Clinical trial NCT03529188: French Version of the Scales of Fear of Hypoglycaemia in Children With Type 1 Diabetes and Their Parents
Official title: Validation of the French Version of the Three Scales for Assessing the Fear of Type 1 Hypoglycemia (HFS-C, HFS-PYC and HFS-P) in Children, Adolescents and Their Parents by a Monocentric Transverse Psychometric Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Type 1
Keywords: Diabetes type 1
Child ans teenager
Fear of Hypoglycaemia
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2018-05-18
Enrollment: 210
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Child and teenager with Type 1 diabetes defined by an hyperglycemia higher than 2g/l, polyuria, polydipsia and positive antibody.

Brief summary: Type 1 diabetes usually appears brutally in children or young adults. While many factors of poor glycemic balance have been identified in the literature (age, socio-cultural and socio-economic level, family structure, adherence etc.), it turns out that hypoglycemia is the most common acute complications. It would be an important physiological and psychological barrier for the patient and his parents to manage this diabetes, the latter seeking to keep the blood glucose levels above the objectives in order to avoid the occurrence of a hypoglycemia, especially nocturnal.

If there is a questionnaire currently validated as a tool to measure the fear of hypoglycemia (HFS, Hypoglycemia Fear Survey is available in three versions: L'HFS-Child (HFS-C) for children over 6 years old, HFS-Parents of Young children ( HFS-PYC) for parents of young children (under 8 years of age) and HFS-Parents (HFS-P)) for parents of children over 8 years of age, on the other hand, there are no French and no French studies have evaluated the prevalence and impact of the fear of hypoglycemia in French patients with type 1 diabetes.

It is therefore essential to use a reliable and valid tool to identify patients affected by the fear of hypoglycemia, which can be an obstacle to improve glycemic control and to an optimum quality of life. Having a tool in French and validated on the scientific level would allow to propose adapted therapeutic treatments (psychological follow-up, individual or collective sessions of therapeutic education, material assistance (sensor of blood glucose, pump with insulin stop...) In order to both improve metabolic balance while increasing the quality of life of patients by lowering secondary anxiety to hypoglycemia


Eligibility criteria: Inclusion Criteria:

* Age between 2 and 18 years
* Type 1 diabetes defined by an hyperglycemia higher than 2g/l, polyuria, polydipsia and positive antibody
* insulin-treated type 2 diabetes by daily injections or insulin pump

Exclusion Criteria:

* Trouble to read
* Trouble to understand
* Trouble to answer to the questionnaire
* Opposition.

Primary outcomes:
measure: HFS-Child score,
timeFrame: Month 0
measure: HFS-PYC score
timeFrame: Month 0, Month 3 (+/- 30 days)
measure: HFS-Parent score
timeFrame: Month 0, Month 3 (+/- 30 days)
Secondary outcomes:
measure: Questionnaire Survey "children "
timeFrame: Month 0, Month 3 (+/- 30 days)
measure: Questionnaire Survey "parents "
timeFrame: Month 0, Month 3 (+/- 30 days)
measure: HbA1C
timeFrame: Month 0, Month 3 (+/- 30 days)
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
city: Lorient
country: France
facility: Centre Hospitalier de Bretagne Sud
city: Paris cedex 19
country: France
facility: Hôpital Universitaire Robert-Debré
Study officials:
References: