Recruiting

Bios Device

Sponsor:

GraphWear Technologies Inc.

Code:

NCT04226846

Conditions

Type 1 Diabetes

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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 ID

NCT04226846

Start date

Dec 9, 2019

Status verified date

Jan, 2020

Completion date

Mar 15, 2020

Anticipated

Primary completion date

Mar 15, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Comparison between Bios device readings and glucose values [ Time Frame: 2 weeks ]

Central Contacts and Locations

Locations

Diablo Clinical Research, Inc

Recruiting

Walnut Creek, California, United States, 94598

Contacts

More Information

Sponsor

GraphWear Technologies Inc.

Last update posted

Jan 13, 2020

Last verified

Jan, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by GraphWear Technologies Inc. on 2020-01-13.