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.
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.
Study Type
OBSERVATIONAL
Enrollment
851
During a regular diabetes follow-up consultation, the patient is asked to complete the CUTADIAB questionnaire on a tablet, entirely dedicated to the study
AP-HP, Lariboisière Hospital, Department of Diabetes and Endocrinology
Paris, France
AP-HP, Pitié-Salpêtrière Hospital, Diabetes and Metabolic Diseases Department
Paris, France
AP-HP, Cochin Hospital, Department of Diabetology
Paris, France
AP-HP, Bichat Hospital, Department of Diabetology, Endocrinology and Nutrition
Paris, France
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.
Time frame: Single visit at day 0
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
Time frame: 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)
Time frame: 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
Time frame: Single visit at day 0
Percentage of positive responses to the question concerning the delay of appearance of skin manifestation
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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
Time frame: 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):
Time frame: 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
Time frame: Single visit at day 0