Evaluation of Modified Adhesives With Dexcom G6 Sensor
Completed
- Conditions
- Diabetes
- Registration Number
- NCT04840446
- Lead Sponsor
- DexCom, Inc.
- Brief Summary
The purpose of the study is to collect and compare information on the performance of CGM adhesives in adults.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
- Age 18 or older;
- No previously self-reported adhesive reactions to the any continuous glucose monitor (CGM);
Exclusion Criteria
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adhesiveness and survivability of the adhesives 10-days Number of adhesives that survive on the body during wear period
- Secondary Outcome Measures
Name Time Method Skin irritation with the adhesives 10-days Proportion of participants who self-report skin irritation during wear period.
Occurrence of adverse events with the adhesives 10-days Highest Draize scale score for adhesive erythema, and edema during wear period. Recorded medical adhesive-related skin injuries (MARSI) and severity during wear period.
Assess user preference or acceptance of the adhesives worn during the study 10-days 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.
Trial Locations
- Locations (1)
Jaeb Center for Health Research
🇺🇸Tampa, Florida, United States