Summary

for people ages 18-60 (full criteria)
at San Diego, California and other locations
study started
estimated completion:
Edward C Chao

Description

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.

Official Title

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

Details

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.

Keywords

Diabetes Mellitus Sensor Glucose Sweat Pilocarpine Adhesive glucose sensor

Eligibility

You can join if…

Open to people ages 18-60

  • 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.

You CAN'T join if...

  • 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.

Locations

  • UCSD Altman Clinical and Translational Research Institute accepting new patients
    San Diego California 92161 United States
  • UCSD accepting new patients
    San Diego California 92161 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT03460964
Lead Scientist
Edward C Chao
Study Type
Interventional
Last Updated