Diabetes Mellitus, Type 1PRECADIABNCT04530292
Home Intervention and Social Precariousness in Childhood Diabetes
A study testing Intervention by a pediatric nurse at the child's home in people with Diabetes Mellitus, Type 1, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
A pilot study of children whose families are in a precarious situation, who will benefit from a targeted at-home intervention by a pediatric nurse. Visits will be organized during the first, fourth and sixth months after the discovery of diabetes. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Intervention by a pediatric nurse at the child's home
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- 28 Sep 2020to 15 Jun 2022
- Phase
- Interventional
- 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 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- For the prospective group (strategy under study):
- Absence of the therapeutic education nurse during the child's hospitalization
- Child and/or family who do not speak French
- Family benefiting from the PASS
- Intention of leaving the Gironde department in the first six months of the study
- T1D with associated chronic pathological conditions other than hypothyroidism and celiac disease
Show all 10Show fewer
- For the retrospective group (classic strategy):
- Child and/or family who do not speak French
- Family benefiting from the PASS
- T1D with associated chronic pathological conditions other than hypothyroidism and celiac disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Impact of a Home-based Intervention by a Pediatric Nurse to Prevent Diabetes Imbalance Within One Year of Its Discovery in Children Whose Parents Are in a Precarious Social Situation (PRECADIAB)
A pilot study of children whose families are in a precarious situation, who will benefit from a targeted at-home intervention by a pediatric nurse. Visits will be organized during the first, fourth and sixth months after the discovery of diabetes. The HbA1C measured 12 months after the diabetes diagnosis will be compared to the HbA1C obtained in an historical cohort that did not receive at-home therapeutic education.
Read the detailed description
The EPICES score is an individual indicator of precariousness associated with indicators of access to health care and indicators of health. For this score, 30 is considered as the precariousness threshold. It is collected during the follow-up of our cohort of diabetic children and the data is obtained from the parent accompanying the child.
In 2016, we found in this cohort that a context of precariousness was associated with a very poor result of glycated hemoglobin (HbA1C) (Lamaraud J et al., 2017). The imbalance of diabetes was detectable as early as one year after diagnosis and persisted despite additional educational interventions. Therapeutic education allows families in precarious situations to acquire, during the initial hospitalization, knowledge that meets the security objectives and is adapted to the care of their child. However, we have noticed that it can be difficult for some families to apply this knowledge when they are back in their home.
Thus, we are planning to set up a coordinated intervention by a pediatric nurse at the child's home to support the parents in the implementation of the theoretical knowledge acquired at the hospital.
Three home visits will be set up by a nurse during the first six months of the discovery of diabetes in the child. These visits will be organized during the first, fourth and sixth months after the discovery of diabetes and last about 2 hours each time. An additional visit may be set up according to the needs of families. The HbA1C measured 12 months after the diabetes diagnosis will be compared to the HbA1C obtained in an historical cohort that did not receive at-home therapeutic education.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Intervention by a pediatric nurse at the child's home
- Keywords
- Pediatric type-1 diabetes, Therapeutic education, Social precariousness
- 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.
Intervention by a pediatric nurse at the child's homeBehavioural
Also called strategy under study ( for prospective group)
The intervention will consist of a coordinated intervention by a pediatric nurse at the child's home to support the parents in the implementation of the theoretical knowledge acquired at the hospital.
Three home visits will be set up by a nurse during the first six months of the discovery of diabetes in the child. These visits will be organized during the first, fourth and sixth months after the discovery of diabetes and last about 2 hours each time. An additional visit may be set up according to the needs of families.
| Study group | Role | What they receive |
|---|---|---|
| intervention by a pediatric nurse at the child's home | Experimental | The pediatric nurse will visit the patient's home 3 times during the first six months of the discovery of diabetes in children. These visits will be organized during the first, fourth and sixth months after the discovery of diabetes and last about 2 hours each time. An additional visit can be organized according to the needs of families.
The pediatric nurse will ensure the implementation of learning in terms of drug therapy (modality of insulin administration, adaptation of insulin doses) and diet, according to the knowledge acquired during the initial hospitalization. She will offer her help to the families to make a connection with the school and after-school activities of the child.
