<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/NCT03008239</url>
  </required_header>
  <id_info>
    <org_study_id>P-4.5-C-01</org_study_id>
    <nct_id>NCT03008239</nct_id>
  </id_info>
  <brief_title>Effectiveness and Safety Study of the Percutaneous Optical Fibre Glucose Sensor (FiberSense)</brief_title>
  <official_title>Effectiveness and Safety Study of the Percutaneous Optical Fibre Glucose Sensor (FiberSense) for Home Use in Diabetic and Prediabetic Individuals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lee's Pharmaceutical Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lee's Pharmaceutical Limited</source>
  <oversight_info>
    <has_dmc>Yes</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 study evaluates the performance and safety of the fluorescence based fibre optic glucose&#xD;
      sensor for home usage.24 subjects will take part in the study, including 4 pre-diabetic&#xD;
      subjects, 8 Type I diabetic patients, 8 Type II diabetic patients and 4 diabetic patients who&#xD;
      require continuous ambulatory peritoneal dialysis (CAPD). Type 1, Type 2 and prediabetic&#xD;
      subjects will wear one FiberSense sensor, randomly allocated to either the upper arm (50%) or&#xD;
      abdomen (50%) for 28 days. In addition, these subjects will wear a Dexcom sensor on the other&#xD;
      side of the abdomen for 7 days in one of the four study weeks. In all 4 CAPD subjects, one&#xD;
      FiberSense sensor will be placed in the upper arm for 28 days. No additional comparator&#xD;
      sensor will be placed in CAPD subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The FiberSense system is a glucose-monitoring device indicated for continually recording&#xD;
      interstitial fluid glucose levels in patients ages 18 and older with insulin dependent&#xD;
      diabetes mellitus for the purpose of improving diabetes management. The System is intended&#xD;
      for use by patients at home and in health care facilities.&#xD;
&#xD;
      The FiberSense system is indicated for use as an adjunctive device to complement, not&#xD;
      replace, information obtained from standard home glucose monitoring devices.&#xD;
&#xD;
      The FiberSense system aids in the detection of episodes of hyperglycemia and hypoglycemia,&#xD;
      facilitating both acute and long-term therapy adjustments, which may minimize these&#xD;
      excursions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">November 14, 2017</start_date>
  <completion_date type="Anticipated">October 2019</completion_date>
  <primary_completion_date type="Actual">July 10, 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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood glucose</measure>
    <time_frame>28 days</time_frame>
    <description>The primary endpoint is the proportion of FiberSense readings within ≤15% of the reference (YSI) reading for blood glucose levels &gt;100 mg/dl, and the proportion of FiberSense readings within ≤15 mg/dl of the YSI reading for blood glucose levels ≤100 mg/dl, for paired samples taken during the in-clinic sessions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse Events reporting</measure>
    <time_frame>35 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Relatives Differences from YSI</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Relatives Differences from YSI</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Absolute Relative Differences from YSI</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Absolute Relative Differences from YSI</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypoglycemia detection rates</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hyperglycemia detection rates</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of glucose rate of change of FiberSense sensor compared to glucose rate of change of YSI</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lag time between FiberSense readings and YSI results during induced glucose excursions</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Agreement and accuracy relative to SMBG readings (same model to be used by all subjects)</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calibration stability</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensor stability</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensor life</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>User satisfaction questionnaire score</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood maltose concentrations</measure>
    <time_frame>28 days</time_frame>
    <description>Measured in CAPD subjects during the V1 in-clinic session</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>FiberSense sensor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Type 1, Type 2 and prediabetic subjects will wear one FiberSense sensor, randomly allocated to either the upper arm (50%) or abdomen (50%) for 28 days. In addition, these subjects will wear a Dexcom sensor on the other side of the abdomen for 7 days in one of the four study weeks.&#xD;
In all 4 CAPD subjects, one FiberSense sensor will be placed in the upper arm for 28 days. No additional comparator sensor will be placed in CAPD subject.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FiberSense sensor</intervention_name>
    <description>The FiberSense system is a glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients ages 18 and older with insulin dependent diabetes mellitus for the purpose of improving diabetes management.</description>
