<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/NCT03008044</url>
  </required_header>
  <id_info>
    <org_study_id>P-4.4-C-01</org_study_id>
    <nct_id>NCT03008044</nct_id>
  </id_info>
  <brief_title>Evaluation of a Percutaneous Optical Fibre Glucose Sensor (FiberSense System)</brief_title>
  <official_title>Evaluation of a Percutaneous Optical Fibre Glucose Sensor (FiberSense) Across the Glycemic Range With Rapid Glucose Excursions Using the Glucose Clamp</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single center prospective study. The purpose of this study is to assess the&#xD;
      performance of FiberSense system across the glucose measurement ranges (from hypoglycemia to&#xD;
      hyperglycemia) as compared with a gold standard reference laboratory method (YSI glucose) in&#xD;
      healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The FiberSense system is intended to be used by diabetic patients in a home use setting as a&#xD;
      CGM system using the interstitial fluid (ISF) glucose as an indicator of blood glucose&#xD;
      levels.The purpose of this study is to assess the performance of FiberSense system across the&#xD;
      glucose measurement ranges (from hypoglycemia to hyperglycemia) as compared with a gold&#xD;
      standard reference laboratory method (YSI glucose) in healthy volunteers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2016</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</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>Sequential Assignment</intervention_model>
    <intervention_model_description>For the first 10 subjects, all sensors will be removed after the end of the clamp measurement day.&#xD;
The last 2 subjects will continue to wear the three sensors after the clamp study. The second clamp study will take place at Day 7±1. After the second clamp study, the commercial CGM sensor will be removed. The two FiberSense sensors will be worn for up to Day 14.</intervention_model_description>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall performance of the FiberSense device as compared with YSI</measure>
    <time_frame>1 day</time_frame>
    <description>Proportion of FiberSense readings within ≤15% of the reference (YSI) reading for blood glucose levels &gt;100 mg/dl (5.55 mmol/l), and the proportion of FiberSense readings within ≤15 mg/dl (0.83 mmol/l) of the YSI reading for blood glucose levels ≤100 mg/dl.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean relative differences in FiberSense measured glucose from the reference laboratory standard (YSI)</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Absolute Relative Differences in FiberSense measured glucose from the reference laboratory method (YSI)</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of glucose rate of change measured by FiberSense sensor compared to glucose rate of change measured using the reference laboratory method (YSI)</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lag time between FiberSense readings and reference laboratory method (YSI) results during induced glucose excursions</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Precision of FiberSense system readings: Precision Absolute Relative Differences with comparison of FiberSense system locations (inter and intra)</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of readings that are within 15% of the YSI values</measure>
    <time_frame>1 day</time_frame>
    <description>Comparisons of the percentage of readings from Dexcom and Fibersense, and comparisons of the percentage of readings from Bayer Contour Next and Fibersense, will be done separately during analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of readings that are within 20% of the YSI values</measure>
    <time_frame>1 day</time_frame>
    <description>Comparisons of the percentage of readings from Dexcom and Fibersense, and comparisons of the percentage of readings from Bayer Contour Next and Fibersense, will be done separately during analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of readings that are within 30% of the YSI values</measure>
    <time_frame>1 day</time_frame>
    <description>Comparisons of the percentage of readings from Dexcom and Fibersense, and comparisons of the percentage of readings from Bayer Contour Next and Fibersense, will be done separately during analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of readings that are within 40% of the YSI values</measure>
    <time_frame>1 day</time_frame>
    <description>Comparisons of the percentage of readings from Dexcom and Fibersense, and comparisons of the percentage of readings from Bayer Contour Next and Fibersense, will be done separately during analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of readings that are greater than 40% of the YSI values</measure>
    <time_frame>1 day</time_frame>
    <description>Comparisons of the percentage of readings from Dexcom and Fibersense, and comparisons of the percentage of readings from Bayer Contour Next and Fibersense, will be done separately during analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Event Reporting</measure>
    <time_frame>14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median relative differences in FiberSense measured glucose from the reference laboratory standard (YSI)</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Absolute Relative Differences in FiberSense measured glucose from the reference laboratory method (YSI)</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>Device: FiberSense system</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 subjects will wear 2 FiberSense system in abdomen and upper arm respectively and Dexcom G4 Platinum CGM sensor for 1 day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Extension Phase</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 subjects will extend the wearing of the sensors up to 14 days (2 FiberSense systems to Day 14 and Dexcom sensor to Day 7±1) after the glucose clamp study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FiberSense system</intervention_name>
    <description>A novel CGM system based on a FiberSense system placed through the dermis of the patient.</description>
    <arm_group_label>Device: FiberSense system</arm_group_label>
    <arm_group_label>Extension Phase</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female age ≥ 18 years old.&#xD;
&#xD;
          -  Nondiabetic subjects with normal fasting plasma glucose and HbA1c (≤5.6%)&#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 bathing and swimming during their participation in the&#xD;
             measurement 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;
          -  Currently pregnant, as demonstrated by a positive pregnancy test at screening and on&#xD;
             day of first sensor insertion&#xD;
&#xD;
          -  Impaired hepatic function measured as alanine aminotransferase (ALT) or aspartate&#xD;
             aminotransferase (AST) ≥ three times the upper reference limit.&#xD;
&#xD;
          -  Impaired renal function measured as serum creatinine &gt; 1.2 times above the upper limit&#xD;
             of normal.&#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;
          -  History of epilepsy&#xD;
&#xD;
          -  History of cardiac arrhythmias&#xD;
&#xD;
          -  Clinically significant abnormality on ECG at screening&#xD;
&#xD;
          -  An identified protected vulnerable patient (including but not limited to those in&#xD;
             detention, or a prisoner).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</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>August 2017</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>August 9, 2017</last_update_submitted>
  <last_update_submitted_qc>August 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2017</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/NCT03008044
org study id: P-4.4-C-01
nct id: NCT03008044
lead sponsor: 
has dmc: Yes
This is a single center prospective study. The purpose of this study is to assess the
      performance of FiberSense system across the glucose measurement ranges (from hypoglycemia to
      hyperglycemia) as compared with a gold standard reference laboratory method (YSI glucose) in
      healthy volunteers.
