Adhesive Materials for Continuous Glucose Monitoring Systems | NCT03340467

Studies
Adhesive Materials for Continuous Glucose Monitoring Systems

NCT03340467

Sponsor

Metronom Health

Status

Withdrawn

Last Update Posted

Aug 19, 2019Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus

Interventions

CGM patch

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor decision

Expanded Access Info

Start Date

Aug 1, 2018Estimated

Primary Completion Date

Sep 30, 2018Estimated

Completion Date

Sep 30, 2018Estimated

First Submitted Date

Nov 8, 2017

First Submission Date that Met QC Criteria

Nov 8, 2017

First Posted Date

Nov 13, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 14, 2019

Last Update Posted Date

Aug 19, 2019Actual

Name	Class
Medical University of Graz	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
CGM patch	Device	Patient receives four CGM patches.	CGM patch

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases