Comparison of Insulin's Injection Before or After the Meal in Type 1 Diabetic Patients Treated With Insulin Pump
NCT02546401
Autoimmune Diseases, Diabetes Mellitus
Brest, France
View Trial DetailsNCT Number: NCT03529188
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
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Notify Me2 year–18 year
All sexes
Observational
CHRU de Brest, Brest, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Month 0, Month 3 (+/- 30 days)
Change in Anxiety related to the phenomenon of hypoglycemia
Time frame: Month 0, Month 3 (+/- 30 days)
Change of Behaviour adopted by the parent in order to avoid the occurrence of hypoglycemia
Time frame: Month 0, Month 3 (+/- 30 days)
Diabetes impact on relationships, activity, alimentation ... " children"
Time frame: Month 0, Month 3 (+/- 30 days)
Diabetes impact on relationships, activity, alimentation ... " parents"
Time frame: Month 0, Month 3 (+/- 30 days)
percentage value
University Hospital, Brest
Other
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
Acronym: FHS
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