<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/NCT02241993</url>
  </required_header>
  <id_info>
    <org_study_id>11619</org_study_id>
    <nct_id>NCT02241993</nct_id>
  </id_info>
  <brief_title>The Multi-Sensor Distance Accuracy Study</brief_title>
  <official_title>The Accuracy Benefit of Dual vs Single Amperometric Glucose Sensors in Persons With Type 1 Diabetes: Effect of Inter-sensor Distance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Leona M. and Harry B. Helmsley Charitable Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oregon Health and Science University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to test the accuracy benefit of having two glucose sensors (over&#xD;
      one sensor alone) when they are positioned: 2mm, 10mm, 20mm, or 30mm apart. It is not yet&#xD;
      known how close two sensors can be and still work correctly.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An artificial pancreas system will likely require multiple glucose sensing elements to&#xD;
      function safely. It is not yet known how close two glucose sensors can be placed and still&#xD;
      work properly. Meaning, if one is reading inaccurately,and the other is positioned adjacent&#xD;
      to it, will it read inaccurately also, defeating the purpose of having two sensors. Twenty&#xD;
      adult subjects with Type 1 diabetes will wear four Medtronic REAL-Time glucose sensors during&#xD;
      two separate 10-hour studies. The inter-sensor distances of each pair to be tested will be:&#xD;
      2, 10, 20, and 30mm apart. The sensors will be inserted the day prior to the study day to&#xD;
      allow for signal stabilization and calibration. During the study day, arterialized venous&#xD;
      blood will be drawn every 15 minutes to measure blood glucose. The sensor values and&#xD;
      interstitial values will be recorded from each sensor receiver at each time point. Subjects&#xD;
      will be fed two standardized meals and given pre-meal insulin based on their typical insulin&#xD;
      to carbohydrate ratio.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2010</start_date>
  <completion_date type="Actual">January 2011</completion_date>
  <primary_completion_date type="Actual">January 2011</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Difference between very large sensor accuracy errors (≥50% from reference glucose) with the simultaneous use of four sensors vs one sensor.</measure>
    <time_frame>9-hour collection period, X 2</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference between mean absolute relative difference with the simultaneous use of four sensors vs one sensor.</measure>
    <time_frame>9-hour glucose level collection, X 2</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Type 1 diabetic</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        clinical practice Type 1 patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Type 1 diabetes mellitus diagnosed for at least 6 months&#xD;
&#xD;
          2. Current usage of multiple daily injections or subcutaneous insulin pump treatment&#xD;
&#xD;
          3. Age 18-65 years&#xD;
&#xD;
          4. HbA1c of 6.0 - 9.5% at screening visit&#xD;
&#xD;
          5. BMI 21-35&#xD;
&#xD;
          6. Willingness to follow all study procedures, including attending all clinic visits&#xD;
&#xD;
          7. Willingness to sign informed consent and HIPAA documents&#xD;
&#xD;
        Exclusion Criteria: Subjects presenting with any of the following will not be included in&#xD;
        the study.&#xD;
&#xD;
          1. Pregnancy or Lactation: for women of childbearing potential there is a requirement for&#xD;
             a negative urine pregnancy test.&#xD;
&#xD;
          2. Renal insufficiency (serum creatinine of 2.0 mg/dL or greater). Serum ALT or AST equal&#xD;
             to or greater than 3 times the upper limit of normal; hepatic synthetic insufficiency&#xD;
             as defined as a serum albumin of less the 3.3 g/dL; or serum bilirubin of over 2.&#xD;
&#xD;
          3. Hematocrit of less than or equal to 34%.&#xD;
&#xD;
          4. Congestive heart failure, NYHA class III or IV.&#xD;
&#xD;
          5. Visual impairment preventing reading of glucose meter values.&#xD;
&#xD;
          6. Active coronary artery disease as manifested by unstable angina, or a myocardial&#xD;
             infarction or therapeutic coronary percutaneous procedure (e.g., PTCA, stent&#xD;
             placement) or CABG within the past 4 months.&#xD;
&#xD;
          7. Active foot ulceration.&#xD;
&#xD;
          8. Severe peripheral arterial disease characterized by ischemic rest pain or severe&#xD;
             claudication.&#xD;
&#xD;
          9. Cerebrovascular accident within the past 6 months.&#xD;
&#xD;
         10. Active alcohol abuse, substance abuse, or severe mental illness (as judged by the&#xD;
             principal investigator).&#xD;
&#xD;
         11. Active malignancy, except basal cell or squamous cell skin cancers.&#xD;
&#xD;
         12. Major surgical operation within 30 days prior to screening.&#xD;
&#xD;
         13. Seizure disorder (epilepsy).&#xD;
