Biolinq says its CGM can measure blood glucose in the skin
Biolinq’s prototype continuous glucose monitor (Image from Biolinq)
Biosensor developer Biolinq (San Diego) used the conference to show the feasibility of its prototype microneedle CGM, which the company said showed a high correlation between dermal interstitial glucose and venous blood glucose in two separate clinical studies. The current Biolinq CGM is an investigational device available for use only in approved clinical studies.
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 was designed with no introducer needle so application would be pain-free application and the CGM could be worn almost anywhere on the body.
Company CEO Jared Tangney presented the results from the late-breaking first-in-human study, which showed a 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.
“The team at Biolinq has been working for many years to establish the benefits of dermal sensing for CGM,” Tangney said in a news release. “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.”
Phase 1 of the study consisted of 5 subjects without diabetes and 10 subjects with diabetes who wore the Biolinq sensor for 2 days. In the second phase, 10 subjects with diabetes wore the Biolinq sensor for 7 days. Data from the Biolinq devices was compared to venous blood reference measurements.
“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,” said principal investigator Dr. Mark Christiansen, co-medical director of Diablo Clinical Research.
Biolinq said it is targeting the clearance of the device through the FDA iCGM pathway. Further studies of the device are planned for later this year.
