Diabetes Type 1FHSNCT03529188
French Version of the Scales of Fear of Hypoglycaemia in Children With Type 1 Diabetes and Their Parents
An observational study of Diabetes Type 1, run by University Hospital, Brest at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Diabetes Type 1
- How many people
- 194 participants
- Where
- 3 sitesFrance
- Study dates
- 3 Aug 2018to 25 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Child and teenager with Type 1 diabetes defined by an hyperglycemia higher than 2g/l, polyuria, polydipsia and positive antibody.
Who may be able to join
- 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
Who cannot join
- Trouble to read
- Trouble to understand
- Trouble to answer to the questionnaire
- Opposition.
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHRU de Brest
Brest, 29609
Centre Hospitalier de Bretagne Sud
Lorient, 56322
Hôpital Universitaire Robert-Debré
Paris, 75 935
About this study
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
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
- Conditions
- Diabetes Type 1
- Keywords
- Diabetes type 1, Child ans teenager, Fear of Hypoglycaemia
- Medical subject headings
- Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
HFS-Child score,
Change of Behaviour adopted by the patient in order to avoid the occurrence of hypoglycemia and worry about low blood sugar
Measured: Month 0
HFS-PYC score
Change in Anxiety related to the phenomenon of hypoglycemia
Measured: Month 0, Month 3 (+/- 30 days)
HFS-Parent score
Change of Behaviour adopted by the parent in order to avoid the occurrence of hypoglycemia
Measured: Month 0, Month 3 (+/- 30 days)
Secondary outcomes (3)
Questionnaire Survey "children "
Diabetes impact on relationships, activity, alimentation ... " children"
Measured: Month 0, Month 3 (+/- 30 days)
Questionnaire Survey "parents "
Diabetes impact on relationships, activity, alimentation ... " parents"
Measured: Month 0, Month 3 (+/- 30 days)
HbA1C
percentage value
Measured: Month 0, Month 3 (+/- 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start3 Aug 2018
- Primary completion25 Dec 2020
- Study completion25 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 1Studies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529188
- Sponsor's protocol ID
- FOH (29BRC17.0161)
- Acronym
- FHS
- Status last verified
- Jun 2026
- First submitted
- 13 Mar 2018
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03529188
- Acronym / sponsor ID
- FHS / FOH (29BRC17.0161)
- Conditions
- Diabetes Type 1
- Keywords
- Diabetes type 1, Child ans teenager, Fear of Hypoglycaemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 3 Aug 2018 (actual)
- Primary completion
- 25 Dec 2020 (actual)
- Study completion
- 25 Dec 2020 (actual)
- First posted
- 18 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Child and teenager with Type 1 diabetes defined by an hyperglycemia higher than 2g/l, polyuria, polydipsia and positive antibody.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Trouble to read
- Trouble to understand
- Trouble to answer to the questionnaire
- Opposition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
HFS-PYC score
Time frame: Month 0, Month 3 (+/- 30 days)
Change in Anxiety related to the phenomenon of hypoglycemia
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
3 secondary outcomes
Questionnaire Survey "children "
Time frame: Month 0, Month 3 (+/- 30 days)
Questionnaire Survey "parents "
Time frame: Month 0, Month 3 (+/- 30 days)
HbA1C
Time frame: Month 0, Month 3 (+/- 30 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Type 1, run by University Hospital, Brest at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HFS-Child score, (time frame: Month 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.