Epidermal Adhesive Sensors to Enhance Continuous Glucose Measurement in Patients With Diabetes: The EASE Study
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus
Started Sep 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2019
CompletedFirst Posted
Study publicly available on registry
September 12, 2019
CompletedStudy Start
First participant enrolled
September 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedJuly 30, 2020
July 1, 2020
1.7 years
September 9, 2019
July 28, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Interstitial fluid glucose readings
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 Outcomes (1)
Acceptablility of sensor
At end of study testing sessions, at 8 hours
Study Arms (1)
Measuring glucose
EXPERIMENTALMeasuring glucose from interstitial fluid
Interventions
We will not conduct an intervention, but will obtain measurements from a continuous, non-invasive glucose sensor, and compare with those from a glucometer.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Diego
San Diego, California, 92037, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edward C Chao, DO
UCSD
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor of Medicine
Study Record Dates
First Submitted
September 9, 2019
First Posted
September 12, 2019
Study Start
September 26, 2019
Primary Completion
June 1, 2021
Study Completion
June 1, 2021
Last Updated
July 30, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share