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Completed

NCT Number: NCT04454827

Fear of Hypoglycemia in Children and Adolecents With Type 1 Diabetes

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.

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Key information

Age range

1 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Children's Hospital Ljubljana

Ljubljana, Slovenija/Osrednja Regija, 1000, Slovenia

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Fear of Hypoglycemia

    Time frame: 5 months

    Questionnaires

Secondary outcomes

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

    Time frame: 1 year

    If available

  2. HbA1c

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Ljubljana, Faculty of Medicine

Other

Registry information

Official study title

Fear of Hypoglycemia in Children and Adolecents With Type 1 Diabetes and Their Parents

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 2, 2020
Registry last updated
Jul 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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