<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/NCT04485351</url>
  </required_header>
  <id_info>
    <org_study_id>2020PI137</org_study_id>
    <nct_id>NCT04485351</nct_id>
  </id_info>
  <brief_title>Assessing the Impact of the COVID-19 Lockdown on Metabolic Control and Access to Health Care in Patients With Diabetes</brief_title>
  <acronym>CONFI-DIAB</acronym>
  <official_title>Assessing the Impact of the COVID-19 Lockdown on Metabolic Control and Access to Health Care in Patients With Diabetes: a Monocentric Cross-sectional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, France</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>
      The outbreak of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the&#xD;
      COVID-19 (Coronavirus Disease-2019) in December 2019 has led to an unprecedented&#xD;
      international health situation. Exceptional measures have been taken by public authorities&#xD;
      worldwide in order to slow the spread of the virus and prevent healthcare systems from&#xD;
      becoming overloaded. In France, a national lockdown has been established during approximately&#xD;
      2 months to increase social distancing and restrict population movements. Hospital routine&#xD;
      care appointments have been cancelled, in order to reallocate medical resources towards&#xD;
      COVID-19 units and limit contacts between patients within hospitals or waiting rooms. While&#xD;
      the virus itself, the disease and potential treatments are currently extensively studied,&#xD;
      little data are available on the effect of these public health decisions on the management of&#xD;
      a chronic condition such as diabetes.&#xD;
&#xD;
      The French regional CONFI-DIAB study aims at assessing the collateral impact of routine care&#xD;
      cancellation during the national lockdown due to COVID-19 in patients with a chronic&#xD;
      condition such as diabetes. Special attention will be given to metabolic control and access&#xD;
      to health care.&#xD;
&#xD;
      This cross-sectional study should provide information on the consequences of a global&#xD;
      lockdown and the associated routine care cancellation on the management of diabetes, and&#xD;
      inform future decision making in the event of a new pandemic.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">July 2020</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">August 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Compare glycated hemoglobin levels of patients with diabetes from the University Hospital of Nancy between the period preceding and following the lockdown related to the COVID-19 pandemic.</measure>
    <time_frame>6 months period prior to lockdown - 6 weeks period following the end of the lockdown</time_frame>
    <description>HbA1c levels before and after the lockdown period. A 3 months period is required between the 2 values.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Describe the clinical and biological characteristics of patients with diabetes followed in routine care at the University Hospital of Nancy</measure>
    <time_frame>6 weeks period following the end of the lockdown</time_frame>
    <description>Use type of diabetes, BMI, lipid profile, micro- and macro-comorbidities and usual therapies from medical records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Describe the change from baseline of biological and clinical parameters of patients with diabetes followed in routine care at the University Hospital of Nancy between the period preceding and following the lockdown.</measure>
    <time_frame>6 months period prior to lockdown - 6 weeks period following the end of the lockdown</time_frame>
    <description>Use BMI, lipid profile, renal and hepatic function from medical records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Describe the proportion of patients who presented with one or more significant clinical event during the lockdown.</measure>
    <time_frame>6 weeks period following the end of the lockdown</time_frame>
    <description>Ketosis, Ketoacidosis, severe hypoglycemia, COVID-19 infection, hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Describe the proportion of patients who forgot and/or discontinued one or several medication(s) during the lockdown.</measure>
    <time_frame>6 weeks period following the end of the lockdown</time_frame>
    <description>Proportion of patients who forgot and/or discontinued one or several medication(s), medication involved, duration and frequency of omission/discontinuation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Describe the proportion of patients who changed their lifestyle's habits during the lockdown.</measure>
    <time_frame>6 weeks period following the end of the lockdown</time_frame>
    <description>Porportion of patients who modified their usual level of physical activity and/or their consumption of alcohol and/or tobacco</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Describe healthcare consumption of patients with diabetes during the lockdown.</measure>
    <time_frame>6 weeks period following the end of the lockdown</time_frame>
    <description>Proportion of patients who consulted their GP, a specialist physician, pharmacist, biologist, nurse, paramedic, other healthcare professional; type of visit (regular face to face, telemedecine); method for prescription renewal; reason for delay in care; hospitalization (excluding for COVID-19)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Describe the proportion of patients who (1) was tested for SARS-CoV-2 by PCR, (2) developped COVID-19 confirmed by PCR and (3) was hospitalized due to the severity of COVID-19.</measure>
    <time_frame>6 weeks period following the end of the lockdown</time_frame>
    <description>Proportion of patients who (1) was tested for SARS-CoV-2 by PCR, (2) developped COVID-19 confirmed by PCR and (3) was hospitalized due to the severity of COVID-19.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">700</enrollment>
  <condition>Diabetes Mellitus</condition>
  <condition>Coronavirus Infection</condition>
  <condition>Metabolic Disease</condition>
  <condition>Glucose Metabolism Disorders</condition>
  <arm_group>
    <arm_group_label>Diabetic patients from the University Hospital of Nancy</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no intervention</intervention_name>
    <description>no intervention</description>
    <arm_group_label>Diabetic patients from the University Hospital of Nancy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Diabetic patients routinely followed by a specialist physician from the University Hospital&#xD;
        of Nancy for diabetes&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients&#xD;
&#xD;
