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Completed

NCT Number: NCT03529188

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

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

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Key information

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Brest, Brest, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. HFS-Child score,

    Time frame: Month 0

    Change of Behaviour adopted by the patient in order to avoid the occurrence of hypoglycemia and worry about low blood sugar

  2. HFS-PYC score

    Time frame: Month 0, Month 3 (+/- 30 days)

    Change in Anxiety related to the phenomenon of hypoglycemia

  3. HFS-Parent score

    Time frame: Month 0, Month 3 (+/- 30 days)

    Change of Behaviour adopted by the parent in order to avoid the occurrence of hypoglycemia

Secondary outcomes

  1. Questionnaire Survey "children "

    Time frame: Month 0, Month 3 (+/- 30 days)

    Diabetes impact on relationships, activity, alimentation ... " children"

  2. Questionnaire Survey "parents "

    Time frame: Month 0, Month 3 (+/- 30 days)

    Diabetes impact on relationships, activity, alimentation ... " parents"

  3. HbA1C

    Time frame: Month 0, Month 3 (+/- 30 days)

    percentage value

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study 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

Acronym: FHS

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 18, 2018
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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