Status:
TERMINATED
Measuring Sweat Glucose of Patients With Diabetes - The ENGAGE Study
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-60 years
Phase:
NA
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 ...
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 corre...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2019
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03460964
Start Date
May 1 2018
End Date
September 5 2019
Last Update
July 9 2020
Active Locations (2)
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1
UCSD Altman Clinical and Translational Research Institute
San Diego, California, United States, 92161
2
UCSD
San Diego, California, United States, 92161