News

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.

CGM WSG article



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

Real-World Data from Medtronic's Guardian Connect & Sugar.IQ Shows Improved Outcomes

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This week at the American Diabetes Association (ADA) Annual Meeting, Medtronic announced real-world data on its Guardian Connect continuous glucose monitoring (CGM) system and Sugar.IQ diabetes assistant app. The Guardian Connect system and Sugar.IQ app empower people using multiple daily injections (MDI) to more proactively manage their diabetes with meaningful, personalized insights. The real-world data was recorded by users of the Guardian Connect CGM paired with the Sugar.IQ.

Sugar.IQ diabetes assistant is a separate app that continually analyzes how an individual's glucose levels respond to food intake, insulin dosages, daily routines, and other factors. The Sugar.IQ app combines data from the Guardian Connect CGM system with artificial intelligence technology from IBM Watson Health to detect important patterns and trends for people with diabetes and help them make more informed decisions on how to better manage glucose levels and stay within target range.

The data showed that people using the Guardian Connect system with the Sugar.IQ app experienced 4.1% more Time in Range (63.4%) compared to Guardian Connect alone (59.3%), which represents about one extra hour per day. And those who also used the optional Glycemic Assist feature to review their response to specific foods increased Time in Range by an additional 4% compared to those not using that feature.

Learn more from the official Medtronic press release.

Noteworthy Positive Trial Results for Tandem's Closed Loop System

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The diabetes community is excited about positive results from two Tandem studies that were announced earlier this week. Data from the studies has demonstrated that Tandem's advanced hybrid closed-loop system has achieved the primary outcome of increasing time in range (70-180 mg/dL) without any severe hypoglycemic events for both adult and pediatric age groups.

Tandem's t:slim X2 insulin pump with Control-IQ technology utilizes Dexcom G6 continuous glucose monitoring (CGM) sensor values to predict glucose levels and adjust insulin delivery to prevent highs and lows, while still allowing the user to manually bolus for meals. The system also automates correction boluses, a feature not commercially available today on automated insulin delivery devices.

Read the entire press release for many more details on the studies and outcomes. This news supports Tandem as the company moves toward a future FDA approval on their closed loop system, expected later this year.

In the News: The Omnipod DASH Now Available in the U.S.

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Insulet's Omnipod DASH is now officially available in the United States. The Omnipod DASH™ System combines a tubeless, waterproof, wearable Pod that provides up to 72 hours of non-stop insulin with an easy-to-use, touch-screen, Bluetooth®-enabled Personal Diabetes Manager (PDM) that looks like a normal smartphone. The Pod can be worn anywhere you would administer an injection. Placement is easy, completed with the touch of a button and without even seeing a needle. The DASH system is available with limited release right now, and Healthy Living anticipates providing the system at the end of this year or early in 2020.

There are two components to the DASH system.

The Pod:

  • The Pod is a small, waterproof device that you fill with insulin and wear directly on your body.

  • The Pod includes a small, flexible cannula that inserts automatically with the push of a button.

  • The Pod communicates wirelessly with the Personal Diabetes Manager (PDM) to program insulin delivery.

The Personal Diabetes Manager (PDM):

  • Multiple PDM features support how you control your insulin.

  • The system includes two mobile apps and accompanying widgets.

  • Compatibility with other systems simplifies the tracking and recording of data.


Beyond Type 1 addresses the updates in the Omnipod DASH system:

What’s New in the DASH™ System?

  • Updated PDM (Personal Diabetes Manager) – The handheld portion of the Omnipod Insulin Management System got an update and will feature a color touchscreen display.

  • Bluetooth wireless technology – DASH™ PDM and Pod will communicate via Bluetooth, laying the groundwork for current and future integrations with compatible technology – like meters, CGM, and management apps.

  • Meter integration – DASH™ will be optimized for use with CONTOUR® NEXT ONE Blood Glucose Meter for the transfer of blood glucose readings to the PDM’s bolus calculator via Bluetooth – The PDM will no longer have a built-in BGM.

  • Diabetes management app integrations – The Omnipod Display and Omnipod View apps will provide users and their caregivers easy access to their insulin therapy information on their smartphones.

    • Omnipod DISPLAY allows users to discreetly monitor their PDM data on their smartphones.

    • Omnipod DISPLAY on a smartphone will include a “Find My PDM” feature.

