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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Device: Subcutaneous glucose monitoring device

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
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77025
      • Practice of Eric Orzeck, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients	Device: Subcutaneous glucose monitoring device; monitor interstitial glucose level every 5 min over 4 hours; Other Names: Fluorescence Affinity Sensor (FAS)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
examine insertion site while the FAS is worn, and after seven days of FAS removal	3 months
assess comfort level during FAS insertion, when worn during normal activities, and during FAS removal	3 months

Collaborators and Investigators

• Sponsor: BioTex, Inc.
• Collaborators: Endocrinoloogy Associates Houston
• Investigators: Principal Investigator: Ralph Dutt-Ballerstadt, Ph.D., BioTex, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: February 8, 2010
• First Submitted That Met QC Criteria: February 9, 2010
• First Posted (Estimate): February 10, 2010

Study Record Updates

• Last Update Posted (Estimate): February 4, 2016
• Last Update Submitted That Met QC Criteria: February 3, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: diabetes; biosensor; fluorescence; type II diabetes; affinity; subcutaneous glucose monitoring; type I Diabetes
• Other Study ID Numbers: FAS-2009-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES