Clinical trial NCT04454827: Fear of Hypoglycemia in Children and Adolecents With Type 1 Diabetes
Official title: Fear of Hypoglycemia in Children and Adolecents With Type 1 Diabetes and Their Parents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus
Fear of Hypoglycemia
Keywords: Type 1 Diabetes Mellitus
Fear of Hypoglycemia
Lead sponsor: University of Ljubljana, Faculty of Medicine
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 316
Sex: ALL
Minimum age (years): 1
Maximum age (years): 25
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolescents with type 1 diabetes and their parents

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.

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)

Primary outcomes:
measure: Fear of Hypoglycemia
timeFrame: 5 months
Secondary outcomes:
measure: Time in ranges (below 3.9, 3.9-10, above 10 mmol/l
timeFrame: 1 year
measure: HbA1c
timeFrame: 1 year
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Children's Hospital Ljubljana
state: Slovenija/Osrednja Regija
Study officials:
References: