Status:
COMPLETED
Fear of Hypoglycemia in Children and Adolecents With Type 1 Diabetes
Lead Sponsor:
University of Ljubljana, Faculty of Medicine
Conditions:
Type 1 Diabetes Mellitus
Fear of Hypoglycemia
Eligibility:
All Genders
1-25 years
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...
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 c...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2019
Estimated Enrollment :
316 Patients enrolled
Trial Details
Trial ID
NCT04454827
Start Date
April 1 2019
End Date
September 30 2019
Last Update
July 2 2020
Active Locations (1)
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1
University Children's Hospital Ljubljana
Ljubljana, Slovenija/Osrednja Regija, Slovenia, 1000