Assessing skin reactions to diabetes monitoring devices in children
Skin Tolerance of Medical Devices for Diabetes Monitoring and Treatment in Children With Type 1 Diabetes, an Observational, Retrospective, Single-center Study.
This study is trying to find out how common skin reactions are in kids with type 1 diabetes who use devices like insulin pumps and glucose sensors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Central Hospital, Nancy, France Academic / other |
| Locations | 1 site (Nancy) |
| Trial ID | NCT05932953 on ClinicalTrials.gov |
What this trial studies
This observational study aims to determine the prevalence of skin reactions in children with type 1 diabetes who use diabetes monitoring and treatment devices, such as insulin pumps and blood glucose sensors. The study will collect data through questionnaires completed by participants to assess any adverse skin reactions they may experience. Given the increasing incidence of type 1 diabetes and the importance of these devices for effective management, understanding the prevalence of skin allergies is crucial for improving patient care. The study seeks to fill a gap in existing research, which has often focused on adult populations or small sample sizes.
Who should consider this trial
Good fit: Ideal candidates for this study are children under 18 years of age who have been diagnosed with type 1 diabetes for more than one month and are currently using an insulin pump or blood glucose sensor.
Not a fit: Patients with other types of diabetes or those who have been diagnosed with type 1 diabetes for less than one month may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for children with type 1 diabetes by identifying and mitigating skin reactions to essential monitoring devices.
How similar studies have performed: While there have been studies on skin reactions to diabetes devices, this study is novel in its focus on a pediatric population and aims to provide more comprehensive data on this issue.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nancy
- CHRU Nancy — Nancy, France (Recruiting)
Study contacts
- Principal investigator: Emeline RENARD, PhD — CHRU Nancy
- Study coordinator: emeline RENARD, PhD
- Email: e.renard@chru-nancy.fr
- Phone: +33323155311
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.