A Feasibility Study to Assess Critical Aspects of Fluorescence Affinity Sensor (FAS) Performance and Safety Over Several Hours
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | November 2009 |
| End Date: | August 2012 |
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.
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.
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).
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.
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