Rush for COVID Vaccine Hinders Diabetes Tech Advancements

Modern science is amazing. The COVID-19 pandemic, which is still shaking the world as we know it, is quickly getting controlled due to fast scientific progress and the vaccine rollout (in the United States, at least).

Having an effective vaccine come to market within a year of the appearance of a novel disease is unheard of; most medicines take decades for adequate approval processes within the Food and Drug Administration (FDA) to be completed. This feat is incredible.

That being said, with all of the rush to get a vaccine to the masses, the FDA pushed the Pfizer, Moderna, and Johnson & Johnson vaccines literally to the front of the approval line, delaying other important medical and technological advancements, including those related to diabetes.

While the vaccine did (and should!) take precedent here, the delays have been tough for people with diabetes in many ways. 

The head of the FDA’s device center, Jeff Shuren, described a “tsunami” of product applications from companies hoping to join the fight against the COVID-19 pandemic.

Those applications include over 1,200 submissions for products like diagnostic tests, ventilators, and digital technology, all of which have slowed their work in other diseases, including diabetes.

Shuren went on to say that review times had begun to increase amid growing backlogs due to the high volume. 

The agency is trying to make as much space as possible to approve COVID-19 related vaccines, medicine, and technology quickly to end the pandemic, which has taken precedence over almost everything else. Experts suspect that the FDA may not be able to meet its own timelines going forward.

In addition, lockdowns and social distancing regulations halted clinical trials and product releases. It’s been a tough year for diabetes tech firms to get much done.

The following products, and their release dates, have been most affected by the pandemic:

Senseonics’ 180-Day Eversense Glucose Monitor

The Eversense continuous glucose monitor (CGM) is a device implanted under the skin that lasts for 90 days. The newest version of their CGM system aims to double its lifespan to 180 days without changing a sensor.

What was supposed to be released in early 2021 now faces delays of up to two months for its application to the FDA while the agency tasks its staff with emergency reviews of coronavirus tests and other medical devices. The new release date of the model is scheduled for mid-2021.

The Omnipod 5 (Originally “Horizon”)

Insulet’s Omnipod 5 system, which utilizes CGM data to make automated adjustments to basal insulin throughout the day, will be the company’s first hybrid-closed loop system.

Similar to the T-slim Control IQ system, this insulin pump will provide mobile app control and insulin dosing from a smartphone, eliminating the need to carry their hallmark Personal Diabetes Manager (PDM) around to control the release of insulin.

While significantly delayed due to the COVID-19 pandemic, Insulet said during its Nov. 4, 2020 investor update call that it had recently finished its clinical trial and was finalizing its FDA submission.

They hope to launch their product by June of 2021.

Medtronic 780G

Also known as the Advanced Hybrid-Closed Loop (AHCL) system, this system will improve upon its first iterations of the hybrid-closed loop system, the 670g and 770g. Hoping to seek approval for adults and children as young as two, this system includes:

  • A CGM sensor that will require just one calibration on the first day of wear and no further calibrations after that
  • Automatic correction bolus delivery every 5 minutes, in conjunction with CGM readings, that can automatically bolus for missed meal doses.
  • A lower glucose target range, adjustable between 100-120 mg/dL
  • Different insulin duration times, to adjust for the “tail” of your insulin (eg, Fiasp vs. Humalog)
  • Built-in Bluetooth to share data and provide remote software updates

Due to the pandemic, the approval for this device has been delayed, but Medtronic confirmed that it had submitted its application for review to the FDA in February, 2021.

They hope to have a commercial launch sometime in 2021.

Dexcom G7

The much-anticipated Dexcom G7 continuous glucose monitor (CGM) was also delayed due to the pandemic, but it should be worth the wait. You’ll no longer need to buy separate transmitters; each sensor is a complete and disposable transmitter/sensor integrated system. Some other great features include:

  • No calibrations, much like the G6
  • At the start, wear time will be 10 days, but eventual use will include a 14-15 day feature, also without any calibrations
  • Smaller and thinner: the newest CGM will be 60% smaller than the G6
  • One hour warm-up period

Dexcom CEO Kevin Sayer said that the company eventually plans to have different versions of the G7 for different people.

