xml: <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/NCT05977205</url>
    </required_header>
    <id_info>
      <org_study_id>NL73778.058.20</org_study_id>
      <nct_id>NCT05977205</nct_id>
    </id_info>
    <brief_title>COVID-19 Glycemic Control Study</brief_title>
    <official_title>The Impact of Self-quarantining on Glycemic Control, Diabetes Self-management and Distress During the Coronavirus Outbreak</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Leiden University Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Leiden University Medical Center</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 mellitus is a chronic disease characterized by the inability of the body to maintain&#xD;
        normoglycemia. Treatment of diabetes relies mostly on diabetes self-management, requiring a&#xD;
        large investment of time and energy on a daily basis. Psychological wellbeing, behavioral&#xD;
        patterns and social context play a major role in diabetes self-management and glycemic&#xD;
        control. Social isolation behavior (self-quarantining) may impact glycemic control by&#xD;
        influencing daily routines, therapy adherence, physical activity, and self-measurement and&#xD;
        eating behaviors. Therefore, a period of nationwide self-quarantine, such as during the&#xD;
        lockdown issued during the COVID-19 outbreak in the Netherlands, may have a large effect on&#xD;
        glycemic control in patients with diabetes.&#xD;
  &#xD;
        In this observational cross sectional study, we aim to assess the impact of long-term&#xD;
        self-quarantine on glycemic control, diabetes self-management and distress in patients with&#xD;
        type 1 and type 2 diabetes mellitus.&#xD;
  &#xD;
        A specific subgroup of patients with T1D are those with complicated diabetes who have&#xD;
        received a pancreas or islet transplantation and use immunosuppression, having multiple risk&#xD;
        factors for severe COVID-19. The impact of lockdown strategies on mental and physical health&#xD;
        is expectedly even greater in patients at even higher risk for severe COVID-19. We therefore&#xD;
        additionally investigated differences in behavioral, mental and physical implications of a&#xD;
        nationwide lockdown on patients with type 1 diabetes with and without islet or pancreas&#xD;
        transplantation.&#xD;
  &#xD;
        Measurements will be performed during the lockdown period. Patients will be asked to perform&#xD;
        a fingerprick HbA1c measurement once, sent back to the LUMC by mail. Data from continuous or&#xD;
        flash glucose monitoring devices will be collected according to standard clinical practice.&#xD;
        Furthermore, patients will be asked to fill out an online questionnaire once on diabetes&#xD;
        self-management behavior, well-being and distress, along with questions about health status,&#xD;
        level of education, medication use, employment, social situation and the impact of&#xD;
        self-quarantine on daily routines. In this questionnaire, we ask patients to compare certain&#xD;
        aspects of their life (e.g. anxiety, stress, weight, physical activity, glycemic control) at&#xD;
        the time of the lockdown to before the lockdown. Data on demographics, type of diabetes,&#xD;
        weight, BMI and HbA1c prior to the COVID-19 outbreak will be derived from the patient's&#xD;
        electronic health file.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 2, 2020</start_date>
    <completion_date type="Actual">July 10, 2020</completion_date>
    <primary_completion_date type="Actual">July 10, 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>Glycemic control</measure>
      <time_frame>HbA1c measurement during lockdown (8 - 11 weeks after the start of the lockdown (March 15th 2020)) compared to last measurement before lockdown (last known measurement before March 15th 2020)</time_frame>
      <description>HbA1c (mmol/mol Hb)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Glycemic control</measure>
      <time_frame>2 week period during lockdown compared to 2 week period before lockdown</time_frame>
      <description>Continuous Glucose Measurement parameters (time in range, time above range, time below range)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stress</measure>
      <time_frame>PSS During lockdown + self-comparison change to before lockdown (questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))</time_frame>
      <description>Perceived Stress Scale (PSS) + self-reported change in stress during lockdown compared to before lockdown</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anxiety</measure>
      <time_frame>Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))</time_frame>
      <description>Self-reported change in anxiety during lockdown compared to before lockdown</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Weight</measure>
      <time_frame>Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))</time_frame>
      <description>Self-reported weight change during lockdown compared to before lockdown</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical activity</measure>
      <time_frame>Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))</time_frame>
