News of the Center
News Archive — Fall 2020
Message From the Director
Much has changed since our last newsletter. COVID-19 has changed everything in our world. And diabetes has emerged as being a significant risk factor for doing poorly with the disease. However, the good news is that well controlled diabetes is much less of a risk than poorly controlled diabetes. People with access to healthcare and the ability to stay home and safe, practicing social distancing, hand washing and wearing masks are doing well. Even with the sudden switch from in-person to telemedicine visits I believe I can keep each of my Westside patients appropriately treated and protected from harm, at least from diabetes worsening COVID-outcomes.
Personally, I have come to enjoy telemedicine visits because I still get to interact with all of you, in just a slightly different format. I believe that it keeps us safer, reducing unnecessary visits to a medical facility. In Los Angeles County our rates of hospitalization for COVID are increasing (we are not seeing the end of the “first wave”, in fact an increase) so we all need to avoid exposure as much as possible. Personally, out of a concern for safety for all, I plan on doing primarily telemedicine visits until we have a vaccine or effective treatment for COVID-19.
However, there are some caveats. First, our office is open for blood drawing, A1C measurements, vaccinations (obviously not COVID), etc. Dr. Orrange does in-person primary care appointments. I will be available to see people in-person every Monday if there is a reason that a telemedicine visit won’t work. We have very strict infection-control standards in the office and all visits must be scheduled in advance. Everyone is expected to wear a mask.
If you need your labs drawn we can do it in the office or I can send a request to Quest or Lab Corps. This is very simple to do (thanks to COVID). I send in the order electronically and receive the result on-line. All you have to do is make an appointment to have your blood drawn.
To prepare for your telemedicine appointment it is important that you have downloaded all your device data to the Cloud—whether it is to Tidepool, LibreView, Clarity, Tandem or some other system. That way we can review the data together and make treatment decisions, just like we do it in-person. For many of you, who don’t normally wear a device, I am prescribing a Libre continuous glucose monitor that you can get from your pharmacy which allows you and I to both get BETTER than usual data on your diabetes control (another positive about COVID).
Heartbreakingly COVID-19 has worsened health care disparities throughout Los Angeles to a level I never imagined possible. I have worked in underserved communities throughout my career and have never seen such suffering, both from the virus and well as its economic fallout. I have not stopped physically going to work in East LA (the epicenter for COVID-19 in Los Angeles County) once weekly, because those patients lack the smart phones and computers needed for effective telemedicine. We are working hard to create systems to provide them better remote care.
We need to work to help each other through this crisis, which isn’t going away anytime soon. It is incredibly gratifying to see how well my Westside patients are all doing, because it is possible to stay safe even though I know there are challenges for each of us. However, now, more than ever we need to help those less fortunate, who are being hospitalized for COVID and dying due to a wide range of causes, diabetes among them.
Please stay safe and know that I am here to help.
The American Diabetes Association 80th Scientific Sessions was held this year in a virtual format and instead of seeing all my diabetes colleagues in Chicago this year, I pre-recorded my sessions and watched webinar versions sheltered at home.
I missed the comradery of seeing old friends and making new ones, but there were also benefits in having on-demand access to the sessions that allowed me to view more of the sessions without running from room to room in a big convention center and worrying about which session to watch when some of my favorites were scheduled at the same time. I could also fast forward through the boring parts.
After years of headline announcements on the protective benefits of the GLP-1 and SGLT2 drug classes we have reached the end of the series of big cardiovascular safety trials on these medications with the results of the VERTIS-CV trial on the Steglatro, the most recent SGLT2 drug approved. As all other medications in this class it reduced the risk for heart failure but was less impressive on other cardiovascular markers and showed less benefit on kidney than others in the class.
A surprise finding from one clinical trial designed to study heart failure was that the SGLT2-inhibitor Farxiga prevented the development of diabetes in people with prediabetes by 32%. This effect was different from the impact of metformin on the development of diabetes, which is interesting. Now we need to do the research to figure out why and if it does this in a larger group of individuals.
The other big trend is diabetes care has been the evolution of hybrid closed loop insulin pumps (also called the “artificial pancreas".) Tandem's Control-IQ system is now approved for children ages of 6-13 years. There was impressive real-world data presented that showed a time in range number of 78% percent (translating to an A1C of <7%). There is a learning curve to starting this system, but we are seeing similar numbers in our patients as well.
Two systems not yet on the market also presented data at the meeting. Data was presented on Insulet’s Omnipod 5 Automated Glucose Control System powered by Horizon and Medtronic MiniMed 780G Advanced Hybrid Closed Loop System. The OmniPod will be an update to their current tubeless DASH system. The 780G was approved in Europe and will still use a sensor that requires calibration two time a day. However, the algorithms are better than for the 670G and will help lower after eating blood glucose levels more effectively. Both systems still need FDA approval and are expected to be available next year.
