Feasibility Trial of the Bios Device for Continuous Glucose Monitoring

NCT ID: NCT04226846

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-09
• Study Completion Date: 2020-03-15

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.

Conditions

Type 1 Diabetes; Type 2 Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

Exclusion Criteria

1. 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;

2. 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;

3. History of substance abuse within 6 months of study start;

4. Use of any illicit drugs during the duration of the study period;

5. Marijuana use during the duration of the study period;

6. If female, subject is pregnant or nursing;

7. Subject is on active dialysis;

8. Subjects whom the Principal Investigator believes may not be an appropriate candidate for this device.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GraphWear Technologies Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Diablo Clinical Research, Inc

Walnut Creek, California, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Emily Galdes

Role: primary

egaldes@diabloclinical.com

925-930-7267

Other Identifiers

GRAPHWEAR 001

Identifier Type: -

Identifier Source: org_study_id