      <description>Self-reported change in physical activity during lockdown compared to before lockdown</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Glycemic control and insulin requirements</measure>
      <time_frame>Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))</time_frame>
      <description>Self-reported change in difficulty with glycemic control and insulin requirements during lockdown compared to before lockdown</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Social isolation behaviour</measure>
      <time_frame>Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))</time_frame>
      <description>Self-reported social isolation behaviour during lockdown</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fear of COVID-19 infection</measure>
      <time_frame>Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))</time_frame>
      <description>Fear of contracting COVID-19, scored using a Visual Analogue Scale (1-10), during lockdown</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Actual">492</enrollment>
    <condition>Type 1 Diabetes</condition>
    <condition>Type 2 Diabetes</condition>
    <arm_group>
      <arm_group_label>Type 1 Diabetes</arm_group_label>
      <description>280 patients with type 1 diabetes</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Type 2 Diabetes</arm_group_label>
      <description>155 patients with type 2 diabetes</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Type 1 Diabetes with Islet or Pancreas Transplantation</arm_group_label>
      <description>23 patients with islet transplantation, 7 with pancreas transplantation, 27 with simultaneous pancreas-kidney transplantation</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>No interventions, observational study</intervention_name>
      <description>Not applicable, no interventions, observational study</description>
      <arm_group_label>Type 1 Diabetes</arm_group_label>
      <arm_group_label>Type 1 Diabetes with Islet or Pancreas Transplantation</arm_group_label>
      <arm_group_label>Type 2 Diabetes</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with type 1 diabetes (with and without islet or pancreas transplantation) and type&#xD;
          2 diabetes, recruited from the diabetes outpatient clinic of the LUMC.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years&#xD;
  &#xD;
            -  Diagnosed with type 1 or type 2 diabetes&#xD;
  &#xD;
            -  Ability to perform fingerpricks&#xD;
  &#xD;
            -  Sufficient comprehension of the Dutch language&#xD;
  &#xD;
            -  Ability to fill out online questionnaires&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Newly diagnosed malignancy, with the exclusion of non-melanoma skin cancer, in the&#xD;
               previous 6 months&#xD;
  &#xD;
            -  Chemotherapy or immunotherapy for malignancy&#xD;
  &#xD;
            -  Admission to hospital or rehabilitation center&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Eelco JP de Koning, MD PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Leiden University Medical Center</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Leiden University Medical Center</name>
        <address>
          <city>Leiden</city>
          <state>Zuid-Holland</state>
          <zip>2333 ZA</zip>
          <country>Netherlands</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Leiden University Medical Center</investigator_affiliation>
      <investigator_full_name>Eelco JP de Koning</investigator_full_name>
      <investigator_title>Principal Investigator, Professor in Diabetology</investigator_title>
    </responsible_party>
    <keyword>COVID-19 Pandemic</keyword>
    <keyword>Type 1 Diabetes</keyword>
    <keyword>Type 2 Diabetes</keyword>
    <keyword>Beta Cell Transplantation</keyword>
    <keyword>Social isolation</keyword>
    <keyword>Glycemic control</keyword>
    <keyword>Distress</keyword>
    <keyword>COVID-19 Lockdown</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>Diabetes Mellitus, Type 1</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Informed Consent Form</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>April 24, 2020</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT05977205/Prot_ICF_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05977205
  org study id: NL73778.058.20
  nct id: NCT05977205
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Diabetes mellitus is a chronic disease characterized by the inability of the body to maintain
        normoglycemia. Treatment of diabetes relies mostly on diabetes self-management, requiring a
        large investment of time and energy on a daily basis. Psychological wellbeing, behavioral
        patterns and social context play a major role in diabetes self-management and glycemic
        control. Social isolation behavior (self-quarantining) may impact glycemic control by
        influencing daily routines, therapy adherence, physical activity, and self-measurement and
        eating behaviors. Therefore, a period of nationwide self-quarantine, such as during the
        lockdown issued during the COVID-19 outbreak in the Netherlands, may have a large effect on
        glycemic control in patients with diabetes.
