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A Feasibility Study to Assess Critical Aspects of Fluorescence Affinity Sensor (FAS) Performance and Safety Over Several Hours (FAS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01065948
First Posted: February 10, 2010
Last Update Posted: February 4, 2016
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. Read our disclaimer for details.
Collaborator:
Endocrinoloogy Associates Houston
Information provided by (Responsible Party):
BioTex, Inc.
  Purpose
The goal of this clinical research study is to learn about a new minimally invasive glucose monitoring device called Fluorescence Affinity Sensor (FAS). In this study, the FAS will be used to determine its effectiveness for glucose monitoring. Researchers want to find out how the device performs at two different body sites (forearm and abdomen) over 4 hours. The safety and comfort level of the device will also be studied.

Condition Intervention Phase
Diabetes Device: Subcutaneous glucose monitoring device Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Feasibility Study to Assess Critical Aspects of FAS Performance and Safety Over Several Hours

Further study details as provided by BioTex, Inc.:

Primary Outcome Measures:
  • examine accuracy of FAS response to glucose changes in subcutaneous tissue (compared to blood glucose concentrations measured with reference method) [ Time Frame: 3 months ]
  • monitor safety and performance of FAS response in two different body sites (abdomen, forearm) [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • examine insertion site while the FAS is worn, and after seven days of FAS removal [ Time Frame: 3 months ]
  • assess comfort level during FAS insertion, when worn during normal activities, and during FAS removal [ Time Frame: 3 months ]

Enrollment: 12
Study Start Date: November 2009
Study Completion Date: August 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients Device: Subcutaneous glucose monitoring device
monitor interstitial glucose level every 5 min over 4 hours
Other Name: Fluorescence Affinity Sensor (FAS)

Detailed Description:
The FAS glucose monitoring system is a minimally invasive glucose monitoring device which is not yet approved by the FDA. The FAS system will be used in this study to monitor glucose levels during a glucose tolerance test (GTT) performed in Dr.Orzeck practice. The FAS measures glucose levels in skin tissue of the forearm or the abdomen at a depth of less than 1 mm by inserting a small needle-like device. During the 4-hour GTT, the needle-like FAS is left in the skin tissue. The FAS performance has indicated in prior experiments that it is more stable than competitive commercial glucose-sensing devices. Due to its unique design, its glucose response is more accurate, and less affected by certain drugs (such as pain medicine).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female and male patients with Type I and II diabetes requiring injectable insulin from age 18-80.

Exclusion Criteria:

  • Patients with fasting glucose concentration larger than 200 mg/dL will be excluded from the study.
  • Children under the age of 18 will not be included because Texas state law would not allow such participants to give informed consent on their own.
  • Patients who are required to take certain medications including corticosteroids, diuretics, anticonvulsants, birth-control pills, non-steroidal anti-inflammatory drugs (NSAIDs) and certain high-blood pressure medications will be excluded from the study.
  • Pregnant women or any patient who cannot participate in an oral glucose tolerance test will also be excluded from the study. Presence of pacemaker or defibrillator.
  Contacts and Locations
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): NCT01065948


Locations
United States, Texas
Practice of Eric Orzeck, MD
Houston, Texas, United States, 77025
Sponsors and Collaborators
BioTex, Inc.
Endocrinoloogy Associates Houston
Investigators
Principal Investigator: Ralph Dutt-Ballerstadt, Ph.D. BioTex, Inc.
  More Information

Responsible Party: BioTex, Inc.
ClinicalTrials.gov Identifier: NCT01065948     History of Changes
Other Study ID Numbers: FAS-2009-05
First Submitted: February 8, 2010
First Posted: February 10, 2010
Last Update Posted: February 4, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by BioTex, Inc.:
subcutaneous glucose monitoring
diabetes
fluorescence
affinity
biosensor
type I Diabetes
type II diabetes