Diabetes Mellitus
Conditions
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.
Interventions
DEVICEGlucose 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.
Sponsors
University of California, San Diego
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Acceptablility of sensor | At end of study testing sessions, at 8 hours | Will survey pts |
Countries
United States
Contacts
Primary ContactCarolyn Hernandez, BS
Outcome results
None listed