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:
Collaborator:
Endocrinoloogy Associates Houston
Information provided by (Responsible Party):
BioTex, Inc.
ClinicalTrials.gov Identifier:
NCT01065948
First received: February 8, 2010
Last updated: February 3, 2016
Last verified: February 2016

February 8, 2010
February 3, 2016
November 2009
June 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01065948 on ClinicalTrials.gov Archive Site
  • 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 ]
• examine insertion site while the FAS is worn, and after seven days of FAS removal. • assess comfort level during FAS insertion, when worn during normal activities, and during FAS removal. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Feasibility Study to Assess Critical Aspects of Fluorescence Affinity Sensor (FAS) Performance and Safety Over Several Hours
A Feasibility Study to Assess Critical Aspects of FAS Performance and Safety Over Several Hours
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.
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).
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Diabetes
Device: Subcutaneous glucose monitoring device
monitor interstitial glucose level every 5 min over 4 hours
Other Name: Fluorescence Affinity Sensor (FAS)
Experimental: Patients
Intervention: Device: Subcutaneous glucose monitoring device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
August 2012
June 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01065948
FAS-2009-05
Yes
Yes
Not Provided
BioTex, Inc.
BioTex, Inc.
Endocrinoloogy Associates Houston
Principal Investigator: Ralph Dutt-Ballerstadt, Ph.D. BioTex, Inc.
BioTex, Inc.
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP