Measuring Sweat Glucose of Patients With Diabetes - The ENGAGE Study

• Sponsor: University of California, San Diego (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03460964
• Collaborator: National Institutes of Health (NIH) (NIH)
• Enrollment: 2
• Locations: 2
• Arm: 1
• Actual Duration (Months): 16.2
• Patient Per Site: 1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Device: Adhesive glucose sensor; Drug: Pilocarpine	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Evaluating Non-Invasive Measurement of Sweat Glucose of Patients With Diabetes - The ENGAGE Study
• Actual Study Start Date: May 1, 2018
• Actual Primary Completion Date: Sep 5, 2019
• Actual Study Completion Date: Sep 5, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients with Diabetes 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; 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; Drug: Pilocarpine; 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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSD Altman Clinical and Translational Research Institute	San Diego	California	United States	92161
2	UCSD	San Diego	California	United States	92161

Sponsors and Collaborators

• University of California, San Diego
• National Institutes of Health (NIH)

Investigators

• Principal Investigator: Edward C Chao, DO, UCSD

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Edward Chao, Associate Clinical Professor, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT03460964
• Other Study ID Numbers: SD; UL1TR001442
• First Posted: Mar 9, 2018
• Last Update Posted: Jul 9, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Edward Chao, Associate Clinical Professor, University of California, San Diego: Sensor; Glucose; Sweat
• Additional relevant MeSH terms: Diabetes Mellitus; Pilocarpine

Study Results

No Results Posted as of Jul 9, 2020