Chronic Disease and Diabetes Involves Multi-Disciplinary Healthcare Professionals
Healthcare professionals are involved in the detection, monitoring, management and treatment of chronic disease conditions and diabetes. The American Diabetes Association has stated that early detection is critical to improving the outcome.
In the U.S. there are about 25.8 million people with diabetes and another estimated 79 million with pre-diabetes. "The Centers for Disease Control and Prevention (CDC) has declared diabetes at epidemic levels in the United States. The CDC estimates 90% of those with pre-diabetes don’t know they have the condition." The World Health Organization estimates 220 million people live with diabetes worldwide today and will more than double by 2030.
In early 2013 Freedom Meditech received FDA clearance for the first-in-class CLEARPATH DS-120™ device that detects autofluorescence of the crystalline lens of the eye. In independent scientific studies published in peer-reviewed journals, elevated autofluorescence measurements have been linked to high levels of advanced glycosylated end products, which accumulate in the presence of diabetes and uncontrolled glucose over time.
Substantial independent data supports correlation between autofluorescence and diabetes[1]:
- Lens fluorescence is greater in patients with diabetes compared to patients without
- Increased lens autofluorescence was due to the irreversible accumulation of Advanced Glycation End-products (AGEs) and served as an index of long-term glycemic control
- Data indicates there is currently an average seven year lag time between the onset and diagnosis of diabetes
- Fluorescence increases linearly with age in both people with diabetes and without, but was significantly higher in all ages of people with diabetes
If you would like to participate in our no-obligation clinical program, please contact us at 858-638-1433.
Our current offerings include:
ClearPath DS-120™ Lens Fluorescence Biomicroscope
The ClearPath DS-120™ received 510(k) market clearance from the United States Food and Drug Administration, effective January 31, 2013.
The ClearPath DS-120™ is a proprietary non-invasive ophthalmic measurement tool that detects autofloresence of the crystalline lens of the eye. In independent scientific studies published in peer-reviewed journals, elevated autofluorescence measurements have been linked to high levels of advanced glycosylated end products which accumulate as a result of the aging process and the presence of systemic disease. This bio-photonic approach is appealing to healthcare providers and patients because the test is:
- Non-Invasive - There is no need for dilation, blood draw, or other patient preparation
- Quick - the test begins and ends within six seconds
- Immediate - Quantitative results are provided at the point of care with no need to wait several days test results
- Reliable - Has demonstrated a Repeatability and Reproducibility error of only 5.8 % and 6.4% respectively, which is more precise than comparable standard of care ophthalmic devices widely utilized by health care providers today.
- No Hassle - No fasting is required by the patient and no biohazard waste is generated that requires disposal by the clinican
Non-Invasive Glucose Monitoring for Diabetes
Our non-invasive glucose monitor is an investigational device not yet approved for market or sale in the United States
The non-invasive glucose monitor, is a rapid non-invasive, point of care, personal glucose meter that is operated by holding the small handheld device in front of the eye similar to a miniature telescope. Our non-invasive glucose monitor is planned to offer many benefits over the existing “finger prick”glucose test. The benefits include:
- Direct measurement of glucose in aqueous
- Painless
- Easy to use - no prick, no blood or bio waste
- Personalized glucose meter point of care
- Convenient
- Each test is calibrated ensuring quality reading
- Easy to read large number display
- Readings over time are captured and retained for computer down load:
- Tracks patient compliance
- Trending data
- Multiple test provide trend for better therapeutic decisions
- Out of control glucose excursions correlation with therapy
More Information Available for Download