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

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

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Other: CUTADIAB questionnaire

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.

• Study Type: Observational
• Enrollment (Actual): 851

Contacts and Locations

• Study Contact: Name: Agnès SOLA GAZAGNES, MD; Phone Number: +33158412318; Email: agnes.sola@aphp.fr
• Study Contact Backup: Name: Jean-Pierre RIVELINE, MD PhD; Phone Number: +33149959021; Email: jeanpierre.riveline@aphp.fr

Study Locations

• France
  • Paris, France, 75010
    • AP-HP, Lariboisière Hospital, Department of Diabetes and Endocrinology
  • Paris, France, 75013
    • AP-HP, Pitié-Salpêtrière Hospital, Diabetes and Metabolic Diseases Department
  • Paris, France, 75014
    • AP-HP, Cochin Hospital, Department of Diabetology
    • Contact: Agnès SOLA GAZAGNES, MD; Phone Number: +33158412318; Email: agnes.sola@aphp.fr
    • Contact: Marc DIEDISHEIM, MD; Phone Number: +33158413966; Email: marc.diedisheim@aphp.fr
  • Paris, France, 75877
    • AP-HP, Bichat Hospital, Department of Diabetology, Endocrinology and Nutrition

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Major diabetic subjects having used a system with adhesives; 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).	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Agnès SOLA GAZAGNES, MD, AP-HP, Cochin Hospital, Department of Diabetology

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2021
• Primary Completion (Actual): November 17, 2021
• Study Completion (Actual): November 17, 2021

Study Registration Dates

• First Submitted: February 26, 2021
• First Submitted That Met QC Criteria: April 16, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 30, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Skin Manifestations
• Other Study ID Numbers: APHP200089; 2019-A03208-49 (Other Identifier: IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No