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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001442 | U.S. NIH Grant/Contract | View source |
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Could not perform accurate measures due to equipment and sensor issues.
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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This pilot clinical trial will explore the accuracy and acceptability of a non-invasive, wearable glucose sensor in patients living with DM. This study will compare needleless glucose sensor readings from sweat with glucometer measurements from patients with any type of diabetes at fasting, and after a meal.
There is an unmet need for a non-invasive glucose monitoring device. UCSD nanoengineers developed a flexible, ultra-thin sensor adherent to the skin, similar to a temporary tattoo. Sweat glucose correlates with blood glucose. This proposed study would be the first to examine this needle-free glucose sensor to measure glucose in endogenous sweat in individuals with DM, and would serve as the basis for future development of a continuous, non-invasive sensor. The investigators hypothesize that compared with a glucometer, a tattoo sensor can accurately measure sweat glucose in patients with DM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Diabetes | Experimental | All participants will receive a minimum of 2 doses of pilocarpine 0.1 mL gel, applied to the skin via the glucose sensor to induce sweat. Glucose will be measured with both an adhesive (needle-free) glucose sensor and a glucometer, at fasting, and time points ranging from 15 to 200 minutes after consuming a standardized meal. There are no other interventions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adhesive glucose sensor | Device | Will assess sensor's performance by comparing readings from an adhesive glucose sensor with those from a glucometer. pilocarpine 0.1 mL gel, applied to the skin via the glucose sensor to induce sweat |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose measurements | Comparing glucose readings from the sensor with those from a glucometer | Fasting, and time points ranging from 15 to 200 minutes after consuming a standardized meal. Participants can complete this study in 1 or 2 visits. The study team anticipates to complete this clinical trial in approximately 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of sensor | Will ask participants for written and verbal feedback | The investigators will collect this data at the completion of the study, after the fasting and post-meal glucose readings (at time points ranging from 15 to 200 minutes) are collected. |
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Inclusion Criteria:
Exclusion Criteria:
Known or suspected gallstones or gallbladder disease
Kidney stones
Conditions that affect your thinking and/or memory, including Parkinson's disease and Alzheimer's disease
Asthma
Chronic obstructive pulmonary disease (COPD)
Glaucoma
Irritable Bowel Syndrome
Pregnancy - a pregnancy test will be obtained for each woman of child-bearing age.
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| Name | Affiliation | Role |
|---|---|---|
| Edward C Chao, DO | UCSD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Altman Clinical and Translational Research Institute | San Diego | California | 92161 | 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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| ID | Term |
|---|---|
| D010862 | Pilocarpine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Pilocarpine | Drug | Pilocarpine 0.1 mL gel, applied to the skin via the glucose sensor to induce sweat; will apply a minimum of 2 doses to each participant. |
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| UCSD |
| San Diego |
| California |
| 92161 |
| United States |