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AzTrials

DiabetesCUTADIABNCT04853810

Skin Manifestations Associated With Adhesives in Diabetes Technology Tools

An observational study of Diabetes, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes
What is being tested?
CUTADIAB questionnaire
Type of treatment
Pill or oral medicine
How many people
851 participants
Where
4 sitesFrance
Study dates
17 May 2021to 17 Nov 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

  • 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.

Who cannot join

  • Illiteracy
  • Refusal to participate in the study (refusals will be counted)
  • Patient under guardianship or curatorship

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • AP-HP, Lariboisière Hospital, Department of Diabetes and Endocrinology

    Paris, 75010

  • AP-HP, Pitié-Salpêtrière Hospital, Diabetes and Metabolic Diseases Department

    Paris, 75013

  • AP-HP, Cochin Hospital, Department of Diabetology

    Paris, 75014

  • AP-HP, Bichat Hospital, Department of Diabetology, Endocrinology and Nutrition

    Paris, 75877

Other trials in France

About this study

Official title: 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.

Read the 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.
Conditions
Diabetes
Being tested
CUTADIAB questionnaire
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CUTADIAB questionnaireOther

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

Study groups in NCT04853810
Study groupRoleWhat they receive
Major diabetic subjects having used a system with adhesivesMajor 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).
Receives: Other: CUTADIAB questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Single visit at day 0

Secondary outcomes (6)

  1. 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

    Measured: Single visit at day 0

  2. Consequences of skin reactions

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

    Measured: Single visit at day 0

  3. 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

    Measured: Single visit at day 0

  4. 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

    Measured: Single visit at day 0

  5. 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):

    Measured: Single visit at day 0

  6. 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

    Measured: Single visit at day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2021
  2. Study start17 May 2021
  3. Primary completion17 Nov 2021
  4. Study completion17 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
851 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04853810
Sponsor's protocol ID
APHP200089
Other IDs
2019-A03208-49
Acronym
CUTADIAB
Status last verified
Dec 2023
First submitted
26 Feb 2021
Last updated
3 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 36763338

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of skin intolerance to adhesives in diabetic patients (time frame: Single visit at day 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04853810, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.

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