Influence of Type 1 Diabetes (T1DM) Treatment Type on Mental Workload

Type 1 Diabetes Clinical Trial

— CHAM&DIAB  

Official title:

Influence du Type de Traitement du diabète de Type 1 (DT1) Sur la Charge Mentale Des Adolescents Avec un DT1 et Des Parents Ayant un Enfant Avec DT1.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06165159
• Other study ID #: 49RC23_0257
• Status: Not yet recruiting
• Start date: January 1, 2024
• Est. completion date: September 2024

Study information

• Verified date: December 2023
• Source: University Hospital, Angers
• Contact: Emmanuelle LABARRE
• Phone: +33241354053
• Email: Emmanuelle.Labarre[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Influence of the type of treatment for type 1 diabetes (pump versus multiple injections versus closed loop) on the treatment burden of children and adolescents and their parents.

Description:

"The guidelines for the treatment of children and adolescents with type 1 diabetes emphasise an individualised approach to the child and provide target values (time in range, glycaemia and coefficient of variation). These recommendations aim to prevent long-term complications. It is rarely possible to achieve and maintain this level of control over the long term. Achieving these recommendations requires a great deal of investment from children and their families, which can significantly increase their psychological workload and reduce their quality of life. The main aim of this study was to assess burden of treatment according to the treatment type (pump versus multiple injections versus closed loop) on a large scale."

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 800
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

Inclusion Criteria:

• Children over the age of 8 whose type 1 diabetes has been diagnosed for at least 6 months
• Parents or people involved in the day-to-day life of children with type 1 diabetes who have been diagnosed for at least 6 months

Exclusion Criteria:

• Parents not involved in managing their child's type 1 diabetes (child in care)
• Have already completed the questionnaire (one questionnaire completed per child and their parents or family caregivers)

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Treatment
• Type 1 Diabetes

Intervention

Other:
• children and adolescents with type 1 diabetes and their parents
"Children over the age of 8 with type 1 diabetes diagnosed more than 6 months ago in France, followed in one of the hospitals that are members of the Aide aux Jeunes Diabétiques (AJD) association. Parents or people involved in the day-to-day life of children with type 1 diabetes diagnosed at least 6 months ago, whose child is being followed in France in one of the hospitals affiliated to the AJD association."

Locations

Country	Name	City	State
France	Emmanuelle LABARRE	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome corresponds to the score obtained after completing the study questionnaire. The questionnaire is completed at the participation agreement.	The primary outcome is the treatment burden according to the treatment modality (semi-closed loop versus insulin pump versus multi-injection) assessed using a specific questionnaire	1 day