CUTADIAB OBSERVATORY Investigation of the Skin Manifestations Associated With the Adhesives of Technological Tools for Diabetes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 851
- Locations
- 4
- Primary Endpoint
- Percentage of skin intolerance to adhesives in diabetic patients
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The use of technological tools in the treatment of diabetes has intensified and become common in recent years. Many of these systems adhere to the skin with an adhesive in place between 2 and 14 days. The objective of this study is to determine the prevalence and consequences of skin reactions to skin adhesive systems for the treatment of diabetes.
Detailed Description
The use of technological tools in the treatment of diabetes has intensified and become common in recent years. Many of these systems adhere to the skin with an adhesive in place for between 2 and 14 days, or even longer, depending on the system under consideration. Unfortunately, an increase in skin reactions has been observed in diabetic patients using these new technologies, sometimes leading to discontinuation. The number of studies evaluating the cutaneous tolerance of the patches used by these technologies is limited, so the prevalence of these skin intolerances is unknown. The objective of this study is to determine the prevalence and consequences of skin reactions to skin adhesive systems for the treatment of diabetes. It will be implemented with the following design: * observational, cross-sectional, multicentre study involving 4 Diabetology centres and over a period of 6 months. * Establishment of an observatory on skin reactions to FreeStyle Libre® (FSL) and all other adhesive systems related to new technologies for the treatment of diabetes * A questionnaire will be systematically proposed to the patients concerned, during the usual diabetes follow-up consultations made by all investigators.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men and Women
- •Adult (≥ 18 years old)
- •All types diabetes (1, 2, other)
- •Any patient who wears or has worn an adhesive system for the treatment of diabetes (insulin pump, and/or continuous glucose monitoring system) within the last 10 years.
- •Seen consecutively in consultation
- •Patient who was informed on the research and are not opposed to participation.
Exclusion Criteria
- •Illiteracy
- •Refusal to participate in the study (refusals will be counted)
- •Patient under guardianship or curatorship
Outcomes
Primary Outcomes
Percentage of skin intolerance to adhesives in diabetic patients
Time Frame: Single visit at day 0
Percentage of skin intolerance in diabetic patients - all types of diabetes - using or having used in the last 10 years adhesive systems integrated into diabetes medical devices: patch insulin pump, pump with externalized catheter or continuous glucose measurement system.
Secondary Outcomes
- Consequences of skin reactions(Single visit at day 0)
- Prevalence of skin reactions by adhesive system(Single visit at day 0)
- Semiological description of skin lesions(Single visit at day 0)
- Percentage of positive responses to the question concerning patient approaches to avoid skin reaction(Single visit at day 0)
- Percentage of positive responses to the question concerning the delay of appearance of skin manifestation(Single visit at day 0)
- Evolution of lesions(Single visit at day 0)