xml: <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/NCT05995756</url>
    </required_header>
    <id_info>
      <org_study_id>NPI031-CIP-001</org_study_id>
      <nct_id>NCT05995756</nct_id>
    </id_info>
    <brief_title>Evaluate the Safety and Efficacy of Sinocare CGM System Regarding Real Time Glucose Level Monitoring</brief_title>
    <official_title>Evaluate the Safety and Efficacy of Sinocare CGM System Regarding Real Time Glucose</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sinocare</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sinocare</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>
        From Jan 2022 to June 2022, 120 subjects (22-75 years of age, mean ±standard deviation [SD]&#xD;
        of 53.20 ±14.49 years) with type 1 or type 2 diabetes participated in the study in P.R.&#xD;
        China. Subjects wore two sensors in the abdomen which were paired with smart devices running&#xD;
        a glucose monitoring mobile application (i3/H3 CGM APP). Subjects were asked to undergo one&#xD;
        in-clinic visit (on one of the study days 2, 7-9, or 15) for 7-hour long YSI frequent&#xD;
        sampling test (FST) periods, where intravenous (IV) blood samples were drawn every 15 min and&#xD;
        analyzed using the YSI 2300 STAT Plus Glucose &amp; Lactate Analyzer (Yellow Springs Instrument,&#xD;
        YSI Life Sciences, Yellow Springs, OH).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 20, 2021</start_date>
    <completion_date type="Actual">June 30, 2022</completion_date>
    <primary_completion_date type="Actual">June 30, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>overall mean absolute relative difference (MARD)</measure>
      <time_frame>8 or 15 days</time_frame>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">120</enrollment>
    <condition>Type 1 or Type 2 Diabetes</condition>
    <arm_group>
      <arm_group_label>In pateint</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Out pateint</arm_group_label>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Adult (Aged ≥18) TD1 and TD2&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Aged ≥18 years, male or female;&#xD;
  &#xD;
            2. Clinically diagnosed with diabetes;&#xD;
  &#xD;
            3. Being willing to wear the investigational device for the duration set according to its&#xD;
               service life, and conduct glucose monitoring;&#xD;
  &#xD;
            4. Consent to participate in this clinical study, and sign the Informed Consent Form&#xD;
               (ICF).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Disagree to wear the investigational device continuously according to the requirements&#xD;
               of the trial;&#xD;
  &#xD;
            2. Refuse venous blood collection for 7 consecutive hours (every 15 minutes) on a certain&#xD;
               day during the trial;&#xD;
  &#xD;
            3. Plan to undergo magnetic resonance imaging (MRI) during the clinical trial;&#xD;
  &#xD;
            4. With diffuse subcutaneous nodules at the wearing site of the investigational device;&#xD;
  &#xD;
            5. Have a history of diabetic ketoacidosis or hyperosmolar hyperglycemic state within the&#xD;
               6 months prior to screening;&#xD;
  &#xD;
            6. With mental disorders, lack of self-control and inability to express clearly;&#xD;
  &#xD;
            7. Have participated in any other clinical trial within the past 1 month;&#xD;
  &#xD;
            8. Where the investigator thinks not suitable for being enrolled.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Beijing Pinggu Hospital</name>
        <address>
          <city>Beijing</city>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Peking University People's Hospital</name>
        <address>
          <city>Beijing</city>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>The Second Xiangya Hospital of Central South University</name>
        <address>
          <city>Changsha</city>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</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>
  
  
text: 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/NCT05995756
  org study id: NPI031-CIP-001
  nct id: NCT05995756
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  From Jan 2022 to June 2022, 120 subjects (22-75 years of age, mean ±standard deviation [SD]
        of 53.20 ±14.49 years) with type 1 or type 2 diabetes participated in the study in P.R.
        China. Subjects wore two sensors in the abdomen which were paired with smart devices running
        a glucose monitoring mobile application (i3/H3 CGM APP). Subjects were asked to undergo one
        in-clinic visit (on one of the study days 2, 7-9, or 15) for 7-hour long YSI frequent
        sampling test (FST) periods, where intravenous (IV) blood samples were drawn every 15 min and
        analyzed using the YSI 2300 STAT Plus Glucose & Lactate Analyzer (Yellow Springs Instrument,
        YSI Life Sciences, Yellow Springs, OH).
  observational model: Cohort
  time perspective: Prospective
  measure: overall mean absolute relative difference (MARD)
  time frame: 8 or 15 days
  arm group label: In pateint
  arm group label: Out pateint
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  facility: 
  facility: 
  country: China
  responsible party type: Sponsor
  sharing ipd: No