Feasibility Trial of the Bios Device for Continuous Glucose Monitoring

Study Overview
=================
Brief Summary
-----------------
The study is an open-label, prospective, within-subject comparison of the Bios device readings versus venous blood sample glucose readings, glucose readings from a Dexcom CGM and an SMBG device in subjects previously diagnosed with Type 1 or Type 2 diabetes mellitus.

Official Title
-----------------
A Clinical Feasibility Study of the Bios Device for Continuous Glucose Monitoring in Subjects With Type 1 or Type 2 Diabetes Mellitus

Conditions
-----------------
Type 1 Diabetes, Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is at least 18 years of age; Subject has had a diagnosis of diabetes mellitus either Type I or Type II; 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; Subject able to wear multiple CGM devices simultaneously; 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. 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; 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; Subject is able to read and understand the Informed Consent Form and has voluntarily provided written informed consent; In the Principal Investigator's opinion, subject is able to be compliant with provisions laid out in this protocol. Exclusion Criteria: Subjects with any physical or behavioral disorder, which, in the opinion of the Principal Investigator, may interfere with the use of the device or compliance with the study protocol; Subject has any of the following: a skin condition that precludes wearing of the device; a known allergy that precludes wearing of the device; tattoos or other skin alterations that may interfere with device placement and/or operation; History of substance abuse within 6 months of study start; Use of any illicit drugs during the duration of the study period; Marijuana use during the duration of the study period; If female, subject is pregnant or nursing; Subject is on active dialysis; Subjects whom the Principal Investigator believes may not be an appropriate candidate for this device.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between Bios device readings and glucose values | The primary objective of this study is to compare the glucose measurements collected by the Bios device to glucose values measured with a blood glucose lab analyzer (e.g., YSI), glucose values obtained with a self-monitoring blood glucose device (SMBG) and readings from the Dexcom System in subjects previously diagnosed with Type 1 or Type 2 diabetes mellitus. | 2 weeks |