<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/NCT02244073</url>
  </required_header>
  <id_info>
    <org_study_id>2013.808</org_study_id>
    <secondary_id>2013-A00806-39</secondary_id>
    <nct_id>NCT02244073</nct_id>
  </id_info>
  <brief_title>Individualized Blood Glucose Control in ICU. The CONTROLING Study. A Double Blinded Multicentric Randomized Study.</brief_title>
  <acronym>CONTROLING</acronym>
  <official_title>Individualized Blood Glucose Control in ICU.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      During the last 2 decades, the management of hyperglycemia in critically ill patients has&#xD;
      become one of the most discussed topics in the intensive-care field. The initial data&#xD;
      suggesting significant benefit from the normalization of blood glucose levels in critically&#xD;
      ill patients using intensive intravenous insulin therapy (Van den Berghe G et al. N Engl J&#xD;
      Med. 2001) has been tempered by later studies (Finfer S et al. N Engl J Med. 2009). Some&#xD;
      studies suggested that strict blood glucose control might benefit in non-diabetic patient and&#xD;
      worsen outcomes in diabetics. We hypothesized that an individualized blood glucose target&#xD;
      based on glycated hemoglobin measured at ICU admission would improve outcome when compared to&#xD;
      a standard care of maintaining blood glucose bellow 10 mmol/l (180 mg/dl). We designed a&#xD;
      randomized double blinded study in which Blood glucose control is piloted in both groups by a&#xD;
      web-guided protocol that directly gives instruction to nurses&#xD;
      (https://extranet.chu-lyon.fr/cpg). The study will enroll 4200 patients in 10 centers.&#xD;
      Primary end point is 90 d outcome after randomization.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Data safety monitoring board decision&#xD;
  </why_stopped>
  <start_date>May 2015</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>90 days after randomization</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>28 days after randomization and at ICU discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of intensive care unit stay</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for respiratory support, vasopressor support, dialysis and non-prophylactic antibiotics</measure>
    <time_frame>during ICU stay (on average 10 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence and severity of severe hypoglycemia (less than 2.2 mmol/l)</measure>
    <time_frame>during ICU stay (on average 10 days)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2069</enrollment>
  <condition>Critical Illness</condition>
  <arm_group>
    <arm_group_label>Individualized blood glucose target</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Maintain blood glucose in individualized target based on glycated hemoglobin level (A1c); Blood glucose level is maintained bellow 1.59 × A1c - 1.59 (mmol/l).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional blood glucose target</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Maintain blood glucose bellow 10 mmol/l.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Human insulin - Insulin administration to control blood glucose level.</intervention_name>
    <description>On ICU admission, the glycated hemoglobin level (A1c) is measured and insulin IV is possibly administered using a web based nurse driven insulin infusion protocol (https://extranet.chu-lyon.fr/cpg) to maintain blood glucose level below 10 mmol/l. Glycated hemoglobin result triggers patient randomization. Thereafter, during ICU stay, blood glucose level is maintained either below 1.59 × A1c - 1.59 (mmol/l) (Individualized blood glucose target group), or bellow 10 mmol/l (Conventional blood glucose target group).</description>
    <arm_group_label>Conventional blood glucose target</arm_group_label>
    <arm_group_label>Individualized blood glucose target</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients are eligible for INCLUSION in the study if ALL the following criteria are met:&#xD;
&#xD;
          -  Patient is 18 year old or older;&#xD;
&#xD;
          -  At time of the patient's admission to the ICU the treating ICU specialist expects the&#xD;
             patient will require treatment in the ICU that extends beyond the calendar day&#xD;
             following the day of admission.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients will be EXCLUDED from the study if ONE or MORE of the following criteria are&#xD;
             present:&#xD;
&#xD;
               -  Patient or legal surrogate decision maker does not accept the participation to&#xD;
                  the study;&#xD;
&#xD;
               -  Imminent death (anticipated in less than 48 hours);&#xD;
&#xD;
               -  The treating clinicians are not committed to full supportive care (no&#xD;
                  resuscitation, no renal replacement therapy limits in dose of vasoactive&#xD;
                  support);&#xD;
&#xD;
               -  Patient is expected to be eating before the end of the day following admission;&#xD;
&#xD;
               -  Admission in ICU for hypoglycemic encephalopathy or patient at risk for&#xD;
                  hypoglycaemia ( e.g. known insulin secreting tumour or history of unexplained or&#xD;
                  recurrent hypoglycaemia or fulminant hepatic failure);&#xD;
&#xD;
               -  If a patient has previously been enrolled in the CONTROLING Study (patients&#xD;
