Diabetes has become one of the largest global health emergencies of the 21st century. Prevalence of diabetes vascular complications is increasing despite medical advancements. The lifespan of a patient with diabetes is reduced by 12 years due to vascular complications with significant impact on quality of life. However, there are no current methods of assessment of vascular function in diabetes which can be used early for diagnosis or for targeted reversibility.
Vascular disease starts from activation of the endothelial cells lining the blood vessels, which if prolonged may lead to decrease in distensibility. Hence, a device which measures distensibility of a distal vessel, in a non-invasive and user-friendly manner should be a good biomarker for preclinical disease.
We have developed a device with the capability to measure distensibility in the radial artery based on the electromagnetic effects of haemodynamic modulation. In a proof-of-concept study, we demonstrated that the measurements from this device correlate with diabetes, traditional cardiovascular risk factors and the Framingham risk score.
We aim to improve health and reduce illness in metabolic disorders through patient-centred, early vascular function assessment that is accessible, cost-effective, non-invasive and effective. Our target market focus is on the primary care physicians and diabetes care clinics at the initial stages.
For the next stage of development, we are seeking industry partners to enhance the prototype so as to improve the ease of obtaining measurements and minimise patient discomfort. Clinical trials in a larger population will be conducted with the re-designed product.
TECHNOLOGY FEATURES & SPECIFICATIONS
Our device is able to measure maximum distensibility (comprising of both reactive hyperaemia and arterial stiffness) in radial artery in a non-invasive manner but still retain reliability with minimum inter-individual variations. Briefly our device measures the capability of radial artery to dilate after a period of occlusion which reflects the capability of artery to accommodate to high flow. We have observed strong correlations with the Framingham risk scores and other conventional risk score engines in healthy individuals and T2DM individuals.
There are current devices in the market which measure vascular function at other sites, one of which measures endothelial function only, which has a higher degree of variability and does not produce consistent results. Administration of these require training and each costing approximately five-figures range. Devices are available which measures arterial stiffness. These devices were priced very highly with expensive consumables per measurement, difficult to administer and provide very inconsistent results. Our device is able to surpass these hurdles as we plan to provide the service at a relatively lower cost, is easy to administer and can be done by any nurse in the clinic and the results have lower variability.
Our proposed solution has easy access, non-invasive and preclinical information to establish cut-offs such that risk stratification can be done. If significant correlations are seen with significant research and standardisation methods, it may become a significant tool required in every clinic as a sum measure of effect of control of the chronic diseases: diabetes mellitus, hypertension and hyperlipidaemia.
The technology has the potential to improve healthcare in various ways:
1. By risk stratification of individuals in the primary care clinic, it can help to identify individuals who are at higher risk to develop macrovascular complications so that these individuals can be targeted for intensive control and/or specialist care as a priority. This will help to direct the resources in an appropriate manner.
2. In the tertiary diabetes clinics, since in individuals with diabetes we will be able to see the effects of hyperglycaemia on the vasculature in a tangible manner we can personalize the treatment targets to achieve optimum results and a potential reduction in complications.
Other possible applications:
Rheumatology Clinics: Individuals with autoimmune conditions like rheumatoid arthritis also have higher risk of vascular complications and they need early measures of vascular function to guide treatment types.
Clinical Research Centres: This measurement can be used as an intermediate surrogate marker for cardiovascular disease. Researchers can study intermediate outcomes for nutrition, lifestyle and therapeutic interventions in terms of vascular risk.
General Wellness Clinics: emphasizing on lifestyle therapy to monitor progress in level of vascular fitness with improvements in lifestyle.
Hospitals and Emergency Services: Individuals with acute presentations of infections which can subsequently lead to shock can be identified early be measuring the vascular function as well.