Implantable Glucose Monitor Shows Promise in Early Human Trial

Glucotrack, a startup developing an innovative implantable continuous glucose monitor (CGM), has released encouraging data from its first-in-human trial. The study, presented at the American Diabetes Association's Scientific Sessions in June, marks a significant step forward in the pursuit of long-term, minimally invasive glucose monitoring solutions for diabetes management.

Novel Implantable CGM Technology

Glucotrack's device represents a departure from traditional wearable CGMs, offering a unique approach to glucose monitoring. Unlike current market-leading CGMs that measure glucose levels in interstitial fluid, Glucotrack's implant is placed directly in the subclavian vein near the collarbone, allowing for direct blood glucose measurements.

CEO Paul Goode, a veteran of the diabetes technology industry with experience at Dexcom and MiniMed (now part of Medtronic), explained that the implantation procedure is similar to that used for pacemakers. The device is inserted two inches into the vein, potentially offering improved accuracy and reduced lag time compared to subcutaneous sensors.

Promising Early Results

The initial study, involving 10 participants observed for four days inpatient and one week after device removal, met its primary safety and performance endpoints. Key findings include:

• No serious adverse events reported during the study period
• A mean absolute relative difference (MARD) of 7.7%, indicating competitive accuracy with current CGM systems
• The potential for the implant to last up to three years, significantly longer than existing options

While Goode cautions that the data is preliminary and not statistically significant, the results suggest that Glucotrack's technology could address common issues with wearable CGMs, such as skin irritation from adhesives and measurement lag during rapid glucose changes.

Next Steps and Market Implications

Glucotrack has received approval for a larger study in Australia, which will involve 30 participants and test the implanted CGM for a full year. The company is also in discussions with the FDA, aiming to initiate a U.S. study next year.

The emergence of Glucotrack's technology could have significant implications for the CGM market. Currently, Senseonics holds the distinction of offering the only FDA-cleared implantable CGM, with a wear time of up to one year. Glucotrack's potential three-year lifespan could provide a compelling alternative for patients seeking longer-term solutions.

As the diabetes technology landscape continues to evolve, the development of longer-lasting, more accurate CGMs could significantly improve the quality of life for millions of people managing diabetes worldwide. The success of Glucotrack's ongoing trials and potential market entry will be closely watched by industry observers and patients alike.