Feasibility Trial of the Bios Device for Continuous Glucose Monitoring

• Conditions: Type 1 Diabetes; Type 2 Diabetes

• Registration Number: NCT04226846
• Lead Sponsor: GraphWear Technologies Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-09
• Study First Submitted: 2019-12-30
• Status Verified: 2020-01
• Study First Submitted QC: 2020-01-09
• Last Update Submitted: 2020-01-09
• Study First Posted: 2020-01-13
• Last Update Posted: 2020-01-13
• Primary Completion: 2020-03-15
• Study Completion: 2020-03-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison between Bios device readings and glucose values	2 weeks	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.

Trial Locations

Locations (1)

Diablo Clinical Research, Inc; 🇺🇸 Walnut Creek, California, United States