    • Omnipod VIEW allows parents and caregivers to monitor their loved ones’ diabetes more easily.

    • The iOS Today View widget allows users and their care teams to see their or their loved ones’ PDM and continuous glucose monitor (CGM) data on one smartphone screen with one swipe.

  • New Pods – The DASH™ pods will look and work the same, but have been updated for Bluetooth compatibility with the DASH™ PDM. Old pods will not work with the new PDM.

  • Rechargeable Battery – The DASH™ PDM will require recharging of its lithium ion battery, replacing the AAA batteries used in current Omnipod PDMs.

  • Payment Structure – The DASH™ PDM will be offered at no cost with the purchase of Pods.

Medtronic Moves Beyond A1C with CGM

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In early April, Medtronic entered into a "value-based outcomes agreement" with Blue Cross Blue Shield of Minnesota, and the two organizations have agreed to use a metric other than the gold standard A1C test to measure members' success using the device. A Medtronic spokeswoman recently told Diabetes Mine that Guardian Connect has become the first-ever stand-alone CGM using "Time in Range" as the key metric. Many advocates and innovators in the diabetes community have been pushing to move "beyond A1C.”

Medtronic's press release about their "Time in Range" metric explains:

"Time in Range (TIR) is a standard measurement in diabetes management that tracks the amount of time a person’s glucose is in their target range with 70-180 mg/dL being the standard range. Spending more Time in Range helps minimize both short- and long-term health complications from going too high or low. Results from an analysis of people who used the predictive alerts feature on the Guardian Connect system showed that they experienced fewer high events 39 percent of the time (vs. 10% without alerts) and fewer low events 60% of the time (vs. 33% without alerts)."

Medtronic also has been promoting their Time in Range infographic:

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Diabetes Mine explained how Medtronic's reimbursements will work with Blue Cross Blue Shield:

"With Blue Cross Blue Shield, they are actually tying insurance payments to the amount of time users spend in this healthy glucose range -- an approach known as "value-based payments." So if a Medtronic CGM user does not manage to stay in that ideal 70-180 mg/dL range for a certain amount of time when using the device, then Medtronic will actually pay back the cost to the insurance company."

Learn more from Medtronic.

Happy Birthday Dexcom & Updates to the Dexcom G6 iOS App

This year, Dexcom (founded in 1999) celebrates its 20th birthday! Over 20 years, Dexcom has brought us groundbreaking technology, and there are many changes, including growth and expansion, on the horizon. Read more at the Diabetes Mine blog "Dexcom Hits 20-Year Birthday with Exciting New Tech, Corporate Restructuring." According to the Diabetes Mine article, these are the...

Six New Changes to the Dexcom G6 App for Apple

  1. Siri Assist – You can now ask Siri to read Dexcom G6 glucose readings aloud and display graphs directly on the lock screen.

  2. More Followers – With an expanded Dexcom SHARE function, you can now share glucose readings with up to 10 people (in the past the max was five).

  3. 24-hour Sensor Expiration Reminder – The app now offers an automatic 24-hour reminder before it’s time to replace a sensor, in addition to the existing 2-hour and 6-hour reminders.

  4. CLARITY App at Your Fingertips – You can now launch the Dexcom CLARITY app directly from the Dexcom G6 app for more retrospective glucose reports, rather than having to exit the G6 app and go into the separate CLARITY app.

  5. Extra Integration – They've also added a feature allowing Google Fit to display Dexcom G6 data on a three-hour delay (this lag is a regulatory hurdle being discussed with FDA).

  6. Apple Watch Feature – Users can also add an icon to check their glucose level when customizing the face of their Apple Watch Series 4. Unfortunately, Dexcom doesn't yet allow for direct-to-watch functionality; you still need the smartphone as the middleman between the CGM and Apple Watch.

Learn more about Dexcom CGM here.

February Is American Heart Month!

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This month is a great time to zero in on some of the ways we can keep our hearts healthy. This month, the National Heart, Lung, and Blood Institute has launched #OurHearts, an initiative to encourage everyone to adopt heart healthy behaviors, together. Studies show that if you join forces at home, at work, in your community, or online, you have a better chance of staying motivated.

Start with small steps:

  1. Move more.

    Remember - Some physical activity is better than none.

  2. Aim for a healthy weight.

    Choose - Heart healthy foods and regular exercise help you achieve and maintain a healthy weight.

  3. Eat healthy foods.

    Try - Find an eating plan that is successful for you and supports your diabetes management.

  4. Quit smoking.

    Ask - Your family and friends can support you in your efforts to become a non-smoker.

There is a lot you can do to prevent heart disease. Work with your family, friends, or neighbors to meet your heart health goals! Learn more at:
https://www.heart.org/en/health-topics/diabetes/why-diabetes-matters/cardiovascular-disease--diabetes
https://www.nhlbi.nih.gov/health-topics/education-and-awareness/heart-month
https://www.heart.org/

Two New Glucagon Formulations Await FDA Approval in 2019

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If not treated quickly, mild or moderate low blood sugar can become severe. Glucagon is a treatment for very low blood sugar (severe hypoglycemia) which may affect people with diabetes. Two new versions are hoping to hit the market soon (these would be the first new types of glucagon in more than six decades).

  • After years of research, Eli Lilly has created a glucagon version that you "puff up your nose" to quickly boost blood sugar. Last summer, Lilly filed its nasal, dry powder glucagon for regulatory review in both the U.S. and Europe.

  • Xeris Pharmaceuticals has created a glucagon emergency pen that requires no mixing or prep, with an FDA meeting set for June of this year. The Xeris glucagon rescue pen would be the first ready-to-use, room-temperature stable liquid glucagon in an auto-injector to treat severe hypoglycemia.

Hopefully both will launch by the end of this year!

New Slimmer, Low-Cost CGM Coming from Dexcom & Verily

The sensor on the left is the Dexcom G6 CGM, and the sensor on the right is their new CGM, expected in about two years. This new device was previously described as "the thinnest CGM ever."

The sensor on the left is the Dexcom G6 CGM, and the sensor on the right is their new CGM, expected in about two years. This new device was previously described as "the thinnest CGM ever."

Dexcom plans to bring a new, lower cost, slimmer, disposable continuous glucose monitor (CGM) to market in 2020/2021 in partnership with Verily. Notable features of the new CGM will include:

  • Significantly lower cost - for greater accessibility

  • Fully disposable with no separate transmitter - after sensor wear is complete, the entire piece is thrown out and replaced

  • No fingersticks - like the Dexcom G6

  • Extended wear - approximately 14 days

  • Sends data straight to Smartphone - via Bluetooth

This information came from the diaTribe blog. According to diaTribe, "This sensor will be made widely available to people with diabetes who are on intensive insulin therapy (pumps or multiple daily injections) and those with type 2 diabetes on pills or no medication."

This is an exciting technology to look forward to for better diabetes management for more people. We'll keep you in the loop as more news emerges from Dexcom. To learn more about CGM options available today, call us at 866.779.8512, Option 2.

Medtronic Founder Earl Bakken Turned a Tiny Repair Shop Into a Giant of Medical Technology from WSJ

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I just learned about what a fascinating and inspiring man Earl Bakken was. He co-founded Medtronic in 1949 with the unassuming goal of repairing medical equipment. But in the mid-50s, a heart surgeon in Minneapolis asked Bakken to create a pacemaker that didn’t need to be plugged in, and a few weeks later, he had invented a wearable pacemaker powered by a battery. Mr. Bakken was an inventor from an early age, and his worked sustained him late into his life. Bakken died on October 21 at the age of 94, and back in 2010 he was using his second pacemaker and third or fourth insulin pump!

Please take a moment to read the lovely Wall Street Journal article that commemorates Bakken’s life. I found this part especially interesting:

He worried that children no longer take gadgets apart. Even engineers “never get the sense of the actual object they’re designing on a screen,” he wrote. “They make faulty assumptions because they have never taken the real thing apart and put it back together again. They’ve never jiggled it in their hand, never gotten a feel for its density and heft, never lifted it to their nose and smelled it. What a pity for them—and maybe for the rest of us as well.”

We are thankful today to Medtronic Diabetes for providing insulin pump and CGM technology to many of our patients. Just like their founder, they are in the business of changing lives.

Let's Celebrate Diabetes Awareness Month!

Diabetes Awareness Month 2018 starts today, and World Diabetes Day is celebrated globally on November 14 to raise awareness about both Type 1 and Type 2 diabetes! Here are some ideas about how to get involved from some of our favorite advocacy organizations!

