"Evaluation of a Continuous Blood Glucose Monitor: A Novel and Non-Invasice Wearable Using Bioimpedance Technology
Abstract
Background:
Frequent blood glucose level (BGL) monitoring is essential for effective diabetes management. Poor compliance is common due to the painful finger pricking or subcutaneous lancet implantation required from existing technologies. There are currently no commercially available non-invasive devices that can effectively measure BGL. In this real-world study, a prototype non-invasive continuous glucose monitoring system (NI-CGM) developed as a wearable ring was used to collect bioimpedance data. The aim was to develop a mathematical model that could use these bioimpedance data to estimate BGL in real time.
Methods:
The prototype NI-CGM was worn by 14 adult participants with type 2 diabetes for 14 days in an observational clinical study. Bioimpedance data were collected alongside paired BGL measurements taken with a Food and Drug Administration (FDA)-approved self-monitoring blood glucose (SMBG) meter and an FDA-approved CGM. The SMBG meter data were used to improve CGM accuracy, and CGM data to develop the mathematical model.
Results:
A gradient boosted model was developed using a randomized 80-20 training-test split of data. The estimated BGL from the model had a Mean Absolute Relative Difference (MARD) of 17.9%, with the Parkes error grid (PEG) analysis showing 99% of values in clinically acceptable zones A and B.
Conclusions:
This study demonstrated the reliability of the prototype NI-CGM at collecting bioimpedance data in a real-world scenario. These data were used to train a model that could successfully estimate BGL with a promising MARD and clinically relevant PEG result. These results will enable continued development of the prototype NI-CGM as a wearable ring."
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About Project Diabetes
Funding Strategies client Project Diabetes has developed a blood sugar monitoring ring that allows painless, needle free blood sugar monitoring - the future of care for ½ a billion diabetics.
The ring collects bioimpedance data and sends it to the Company's App. The App sends the data to the Company's AI solution in the cloud. The proprietary AI converts that raw data into an accurate blood sugar reading. The Company is now looking to commercialise its ring and App. Find out more here.
About Funding Strategies
Funding Strategies is an Australian based capital markets firm providing venture equity capital and finance services to small business and companies seeking capital for growth and expansion in the unlisted and pre-IPO capital markets. We work with predominately private and public companies, and sophisticated investors. If you would like more information about Project Diabetes, please email brisbane@fundingstrategies.com.au or phone +61 7 3160 2840.