For example, people with type 2 diabetes who don’t use insulin (or even the general public) might opt for a much simpler interface than people with type 1 diabetes, who will want all of the alarms and settings.

Abbott Freestyle Libre 3

For years, the FreeStyle Libre from Abbott Diabetes was a considered Flash Glucose Monitor (FGM), because it only reported blood sugar levels whenever a user scanned their sensor with a receiver or smartphone.

That will change with the new edition: The Freestyle Libre 3 will function as a real-time CGM, because it won’t require sensor scanning to get a “flash” of blood glucose data. It will instead provide trends and graphs to track blood sugars throughout the day.

The Libre 3 generates real-time blood sugar readings every minute (as opposed to Dexcom’s every 5 minutes), displaying the result on a mobile app on your smartphone. This version also has optional high and low blood sugar alarms, a feature introduced with the Libre 2 in 2020.

Additionally, the sensor is much smaller and thinner (a 70% size reduction), and is kinder to the earth, using 41% less plastic overall.

The Libre 3 received global approval in September 2020. The timeline in the US has been pushed backwards, but with clinical trials now complete, we’ll likely see the Libre 3 applications submitted to the FDA mid-2021.

While the hustle for an effective COVID-19 vaccine has been nothing short of miraculous, people with diabetes don’t want to wait any longer!

Hopefully, with the hastened release of the vaccine, we can see more diabetes technology hit the market in 2021. 

Source: diabetesdaily.com

So You Got a CGM – Now What?

This content originally appeared on diaTribe. Republished with permission.

By Katie Mahoney, Hanna Gutow, and Diana Isaacs

If you just got a continuous glucose monitoring system, you may be wondering how to use it most effectively and how to understand your glucose data. Read our tips, tricks, and things to consider.

Congratulations – you got a continuous glucose monitor (CGM), an excellent tool to support diabetes management. Hopefully you’re feeling optimistic and excited that you have the opportunity to use this technology.

It’s most likely that you and your healthcare team decided that using a CGM is the optimal way for you to manage your diabetes. Perhaps you were given a prescription for a personal CGM. Or maybe you’re trying CGM as part of Dexcom’s Hello Dexcom program (a free ten-day trial), through Abbott’s MyFreestyle program (a free 14-day trial), or as part of Medtronic’s CGM Discount Access program. You might also be trying professional CGM, which is owned by your healthcare clinic and worn on a short-term basis.

If you haven’t yet been able to get CGM, ask your healthcare team if you can get a trial device or get a prescription. CGM is recommended for anyone with diabetes who takes mealtime insulin. While many people with diabetes currently don’t have access to CGM, we’re hopeful that more and more individuals will be able to use this technology in the future. Regardless of what brings you to using a CGM, we’ve created a three-part guide to help you get started, including tips, tricks, and considerations.

Click to jump down to a section:

Part 1: Before you apply your CGM

Learn the basics.

Before you start using your CGM, it can be helpful to understand its basic features. Continuous glucose monitors (CGM) measure the body’s glucose (or sugar) levels by sensing the glucose present in tissue fluid (also called interstitial fluid). While a blood glucose meter (BGM) provides a measurement of the blood glucose level at a specific moment in time (when you prick your finger), CGMs provide a new glucose level every one to five minutes – depending on the device, that’s 288 to 1,440 times per day. A CGM provides a constant stream of information on glucose levels, trends, and patterns.

A CGM can either be transcutaneous (it goes through your skin) or implanted (it lies under your skin). CGMs require three basic parts:

  1. A sensor that monitors real-time glucose levels under your skin.
  2. A transmitter that sits on top of the sensor and sends glucose information to a smartphone app, reader, or receiver. In transcutaneous systems, the sensor and transmitter are connected as one small on-body device. Some transmitters are disposable with the sensor while others require an additional step to attach. In implanted systems, the transmitter is attached to the skin and can be removed without harming the sensor below the skin.
  3. A smartphone app, reader, or receiver to collect and display your data.

