Innovative diagnostic device for the early detection of diabetic neuropathy in diabetes patients

Periodic Reporting for period 1 - INNODIAB (Innovative diagnostic device for the early detection of diabetic neuropathy in diabetes patients)

Okres sprawozdawczy: 2015-07-01 do 2015-10-31

387 million people in the world have diabetes today – a number predicted to grow to around 592 million by 2035. In Europe alone, IDF (International Diabetes Federation) data indicates a staggering growth from today’s 52 million people with diabetes, up to 68,9 million in 2035, or 7,9% prevalence to over 10%.

Diabetes affects the way the body uses food for growth and energy. There are two main forms of diabetes: type 1 and type 2. Type 1 is a lifelong autoimmune disease that develops when the body produces an immune response against its own cells, destroying the insulin-producing beta cells in the pancreas. As a result the pancreas stops producing insulin, often – but not always – at young age. Far more common is type 2 diabetes, which accounts for 90% of all people with diabetes and is caused by a combination of lifestyle and genetic factors.

People with Type 1 diabetes need to start taking insulin as soon as they are diagnosed and must continue to do so for the rest of their lives. People with type 2 diabetes need different treatments as the disease progresses. Initially, life style changes including diet and exercise, and one or more oral medicines may be sufficient. If treatment goals are not met, medicines such as GLP-1 therapy, basal insulin and/or rapid-acting insulin may be added to better balance the blood glucose round the clock.

A significant challenge in managing diabetes with insulin is to maintain appropriate blood glucose levels, adjusting insulin dosing as necessary to balance the impact of food and exercise to avoid either high blood glucose levels (hyperglycaemia). High blood glucose levels can lead to long-term complications, whilst low blood glucose levels (hypoglycaemia) can lead to seizures, unconsciousness or, in rare cases, death.

Diabetes is a leading cause of non-traumatic lower-limb amputations caused by Distal Neuropathy (DNP). Approximately 20–25% of all diabetic patients will present with lower extremity ulceration at some time in their lives. Only 2/3 heals without surgery, 5-year survival rate of foot ulcers can be as low as 56% at some clinics, in the same order as for many cancers. (Data from NHS, UK).

In human as well as financial terms, the burden of diabetes is high, being a factor in 4,9 million deaths and accounting for some 612 Billion USD in health spending (11% of the total spend worldwide) in 2014, according to the IDF (International Diabetes Foundation).What all countries have in common is that the diabetes pandemic cannot be ignored. From both the human and economic perspective, it is important that countries have a plan for how to address diabetes with a view to minimising both the personal strains and the financial burden of diabetes.

The objective of this report addresses the opportunity, the importance and the activities required to use Multi Frequency Vibrometry technique for the early diagnose of Distal Neuropathy to reduce/delay/prevent the Diabetic foot ulcers and amputations.

An extensive literature investigation was performed and several meetings and discussions were held with both key opinion leaders as well as with nurses at health clinics in Sweden, the UK, Germany and Denmark providing foot care for diabetic patients.

What became clear during this Phase 1 study was that the problem is even larger and more acute to deal with than we first estimated. This has strengthen us in our believe that the unmet need to reduce both Diabetic Foot Ulcers (DFU) and the very severe follow-on complications with amputations, requires a strong effort from stakeholders both on a national level as well as on a European level, with a very big opportunity worldwide, as the Diabetes is ever increasing into epidemic proportions.

In 2011 the UN held a High-Level Summit on Non-Communicable Diseases (NCDs), a major milestone in the history of global health and development. At this meeting world leaders made an unprecedented commitment to accelerate global progress on diabetes and NCDs.

As a consequence from this meeting, IDF developed a Roadmap Programme, including Guidelines for National Guidelines for Diabetes and monitoring of Diabetes related complications. In these Guidelines it clearly states that diabetes patients shall have a right to receive regularly monitoring of Diabetic NeuroPathy (DNP) as can be seen from the following excerpts from the Guideline for National Diabetes Programmes:

“8. Clinical monitoring for the early detection of diabetes complications

All people with diabetes should be monitored regularly to assess the status of their metabolic control, the possible need for treatment changes, and to detect the onset of complications at an early stage where interventions can then slow or prevent their progression. Physical and laboratory assessments should be regular and should include:
- measurement of glycated haemoglobin ( HbA1c)
- assessment of lipids
- measurement of blood pressure
- measurement of kidney function (ideally by albuminuria)
- retinal examination through dilated pupils
- foot examination (including testing sensation perception with a10g monofilament)
- weight assessment.”

http://www.idf.org/webdata/Guide-to-NDP_web.pdf

The conclusion we make is that for 6 of the above mentioned 7 required assessments procedures are already in place to detect the onset of complications at an early stage where interventions can then slow or prevent their progression, except for the sensation perceptions.

However, it has also absolutely been clear that Monofilament does not fulfil this requirement. Hence, Vibrosense Dynamics have an absolute unique opportunity to play a major role with high impact both for the Healthcare systems in Europe, as well as on the worldwide scene.

In a systematic review of over 30 scientific articles, involving over 8000 patients (Feng et al, 2009), indicated a very large variations in specificity, sensitivity and predictive value from as low as 36% up to 100% for monofilament. Other methods (tuning fork, and biothesiometer) shows similar ranges. This means that many patients are missed or are wrongly diagnosed with DNP.

When patients are diagnosed with DNP they should be referred to a foot clinic for specially shoe fitting (practice varies between EU countries). However, with low specificity, sensitivity and/or predictability, many patients are therefore sent first of all too late and for the wrong reasons, and patients who should be sent are missed. Hence, we want to reduce the level of False Positive and False Negative, and provide more accurate and early diagnosis of DNP to aid more intensive diabetes management of the right patients.

Every 20 seconds a diabetic foot is amputated somewhere in the world!

We expect Multi-Frequency Vibrometry to have a significant impact on reducing Diabetic Foot Ulcers (DFU) and consequential damages such as amputations.

Our method helps diabetes care to prevent foot ulcers and amputations through early detection of loss of sensibility in the feet. With early detection and preventive measures, it will be possible to avoid foot ulcers before they occur. In the UK alone, the estimated annual NHS expenditure (2013) for ulceration and amputation is around £650 million, or £1 in every £150 of total NHS spending. Hence, through significantly increasing the specificity and sensitivity, we expect to send the right patient at the right time for further and stricter diabetic control with multi-disciplinary teams to reduce the rate of DFU and amputations.

The current ratio between wound care and amputation in relation to preventive measures is 80/20 i.e. 80% of all cost related to health care of the diabetic foot goes to wound care and amputation. According to all experts of the Diabetic Foot, most foot ulcers and amputations could be avoided provided that Diabetic NeuroPathy (DNP) could be diagnosed at an early stage. This is not possible with current diagnostic tools.

Here we foresee a huge potential for Multi-Frequency Vibrometry (MFV) which not only may detect DNP at a very early stage, i.e. we are convinced that MFV may become a full range diagnostic tool for Screening, Diagnosis and Monitoring.

As a result, a lot of pain and suffer may be avoided, whilst the health care will save a significant amount of spending for the total health care cost of the Diabetic Foot

Prototype Device for examination of diabetes feet

Periodic Reporting for period 1 - INNODIAB (Innovative diagnostic device for the early detection of diabetic neuropathy in diabetes patients)

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