CUTADIAB: Skin Manifestations Associated With Adhesives in Diabetes Technology Tools

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04853810
Collaborator
(none)
800
4
12
200
16.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
800 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
CUTADIAB OBSERVATORY Investigation of the Skin Manifestations Associated With the Adhesives of Technological Tools for Diabetes
Anticipated Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Percentage of skin intolerance to adhesives in diabetic patients [Single visit at day 0]

    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.

Secondary Outcome Measures

  1. Prevalence of skin reactions by adhesive system [Single visit at day 0]

    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

  2. Consequences of skin reactions [Single visit at day 0]

    Consequences of skin reactions (continuation / compliance / stopping / stopping then resuming and a delay time before resuming)

  3. Percentage of positive responses to the question concerning patient approaches to avoid skin reaction [Single visit at day 0]

    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

  4. Percentage of positive responses to the question concerning the delay of appearance of skin manifestation [Single visit at day 0]

    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

  5. Semiological description of skin lesions [Single visit at day 0]

    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):

  6. Evolution of lesions [Single visit at day 0]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 AP-HP, Lariboisière Hospital, Department of Diabetes and Endocrinology Paris France 75010
2 AP-HP, Pitié-Salpêtrière Hospital, Diabetes and Metabolic Diseases Department Paris France 75013
3 AP-HP, Cochin Hospital, Department of Diabetology Paris France 75014
4 AP-HP, Bichat Hospital, Department of Diabetology, Endocrinology and Nutrition Paris France 75877

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Agnès SOLA GAZAGNES, MD, AP-HP, Cochin Hospital, Department of Diabetology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT04853810
Other Study ID Numbers:
  • APHP200089
  • 2019-A03208-49
First Posted:
Apr 21, 2021
Last Update Posted:
May 4, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 4, 2021