CGMs have a variety of features that differ by brand and model, including the amount of time the CGM needs to “warm up” before glucose readings are available, how long you can wear a CGM sensor before needing to replace it, and alarms that alert you to highs and lows. You can learn more about CGM devices here. For brand-specific resources and information, click here to jump down.

Personal CGM vs. Professional CGM

The CGMs that we just described are called personal CGMs – they are owned by the person with diabetes and used for a long period of time. They are available as real-time CGMs, where the data can be continuously viewed, or as intermittently-scanned CGMs, where information is recorded all of the time, but you need to scan the sensor to view the data.

Another type of CGM is called “professional CGM.” Professional CGMs are given to someone with diabetes for a short session (usually one to two weeks) to better understand that person’s glucose levels. After the wear period, the person will review the data with their healthcare professional. This can provide insights that inform the person’s diabetes treatment, and it can help healthcare professionals recommend therapy and lifestyle recommendations that lead to better glucose management.

Some professional CGMs have a real-time mode, meaning that the user can see their glucose levels while wearing the device. Other professional CGMs have a “blinded” mode. Blinded CGM means that you cannot look at their glucose values on-demand; instead, all of your glucose data is stored and shared with your healthcare professional. This can help your healthcare team identify hypoglycemia (or low blood sugar levels). If you get a blinded professional CGM, your healthcare team will analyze the data and discuss it with you once your wear period is complete.

While long-term, real-time CGM is most effective for day-to-day diabetes management, especially for insulin users, professional CGM can be an important tool for people who are not using personal CGM. Periodic use of CGM can help people learn the effects of food and physical activity on glucose levels, even for those not taking any diabetes medications.

Reflect on your goals, know your targets, and make a plan to respond to highs and lows.

It can be helpful to reflect on your CGM goals, set your glucose targets, make plans for responding to your glucose readings, and decide with whom you want to share your data:

  • Reflect on your CGM goals. Perhaps you want to use CGM to prevent hypoglycemia using its alert system, or to prevent hyperglycemia and increase your Time in Range, or to manage glucose during exercise. Or, maybe you and your healthcare team are going to use professional CGM for two weeks to explore how your lifestyle habits affects your glucose levels. Regardless, the ultimate goal of CGM is to improve your diabetes management.
  • Know your personal glucose targets and make a plan with your healthcare team for how you’ll respond to hyperglycemia and hypoglycemia. Knowing your target glucose range is important for responding to your real-time glucose values. For most people with diabetes the target range is 70-180mg/dl – learn more about Time in Range goals here. Make a plan that incorporates glucose trend arrows from your CGM to help you prevent big spikes out of range. Here are some prompts for you to discuss with your healthcare team:
    • What is my glucose target when I wake up and before meals?
    • What should my glucose level be two hours after a meal? If it is above that value, what actions should I take to bring my glucose levels down?
    • What is my glucose target before bed?
    • What high glucose level should I try to avoid? What should I do if my glucose gets that high?
    • What low glucose level should I try to avoid? What should I do if my glucose gets that low? What should I do if my glucose levels are trending down?

Part 2: Applying your CGM

Connect the CGM to the app and set the system up.

Download the mobile app associated with your CGM system if available. If you’re using a receiver (Dexcom device) or reader (Libre device), make sure it’s charged daily. The CGM should come with instructions for applying the sensor (every seven, ten, or 14 days) and pairing the app, reader, or receiver with your sensor and transmitter. If you have an implanted CGM, it will be applied by a healthcare professional and can last up to 90 days. To jump to brand-specific instructions and tutorials, click here. To learn about CGM adhesives and tips for keeping your CGM on, check out Adam Brown’s suggestions on the topic.

