Clinical trial NCT04853810: Skin Manifestations Associated With Adhesives in Diabetes Technology Tools
Official title: CUTADIAB OBSERVATORY Investigation of the Skin Manifestations Associated With the Adhesives of Technological Tools for Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 851
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

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.

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

Primary outcomes:
measure: Percentage of skin intolerance to adhesives in diabetic patients
timeFrame: Single visit at day 0
Secondary outcomes:
measure: Prevalence of skin reactions by adhesive system
timeFrame: Single visit at day 0
measure: Consequences of skin reactions
timeFrame: Single visit at day 0
measure: Percentage of positive responses to the question concerning patient approaches to avoid skin reaction
timeFrame: Single visit at day 0
measure: Percentage of positive responses to the question concerning the delay of appearance of skin manifestation
timeFrame: Single visit at day 0
measure: Semiological description of skin lesions
timeFrame: Single visit at day 0
measure: Evolution of lesions
timeFrame: Single visit at day 0
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP, Lariboisière Hospital, Department of Diabetes and Endocrinology
city: Paris
country: France
facility: AP-HP, Pitié-Salpêtrière Hospital, Diabetes and Metabolic Diseases Department
city: Paris
country: France
facility: AP-HP, Cochin Hospital, Department of Diabetology
city: Paris
country: France
facility: AP-HP, Bichat Hospital, Department of Diabetology, Endocrinology and Nutrition
Study officials:
affiliation: AP-HP, Cochin Hospital, Department of Diabetology
name: Agnès SOLA GAZAGNES, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Diedisheim M, Pecquet C, Julla JB, Carlier A, Potier L, Hartemann A, Jacqueminet S, Vidal-Trecan T, Gautier JF, Dubois Laforgue D, Fagherazzi G, Roussel R, Larger E, Sola-Gazagnes A, Riveline JP. Prevalence and Description of the Skin Reactions Associated with Adhesives in Diabetes Technology Devices in an Adult Population: Results of the CUTADIAB Study. Diabetes Technol Ther. 2023 Apr;25(4):279-286. doi: 10.1089/dia.2022.0513. Epub 2023 Feb 24.