<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/NCT04473430</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00114840</org_study_id>
    <secondary_id>MH121653</secondary_id>
    <secondary_id>1K23DK123384-01</secondary_id>
    <nct_id>NCT04473430</nct_id>
  </id_info>
  <brief_title>Study to Determine the Efficacy of Real-time CGM in Preventing Hypoglycemia Among Insulin-treated Patients With DM2 on Hemodialysis, Compared to Standard of Care (POC BG)</brief_title>
  <official_title>Study to Determine the Efficacy of Real-time CGM in Preventing Hypoglycemia Among Insulin-treated Patients With DM2 on Hemodialysis, Compared to Standard of Care (POC BG)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is conducted to assess the efficacy of real-time CGM data in preventing&#xD;
      hypoglycemia in patients with type 2 diabetes and end-stage kidney disease (ESKD), treated&#xD;
      with insulin therapy and receiving hemodialysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is conducted to assess the efficacy of real-time CGM data in preventing&#xD;
      hypoglycemia among patients with type 2 diabetes (DM2), treated with insulin and receiving&#xD;
      hemodialysis. The study will provide novel insights into the glycemic exposure patterns among&#xD;
      dialysis patients and will provide preliminary data for future outcomes-based studies&#xD;
      determining the best glycemic targets for this group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 5, 2020</start_date>
  <completion_date type="Anticipated">October 2023</completion_date>
  <primary_completion_date type="Anticipated">October 2023</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Patients with type 2 DM treated with insulin and receiving hemodialysis will use a real-time/personal CGM for 4 weeks (Intervention-Control Group), then 2 weeks of wash-out period, and cross over to use POC BG for 4 weeks; and vice versa (Control-Intervention Group).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Differences in mean percentage time-in-hypoglycemia (&lt; 70 mg/dL) during the intervention phase, compared to control in both phases (i.e. intervention-control vs. control-intervention).</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Differences in mean percentage time-in-hypoglycemia (&lt; 70 mg/dL) during the intervention phase, compared to control in both phases (i.e. intervention-control vs. control-intervention).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>% time in target range (70-180 mg/dl) during the intervention phase, compared to control in both groups (i.e. intervention-control vs. control-intervention)</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>% time in target range (70-180 mg/dl) during the intervention phase, compared to control in both groups (i.e. intervention-control vs. control-intervention)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean % time in hypoglycemia (&lt; 54 mg/dL)</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>% time in hypoglycemia (&lt;54 mg/dL) during the intervention phase, compared to control in both groups (i.e. intervention-control vs. controlintervention).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% time in hyperglycemia (&gt;180 mg/dL)</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>% time in hyperglycemia (&gt;180 mg/dL) during the intervention phase, compared to control in both groups (i.e. intervention-control vs. controlintervention).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% time in hyperglycemia (&gt;250 mg/dl)</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>% time in hyperglycemia (&gt;250 mg/dL) during the intervention phase, compared to control in both groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic variability [% coefficient of variation (%CV)</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>% coefficient of variation will be measured during the intervention phase, compared to control in both groups (i.e. intervention-control vs. contro-intervention).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean amplitude of glucose excursions (MAGE)</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Mean amplitude of glucose excursions (MAGE) will be measured during the intervention phase, compared to control in both groups (i.e. intervention-control vs. control-intervention).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1C at 3 months follow up</measure>
    <time_frame>Baseline, Up to 3 months</time_frame>
    <description>Change in HbA1C at 3 months follow up from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hospitalization or emergency room visits for hypoglycemia</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Rate of hospitalization or emergency room visits for hypoglycemia will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hospitalization or emergency room visits for diabetes ketoacidosis</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Rate of hospitalization or emergency room visits for diabetes ketoacidosis will be recorded</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>End-Stage Renal Disease</condition>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Real-time Dexcom CGM, then Point-Of-Care Blood Glucose Group (Intervention-Control Group)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with type 2 DM treated with insulin and receiving hemodialysis will use a real-time/personal CGM for 4 weeks (Intervention-Control Group), then 2 weeks of wash-out period, and cross over to use POC BG for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Point-Of-Care Blood Glucose (Control) then Real-time Dexcom CGM Group (Control-Intervention Group)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with type 2 DM treated with insulin and receiving hemodialysis will use POC BG for 4 weeks, then 2 weeks of wash-out period, and cross over to use a real-time/personal CGM for 4 weeks (Control-Intervention Group).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dexcom real-time G6 Continuous Glucose Monitoring System (CGM)</intervention_name>
    <description>Dexcom G6, a factory-calibrated CGM system, is innovative in many aspects: 1) it does not require finger stick POC BG for calibration, 2) the sensor is small, compact, light-weight, 3) has no interference with several substance and drugs, and 4) protective &quot;urgent low soon&quot; alarm, with proven prediction of hypoglycemia within 20 minutes in advance. The sensor uses a novel semi-permeable membrane that blocks interference with most clinically relevant substances, including high levels of urea and creatinine, and commonly used medications. Dexcom G6 CGM is a commercially-available, minimally invasive sensor, with a flexible and thin wire that is inserted into the abdominal subcutaneous tissue. Dexcom G6 monitors glucose continuously (24 hrs) and displays real-time glucose values, glucose trends/arrows and alarms, including the &quot;urgent low soon&quot; alarm (predictive of hypoglycemia &lt; 55 mg/dL within the preceding 20 minutes).</description>
    <arm_group_label>Point-Of-Care Blood Glucose (Control) then Real-time Dexcom CGM Group (Control-Intervention Group)</arm_group_label>
    <arm_group_label>Real-time Dexcom CGM, then Point-Of-Care Blood Glucose Group (Intervention-Control Group)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>POC BG</intervention_name>
    <description>POC BG (standard of care) uses commercially-available glucose meters for blood glucose monitoring. It is approved to be used in dialysis populations.</description>
    <arm_group_label>Point-Of-Care Blood Glucose (Control) then Real-time Dexcom CGM Group (Control-Intervention Group)</arm_group_label>
    <arm_group_label>Real-time Dexcom CGM, then Point-Of-Care Blood Glucose Group (Intervention-Control Group)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult subjects with type 2 diabetes&#xD;
&#xD;
          -  receiving hemodialysis (for at least 90 days)&#xD;
&#xD;
          -  treated with insulin therapy [basal insulin alone (glargine U100, glargine U300,&#xD;
             determir, degludec, NPH)], or in combination with bolus insulin (at least one or more&#xD;
             injections of aspart, lispro, glulisine, regular insulin) or in combination with&#xD;
             incretin therapy (DPPIV or GLP1)&#xD;
&#xD;
          -  willingness to wear the CGM&#xD;
&#xD;
          -  currently performing self-monitored blood glucose (at least 2 times daily).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  use of sulfonylureas or thiazolidinediones alone or in combination with insulin&#xD;
&#xD;
          -  use of personal/real-time CGM 3 months prior to study entry (blinded CGM is allowed)&#xD;
&#xD;
          -  prior use of insulin pumps or hybrid close loop systems (for at least the prior 28&#xD;
             days)&#xD;
&#xD;
          -  current or anticipated use of stress steroids doses (prednisone ≤5mg or its equivalent&#xD;
             is allowed)&#xD;
&#xD;
          -  subjects who are sensitive or allergic to adhesive&#xD;
&#xD;
          -  extensive skin changes/diseases that preclude wearing the required number of devices&#xD;
             on normal skin (e.g., extensive psoriasis, recent burns or severe sunburn, extensive&#xD;
             eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the&#xD;
             proposed wear sites&#xD;
&#xD;
          -  any condition that, in the opinion of the Investigator, would interfere with their&#xD;
             participation in the trial (e.g., marked visual or hearing impairment, active alcohol&#xD;
             or drug abuse, mental illness) or pose excessive risk to study staff handling venous&#xD;
             blood samples&#xD;
&#xD;
          -  situations that will limit the subject's ability to comply with the protocol (per&#xD;
             investigator discretion)&#xD;
&#xD;
          -  active malignancy&#xD;
&#xD;
          -  unable to give informed consent&#xD;
&#xD;
          -  at least 10% of time spent in clinical relevant hypoglycemia (&lt;54 mg/dl) during&#xD;
             blinded CGM period&#xD;
&#xD;
          -  significant hypoglycemia (&lt; 40 mg/dL)&#xD;
&#xD;
          -  severe hyperglycemia (BG&gt; 400 mg/dL)&#xD;
&#xD;
          -  extensive skin abnormalities at insertion sites&#xD;
&#xD;
          -  pregnancy or breastfeeding&#xD;
&#xD;
          -  severe anemia (Hemoglobin &lt; 5 mg/dl)&#xD;
&#xD;
          -  polycythemia (Hemoglobin &gt;17 mg/dl)&#xD;
&#xD;
          -  subjects taking acetaminophen (more than 1 gr every six hours)&#xD;
&#xD;
          -  hydroxyurea (may cause interference with the sensor membrane).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guillermo Umpierrez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emory Clinic</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grady Health System (non-CRN)</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>May 10, 2023</last_update_submitted>
  <last_update_submitted_qc>May 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Rodolfo Galindo</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>ESRD</keyword>
  <keyword>Continuous Glucose Monitoring</keyword>
  <keyword>Diabetes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Hypoglycemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Start 6 months after publication End 12 months after publication</ipd_time_frame>
    <ipd_access_criteria>Researchers who provide a methodologically sound proposal to achieve the aims in the approved proposal will get access. Proposals should be directed to rodolfo.galindo@emory.edu.&#xD;
To gain access, data requestors will need to sign a data access agreement.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 31, 2023</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/30/NCT04473430/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04473430
org study id: IRB00114840
secondary id: MH121653
secondary id: 1K23DK123384-01
nct id: NCT04473430
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The study is conducted to assess the efficacy of real-time CGM data in preventing
      hypoglycemia in patients with type 2 diabetes and end-stage kidney disease (ESKD), treated
      with insulin therapy and receiving hemodialysis.
The study is conducted to assess the efficacy of real-time CGM data in preventing
      hypoglycemia among patients with type 2 diabetes (DM2), treated with insulin and receiving
      hemodialysis. The study will provide novel insights into the glycemic exposure patterns among
      dialysis patients and will provide preliminary data for future outcomes-based studies
      determining the best glycemic targets for this group.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Patients with type 2 DM treated with insulin and receiving hemodialysis will use a real-time/personal CGM for 4 weeks (Intervention-Control Group), then 2 weeks of wash-out period, and cross over to use POC BG for 4 weeks; and vice versa (Control-Intervention Group).
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Differences in mean percentage time-in-hypoglycemia (< 70 mg/dL) during the intervention phase, compared to control in both phases (i.e. intervention-control vs. control-intervention).
time frame: Up to 3 months
description: Differences in mean percentage time-in-hypoglycemia (< 70 mg/dL) during the intervention phase, compared to control in both phases (i.e. intervention-control vs. control-intervention).
measure: % time in target range (70-180 mg/dl) during the intervention phase, compared to control in both groups (i.e. intervention-control vs. control-intervention)
time frame: Up to 3 months
description: % time in target range (70-180 mg/dl) during the intervention phase, compared to control in both groups (i.e. intervention-control vs. control-intervention)
measure: Mean % time in hypoglycemia (< 54 mg/dL)
time frame: Up to 3 months
description: % time in hypoglycemia (<54 mg/dL) during the intervention phase, compared to control in both groups (i.e. intervention-control vs. controlintervention).
measure: % time in hyperglycemia (>180 mg/dL)
time frame: Up to 3 months
description: % time in hyperglycemia (>180 mg/dL) during the intervention phase, compared to control in both groups (i.e. intervention-control vs. controlintervention).
measure: % time in hyperglycemia (>250 mg/dl)
time frame: Up to 3 months
description: % time in hyperglycemia (>250 mg/dL) during the intervention phase, compared to control in both groups
measure: Glycemic variability [% coefficient of variation (%CV)
time frame: Up to 3 months
description: % coefficient of variation will be measured during the intervention phase, compared to control in both groups (i.e. intervention-control vs. contro-intervention).
measure: Mean amplitude of glucose excursions (MAGE)
time frame: Up to 3 months
description: Mean amplitude of glucose excursions (MAGE) will be measured during the intervention phase, compared to control in both groups (i.e. intervention-control vs. control-intervention).
measure: Change in HbA1C at 3 months follow up
time frame: Baseline, Up to 3 months
description: Change in HbA1C at 3 months follow up from baseline
measure: Number of hospitalization or emergency room visits for hypoglycemia
time frame: Up to 3 months
description: Rate of hospitalization or emergency room visits for hypoglycemia will be recorded
measure: Number of hospitalization or emergency room visits for diabetes ketoacidosis
time frame: Up to 3 months
description: Rate of hospitalization or emergency room visits for diabetes ketoacidosis will be recorded
arm group label: Real-time Dexcom CGM, then Point-Of-Care Blood Glucose Group (Intervention-Control Group)
arm group type: Experimental
description: Patients with type 2 DM treated with insulin and receiving hemodialysis will use a real-time/personal CGM for 4 weeks (Intervention-Control Group), then 2 weeks of wash-out period, and cross over to use POC BG for 4 weeks.
arm group label: Point-Of-Care Blood Glucose (Control) then Real-time Dexcom CGM Group (Control-Intervention Group)
arm group type: Experimental
description: Patients with type 2 DM treated with insulin and receiving hemodialysis will use POC BG for 4 weeks, then 2 weeks of wash-out period, and cross over to use a real-time/personal CGM for 4 weeks (Control-Intervention Group).
intervention type: Device
intervention name: Dexcom real-time G6 Continuous Glucose Monitoring System (CGM)
description: Dexcom G6, a factory-calibrated CGM system, is innovative in many aspects: 1) it does not require finger stick POC BG for calibration, 2) the sensor is small, compact, light-weight, 3) has no interference with several substance and drugs, and 4) protective "urgent low soon" alarm, with proven prediction of hypoglycemia within 20 minutes in advance. The sensor uses a novel semi-permeable membrane that blocks interference with most clinically relevant substances, including high levels of urea and creatinine, and commonly used medications. Dexcom G6 CGM is a commercially-available, minimally invasive sensor, with a flexible and thin wire that is inserted into the abdominal subcutaneous tissue. Dexcom G6 monitors glucose continuously (24 hrs) and displays real-time glucose values, glucose trends/arrows and alarms, including the "urgent low soon" alarm (predictive of hypoglycemia < 55 mg/dL within the preceding 20 minutes).
arm group label: Point-Of-Care Blood Glucose (Control) then Real-time Dexcom CGM Group (Control-Intervention Group)
arm group label: Real-time Dexcom CGM, then Point-Of-Care Blood Glucose Group (Intervention-Control Group)
intervention type: Diagnostic Test
intervention name: POC BG
description: POC BG (standard of care) uses commercially-available glucose meters for blood glucose monitoring. It is approved to be used in dialysis populations.
arm group label: Point-Of-Care Blood Glucose (Control) then Real-time Dexcom CGM Group (Control-Intervention Group)
arm group label: Real-time Dexcom CGM, then Point-Of-Care Blood Glucose Group (Intervention-Control Group)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Guillermo Umpierrez, MD
role: Principal Investigator
affiliation: Emory University
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Rodolfo Galindo
investigator title: Principal Investigator
mesh term: Kidney Failure, Chronic
mesh term: Hypoglycemia
sharing ipd: Yes
ipd description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared
ipd info type: Study Protocol
ipd time frame: Start 6 months after publication End 12 months after publication
ipd access criteria: Researchers who provide a methodologically sound proposal to achieve the aims in the approved proposal will get access. Proposals should be directed to rodolfo.galindo@emory.edu.
To gain access, data requestors will need to sign a data access agreement.
provided document: 