Feasibility Trial of the Bios Device for Continuous Glucose Monitoring

January 9, 2020 updated by: GraphWear Technologies Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Walnut Creek, California, United States, 94598

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects previously diagnosed with Type 1 or Type 2 diabetes mellitus

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Comparison between Bios device readings and glucose values
Time Frame: 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.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GraphWear Technologies Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 9, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GRAPHWEAR 001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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