Measuring Sweat Glucose of Patients With Diabetes - The ENGAGE Study

University of California, San Diego2 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus

Interventions

Adhesive glucose sensorDEVICE

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

PilocarpineDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (2)

UCSD Altman Clinical and Translational Research Institute

San Diego, California, United States

UCSD

San Diego, California, United States

Outcomes

Primary Outcomes

Glucose measurements

Comparing glucose readings from the sensor with those from a glucometer

Time frame: 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

Acceptability of sensor

Will ask participants for written and verbal feedback

Time frame: 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.

Data from ClinicalTrials.gov

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