The FiberSense system is intended to be used by diabetic patients in a home use setting as a
      CGM system using the interstitial fluid (ISF) glucose as an indicator of blood glucose
      levels.The purpose of this study is to assess the performance of FiberSense system across the
      glucose measurement ranges (from hypoglycemia to hyperglycemia) as compared with a gold
      standard reference laboratory method (YSI glucose) in healthy volunteers.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: For the first 10 subjects, all sensors will be removed after the end of the clamp measurement day.
The last 2 subjects will continue to wear the three sensors after the clamp study. The second clamp study will take place at Day 7±1. After the second clamp study, the commercial CGM sensor will be removed. The two FiberSense sensors will be worn for up to Day 14.
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Overall performance of the FiberSense device as compared with YSI
time frame: 1 day
description: Proportion of FiberSense readings within ≤15% of the reference (YSI) reading for blood glucose levels >100 mg/dl (5.55 mmol/l), and the proportion of FiberSense readings within ≤15 mg/dl (0.83 mmol/l) of the YSI reading for blood glucose levels ≤100 mg/dl.
measure: Mean relative differences in FiberSense measured glucose from the reference laboratory standard (YSI)
time frame: 1 day
measure: Mean Absolute Relative Differences in FiberSense measured glucose from the reference laboratory method (YSI)
time frame: 1 day
measure: Accuracy of glucose rate of change measured by FiberSense sensor compared to glucose rate of change measured using the reference laboratory method (YSI)
time frame: 1 day
measure: Lag time between FiberSense readings and reference laboratory method (YSI) results during induced glucose excursions
time frame: 1 day
measure: Precision of FiberSense system readings: Precision Absolute Relative Differences with comparison of FiberSense system locations (inter and intra)
time frame: 1 day
measure: Percentage of readings that are within 15% of the YSI values
time frame: 1 day
description: Comparisons of the percentage of readings from Dexcom and Fibersense, and comparisons of the percentage of readings from Bayer Contour Next and Fibersense, will be done separately during analysis.
measure: Percentage of readings that are within 20% of the YSI values
time frame: 1 day
description: Comparisons of the percentage of readings from Dexcom and Fibersense, and comparisons of the percentage of readings from Bayer Contour Next and Fibersense, will be done separately during analysis.
measure: Percentage of readings that are within 30% of the YSI values
time frame: 1 day
description: Comparisons of the percentage of readings from Dexcom and Fibersense, and comparisons of the percentage of readings from Bayer Contour Next and Fibersense, will be done separately during analysis.
measure: Percentage of readings that are within 40% of the YSI values
time frame: 1 day
description: Comparisons of the percentage of readings from Dexcom and Fibersense, and comparisons of the percentage of readings from Bayer Contour Next and Fibersense, will be done separately during analysis.
measure: Percentage of readings that are greater than 40% of the YSI values
time frame: 1 day
description: Comparisons of the percentage of readings from Dexcom and Fibersense, and comparisons of the percentage of readings from Bayer Contour Next and Fibersense, will be done separately during analysis.
measure: Adverse Event Reporting
time frame: 14 days
measure: Median relative differences in FiberSense measured glucose from the reference laboratory standard (YSI)
time frame: 1 day
measure: Median Absolute Relative Differences in FiberSense measured glucose from the reference laboratory method (YSI)
time frame: 1 day
arm group label: Device: FiberSense system
arm group type: Experimental
description: 10 subjects will wear 2 FiberSense system in abdomen and upper arm respectively and Dexcom G4 Platinum CGM sensor for 1 day.
arm group label: Extension Phase
arm group type: Experimental
description: 2 subjects will extend the wearing of the sensors up to 14 days (2 FiberSense systems to Day 14 and Dexcom sensor to Day 7±1) after the glucose clamp study.
intervention type: Device
intervention name: FiberSense system
description: A novel CGM system based on a FiberSense system placed through the dermis of the patient.
arm group label: Device: FiberSense system
arm group label: Extension Phase
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
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