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Diabetes

According to the International Diabetes Federation's (IDF) estimate in 2018, about 425 million people worldwide suffered from diabetes. Diabetes is defined as chronically elevated blood sugar due to decreased insulin production in relation to the need or impaired insulin effect in the cells.  It can also be a combination of these. Diabetes is diagnosed with fasting blood sugar, HbA1c (long-term sugar), or with glucose tolerance test.

Medical background for diabetes

The disease is usually divided into two groups: type I and II. In recent years, several subgroups have been discovered. These subgroups are jointly characterized by elevated blood sugar levels, either due to (absolute or relative) lack of insulin or insufficient effect of insulin. The latter also called insulin resistance.

Complications of diabetes

Elevated blood sugar levels can cause permanent damage to the body's organs. One risk is that the body's blood vessels are calcified, which can lead to cardiovascular diseases. Another common complication is nerve damage (neuropathy) that can affect different parts of the nervous system. Neuropathy in the feet (and hands) leads to impaired sensitivity, which increases the risk of chronic wounds (foot ulcers) and also a special type of pain. Diabetic neuropathy also results in poorer balance and impairs the ability to heal any wounds.

High community costs

In addition to the patients' suffering, diabetes also leads to substantial healthcare costs for the society. Treatment of diabetes complications, especially foot ulcers, is very costly, especially in view of the large extent of the disease and rapid growth rate. Amputations cause long periods of care, rehabilitation, increased need for nursing and domestic help, and loss of production.

Foot ulcers and amputation

Diabetic Peripheral Neuropathy (DPN) are nerve damage caused by diabetes. It usually begins in the feet, which leads to reduced sensitivity in the soles of the feet. The damage evolves slowly (not recognised) and once the injuries are detected it can be difficult to reverse the condition which greatly increase the risk of getting foot ulcers.

Need for regular examination

To detect neuropathy (DPN), the feet should be examined by a doctor or diabetes nurse at least once a year. The examination should include a test of the ability to feel vibration and pressure of the feet. Patients with DPN can get various aids, such as offload by special made shoes or insole. They can also be offered medical foot care.

For advanced foot ulcers, it is common that the whole or parts of the foot is amputated. A very large part of all amputations worldwide are made on patients with diabetes.
 

Clinical Benefit – Diabetes

The VibroSense Meter II (VSM II) is intended for primary and specialist care and researchers who work with treatment, diagnosis or rehabilitation of peripheral neuropathy (DPN), especially in feet. The clinical benefit of VSM II is to help physicians and patients find early, positive or negative, changes in the sensory capability of the feet.

Target Profile for VSM II within Diabetes:

Target group

Clinical targets

Clinical use

Children and adolescent with DMT1* 
(Specialist care)

Examination of the foot with  VSM II once every six month

Adults with DMT1*
(Specialist care)

Examination of the foot with VSM II once every year

Adults with DMT2*
(Primary care)

Examination of the foot with VSM II once every year

* DMT1;2: Diabetes Mellitus 1;2
** DPN: Diabetes Perifer Neuropati