  
        In this observational cross sectional study, we aim to assess the impact of long-term
        self-quarantine on glycemic control, diabetes self-management and distress in patients with
        type 1 and type 2 diabetes mellitus.
  
        A specific subgroup of patients with T1D are those with complicated diabetes who have
        received a pancreas or islet transplantation and use immunosuppression, having multiple risk
        factors for severe COVID-19. The impact of lockdown strategies on mental and physical health
        is expectedly even greater in patients at even higher risk for severe COVID-19. We therefore
        additionally investigated differences in behavioral, mental and physical implications of a
        nationwide lockdown on patients with type 1 diabetes with and without islet or pancreas
        transplantation.
  
        Measurements will be performed during the lockdown period. Patients will be asked to perform
        a fingerprick HbA1c measurement once, sent back to the LUMC by mail. Data from continuous or
        flash glucose monitoring devices will be collected according to standard clinical practice.
        Furthermore, patients will be asked to fill out an online questionnaire once on diabetes
        self-management behavior, well-being and distress, along with questions about health status,
        level of education, medication use, employment, social situation and the impact of
        self-quarantine on daily routines. In this questionnaire, we ask patients to compare certain
        aspects of their life (e.g. anxiety, stress, weight, physical activity, glycemic control) at
        the time of the lockdown to before the lockdown. Data on demographics, type of diabetes,
        weight, BMI and HbA1c prior to the COVID-19 outbreak will be derived from the patient's
        electronic health file.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Glycemic control
  time frame: HbA1c measurement during lockdown (8 - 11 weeks after the start of the lockdown (March 15th 2020)) compared to last measurement before lockdown (last known measurement before March 15th 2020)
  description: HbA1c (mmol/mol Hb)
  measure: Glycemic control
  time frame: 2 week period during lockdown compared to 2 week period before lockdown
  description: Continuous Glucose Measurement parameters (time in range, time above range, time below range)
  measure: Stress
  time frame: PSS During lockdown + self-comparison change to before lockdown (questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))
  description: Perceived Stress Scale (PSS) + self-reported change in stress during lockdown compared to before lockdown
  measure: Anxiety
  time frame: Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))
  description: Self-reported change in anxiety during lockdown compared to before lockdown
  measure: Weight
  time frame: Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))
  description: Self-reported weight change during lockdown compared to before lockdown
  measure: Physical activity
  time frame: Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))
  description: Self-reported change in physical activity during lockdown compared to before lockdown
  measure: Glycemic control and insulin requirements
  time frame: Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))
  description: Self-reported change in difficulty with glycemic control and insulin requirements during lockdown compared to before lockdown
  measure: Social isolation behaviour
  time frame: Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))
  description: Self-reported social isolation behaviour during lockdown
  measure: Fear of COVID-19 infection
  time frame: Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))
  description: Fear of contracting COVID-19, scored using a Visual Analogue Scale (1-10), during lockdown
  arm group label: Type 1 Diabetes
  description: 280 patients with type 1 diabetes
  arm group label: Type 2 Diabetes
  description: 155 patients with type 2 diabetes
  arm group label: Type 1 Diabetes with Islet or Pancreas Transplantation
  description: 23 patients with islet transplantation, 7 with pancreas transplantation, 27 with simultaneous pancreas-kidney transplantation
  intervention type: Other
  intervention name: No interventions, observational study
  description: Not applicable, no interventions, observational study
  arm group label: Type 1 Diabetes
  arm group label: Type 1 Diabetes with Islet or Pancreas Transplantation
  arm group label: Type 2 Diabetes
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Eelco JP de Koning, MD PhD
  role: Principal Investigator
  affiliation: Leiden University Medical Center
  facility: 
  country: Netherlands
  responsible party type: Principal Investigator
  investigator affiliation: Leiden University Medical Center
  investigator full name: Eelco JP de Koning
  investigator title: Principal Investigator, Professor in Diabetology
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 2
  mesh term: Diabetes Mellitus, Type 1
  sharing ipd: Undecided
  provided document: 