Adhesive Materials for Continuous Glucose Monitoring Systems

NCT ID: NCT03340467

Last Updated: 2019-08-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2018-09-30

Brief Summary

Within the present study 4 different band-aid/adhesive combinations will be tested in patients with type 1 diabetes and type 2 diabetes with regard to adherence to the body and allergic potential. The study period is set to 21 days following adhesive material placement to cover the maximum expected wear-time of the novel CGM system (14 days) plus an additional seven days to ensure that adhesive material is tested for a sufficient time-period and differences in adhesion can clearly be observed.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

CGM patch

Patient receives four models of CGM patches. Adhesion sites are randomly allocated (1 on each upper arm, 2 on the abdomen).

Group Type: EXPERIMENTAL

CGM patch

Intervention Type: DEVICE

Patient receives four CGM patches.

Interventions

CGM patch

Patient receives four CGM patches.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Informed consent obtained after being advised of the nature of the study
• Male or female aged ≥18 years
• Type 1 diabetes for at least 6 months according to the WHO definition or Type 2 diabetes for at least 6 months according to the WHO definition
• Body Mass Index (BMI) <45 kg/m²
• Willing and able to wear 4 different band-aid/adhesive materials for the duration of the study and undergo all study procedures
• HbA1c ≤86 mmol/mol

Exclusion Criteria

• Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject
• Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods
• Any mental condition rendering the subject incapable of giving his consent
• Subject is using any medication that significantly impacts immune response (oral steroids)
• Has severe medical or psychological condition(s) or chronic conditions/infections that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study
• Subject is actively enrolled in another clinical trial
• Known severe hypersensitivity to adhesive or skin lesions that hinder band-aid application
• Inability of the subject to comply with all study procedures
• Inability of the subject to understand the subject information
• Has children two years of age or younger
• Vulnerable patients, patients deprived from liberty and patients with a physical or mental state altered by disease, age or disability which impacts their ability to defend their interests and for which protection measures are taken ("protected majors" as per French law).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: collaborator

Metronom Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julia Mader,, Ass Prof

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Other Identifiers

ADHERE_01

Identifier Type: -

Identifier Source: org_study_id