Feasibility Trial of the Bios Device for Continuous Glucose Monitoring

NCT04226846 | Unknown

• 1 other identifier: GRAPHWEAR 001
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Comparison between Bios device readings and glucose values

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects previously diagnosed with Type 1 or Type 2 diabetes mellitus

You may qualify if:

• Subject is at least 18 years of age;
• Subject has had a diagnosis of diabetes mellitus either Type I or Type II;
• 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;
• Subject able to wear multiple CGM devices simultaneously;
• 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.
• 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;
• 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;
• Subject is able to read and understand the Informed Consent Form and has voluntarily provided written informed consent;
• In the Principal Investigator's opinion, subject is able to be compliant with provisions laid out in this protocol.

You may not qualify if:

• 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;
• 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;
• History of substance abuse within 6 months of study start;
• Use of any illicit drugs during the duration of the study period;
• Marijuana use during the duration of the study period;
• If female, subject is pregnant or nursing;
• Subject is on active dialysis;
• Subjects whom the Principal Investigator believes may not be an appropriate candidate for this device.

Sponsors & Collaborators

• GraphWear Technologies Inc.: lead

Study Sites (1)

Diablo Clinical Research, Inc

Walnut Creek, California, 94598, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 13, 2020
• Study Start: December 9, 2019
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

US (1)