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

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

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

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

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

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)

December 9, 2019

Primary Completion (Anticipated)

March 15, 2020

Study Completion (Anticipated)

March 15, 2020

Study Registration Dates

First Submitted

December 30, 2019

First Submitted That Met QC Criteria

January 9, 2020

First Posted (Actual)

January 13, 2020

Study Record Updates

Last Update Posted (Actual)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 9, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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