In addition to these visits, the child and his family will come to the hospital as part of the regular medical follow-up: consultations with the pediatric diabetologist at the 3rd and 6th month and at 1 year of the discovery of diabetes. Receives: Behavioral: Intervention by a pediatric nurse at the child's home |
| Classic strategy (for retrospective group) | No intervention | The child and his family benefited from a consultation with a pediatric nurse at 1 month of the discovery of T1D and had medical consultations with the pediatric diabetologist at the 3rd and 6th month and at 1 year of the discovery of diabetes. The data from this group were collected in a previous study (collection of retrospective data) for children whose parents were in a precarious social situation and whose management was traditional. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of HbA1c (%) one year after the discovery of diabetes.
The Glycated hemoglobin (HbA1C) measured 12 months after the diabetes diagnosis
Measured: 12 months after the diabetes diagnosis
Secondary outcomes (7)
Number of visits actually carried out in the interventional arm
3 visits are planned but an additional visit may be set up according to the needs of families.
It is also possible that some visits cannot take place. The number of visits actually made will therefore be recorded.
Measured: 12 months after the diabetes diagnosis
Evaluation of the satisfaction with the intervention of the children and parents
Evaluation of the satisfaction with the intervention of the children and parents, measured with a standard visual analogue scale at the end of the intervention of the pediatric nurse
Measured: 12 months after the diabetes diagnosis
Evaluation of the satisfaction with the intervention of the pediatric endocrinology department's caregivers
Evaluation of the satisfaction of the pediatric endocrinology department's caregivers (pediatric diabetologists, nurses, dieticians) with the intervention, measured with a standard visual analogue scale at the end of the intervention of the pediatric nurse
Measured: 12 months after the diabetes diagnosis
Evaluation of the satisfaction with the intervention of the external partners
Evaluation of the satisfaction of the external partners (doctor or pediatrician, providers) with the intervention, measured with a standard visual analogue scale at the end of the intervention of the pediatric nurse
Measured: 12 months after the diabetes diagnosis
Unscheduled hospital visits in the context of T1D
Number of emergency visits and hospitalizations
Measured: Through study completion, 12 months after the diabetes diagnosis
Percentage of time spent in the target for patients with Freestyle sensor
Percentage of time spent in the target (subcutaneous glucose measurement between 70 and 180 mg/dl) during the last month of the study for patients with Freestyle sensor
Measured: during the last month of the study, between 11 and 12 months after the diabetes diagnostic
Percentage of time spent wearing the sensor for patients with Freestyle sensor
Percentage of time spent wearing the sensor during the last month of the study for patients with Freestyle sensor
Measured: during the last month of the study, between 11 and 12 months after the diabetes diagnostic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start28 Sep 2020
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magali GIMENEZ, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04530292
- Sponsor's protocol ID
- CHUBX 2018/56
- Acronym
- PRECADIAB
- Status last verified
- Feb 2024
- First submitted
- 24 Aug 2020
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of a Home-based Intervention by a Pediatric Nurse to Prevent Diabetes Imbalance Within One Year of Its Discovery in Children Whose Parents Are in a Precarious Social Situation (PRECADIAB)
- ClinicalTrials.gov ID
- NCT04530292
- Acronym / sponsor ID
- PRECADIAB / CHUBX 2018/56
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Pediatric type-1 diabetes, Therapeutic education, Social precariousness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 28 Aug 2020 (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.
A pilot study of children whose families are in a precarious situation, who will benefit from a targeted at-home intervention by a pediatric nurse. Visits will be organized during the first, fourth and sixth months after the discovery of diabetes. The HbA1C measured 12 months after the diabetes diagnosis will be compared to the HbA1C obtained in an historical cohort that did not receive at-home therapeutic education.
Detailed description
The EPICES score is an individual indicator of precariousness associated with indicators of access to health care and indicators of health. For this score, 30 is considered as the precariousness threshold. It is collected during the follow-up of our cohort of diabetic children and the data is obtained from the parent accompanying the child.
In 2016, we found in this cohort that a context of precariousness was associated with a very poor result of glycated hemoglobin (HbA1C) (Lamaraud J et al., 2017). The imbalance of diabetes was detectable as early as one year after diagnosis and persisted despite additional educational interventions. Therapeutic education allows families in precarious situations to acquire, during the initial hospitalization, knowledge that meets the security objectives and is adapted to the care of their child. However, we have noticed that it can be difficult for some families to apply this knowledge when they are back in their home.
