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Fear of Hypoglycemia in Children and Adolecents With Type 1 Diabetes

Sponsor
University of Ljubljana, Faculty of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT04454827
Collaborator
(none)
316
Enrollment
1
Location
6
Actual Duration (Months)
52.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    316 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Fear of Hypoglycemia in Children and Adolecents With Type 1 Diabetes and Their Parents
    Actual Study Start Date :
    Apr 1, 2019
    Actual Primary Completion Date :
    Aug 31, 2019
    Actual Study Completion Date :
    Sep 30, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Fear of Hypoglycemia [5 months]

      Questionnaires

    Secondary Outcome Measures

    1. Time in ranges (below 3.9, 3.9-10, above 10 mmol/l [1 year]

      If available

    2. HbA1c [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 25 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Type 1 diabetes for more than 0.5 year

    • Age ≥ 1 year up to 25 years (inclusive)

    • The subject/carer is willing to follow study specific instructions

    Exclusion Criteria:

    • Youth with maturity-onset diabetes of the young, hybrid, other, or missing type

    • Any significant diseases / conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study

    • Current use of the following medications: medications that are used to lower blood glucose such as Pramlintide, Metformin and GLP-1 analogs. Beta blockers, glucocorticoids and other medications, which in the judgment of the investigator would be a contraindication to participation in the study (Anticoagulant therapy e.g. Plavix, LMW heparin, Coumadin, Immunosuppressant therapy)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Children's Hospital Ljubljana Ljubljana Slovenija/Osrednja Regija Slovenia 1000

    Sponsors and Collaborators

    • University of Ljubljana, Faculty of Medicine

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Ljubljana, Faculty of Medicine
    ClinicalTrials.gov Identifier:
    NCT04454827
    Other Study ID Numbers:
    • Hypo-Fear-T1D-SI
    First Posted:
    Jul 2, 2020
    Last Update Posted:
    Jul 2, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Ljubljana, Faculty of Medicine
    Type 1 Diabetes Mellitus
    Fear of Hypoglycemia
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 1
    Hypoglycemia

    Study Results

    No Results Posted as of Jul 2, 2020