Once your system is set up, your CGM will need to “warm up” before you can see your data. Different models have different warm-up periods, but this will generally take one to two hours, after which your data will be accessible either directly (Dexcom, Guardian, Eversense) or by scanning your sensor (FreeStyle Libre). The warm up period for the implantable Eversense system is 24 hours.

For many people starting to use a CGM, video tutorials can be quite helpful. If you have the opportunity, it’s good to meet with a diabetes care and education specialist or your local pharmacist (if picking up your CGM from a pharmacy). Here are set-up and application tips and tutorials for your CGM:

Part 3: Understanding your CGM data

Once you’re set up with your CGM and the warm up period is complete, you can access your data. There are two types of data you’ll want to pay attention to: real-time data and past data.

Interpret your real-time data.

Depending on the CGM brand you’re using, you can either access your glucose data at any time by looking at an app on your phone, your smart watch, or your receiver. For those using an intermittently-scanned CGM, you can view your glucose levels by scanning your sensor with your smart phone or reader. Looking at your data can feel overwhelming at first, so we recommend focusing on two aspects of your real-time data:

  • First, look at your CGM glucose value. Is it in your target range? If your glucose level is out of range, which steps of your plan should you follow?

If you’re experiencing hypoglycemia in particular, make sure you act right away to increase your glucose levels.

  • Second, look at the trend arrow. Your CGM provides a “trend arrow,” to tell you the direction and speed with which your glucose values are changing. The trend arrow is helpful for understanding what’s going on and how you can respond. For example, if your glucose value is 90 mg/dl and your trend arrow shows that your glucose levels are going down, you may need to take action to prevent hypoglycemia; if your glucose value is 90 mg/dl and your trend arrow shows your glucose levels are increasing, you are likely not going to develop hypoglycemia.

Trend arrows can help with premeal insulin dosing, before and after exercise, before bed, and to understand where your glucose will be trending in the next 30 minutes. Trend arrows are particularly beneficial when used with insulin on board (short-acting insulin that was recently taken for food or to correct a high glucose level and is still working in the body). For example, if your trend arrows are going down and you have insulin on board from an insulin dose given two hours previously, your risk of hypoglycemia is even greater.

For those not using insulin, trend arrows can help understand how different foods and activities affect glucose levels. For example, if a person sees that the arrow is rising rapidly after a certain meal or snack, they can go for a walk to try to bring it down. It may also signal that next time you should consider a smaller portion size or try to add protein or fat to prevent glucose levels from rising as quickly.

Each CGM has a slightly different interpretation of the arrows, but here’s a general idea of what the trend arrows can tell you.

data

Image source: diaTribe

We recommend working with your healthcare team to decide how often to check your glucose levels. Many people benefit from checking glucose when waking up, before meals, before physical activity, and at bedtime. Some people benefit from checking one to two hours after meals. A person should also check their CGM any time they feel symptoms of high or low glucose. CGM alarms are especially helpful for monitoring glucose levels as they change – more on this below.

Interpret your past data.

Once you’ve used your CGM for a few days, you can see your recent daily trends and the amount of time you’re spending in the target range (70-180 mg/dl). This is also called retrospective data. It is beneficial to review your glucose data regularly to understand how your lifestyle – like the food you eat, your exercise habits, your stress levels, and medications you use – affects your glucose levels. Look at your glucose levels over the past two weeks, one month, and three months; talk with your healthcare team about trends that you are noticing and how they might be addressed. Learn about the many factors that affect glucose here.

During diabetes care appointments, your healthcare team can view this data in an Ambulatory Glucose Profile (AGP) report and use it to talk with you about how your diabetes management is going and any potential adjustments to your care plan. This should be a collaborative discussion between you and your healthcare team about how your diabetes data compares to your management goals and what changes could be made.

Each CGM system offers a standardized one-page report, called an ambulatory glucose profile (AGP). The AGP includes three important components:

  1. CGM key metrics
  2. 24-hour profile
  3. Daily glucose patterns

Although there are many ways to view your glucose data, the AGP report often has all of the information that you need. We’ll explain the three main pieces below. To learn more, read our in-depth piece on understanding your AGP report: “Making the Most of CGM: Uncover the Magic of Your Ambulatory Glucose Profile.”

CGM key metrics

More green, less red.

The time in range bar shows the percentage of time you spend in five glycemic ranges:

  • data

    Image source: diaTribe

    Time in Range: glucose levels between 70-180 mg/dl

  • Time Below Range: glucose levels below 70 mg/dl
  • Time in severe hypoglycemia: glucose levels below 54 mg/dl
  • Time Above Range: glucose levels above 180 mg/dl
  • Time in severe hyperglycemia: glucose levels above 250 mg/dl

Your goal is to grow the green bar and shrink the red bars – in other words, increase Time in Range and decrease time Below Range and time in severe hypoglycemia. See more on Time in Range goals and standard targets.

24-hour profile, also known as Ambulatory Glucose Profile (AGP).

chart

Image source: diaTribe

How do you figure out how to change your diabetes management to increase your Time in Range and decrease your Time Below and Above Range? That’s where the 24-hour profile is helpful, which shows your daily glucose trends across the full 24-hour day.

  • Understanding what the 24-hour profile shows: The black line represents your median glucose level throughout the day based on data from a set period of your CGM use (e.g., the last two weeks). The blue shaded areas help show how much your glucose levels vary at different points in the day.
  • Using the data: Compare different times of day to see what might be influencing your glucose numbers. For example, while the person shown above has glucose readings that vary greatly at 3pm (indicated by a very wide shaded area), their 8am glucose numbers are much more consistent (the shaded area at 8am is narrower), despite being higher. This person also regularly sees a spike in sensor glucose readings at around 9am. What’s causing that increase? Maybe it’s a higher carbohydrate breakfast choice, forgetting to bolus, not bolusing early enough, or not accounting for all the carbs in breakfast. Reflecting on what is causing a spike or valley can help you make behavior changes to reduce fluctuations and increase your Time in Range.
  • chart

    Image source: diaTribe

    The goal: The overall goal is to keep your glucose levels in your target range without big spikes or valleys, sometimes called “flat, narrow, in range” (FNIR). In the AGP above, the green box represents the user’s target sensor glucose range (70-180 mg/dl). While the user stays in range overnight and in the afternoon, they tend to see spikes in the morning and evening. With the goal of FNIR in mind, you can look at your long-term data and ask, what’s making it possible for me to stay in range? What is making my glucose spike or fall?

  • The good news is the goal for most people is to spend 70% or more Time in Range. However, increasing your Time in Range by even 5% (an extra hour per day in range!) can be helpful. You don’t have to reach perfection to improve clinical outcomes.

Daily glucose profiles.

With your trend data, you also can see your daily 24-hour glucose profiles from the last two weeks. The figures show the target range (70-180 mg/dl) in gray, spikes above 180 mg/dl (hyperglycemia) in yellow, and valleys below 70 mg/dl (hypoglycemia) in red. Viewing the data day by day can help you evaluate how specific factors and behaviors impacted your glucose values on a certain day.

data

Image source: diaTribe

To make the most out of your daily glucose profiles, it can be helpful to log your daily food and exercise to compare with your glucose profile and see which behaviors help you stay in range and which ones tend to make you go out of range.

A helpful tool when reviewing your data with your healthcare team is called DATAA. Which stands for:

  • Data – look at your diabetes data together
  • Assess Safety – Look for and try to solve Time Below Range (hypoglycemia) first
  • Time in Range – Discuss what’s working and how to replicate that by looking for the times of day or the days of the week when Time in Range was the highest
  • Areas to Improve – Note when you spent more Time Above Range (hyperglycemia) and discuss ways to reduce this
  • Action Plan – Develop an action plan together

Other Tips, Tricks, and Considerations

1. Exercise & your CGM

To learn about how to use your CGM before, during, and after exercise, check out our article “Exercise Well with Your CGM – Recommendations, Glucose Trends, and Strategies.”

An important note about exercising with a CGM: There can be a difference between CGM glucose measurements and BGM glucose measurements due to what we call a “lag.” Changes in glucose levels in interstitial fluid are not seen as quickly as they are in the blood. At rest, the interstitial glucose lags about five minutes behind the blood glucose; in situations when glucose changes rapidly, such as during exercise, lag time can increase up to 24 minutes. This means that your CGM readings aren’t always going to be accurate during exercise. This lag can also occur outside of exercise, any time your glucose levels are rising or falling quickly.

2. How to make CGM alarms your friend

Adam Brown has written about how it can be helpful to think about your CGM as a partner in your diabetes management, rather than a nag that points out when you’re not in range. Alarms can be useful tools. By alerting you to current or predicted highs and lows, as well as rate of change, you can increase your Time in Range and see your 24-hour glucose profile become flatter, narrower, and more in range. You can personalize your CGM alarm settings to your preferred thresholds or turn them off completely (though some devices won’t let you turn off an urgent low alarm at 55 mg/dl). It’s helpful to work with your diabetes care team to determine your individualized alarm settings.

3. Sharing data with friends, family, and care-partners

The ability to share your real-time glucose data with your care-partners and loved ones is a huge plus of using CGM – your support network can help you track your glucose levels and keep them in range. At the same time, sharing your data with others makes some people nervous and self-conscious. Decide who you want to share your data with and talk with that person about boundaries and how you want to communicate about your data. For more on how to approach these conversations, check out Kerri Sparling’s “To Share or Not to Share: My Approach to Diabetes Data,” and “How to Coach Your Care-Partner on CGM Data.”

4. How to talk to your healthcare team about your CGM

Now that you’re using a CGM, talking with your healthcare team about your CGM data should become a key part of every visit.

Ahead of the visit: To help visits go smoothly, many healthcare professionals will ask you to upload your CGM data before you come into the office (or before your telehealth appointment) so they can review the data and be prepared to talk with you. Learn about uploading your data here. Note: some CGM systems upload automatically once connected to the clinic’s data portal. It’s also helpful to look over your data – like your AGP report – and come up with questions to ask your healthcare professional ahead of the visit. You may have questions about parts of your daily glucose profile that you don’t understand, areas where you’re having a hard time staying in range, or just general questions to help you navigate your data.

During the visit: To make sure that you and your healthcare professional are on the same page, it can be helpful to take a few minutes at the beginning of your appointment to explain your interpretation of your data in your own words. This may be a good time to start a conversation on any questions you may have prepared ahead of your visit. It is also important to take time with your care team to develop an action plan based on your CGM data with a few straightforward priorities for you to focus on before your next visit.

Brand-Specific Resources

While any CGM can help improve your diabetes management, there are some differences between the currently available systems that you may want to consider or talk about with your healthcare team – see our chart comparing different CGMs here. Specifically, we recommend asking your healthcare professional about how alarms may be able to alert you to times of hyperglycemia or hypoglycemia, what it means if you have to calibrate your CGM, and how to use your CGM with smart insulin pens, mobile apps, or even insulin pumps in an automated insulin delivery (AID) system.

To reach out to CGM companies for product support, contact their customer service departments:

  • Abbott: +1-855-632-8658
  • Dexcom: +1-888-738-3646
  • Medtronic: +1-800-646-4633
  • Senseonics: +1-844-736-7348

This article is part of a series on Time in Range.

The diaTribe Foundation, in concert with the Time in Range Coalition, is committed to helping people with diabetes and their caregivers understand Time in Range to maximize patients’ health. Learn more about the Time in Range Coalition here.

Source: diabetesdaily.com

Making the Most of CGM: Uncover the Magic of Your Ambulatory Glucose Profile

This content originally appeared on diaTribe. Republished with permission.

