Adhesive Materials for Continuous Glucose Monitoring Systems

Not Applicable

Withdrawn

• Conditions: Diabetes Mellitus
• Interventions: Device: CGM patch

• Registration Number: NCT03340467
• Lead Sponsor: Metronom Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-08
• Study First Submitted QC: 2017-11-08
• Study First Posted: 2017-11-13
• Study Start: 2018-08-01
• Primary Completion: 2018-09-30
• Study Completion: 2018-09-30
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-14
• Last Update Posted: 2019-08-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Survival rate	21 days	14 days survival rate of different models of CGM patches to fixate a CGM sensor system.

Secondary Outcome Measures

Name	Time	Method
Attachment site reactions	21 days	Erythema, edema and blister formation according to ICDRG scoring system
Survival time	21 days	Survival time (time to peel-off) of different models of CGM patches to fixate a CGM sensor system