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

NCT05932953 | Unknown

• 1 other identifier: 2022PI015
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cutaneous Allergy; Diabetes Mellitus, Type 1; Atopic Disorders

Keywords

diabetes mellitus, type 1; cutaneous allergy; atopic disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• - 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

  24 months

Interventions

questionary OTHER

questionary about cutaneous tolerance

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU Nancy

Nancy, 54500, France

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Emeline RENARD, PhD

  CHRU Nancy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

emeline RENARD, PhD

CONTACT

+33323155311; e.renard@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: July 6, 2023
• Study Start: May 15, 2022
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: July 6, 2023

Record last verified: 2023-07

Locations

FR (1)