Diabetes Mellitus
Conditions
Keywords
Sensor, Glucose, Sweat
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAdhesive glucose sensor
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
DRUGPilocarpine
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.
Sponsors
National Institutes of Health (NIH)
University of California, San Diego
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Individuals with an existing diagnosis of diabetes mellitus, of any type, defined as having a fasting plasma glucose (FPG) \> 126 mg/dL, or hemoglobin A1c (HbA1c) \> 6.5%. * Ability to provide informed consent for participation.
Exclusion criteria
* Individuals who do not have diabetes. * Those who have an allergy to pilocarpine. * Frequent episodes of low blood sugar (hypoglycemia), have no warning symptoms of hypoglycemia (hypoglycemia unawareness), or are at high risk of having hypoglycemia. * If taking any of the following medications: any beta-blockers (including atenolol, carvedilol, metoprolol, and propanolol), chlorthalidone, hydrochlorothiazide, oxybutynin, and tiotropium. * Individuals who have the following conditions, for which it is not safe to take pilocarpine, including: 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose measurements | 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. | Comparing glucose readings from the sensor with those from a glucometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of sensor | 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. | Will ask participants for written and verbal feedback |
Countries
United States
Outcome results
None listed