Epidermal Adhesive Sensors to Enhance Continuous Glucose Measurement in Patients With Diabetes: The EASE Study

NCT ID: NCT04088201

Last Updated: 2020-07-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-26
• Study Completion Date: 2021-06-30

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 Design

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

Study Groups

Measuring glucose

Measuring glucose from interstitial fluid

Group Type: EXPERIMENTAL

Glucose measurements

Intervention Type: DEVICE

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

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Edward Chao

Clinical Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edward C Chao, DO

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

University of California, San Diego

San Diego, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Carolyn Hernandez, BS

Role: CONTACT

c1hernandez@health.ucsd.edu

562-787-0951

Facility Contacts

Carolyn Hernandez, BA

Role: primary

jhmills@ucsd.edu

858-246-5145

Edward Chao, DO

Role: backup

ecchao@ucsd.edu

619-400-5050 ext. Chao

Related Links

http://cws.ucsd.edu/research

Related Info

Other Identifiers

190708

Identifier Type: -

Identifier Source: org_study_id