<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/NCT03020264</url>
  </required_header>
  <id_info>
    <org_study_id>RC16_0351</org_study_id>
    <nct_id>NCT03020264</nct_id>
  </id_info>
  <brief_title>Frequency of Hypoglycemia in Patients With Type 2 Diabetes Under Insulin Therapy Older Than 75 Years in Real Life</brief_title>
  <acronym>HYPOAGE</acronym>
  <official_title>Frequency of Hypoglycemia in Patients With Type 2 Diabetes Under Insulin Therapy Older Than 75 Years in Real Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</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>
      Diabetes is a chronic and progressive disease that affects nearly 3.5 million people in&#xD;
      France.&#xD;
&#xD;
      Currently the investigators are seeing an aging of the population explained by the increase&#xD;
      in life expectancy and thus an increasing incidence of diabetes in the elderly. However, the&#xD;
      frequency of hypoglycemia in older vulnerable patients remains poorly characterized&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    COVID-19&#xD;
  </why_stopped>
  <start_date type="Actual">November 28, 2017</start_date>
  <completion_date type="Actual">June 18, 2020</completion_date>
  <primary_completion_date type="Actual">June 18, 2020</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of confirmed or severe hypoglycemia</measure>
    <time_frame>1 month</time_frame>
    <description>Percentage of patients with at least one episode of confirmed and / or severe hypoglycaemia by measuring capillary blood glucose during 4 weeks of prospective follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of events / patient / month of severe hypoglycemia</measure>
    <time_frame>1 month</time_frame>
    <description>Number of confirmed severe hypoglycaemia episodes (events / patient / month), symptomatic or asymptomatic, occurring in patients during 4 weeks of prospective follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hospitalizations due to hypoglycemia</measure>
    <time_frame>1 month</time_frame>
    <description>Number and duration of hospital stays</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of asymptomatic confirmed (blood glucose value &lt;0.70g / L) hypoglycemia</measure>
    <time_frame>1 month</time_frame>
    <description>Confirmed asymptomatic hypoglycaemia (events / patient / month) occurring in patients collected with the FREESTYLE Libre Pro glucose sensor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hypoglycaemia in elderly patients admitted to EHPAD</measure>
    <time_frame>1 month</time_frame>
    <description>Confirmed hypoglycaemia (events / patient / month), symptomatic or asymptomatic, occurring in patients hospitalized in long-term geriatric care sector.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of confirmed nocturnal hypoglycaemia (occurring between 0h00-6h00)</measure>
    <time_frame>1 month</time_frame>
    <description>Confirmed nocturnal hypoglycaemia (events / patient / month), symptomatic or asymptomatic, occurring in patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of confirmed hypoglycaemia with a threshold blood glucose value &lt;0.54g / L (neuroglucopenic threshold)</measure>
    <time_frame>1 month</time_frame>
    <description>Confirmed neuroglucopenic hypoglycaemia (events / patient / month), symptomatic or asymptomatic, occurring in patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of pseudo-hypoglycaemia and unconfirmed hypoglycaemia (Symptoms consistent with hypoglycemia, but with a blood glucose value ≥ 70 mg / dL)</measure>
    <time_frame>1 month</time_frame>
    <description>Confirmed pseudo-hypoglycaemia and unconfirmed hypoglycaemia (events / patient / month), occurring in patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score for fear of hypoglycemia in elderly diabetic patients</measure>
    <time_frame>1 month</time_frame>
    <description>Score for fear of hypoglycaemia (HFS-II)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of confirmed and severe hypoglycaemia in patients with type 2 diabetes aged 75 years and older in &quot;vigorous&quot; and &quot;vulnerable&quot; subgroups of patients according to a geriatric assessment score</measure>
    <time_frame>1 month</time_frame>
    <description>Confirmed hypoglycaemia (events / patient / month), symptomatic or asymptomatic, occurring in patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of the transition to ER due to hypoglycemia</measure>
    <time_frame>1 month</time_frame>
    <description>Number and duration of emergency stays</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of falls due to hypoglycemia</measure>
    <time_frame>1 month</time_frame>
    <description>Number of falls and loss of autonomy (no home support)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of death due to hypoglycemia</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">161</enrollment>
  <condition>Type2 Diabetes</condition>
  <condition>Elderly</condition>
  <condition>Hypoglycemia</condition>
  <arm_group>
    <arm_group_label>Patients older than 75 years</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Collection of hypoglycaemia épisodes with the glycemic sensor FREESTYLE Libre Pro</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>glycemic sensor FREESTYLE Libre Pro</intervention_name>
    <description>Collection of hypoglycemia episodes with glycemic sensor FREESTYLE Libre Pro</description>
    <arm_group_label>Patients older than 75 years</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female ≥ 75 years of age;&#xD;
&#xD;
          -  Type 2 diabetes for at least 1 year and treated with insulin for at least 6 months;&#xD;
&#xD;
          -  Treated with basal insulin (ie glargine U100: Lantus®, Abasaglar®, glargine U300:&#xD;
             Toujeo®, detemir: levemir®, NPH), premix (ie Novomix® and Humalog Mix®), and / Insulin&#xD;
             associated or not with one or more oral and / or injectable antidiabetic agents&#xD;
             (analog of GLP1...);&#xD;
&#xD;
          -  Benefiting from at least 1 capillary glucose per day (carried out by the patient&#xD;
             himself or a caregiver);&#xD;
&#xD;
          -  Benefiting from a standardized geriatric assessment;&#xD;
&#xD;
          -  Signature of informed consent&#xD;
&#xD;
