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

December 8, 2023 updated by: University Hospital, Angers

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary outcome corresponds to the score obtained after completing the study questionnaire. The questionnaire is completed at the participation agreement.
Time Frame: 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
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: Emmanuelle LABARRE, Angers University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

November 23, 2023

First Submitted That Met QC Criteria

December 8, 2023

First Posted (Estimated)

December 11, 2023

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 8, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 49RC23_0257

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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