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

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ClinicalTrials.gov Identifier: NCT03529188
Recruitment Status : Recruiting
First Posted : May 18, 2018
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
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


Condition or disease
Diabetes Type 1

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Study Type : Observational
Estimated Enrollment : 210 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : August 3, 2018
Estimated Primary Completion Date : September 9, 2020
Estimated Study Completion Date : September 9, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   male or female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Child and teenager with Type 1 diabetes defined by an hyperglycemia higher than 2g/l, polyuria, polydipsia and positive antibody.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529188


Contacts
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Contact: Chantal METZ 02 29 02 00 04 chantal.metz@chu-brest.fr
Contact: Chantal METZ chantal.metz@chu-brest.fr

Locations
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France
CHRU de Brest Recruiting
Brest, France, 29609
Contact: Chantal METZ       chantal.metz@chu-brest.fr   
Centre Hospitalier de Bretagne Sud Recruiting
Lorient, France, 56322
Contact: Raphaël TEISSIER       r.teissier@ch-bretagne-sud.fr   
Hôpital Universitaire Robert-Debré Recruiting
Paris cedex 19, France, 75 935
Contact: Elise BISMUTH-REISMAN       elise.bismuth@gmail.com   
Sponsors and Collaborators
University Hospital, Brest
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03529188    
Other Study ID Numbers: FOH (29BRC17.0161)
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected data that underlie results in a publication
Supporting Materials: Study Protocol
Time Frame: Data will be available after the publication of result and ending three years maximum following the last visit of the last patient
Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. requestors will be required to sign and complete a data access agreement

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Brest:
Diabetes type 1
Child ans teenager
Fear of Hypoglycaemia
Additional relevant MeSH terms:
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Hypoglycemia
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases