<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/NCT02980588</url>
  </required_header>
  <id_info>
    <org_study_id>Zhongda-ICU-SGC</org_study_id>
    <nct_id>NCT02980588</nct_id>
  </id_info>
  <brief_title>The Effects of SGC on Glucose Control in Critically Ill Patients With Sepsis</brief_title>
  <official_title>Comparing SGC and Conventional Empiric Treatment for Glucose Control in Critically Ill Patients With Sepsis in ICU</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Southeast University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Southeast University, China</source>
  <brief_summary>
    <textblock>
      Poorly glycemic control in critically ill patients can increase their mortality, while safe&#xD;
      and efficient glucose control is laborious and time-consuming. The Space Glucose Control&#xD;
      which is installed with eMPC(enhanced Model Predictive Control) can get the blood glucose&#xD;
      target range safely and effectively through regulating insulin dose rate, and decrease the&#xD;
      glucose variability. This study is a random controlled trial involving the patients with&#xD;
      sepsis in intensive care unit in order to evaluate the difference of safety and efficacy of&#xD;
      blood glucose control between SGC directed and conventional treatment. At last, the trial&#xD;
      results can determine whether the Space Glucose Control can control blood glucose safely and&#xD;
      effectively in the patients with sepsis in intensive care units.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Design: The study was conducted as a single-centre, open randomized controlled, parallel&#xD;
      trial.&#xD;
&#xD;
      Study population: Adult general ICU patients with sepsis and assumed to require at least 3&#xD;
      days of intensive care were recruited. Patients fulfilling the inclusion criterion of&#xD;
      glucose≥9.0 mmol/L were randomly assigned using serially numbered to either the intervention&#xD;
      group (BG control by SGC) or the control group (conventional empiric BG management). The both&#xD;
      group aim to establish the BG levels 5.8-8.9mmol/L.&#xD;
&#xD;
      Study protocol: BG measurements were performed using glucometer to test the fingertip&#xD;
      capillary blood sample for the BG levels. As for patients with shock or required vasopressor,&#xD;
      arterial BG was sampled to measure through the glucometer. Insulin was infused intravenously&#xD;
      applying the standard perfusor of the ICU. Average glucose, glucose variability, SOFA score,&#xD;
      APACHE II score, and HLA-DR were recorded. All trial-related activities were carried out&#xD;
      until the end of the patient's ICU stay, or for a period of 72 hours. Meanwhile, enteral and&#xD;
      parenteral nutrition was administrated to patients according to their condition.&#xD;
&#xD;
      Statistical analysis was performed on an intention-to-treat basis. The percentage of values&#xD;
      in the target range (5.8-8.9mmol/L) was defined as primary end point for the assessment of&#xD;
      glucose control. Data are reported as mean±SD values if not otherwise indicated. Data&#xD;
      analysis was performed using SPSS19.0.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">May 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>glucose variability</measure>
    <time_frame>up to 3days</time_frame>
    <description>mean blood glucose, standard deviation (SD) for the mean glucose,minimum and maximum glucose levels</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HLADr</measure>
    <time_frame>up to 3days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Sepsis</condition>
  <condition>Hyperglycemia</condition>
  <condition>Critical Illness</condition>
  <arm_group>
    <arm_group_label>conventional empirical glycemic control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>the patients' blood glucose is controlled by physician according to their experience through insulin subcutaneous injection or insulin continuous infusion whose dosage is determinated by the physician.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SGC directed glycemic control</intervention_name>
    <description>the patients' blood glucose is controlled by SGC system through insulin continuous infusion whose dosage is determinated by SGC</description>
    <arm_group_label>conventional empirical glycemic control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Admitted to the ICU&#xD;
&#xD;
          2. At least one BG measurement 9.0mmol/L or higher&#xD;
&#xD;
          3. Expected to stay in ICU ≥3 days;&#xD;
&#xD;
          4. critically ill patients with sepsis&#xD;
&#xD;
          5. SOFA score≤2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Aged &lt; 18 years;&#xD;
&#xD;
          2. Admitted because of diabetic ketoacidosis or nonketotic hyperosmolar state&#xD;
&#xD;
          3. Pregnant&#xD;
&#xD;
          4. In a state in which death was perceived as imminent&#xD;
&#xD;
          5. Without written informed consent&#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_contact>
    <last_name>Min Mo, Doctor</last_name>
    <phone>13914719904</phone>
    <email>momin_2002@163.com</email>
  </overall_contact>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>November 29, 2016</last_update_submitted>
  <last_update_submitted_qc>November 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Southeast University, China</investigator_affiliation>
    <investigator_full_name>Chun Pan</investigator_full_name>
    <investigator_title>Dcotor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sepsis</mesh_term>
    <mesh_term>Toxemia</mesh_term>
    <mesh_term>Hyperglycemia</mesh_term>
    <mesh_term>Critical Illness</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/NCT02980588
org study id: Zhongda-ICU-SGC
nct id: NCT02980588
lead sponsor: 
Poorly glycemic control in critically ill patients can increase their mortality, while safe
      and efficient glucose control is laborious and time-consuming. The Space Glucose Control
      which is installed with eMPC(enhanced Model Predictive Control) can get the blood glucose
      target range safely and effectively through regulating insulin dose rate, and decrease the
      glucose variability. This study is a random controlled trial involving the patients with
      sepsis in intensive care unit in order to evaluate the difference of safety and efficacy of
      blood glucose control between SGC directed and conventional treatment. At last, the trial
      results can determine whether the Space Glucose Control can control blood glucose safely and
      effectively in the patients with sepsis in intensive care units.
Design: The study was conducted as a single-centre, open randomized controlled, parallel
      trial.

