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The Game-Changing Approval of the First Over-The-Counter Continuous Glucose Monitor

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Dr Paul Chidester, MD, FACP

Chief Medical Officer

This week, the FDA cleared the first over-the-counter-integrated continuous glucose monitor (iCGM) for marketing. This particular iCGM glucose biosensor is designed to help adult patients who are not on insulin, monitor their blood glucose levels in a noninvasive way. This particular iCGM glucose biosensor is meant for patients with or without diabetes to better understand the impact of diet and exercise on their blood glucose levels, giving patients more insight into trends related to their blood glucose levels.

Here at Monarch, we are committed to improving outcomes for all patients with diabetes and while our solutions focus on improved glycemic control in hospital settings, we are excited at the possibilities that a device such as this one can bring. This clearance could greatly increase access for patients with diabetes as this device can be purchased without a prescription from a doctor and regardless of access to health insurance if priced reasonably.

Continuous glucose monitoring (CGM) offers numerous advantages, especially for individuals managing diabetes or those interested in closely monitoring their glucose levels for health optimization. One of the biggest advantages of continuous glucose monitoring is that it offers real time data without a fingerstick, empowering patients to make adjustments to diet and exercise in response.

Studies have shown that the use of CGMs can lead to reductions in HbA1c levels, which is an indicator of average blood glucose levels over the past two to three months. From a clinician’s perspective, I see this benefiting patients coming into the inpatient setting with better managed glucose levels which can prove advantageous for short term and long-term recovery. However, whether the use of CGMs impacts outcomes in the inpatient setting remains to be seen. I explore this topic further in a blog post CGM in the Hospital: Is it Ready for the Main Stage?.

In summary, at Monarch Medical Technologies we are pleased to see the expansion of patient centric technology to enhance the opportunity for improved patient outcomes.

About the author

Dr Paul Chidester, MD, FACP | Chief Medical Officer

Dr. Paul Chidester is the Chief Medical Officer for Monarch Medical Technologies. After practicing for two decades as a nephrologist, he assumed a senior leadership role at Sentara Healthcare where he led the implementation of computerized insulin dosing software. He is involved with product development and customer engagement at Monarch Medical Technologies where the focus is to provide precision insulin dosing for patients. His key interest is working to further enhance this precision through the use of technologies such as CGM.

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