Fear of Hypoglycemia in Children and Adolecents With Type 1 Diabetes

NCT ID: NCT04454827

Last Updated: 2020-07-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 316 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2019-09-30

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.

Conditions

Type 1 Diabetes Mellitus; Fear of Hypoglycemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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)

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ljubljana, Faculty of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Children's Hospital Ljubljana

Ljubljana, Slovenija/Osrednja Regija, Slovenia

Countries

Slovenia

Other Identifiers

Hypo-Fear-T1D-SI

Identifier Type: -

Identifier Source: org_study_id