Epidermal Adhesive Sensors to Enhance Continuous Glucose Measurement in Patients With Diabetes: The EASE Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus
- Sponsor
- University of California, San Diego
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Interstitial fluid glucose readings
- Last Updated
- 5 years ago
Overview
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.
Investigators
Edward Chao
Clinical Professor of Medicine
University of California, San Diego
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.
Outcomes
Primary Outcomes
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 Outcomes
- Acceptablility of sensor(At end of study testing sessions, at 8 hours)