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:
- Implantable Sensor: lasts up to 90 day in US, 180 days in Europe (Eversense XL).
- 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.
- 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?
- 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.
- 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.
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.