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Feasibility Trial of the Bios Device for Continuous Glucose Monitoring

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04226846
Recruitment Status : Recruiting
First Posted : January 13, 2020
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Type 1 Diabetes Type 2 Diabetes

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Clinical Feasibility Study of the Bios Device for Continuous Glucose Monitoring in Subjects With Type 1 or Type 2 Diabetes Mellitus
Actual Study Start Date : December 9, 2019
Estimated Primary Completion Date : March 15, 2020
Estimated Study Completion Date : March 15, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects previously diagnosed with Type 1 or Type 2 diabetes mellitus
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04226846


Locations
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United States, California
Diablo Clinical Research, Inc Recruiting
Walnut Creek, California, United States, 94598
Contact: Emily Galdes    925-930-7267    egaldes@diabloclinical.com   
Sponsors and Collaborators
GraphWear Technologies Inc.
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Responsible Party: GraphWear Technologies Inc.
ClinicalTrials.gov Identifier: NCT04226846    
Other Study ID Numbers: GRAPHWEAR 001
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases