Measuring Sweat Glucose of Patients With Diabetes - The ENGAGE Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluating Non-Invasive Measurement of Sweat Glucose of Patients With Diabetes - The ENGAGE Study

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: Adhesive glucose sensor
* Drug: Pilocarpine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with Diabetes<br>All participants will receive a minimum of 2 doses of pilocarpine 0.1 mL gel, applied to the skin via the glucose sensor to induce sweat. Glucose will be measured with both an adhesive (needle-free) glucose sensor and a glucometer, at fasting, and time points ranging from 15 to 200 minutes after consuming a standardized meal. There are no other interventions. | Device: Adhesive glucose sensor<br>* 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<br>Drug: Pilocarpine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose measurements | Comparing glucose readings from the sensor with those from a glucometer | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of sensor | Will ask participants for written and verbal feedback | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sensor, Glucose, Sweat