Thus, we are planning to set up a coordinated intervention by a pediatric nurse at the child's home to support the parents in the implementation of the theoretical knowledge acquired at the hospital.
Three home visits will be set up by a nurse during the first six months of the discovery of diabetes in the child. These visits will be organized during the first, fourth and sixth months after the discovery of diabetes and last about 2 hours each time. An additional visit may be set up according to the needs of families. The HbA1C measured 12 months after the diabetes diagnosis will be compared to the HbA1C obtained in an historical cohort that did not receive at-home therapeutic education.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention by a pediatric nurse at the child's home | Experimental | Behavioral: Intervention by a pediatric nurse at the child's homeThe pediatric nurse will visit the patient's home 3 times during the first six months of the discovery of diabetes in children. These visits will be organized during the first, fourth and sixth months after the discovery of diabetes and last about 2 hours each time. An additional visit can be organized according to the needs of families. The pediatric nurse will ensure the implementation of learning in terms of drug therapy (modality of insulin administration, adaptation of insulin doses) and diet, according to the knowledge acquired during the initial hospitalization. She will offer her help to the families to make a connection with the school and after-school activities of the child. In addition to these visits, the child and his family will come to the hospital as part of the regular medical follow-up: consultations with the pediatric diabetologist at the 3rd and 6th month and at 1 year of the discovery of diabetes. |
| Classic strategy (for retrospective group) | No intervention | –The child and his family benefited from a consultation with a pediatric nurse at 1 month of the discovery of T1D and had medical consultations with the pediatric diabetologist at the 3rd and 6th month and at 1 year of the discovery of diabetes. The data from this group were collected in a previous study (collection of retrospective data) for children whose parents were in a precarious social situation and whose management was traditional. |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Absence of the therapeutic education nurse during the child's hospitalization
- Child and/or family who do not speak French
- Family benefiting from the PASS
- Intention of leaving the Gironde department in the first six months of the study
- T1D with associated chronic pathological conditions other than hypothyroidism and celiac disease
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 |
|---|---|---|
| Intervention by a pediatric nurse at the child's homeAlso: strategy under study ( for prospective group)The intervention will consist of a coordinated intervention by a pediatric nurse at the child's home to support the parents in the implementation of the theoretical knowledge acquired at the hospital. Three home visits will be set up by a nurse during the first six months of the discovery of diabetes in the child. These visits will be organized during the first, fourth and sixth months after the discovery of diabetes and last about 2 hours each time. An additional visit may be set up according to the needs of families. | Behavioural | intervention by a pediatric nurse at the child's home |
Primary outcome
Measurement of HbA1c (%) one year after the discovery of diabetes.
Time frame: 12 months after the diabetes diagnosis
The Glycated hemoglobin (HbA1C) measured 12 months after the diabetes diagnosis
7 secondary outcomes
Number of visits actually carried out in the interventional arm
Time frame: 12 months after the diabetes diagnosis
Evaluation of the satisfaction with the intervention of the children and parents
Time frame: 12 months after the diabetes diagnosis
Evaluation of the satisfaction with the intervention of the pediatric endocrinology department's caregivers
Time frame: 12 months after the diabetes diagnosis
Evaluation of the satisfaction with the intervention of the external partners
Time frame: 12 months after the diabetes diagnosis
Unscheduled hospital visits in the context of T1D
Time frame: Through study completion, 12 months after the diabetes diagnosis
Percentage of time spent in the target for patients with Freestyle sensor
Time frame: during the last month of the study, between 11 and 12 months after the diabetes diagnostic
Percentage of time spent wearing the sensor for patients with Freestyle sensor
Time frame: during the last month of the study, between 11 and 12 months after the diabetes diagnostic
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 20 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Magali GIMENEZ principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention by a pediatric nurse at the child's home in people with Diabetes Mellitus, Type 1, run by University Hospital, Bordeaux 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 0 inclusion and 10 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 20 Feb 2024. 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?
Measurement of HbA1c (%) one year after the discovery of diabetes. (time frame: 12 months after the diabetes diagnosis). 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 20 Feb 2024.