Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Justification :
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| questionary | Other | questionary about cutaneous tolerance |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| - 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. | 24 months |
| Search for risk factors associated with skin side effect |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| emeline RENARD, PhD | Contact | +33323155311 | e.renard@chru-nancy.fr |
| Name | Affiliation | Role |
|---|---|---|
| Emeline RENARD, PhD | CHRU Nancy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU Nancy | Recruiting | Nancy | 54500 | France |
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Odds ratio calculated for risk factors suspected in skin reaction |
| 24 months |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |