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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: Glucose measurements


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Measuring glucose<br>Measuring glucose from interstitial fluid | Device: Glucose measurements<br>* We will not conduct an intervention, but will obtain measurements from a continuous, non-invasive glucose sensor, and compare with those from a glucometer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptablility of sensor | Will survey pts | At end of study testing sessions, at 8 hours |