Feasibility Trial of the Bios Device for Continuous Glucose Monitoring

Inclusion Criteria

• •1. Subject is at least 18 years of age;
• •2. Subject has had a diagnosis of diabetes mellitus either Type I or Type II;
• •3. For insulin-using subjects only: subject will not inject insulin or wear an insulin pump insertion set within a 10 cm distance of any Bios device;
• •4. Subject able to wear multiple CGM devices simultaneously;
• •5. Subject is either a patient diagnosed with Type I diabetes mellitus currently wearing a Dexcom CGM device or a patient diagnosed with Type II diabetes mellitus who will agree to use a Dexcom CGM device during participation in the study. There are no restrictions on the model of the Dexcom CGM device.
• •6. Subject agrees to provide a log of medications (prescription and over-the-counter) and dietary supplements (e.g., vitamins) taken during the study period, including dosage;
• •7. Subject has a smart device that complies with the requirements listed in Attachment 1 of this protocol and is willing to download and run the GraphWear Patient application on their device;
• •8. Subject is able to read and understand the Informed Consent Form and has voluntarily provided written informed consent;
• •9. In the Principal Investigator's opinion, subject is able to be compliant with provisions laid out in this protocol.