The first part of this piece focuses on the Time-In-Range Vs A1C chatter that’s been bantering about over the past year and a half and why both are important.
The second part provides a deep dive into the Eversense CGM, providing the highlights the features that jumped off the screen for me during the Novel Technologies in CGMS session.

Time In Range Or A1C - Why Not Both?
Lutz Heinemann, PhD Science Consulting in Diabetes, CMbH

Over the past 18 months, there’s been a lot of discussion re: Time-In-Range versus A1C. Dr. Heinemann’s presentation posed the question: WHY NOT BOTH?
Both are critical tools in diabetes management, both have pros and cons for the person living with diabetes, healthcare professionals and payors.

This presentation ticked a lot of boxes for me - personally and professionally as a person with diabetes.

The Breakdown

A1C Pros
Accepted by both regulatory agencies and health insurance companies, less expensive cost wise (cost of test versus cost of sensor/device), multiple measurement methods with standardized quality control across the board, allowing for traceability, and focuses on long term control.

A1C Cons
An A1c number isn’t necessarily tangible to the person living with diabetes — there’s a disconnect. An A1c doesn’t show acute glucose swings, glycemic variabilities, doesn’t allow for rapid changes in treatment, and requires much of the person with diabetes — mentally and physically. Try being perfect for 3 months without diabetes — it’s damn near impossible. Now add diabetes to your equation.

TiR Pros
The concept of Time-In-Range is more tangible for a person with diabetes to understand and track — at least IMO. The immediate and added visual of graphs helps us in all of the above. TiR reflects acute glucose swings and glycemic variability, allowing for rapid changes in treatment which results in meaningful change. TiR focuses on incremental periods of, well…  time spent in the specified range, and also highlights both time below and above that range.

TiR Cons
Acceptance is low by health insurance and regulatory agencies, cost, and requires a considerable effort of the person with diabetes wearing the technology.

Common Ground
Both require considerable amounts of time and effort from people living with diabetes. We’re the ones getting lab work done, doing the blood checks, wearing the diabetes devices— being graded on our diabetes and financing all of the above — not the healthcare professionals — and HCPs need to acknowledge and remember all the hard work PWD do.

Using TiR to our advantage results in an improved A1C and prolonged good health - that’s a win-win in my book.

Glucose Monitoring - Novel Technologies in CGMS
There was so much information coming at me in this session it was hard to keep up.
I focused my report on a deep dive into the tech features and innovations for the Eversense CGM.

Eversense CGM
Heads-Up: I’d already written about some highlights mentioned in the presentation in my first DTM2020 article, which is below this one. No worries, there was plenty of WOW that I was learning about in real time! 

Accuracy, Accuracy, Accuracy
An independent 3 three-way accuracy comparison study by Mass General Hospital and published in Diabetes Technology And Therapeutics in 2019, focusing on 23 subjects with T1 wearing the Eversense, Dexcom G5, and Abbott Freestyle Libre Pro, simultaneously for 6 weeks, in a free-living and using the Bionic Pancreas.

The Results
The CGM with the lowest nominal **MARD (14.8%) was Eversense, followed by the Dexcom G5 (16.3%), and Libre Pro (18%).

180 Days Is A Magic Number
As in a PMA (Pre Market Approval), has been filed with the FDA by Eversense for 180 Eversense to be available in The US - twice the duration of the current 90 day sensor and half the calibration (once a day), after the first 21 days of usage. 

Eversense’s Smart Transmitter Is…, Well… SMART - And Designed With A PWD In Mind

• Powers sensor and calculates glucose.
• Very low occurrence of skin reaction.
• Can be removed without replacing sensor.
• Lightweight and water resistant.
• App Design provides glucose trends, alerts and prompts for user calibration.
• On body vibration (which I refer to as OBV) alerts for lows and highs when you don’t have the App with you.
• OBV alerts also consider the PWD’s partner — who, like the PWD, deals with alarm fatigue.
• On a personal note: I appreciate that the OBV alerts allow for more discreet interruptions — like for instance when you’re in a meeting and all of sudden your high and or low alarm starts screaming — or the opposite, when your CGM is on vibrate, but is buried at the bottom of your computer bag, in a noisy meeting and you don’t hear the high alarm all. But I digress.

Eversense Virtual Education

• Eversense has fully embraced virtual device training for both people with diabetes and Healthcare Professionals - holding remote Patient Education classes for both.
• Endo’s are very interested in learning the in-office insertion procedure and there’s similar interests from surgeons, Nurse Practitioners, and Physicians Assistants as referrals.
• 40 Primary Care Physicians have already been certified for Eversense insertion, 200 are in the process of becoming certified.

