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Not yet recruitingNCT06165159CHAM&DIABUpdated Dec 11, 2023

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

An observational study in Type 1 Diabetes and Treatment, sponsored by University Hospital, Angers. Not yet recruiting at 1 site in France. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2023-12-11.

Sponsored by University Hospital, Angers · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 4 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
800
Ages
8 Years and older
Sex
All
01

Study 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.

Read the 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."

02

Conditions studied

  • Type 1 Diabetes
  • Treatment

Keywords

  • Type 1 diabetes
  • Children
  • Adolescents
  • Parents
  • Pump
  • Multiple injections
  • Closed loop
  • Burden of treatment
  • Quality of life
03

In context

Diabetes Mellitus, Type 1

3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.

This study's planned enrollment of 800 is above the median of 120 across 748 observational studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years and older
Sexes eligible
All
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.

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

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)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
800 participants (estimated)
Patient registry
No

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."

06

What researchers measure

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

    Time frame: 1 day

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06165159
Lead sponsor
University Hospital, Angers
Responsible party
Sponsor
First posted
Dec 11, 2023
Start date
Jan 1, 2024 (estimated)
Primary completion
Jun 2024 (estimated)
Completion
Sep 2024 (estimated)
Last update
Dec 11, 2023

Study contacts

Emmanuelle LABARRE
Contact
Emmanuelle.Labarre@chu-angers.fr
+33241354053
Emmanuelle LABARRE
principal investigator · Angers University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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