<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/NCT03785301</url>
  </required_header>
  <id_info>
    <org_study_id>KY20170904-04</org_study_id>
    <nct_id>NCT03785301</nct_id>
  </id_info>
  <brief_title>Effect of FGM on Glucose Control in Diabetic Patients</brief_title>
  <official_title>Effect of FGM on Glucose Control in Diabetic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanjing First Hospital, Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanjing First Hospital, Nanjing Medical University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to assess the eﬀect of FGM on glycemic control compared with SMBG&#xD;
      using a randomised controlled study design in adults with type 2 diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Flash glucose monitoring (FGM) is a newly introduced Glucose Monitoring system. The aim of&#xD;
      the study is to assess the eﬀect of FGM on glycemic control compared with standard blood&#xD;
      glucose monitoring (SMBG) using a randomised controlled study design in adults with type 2&#xD;
      diabetes. Subjects will use unmasked FGM once a month or SMBG to monitor glucose level for 3&#xD;
      months. Patients in the SMBG group will wear masked FGM to collect glycaemic variability data&#xD;
      for comparison to the intervention group of the study. The primary outcome, HbA1c, will be&#xD;
      cpmpared at baseline and 3 month. Glucose control parameters provided by unmasked and masked&#xD;
      FGM will be compared in the two groups, including mean blood glucose (MBG), coefficient of&#xD;
      variation (CV), area under the curve (AUC), Time in Range(TIR), etc.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 20, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HbA1c</measure>
    <time_frame>3 months</time_frame>
    <description>Difference in HbA1c between intervention and control group at 3 month adjusting for baseline HbA1c</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>mean blood glucose (MBG)</measure>
    <time_frame>1,2,3 months</time_frame>
    <description>Difference in HbA1c between intervention and control group at 1, 2, and 3 month.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>coefficient of variation (CV)</measure>
    <time_frame>1,2,3 months</time_frame>
    <description>Difference in CV between intervention and control group at 1, 2, and 3 month.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>area under the curve (AUC)&lt;3.9mmol/L and &gt;10mmol/L</measure>
    <time_frame>1,2,3 months</time_frame>
    <description>Difference in AUC&lt;3.9mmol/L and &gt;10mmol/L between intervention and control group at 1, 2, and 3 month.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time in Range (TIR)</measure>
    <time_frame>1,2,3 months</time_frame>
    <description>Difference in time in range 3.9-10 mmol/L between intervention and control group at 1, 2, and 3 month.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FGM accuracy</measure>
    <time_frame>during FGM</time_frame>
    <description>Accuracy of FGM values versus reference blood glucose values (Consensus Error Grid (CEG) analysis and calculation of the Mean Absolute Relative Difference (MARD)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>FGM group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Diabetic patients will use FreeStyle Libre Flash Glucose Monitoring (FGM) system(unmasked) to monitor glucose level once a month for 3 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SMBG group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Diabetic patients will use Standard Blood Glucose Monitoring (SMBG) to monitor glucose level for 3 months. A 14-day masked wear of FreeStyle Libre H Flash Glucose Monitoring system is included for these subjects once a month, to collect glycaemic variability data for comparison to the intervention group of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Freestyle Libre Flash Glucose Monitoring</intervention_name>
    <description>Freestyle Libre Flash Glucose Monitoring will be used in diabetic patients once a month for therr months to monitor glucose level. Patients could scan the sensor to get the glucose level at any time as they want. They could alter thier diet and exercise according to the glucose levels. Patients will be required to keep track of food and exercise during wearing FGM sensor. Physicians would adjust patients' medication according their glucose profile provided by FGM, A1c, and diet and exercise every month.</description>
    <arm_group_label>FGM group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. &gt;18 years old;&#xD;
&#xD;
          2. diagnosed as having diabetes who were willing to perform the study and complete the&#xD;
             data collection;&#xD;
&#xD;
          3. in stable condition prior to the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. pregnancy or attempting to conceive;&#xD;
&#xD;
          2. known allergy to medical grade adhesive or isopropyl alcohol used to prepare the skin;&#xD;
&#xD;
          3. skin lesions, scarring, redness, infection, or edema at the sensor application sites;&#xD;
&#xD;
          4. patients whose conditions were extremely severe and not stable.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ma Jianhua, MD</last_name>
    <role>Study Chair</role>
    <affiliation>The First Affiliated Hospital with Nanjing Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ma Jianhua, MD</last_name>
    <phone>8625-52887092</phone>
    <email>majianhua196503@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Nanjing First Hostital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianhua Ma, Doctor</last_name>
      <phone>+8618951670116</phone>
      <email>majianhua196503@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>June 9, 2019</last_update_submitted>
  <last_update_submitted_qc>June 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03785301
org study id: KY20170904-04
nct id: NCT03785301
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to assess the eﬀect of FGM on glycemic control compared with SMBG
      using a randomised controlled study design in adults with type 2 diabetes.