      Study population: Adult general ICU patients with sepsis and assumed to require at least 3
      days of intensive care were recruited. Patients fulfilling the inclusion criterion of
      glucose≥9.0 mmol/L were randomly assigned using serially numbered to either the intervention
      group (BG control by SGC) or the control group (conventional empiric BG management). The both
      group aim to establish the BG levels 5.8-8.9mmol/L.

      Study protocol: BG measurements were performed using glucometer to test the fingertip
      capillary blood sample for the BG levels. As for patients with shock or required vasopressor,
      arterial BG was sampled to measure through the glucometer. Insulin was infused intravenously
      applying the standard perfusor of the ICU. Average glucose, glucose variability, SOFA score,
      APACHE II score, and HLA-DR were recorded. All trial-related activities were carried out
      until the end of the patient's ICU stay, or for a period of 72 hours. Meanwhile, enteral and
      parenteral nutrition was administrated to patients according to their condition.

      Statistical analysis was performed on an intention-to-treat basis. The percentage of values
      in the target range (5.8-8.9mmol/L) was defined as primary end point for the assessment of
      glucose control. Data are reported as mean±SD values if not otherwise indicated. Data
      analysis was performed using SPSS19.0.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: glucose variability
time frame: up to 3days
description: mean blood glucose, standard deviation (SD) for the mean glucose,minimum and maximum glucose levels
measure: HLADr
time frame: up to 3days
arm group label: conventional empirical glycemic control
arm group type: Other
description: the patients' blood glucose is controlled by physician according to their experience through insulin subcutaneous injection or insulin continuous infusion whose dosage is determinated by the physician.
intervention type: Device
intervention name: SGC directed glycemic control
description: the patients' blood glucose is controlled by SGC system through insulin continuous infusion whose dosage is determinated by SGC
arm group label: conventional empirical glycemic control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Min Mo, Doctor
phone: 13914719904
email: momin_2002@163.com
responsible party type: Principal Investigator
investigator affiliation: Southeast University, China
investigator full name: Chun Pan
investigator title: Dcotor
mesh term: Sepsis
mesh term: Toxemia
mesh term: Hyperglycemia
mesh term: Critical Illness