Measuring Sweat Glucose of Patients With Diabetes - The ENGAGE Study
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 3/31/2019 |
| Start Date: | May 10, 2018 |
| End Date: | December 2022 |
Evaluating Non-Invasive Measurement of Sweat Glucose of Patients With Diabetes - The ENGAGE Study
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.
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.
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.
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.
We found this trial at
2
sites
San Diego, California 92161
Principal Investigator: Edward C Chao, DO
Phone: 619-916-8719
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