Type 1 Diabetes MellitusDIABECONCT03980353
Difficulties and Obstacles to the Integration in Community of Children With Type 1 Diabetes Before Primary School.
An observational study of Type 1 Diabetes Mellitus, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The incidence of type 1 diabetes is increasing worldwide and in France, including among young children. Type 1 diabetes has consequences for integration in community, especially on the management of hypoglycemia and hyperglycemia, mealtimes, participation in sporting activities and school trips. Read more about this study
- Who is it for?
- Ages 12 months to 8 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Questionnaires
- How many people
- 146 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2019to 1 Nov 2019
- 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 12 months to 8 years
- All sexes
- No healthy volunteers
- Child
Study population: Children 1 year to 8 years old with Type 1 diabetes followed by the Diabetology Department of Lyon Pediatric Hospital.
Who may be able to join
- Children:
- Type 1 Diabetes
- Followed in the diabetology department of Lyon pediatric hospital
- Who are too young to go to primary school in 2018-2019
- Residing in the Rhône-Alpes region of France
- No parental opposition to the completion of the questionnaire (reflection period of 15 days after receipt the leaflet information)
Show all 9Show fewer
- For school directors, school doctors, pediatricians, child and maternal protection center doctors
- Questionnaire responses will be considered as evidence of no opposition.
- Directors of nurseries and childminders who will agree to answer the telephone questionnaire after parents allow the study team to contact them
Who cannot join
- Children:
- Child requiring another facilities for school (food allergies, celiac disease…)
- Language barrier not permitting a response to the questionnaires
- For childminders and nursery directors
- refusal of parents to contact them
- refusal to participate declared during the telephone interview
- For school directors, doctors and school doctors
- No prior involvement in the reception in community of a type 1 diabetes child
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'endocrinologie pédiatrique Hôpital Femme mère enfant
Bron, 69500
About this study
Official title: Evaluation of Difficulties and Obstacles to the Integration in Community of Children With Type 1 Diabetes Before Primary School, Followed by the Diabetology Department of Lyon Pediatric Hospital.
The incidence of type 1 diabetes is increasing worldwide and in France, including among young children.
Type 1 diabetes has consequences for integration in community, especially on the management of hypoglycemia and hyperglycemia, mealtimes, participation in sporting activities and school trips.
Read more
This works' purpose is to describe obstacles and difficulties to the integration in community before primary school (day care center, childminder, and nursery school) of a complete sample of children with type 1 diabetes followed in the Diabetology Department of Lyon Pediatric Hospital, at the start of the school year 2018-2019. The investigating team will carry out a descriptive study, using different questionnaires addressed to the professionals (nursery school directors, day care nursery directors, childminders, school doctors, pediatricians and doctors of child and maternal protection centers) and to the parents of children with type 1 diabetes. These different questionnaires will help to take into account different points of view, in order to identify all the obstacles to integration of children with type 1 diabetes in community.
Through this work, secondary information actions through training and/or information leaflets will be carried out in order to facilitate the reception of these children in the community.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Questionnaires
- 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.
QuestionnairesOther
The questionnaires have two parts: a general part and a second part focused on the integration in community of the type 1 diabetes children with specific questions about blood glucose, mealtimes, sporting activities and school trips.
| Study group | Role | What they receive |
|---|---|---|
| Children before entrance in primary school | Children with type 1 diabetes, who are too young to go to primary school at the start of the school year 2018-2019, followed in the Diabetology Department of Lyon Pediatric Hospital. Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of community integration obstacles for children with type 1 diabetes
Participants will respond to a multi-question interview by telephone or a paper questionnaire. The questions will focus on the child's lifestyle (such as meal times, activities, blood glucose levels...) in order to identify integration obstacles
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start1 Aug 2019
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie BENDELAC, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980353
- Sponsor's protocol ID
- 69HCL19_0218
- Other IDs
- 2019-A01571-56
- Acronym
- DIABECO
- Status last verified
- Feb 2020
- First submitted
- 6 Jun 2019
- Last updated
- 13 Feb 2020
- 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 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Difficulties and Obstacles to the Integration in Community of Children With Type 1 Diabetes Before Primary School, Followed by the Diabetology Department of Lyon Pediatric Hospital.
- ClinicalTrials.gov ID
- NCT03980353
- Acronym / sponsor ID
- DIABECO / 69HCL19_0218
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 10 Jun 2019 (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.
The incidence of type 1 diabetes is increasing worldwide and in France, including among young children.
Type 1 diabetes has consequences for integration in community, especially on the management of hypoglycemia and hyperglycemia, mealtimes, participation in sporting activities and school trips.
This works' purpose is to describe obstacles and difficulties to the integration in community before primary school (day care center, childminder, and nursery school) of a complete sample of children with type 1 diabetes followed in the Diabetology Department of Lyon Pediatric Hospital, at the start of the school year 2018-2019. The investigating team will carry out a descriptive study, using different questionnaires addressed to the professionals (nursery school directors, day care nursery directors, childminders, school doctors, pediatricians and doctors of child and maternal protection centers) and to the parents of children with type 1 diabetes. These different questionnaires will help to take into account different points of view, in order to identify all the obstacles to integration of children with type 1 diabetes in community.
Through this work, secondary information actions through training and/or information leaflets will be carried out in order to facilitate the reception of these children in the community.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children before entrance in primary school | – | Other: QuestionnairesChildren with type 1 diabetes, who are too young to go to primary school at the start of the school year 2018-2019, followed in the Diabetology Department of Lyon Pediatric Hospital. |
Who may qualify
- Ages
- 12 months to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children 1 year to 8 years old with Type 1 diabetes followed by the Diabetology Department of Lyon Pediatric Hospital.
Key inclusion criteria (9 listed)
- Type 1 Diabetes
- Followed in the diabetology department of Lyon pediatric hospital
- Who are too young to go to primary school in 2018-2019
- Residing in the Rhône-Alpes region of France
- No parental opposition to the completion of the questionnaire (reflection period of 15 days after receipt the leaflet information)
Key exclusion criteria (8 listed)
- Child requiring another facilities for school (food allergies, celiac disease…)
- Language barrier not permitting a response to the questionnaires
- For childminders and nursery directors
- refusal of parents to contact them
- refusal to participate declared during the telephone interview
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 |
|---|---|---|
| QuestionnairesThe questionnaires have two parts: a general part and a second part focused on the integration in community of the type 1 diabetes children with specific questions about blood glucose, mealtimes, sporting activities and school trips. | Other | Children before entrance in primary school |
Primary outcome
Identification of community integration obstacles for children with type 1 diabetes
Time frame: 15 minutes
Participants will respond to a multi-question interview by telephone or a paper questionnaire. The questions will focus on the child's lifestyle (such as meal times, activities, blood glucose levels...) in order to identify integration obstacles
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
Related trials for Type 1 Diabetes Mellitus
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
Nathalie BENDELAC, MD principal investigator
Hospices Civils de Lyon
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 Mellitus, run by Hospices Civils de Lyon 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 9 inclusion and 8 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: finished, as of the sponsor's last update on 13 Feb 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of community integration obstacles for children with type 1 diabetes (time frame: 15 minutes). 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 13 Feb 2020.