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French Version of the Scales of Fear of Hypoglycaemia in Children With Type 1 Diabetes and Their Parents

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03529188
Acronym
FHS
Enrollment
194
Registered
2018-05-18
Start date
2018-08-03
Completion date
2020-12-25
Last updated
2026-06-25

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

Conditions

Diabetes Type 1

Keywords

Diabetes type 1, Child ans teenager, Fear of Hypoglycaemia

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

Interventions

None listed

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
HFS-Child score,Month 0Change of Behaviour adopted by the patient in order to avoid the occurrence of hypoglycemia and worry about low blood sugar
HFS-PYC scoreMonth 0, Month 3 (+/- 30 days)Change in Anxiety related to the phenomenon of hypoglycemia
HFS-Parent scoreMonth 0, Month 3 (+/- 30 days)Change of Behaviour adopted by the parent in order to avoid the occurrence of hypoglycemia

Secondary

MeasureTime frameDescription
Questionnaire Survey "children "Month 0, Month 3 (+/- 30 days)Diabetes impact on relationships, activity, alimentation ... " children"
Questionnaire Survey "parents "Month 0, Month 3 (+/- 30 days)Diabetes impact on relationships, activity, alimentation ... " parents"
HbA1CMonth 0, Month 3 (+/- 30 days)percentage value

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 26, 2026