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

NCT ID: NCT03529188

Last Updated: 2020-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-03

Study Completion Date

2020-12-03

Brief Summary

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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

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Conditions

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Diabetes Type 1

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHRU de Brest

Brest, , France

Site Status RECRUITING

Centre Hospitalier de Bretagne Sud

Lorient, , France

Site Status RECRUITING

Hôpital Universitaire Robert-Debré

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Chantal METZ

Role: CONTACT

02 29 02 00 04

Chantal METZ

Role: CONTACT

Facility Contacts

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Chantal METZ

Role: primary

Raphaël TEISSIER

Role: primary

Elise BISMUTH-REISMAN

Role: primary

Other Identifiers

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FOH (29BRC17.0161)

Identifier Type: -

Identifier Source: org_study_id

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