<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/NCT04454827</url>
  </required_header>
  <id_info>
    <org_study_id>Hypo-Fear-T1D-SI</org_study_id>
    <nct_id>NCT04454827</nct_id>
  </id_info>
  <brief_title>Fear of Hypoglycemia in Children and Adolecents With Type 1 Diabetes</brief_title>
  <official_title>Fear of Hypoglycemia in Children and Adolecents With Type 1 Diabetes and Their Parents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Ljubljana, Faculty of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Ljubljana, Faculty of Medicine</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute symptoms of hypoglycemia influence all aspects of every day life and reduce quality of&#xD;
      life of children and adolescents with type 1 diabetes and their parents. Encountering with&#xD;
      hypoglycemia can result in fobic fear of low blood glucose levels in patients with type 1&#xD;
      diabetes and their parents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fear of hypoglycemia is the most commonly reported problem in type 1 diabetes. By definition,&#xD;
      hypoglycemia is a state of low blood glucose that is lower than 3,6 mmol/L. It can lead to&#xD;
      uncomfortable counter-regulatory symptoms such as headaches, nervousness, weakness sweating,&#xD;
      confusion, irritability, sleepiness and dizziness. In worst cases hypoglycemia can lead to&#xD;
      loss of consciousness, seizures and death.&#xD;
&#xD;
      Unpredictability of episodes of hypoglycemia causes patients with diabetes and their family&#xD;
      members to develop symptoms of anxiety and concerns related to hypoglycemia. The acute&#xD;
      symptoms affect all fields of every day life and decrease quality of life of children and&#xD;
      adolescents with type 1 diabetes and their parents. In some individuals and their families&#xD;
      fear of hypoglycemia can lead to maintaining higher levels of blood glucose, excessive&#xD;
      glucose monitoring, sleep deprivation, stress, obsessivity in self control, dependency to&#xD;
      others etc.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">August 31, 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Fear of Hypoglycemia</measure>
    <time_frame>5 months</time_frame>
    <description>Questionnaires</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time in ranges (below 3.9, 3.9-10, above 10 mmol/l</measure>
    <time_frame>1 year</time_frame>
    <description>If available</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1c</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">316</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <condition>Fear of Hypoglycemia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Children and adolescents with type 1 diabetes and their parents&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 1 diabetes for more than 0.5 year&#xD;
&#xD;
          -  Age ≥ 1 year up to 25 years (inclusive)&#xD;
&#xD;
          -  The subject/carer is willing to follow study specific instructions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Youth with maturity-onset diabetes of the young, hybrid, other, or missing type&#xD;
&#xD;
          -  Any significant diseases / conditions including psychiatric disorders and substance&#xD;
             abuse that in the opinion of the investigator is likely to affect the subject's&#xD;
             ability to complete the study&#xD;
&#xD;
          -  Current use of the following medications: medications that are used to lower blood&#xD;
             glucose such as Pramlintide, Metformin and GLP-1 analogs. Beta blockers,&#xD;
             glucocorticoids and other medications, which in the judgment of the investigator would&#xD;
             be a contraindication to participation in the study (Anticoagulant therapy e.g.&#xD;
             Plavix, LMW heparin, Coumadin, Immunosuppressant therapy)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>25 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>University Children's Hospital Ljubljana</name>
      <address>
        <city>Ljubljana</city>
        <state>Slovenija/Osrednja Regija</state>
        <zip>1000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Slovenia</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Type 1 Diabetes Mellitus</keyword>
  <keyword>Fear of Hypoglycemia</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 1</mesh_term>
    <mesh_term>Hypoglycemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04454827
org study id: Hypo-Fear-T1D-SI
nct id: NCT04454827
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Acute symptoms of hypoglycemia influence all aspects of every day life and reduce quality of
      life of children and adolescents with type 1 diabetes and their parents. Encountering with
      hypoglycemia can result in fobic fear of low blood glucose levels in patients with type 1
      diabetes and their parents.
Fear of hypoglycemia is the most commonly reported problem in type 1 diabetes. By definition,
      hypoglycemia is a state of low blood glucose that is lower than 3,6 mmol/L. It can lead to
      uncomfortable counter-regulatory symptoms such as headaches, nervousness, weakness sweating,
      confusion, irritability, sleepiness and dizziness. In worst cases hypoglycemia can lead to
      loss of consciousness, seizures and death.

      Unpredictability of episodes of hypoglycemia causes patients with diabetes and their family
      members to develop symptoms of anxiety and concerns related to hypoglycemia. The acute
      symptoms affect all fields of every day life and decrease quality of life of children and
      adolescents with type 1 diabetes and their parents. In some individuals and their families
      fear of hypoglycemia can lead to maintaining higher levels of blood glucose, excessive
      glucose monitoring, sleep deprivation, stress, obsessivity in self control, dependency to
      others etc.
observational model: Cohort
time perspective: Prospective
measure: Fear of Hypoglycemia
time frame: 5 months
description: Questionnaires
measure: Time in ranges (below 3.9, 3.9-10, above 10 mmol/l
time frame: 1 year
description: If available
measure: HbA1c
time frame: 1 year
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: 25 Years
facility: 
country: Slovenia
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Hypoglycemia
sharing ipd: Undecided