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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04088201
• Other study ID #: 190708
• Status: Recruiting
• Phase: N/A
• Start date: September 26, 2019
• Est. completion date: June 2021

Study information

• Verified date: July 2020
• Source: University of California, San Diego
• Contact: Carolyn Hernandez, BS
• Phone: 562-787-0951
• Email: c1hernandez[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
United States	University of California, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Acceptablility of sensor	Will survey pts	At end of study testing sessions, at 8 hours

External Links

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