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

Not yet recruiting

• Conditions: Treatment; Type 1 Diabetes

• Registration Number: NCT06165159
• Lead Sponsor: University Hospital, Angers

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."

Study Timeline

• Study First Submitted: 2023-11-23
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-08
• Last Update Submitted: 2023-12-08
• Study First Posted: 2023-12-11
• Last Update Posted: 2023-12-11
• Study Start: 2024-01-01
• Primary Completion: 2024-06
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 800

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome corresponds to the score obtained after completing the study questionnaire. The questionnaire is completed at the participation agreement.	1 day	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

Trial Locations

Locations (1)

Emmanuelle LABARRE; 🇫🇷 Angers, France