According to the World Health Organization (WHO), India had 69.2 million people living with diabetes in 2015. By 2030, it is expected to touch 100 million. Known as ‘the silent killer’, diabetes is a chronic metabolic disease caused by reduced insulin produced by the body. People with poor control over their blood sugar risk disease or damage to the eyes, heart, kidneys and other organs.
A less-monitored — yet widely prevalent — a complication of chronic diabetes is nerve damage, or neuropathy, that affects the feet. The person does not feel and, hence, does not notice an injury. The injury does not heal, turning into an ulcer. If untreated, this leads to gangrene and requires amputation, ranging from toe to the entire leg. This creates disability, deteriorates functional independence and aggravates the diabetic condition.
A diabetic foot amputation takes place every few minutes in India, according to some estimates. These can be prevented by a holistic examination of the feet, diagnosing the condition early and taking proper care. The examination includes checking the perception of touch, vibration and temperature stimuli applied to the soles of the patient’s feet. These tests are subjective — relying on the perceived response of patients and, hence, need to be repeated.
Dr Rajani Mullerpatan, Director, Centre for Human Movement Science (MGMCHMS), at the MGM Institute of Health Sciences, Navi Mumbai, noticed that the soles of diabetic patients are stiffer compared to those of a normal patient. She hypothesised that a single device for objective testing of the stiffness of the soles of a patient’s feet will replace several existing tests and help in mass screening and monitoring the foot complication. She approached the Biomedical Engineering and Technology incubation Centre (BETiC) at IIT-Bombay with a concept design to develop a novel device for early detection of diabetic neuropathy. The team developed several versions with clinical input from the MGMCHMS team.
Nishant Kathpal, an IIT-B student, who developed the latest version of the portable diabetic foot screener, declined an offer from Intel to commercialise the product. He incubated a company, called Ayati Devices, at SINE, the business incubator of IIT-Bombay. His team won the coveted Biotechnology Ignition Grant of Rs 5 million from BIRAC, New Delhi. The funds are being used for pilot batch production, as well as clinical trials at MGM and other hospitals. The latest version of the product was launched on October 2, 2019.
‘Our device has a short plunger that presses the sole and measures the reaction force to obtain the stiffness value. The device is fully automatic and can be connected to a mobile phone to screen the results. These are categorized as green (safe), orange (borderline) and red (diabetic foot condition). The screening takes less than two minutes, compared with over 15 minutes by other products in the market. Early detection of the diabetic foot neuropathy condition will enable more effective treatment, preventing millions of such foot amputations worldwide’
- Nishant Kathpal, IIT-B student
The device is slated for testing on a large number of patients with diabetic neuropathy to generate objective data to create the three categories that will be mapped against normative values from other people with diabetes.
According to Dr Rupesh Ghyar, Senior Executive Officer, BETiC, the device has successfully passed mechanical and electrical safety tests carried out in accredited regional test labs, in accordance with international standards. It has also received a ‘no-objection’ certificate from the CDSCO, New Delhi, which regulates the manufacturing and marketing of pharmaceutical drugs and medical devices in India.
The team recently won the best IoT Healthcare Innovation award at the IoT Congress, 2019, in Bengaluru. They will also be showcasing the device at the Go Global India Program in London on December 1. In February 2020, the device will be presented at the Swissnex Academia Industry Training Workshop in Switzerland and Advanced Technologies and Treatments for Diabetes Conference in Spain.