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| Name | Class |
|---|---|
| Jaeb Center for Health Research | OTHER |
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The purpose of the study is to collect and compare information on the performance of CGM adhesives in adults.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexcom Continuous Glucose Monitoring System | Device | Dexcom Sensor |
| Measure | Description | Time Frame |
|---|---|---|
| Adhesiveness and survivability of the adhesives | Number of adhesives that survive on the body during wear period | 10-days |
| Measure | Description | Time Frame |
|---|---|---|
| Skin irritation with the adhesives | Proportion of participants who self-report skin irritation during wear period. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Potential study participants will be identified via diabetes patient website and/or virtual registry.
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| Name | Affiliation | Role |
|---|---|---|
| Thomas J Mouse, BS | Jaeb Center for Health Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jaeb Center for Health Research | Tampa | Florida | 33647 | United States |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 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. | 10-days |