<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/NCT03276949</url>
  </required_header>
  <id_info>
    <org_study_id>2002948</org_study_id>
    <nct_id>NCT03276949</nct_id>
  </id_info>
  <brief_title>Non-invasive Glucose Measurement Using Laser Technology</brief_title>
  <acronym>(Raman)</acronym>
  <official_title>Non-Invasive Glucose Measurement Using Raman Spectroscopy During Oral Glucose Tolerance Test</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Missouri-Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Massachusetts Institute of Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Missouri-Columbia</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>
      This study is to evaluate the capability of Raman spectroscopy as a non-invasive method for&#xD;
      monitoring concentrations of glucose by illuminating a small spot on the skin, collecting and&#xD;
      analyzing the return light. The glucose measurements obtained by Raman Spectroscopy are&#xD;
      correlated with those obtained using YSI glucose analyzer and ACCUCHECK instruments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diabetes mellitus (DM), caused by impairment in the glucose metabolism is a worldwide&#xD;
      epidemic. It is projected that by the year 2035 there will be approximately 592 million&#xD;
      diabetic patients. Blood glucose (BG) levels are finely regulated by insulin secretion and&#xD;
      any defects in the secretion or function can lead to DM. As no well-established medical&#xD;
      intervention for DM has been known till date, continuous monitoring of BG is the only way to&#xD;
      avoid secondary metabolic complications such as strokes, heart attacks, high blood pressure,&#xD;
      blindness and coma. Diagnosis and therapeutic monitoring of diabetes requires direct&#xD;
      measurement of plasma (or blood) glucose. Measurement of the fasting glucose level is the&#xD;
      preferred test for diagnosis of diabetes in children and non-pregnant adults, while the oral&#xD;
      glucose tolerance test (OGTT) is the preferred method of diagnosis for gestational diabetes.&#xD;
      In addition, patients with an established diagnosis of insulin-dependent diabetes (all type-I&#xD;
      and many type-II) require frequent glucose measurements for therapeutic monitoring. Emergence&#xD;
      of hand-held glucose sensors have enabled patients with the ability to self-monitor the BG&#xD;
      level. The frequent monitoring requires small blood sample (&lt;1 µL) obtained by a&#xD;
      &quot;finger-pricking&quot; and electrochemical sensing using a portable 'glucometer'. However the&#xD;
      procedure is inconvenient, results in poor patient compliance and lacks in providing real&#xD;
      time information about concentration changes. Regardless of the clinical test performed,&#xD;
      withdrawal of blood or interstitial fluid is currently required for measurement of BG levels.&#xD;
&#xD;
      The proposed study is based on preliminary research supported by the MIT Laser Biomedical&#xD;
      Research Center (LBRC), and promising results obtained with spectroscopic measurement of&#xD;
      blood glucose in the laboratory, in an experimental animal model, and in a small cohort of&#xD;
      human subject volunteers. In order to make non-invasive glucose measurement a viable clinical&#xD;
      technology, however, a methodological implementation and validation from bench to bedside is&#xD;
      required. In the application, we propose to accomplish this goal by means of a&#xD;
      carefully-designed translational research study employing specifically-designed&#xD;
      instrumentation and methods for pre-clinical validation and early clinical studies in human&#xD;
      subjects. These studies will incrementally increase in data complexity, culminating in a&#xD;
      clinical study in human subjects, as well as a non-invasive, spectroscopic glucose tolerance&#xD;
      test as an alternative to OGTT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 22, 2016</start_date>
  <completion_date type="Actual">March 13, 2017</completion_date>
  <primary_completion_date type="Actual">April 29, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Non-Invasive Random Glucose Measurement using Raman Spectroscopy during Oral Glucose Tolerance Test</measure>
    <time_frame>Two weeks</time_frame>
    <description>Blood glucose measurement using Raman spectroscopy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Non-Invasive Random Glucose Measurement using Raman Spectroscopy</measure>
    <time_frame>Two weeks</time_frame>
    <description>Correlation with Serum and capillary blood glucose measurement</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Oral Glucose Tolerance Test</condition>
  <arm_group>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <description>Non-diabetic healthy men/women in between age group 18-80 years (all races and ethnicity) will be included for blood glucose measurements</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Blood glucose measurement</intervention_name>
    <description>Device used to measure blood glucose levels</description>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <other_name>Raman Spectroscopy BLOOD GLUCOSE LEVEL MEASUREMENT</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All races and ethnicity&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        wenty healthy men and women will be studied who will be&#xD;
&#xD;
          -  Non diabetic&#xD;
&#xD;
          -  Age group between 18 - 80 years&#xD;
&#xD;
          -  Prior fasting blood glucose (FBG) values less than or equal to 125 mg/dL&#xD;
&#xD;
          -  All races and ethnicity&#xD;
&#xD;
          -  Smokers and nonsmokers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with a known diabetic condition&#xD;
&#xD;
          -  With FBG greater than 125 mg/dl or random blood sugar above 200 mg/dL since the study&#xD;
             requires observing normal glucose level changes during oral glucose tolerance test.&#xD;
&#xD;
          -  Subjects with prior indication of skin irritation or with visible skin rashes&#xD;
&#xD;
          -  Any phobia for mechanical device or needle&#xD;
&#xD;
          -  Pregnant women will be excluded from the study due to the required blood drawing.&#xD;
&#xD;
          -  Children will be excluded as they may not tolerate IV line placement or comply with&#xD;
             finger-pricking&#xD;
&#xD;
          -  Subjects should not have given blood prior to 8 weeks of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Uzma Khan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Missouri-Columbia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anandhi Upendran</last_name>
    <role>Study Director</role>
    <affiliation>University of Missouri-Columbia</affiliation>
  </overall_official>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>September 7, 2017</last_update_submitted>
  <last_update_submitted_qc>September 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Missouri-Columbia</investigator_affiliation>
    <investigator_full_name>Uzma Z Khan</investigator_full_name>
    <investigator_title>Associate Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Blood glucose</keyword>
  <keyword>non-invasive</keyword>
  <keyword>Raman spectroscopy</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data will be shared with MIT for analysis</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>One year after publication</ipd_time_frame>
  </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/NCT03276949
org study id: 2002948
nct id: NCT03276949
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is to evaluate the capability of Raman spectroscopy as a non-invasive method for
      monitoring concentrations of glucose by illuminating a small spot on the skin, collecting and
      analyzing the return light. The glucose measurements obtained by Raman Spectroscopy are
      correlated with those obtained using YSI glucose analyzer and ACCUCHECK instruments.
Diabetes mellitus (DM), caused by impairment in the glucose metabolism is a worldwide
      epidemic. It is projected that by the year 2035 there will be approximately 592 million
      diabetic patients. Blood glucose (BG) levels are finely regulated by insulin secretion and
      any defects in the secretion or function can lead to DM. As no well-established medical
      intervention for DM has been known till date, continuous monitoring of BG is the only way to
      avoid secondary metabolic complications such as strokes, heart attacks, high blood pressure,
      blindness and coma. Diagnosis and therapeutic monitoring of diabetes requires direct
      measurement of plasma (or blood) glucose. Measurement of the fasting glucose level is the
      preferred test for diagnosis of diabetes in children and non-pregnant adults, while the oral
      glucose tolerance test (OGTT) is the preferred method of diagnosis for gestational diabetes.
      In addition, patients with an established diagnosis of insulin-dependent diabetes (all type-I
      and many type-II) require frequent glucose measurements for therapeutic monitoring. Emergence
      of hand-held glucose sensors have enabled patients with the ability to self-monitor the BG
      level. The frequent monitoring requires small blood sample (<1 µL) obtained by a
      "finger-pricking" and electrochemical sensing using a portable 'glucometer'. However the
      procedure is inconvenient, results in poor patient compliance and lacks in providing real
      time information about concentration changes. Regardless of the clinical test performed,
      withdrawal of blood or interstitial fluid is currently required for measurement of BG levels.

      The proposed study is based on preliminary research supported by the MIT Laser Biomedical
      Research Center (LBRC), and promising results obtained with spectroscopic measurement of
      blood glucose in the laboratory, in an experimental animal model, and in a small cohort of
      human subject volunteers. In order to make non-invasive glucose measurement a viable clinical
      technology, however, a methodological implementation and validation from bench to bedside is
      required. In the application, we propose to accomplish this goal by means of a
      carefully-designed translational research study employing specifically-designed
      instrumentation and methods for pre-clinical validation and early clinical studies in human
      subjects. These studies will incrementally increase in data complexity, culminating in a
      clinical study in human subjects, as well as a non-invasive, spectroscopic glucose tolerance
      test as an alternative to OGTT.
observational model: Other
time perspective: Other
measure: Non-Invasive Random Glucose Measurement using Raman Spectroscopy during Oral Glucose Tolerance Test
time frame: Two weeks
description: Blood glucose measurement using Raman spectroscopy
measure: Non-Invasive Random Glucose Measurement using Raman Spectroscopy
time frame: Two weeks
description: Correlation with Serum and capillary blood glucose measurement
arm group label: Healthy volunteers
description: Non-diabetic healthy men/women in between age group 18-80 years (all races and ethnicity) will be included for blood glucose measurements
intervention type: Device
intervention name: Blood glucose measurement
description: Device used to measure blood glucose levels
arm group label: Healthy volunteers
other name: Raman Spectroscopy BLOOD GLUCOSE LEVEL MEASUREMENT
Blood samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Uzma Khan, MD
role: Principal Investigator
affiliation: University of Missouri-Columbia
last name: Anandhi Upendran
role: Study Director
affiliation: University of Missouri-Columbia
responsible party type: Principal Investigator
investigator affiliation: University of Missouri-Columbia
investigator full name: Uzma Z Khan
investigator title: Associate Professor of Medicine
sharing ipd: Yes
ipd description: Data will be shared with MIT for analysis
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: One year after publication