Measuring Sweat Glucose of Patients With Diabetes - The ENGAGE Study

Not Applicable

Terminated

• Conditions: Diabetes Mellitus
• Interventions: Device: Adhesive glucose sensor; Drug: Pilocarpine

• Registration Number: NCT03460964
• Lead Sponsor: University of California, San Diego

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.

Study Timeline

• Study First Submitted: 2018-02-23
• Study First Submitted QC: 2018-03-07
• Study First Posted: 2018-03-09
• Study Start: 2018-05-01
• Primary Completion: 2019-09-05
• Study Completion: 2019-09-05
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-07
• Last Update Posted: 2020-07-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with Diabetes	Adhesive glucose sensor	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.
Patients with Diabetes	Pilocarpine	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.

Primary Outcome Measures

Name	Time	Method
Glucose measurements	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.	Comparing glucose readings from the sensor with those from a glucometer

Secondary Outcome Measures

Name	Time	Method
Acceptability of sensor	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.	Will ask participants for written and verbal feedback

Trial Locations

Locations (2)

UCSD Altman Clinical and Translational Research Institute; 🇺🇸 San Diego, California, United States

UCSD; 🇺🇸 San Diego, California, United States