Skin Manifestations Associated With Adhesives in Diabetes Technology Tools

Study 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.

Official Title
-----------------
CUTADIAB OBSERVATORY Investigation of the Skin Manifestations Associated With the Adhesives of Technological Tools for Diabetes

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Other: CUTADIAB questionnaire


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Major diabetic subjects having used a system with adhesives<br>Major diabetic subjects, whatever the etiology of diabetes, using or having used in the last 10 years a system with skin adhesives, i.e. insulin patch pump (e.g. OMNIPOD®, cell Novo®), pump with externalized catheter (e.g. MINIMED 640G®, YpsoPump®) or continuous glucose measurement system (Free Style®, DexCom® sensors, Enlite® sensors). | Other: CUTADIAB questionnaire<br>* During a regular diabetes follow-up consultation, the patient is asked to complete the CUTADIAB questionnaire on a tablet, entirely dedicated to the study<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of skin intolerance to adhesives in diabetic patients | 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. | Single visit at day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of skin reactions by adhesive system | Skin intolerance in diabetic patients - all types of diabetes combined - using or having used adhesive systems integrated in diabetes medical devices, depending on the systems used | Single visit at day 0 | 
| Consequences of skin reactions | Consequences of skin reactions (continuation / compliance / stopping / stopping then resuming and a delay time before resuming) | Single visit at day 0 | 
| Percentage of positive responses to the question concerning patient approaches to avoid skin reaction | The patient is asked to answer the question Do you use or have you used any tips to avoid or treat these skin manifestations by choosing between the responses provided below (several possible items): no cortisone ointment on removal from the system name of the ointment used:… .. other ointment when removing the system name of the ointment used:… .. adhesive between skin and system name of the adhesive used other protection between the skin and the system (ointment, spray, etc.) name of the protection used stop using product before installation change of the installation location of the system with the same reaction change of the installation location of the system with improvement stop using product before installation | Single visit at day 0 | 
| Percentage of positive responses to the question concerning the delay of appearance of skin manifestation | The patient is asked to answer the question what time passed between the first use of the pump and the first appearance of skin manifestations by choosing between the responses provided below: from the 1st installation less than a week less than a month between 1 and 2 months between 2 and 6 months more than 6 months | Single visit at day 0 | 
| Semiological description of skin lesions | The patient is asked to describe his skin manifestations by choosing between the responses provided below (several possible items): redness change in skin color (other than redness) vesicles (blisters) / bubbles peeling (loss of small pieces of skin) it itches it hurts it flows redness or bubbles are strictly localized under the adhesive redness or bubbles overflow from the adhesive infection (abscess or other) requiring treatment antibiotic therapy / surgery (several items possible) other (in full): | Single visit at day 0 | 
| Evolution of lesions | The patient is asked to answer the question How long is the reaction present? by choosing between the responses provided below : less than an hour more than an hour and less than 24 hours more than 24 hours and less than a week more than a week and less than a month more than a month the reaction never went away | Single visit at day 0 |