          -  Patient with diabetes known for at least 6 months before inclusion&#xD;
&#xD;
          -  Patient followed by a specialist physician from the University Hospital of Nancy for&#xD;
             routine care within the 6 months prior to the lockdown.&#xD;
&#xD;
          -  Patient who was assessed for prioritization of care following the end of the lockdown&#xD;
             by the department of endocrinology, diabetology and nutrition&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects opposed to the use of their data&#xD;
&#xD;
          -  Minors, adults under guardianship, protected persons&#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>Lisa Ludwig, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>PA</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lisa Ludwig, Dr</last_name>
    <phone>+33383155056</phone>
    <email>L.LUDWIG@chru-nancy.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Regional Hospital of Nancy</name>
      <address>
        <city>Nancy</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lisa Ludwig, Dr</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 23, 2020</last_update_submitted>
  <last_update_submitted_qc>July 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>diabetes mellitus</keyword>
  <keyword>lockdown</keyword>
  <keyword>covid-19</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Metabolic Diseases</mesh_term>
    <mesh_term>Glucose Metabolism Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04485351
org study id: 2020PI137
nct id: NCT04485351
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The outbreak of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the
      COVID-19 (Coronavirus Disease-2019) in December 2019 has led to an unprecedented
      international health situation. Exceptional measures have been taken by public authorities
      worldwide in order to slow the spread of the virus and prevent healthcare systems from
      becoming overloaded. In France, a national lockdown has been established during approximately
      2 months to increase social distancing and restrict population movements. Hospital routine
      care appointments have been cancelled, in order to reallocate medical resources towards
      COVID-19 units and limit contacts between patients within hospitals or waiting rooms. While
      the virus itself, the disease and potential treatments are currently extensively studied,
      little data are available on the effect of these public health decisions on the management of
      a chronic condition such as diabetes.

      The French regional CONFI-DIAB study aims at assessing the collateral impact of routine care
      cancellation during the national lockdown due to COVID-19 in patients with a chronic
      condition such as diabetes. Special attention will be given to metabolic control and access
      to health care.

      This cross-sectional study should provide information on the consequences of a global
      lockdown and the associated routine care cancellation on the management of diabetes, and
      inform future decision making in the event of a new pandemic.
observational model: Cohort
time perspective: Cross-Sectional
measure: Compare glycated hemoglobin levels of patients with diabetes from the University Hospital of Nancy between the period preceding and following the lockdown related to the COVID-19 pandemic.
time frame: 6 months period prior to lockdown - 6 weeks period following the end of the lockdown
description: HbA1c levels before and after the lockdown period. A 3 months period is required between the 2 values.
measure: Describe the clinical and biological characteristics of patients with diabetes followed in routine care at the University Hospital of Nancy
time frame: 6 weeks period following the end of the lockdown
description: Use type of diabetes, BMI, lipid profile, micro- and macro-comorbidities and usual therapies from medical records
measure: Describe the change from baseline of biological and clinical parameters of patients with diabetes followed in routine care at the University Hospital of Nancy between the period preceding and following the lockdown.
time frame: 6 months period prior to lockdown - 6 weeks period following the end of the lockdown
description: Use BMI, lipid profile, renal and hepatic function from medical records
measure: Describe the proportion of patients who presented with one or more significant clinical event during the lockdown.
time frame: 6 weeks period following the end of the lockdown
description: Ketosis, Ketoacidosis, severe hypoglycemia, COVID-19 infection, hospitalization
measure: Describe the proportion of patients who forgot and/or discontinued one or several medication(s) during the lockdown.
time frame: 6 weeks period following the end of the lockdown
description: Proportion of patients who forgot and/or discontinued one or several medication(s), medication involved, duration and frequency of omission/discontinuation
measure: Describe the proportion of patients who changed their lifestyle's habits during the lockdown.
time frame: 6 weeks period following the end of the lockdown
description: Porportion of patients who modified their usual level of physical activity and/or their consumption of alcohol and/or tobacco
measure: Describe healthcare consumption of patients with diabetes during the lockdown.
time frame: 6 weeks period following the end of the lockdown
description: Proportion of patients who consulted their GP, a specialist physician, pharmacist, biologist, nurse, paramedic, other healthcare professional; type of visit (regular face to face, telemedecine); method for prescription renewal; reason for delay in care; hospitalization (excluding for COVID-19)
measure: Describe the proportion of patients who (1) was tested for SARS-CoV-2 by PCR, (2) developped COVID-19 confirmed by PCR and (3) was hospitalized due to the severity of COVID-19.
time frame: 6 weeks period following the end of the lockdown
description: Proportion of patients who (1) was tested for SARS-CoV-2 by PCR, (2) developped COVID-19 confirmed by PCR and (3) was hospitalized due to the severity of COVID-19.
arm group label: Diabetic patients from the University Hospital of Nancy
intervention type: Other
intervention name: no intervention
description: no intervention
arm group label: Diabetic patients from the University Hospital of Nancy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lisa Ludwig, Dr
role: Principal Investigator
affiliation: PA
last name: Lisa Ludwig, Dr
phone: +33383155056
email: L.LUDWIG@chru-nancy.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Coronavirus Infections
mesh term: Diabetes Mellitus
mesh term: Metabolic Diseases
mesh term: Glucose Metabolism Disorders
sharing ipd: No