In this PWD’s opinion Primary Care Physicians becoming Eversense certified means more PCPs will learn about the realities of diabetes in real time and day-to-day. In the process they will obtain a better understanding of living with diabetes, a working knowledge of a critical piece of diabetes technology, and an understanding about why TiR is crucial for better diabetes management  — leading to better A1C and long term health for their patients with diabetes.
Bottom Line: All of the above benefits people with diabetes physically and emotionally.

Eversense Future Innovations

• Extending the life of the sensor up to 365 days, a marked reduction in calibration — hopefully up to once a week.
• Flash or swipe capability to combine CGM/FGM functionality both in one device.
• iCGM and integration with multiple devices and systems including closed-loop systems, connected pens, and other devices! LOVE that pens are included!

Overall, I was excited to learn more about the Eversense and can see the 180 day version being a valuable and advanced tool for people with diabetes.

I’m looking forward to seeing further progress from Senseonics as they bring this next innovation to the diabetes community.

For the record, the answer is plenty. Here are the highlights from this session that jumped off the screen for me and had me nodding my head in agreement!

BGM In The 21st Century - A Perspective
Robert Schumm, MBA President of Ascensia Diabetes Care

To paraphrase Robert Schumm, President of Ascensia Diabetes Care: A meter is often the first tool given after diabetes diagnoses - engaging the newly diagnosed to actively participate in their diabetes, and providing them (and their diabetes team) with the fundamental metrics as to what’s going on inside their bodies.

Reliable glucose data is critical/key to managing diabetes - which is why BGM will always be important. Here are some of the ways that came up in this discussion.

Type 1s

• BGM will act as a partner/supplement for a CGM, supporting t1s using both CGM and BGM.
• Accuracy is a foundational component to any diagnostic, including diabetes. BGM is more accurate with smaller failure margins than CGMs.
• The more accurate a BGM, the more accurate the CGM - which is why CGM / BGM partnering is key.

Even with CGM, BGM is needed for a variety of reasons:

• Day one of sensor use, during sensor warmup
• No value or trend arrow
• During rapid rate change
• When symptoms don’t match the number on the screen
• When taking acetaminophen
• Sensor vacations
• Transmission issues
• Waiting on supplies
• Closed-loop diagnostics
• Anytime accuracy is in question. “When in doubt, get your meter out.”

Type 2s

• BGM is more cost effective for people with type 2 diabetes – both for those who use insulin and those who don’t.
• Studies have shown that checking BGM has a positive influence on blood sugar management when the results are used to modify behavior or treatment.
• People with diabetes who are more engaged with their diabetes have better diabetes management.

Emerging Markets

BGM is effective in emerging markets.
Diabetes is rising on a global scale and awareness, access, affordability are crucial. Many in emerging markets can’t afford to pay for CGM out of pocket. However, people in emerging markets either have better access to BGM and or are able to afford BGM themselves.

Established Markets

CGM use is expected to show continual growth in established markets, but newer technology doesn’t always result in better metrics.
Diabetes costs haven’t been reduced by the introduction of new diabetes therapies and technologies.

Ascensia very much believes in CGM tech, which is why they’ve partnered with Senseonics for the Eversense CGM, “but strongly believe, that there will always be a need for the tried, true, and more accessible and affordable BGM.”

Applications of BGM
Dr. Richard Bergenstal, MD - International Diabetes Center, Minnesota

Key Takeaways

• Blood Glucose Monitoring must to lead to action. BGM needs to take a page from the CGM playbook and streamline and display their data in a logical way, similar to TiR for BGM, which Dr. Bergenstal refer’s to as BGM, “Percent of The Total Values”.
• BGM remains an important tool for PWDs, as long as there is a plan and support to adjust lifestyle or meds.
• Intermittent use of CGM throughout the year because of cost — wear a CGM for a few weeks/months in order to outline areas where BGM checks should be done.
• Sidebar and in this PWD’s opinion: Data that is organized, easy to understand, and simple to read makes it easier for me as a PWD, stops me from feeling overwhelmed and means I am more likely to actually follow through with actions that will lead to positive changes in my diabetes management.

Is BGM Dead?
Dr. Steven Edelman, MD Clinical Professor Medicine at University of California, San Diego School of Medicine, “The Multi-Tasker” at TCOYD.Org

When posed with the “is BGM dead,” question as his presentation topic, Dr. Edelman’s response was a resounding : HELL NO - Not for a long time! And while he acknowledged that as CGM usage goes up, BGM usage will go down, that doesn’t mean it’s going way — there’s a need for it BGM globally and locally. 
Sidebar: This is also where he gave a shout to Ascensia for having the most accurate meter on the market!

