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

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.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06165159
Acronym
CHAM&DIAB
Enrollment
800
Registered
2023-12-11
Start date
2024-01-01
Completion date
2024-09-30
Last updated
2023-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment, Type 1 Diabetes

Keywords

Type 1 diabetes, Children, Adolescents, Parents, Pump, Multiple injections, Closed loop, Burden of treatment, Quality of life

Brief 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.

Detailed 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.

Interventions

OTHERchildren 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.

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
The primary outcome corresponds to the score obtained after completing the study questionnaire. The questionnaire is completed at the participation agreement.1 dayThe 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

Countries

France

Contacts

Primary ContactEmmanuelle LABARRE
Emmanuelle.Labarre@chu-angers.fr+33241354053

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026