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

NCT ID: NCT06165159

Last Updated: 2023-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-09-30

Brief Summary

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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

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"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."

Conditions

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Type 1 Diabetes Treatment

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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."

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emmanuelle LABARRE

Role: PRINCIPAL_INVESTIGATOR

Angers University Hospital

Locations

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Emmanuelle LABARRE

Angers, , France

Site Status

Countries

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France

Central Contacts

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Emmanuelle LABARRE

Role: CONTACT

Phone: +33241354053

Email: [email protected]

Facility Contacts

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Emmanuelle LABARRE

Role: primary

Other Identifiers

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49RC23_0257

Identifier Type: -

Identifier Source: org_study_id