A clinical trial on children with type 1 diabetes started earlier than planned

A clinical study on hands and feet on children with type 1 diabetes has started earlier than expected. The study aims to compare the sensibility in fingers and foot sole between children with type 1 diabetes and children who do not have diabetes using VibroSense Dynamics method Multi Frequency Vibrometry
 
The study is conducted in collaboration with the Pediatrics clinic at Skånes University Hospital where children with type 1 diabetes shall be examined. The aim is to compare the sensitivity in the hands and soles of the feet with reference values from children who do not have diabetes. The purpose is to investigate if Multi Frequency Vibrometry can be used to detect incipient nerve damage, i.e. peripheral neuropathy in children with diabetes. Early detection of peripheral neuropathy is essential to be able to prevent or delay the onset of nerve damage caused by diabetes.

The collection of reference values has been made in a study in healthy children aged 7-19 years and whose results were published in the scientific journal PLoS ONE. The study concluded that Multi Frequency Vibrometry can be a valuable method for detecting neuropathy in children and adolescents.

- Multi-frequency Vibrometry to investigate the tactile sense, may provide opportunities for early detection of neuropathy in children and to examine factors behind the development of any existing neuropathy. We hope to get results from the study at the beginning of next year, partly because we have a good picture on the tactile sense in healthy children and adolescents from a recently published study by the Children's Hospital, says Lars Dahlin, Professor of Hand Surgery at Skåne University Hospital.

Peripheral neuropathy is nerve damages in the body's peripheral parts such as hand, arm or foot. Symptoms include numbness, tingling, loss of sensitivity and pain in the hands or soles of the feet. Diabetes is one of the most common reasons for children and adults to suffer from peripheral neuropathy. But there are many other causes, such as genetic inheritance, hormonal imbalance, or medications.

- It is positive for the company that the study started earlier than expected because it shows that there is great interest and that we can move forward faster. Diagnosis of peripheral neuropathy in children is very difficult since the nervous system is fully developed at a late age i.e. 16-18 years. We also note that our Device can be used for other indications in addition to diabetes because peripheral neuropathy has many causes, such as side effects from medications or chemotherapy for cancer treatment, said Toni Speidel, CEO VibroSense Dynamics.

About foot ulcers and the VibroSense Meter system
All people with diabetes, both type I and II, have increased risk of getting foot ulcers, which in the worst case lead to amputation of all or part of the foot. This complication is often unnecessary according to medical experts, provided that impaired sensitivity is detected early. For early detection, preventive measures can be initiated, which can prevent a great deal of suffering and reduce the costs significantly. In 2014 the health care costs related to diabetes was estimated to at least 612 billion dollars worldwide.

VibroSense Dynamic’s device, the VibroSense Meter, can detect loss of sensitivity in hands at a very early stage. Pilot studies on feet have shown very promising results, so good that the company will develop a new device for examination of feet utilizing Multi Frequency Vibrometry. The objective is that the development shall be completed latest at the second half of 2017.

Contact
Toni Speidel, CEO VibroSense Dynamics AB, 070-893 21 07, and info@vibrosense.se.
www.vibrosense.se

About VibroSense Dynamics AB (publ)
VibroSense Dynamics AB (publ) develops and markets medical devices and services for diagnostics of nerve damage in hands and feet to Diabetes clinics, Occupational health care, Hospitals, Clinics and Scientists. The company was founded in 2005 and has its headquarters in Malmö, Sweden.

About Us

VibroSense Dynamics AB (public) develops and markets efficient systems for early detection and diagnosis of peripheral sensory neuropathy, i.e. disease of large nerve fibers and nerve trunks in the legs and arms. The Company, founded in 2005, is listed on the Small Cap list AktieTorget since May 2015. The product portfolio includes a CE-marked medical device, the VibroSense Meter, for diagnostics of impaired sensitivity in the hands. www.vibrosense.com

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