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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:
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
  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:


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 ]

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

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: February 8, 2010
Last Updated: February 3, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Yes

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

ClinicalTrials.gov processed this record on September 23, 2016