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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by BioTex, Inc..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Eric Orzeck's Practice
Information provided by:
BioTex, Inc.
ClinicalTrials.gov Identifier:
NCT01065948
First received: February 8, 2010
Last updated: February 16, 2010
Last verified: February 2010
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Feasibility Study to Assess Critical Aspects of FAS Performance and Safety Over Several Hours

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
Drug Information available for: Dextrose
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
  • monitor safety and performance of FAS response in two different body sites (abdomen, forearm) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 20
Study Start Date: November 2009
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01065948

Contacts
Contact: Ralph Dutt-Ballerstadt, Ph.D. 713-741 0111 ralph@biotexmedical.com
Contact: Ashok Gowda, Ph.D. 713-741 0111 ashok@biotexmedical.com

Locations
United States, Texas
Practice of Eric Orzeck, MD Recruiting
Houston, Texas, United States, 77025
Contact: Eric Orzeck, MD     713-797-9922     eric@ericorzeckmd.com    
Contact: Rachel Taylor, BS     713-797-9922     nurseracheltaylor@yahoo.com    
Principal Investigator: Eric Orzeck, MD            
Sponsors and Collaborators
BioTex, Inc.
Eric Orzeck's Practice
Investigators
Principal Investigator: Ralph Dutt-Ballerstadt, Ph.D. BioTex, Inc.
  More Information

No publications provided

Responsible Party: Ralph Dutt-Ballerstadt, Ph.D., BioTex, Inc.
ClinicalTrials.gov Identifier: NCT01065948     History of Changes
Other Study ID Numbers: FAS-2009-05
Study First Received: February 8, 2010
Last Updated: February 16, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013