Most people with Type 1 or Type 2 diabetes measure their blood glucose levels multiple times daily with an invasive finger-prick test. The prick test stings a bit for a short time, but the aggravation of acquiring, carrying, and remembering to use the gear is even more irksome. Lakka Health, a Finish health tech company, filed a study design to evaluate a new, non-invasive sensor-based technology to detect low blood sugar this spring. DCB (Diabetes Center Berne) Research AG is the study sponsor. The study will be conducted in collaboration with University Hospital Inselspital, Berne.
Instead of measuring blood glucose levels directly, the Lakka study will use the company’s Sorku wearable armband device to measure volatile organic compounds (VOCs) discharged through the skin. According to Lakka Health, when the blood glucose level falls too low or drops fast, diabetics emit specific VOCs. Lakka patented a temperature cycle operation (TCO) that boosts the sensitivity and selectivity of extremely low-concentrated VOCs by ramping the temperature. The clinical study’s first aim is to ascertain the VOC signal characteristics the Sokru device detects when Type 1 diabetes patients fast, inject insulin, and intake glucose. The study’s second objective is to determine if VOC concentrations correspond to various glycemia levels, from hypoglycemia to hyperglycemia.
It’s important to note that the Sokru test is a first-level clinical study, with just 10 participants in a single group model. If Lakka Health’s Sokru first clinical evaluation results indicate valid and reliable associations between blood glucose levels and specific VOC emissions through patients’ skin, further testing will be in order. The potential upside is a passive, non-invasive blood glucose testing method that could simplify the lives of people with diabetes. Or not. We look forward to seeing the results of the Sorku study.