Check This Out: “Imagine 288 Fingersticks a Day”

I came to rely on my CGM as my personal blood sugar “GPS.”
- Michael Hattori

Image credit: FreeStyle Libre (www.freestyle.abbott)

The purpose of this post is actually to introduce you to an awesome article from diaTribe about the life-changing effects of CGM for a nurse who discovered he was living with type 2 diabetes. Read the article here. He used the power and knowledge provided by CGM (continuous glucose monitoring) to change his health strategy and outlook and overall diabetes management, putting his type 2 diabetes into remission. Read his own words. I love this article; it is an amazing testimony to the experiential learning opportunities and health benefits provided by using a CGM!

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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An Artificial Pancreas Primer

We have heard the term many times, but there is so much more to understand. What is an artificial pancreas? 

An artificial pancreas (AP) is a system designed to mimic what a healthy pancreas does: monitor glucose levels and deliver insulin as needed. Its goal is to automate blood glucose control as much as possible, so the wearer does not have to perform constant fingerpricks and be so involved in decision making and insulin dosing based on those readings. Although different names have been out there for awhile - artificial pancreas, closed loop system, and bionic system, the technology is now officially being referred to as AID (Automated Insulin Delivery) systems. At this point, the FDA has approved two AID systems - the Medtronic MiniMed 670G and Control-IQ from Tandem Diabetes Care. At least 11 other companies are working hard on inventing their own versions as well, which is extremely encouraging! 

The components of current AP systems include:

• an insulin pump, which provides a continuous flow of insulin into the body via an “infusion site” or small cannula inserted in the skin

• a CGM that takes ongoing blood sugar readings via a little sensor worn on the skin that has its own separate cannula from the pump. There are currently two CGMs on the market in the U.S. from Dexcom and Medtronic.

• a controller (usually a smartphone) that includes the display screen where users can see glucose data

• algorithm software, the “brain” of the system, that crunches the numbers to predict where glucose levels are headed and then tells the pump what to do

• glucagon, a hormone that rapidly increases blood glucose, used here as an antidote to hypoglycemia (low blood sugar)

Find out much more about AP technology from Diabetes Mine 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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How to Clean Your Insulin Pump & CGM

Whether you use one or both, Medtronic has some great advice for keeping your insulin pump and CGM clean. These tips can help set you up for success with cleaning your devices. Wash your hands, gather your cleaning supplies, and get going!

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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.

Revisiting Seven Leading Benefits of CGM

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Although continuous glucose monitoring (CGM) isn't the newest news anymore, it continues to be some of the best news in diabetes technology. Find out more about the opportunity for better diabetes management.

CGM:

1. Measures the body's glucose levels in real time, providing a new glucose level every five minutes

2. Provides a good way to monitor time spent "in range"

3. Gives warnings if users are trending toward hypo or hyperglycemia, including threshold alerts

4. Measures your blood sugar repeatedly without fingersticks (some CGMs do not require fingerstick calibrations)

5. Gives you the knowledge of how every single thing affects your blood sugar, while awake and asleep

6. Allows you to see the effect of food in real time

7. Offers you the power to make more informed treatment decisions

Learn more about the CGMs Healthy Living offers here.

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.

Getting Started with CGM: A Walkthrough

CGMs (continuous glucose monitors) can reduce the stress and uncertainty related to glucose monitoring. Healthy Living is here to help lessen the challenges of acquiring and maintaining a CGM. And it’s easy to get started! Our team will guide you through the whole process.

Here is a preview of what your first conversation with us might include, plus some other details of the progression of obtaining a CGM system.

Intro: Is this your first CGM system? If not, when was the last time you received supplies?

Basic Information: We ask questions to gather patient demographic info, insurance info, and doctor information.

CGM Options: What system are you looking for? We offer Dexcom G5, Dexcom G6, Guardian Connect, or FreeStyle Libre CGM.

Medicare CGM Requirements: Medicare patients must use the Dexcom G5 or FreeStyle Libre system, because Medicare doesn’t cover Medtronic supplies. Must be testing 4x/day and injecting insulin 3x/day.

Authorization & Documentation: If your insurance requires an authorization, the Healthy Living team will gather the appropriate docs, including prescription, chart notes, and 30 days of continuous logs. Once authorization is submitted, you can expect a response time of 7-14 days for most insurance companies, and 30-45 days for straight Medicaid.

Planning for Payment: We will ask for a credit card to place on file to charge once the order is ready to ship. We will never charge you without your permission.

Follow-Up with the Doctor: We will ask you to follow up with your doctor’s office to request required documents for authorization, and we will also reach out to your doctor every 3-4 days until the necessary documents are obtained.

Updates: We will text or call with updates about your account. You will also receive an email with a summary of our conversation and will be given access to our online portal to track the status of the initial CGM order.

Ready for your CGM?

Contact us using your preferred contact method. We have three different ways of helping you - choose whichever is best for you!

1. Call 866.779.8512.

2. Text “CGM” to 248.577.9903.

3. Fill out the form below.

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.

Medtronic’s Next-Gen Hybrid Closed Loop System

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Medtronic's next-gen hybrid closed loop system will be the Minimed 780G, designed to help patients enjoy greater freedom and less burdens. Currently, the 780G is being studied in an in-home trial with 350 adult and pediatric patients with type 1 diabetes participating, using the device over a three-month period. The in-home study is estimated to be completed in January of 2020, with the results presented in July, 2020.

What should you expect from the new Medtronic system?

• New vertical "modern" look

• Automatic correction bolusing

• A new algorithm, that according to Medtronic is more accurate and reliable

• A function to automatically adjust for missed meals

• Adjustable target range, down to 100 mg/dL

• Option for remote software updates

• Bluetooth connectivity

Stay tuned for a launch date and other news on the Minimed 780G!

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.