Skin Manifestations Associated With Adhesives in Diabetes Technology Tools

NCT04853810 | Completed

• 2 other identifiers: APHP2000892019-A03208-49
• Study Type: observational
• Target: 851
• Locations: 1 country
• Sites: 4

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (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.

  Single visit at day 0

Secondary Outcomes (6)

• 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

Study Arms (1)

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

Interventions

CUTADIAB questionnaire OTHER

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

Major diabetic subjects having used a system with adhesives

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (4)

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

Paris, 75010, France

Location

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

Paris, 75013, France

Location

AP-HP, Cochin Hospital, Department of Diabetology

Paris, 75014, France

Location

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

Paris, 75877, France

Location

Related 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 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.

  PMID: 36763338 RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Agnès SOLA GAZAGNES, MD

  AP-HP, Cochin Hospital, Department of Diabetology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: April 21, 2021
• Study Start: May 17, 2021
• Primary Completion: November 17, 2021
• Study Completion: November 17, 2021
• Last Updated: January 3, 2024

Record last verified: 2023-12

Locations

FR (4)