Glucotrack has cleared the first human clinical study of its long-term continuous glucose monitoring implant, designed to live under the skin for as long as three years.
The company’s real-time sensor is placed within the subclavian vein, located under the collarbone—to collect sugar levels directly from the bloodstream, and avoid the potential lag times of reading the interstitial fluid among cells just beneath the skin.
The prospective, single-arm study included six participants with Type 1 or Type 2 diabetes who were staying in a hospital for at least four days, to evaluate the safety of the sensor placement procedure as well as its removal by an interventional cardiologist.
The trial met its primary endpoint, with no procedure- or device-related serious complications reported in the week following the removal of the sensor lead, the company said. The study also confirmed the implant’s ability to take glucose readings from within the vein.
“While neither the study nor prototype system was designed to evaluate sensor accuracy, the system performed as expected with similar accuracy results as previously seen in our animal studies,” Glucotrack President and CEO Paul Goode said in a statement. “With these positive results, the promise of continuous blood glucose monitoring is one step closer to reality.”
The company’s final version aims to deliver an implantable device with no external components worn on the skin.
This week also saw Glucotrack aim to raise $3 million through a public share offering, with about 2.6 million shares of common stock priced at $1.15 apiece.