Type 1 DiabetesCHAM&DIABNCT06165159
Influence of Type 1 Diabetes (T1DM) Treatment Type on Mental Workload
An observational study of Type 1 Diabetes and Treatment, run by University Hospital, Angers at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Type 1 Diabetes, Treatment
- What is being tested?
- children and adolescents with type 1 diabetes and their parents
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2024to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
France1 site
Emmanuelle LABARRE
Angers, 49000
Emmanuelle LABARRE, +33241354053, Emmanuelle.Labarre@chu-angers.fr
About this study
Official title: 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.
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."
- Conditions
- Type 1 Diabetes, Treatment
- Being tested
- children and adolescents with type 1 diabetes and their parents
- Keywords
- Type 1 diabetes, Children, Adolescents, Parents, Pump, Multiple injections, Closed loop, Burden of treatment, Quality of life
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
children and adolescents with type 1 diabetes and their parentsOther
"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."
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start1 Jan 2024 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Emmanuelle LABARRE, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165159
- Sponsor's protocol ID
- 49RC23_0257
- Acronym
- CHAM&DIAB
- Status last verified
- Dec 2023
- First submitted
- 23 Nov 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06165159
- Acronym / sponsor ID
- CHAM&DIAB / 49RC23_0257
- Conditions
- Type 1 Diabetes, Treatment
- Keywords
- Type 1 diabetes, Children, Adolescents, Parents, Pump, Multiple injections, Closed loop, Burden of treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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." | Other | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuelle LABARRE principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes and Treatment, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emmanuelle LABARRE (+33241354053, Emmanuelle.Labarre@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.