Cutaneous AllergyNCT05932953
Skin Tolerance of Medical Devices for Diabetes Monitoring and Treatment in Children With Type 1 Diabetes
An observational study of Cutaneous Allergy and Diabetes Mellitus, Type 1, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
In view of the emergence over the last few years of adverse skin reactions caused by diabetes monitoring and treatment devices, which have become essential to the optimal management of these patients, it is necessary to determine the real prevalence of these side effects. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cutaneous Allergy, Diabetes Mellitus, Type 1, Atopic Disorders
- What is being tested?
- questionary
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 15 May 2022to 1 Nov 2023
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children aged 0 to 18 years, type 1 diabetics, followed at the CHRU of Nancy and wearing a blood glucose sensor and/or an insulin pump.
Who may be able to join
- -Children under 18 years of age
- Diabetic (type 1) for more than one month at the time of data collection and questionnaire completion
- Wearing an insulin pump and/or a blood glucose sensor.
Who cannot join
- - Parental refusal to participate in the study.
- Other types of diabetes than type 1 (type 2 diabetes, MODY...)
- Diabetes diagnosed less than one month before data collection and questionnaire completion
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU Nancy
Nancy, 54500
Emeline RENARD, PhD, +3383155311, e.renard@chru-nancy.fr
About this study
Official title: Skin Tolerance of Medical Devices for Diabetes Monitoring and Treatment in Children With Type 1 Diabetes, an Observational, Retrospective, Single-center Study.
In view of the emergence over the last few years of adverse skin reactions caused by diabetes monitoring and treatment devices, which have become essential to the optimal management of these patients, it is necessary to determine the real prevalence of these side effects.
Here the investigators performed a prospective study about prevalence of skin reactions in a group of children with type 1 diabetes.
Read the detailed description
Justification :
- The incidence of type 1 diabetes in children is increasing every year.
- The use of blood glucose sensors has a positive impact on blood glucose control by limiting glucose variability, reducing hypoglycemia and improving long-term blood glucose control.
- The first cases of allergic contact dermatitis secondary linked to the use of an insulin pump were identified in 1995.
- Several recent studies report a high prevalence of allergic contact dermatitis caused to blood glucose sensors, but these studies are conducted on small samples and in most cases these samples include both adults and children.
- The actual prevalence of children with adverse skin reactions secondary to their diabetes monitoring and treatment devices is probably underestimated
- IBOA was the first responsible allergen identified in 2016. It is the most common allergen responsible for these allergic contact dermatitis3, but other allergens have also been identified recently.
- It is difficult to say how many diabetic patients have ever developed a contact allergy to IBOA, or other acrylates, in their skin devices. Typically, the reaction does not appear until after prolonged use, usually after several months.
- Very few studies have looked at the impact on children's quality of life. In view of the emergence over the last few years of adverse skin reactions caused by diabetes monitoring and treatment devices, which have become essential to the optimal management of these patients, it is necessary to determine the real prevalence of these side effects. The research of risk factors associated with the appearance of these lesions, as well as the impact on patient's quality of life is essential, so as to be able to prevent them and treat them if necessary.
General outline of the study:
Epidemiological, observational, cross-sectional, retrospective study carried out on a sample of the target population after collecting data both on questionnaires and in the patients' medical files. The questionnaires and the data sought in the patients' files will be collected over a period of 1 year, after obtaining the parents' non objection. The questionnaires will be distributed by the medical and paramedical team of the pediatric diabetes service of the Nancy CHRU. They will be hand-delivered to the physician leading the quarterly follow-up visit of the child's. No additional consultation will be undertaken.
- Being tested
- questionary
- Keywords
- diabetes mellitus, type 1, cutaneous allergy, atopic disorders
- 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.
questionaryOther
questionary about cutaneous tolerance
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of children,with current skin intolerance (eczema symptoms measured by questionnaire) to an insulin pump and/or blood glucose sensor assessed by an autoquestionnary.
Prevalence of of children, under 18 years of age, with type 1 diabetes with current skin intolerance to an insulin pump and/or blood glucose sensor. Pruritus, erythema, scaling, vesicles, and scratching lesions that appear at the infusion set site location of blood glucose sensors and insulin pumps are considered skin intolerance. (evaluated by questionnaire)
Measured: 24 months
Secondary outcomes (2)
- Prevalence of skin side effects (eczema symptoms measured by questionnaire) for sensors and insulin pumps each one taken.
- Prevalence of skin side effects (eczema symptoms measured by questionnaire) for sensors and insulin pumps each one taken.
Measured: 24 months
Search for risk factors associated with skin side effect
Odds ratio calculated for risk factors suspected in skin reaction
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start15 May 2022
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous AllergyStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Other
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RENARD Emeline, Central Hospital, Nancy, France
- Investigators
- Emeline RENARD, PhD, Principal investigator, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932953
- Sponsor's protocol ID
- 2022PI015
- Status last verified
- Jul 2023
- First submitted
- 9 May 2022
- Last updated
- 6 Jul 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 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Tolerance of Medical Devices for Diabetes Monitoring and Treatment in Children With Type 1 Diabetes, an Observational, Retrospective, Single-center Study.
- ClinicalTrials.gov ID
- NCT05932953
- Acronym / sponsor ID
- 2022PI015
- Keywords
- diabetes mellitus, type 1, cutaneous allergy, atopic disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 15 May 2022 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 6 Jul 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.
In view of the emergence over the last few years of adverse skin reactions caused by diabetes monitoring and treatment devices, which have become essential to the optimal management of these patients, it is necessary to determine the real prevalence of these side effects.
Here the investigators performed a prospective study about prevalence of skin reactions in a group of children with type 1 diabetes.
Detailed description
Justification :
- The incidence of type 1 diabetes in children is increasing every year.
- The use of blood glucose sensors has a positive impact on blood glucose control by limiting glucose variability, reducing hypoglycemia and improving long-term blood glucose control.
- The first cases of allergic contact dermatitis secondary linked to the use of an insulin pump were identified in 1995.
- Several recent studies report a high prevalence of allergic contact dermatitis caused to blood glucose sensors, but these studies are conducted on small samples and in most cases these samples include both adults and children.
- The actual prevalence of children with adverse skin reactions secondary to their diabetes monitoring and treatment devices is probably underestimated
- IBOA was the first responsible allergen identified in 2016. It is the most common allergen responsible for these allergic contact dermatitis3, but other allergens have also been identified recently.
- It is difficult to say how many diabetic patients have ever developed a contact allergy to IBOA, or other acrylates, in their skin devices. Typically, the reaction does not appear until after prolonged use, usually after several months.
- Very few studies have looked at the impact on children's quality of life. In view of the emergence over the last few years of adverse skin reactions caused by diabetes monitoring and treatment devices, which have become essential to the optimal management of these patients, it is necessary to determine the real prevalence of these side effects. The research of risk factors associated with the appearance of these lesions, as well as the impact on patient's quality of life is essential, so as to be able to prevent them and treat them if necessary.
General outline of the study:
Epidemiological, observational, cross-sectional, retrospective study carried out on a sample of the target population after collecting data both on questionnaires and in the patients' medical files. The questionnaires and the data sought in the patients' files will be collected over a period of 1 year, after obtaining the parents' non objection. The questionnaires will be distributed by the medical and paramedical team of the pediatric diabetes service of the Nancy CHRU. They will be hand-delivered to the physician leading the quarterly follow-up visit of the child's. No additional consultation will be undertaken.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children aged 0 to 18 years, type 1 diabetics, followed at the CHRU of Nancy and wearing a blood glucose sensor and/or an insulin pump.
Key inclusion criteria (3 listed)
- -Children under 18 years of age
- Diabetic (type 1) for more than one month at the time of data collection and questionnaire completion
- Wearing an insulin pump and/or a blood glucose sensor.
Key exclusion criteria (3 listed)
- - Parental refusal to participate in the study.
- Other types of diabetes than type 1 (type 2 diabetes, MODY...)
- Diabetes diagnosed less than one month before data collection and questionnaire completion
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 |
|---|---|---|
| questionaryquestionary about cutaneous tolerance | Other | – |
Primary outcome
Prevalence of children,with current skin intolerance (eczema symptoms measured by questionnaire) to an insulin pump and/or blood glucose sensor assessed by an autoquestionnary.
Time frame: 24 months
Prevalence of of children, under 18 years of age, with type 1 diabetes with current skin intolerance to an insulin pump and/or blood glucose sensor. Pruritus, erythema, scaling, vesicles, and scratching lesions that appear at the infusion set site location of blood glucose sensors and insulin pumps are considered skin intolerance. (evaluated by questionnaire)
2 secondary outcomes
- Prevalence of skin side effects (eczema symptoms measured by questionnaire) for sensors and insulin pumps each one taken.
Time frame: 24 months
Search for risk factors associated with skin side effect
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 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.
Emeline RENARD, PhD principal investigator
CHRU Nancy
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 Cutaneous Allergy and Diabetes Mellitus, Type 1, run by Central Hospital, Nancy, France 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 3 inclusion and 3 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 6 Jul 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 emeline RENARD, PhD (+33323155311, e.renard@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of children,with current skin intolerance (eczema symptoms measured by questionnaire) to an insulin pump and/or blood glucose sensor assessed by an autoquestionnary. (time frame: 24 months). 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 6 Jul 2023.