Vibrometry - a new diagnostic method to detect neuropathy in diabetes
| Reference number | |
| Coordinator | VIBROSENSEDYNAMICS AB |
| Funding from Vinnova | SEK 3 719 000 |
| Project duration | November 2014 - December 2018 |
| Status | Completed |
Purpose and goal
Today´s methods for diagnosing diabetes related nerve damage in the feet are crude and imprecise why such nerve damage is discovered too late. The purpose of the project has been to investigate whether MutiFrequency Vibrometry (MFV) is a more sensitive method that can support early diagnosis of onset of nerve damage in feet caused by diabetes. The aim of the project has been to adapt MFV to sensory measurement on the sole of the foot in patients with diabetes and to conduct clinical studies on healthy subjects and on patients with type 1 diabetes.
Expected results and effects
A prototype with a stronger vibrator has been developed and used in three clinical trials. Reference data has been collected from 882 healthy subjects (589 women, 292 men). Collected data is added as reference values in a developed and CE marked medical device. The feet of 608 people with type 1 diabetes were investigated and significant correlation was detected between: - Foot ulcer and impaired sensitivity at low frequencies 8-16 Hz - Improved HbA1c and improved sensitivity For the first time ever, it has been shown that it may be possible to reverse nerve damage in feet caused by diabetes.
Planned approach and implementation
The project was conducted in collaboration with three parties, 1. VibroSense Dynamics AB (coordinator), 2. The Department of Translational Medicine, section. for Hand Surgery Malmö Lund University and 3. The Clinic of Endocrinology - Skåne University Hospital. Clinical studies were performed by Hand Surgery and Endocrinology in Malmö. Data has been analysed in cooperation between all three parties. In the long term, the obtained result is expected to be of primary importance for primary and specialist care of patients with diabetes.