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

Diabetes Type 1 Clinical Trial

— FHS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03529188
• Other study ID #: FOH (29BRC17.0161)
• Status: Recruiting
• Start date: August 3, 2018
• Est. completion date: December 3, 2020

Study information

• Verified date: October 2020
• Source: University Hospital, Brest
• Contact: Chantal METZ
• Phone: 02 29 02 00 04
• Email: chantal.metz[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: December 3, 2020
• Est. primary completion date: December 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Diabetes Type 1
• Hypoglycemia

Locations

Country	Name	City	State
France	CHRU de Brest	Brest
France	Centre Hospitalier de Bretagne Sud	Lorient
France	Hôpital Universitaire Robert-Debré	Paris cedex 19

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HFS-Child score,	Change of Behaviour adopted by the patient in order to avoid the occurrence of hypoglycemia and worry about low blood sugar	Month 0
Primary	HFS-PYC score	Change in Anxiety related to the phenomenon of hypoglycemia	Month 0, Month 3 (+/- 30 days)
Primary	HFS-Parent score	Change of Behaviour adopted by the parent in order to avoid the occurrence of hypoglycemia	Month 0, Month 3 (+/- 30 days)
Secondary	Questionnaire Survey "children "	Diabetes impact on relationships, activity, alimentation ... " children"	Month 0, Month 3 (+/- 30 days)
Secondary	Questionnaire Survey "parents "	Diabetes impact on relationships, activity, alimentation ... " parents"	Month 0, Month 3 (+/- 30 days)
Secondary	HbA1C	percentage value	Month 0, Month 3 (+/- 30 days)