Recruiting

Epidermal Sensors

Sponsor:

UCLA

Code:

NCT04088201

Conditions

Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Glucose measurements

Study Details

Brief summary:

Self-testing of glucose by patients living with diabetes mellitus (DM) involves needles, which can cause discomfort or inconvenience; these and other factors can lead to decreased willingness to perform these checks that are vital to DM management. While technology has evolved, a needle-free glucose monitoring device is currently not available. The investigators are studying a glucose sensor that adheres to the skin, similarly to a temporary tattoo. This sensor can now obtain continuous readings. As it has not yet been tested in individuals with DM, this study will examine its accuracy and acceptability in these patients. Results from this clinical trial could serve as the basis for further development of a non-invasive, wearable glucose sensor that can provide measurements of glucose levels continuously.

Conditions

Diabetes Mellitus

Study ID

NCT04088201

Start date

Sep 26, 2019

Status verified date

Jul, 2020

Completion date

Jun, 2021

Anticipated

Primary completion date

Jun, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • An existing diagnosis of diabetes mellitus, either T1DM or T2DM, or any other type or etiology of diabetes
  • Ability to provide informed consent for participation.

Exclusion Criteria:

  • Individuals without diabetes
  • Those who cannot speak or read English. We are limiting participation to those who read and speak English, as this is a pilot study of a small number of participants, that will very unlikely offer the prospect of direct benefit from participating.
  • Individuals who have frequent hypoglycemia, hypoglycemia unawareness, or who are at high risk for hypoglycemia.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Measuring glucose

Measuring glucose from interstitial fluid

Interventions

Glucose measurements

We will not conduct an intervention, but will obtain measurements from a continuous, non-invasive glucose sensor, and compare with those from a glucometer.

Primary outcome measure

  • Interstitial fluid glucose readings [ Time Frame: Hourly, up to 8 hours ]

Central Contacts and Locations

Central contacts

Carolyn Hernandez, BS

562-787-0951c1hernandez@health.ucsd.edu

Locations

University of California, San Diego

Recruiting

San Diego, California, United States, 92037

Contacts

Carolyn Hernandez, BA

858-246-5145jhmills@ucsd.edu

Edward Chao, DO

619-400-5050ecchao@ucsd.edu

Principal Investigator:

Edward C Chao, DO

More Information

Sponsor

University of California, San Diego

Last update posted

Jul 30, 2020

Last verified

Jul, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2020-07-30.