          -  Patient benefiting from a social security system.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Male or female aged &lt;75 years;&#xD;
&#xD;
          -  Person without diabetes or type 1 diabetes;&#xD;
&#xD;
          -  Patient treated only lifestyle modifications and / or oral anti-diabetic drugs and /&#xD;
             or GLP-1 receptor agonists alone;&#xD;
&#xD;
          -  Subjects with secondary or corticosteroid-induced diabetes;&#xD;
&#xD;
          -  Refusal to participate in the study or inability to collect consent;&#xD;
&#xD;
          -  Patient for whom follow-up of the study procedures is impossible (glycemic record&#xD;
             impossible or insufficient);&#xD;
&#xD;
          -  Patient not eligible for geriatric assessment;&#xD;
&#xD;
          -  Patient already participating in another study;&#xD;
&#xD;
          -  Patient with a severe pathology limiting his life expectancy (palliative care ...)&#xD;
             compromising his participation in the study at the discretion of the investigator;&#xD;
&#xD;
          -  Patient benefiting from a safeguard of justice.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>75 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bertrand CARIOU, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Nantes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Nantes</name>
      <address>
        <city>Nantes</city>
        <state>Loire Atlantique</state>
        <zip>44000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH d'Ancenis</name>
      <address>
        <city>Ancenis</city>
        <zip>44150</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU d'Angers</name>
      <address>
        <city>Angers</city>
        <zip>49100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Sud Francilien</name>
      <address>
        <city>Corbeil-Essonnes</city>
        <zip>91106</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU de Lille</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Poitiers</name>
      <address>
        <city>Poitiers</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Toulouse</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>June 24, 2020</last_update_submitted>
  <last_update_submitted_qc>June 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Type 2 Diabetes</keyword>
  <keyword>Hypoglycemia</keyword>
  <keyword>Elderly</keyword>
  <keyword>Insulinotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Hypoglycemia</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/NCT03020264
org study id: RC16_0351
nct id: NCT03020264
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Diabetes is a chronic and progressive disease that affects nearly 3.5 million people in
      France.

      Currently the investigators are seeing an aging of the population explained by the increase
      in life expectancy and thus an increasing incidence of diabetes in the elderly. However, the
      frequency of hypoglycemia in older vulnerable patients remains poorly characterized
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Number of confirmed or severe hypoglycemia
time frame: 1 month
description: Percentage of patients with at least one episode of confirmed and / or severe hypoglycaemia by measuring capillary blood glucose during 4 weeks of prospective follow-up.
measure: number of events / patient / month of severe hypoglycemia
time frame: 1 month
description: Number of confirmed severe hypoglycaemia episodes (events / patient / month), symptomatic or asymptomatic, occurring in patients during 4 weeks of prospective follow-up.
measure: Number of hospitalizations due to hypoglycemia
time frame: 1 month
description: Number and duration of hospital stays
measure: Number of asymptomatic confirmed (blood glucose value <0.70g / L) hypoglycemia
time frame: 1 month
description: Confirmed asymptomatic hypoglycaemia (events / patient / month) occurring in patients collected with the FREESTYLE Libre Pro glucose sensor
measure: Number of hypoglycaemia in elderly patients admitted to EHPAD
time frame: 1 month
description: Confirmed hypoglycaemia (events / patient / month), symptomatic or asymptomatic, occurring in patients hospitalized in long-term geriatric care sector.
measure: Number of confirmed nocturnal hypoglycaemia (occurring between 0h00-6h00)
time frame: 1 month
description: Confirmed nocturnal hypoglycaemia (events / patient / month), symptomatic or asymptomatic, occurring in patients
measure: Number of confirmed hypoglycaemia with a threshold blood glucose value <0.54g / L (neuroglucopenic threshold)
time frame: 1 month
description: Confirmed neuroglucopenic hypoglycaemia (events / patient / month), symptomatic or asymptomatic, occurring in patients
measure: Number of pseudo-hypoglycaemia and unconfirmed hypoglycaemia (Symptoms consistent with hypoglycemia, but with a blood glucose value ≥ 70 mg / dL)
time frame: 1 month
description: Confirmed pseudo-hypoglycaemia and unconfirmed hypoglycaemia (events / patient / month), occurring in patients
measure: Score for fear of hypoglycemia in elderly diabetic patients
time frame: 1 month
description: Score for fear of hypoglycaemia (HFS-II)
measure: Number of confirmed and severe hypoglycaemia in patients with type 2 diabetes aged 75 years and older in "vigorous" and "vulnerable" subgroups of patients according to a geriatric assessment score
time frame: 1 month
description: Confirmed hypoglycaemia (events / patient / month), symptomatic or asymptomatic, occurring in patients
measure: Number of the transition to ER due to hypoglycemia
time frame: 1 month
description: Number and duration of emergency stays
measure: Number of falls due to hypoglycemia
time frame: 1 month
description: Number of falls and loss of autonomy (no home support)
measure: Number of death due to hypoglycemia
time frame: 1 month
arm group label: Patients older than 75 years
arm group type: Experimental
description: Collection of hypoglycaemia épisodes with the glycemic sensor FREESTYLE Libre Pro
intervention type: Device
intervention name: glycemic sensor FREESTYLE Libre Pro
description: Collection of hypoglycemia episodes with glycemic sensor FREESTYLE Libre Pro
arm group label: Patients older than 75 years
criteria: 
gender: All
minimum age: 75 Years
maximum age: N/A
healthy volunteers: No
last name: Bertrand CARIOU, Pr
role: Principal Investigator
affiliation: CHU de Nantes
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Hypoglycemia