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

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).

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.