Diabetes
Conditions
Keywords
Diabetes, Continuous Glucose Monitoring Systems
Brief summary
The purpose of the study is to collect and compare information on the performance of CGM adhesives in adults.
Interventions
Dexcom Sensor
Sponsors
Jaeb Center for Health Research
DexCom, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age 18 or older; 2. No previously self-reported adhesive reactions to the any continuous glucose monitor (CGM);
Exclusion criteria
1. 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; 2. Current or anticipated use of systemic corticosteroids (oral, injectable, or intravenous)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adhesiveness and survivability of the adhesives | 10-days | Number of adhesives that survive on the body during wear period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed