Studies Show Feasibility of a Minimally Invasive Approach to CGM in the Dermis

Biolinq Inc., a San Diego-based medical device company, announced that the company has successfully demonstrated the feasibility of a minimally invasive continuous glucose monitor (CGM), showing a high correlation between dermal interstitial glucose and venous blood glucose. The results of the firm’s two most recent clinical studies show the feasibility of a microneedle CGM system. The current Biolinq CGM is an investigational device available for use only in approved clinical studies.
 
“The team at Biolinq has been working for many years to establish the benefits of dermal sensing for CGM. We are thrilled to share the promising feasibility data from our recent studies. We believe that this positive data is a major step towards making this product a reality for people with diabetes,” said Jared Tangney, Ph.D., CEO, Biolinq Inc.
 
Biolinq’s novel platform uses dozens of miniature sensors, much less than 1 mm in length, to continuously measure blood glucose in the outer layer of the skin (the dermis). The product has no introducer needle resulting in a pain-free application of the sensors and can be worn almost anywhere on the body. 
 
The company is targeting the clearance of the device through the U.S. Food and Drug Administration iCGM pathway.
 
The study data show the high degree of correlation between the Biolinq sensor raw data and venous blood glucose with little to no lag time, something patients and industry experts believe has the potential to deliver better outcomes to those living with type 1 and type 2 diabetes. 
 
Phase 1 of the study consisted of five subjects without diabetes and 10 subjects with diabetes who wore the Biolinq sensor for two days. In the second phase, 10 subjects with diabetes wore the Biolinq sensor for seven days. Data from the Biolinq devices was compared to venous blood reference measurements.
 
Mark Christiansen, M.D., (co-medical director, Diablo Clinical Research), the principal investigator and an experienced researcher in the field, said: “I am very encouraged by Biolinq’s data, especially the high correlation between the raw sensor signal and the blood glucose and the absence of the venous to interstitial fluid glucose lag time.” 
 
Further studies of the Biolinq CGM are planned for later this year.