By Cindy Takigawa and Frida Velcani

What’s an AGP report, and what does it show? Why does my AGP matter? How can I use an AGP report to improve my blood glucose levels and time in range?

Having diabetes is a full-time job: you have to simultaneously monitor your diet, activity, stress, and even sleep. On top of that, you need to calculate and manage the number of carbs you consume in each meal, and keep careful tabs on your blood sugar levels. The Ambulatory Glucose Profile (AGP) report, developed by the International Diabetes Center, is a tool that provides a simplified way to look at data on your blood glucose patterns and trends. It has been recognized as a standard of care for reporting continuous glucose monitor (CGM) data by the American Diabetes Association. In this article, we explain what an AGP report is and how you can use the information to help you navigate your diabetes management.

CGM App

Image source: diaTribe

What is an ambulatory glucose profile report?

An AGP report is a standardized, single-page report that includes glucose statistics like time in range, a summary glucose profile, and daily glucose graphs. It converts blood glucose readings from a CGM device into a detailed picture, allowing you to quickly visualize the time you spend above and below your target range. The report is based on at least seven days of CGM data, with 14 days of data (or more) considered ideal. Currently, many CGMs include a version of the AGP report in their devices and reporting software.

An AGP report that summarizes data provided by self-monitoring of blood glucose (SMBG) is currently being developed. This article focuses on CGM AGP reports.

Why does my ambulatory glucose profile matter?

The AGP report is the same no matter what device you use – it allows your healthcare team to assess blood glucose levels and trends in a standard way for everyone they see. Below you’ll find sample AGP reports from Abbott, Dexcom, and Senseonics.

The AGP report shows patterns in a user-friendly way so that people with diabetes can easily identify the times of day when glucose levels are consistently low, high, or fluctuating. The general goal for people with diabetes is to have their glucose levels stay within the target range of 70 to 180 mg/dL for at least 70% of the day, spending less than 4% of their time in hypoglycemia (under 70 mg/dL). The information from an AGP report can help you have a discussion with your healthcare team about goals for your diabetes management and ways you can achieve them. The data offered by this report can help make your care far more precise and effective.

What exactly does your AGP show?

The standard AGP (designed by the International Diabetes Center and shown above) will show your data like this:

  • Glucose Statistics and Targets: This section displays metrics including average glucose, glucose variability, and Glucose Management Indicator (GMI), which can be thought of as your predicted A1C. It also includes the dates and number of days in the report, as well as the percent of time that the CGM was used to collect data. While time in range goals can be individualized, the expert-defined goals for various groups of people with diabetes can be found in this section. You can read more about time in range targets here.
  • Time in Ranges: This color-coded bar chart helps you visualize the percentage of time spent above and below your target range.
  • Ambulatory Glucose Profile: This graph combines all of your glucose readings over time to display your trends across a 24-hour period. At the end of this article you can find examples of what this will look like for your specific CGM.
    • Black line: the median of all the readings. Half of your glucose values are above the middle black line and half are below.
    • Green lines: this is your target glucose range.
    • Dark blue area: 50% of glucose values lie in this area.
    • Light blue area: 90% of glucose values lie in this area. This percentage may differ between AGP reports. The International Diabetes Center report includes 90% of glucose values, while the Eversense report shows 80% of glucose values.
    • Dotted blue lines: 5% of the highest and lowest glucose values are above and below this line, respectively.
  • Daily Glucose Profiles: Each box shows your glucose pattern from a single day.
    • Yellow area: instances of high glucose (hyperglycemia).
    • Red area: instances of low glucose (hypoglycemia).

How can I interpret an ambulatory glucose profile report?

An AGP report combines several days of blood glucose readings into one snapshot. Once you have identified daily patterns, you can work with your healthcare team to adjust your medications and insulin dosing to spend more time in range. You may also discuss timing of food or physical activity, what you are eating, or ways to reduce stress. Here are some steps you can take to understand your data:

1.     Look at your time in range. The goal is to shift the numbers into the 70 – 180 mg/dl target range while having fewer lows and extreme highs. Each AGP report includes a bar chart of your time in range; one way to see this goal in action is to aim for more “green” and less “red” on the bar chart.

