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

• Conditions: Diabetes Type 1

• Registration Number: NCT03529188
• Lead Sponsor: University Hospital, Brest

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-13
• Study First Submitted QC: 2018-05-17
• Study First Posted: 2018-05-18
• Study Start: 2018-08-03
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-05
• Last Update Posted: 2020-10-06
• Primary Completion: 2020-12-03
• Study Completion: 2020-12-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Questionnaire Survey "parents "	Month 0, Month 3 (+/- 30 days)	Diabetes impact on relationships, activity, alimentation ... " parents"
Questionnaire Survey "children "	Month 0, Month 3 (+/- 30 days)	Diabetes impact on relationships, activity, alimentation ... " children"
HbA1C	Month 0, Month 3 (+/- 30 days)	percentage value

Trial Locations

Locations (3)

Centre Hospitalier de Bretagne Sud; 🇫🇷 Lorient, France

CHRU de Brest; 🇫🇷 Brest, France

Hôpital Universitaire Robert-Debré; 🇫🇷 Paris cedex 19, France