                  cannot be enrolled in the CONTROLING Study more than once).&#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>Julien BOHE, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospices Civils de Lyon - Centre Hospitalier Lyon Sud</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Nord Franche Comte</name>
      <address>
        <city>Belfort</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de Bourg-en-Bresse</name>
      <address>
        <city>Bourg-en-Bresse</city>
        <zip>01012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Bourgoin-Jallieu</name>
      <address>
        <city>Bourgoin Jallieu</city>
        <zip>38302</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Chartres</name>
      <address>
        <city>Chartres</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Clermont Ferrand - Gabriel Montpied</name>
      <address>
        <city>Clermont Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Dijon - Complexe Hospitalier du Bocage</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Montpellier - Hôpital Lapeyronie</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nice - Hôpital de l'Archet 1</name>
      <address>
        <city>Nice</city>
        <zip>06202</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de Polynésie Française</name>
      <address>
        <city>Papeete</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospices Civils de Lyon - Centre Hospitalier Lyon Sud</name>
      <address>
        <city>Pierre Benite</city>
        <zip>69310</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Salon de Provence</name>
      <address>
        <city>Salon de Provence</city>
        <zip>13658</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Saint Etienne - Hôpital Nord</name>
      <address>
        <city>St Priest en Jarez</city>
        <zip>42277</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2014</study_first_posted>
  <last_update_submitted>January 2, 2018</last_update_submitted>
  <last_update_submitted_qc>January 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>blood glucose target</keyword>
  <keyword>ICU</keyword>
  <keyword>insulin</keyword>
  <keyword>hypoglycemia</keyword>
  <keyword>hyperglycemia</keyword>
  <keyword>glycated hemoglobin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin</mesh_term>
    <mesh_term>Insulin, Globin Zinc</mesh_term>
  </intervention_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/NCT02244073
org study id: 2013.808
secondary id: 2013-A00806-39
nct id: NCT02244073
lead sponsor: 
has dmc: No
During the last 2 decades, the management of hyperglycemia in critically ill patients has
      become one of the most discussed topics in the intensive-care field. The initial data
      suggesting significant benefit from the normalization of blood glucose levels in critically
      ill patients using intensive intravenous insulin therapy (Van den Berghe G et al. N Engl J
      Med. 2001) has been tempered by later studies (Finfer S et al. N Engl J Med. 2009). Some
      studies suggested that strict blood glucose control might benefit in non-diabetic patient and
      worsen outcomes in diabetics. We hypothesized that an individualized blood glucose target
      based on glycated hemoglobin measured at ICU admission would improve outcome when compared to
      a standard care of maintaining blood glucose bellow 10 mmol/l (180 mg/dl). We designed a
      randomized double blinded study in which Blood glucose control is piloted in both groups by a
      web-guided protocol that directly gives instruction to nurses
      (https://extranet.chu-lyon.fr/cpg). The study will enroll 4200 patients in 10 centers.
      Primary end point is 90 d outcome after randomization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: All-cause mortality
time frame: 90 days after randomization
measure: All-cause mortality
time frame: 28 days after randomization and at ICU discharge
measure: Length of intensive care unit stay
time frame: 90 days
measure: Need for respiratory support, vasopressor support, dialysis and non-prophylactic antibiotics
time frame: during ICU stay (on average 10 days)
measure: incidence and severity of severe hypoglycemia (less than 2.2 mmol/l)
time frame: during ICU stay (on average 10 days)
arm group label: Individualized blood glucose target
arm group type: Experimental
description: Maintain blood glucose in individualized target based on glycated hemoglobin level (A1c); Blood glucose level is maintained bellow 1.59 × A1c - 1.59 (mmol/l).
arm group label: Conventional blood glucose target
arm group type: Active Comparator
description: Maintain blood glucose bellow 10 mmol/l.
intervention type: Drug
intervention name: Human insulin - Insulin administration to control blood glucose level.
description: On ICU admission, the glycated hemoglobin level (A1c) is measured and insulin IV is possibly administered using a web based nurse driven insulin infusion protocol (https://extranet.chu-lyon.fr/cpg) to maintain blood glucose level below 10 mmol/l. Glycated hemoglobin result triggers patient randomization. Thereafter, during ICU stay, blood glucose level is maintained either below 1.59 × A1c - 1.59 (mmol/l) (Individualized blood glucose target group), or bellow 10 mmol/l (Conventional blood glucose target group).
arm group label: Conventional blood glucose target
arm group label: Individualized blood glucose target
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Julien BOHE, MD PhD
role: Principal Investigator
affiliation: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Critical Illness
mesh term: Insulin
mesh term: Insulin, Globin Zinc