Speaking Out for Vaccine Prioritization for People with T1D & T2D

As COVID-19 vaccines become available, are you wondering how people with type 1 and type 2 diabetes will be prioritized? This is actually something that many people are asking and many advocacy groups are currently addressing. Here is information about the current status of eligibility and prioritization, as it relates to diabetes, from Diabetes Mine:

Unfortunately, as of early January, the CDC seemed to view type 2 diabetes (T2D) differently than T1D as far as prioritizing COVID-19 vaccine access. People with T2D are categorized as “at increased risk” of more severe illness, according to 2019 CDC dataTrusted Source, considered the “strongest and most consistent evidence.” Those with T1D, however, simply “might be at an increased risk” for severe illness, based on dataTrusted Source that’s considered “limited evidence.”

In the meantime, a growing collection of clinical data shows that T1Ds are indeed at increased risk of more severe COVID-19 outcomes. More recent clinical evidence demonstrates that COVID-19 severity is more than tripled in individuals with T1D. More from the American Diabetes Association:

Currently, the CDC Advisory Committee on Immunization Practices – whose recommendations influence the order in which states are making vaccines are available – classify T1D as a lower risk than T2D for COVID-19. With many states now utilizing the same outdated CDC risk classification to design their vaccine distribution plans some 1.6 million with T1D are at risk for receiving a COVID vaccination later than others in the same risk category.

On January 13, nineteen diabetes organizations signed a letter urging the CDC to immediately prioritize T1D alongside T2D given the common, heightened risk both groups face for the most severe health outcomes of COVID-19. “As the data make clear, differentiating between T1D and T2D for purposes of assessing COVID-19 risk is an error that could cost even more lives, and we urge CDC to correct this immediately,” said Dr. Robert Gabbay, Chief Scientific and Medical Officer for the ADA. Read the letter here.

The ADA was joined by 18 other organizations who signed the letter:

American Diabetes Association
JDRF
Children with Diabetes
Beyond Type 1
American Association of Clinical Endocrinology
American Podiatric Medical Association
Diabetes Leadership Council
Diabetes Patient Advocacy Coalition
Certification Board for Diabetes Care and Education
DiabetesSisters
The diaTribe Foundation
Endocrine Society
Pediatric Endocrine Society
T1D Exchange
College Diabetes Network
YMCA of the USA
National Association of Chronic Disease Directors
Legal Environmental Assistance Foundation, Inc.
Association of Diabetes Care & Education Specialists

A New, Early Option for T1D Screening

When it comes to type 1 diabetes, the more proactive you can be, the better. Thanks to the JDRF, a new program has been launched, aimed at early detection of type 1 diabetes (T1D). The at-home test is accurate, comfortable, and convenient, and is a first for this kind of testing option. The test is called T1Detect, and has been developed by Enable Biosciences.

This new personal test kit works by looking for particular autoantibodies (using an autoantibody detection panel) in the blood that are the most important markers for T1D. JDRF states on its site that “JDRF-funded scientists have discovered that having two or more specific autoantibodies — antibodies that are directed toward your own body or, in the case of T1D, your pancreas — means that you have an almost 100-percent chance of developing T1D.”

Families and individuals can use this type of testing to detect T1D early, so they can plan and prepare. Eighty five percent of T1Ds have no family history, and a diagnosis can arrive suddenly, with potentially life-threatening symptoms already present. Forty percent of the newly diagnosed T1Ds present DKA symptoms at the time of diagnosis. For many, this new program will offer new hope and a way to find out more before reaching a crisis situation.

You can order your own test HERE, and a kit will be mailed to you. When you receive the test, all you will need to do is collect a few dried blood spots (see instructions for more details). The cost of the kit is $55, with subsidized pricing offered for those unable to afford the full price of the kit. Full results can take 4 to 6 weeks to arrive. You will receive your autoantibody results, explanations of what they mean, and next steps to consider.

“T1Detect is the first and only screening program that will enable a broad population to know their risk of T1D,” says JDRF CEO Dr. Aaron Kowalski. “This groundbreaking initiative is an important milestone for JDRF because it will increase awareness about early-stage T1D, provide access to crucial education and support for those at risk, and pave the way to ensuring that T1D screening becomes part of universal, clinical preventive services.”

For more information, including test accuracy as well as a thorough FAQ section, click here. Our blog also references information from this Diabetes Mine post.

The new T1Detect option gives great hope!

Once in a Blue Moon Halloween

Happy Halloween weekend! This Saturday, October 31, will be an extra exciting, super spooky Halloween with a full moon shining over us. The last time a full moon fell on Halloween was in 1944. Whether we see it will depend on cloud cover, but creatures around the world will have the opportunity to witness a Halloween blue hunter’s moon this year. Learn about more specifics of this moon cycle from NASA.