&#xD;
         14. Any concurrent illness, other than diabetes, that is not controlled by a stable&#xD;
             therapeutic regimen.&#xD;
&#xD;
         15. Currently administration of oral or parenteral corticosteroids.&#xD;
&#xD;
         16. Use of an investigational drug within 30 days prior to screening.&#xD;
&#xD;
         17. Bleeding disorder, treatment with warfarin, or platelet count below 50,000.&#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>W. Kenneth Ward, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oregon Health and Science University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Ward WK, Casey HM, Quinn MJ, Federiuk IF, Wood MD. A fully implantable subcutaneous glucose sensor array: enhanced accuracy from multiple sensing units and a median-based algorithm. Diabetes Technol Ther. 2003;5(6):943-52. doi: 10.1089/152091503322640980.</citation>
    <PMID>14709196</PMID>
  </reference>
  <reference>
    <citation>Schmidtke DW, Pishko MV, Quinn CP, Heller A. Statistics for critical clinical decision making based on readings of pairs of implanted sensors. Anal Chem. 1996 Sep 1;68(17):2845-9. doi: 10.1021/ac9602027.</citation>
    <PMID>8794921</PMID>
  </reference>
  <results_reference>
    <citation>Castle JR, Engle JM, El Youssef J, Massoud RG, Yuen KC, Kagan R, Ward WK. Novel use of glucagon in a closed-loop system for prevention of hypoglycemia in type 1 diabetes. Diabetes Care. 2010 Jun;33(6):1282-7. doi: 10.2337/dc09-2254. Epub 2010 Mar 23.</citation>
    <PMID>20332355</PMID>
  </results_reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>November 6, 2013</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>September 15, 2014</last_update_submitted>
  <last_update_submitted_qc>September 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
    <investigator_full_name>W Kenneth Ward MD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>glucose sensor</keyword>
  <keyword>Inter-sensor distance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 1</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/NCT02241993
org study id: 11619
nct id: NCT02241993
lead sponsor: 
collaborator: 
has dmc: No
The purpose of the study is to test the accuracy benefit of having two glucose sensors (over
      one sensor alone) when they are positioned: 2mm, 10mm, 20mm, or 30mm apart. It is not yet
      known how close two sensors can be and still work correctly.
An artificial pancreas system will likely require multiple glucose sensing elements to
      function safely. It is not yet known how close two glucose sensors can be placed and still
      work properly. Meaning, if one is reading inaccurately,and the other is positioned adjacent
      to it, will it read inaccurately also, defeating the purpose of having two sensors. Twenty
      adult subjects with Type 1 diabetes will wear four Medtronic REAL-Time glucose sensors during
      two separate 10-hour studies. The inter-sensor distances of each pair to be tested will be:
      2, 10, 20, and 30mm apart. The sensors will be inserted the day prior to the study day to
      allow for signal stabilization and calibration. During the study day, arterialized venous
      blood will be drawn every 15 minutes to measure blood glucose. The sensor values and
      interstitial values will be recorded from each sensor receiver at each time point. Subjects
      will be fed two standardized meals and given pre-meal insulin based on their typical insulin
      to carbohydrate ratio.
observational model: Case-Only
time perspective: Prospective
measure: Difference between very large sensor accuracy errors (≥50% from reference glucose) with the simultaneous use of four sensors vs one sensor.
time frame: 9-hour collection period, X 2
measure: Difference between mean absolute relative difference with the simultaneous use of four sensors vs one sensor.
time frame: 9-hour glucose level collection, X 2
arm group label: Type 1 diabetic
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: W. Kenneth Ward, MD
role: Principal Investigator
affiliation: Oregon Health and Science University
facility: 
country: United States
citation: Ward WK, Casey HM, Quinn MJ, Federiuk IF, Wood MD. A fully implantable subcutaneous glucose sensor array: enhanced accuracy from multiple sensing units and a median-based algorithm. Diabetes Technol Ther. 2003;5(6):943-52. doi: 10.1089/152091503322640980.
PMID: 14709196
citation: Schmidtke DW, Pishko MV, Quinn CP, Heller A. Statistics for critical clinical decision making based on readings of pairs of implanted sensors. Anal Chem. 1996 Sep 1;68(17):2845-9. doi: 10.1021/ac9602027.
PMID: 8794921
citation: Castle JR, Engle JM, El Youssef J, Massoud RG, Yuen KC, Kagan R, Ward WK. Novel use of glucagon in a closed-loop system for prevention of hypoglycemia in type 1 diabetes. Diabetes Care. 2010 Jun;33(6):1282-7. doi: 10.2337/dc09-2254. Epub 2010 Mar 23.
PMID: 20332355
responsible party type: Principal Investigator
investigator affiliation: Oregon Health and Science University
investigator full name: W Kenneth Ward MD
investigator title: Associate Professor
mesh term: Diabetes Mellitus, Type 1