Skin Manifestations Associated With Adhesives in Diabetes Technology Tools

Diabetes Clinical Trial

— CUTADIAB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04853810
• Other study ID #: APHP200089
• Secondary ID: 2019-A03208-49
• Status: Completed
• Start date: May 17, 2021
• Est. completion date: November 17, 2021

Study information

• Verified date: December 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 851
• Est. completion date: November 17, 2021
• Est. primary completion date: November 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Skin Manifestations

Intervention

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

Locations

Country	Name	City	State
France	AP-HP, Bichat Hospital, Department of Diabetology, Endocrinology and Nutrition	Paris
France	AP-HP, Cochin Hospital, Department of Diabetology	Paris
France	AP-HP, Lariboisière Hospital, Department of Diabetes and Endocrinology	Paris
France	AP-HP, Pitié-Salpêtrière Hospital, Diabetes and Metabolic Diseases Department	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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