Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:10 AM
Study NCT ID:
NCT04454827
Status:
COMPLETED
Last Update Posted:
2020-07-02
First Post:
2020-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fear of Hypoglycemia in Children and Adolecents With Type 1 Diabetes
Sponsor:
University of Ljubljana, Faculty of Medicine
Organization:
Study Overview
Official Title:
Fear of Hypoglycemia in Children and Adolecents With Type 1 Diabetes and Their Parents
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: