Skin Manifestations Associated With Adhesives in Diabetes Technology Tools (CUTADIAB)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Diabetes

Treatments: Other: CUTADIAB questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT04853810

2019-A03208-49 (Other Identifier)

APHP200089

Details and patient eligibility

About

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.

Full 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.

Enrollment: 851 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

851 participants in 1 patient group

Major diabetic subjects having used a system with adhesives

Description:

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).

Treatment:

Other: CUTADIAB questionnaire