Flash glucose monitoring (FGM) is a newly introduced Glucose Monitoring system. The aim of
      the study is to assess the eﬀect of FGM on glycemic control compared with standard blood
      glucose monitoring (SMBG) using a randomised controlled study design in adults with type 2
      diabetes. Subjects will use unmasked FGM once a month or SMBG to monitor glucose level for 3
      months. Patients in the SMBG group will wear masked FGM to collect glycaemic variability data
      for comparison to the intervention group of the study. The primary outcome, HbA1c, will be
      cpmpared at baseline and 3 month. Glucose control parameters provided by unmasked and masked
      FGM will be compared in the two groups, including mean blood glucose (MBG), coefficient of
      variation (CV), area under the curve (AUC), Time in Range(TIR), etc.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: HbA1c
time frame: 3 months
description: Difference in HbA1c between intervention and control group at 3 month adjusting for baseline HbA1c
measure: mean blood glucose (MBG)
time frame: 1,2,3 months
description: Difference in HbA1c between intervention and control group at 1, 2, and 3 month.
measure: coefficient of variation (CV)
time frame: 1,2,3 months
description: Difference in CV between intervention and control group at 1, 2, and 3 month.
measure: area under the curve (AUC)<3.9mmol/L and >10mmol/L
time frame: 1,2,3 months
description: Difference in AUC<3.9mmol/L and >10mmol/L between intervention and control group at 1, 2, and 3 month.
measure: Time in Range (TIR)
time frame: 1,2,3 months
description: Difference in time in range 3.9-10 mmol/L between intervention and control group at 1, 2, and 3 month.
measure: FGM accuracy
time frame: during FGM
description: Accuracy of FGM values versus reference blood glucose values (Consensus Error Grid (CEG) analysis and calculation of the Mean Absolute Relative Difference (MARD)
arm group label: FGM group
arm group type: Experimental
description: Diabetic patients will use FreeStyle Libre Flash Glucose Monitoring (FGM) system(unmasked) to monitor glucose level once a month for 3 months.
arm group label: SMBG group
arm group type: No Intervention
description: Diabetic patients will use Standard Blood Glucose Monitoring (SMBG) to monitor glucose level for 3 months. A 14-day masked wear of FreeStyle Libre H Flash Glucose Monitoring system is included for these subjects once a month, to collect glycaemic variability data for comparison to the intervention group of the study.
intervention type: Device
intervention name: Freestyle Libre Flash Glucose Monitoring
description: Freestyle Libre Flash Glucose Monitoring will be used in diabetic patients once a month for therr months to monitor glucose level. Patients could scan the sensor to get the glucose level at any time as they want. They could alter thier diet and exercise according to the glucose levels. Patients will be required to keep track of food and exercise during wearing FGM sensor. Physicians would adjust patients' medication according their glucose profile provided by FGM, A1c, and diet and exercise every month.
arm group label: FGM group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ma Jianhua, MD
role: Study Chair
affiliation: The First Affiliated Hospital with Nanjing Medical University
last name: Ma Jianhua, MD
phone: 8625-52887092
email: majianhua196503@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor