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

NCT06165159 | Unknown

• 1 other identifier: 49RC23_0257
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes; Treatment

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

children and adolescents with type 1 diabetes and their parents OTHER

"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."

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from the national network of the Association d'Aide aux Jeunes Diabetiques (AJD). The AJD federates local patient associations, which are regularly asked to distribute questionnaires to their members.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Emmanuelle LABARRE

Angers, 49000, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Emmanuelle LABARRE

  Angers University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmanuelle LABARRE

CONTACT

+33241354053; Emmanuelle.Labarre@chu-angers.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 11, 2023
• Study Start: January 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: December 11, 2023

Record last verified: 2023-12

Locations

FR (1)