Why Is BGM Here To Stay? Look At The Numbers

• IDF estimates that there are currently 463 million people with diabetes, 23 million of them are on insulin — both type 1 and type 2. These folks need BGM, and Edelman believes that those T2s not on insulin greatly benefit from BGM.
• Home glucose monitoring: Is and remains an important tool to take and stay in control of your diabetes.
• SAGE Study Statistics: (Study of Adults GlycEmia in T1 DM), which breaks down technology use by age and regions (Western Europe, Eastern Europe, Middle East, Latin America and Asia), in adults with T1, in predefined age groups.

Breakdown of Diabetes Technology in SAGE Study Regions
Fingersticks: 92%
Continuous Glucose Monitor: 23.2%
Blood Ketone Meter: 11.1%
Insulin Pen Injections: 79.9%

75% of the people had some form of insurance. 

24.3% of the world diabetes populations have A1cs less than 7%, with Western Europe having the highest at 27%, and the Middle East Lowest, at 18.9%

Edelman ended his talk with a text he received in November 2020 from an unnamed, top level executive “at a major CGM company.” It said: BGM ain’t dead by a long shot globally

I Agree With All of The Above

WHY? This person living with diabetes deals with calibration issues for the first 48 hours at the start of almost every new sensor; has dealt with false (leaning lows), from inadvertently leaning on my sensors multiple times; isn’t sure what insurance will and won’t cover in 2021; struggles with diabetes technology/alarm fatigue; has received diabetes supplies 2 weeks later than originally promised - time and time again; and strongly believes that choice and flexibility are critical when it comes to diabetes management.

I kicked off the 2020 Virtual Diabetes Technological Meeting by attending an online workshop titled, “CGM and Telehealth, Before, During, And After, COVID-19”, presented by Dr. Francine Kaufman, Chief Medical Officer of Senseonics, the makers of the Eversense Implantable CGM.

The talk was eye opening and the following takeaways stuck with me.

Sidebar: Senseonics, Eversense Implantable CGM is the first implantable CGM (90 days in the US, 180 days in Europe) on the market. The company has partnered with Ascensia Diabetes Care in 2020, granting Ascensia exclusive global distribution rights to Senseonics systems, and they will be handling sales, marketing, and distribution beginning in 2021.

Eversense CGM is a 3 part system consisting of:

1. Implantable Sensor: lasts up to 90 day in US, 180 days in Europe (Eversense XL).
2. Smart transmitter: Powers the sensor, calculates glucose, placed on top of skin and directly over the sensor. The transmitter has a silicone base adhesive which is gentle on the skin than most adhesives on the market. The smart transmitter is removable (for showering, swimming, etc.) and has vibration alerts instead of audio alarms to decrease alarm fatigue.
3. Mobile App: Tracks glucose trends provides alerts, prompts, and data sharing in real time, with up to 5 care partners, and uploads to DMS systems for data review.

Eversense is now covered by insurance for 200 million Americans, including via Medicare/Medicare Advantage. Currently only the 90 day system is approved in the US and Senseonics recently submitted a PMA Application for the 180 day Eversense system to the FDA.

The History of Blood Glucose Diabetes Tech
Dr. Kaufman opened her talk by informing the audience that when she first started her journey as an Endocrinologist 42 years ago, she was required to take 4 glucose values per year, per patient. 4 glucose values per year, per patient. OK, CRAZY and not that long ago!

But that’s where the diabetes world was — there was no diabetes tech — and it was certainly not available on a daily basis for the end user, i.e., the person living with diabetes.

Then BOOM, blood glucose meters hit the market and flipped the diabetes world on its axis — and The DCCT Study (The Diabetes Control And Complications Trial,1982-1993) proved without a doubt just how important daily blood glucose monitoring was in improving the health and quality of life of people with diabetes in the long term.

Cut to the 2000s, with the advent and ever expanding use (and coverage) of CGMs - which took diabetes management to the next level!

According to The T1D Exchange, between 2010 and 2012, 7% of T1ds used CGMs. And in 2016 that number jumped to 30%.

