Diabetes MellitusNCT03340467
Adhesive Materials for Continuous Glucose Monitoring Systems
A study testing CGM patch in people with Diabetes Mellitus, run by Metronom Health.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- CGM patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2018to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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).
About this study
Official title: 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.
- Conditions
- Diabetes Mellitus
- Being tested
- CGM patch
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGM patchDevice
Patient receives four CGM patches.
| Study group | Role | What they receive |
|---|---|---|
| CGM patch | Experimental | Patient receives four models of CGM patches. Adhesion sites are randomly allocated (1 on each upper arm, 2 on the abdomen). Receives: Device: CGM patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
14 days survival rate of different models of CGM patches to fixate a CGM sensor system.
Measured: 21 days
Secondary outcomes (2)
Survival time
Survival time (time to peel-off) of different models of CGM patches to fixate a CGM sensor system
Measured: 21 days
Attachment site reactions
Erythema, edema and blister formation according to ICDRG scoring system
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start1 Aug 2018 (estimated)
- Primary completion30 Sep 2018 (estimated)
- Study completion30 Sep 2018 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metronom Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical University of Graz
- Responsible party
- Sponsor
- Investigators
- Julia Mader,, Ass Prof, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340467
- Sponsor's protocol ID
- ADHERE_01
- Status last verified
- Aug 2019
- First submitted
- 8 Nov 2017
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different Types of Adhesive Materials for Continuous Glucose Monitoring Systems in Subjects With Type 1 and Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03340467
- Acronym / sponsor ID
- ADHERE_01
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Metronom HealthIndustry (pharma, biotech, devices)
- Collaborators
- Medical University of Graz
- Study start
- 1 Aug 2018 (estimated)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 30 Sep 2018 (estimated)
- First posted
- 13 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CGM patch | Experimental | Device: CGM patchPatient receives four models of CGM patches. Adhesion sites are randomly allocated (1 on each upper arm, 2 on the abdomen). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CGM patchPatient receives four CGM patches. | Device | CGM patch |
Primary outcome
Survival rate
Time frame: 21 days
14 days survival rate of different models of CGM patches to fixate a CGM sensor system.
2 secondary outcomes
Survival time
Time frame: 21 days
Attachment site reactions
Time frame: 21 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Mader,, Ass Prof principal investigator
Medical University of Graz
Questions about this trial
What is this clinical trial studying?
A study testing CGM patch in people with Diabetes Mellitus, run by Metronom Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2019.