ClinicalTrials.gov
ClinicalTrials.gov Menu

Measuring Sweat Glucose of Patients With Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03460964
Recruitment Status : Recruiting
First Posted : March 9, 2018
Last Update Posted : March 19, 2018
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Edward Chao, 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Device: Adhesive glucose sensor Drug: Pilocarpine Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sweat

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.




Primary Outcome Measures :
  1. Glucose measurements [ 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. ]
    Comparing glucose readings from the sensor with those from a glucometer


Secondary Outcome Measures :
  1. Acceptability of sensor [ 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. ]
    Will ask participants for written and verbal feedback



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03460964


Contacts
Contact: David Ashley, MPH (858) 246-2223 dashley@ucsd.edu

Locations
United States, California
UCSD Altman Clinical and Translational Research Institute Recruiting
San Diego, California, United States, 92161
Contact: Edward C Chao, DO    619-916-8719    ecchao@ucsd.edu   
Principal Investigator: Edward C Chao, DO         
Sub-Investigator: Joseph Wang, PhD         
UCSD Recruiting
San Diego, California, United States, 92161
Contact: David Ashley, MPH       dashley@ucsd.edu   
Contact: Edward C Chao, DO    619-400-5050    ecchao@ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
National Institutes of Health (NIH)
Investigators
Principal Investigator: Edward C Chao, DO UCSD

Responsible Party: Edward Chao, Associate Clinical Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03460964     History of Changes
Other Study ID Numbers: SD
UL1TR001442 ( U.S. NIH Grant/Contract )
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Edward Chao, University of California, San Diego:
Sensor
Glucose
Sweat

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pilocarpine
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action