Fear of Hypoglycemia in Children and Adolecents With Type 1 Diabetes
Keywords
Abstract
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.
Dates
| Last Verified: | 05/31/2020 |
| First Submitted: | 06/29/2020 |
| Estimated Enrollment Submitted: | 06/29/2020 |
| First Posted: | 07/01/2020 |
| Last Update Submitted: | 06/29/2020 |
| Last Update Posted: | 07/01/2020 |
| Actual Study Start Date: | 03/31/2019 |
| Estimated Primary Completion Date: | 08/30/2019 |
| Estimated Study Completion Date: | 09/29/2019 |
Condition or disease
Phase
Eligibility Criteria
| Ages Eligible for Study | 1 Year To 1 Year |
| Sexes Eligible for Study | All |
| Sampling method | Non-Probability Sample |
| Accepts Healthy Volunteers | No |
| 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) |
Outcome
Primary Outcome Measures
1. Fear of Hypoglycemia [5 months]
Secondary Outcome Measures
1. Time in ranges (below 3.9, 3.9-10, above 10 mmol/l [1 year]
2. HbA1c [1 year]
