Feasibility Trial of the Bios Device for Continuous Glucose Monitoring

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04226846
• Other study ID #: GRAPHWEAR 001
• Status: Recruiting
• Start date: December 9, 2019
• Est. completion date: March 15, 2020

Study information

• Verified date: January 2020
• Source: GraphWear Technologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 1 Diabetes
• Type 2 Diabetes

Locations

Country	Name	City	State
United States	Diablo Clinical Research, Inc	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
GraphWear Technologies Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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