Adhesive Materials for Continuous Glucose Monitoring Systems

Metronom Health

Status

Withdrawn

Conditions

Diabetes Mellitus

Treatments

Device: CGM patch

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03340467

ADHERE_01

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).