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We never were able to start this study, as an NDA agreement had been signed, after we had anticipated enrolling, preventing starting.
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Self-testing of glucose by patients living with diabetes mellitus (DM) involves needles, which causes discomfort or inconvenience eventually lead to decreased willingness to perform such needle-based check-ups that are vital to DM management. While technology has evolved, currently there is no glucose monitoring device that is needle-free. The investigators are studying a glucose sensor that detects glucose non-invasively, from sweat on an individual's fingertip. As it has not yet been tested in individuals with DM, the team will examine its accuracy and acceptability in these patients. Results from this clinical trial could serve as the basis for further development of a non-invasive glucose sensor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sensor group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testing sensor vs glucometer | Device | Will test accuracy of this sensor; there will be no intervention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy: glucose readings in mg/dL | Correlation of touch sensor glucose readings compared with glucometer measurements | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability: questionnaire ratings on a scale of 1-5, with 5 being the highest | ease of use, and any other comments to optimize the design and function of this sensor, as reported by the participants | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward C Chao, DO | University of California, San Diego | Principal Investigator |
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This will include all data collected in the study, sensor glucose readings, as well as glucometer measurements.
approximately 10 yrs
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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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