And this increased usage of CGM has the potential to improve diabetes management. Dr Kaufman explained that a recent multi-center, independent study of health outcomes of Eversense patients in a real world setting, consisting of 100 people with Type 1 diabetes wearing Eversense for 180 days, evaluated by insulin delivery method (insulin pumps and MDI) and prior CGM usage. All participants in the study showed a significant reduction in A1c, and improvement in TiR - achieving 70% TiR for 180 days across the board — with the greatest improvement occurring in the CGM naive group participants.

Moving Past A1c And Embracing Glucose Metrics in the form of TiR

For more than 30 years, diabetes management has been solely A1C driven. An A1c provides a 90 day overall average of diabetes management.

IMO: A1C is 3 month long test — and a super stressful one.

By comparison, Time-in-Range interprets both real world and real time CGM data, allowing for breakdowns, trouble-shooting, and clinical targets tailored for the individual living with diabetes and wearing the hardware.

TiR allows for wiggle room. Challenging diabetes days happen, and are easier to plow through and accept when you remind yourself of the days spent in range. Especially when TiR days start to increase thanks to diabetes trouble shooting by the person with diabetes and their diabetes team!

A few more numbers to marinate on:
Every 10% change in the percentage of time-in-range, equals a 0.08 change in A1C.

“Cardiovascularly” speaking, more time-in-range equals a 30% decrease in heart issues. I first learned about the diabetes/heart/inflammation TiR connection at the 2019 DTM meeting (and wrote about it - Day 2: Diabetes Data From All Sides), In and it has changed my life!

In March of 2020, COVID invaded on every shore, and pushed TiR, telehealth and telemed as critical tools in diabetes care and healthcare across the board.

How Has COVID-19 Impacted People With Diabetes?

1. TiR is crucial —PWDS whose glucose levels had good time-in-range pre-COVID19 diagnoses, have a much higher rate of survival than those who didn’t. Morbidity rates for patients with COVID and poorly controlled blood sugars are 48% versus 15% for COVID diabetes patients with well managed time-in-range. Healthcare professionals utilized and continue to utilize real time data from CGMs to help patients with COVID and healthcare professionals treating them remotely.
2. Rationing: Rationing insulin was already a huge problem for people living with diabetes pre-pandemic, and COVID-19 has exacerbated the problem. According to data from the US, 650,000 insulin dependent PWDs are skipping injections or taking less insulin than they were prescribed, and 3 million people are skipping blood sugar checks in order to conserve test-strips.

Rationing diabetes supplies is the opposite of the CDC’s recommendations for people with diabetes during the age of COVID-19.

Now consider that PWDs with higher A1cs are more likely to ration insulin and supplies, further increasing negative COVID-19 outcomes in the short term and sadly increasing the cost of diabetes complications in the long term.

Pre Pandemic: Where We Were Stood With CGM and TeleHealth
Diabetes Healthcare Providers were committed to glucose monitoring and embracing CGM, and were beginning to accept glucometrics (TiR) + A1c to assess diabetes management.

Remote patient monitoring through BG meters, CGMs and insulin pump uploads was possible. Digital diabetes health programs were being introduced; tools (particularly apps) were blowing up, asynchronous/synchronous data was happening (data collected at one point and responded to later), and telemedicine was slowly being embraced by providers and patients, and unfortunately, not always by payers.

And to paraphrase Dr. Kaufman: Diabetes healthcare professionals were perplexed that a plethora of advances In pharmacotherapy and devices didn’t create seismic shifts in glycemic outcomes.

Where We Are Now - During the Pandemic
Diabetes healthcare pros are actively embracing CGM and glucometrics to assess patient outcomes and engagement in both telemedicine consultations and in office visits — without having A1cs, focusing on TiR and assessing patient engagement.
Providers, patients, and payers quickly adapting to telehealth and virtual support programs for patients.

Post Pandemic (Which Cannot Get Here Soon Enough)
Pandora’s box has been opened, there’s no turning back from virtual clinics; appointments, programs co-existing with in person visits, or the value that CGMs bring to the diabetes management table — with CGM metrics being considered as real-time measures of diabetes management.

With that being said, PWDs and their HCPs will still be striving to achieve their targeted goals, they will just be doing more of it virtually and using different metrics — which may baffle some healthcare providers, but from person with diabetes point of view, it makes perfect sense.

Come Again?
Diabetes is hard work, PWDs make hundreds of diabetes decisions a day, with no time off for vacations or good behavior. Having the tools to track and fine-tune or diabetes in real-time absolutely helps - I won’t go back to the diabetes dark ages, but bottom line, we still live with diabetes. And if diabetes has taught me anything, it’s that just when you think you have your diabetes figured out, diabetes reminds you that it’s a different beast daily.