Adhesive Materials for Continuous Glucose Monitoring Systems

August 14, 2019 updated by: Metronom Health

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CGM patch
Patient receives four models of CGM patches. Adhesion sites are randomly allocated (1 on each upper arm, 2 on the abdomen).
Device: CGM patch
Patient receives four CGM patches.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival rate
Time Frame: 21 days
14 days survival rate of different models of CGM patches to fixate a CGM sensor system.
21 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Metronom Health

Collaborators

Medical University of Graz

Investigators

  • Principal Investigator: Julia Mader,, Ass Prof, Medical University of Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2018

Primary Completion (Anticipated)

September 30, 2018

Study Completion (Anticipated)

September 30, 2018

Study Registration Dates

First Submitted

November 8, 2017

First Submitted That Met QC Criteria

November 8, 2017

First Posted (Actual)

November 13, 2017

Study Record Updates

Last Update Posted (Actual)

August 19, 2019

Last Update Submitted That Met QC Criteria

August 14, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADHERE_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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