Fear of Hypoglycemia in Children and Adolecents With Type 1 Diabetes

Completed

• Conditions: Type 1 Diabetes Mellitus; Fear of Hypoglycemia

• Registration Number: NCT04454827
• Lead Sponsor: University of Ljubljana, Faculty of Medicine

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.

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 Timeline

• Study Start: 2019-04-01
• Primary Completion: 2019-08-31
• Study Completion: 2019-09-30
• Status Verified: 2020-06
• Study First Submitted: 2020-06-30
• Study First Submitted QC: 2020-06-30
• Last Update Submitted: 2020-06-30
• Study First Posted: 2020-07-02
• Last Update Posted: 2020-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 316

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fear of Hypoglycemia	5 months	Questionnaires

Secondary Outcome Measures

Name	Time	Method
Time in ranges (below 3.9, 3.9-10, above 10 mmol/l	1 year	If available
HbA1c	1 year

Trial Locations

Locations (1)

University Children's Hospital Ljubljana; 🇸🇮 Ljubljana, Slovenija/Osrednja Regija, Slovenia