Measuring Sweat Glucose of Patients With Diabetes - The ENGAGE Study

NCT ID: NCT03460964

Last Updated: 2020-07-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2019-09-05

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Adhesive glucose sensor

Intervention Type: DEVICE

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

Pilocarpine

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: DEVICE

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Edward Chao

Associate Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edward C Chao, DO

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

UCSD Altman Clinical and Translational Research Institute

San Diego, California, United States

UCSD

San Diego, California, United States

Countries

United States

Other Identifiers

UL1TR001442

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SD

Identifier Type: -

Identifier Source: org_study_id