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

Diabetes Clinical Trial

— FAS  

Official title:

A Feasibility Study to Assess Critical Aspects of FAS Performance and Safety Over Several Hours

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01065948
• Other study ID #: FAS-2009-05
• Status: Completed
• Phase: Phase 1
• First received: February 8, 2010
• Last updated: February 3, 2016
• Start date: November 2009
• Est. completion date: August 2012

Study information

• Verified date: February 2016
• Source: BioTex, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• Subcutaneous glucose monitoring device
monitor interstitial glucose level every 5 min over 4 hours

Locations

Country	Name	City	State
United States	Practice of Eric Orzeck, MD	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
BioTex, Inc.	Endocrinoloogy Associates Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	examine accuracy of FAS response to glucose changes in subcutaneous tissue (compared to blood glucose concentrations measured with reference method)		3 months	Yes
Primary	monitor safety and performance of FAS response in two different body sites (abdomen, forearm)		3 months	Yes
Secondary	examine insertion site while the FAS is worn, and after seven days of FAS removal		3 months	Yes
Secondary	assess comfort level during FAS insertion, when worn during normal activities, and during FAS removal		3 months	Yes