A blue moon occurs on the rare occasion when there is more than one full moon during a month. A hunter’s moon follows the harvest moon (which fell on October 2 this year). From NASA: According to the Farmer's Almanac, with the leaves falling and the deer fattened, this was the time to hunt. Since the harvesters had reaped the fields, hunters could easily see the animals that had come out to glean (and the foxes that had come out to prey on them). The earliest use of the term "Hunter's Moon" cited in the Oxford English Dictionary is from 1710.

We wish you a very happy and safe Halloween weekend!
Rock those costumes and have fun!

Medtronic Joins the Smart Insulin Pen Market

Earlier this month, Medtronic announced that it is acquiring Companion Medical and its Bluetooth-enabled InPen. The decision will allow Medtronic and InPen to help more people with diabetes (type 1 and type 2) who take multiple daily injections of insulin (MDI). This acquisition also positions Medtronic in a new market with the opportunity to compete with others developing smart insulin pens, including Eli Lilly, Novo Nordisk, and Bigfoot Biomedical.

InPen is a reusable, Bluetooth-enabled smart insulin pen that works with short-acting insulin cartridges and makes insulin injection safer. This is the only FDA-cleared insulin pen that connects with an app to track data and give users personalized dosing recommendations. The InPen app offers a dosing calculator and also computes and displays real-time active insulin on board (IOB). It also allows remote monitoring; users can set the app to auto text message their dosing info to up to five people. The text message can include every insulin dose, as well as blood glucose and carb values. First cleared by the FDA in 2016, the InPen was later FDA approved for use by all ages in June of 2020.

Medtronic's Executive VP and President Sean Salmon addressed their expanded vision aimed at serving people “where they are in their diabetes journey” regardless of the insulin delivery method, in comparison with Medtronic’s original approach of only selling insulin pumps.

A worthy side note, before the purchase, Companion established agreements with both Dexcom and Senseonics for both CGMs to share data directly with the InPen app. Medtronic has stated that it does not plan to discontinue the ability of the InPen to communicate with the Dexcom CGM, even though Medtronic makes a competing product. It makes sense that down the road, Medtronic also plans to integrate its Guardian CGM with the InPen.

New Tech and Product News from Virtual #ADA2020

At the annual American Diabetes Association conference this June (held entirely online this year), lots of research was presented, and as always, a slew of new tech and product news was announced.

Here are some of the highlights!

• Abbott FreeStyle Libre 2 gained FDA approval.

• Two new types of insulin were presented: Eli Lilly's ultra-rapid Lyumjev and Mylan and Biocon's Semglee basal insulin.

• Medtronic has collected pivotal trial data for its upcoming Minimed 780G (Advanced Hybrid Closed Loop System), in preparation for filing for FDA approval.

• Medtronic's 770G has already been filed with the FDA and is considered the "stop-gap" between the 670G and 780G. Read more about Medtronic's tech developments here.

• Tandem announced FDA approval of its Control-IQ system for children ages six and over.

• The closed loop OmniPod 5 is expected in 2021.

• The Dexcom G6 Pro, a clinically focused, professional version of its Dexcom G6 CGM is slated to start shipping to clinics and physicians' offices this month.

Learn more about all of the details of the conference here.

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Approved by FDA! FreeStyle Libre 2 Cleared as iCGM

Abbott's FreeStyle Libre 2 has been approved for use in the U.S. for adults and children (ages four and older) with diabetes. In Abbott's June 15, 2020 press release, Jared Watkin, senior vice president, Diabetes Care, Abbott commented: "We're thrilled to bring our next generation technology on our world-leading sensing platform to both children and adults with diabetes in the U.S. With unsurpassed 14-day accuracy and enhanced features including optional alarms at a fraction of the cost of other CGMs, Abbott's FreeStyle Libre 2 system will change the future of diabetes care in the U.S. the same way it has around the globe."

Highlights of the new iCGM system include:

• FreeStyle Libre 2 is the only integrated continuous glucose monitoring (iCGM) system available that continuously transmits glucose data every minute with customizable, optional real-time alarms to alert users when their glucose is high or low without scanning.

• Now for children and adults with diabetes, this latest technology is the first and only iCGM that sustains performance for up to 14 days, providing trends, insights and actionable data.

• The FreeStyle Libre 2 system includes a self-applied sensor (the size of two-stacked quarters) that is easy to apply and worn on the back of the upper arm, eliminating the need for painful fingersticks to test glucose levels.

The FreeStyle Libre 2 has already launched in several European countries and is coming to others soon. It is not yet known when the FreeStyle Libre 2 will officially roll out in the United States, though Abbott says it will be in the coming weeks.

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Practical Resources for Navigating Diabetes & COVID-19

When it comes to COVID-19, present and future, there are so many questions. But, Coronavirus and diabetes? This brings even more to navigate. A great place for gathering information is a compilation of resources from Diabetes Mine. Their article, Coronavirus and Diabetes: Useful Resources, can be found here. This post will point you in the direction of reliable news relating to the connection between diabetes and COVID-19, and it will offer some practical, hands-on support for staying safe while living with diabetes during these times.

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PBS's Blood Sugar Rising

A new documentary from PBS just came out; it's called Blood Sugar Rising: America's Hidden Diabetes Epidemic. Watch it here! This film addresses the current statistics of diabetes and goes beyond that, looking at the human side of the disease. Diabetes and pre-diabetes affect over 100 million people in the US. It is now predicted that one in three children born since 2000 will develop diabetes. Blood Sugar Rising also reveals new hope in medical treatments and reports on those taking action to improve diabetes management and prevention.

Diabetes Mine features a review of the new documentary, written by Dan Fleshler. The introduction to his comprehensive review states:

“What makes this film different from other recent documentaries on the rising rate of diabetes — like “A Touch of Sugar” or HBO’s “The Weight of the Nation: Obesity and Type 2 Diabetes” — is that “Blood Sugar Rising” has the backing of the nationwide PBS platform. Millions of Americans will hear its stark warning that “it is now predicted that half of the U.S. population will have either diabetes or pre-diabetes by 2025.” The film also stands out because it is very ambitious, covering a lot of territory in about 2 hours. It showcases compelling stories of people wrestling with diabetes management and trying to fend off complications, fighting social and economic problems that contribute to the epidemic, and working on new technology to bring hope to our D-community.”

Check out Blood Sugar Rising and see what you think! Look for your local PBS listings, or you can watch the film here!

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In the News: Hospitals Try Glucose Monitors to Reduce Contact With Covid-19 Patients

Many hospitals are beginning to use remote readings via CGM to monitor blood glucose levels for Covid-19 patients with diabetes. Through the resulting reduced clinician contact, this is helping to curb virus transmission and to preserve scarce protective gear. The entire article can be found in the Wall Street Journal. By using CGM, manual finger-stick or blood draw methods performed by nurses in patients' rooms can be cut back dramatically.

This month, the FDA told DexCom and Abbott Laboratories that they could provide their remote continuous glucose monitors to hospitals to support care of Covid-19 patients. Previously, the companies didn’t ship them to hospitals because they weren’t FDA-approved for inpatient use, though doctors had discretion to allow patients who already had them to continue using them.

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Abbott Donating FreeStyle Libre for Hospitalized Patients with Diabetes During COVID Pandemic

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Abbott has made the generous and mindful decision to make the FreeStyle Libre 14 Day system available in the U.S. for hospitalized patients with diabetes during the COVID-19 pandemic. Read the full press release here.

Key details from the press release include:

-- More than 50% of people with diabetes who have been diagnosed with COVID-19 are hospitalized, according to a report from the Centers for Disease Control and Prevention (CDC).

-- FreeStyle Libre 14 day system can be used by frontline healthcare workers in hospitals to remotely monitor patients with diabetes who can scan to minimize exposure to COVID-19 and preserve use of personal protective equipment (PPE).

-- In partnership with the American Diabetes Association (ADA), Abbott will donate 25,000 FreeStyle Libre 14 day sensors to U.S. hospitals and medical centers in outbreak hotspots to help accelerate access to technology.

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Review to Check Out: First Impressions of Control-IQ

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Tandem's Control-IQ has been exciting news for the diabetes community! But what is it like to live with the new technology? On diaTribe Learn, Kerri Spalding recently shared her experience with getting started and living with the t:slim X2 insulin pump with Control-IQ. I really think this is worth a read. She talks about the transition of upgrading to Control-IQ on her existing pump, how she has utilized the new system, and how the Control-IQ changed and improved her diabetes management. And overall, how it made life a little easier and lighter.

The Future of Dexcom and Type 2 Diabetes

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Making CGM (continuous glucose monitoring) a true standard of care would require gaining insurance coverage for people with Type 2 diabetes. At the recent JP Morgan Healthcare Conference, Diabetes Mine (a wonderful, influential diabetes blog) discussed how Dexcom is planning to handle the next big wave of CGM with their CEO, Kevin Sayer.

The interview covered topics including creating access to CGM for more people and the smaller, cheaper CGM devices that will be next to the market. I was especially interested in the direction that Dexcom will take to include more people living with diabetes, specifically those with Type 2. A recent pilot study by Intermountain Healthcare followed 50 people with T2 diabetes using traditional fingerstick and another 50 who used CGM over the course of a year. The annual cost savings with CGM computed at $5,000 a year per patient, based on hospitalizations, lab tests, drug costs, doctor visits, and follow up calls. This is a massive cost reduction!

Read the entire illuminating article here to learn more about the future of CGM.

Big News: Healthy Living Now Providing Control-IQ

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Have you heard? The Tandem t:slim X2 insulin pump with Control-IQ technology is now available through Healthy Living Medical Supply! This advanced hybrid-closed loop system is designed to help increase time in range (70-180 mg/dL) and is the first system cleared to deliver automatic correction boluses in addition to adjusting insulin to help prevent high and low blood sugar. This is awesome news! The t:slim X2 with Control-IQ is integrated with the Dexcom G6 continuous glucose monitoring system (CGM) which requires no fingersticks for calibration or diabetes treatment decisions.

To get a feel for the new experience, try out Tandem’s free t:simulator App. It lets visitors experience the touchscreen interface of the t:slim X2 pump with Control-IQ technology directly on a mobile device.

All in-warranty t:slim X2 pumpers in the United States have the opportunity to update their software at no cost to begin using Control-IQ. Information about the requirements and update process is available at www.tandemdiabetes.com/X2update.

Benefits of Control-IQ Advanced Hybrid Closed-Loop Technology:

Predicts and helps prevent lows and highs – Control-IQ technology uses CGM readings to predict glucose values 30 minutes ahead and can increase, decrease or stop basal insulin delivery to help keep glucose in range (70-180 mg/dL).

Automatic Correction Boluses – If glucose values are predicted to be above 180 mg/dL, Control-IQ technology calculates a correction bolus with a target of 110 mg/dL and delivers 60 percent of that value. It will do this up to once an hour as needed.

Accommodates for sleep and exercise – Control-IQ technology offers optional settings for sleep and exercise that change the treatment values to better match the different physiologic needs during these activities.

No fingersticks – With Dexcom G6 CGM integration, the Control-IQ feature works with no fingersticks required for mealtime dosing or calibration. Other benefits of the Dexcom G6 CGM include an extended 10-day wear, acetaminophen blocking, and the ability to share real-time CGM data with up to 10 followers.

Easy to use – The system has no complicated criteria to keep Control-IQ technology on. If the CGM signal is temporarily lost, the Control-IQ feature will resume automatically when the CGM is back in range. In the pivotal study, participants gave Control-IQ technology a 4.7 out of 5.0 for ease of use, and a 4.8 out of 5.0 for desire to continue use of the system.

View the full, multimedia press release.

Innovative, Flexible Pump to Deliver Multiple Meds

A new insulin pump concept has appeared on the horizon that has potential to revolutionize the pump experience for people with diabetes, and others. The Evopump is a bandage-like device that can deliver more than one medication subcutaneously to a broad range of people. The Evopump's breakthrough design is soft, thin, and flexible, with precision and therapeutic flexibility.

The Evopump is under development by Boston-area medical device startup Cam Med. Founded in 2014, the company specializes in microfluidic-based drug delivery, and won an innovation award from the T1D Exchange in 2017 and then partnered with JDRF a year later to create this future multi-reservoir flexible patch pump. The Evopump is an electrochemical actuator with no mechanical parts, offering a highly precise flow rate. The company envisions that the Evopump will be used as part of closed loop systems, working with continuous glucose monitors (CGMs).

"With the Evopump’s low profile, flexible form factor and the ability to deliver more than one medication, we are poised to not evolve the on-body insulin delivery market, but to revolutionize that market," says Cam Med's Chief Commercial Officer Richard Spector, who lives with type 1 diabetes and formerly worked at Insulet (creators of the Omnipod tubeless pump). "We are thinking very much outside the box with the Evopump technology -- all the while keeping the user experience as the foundation of our efforts."

Learn more here:

Evopump: A Bandage-Like, Flexible "Patch" Insulin Pump

The Evopump Website

Innovative Pump Delivers Meds

dTech Companies Expand Global Reach

Dexcom and Medtronic both shared exciting news last week! Medtronic announced that they have obtained reimbursement in Germany for the MiniMed 670G Insulin Pump System for patients with type 1 diabetes. Learn more.

Dexcom announced last week that they are now accepting orders for the Dexcom G6 CGM System for people with diabetes ages two years and up in Canada. “We are thrilled to offer the Dexcom G6 CGM system to Canadians and are proud of this innovative technology that enables more effective diabetes management,” said Laura Endres, vice president, and general manager, Dexcom Canada, Inc. Learn more.

In the News: Eversense® CGM Real-World Data from First U.S. Users

The Eversense implantable CGM device has been making waves with its innovative functionality. Last week, Senseonics published Eversense CGM real-world data from the first U.S. users. The following information comes straight from the Business Wire press release for accuracy and clarity:

The real-world data demonstrated that the Eversense CGM System showed strong performance and safety over a 90-day sensor wear period, especially in the low glucose ranges. This data provides real-world evidence desired by patients, healthcare providers and payers on the clinical value and benefit of Eversense.

OVERALL PERFORMANCE

• Wear-time – 83.6% (American Diabetes Association recommends 70% wear-time)

• Time in Range – 62.3% between the ranges of 70 to 180 mg/dL

• Time in Hypoglycemia – 1.2% at <54 mg/dL and only 4% at <70 mg/dL. Users spent only 1.7% of the nighttime in hypoglycemia (<54mg/dL)

• Safety – No device or procedure related serious adverse events over the 90 days

• Conclusion – The Eversense real-world data showed excellent glycemic results, sensor accuracy, and safety. This data demonstrates that the Eversense CGM System is a valuable tool for diabetes management.

The Eversense CGM System consists of a fluorescence-based sensor, a smart transmitter worn over the sensor to facilitate data communication, and a mobile app for displaying glucose values, trends and alerts. In addition to featuring the first long-term and first implantable CGM sensor, the system is also first to feature a smart transmitter that provides wearers with discreet on-body vibratory alerts for high and low glucose and can be removed, recharged and re-adhered without discarding the sensor. The sensor is inserted subcutaneously in the upper arm by a health care provider via a brief in-office procedure.

Learn more about the Eversense CGM System.

In the News: For Many Diabetes Patients, Skin Patches and Phones Are Replacing Finger Pricks

The Wall Street Journal recently featured a story that explains why and how more U.S. diabetes patients are using continuous glucose monitors (CGM) to track their blood sugar. Almost 840,000 patients in the U.S. used the devices as of March 31, more than double the 389,000 using them at the end of 2017, according to Seagrove Partners LLC, a health-care research and consulting firm. The Journal's article has a great diagram showing how CGM works and talks about the importance of this technology to improve quality of life for many people with diabetes.

Friends for Life - An Unforgettable Conference

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"One of the most magical times for people with diabetes happens every year in July, with the annual Friends For Life Conference hosted at Walt Disney World in Orlando, Florida."

Hosted at Disney's Coronado Springs Resort, the Friends for Life conference just wrapped up in July. This is the 20th anniversary of the conference! Friends for Life brings together an international group of world-renowned clinicians, researchers, physicians, adults, children, and families with diabetes, including siblings and children of adults with type 1 diabetes, to learn the most current information in diabetes care. At Friends for Life, participants have the opportunity to gather cutting edge ideas in diabetes management and share their stories to help motivate and inspire others who walk in the same shoes.

Learn more and maybe join the fun next year!

Dexcom Highlights Next-Gen G7 Updates

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This month has been full of diabetes tech news as many manufacturers revealed product updates and research at the ADA 2019 Conference in San Francisco. For a great summary article from Diabetes Mine, check this out.

At the conference, Dexcom highlighted their upcoming next-gen G7 updates. Being developed with Verily, the next-gen G7 product will:

• Have a faster warm-up time than the current G6 startup window

• Include extended wear time of 14-15 days

• Offer a fully-disposable, all-in-one sensor-transmitter with a smaller on-body footprint

• Provide a dramatic cost reduction and more accuracy and reliability

• Allow direct Bluetooth-to-smartphone communication

Dexcom's slating this for later 2020 with a limited launch at first, and then rolling it out more broadly across the U.S. and internationally in 2021.

FreeStyle's LibreLink App Now Compatible with Android

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Starting last week, FreeStyle LibreLink is now available for Android phones, as well as compatible iPhones. FreeStyle LibreLink is a mobile app that enables compatible Android and Apple phones to scan a sensor and display glucose data and trends, including:

• Current glucose reading

• Trend arrow

• Up to eight hours of glucose history

With a quick scan over the sensor, you will have glucose readings anytime and anywhere. You can download the new Android app here.

Learn more about the FreeStyle Libre continuous glucose monitoring (CGM) system by checking out these previous blogs:

Getting to Know Libre CGM

A Review of the FreeStyle Libre Sheds More Light on the New Technology

Healthy Living Now Providing the Abbott Freestyle Libre to Medicare Members