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

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. Identifier: NCT01065948
Recruitment Status : Completed
First Posted : February 10, 2010
Last Update Posted : February 4, 2016
Endocrinoloogy Associates Houston
Information provided by (Responsible Party):
BioTex, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Device: Subcutaneous glucose monitoring device Phase 1

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
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
Study Start Date : November 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : August 2012

Arm Intervention/treatment
Experimental: Patients Device: Subcutaneous glucose monitoring device
monitor interstitial glucose level every 5 min over 4 hours
Other Name: Fluorescence Affinity Sensor (FAS)

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

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

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

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.

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 identifier (NCT number): NCT01065948

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

Responsible Party: BioTex, Inc. Identifier: NCT01065948     History of Changes
Other Study ID Numbers: FAS-2009-05
First Posted: February 10, 2010    Key Record Dates
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
type I Diabetes
type II diabetes