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

October 5, 2020 updated by: University Hospital, Brest

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

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

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Month 0
HFS-PYC score
Time Frame: Month 0, Month 3 (+/- 30 days)
Change in Anxiety related to the phenomenon of hypoglycemia
Month 0, Month 3 (+/- 30 days)
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
Month 0, Month 3 (+/- 30 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire Survey "children "
Time Frame: Month 0, Month 3 (+/- 30 days)
Diabetes impact on relationships, activity, alimentation ... " children"
Month 0, Month 3 (+/- 30 days)
Questionnaire Survey "parents "
Time Frame: Month 0, Month 3 (+/- 30 days)
Diabetes impact on relationships, activity, alimentation ... " parents"
Month 0, Month 3 (+/- 30 days)
HbA1C
Time Frame: Month 0, Month 3 (+/- 30 days)
percentage value
Month 0, Month 3 (+/- 30 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 3, 2018

Primary Completion (ANTICIPATED)

December 3, 2020

Study Completion (ANTICIPATED)

December 3, 2020

Study Registration Dates

First Submitted

March 13, 2018

First Submitted That Met QC Criteria

May 17, 2018

First Posted (ACTUAL)

May 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 6, 2020

Last Update Submitted That Met QC Criteria

October 5, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FOH (29BRC17.0161)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available after the publication of result and ending three years maximum following the last visit of the last patient

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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