Skin Tolerance of Medical Devices for Diabetes Monitoring and Treatment in Children With Type 1 Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Skin Tolerance of Medical Devices for Diabetes Monitoring and Treatment in Children With Type 1 Diabetes, an Observational, Retrospective, Single-center Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05932953
• Other study ID #: 2022PI015
• Status: Recruiting
• Start date: May 15, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: July 2023
• Source: Central Hospital, Nancy, France
• Contact: emeline RENARD, PhD
• Phone: +33323155311
• Email: e.renard[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Here the investigators performed a prospective study about prevalence of skin reactions in a group of children with type 1 diabetes.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: November 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• -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.

Exclusion Criteria:

• - 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

Related Conditions & MeSH terms

• Atopic Disorders
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Other:
• questionary
questionary about cutaneous tolerance

Locations

Country	Name	City	State
France	CHRU Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	- 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
Secondary	Search for risk factors associated with skin side effect	Odds ratio calculated for risk factors suspected in skin reaction	24 months