In other diabetes technology news, the FreeStyle Libre 2 was approved by the FDA has the additional clearance for use in children. The system has improved accuracy and adds Bluetooth connectivity to their current system of scanning the sensor for a reading. The addition of Bluetooth allowed the Libre 2 sensor to join the Dexcom G6 in earning the iCGM designation that will allow it to be integrated with automated insulin delivery systems. The sensor has been available in Europe and the US distribution is rolling out. It has an optional alarm for a low glucose level but still requires that the sensor is “swiped” to give a glucose reading.
Lilly presented data for their tongue-twisting new faster acting insulin sold as Lyumjev that was recently FDA approved for adults with diabetes. It is similar to Fiasp, the other faster acting insulin on the market. Lyumjev will be available in both U-100 and U-200 strength and initially will be sold in pens and is not approved for use in pumps. It will be at least 6 months until insurance will cover it in most cases.
Novo Nordisk also surprised many with the release of phase 2 trial data from a once-weekly basal insulin known as icodec. The insulin had a similar safety and action profile to current long-acting insulins, but not many clinicians were even aware that the once a week insulin was under development and there are interesting questions on who the right patient is to use such a long-acting insulin.
There is some additional good news on the type 1 diabetes prevention capability of teplizumab on the relatives of T1Ds. New data show that a single 14-day infusion of teplizumab, an anti-CD3 monoclonal antibody, leads to a median 3-year delay in type 1 diabetes onset among high-risk individuals compared with placebo. Half of the treatment group remains diabetes free compared to 22% of the placebo group.
Life in East Los Angeles was hard even before the coronavirus infections in Latino communities far outpaced the rest of California. Many in this region are essential workers who often don't have the luxury of working from home. Having diabetes makes life that much harder.
I related the example in one of my Medscape videos of a close family friend who lost his health insurance after being laid-off from his job which cascaded to delaying care for a diabetic foot ulcer that wouldn't heal. After an ER visit and aftercare in a skill nursing facility he contracted COVID-19 and died from a deadly combination of the virus, poorly controlled diabetes and loss of his job.
At our clinic in East Lost Los Angeles there have been many challenges trying to deliver effective telemedicine. Patients do not have access to smart phone or computers and do not have devices, like glucose sensors, that make diabetes management easier (and more accessible for cloud-based visits). To help our patients with type 1 diabetes we were able to receive grant funding from the Helmsley Charitable Trust, to support the health and well-being of vulnerable people living with T1D impacted by COVID-19. This extra support is allowing our staff to outreach to our most vulnerable patient and provide education and patient management.
Additionally, we were able to work with Insulin for Life, another nonprofit organization. They donated Libre continuous glucose monitors so that our patients now have a way to remotely share glucose information with the clinic. In addition to shipping supplies, Certified Diabetes Care and Education Specialist, Martha Walker, RD, has been working overtime to train people how to use the CGM and link data to the clinic. Our staff continues to receive referrals and are doing what they can to help those in need to manage their diabetes.
If you would like to support our COVID-19 emergency response, you can donate online or send a check to our Westside Diabetes Research Center at 150 N. Robertson, Ste. 210, Beverly Hills, CA 90211. Checks should be made out to: USC Anne Peters Diabetes Fund. Please put Act# 23-5120-4220 in the memo line.
Learning Sessions are an opportunity to take a deeper dive in topics of interest generated by our team of diabetes educators, nutritionist and special guests. We also respond to requests from our patients. Let us know your interests and we are happy to create a session if there is enough interest. The current epidemic has taught us all how to use Zoom and we are finding that this is a great way to deliver the Sessions. This is a learning lab for us and our patients, we will try different topics at different times of the day and week.
Our Next Session will be about balancing your life while social distancing and all of the distractions involved with living through a pandemic. We will help you balance “good enough” diabetes treatment with the rest of your your life. See which group is best for you.
Mary Rose Deraco RN, BSN,CDE
Certified Diabetes Educator and Education Program Coordinator
USC Westside Center for Diabetes
Beyond A1C: Improve your health with GMI and TIR
Since the A1C test was developed in the 1970s and accepted as a standard in 2010, people with diabetes had a lab or fingerstick test and see what their average blood glucose was. An increasing group of clinicians and researchers are now looking a CGM values to produce an equivalent value that can be used to construct a management plan to improve diabetes care.
With much of diabetes management moving to telemedicine, many people with diabetes are asking, "How do I get an A1c?" But even before this pandemic, a number of leading researchers and clinicians were questioning the clinical value of the A1c, as it can be misleading based on genetic variability and certain medical conditions. The A1c also disclosed nothing about important glucose fluctuations. We see people with diabetes with a gently undulating 150 mg/dl glucose average who have the same A1c as a person with a glucose bouncing like a yo-yo between 50 and 350 mg/dl.
It is even more common in the clinic to question the results generated by the A1c machine compared to what people with diabetes and providers were seeing on CGM reports. To be sure, the A1c will continue to be useful for research purposes and as a marker for long-term complications, but with widespread continuous glucose monitoring available, we have more data to help people with diabetes manage their diabetes.
For our telemedicine visits, we are using a new metric called the glucose management indicator, or GMI, that is available in many CGM reports. This is a good indicator of the A1c, as it is determined by the average glucose value entered into a formula that generates an equivalent of an A1c. The calculator is available at the Jaeb Center website.
The Dexcom Clarity report can easily generate a 90-day average sensor glucose value, and this GMI is the closest equivalent to the three-month blood glucose concentration. Other software will simply give you a GMI, or average glucose, over a two or four-week period, and that can give you a good idea of your A1c estimate.
Clarity allows you to easily select a time range of 90 days to generate an average CGM glucose and Glucose Management Indicator that is an equivalent to an A1c.
What Do All of These Other Numbers Mean?
While meeting with a person with diabetes, the GMI (or A1c) can still be the headline, but that is history, and we are meeting to talk about the future. How can we understand the current diabetes treatment regimen and behavior that are generating the numbers, and can we devise a plan for improvement?
The first step is for the provider and person with diabetes to view the reports together. Moving to telemedicine actually makes this step easier. Screen sharing allows us to view the reports at the same time, and for many people with diabetes I'm revealing the unseen mysteries of their CGM and pump data. They see the squiggles of the daily glucose tracings and the boxes of numbers on the reports, but unlike the years of educating patients about an overall A1C goal of 7%, we haven't yet stressed the importance of new data in the Ambulatory Glucose Profile (AGP) report, that allows us to create a more personalized diabetes management plan.
Time In Range
Each CGM, meter, and pump company still present their data in a different way, but there is agreement on standardized ranges to display user data. The target is to increase the time in range (TIR) between 70-180 mg/dl. This is the Goldilocks zone that is neither too high nor too low. Above that are the high (180-250 mg/dl) and very high (above 250 mg/dl) zones and the low (54 - 69 mg/dl) and very low (below 54 mg/dl) ranges.
Keeping your glucose level in the 70-180 mg/dl target range 70% of the time will translate to an A1c of 7% or less. This is also the range that participants achieved in the recent clinical trial of the Tandem Control-IQ software. We are finding that the more dedicated early adopters of the pump have TIR numbers in the 80% range and above. Whatever your percentage is now, the goal is to have more of your glucose numbers in the TIR category.
A cloud report that displays the time in the target range plus above and below periods.
Looking outside the TIR target, we next work to reduce the time spent in the very low and the low categories to less than 3%. A short dip into the 65 mg/dl and back up is less concerning than a rapid plunge down to 50 mg/dl that can often produce an over correction. Even more troubling are prolonged lows in the middle of the night. These lows can be reduced by setting CGM alarms or by using a hybrid closed-loop pump.
Spending time in the very high number range above 250 mg/dl - especially for long periods of time - is the biggest contributor to an elevated A1c and increased risk of long-term complications. We worry less about the short post-meal excursions that peak around 220 mg/dl and return to the TIR zone.
No matter what your current TIR distribution, the goal is to move the numbers more in the 70 -180 mg/dl target while having fewer lows and extreme highs.
A sample TIR chart with the ranges defined and a set of target numbers.
Glucose variability is the ups and downs of diabetes; these can be seen in the small thumbnail representations of your individual days in your AGP or pump report. How do they look? Do you see more days that look like rollercoasters or speedbumps? The CGM stat geeks have been arm-wrestling over how to define this up and down variability, and most of them are now focusing on what is called the coefficient of variation (CoV or CV); and the goal is to have a number less than 36%. Your will also see the standard deviation (SD) and the goal there is less the 55%.
Take a look at your thumbnails and identify the days that look more like speedbumps and consider what you did and try to have more days of gentle waves.
Review the thumbnails in your reports and look for the times or days of less variation and try to learn from your success.
With the availability of GMI, TIR and variability profiles, people with diabetes using CGM have less need for an A1c. The details in these reports provide information we can review together, and we can construct a plan to prevent lows and to reduce highs while having less variability and more time in the target range of 70-180 mg/dl.
Now that you are being asked to download a device or upload to the cloud, stop and take a look at the numbers and ask your provider or educator to review them with you to help you understand the reports, which will improve your diabetes care.
• A1c/HbA1c: or hemoglobin A1C, reflects the average levels of blood glucose over approximately 3 months
• GMI: Glucose management Indicator - The average expected A1C level from at least 14 days of CGM data.
• TIR: Time in Range or the percentage of time spent in the target glucose range or between 70 - 180 mg/dl. There is also the time above and below target range.
• AGP: Ambulatory Glucose Profile, a standardized, single page glucose report.