Fear of Hypoglycemia in Children and Adolecents With Type 1 Diabetes

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04454827
• Other study ID #: Hypo-Fear-T1D-SI
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: June 2020
• Source: University of Ljubljana, Faculty of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 316
• Est. completion date: September 30, 2019
• Est. primary completion date: August 31, 2019
• Gender: All
• Age group: 1 Year to 25 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Fear of Hypoglycemia
• Hypoglycemia
• Type 1 Diabetes Mellitus

Locations

Country	Name	City	State
Slovenia	University Children's Hospital Ljubljana	Ljubljana	Slovenija/Osrednja Regija

Sponsors (1)

Lead Sponsor	Collaborator
University of Ljubljana, Faculty of Medicine

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fear of Hypoglycemia	Questionnaires	5 months
Secondary	Time in ranges (below 3.9, 3.9-10, above 10 mmol/l	If available	1 year
Secondary	HbA1c		1 year