
             complete the study&#xD;
&#xD;
          -  Patients with one or more of the following diseases: malignancy, myocardial&#xD;
             insufficiency, nephrologic disease or any other chronic disease&#xD;
&#xD;
          -  Chronic skin problem in the lower inner arm&#xD;
&#xD;
          -  Pregnant or breast feeding women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>M Phillip, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Schneider Children's Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Schneider Children's Medical Center</name>
      <address>
        <city>Petah-Tikva</city>
        <zip>49202</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>August 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>January 10, 2017</last_update_submitted>
  <last_update_submitted_qc>January 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Type 1 Diabetes</keyword>
  <keyword>Hypoglycemia detection</keyword>
  <keyword>Non-invasive sensor</keyword>
  <keyword>Nocturnal hypoglycemia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
    <mesh_term>Hypoglycemia</mesh_term>
  </condition_browse>
  <!-- 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/NCT02225379
org study id: 029514ctil
nct id: NCT02225379
lead sponsor: 
collaborator: 
has dmc: No
Hypo Sense is a non- invasive method for detection of hypoglycemia. The Hypo Sense combines
      an array of non-invasive sensors which monitors the patient's physiological parameters (heart
      & respiration rate, perspiration, skin temperature and arm motion) designed as a wrist watch
      device.

      The Hypo sense is intended for monitoring symptoms of hypoglycemia in diabetic patients in
      hospital environment among type 1 and type 2 diabetes adults as an adjunctive device to
      reference methods

      The proposed study will be consisting of two main segments:

      The primary aim of segment 1 of the study is data collection and calibration of the Hypo
      Sense sensor prototype compared to standard invasive reference glucometer.

      The primary aim of segment 2 of the study is to validate the Hypo Sense prototype performance
      in detecting hypoglycemic events.

      During the first segment of the study we intend to collect in parallel measurements of blood
      glucose using reference method (capillary glucometer) and continuous data generated by the
      non- invasive study device during approximately 4 hours, in which a hypoglycemic event will
      be induced.

      The reference and study device data will be analyzed using multivariate regression model to
      formulate a calibration algorithm model. This model will translate the set of the
      physiological recorded parameters into detection of hypoglycemic events.

      During the second segment of the study we intend to evaluate the validity of the Hypo Sense
      sensor ability to detect hypoglycemic events compared to standard invasive reference method
      (capillary glucometer).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Sensitivity
time frame: At final visit ( week 4 for participants at segment 1 of the study and week 6 for participants at segment 2 of the study)
description: Sensitivity of the Hypo Sense-the proportion of hypoglycemia events detected by the Hypo Sense sensor from total number of hypoglycemic events detected by reference capillary glucometer
measure: Positive Predictive Value of the hypo-Sense
time frame: At final visit ( week 4 for participants at segment 1 of the study and week 6 for participants at segment 2 of the study)
description: Positive Predictive Value of the hypo sense- the proportion of validated ("true") hypoglycemia events detected by the hypo sense sensor from total alerts detected by the Hypo-Sense sensor
arm group label: Hypo-Sense (non invasive sensor)
arm group type: Experimental
description: Parallel measurements of capillary blood glucose using reference method and data generated by the non- invasive study device (Hypo Sense) during approximately 4 hours, in which a hypoglycemic event will be induced.
intervention type: Device
intervention name: Hypo-Sense (non invasive sensor)
description: Parallel measurements of capillary blood glucose using reference methods (both capillary glucometer and continuous sensor) and data generated by the non- invasive study device during approximately 4 hours, in which a hypoglycemic event will be induced.
arm group label: Hypo-Sense (non invasive sensor)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: M Phillip, Prof
role: Principal Investigator
affiliation: Schneider Children's Medical Center
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 1
mesh term: Hypoglycemia