Together, let’s celebrate Diabetes Awareness Month and the many strong individuals and families who live resiliently with diabetes every day!

In the Halloween Spirit: Family Pumpkin Sale Raises Funds for Michigan Boy to Obtain Diabetes Service Dog

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Happy Halloween! We love this story… A pumpkin sale recently helped Ian, a six-year-old who lives with Type 1 diabetes, and his family raise money for a service dog to help him manage his disease. In Sand Lake, Michigan, the Christensen family used their annual pumpkin sale as a fundraiser this year – and as a result, Ian will have a service dog trained specially to help him in less than a year. Ian’s diabetes service dog will be trained to detect the subtle smells in his breath and alert Ian before dangerous blood sugar lows kick in. We are so happy for Ian and his family!

“The world would be a nicer place if everyone had the ability to love as unconditionally as a dog.” ― M.K. Clinton

Dexcom G6 CGM Receives CMS Approval & Will Be Available to Medicare Beneficiaries in Early 2019

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More great news has been announced about CGM! The Dexcom G6 continuous glucose monitor (CGM) will be covered for Medicare beneficiaries, starting in early 2019. CGMs are DME items that provide critical information on blood glucose levels to help patients with diabetes better manage their disease. Coverage for therapeutic CGM includes certain beneficiaries who have either Type 1 or Type 2 diabetes and intensively manage their insulin.

The Dexcom G6 CGM shines because of the following advantages:

  1. Zero fingersticks

  2. Acetaminophen blocking to maintain accuracy while taking Tylenol

  3. Smartphone app that allows data to be shared with family members, providers, and other members of a patient's care team

  4. Super easy application device

  5. Very small and discreet sensor

  6. Integration with the tSlim:X2 insulin pump from Tandem Diabetes, which is also covered by Medicare

Healthy Living will be able to provide the G6 to Medicare members – stay tuned for updates on this exciting news! Read the press release directly from Dexcom.

New Research Broadens the View for Predicting Obesity-Related Disease Risk

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Researchers have developed a more precise and nuanced method for predicting risk of diabetes and cardiovascular disease than traditional body mass index (BMI) measurements. Scientists at Scripps Research have found a way to use molecular “signatures” from people with obesity to predict these risks. The authors of the study wrote, “While BMI correlates well and to a large extent with individual health outcomes, it does not have the sensitivity to identify outliers, some of which carry unique health consequences.”

The research is led by Amalio Telenti, MD, PhD, and shows that predictors of future diabetes and cardiovascular complications for an individual can be found among the body’s metabolites. Metabolites are molecules that all of us produce as we live, breathe, and eat. Scientists study the “metabolome,” which is a person’s collection of hundreds of metabolites. The metabolome creates specific signatures or combinations of variants that can indicate risk. "By looking at metabolome changes, we could identify individuals with a several-fold increase in their risk of developing of diabetes and cardiovascular disease over the ensuing years," says Telenti. Metabolome changes were not always associated with obesity – some people studied were lean but still at risk of disease.

This research looks like it will become a powerful tool for predicting and preventing diabetes and cardiovascular disease in the future. The study suggests that new technologies can broaden the way that scientists think about disease. You can learn a lot more about research related to molecular signatures by reading these two articles:

Research Underway to Create a Cannula with Lower Risk of Infection & Inflammation

A professor at the University of Central Florida, Elizabeth Brisbois, is working to develop a cannula that can be left in place for as long as 30 days while effectively delivering insulin into the body. Cannulas are small tubes that are inserted beneath the skin to deliver insulin into the body as part of an insulin pump system. The cannula can either be part of the infusion set or attached to the actual insulin pump. Normally, over time, the body’s immune system attacks the cannula, with cells creating a film around the cannula that begins to inhibit proper insulin delivery. That is why infusion sets normally need to be changed every two to three days to reduce the risk of infection. 

Brisbois’ goal is to create cannulas that have a lower risk of infection and inflammation, with reduced pain and inconvenience for patients. She and her team are developing cannulas that release nitric oxide, a molecule that can kill bacteria. Nitric oxide is also produced in the body to fight off germs and has an important role in wound healing.

This advance could significantly increase quality of life for people living with type 1 and type 2 diabetes. Brisbois and her team are funded by a recent grant from the JDRF and are collaborating with researchers at the University of Georgia. Learn more about the cannula research here.