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Fear of Hypoglycemia in Children and Adolecents With Type 1 Diabetes

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04454827
Enrollment
316
Registered
2020-07-02
Start date
2019-04-01
Completion date
2019-09-30
Last updated
2020-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fear of Hypoglycemia, Type 1 Diabetes Mellitus

Keywords

Type 1 Diabetes Mellitus, Fear of Hypoglycemia

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.

Interventions

None listed

Sponsors

University of Ljubljana, Faculty of Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 25 Years

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)

Design outcomes

Primary

MeasureTime frameDescription
Fear of Hypoglycemia5 monthsQuestionnaires

Secondary

MeasureTime frameDescription
Time in ranges (below 3.9, 3.9-10, above 10 mmol/l1 yearIf available
HbA1c1 year

Countries

Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026