Adhesive Materials for Continuous Glucose Monitoring Systems

NCT03340467 | Withdrawn

• 1 other identifier: ADHERE_01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Survival rate

  14 days survival rate of different models of CGM patches to fixate a CGM sensor system.

  21 days

Secondary Outcomes (2)

• Survival time

  21 days

• Attachment site reactions

  21 days

Study Arms (1)

CGM patch

EXPERIMENTAL

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

Device: CGM patch

Interventions

CGM patch DEVICE

Patient receives four CGM patches.

CGM patch

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Metronom Health: lead
• Medical University of Graz: collaborator

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Julia Mader,, Ass Prof

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 13, 2017
• Study Start: August 1, 2018
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: August 19, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share