Clinical trial NCT03460964: Measuring Sweat Glucose of Patients With Diabetes - The ENGAGE Study
Official title: Evaluating Non-Invasive Measurement of Sweat Glucose of Patients With Diabetes - The ENGAGE Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Sensor
Glucose
Sweat
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2018-03-09
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Glucose measurements
timeFrame: 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.
Secondary outcomes:
measure: Acceptability of sensor
timeFrame: 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.
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Altman Clinical and Translational Research Institute
state: California
city: San Diego
country: United States
facility: UCSD
state: California
Study officials:
affiliation: UCSD
name: Edward C Chao, DO
role: PRINCIPAL_INVESTIGATOR
References: