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

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ClinicalTrials.gov Identifier: NCT04088201
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
Edward Chao, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Device: Glucose measurements Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Epidermal Adhesive Sensors to Enhance Continuous Glucose Measurement in Patients With Diabetes: The EASE Study
Actual Study Start Date : September 26, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Acceptablility of sensor [ Time Frame: At end of study testing sessions, at 8 hours ]
    Will survey pts



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT04088201


Contacts
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Contact: Jeffrey Mills, BA 619-786-2854 jhmills@ucsd.edu

Locations
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United States, California
University of California, San Diego Recruiting
San Diego, California, United States, 92037
Contact: Jeffrey H Mills, BA    619-786-2854    jhmills@ucsd.edu   
Contact: Edward Chao, DO       ecchao@ucsd.edu   
Principal Investigator: Edward C Chao, DO         
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Edward C Chao, DO UCSD

Additional Information:
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Responsible Party: Edward Chao, Clinical Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04088201     History of Changes
Other Study ID Numbers: 190708
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases