DiabetesNCT04840446
Evaluation of Modified Adhesives With Dexcom G6 Sensor
An observational study of Diabetes, run by DexCom, Inc. at 1 site in United States.
Trial summary
The purpose of the study is to collect and compare information on the performance of CGM adhesives in adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Dexcom Continuous Glucose Monitoring System
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2021to 19 Mar 2021
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Potential study participants will be identified via diabetes patient website and/or virtual registry.
Who may be able to join
- Age 18 or older;
- No previously self-reported adhesive reactions to the any continuous glucose monitor (CGM);
Who cannot join
- Extensive skin changes/diseases that preclude wearing the required number of devices (e.g., history of severe reactions from adhesive wear, extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites;
- Current or anticipated use of systemic corticosteroids (oral, injectable, or intravenous)
Trial locations and contacts
1 site in 1 country.
United States1 site
Jaeb Center for Health Research
Tampa, Florida, 33647
About this study
The purpose of the study is to collect and compare information on the performance of CGM adhesives in adults.
- Conditions
- Diabetes
- Being tested
- Dexcom Continuous Glucose Monitoring System
- Keywords
- Diabetes, Continuous Glucose Monitoring Systems
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom Continuous Glucose Monitoring SystemDevice
Dexcom Sensor
What is being measured
The primary outcome is the main question the study is designed to answer.
Adhesiveness and survivability of the adhesives
Number of adhesives that survive on the body during wear period
Measured: 10-days
Secondary outcomes (3)
Skin irritation with the adhesives
Proportion of participants who self-report skin irritation during wear period.
Measured: 10-days
Occurrence of adverse events with the adhesives
Highest Draize scale score for adhesive erythema, and edema during wear period. Recorded medical adhesive-related skin injuries (MARSI) and severity during wear period.
Measured: 10-days
Assess user preference or acceptance of the adhesives worn during the study
Final day post-study satisfaction questionnaire (for each adhesive) will be given a score by taking the mean response on the scale 1-5. Satisfaction scores will be tabulated by adhesive.
Measured: 10-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start8 Feb 2021
- Primary completion16 Mar 2021
- Study completion19 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- DexCom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jaeb Center for Health Research
- Responsible party
- Sponsor
- Investigators
- Thomas J Mouse, BS, Principal investigator, Jaeb Center for Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840446
- Sponsor's protocol ID
- PTL-904288
- Status last verified
- Apr 2021
- First submitted
- 30 Mar 2021
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Modified Adhesives With Dexcom G6 Sensor
- ClinicalTrials.gov ID
- NCT04840446
- Acronym / sponsor ID
- PTL-904288
- Conditions
- Diabetes
- Keywords
- Diabetes, Continuous Glucose Monitoring Systems
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- DexCom, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Jaeb Center for Health Research
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 16 Mar 2021 (actual)
- Study completion
- 19 Mar 2021 (actual)
- First posted
- 12 Apr 2021 (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.
The purpose of the study is to collect and compare information on the performance of CGM adhesives in adults.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Potential study participants will be identified via diabetes patient website and/or virtual registry.
Key inclusion criteria (2 listed)
- Age 18 or older;
- No previously self-reported adhesive reactions to the any continuous glucose monitor (CGM);
Key exclusion criteria (2 listed)
- Extensive skin changes/diseases that preclude wearing the required number of devices (e.g., history of severe reactions from adhesive wear, extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites;
- Current or anticipated use of systemic corticosteroids (oral, injectable, or intravenous)
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 |
|---|---|---|
| Dexcom Continuous Glucose Monitoring SystemDexcom Sensor | Device | – |
Primary outcome
Adhesiveness and survivability of the adhesives
Time frame: 10-days
Number of adhesives that survive on the body during wear period
3 secondary outcomes
Skin irritation with the adhesives
Time frame: 10-days
Occurrence of adverse events with the adhesives
Time frame: 10-days
Assess user preference or acceptance of the adhesives worn during the study
Time frame: 10-days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
- 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.
Thomas J Mouse, BS principal investigator
Jaeb Center for Health Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by DexCom, Inc. at 1 site in United States.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 12 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adhesiveness and survivability of the adhesives (time frame: 10-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 12 Apr 2021.