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

Completed · Phase 1

Conditions studied: Diabetes

In brief

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.

Key facts

Study ID

NCT01065948

Run by

BioTex, Inc.

People needed

12

Starts

2009-11-01

Expected to finish

2012-08-01

Last updated by the study team

2016-02-04

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Female and male patients with Type I and II diabetes requiring injectable insulin from age 18-80.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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