Adhesive Materials for Continuous Glucose Monitoring Systems

Diabetes Mellitus Clinical Trial

Official title:

Evaluation of Different Types of Adhesive Materials for Continuous Glucose Monitoring Systems in Subjects With Type 1 and Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03340467
• Other study ID #: ADHERE_01
• Status: Withdrawn
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: September 30, 2018

Study information

• Verified date: August 2019
• Source: Metronom Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• CGM patch
Patient receives four CGM patches.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Metronom Health	Medical University of Graz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate	14 days survival rate of different models of CGM patches to fixate a CGM sensor system.	21 days
Secondary	Survival time	Survival time (time to peel-off) of different models of CGM patches to fixate a CGM sensor system	21 days
Secondary	Attachment site reactions	Erythema, edema and blister formation according to ICDRG scoring system	21 days