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

Not Applicable

• Conditions: Diabetes Mellitus
• Interventions: Device: Glucose measurements

• Registration Number: NCT04088201
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-09
• Study First Submitted QC: 2019-09-11
• Study First Posted: 2019-09-12
• Study Start: 2019-09-26
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-28
• Last Update Posted: 2020-07-30
• Primary Completion: 2021-06
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Measuring glucose	Glucose measurements	Measuring glucose from interstitial fluid

Primary Outcome Measures

Name	Time	Method
Interstitial fluid glucose readings	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

Name	Time	Method
Acceptablility of sensor	At end of study testing sessions, at 8 hours	Will survey pts

Trial Locations

Locations (1)

University of California, San Diego; 🇺🇸 San Diego, California, United States