    <arm_group_label>FiberSense sensor</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dexcom Sensor</intervention_name>
    <description>Dexcom is a continuous glucose monitoring (CGM) system. The display device shows the glucose readings and the trend.</description>
    <arm_group_label>FiberSense sensor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type I or II diabetes mellitus requiring insulin in the management of glucose control&#xD;
             for at least one year prior to enrollment or diabetes on continuous ambulatory&#xD;
             peritoneal dialysis or prediabetic individuals with impaired fasting glucose or&#xD;
             impaired glucose tolerance by OGTT&#xD;
&#xD;
          -  Male or female age ≥ 18 years old and ≤ 70 year old.&#xD;
&#xD;
          -  Women who are not pregnant, lactating or planning a pregnancy during their&#xD;
             participation in the clinical study.&#xD;
&#xD;
          -  Willingness, ability and commitment to comply with the testing, procedure and&#xD;
             follow-up outlined in this protocol including (but not limited to) frequency of clinic&#xD;
             visits and use of pre-specified glucose monitoring devices.&#xD;
&#xD;
          -  Willingness to abstain from swimming during their participation in the measurement&#xD;
             phase.&#xD;
&#xD;
          -  In the opinion of the investigator, absence of any physical limitations, addictive&#xD;
             diseases, or underlying medical conditions (including mental health) that may preclude&#xD;
             the patient from being a good study candidate.&#xD;
&#xD;
          -  Written informed consent to participate in the study provided by the patient.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Poorly controlled diabetes mellitus with HbA1C &gt;11%.&#xD;
&#xD;
          -  Currently pregnant, as demonstrated by a positive pregnancy test at screening and on&#xD;
             Day00 .&#xD;
&#xD;
          -  Impaired hepatic function measured as alanine aminotransferase (ALT) or aspartate&#xD;
             aminotransferase (AST) ≥ three times the upper reference limit.&#xD;
&#xD;
          -  Any active acute or chronic disease or condition that, in the opinion of the&#xD;
             investigator, might interfere with the performance of this study.&#xD;
&#xD;
          -  Any active acute or chronic infectious disease that, in the opinion of the&#xD;
             investigator, would pose an excessive risk to study staff.&#xD;
&#xD;
          -  Current use or recent exposure to any medication that in the opinion of the&#xD;
             investigator could have an influence on the patient's ability to participate in this&#xD;
             study or on the performance of the test device.&#xD;
&#xD;
          -  Extensive skin changes/diseases that preclude wearing the required number of devices&#xD;
             on normal skin at the proposed application sites (e.g., extensive psoriasis, recent&#xD;
             burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos,&#xD;
             dermatitis herpetiformis).&#xD;
&#xD;
          -  Have a known allergy to medical-grade adhesives, or known hypersensitivity to any of&#xD;
             the products used in the study.&#xD;
&#xD;
          -  Known current or recent alcohol or drug abuse&#xD;
&#xD;
          -  Blood donation of more than 500 ml within the last three months&#xD;
&#xD;
          -  Currently participating in another investigational study protocol where the testing or&#xD;
             results may interfere with study compliance, diagnostic results, or data collection.&#xD;
&#xD;
          -  Has a MRI scan, CT scan, or diathermy scheduled during the proposed study&#xD;
             participation.&#xD;
&#xD;
          -  An identified protected vulnerable patient (including but not limited to those in&#xD;
             detention, or a prisoner).&#xD;
&#xD;
          -  Women of reproductive potential who are unwilling to adopt contraceptive measures&#xD;
             during the study period&#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>Elaine Chow, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Chinese University of Hong Kong</name>
      <address>
        <city>Sha Tin</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>September 23, 2019</last_update_submitted>
  <last_update_submitted_qc>September 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03008239
org study id: P-4.5-C-01
nct id: NCT03008239
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study evaluates the performance and safety of the fluorescence based fibre optic glucose
      sensor for home usage.24 subjects will take part in the study, including 4 pre-diabetic
      subjects, 8 Type I diabetic patients, 8 Type II diabetic patients and 4 diabetic patients who
      require continuous ambulatory peritoneal dialysis (CAPD). Type 1, Type 2 and prediabetic
      subjects will wear one FiberSense sensor, randomly allocated to either the upper arm (50%) or
      abdomen (50%) for 28 days. In addition, these subjects will wear a Dexcom sensor on the other
      side of the abdomen for 7 days in one of the four study weeks. In all 4 CAPD subjects, one
      FiberSense sensor will be placed in the upper arm for 28 days. No additional comparator
      sensor will be placed in CAPD subjects.
The FiberSense system is a glucose-monitoring device indicated for continually recording
      interstitial fluid glucose levels in patients ages 18 and older with insulin dependent
      diabetes mellitus for the purpose of improving diabetes management. The System is intended
      for use by patients at home and in health care facilities.

      The FiberSense system is indicated for use as an adjunctive device to complement, not
      replace, information obtained from standard home glucose monitoring devices.

      The FiberSense system aids in the detection of episodes of hyperglycemia and hypoglycemia,
      facilitating both acute and long-term therapy adjustments, which may minimize these
      excursions.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Blood glucose
time frame: 28 days
description: The primary endpoint is the proportion of FiberSense readings within ≤15% of the reference (YSI) reading for blood glucose levels >100 mg/dl, and the proportion of FiberSense readings within ≤15 mg/dl of the YSI reading for blood glucose levels ≤100 mg/dl, for paired samples taken during the in-clinic sessions.
measure: Adverse Events reporting
time frame: 35 days
measure: Mean Relatives Differences from YSI
time frame: 28 days
measure: Median Relatives Differences from YSI
time frame: 28 days
measure: Mean Absolute Relative Differences from YSI
time frame: 28 days
measure: Median Absolute Relative Differences from YSI
time frame: 28 days
measure: Hypoglycemia detection rates
time frame: 28 days
measure: Hyperglycemia detection rates
time frame: 28 days
measure: Accuracy of glucose rate of change of FiberSense sensor compared to glucose rate of change of YSI
time frame: 28 days
measure: Lag time between FiberSense readings and YSI results during induced glucose excursions
time frame: 28 days
measure: Agreement and accuracy relative to SMBG readings (same model to be used by all subjects)
time frame: 28 days
measure: Calibration stability
time frame: 28 days
measure: Sensor stability
time frame: 28 days
measure: Sensor life
time frame: 28 days
measure: User satisfaction questionnaire score
time frame: 28 days
measure: Blood maltose concentrations
time frame: 28 days
description: Measured in CAPD subjects during the V1 in-clinic session
arm group label: FiberSense sensor
arm group type: Experimental
description: Type 1, Type 2 and prediabetic subjects will wear one FiberSense sensor, randomly allocated to either the upper arm (50%) or abdomen (50%) for 28 days. In addition, these subjects will wear a Dexcom sensor on the other side of the abdomen for 7 days in one of the four study weeks.
In all 4 CAPD subjects, one FiberSense sensor will be placed in the upper arm for 28 days. No additional comparator sensor will be placed in CAPD subject.
intervention type: Device
intervention name: FiberSense sensor
description: The FiberSense system is a glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients ages 18 and older with insulin dependent diabetes mellitus for the purpose of improving diabetes management.
arm group label: FiberSense sensor
intervention type: Device
intervention name: Dexcom Sensor
description: Dexcom is a continuous glucose monitoring (CGM) system. The display device shows the glucose readings and the trend.
arm group label: FiberSense sensor
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Elaine Chow, Dr.
role: Principal Investigator
affiliation: Chinese University of Hong Kong
facility: 
country: Hong Kong
responsible party type: Sponsor
sharing ipd: No