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

July 28, 2020 updated by: Edward Chao, University of California, San Diego
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92037
        • Recruiting
        • University of California, San Diego
        • Contact:
        • Contact:
        • Principal Investigator:
          • Edward C Chao, DO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Measuring glucose
Measuring glucose from interstitial fluid
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interstitial fluid glucose readings
Time Frame: Hourly, up to 8 hours
Needle-less measurements with an epidermal sensor - pls note, study is to assess how sensor readings compare with those from a glucometer
Hourly, up to 8 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptablility of sensor
Time Frame: At end of study testing sessions, at 8 hours
Will survey pts
At end of study testing sessions, at 8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2019

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

September 9, 2019

First Submitted That Met QC Criteria

September 11, 2019

First Posted (Actual)

September 12, 2019

Study Record Updates

Last Update Posted (Actual)

July 30, 2020

Last Update Submitted That Met QC Criteria

July 28, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 190708

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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