Skin Manifestations Associated With Adhesives in Diabetes Technology Tools

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

Sponsors

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Source Assistance Publique - Hôpitaux de Paris
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.

Overall Status Not yet recruiting
Start Date 2021-05-01
Completion Date 2022-05-01
Primary Completion Date 2021-11-01
Study Type Observational
Primary Outcome
Measure Time Frame
Percentage of skin intolerance to adhesives in diabetic patients Single visit at day 0
Secondary Outcome
Measure Time Frame
Prevalence of skin reactions by adhesive system Single visit at day 0
Consequences of skin reactions 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
Semiological description of skin lesions Single visit at day 0
Evolution of lesions Single visit at day 0
Enrollment 800
Condition
Intervention

Intervention Type: Other

Intervention Name: CUTADIAB questionnaire

Description: During a regular diabetes follow-up consultation, the patient is asked to complete the CUTADIAB questionnaire on a tablet, entirely dedicated to the study

Arm Group Label: Major diabetic subjects having used a system with adhesives

Eligibility

Sampling Method:

Non-Probability Sample

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Agnès SOLA GAZAGNES, MD Principal Investigator AP-HP, Cochin Hospital, Department of Diabetology
Overall Contact

Last Name: Agnès SOLA GAZAGNES, MD

Phone: +33158412318

Email: [email protected]

Location
Facility:
AP-HP, Lariboisière Hospital, Department of Diabetes and Endocrinology | Paris, 75010, France
AP-HP, Pitié-Salpêtrière Hospital, Diabetes and Metabolic Diseases Department | Paris, 75013, France
AP-HP, Cochin Hospital, Department of Diabetology | Paris, 75014, France Agnès SOLA GAZAGNES, MD +33158412318 [email protected]
AP-HP, Bichat Hospital, Department of Diabetology, Endocrinology and Nutrition | Paris, 75877, France
Location Countries

France

Verification Date

2021-04-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: 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).

Acronym CUTADIAB
Study Design Info

Observational Model: Cohort

Time Perspective: Cross-Sectional

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