A brief history of available Glucose Monitoring Solutions:
Blood Glucose is the gold standard in glucose monitoring. Because of this, users have been dealing with endless pricks and needles because of the limited Self Monitoring Blood Glucose (SMBG) Monitoring solutions.
While regulated Continuous Glucose Monitoring solutions that provide glucose readings from Interstitial Fluid are available in the market, these solutions are also invasive and cost-intensive as the patches have an average of 7-14 days of replacement requirement.
Although the cost of CGM devices can still be covered with Medicaid and Medicare programs, the need for patch replacements and the constant presence of the patch on users’ arms often leads to a lack of adaptation in the patients.
An expected Turmoil:
With novel CGM technologies emerging in the market, the glucose monitoring market might see an end to its decades-long battle with finger pricks in 2024! A new set of glucose monitoring solutions is emerging in the consumer market, providing Non-invasive continuous glucose monitoring (NICGM).
These solutions and their potential to deliver continuous, discreet and real-time glucose monitoring can change the way users get their glucose readings. We might also see an accurate and medical-grade NICGM in 2024 as many such consumer CGM companies have embarked on the journey of FDA approval!
What is a Non-invasive Continuous Glucose Monitoring solution?
Majorly designed as wrist-based glucose monitors, these solutions use Electromagnetic Pulses, Optical Sensors and other novel sensors that can read glucose levels in the interstitial fluid without penetrating the skin.
Has there ever been an FDA-approved NICGM?
The efforts for introducing a NICGM were initiated in 2003 when companies like Pendragon Pendra and Cgynus Glucowatch got their FDA clearances. But both these companies were shut within a few years of commercialization as users faced problems of inaccurate results and lack of user-friendly designs!
What are the changes?
There is a unit of measurement that can determine the accuracy of CGM solutions called Mean absolute relative difference (MARD). MARD is calculated by comparing CGM sensor data with reference measurements across all subjects in a study. The collected measurements are then cross-referenced as the average of the absolute difference between the CGM values and the reference values and represented as a percentage average.
If we look at the consumer NICGM in the market, the accuracy of CGMs has improved over the years due to technological advancements in sensor readings. Apart from that, many organizations have focused not only on NICGM but also on continuous monitoring, alerts, and discreet monitoring!
What does it indicate?
With millions invested and a few companies already enrolled in the FDA 510(k) clearance process, the wait for non-invasive CGM might end in 2024! While there are users that are already benefiting from consumer NICGMs; advent of regulated NICGMs can completely change the market dynamics and serve even the high-risk patients with medical-grade accuracy.