2.    Keep track of the usual times you wake up, go to sleep, eat meals and snacks, and are physically active. Food, activity, medication doses, and dozens of other factors can affect your blood glucose levels. Recording these activities and their timing will help you understand your AGP report and the patterns you see.

3.    Identify times when your glucose levels are lowest and highest, and look for times of more variability. Speak with your healthcare professional about what factors may be causing highs, lows, and variability in your AGP and how you can reduce them. The wider the shaded blue areas on your report, the more variability there is in your glucose levels.

4.    If you can, compare your current and past AGP reports, and create an action plan with your healthcare team. What strategies did you use previously to make changes? Identify a few steps to improve your glucose patterns moving forward.

To learn more about how people with diabetes and healthcare professionals can use AGP, click here. For more resources on time in range, check out diaTribe’s comprehensive library here.

Abbott AGP

CGM App

Image source: diaTribe

Dexcom AGP

Dexcom

Image source: diaTribe

Eversense AGP

AGP

Image source: diaTribe

Source: diabetesdaily.com

What’s Coming and What’s Delayed in Continuous Glucose Monitoring?

This content originally appeared on diaTribe. Republished with permission.

By Albert Cai

Updates and delays from Abbott, Dexcom, Medtronic, and Senseonics

With several clinical trials on hold due to the COVID-19 pandemic, we’re bringing you a roundup of the latest updates on future continuous glucose monitors (CGM). Understandably, the FDA also announced a few months ago that it would focus its efforts on devices related to COVID-19. With the disclaimer that it’s impossible to know exactly when the pandemic will subside, when trials might resume, and how FDA reviews might be affected, here is the latest news we’ve heard from companies.

Click to jump to a product, which are organized alphabetically.

Abbott FreeStyle Libre 2

CGM

Image source: Abbott FreeStyle

What’s new? FreeStyle Libre 2 keeps the same “scanning” feature as the original FreeStyle Libre, but adds Bluetooth connectivity. This is important because it enables optional high and low glucose alerts. Users who enable these alerts will be able to get a notification on their reader or phone whenever their glucose reading goes above or below their specified ranges. Looking ahead, the Bluetooth feature will also allow FreeStyle Libre 2 to be part of automated insulin delivery systems (AID), like Insulet’s Omnipod Horizon.

Like the original FreeStyle Libre, FreeStyle Libre 2 has 14-day wear, is factory-calibrated (no fingerstick calibrations required), and can be scanned with either a phone or a reader device (the reader for FreeStyle Libre 2 is blue, instead of black). Importantly, FreeStyle Libre 2 will be offered at the same price as the original FreeStyle Libre.

When’s it coming? The FreeStyle Libre 2 has already launched in a few European countries (we know of Germany and Norway) and will launch in others soon. In the US, FreeStyle Libre 2 has been under FDA review for over a year. In March, Abbott said that it was working through “some finishing items” and was “very confident” the device would be cleared soon.

Dexcom G7

Dexcom

Image source: Dexcom

What’s new? Dexcom’s G7 will be fully disposable (the transmitter and sensor are combined and thrown away together) and have longer wear (we believe somewhere around 14-16 days). Remember that the Dexcom G6 sensor lasts for 10 days but has a transmitter that is re-used for 90 days. The G7 will be considerably slimmer than G6 and will have a lower cost of manufacturing in bulk, though consumer pricing is not yet determined – we imagine it will be similar. The G7 will keep the same accuracy, no fingerstick calibrations, and Bluetooth connectivity as the G6.

Dexcom has been developing G7 in partnership with Verily, the division of Alphabet formerly known as Google Life Sciences. There has been mention from Verily that an accelerometer may also be built-in to the G7 device, but we aren’t sure if that feature made it into the final version of G7. Having a built-in accelerometer could allow the G7 to also track physical activity, like a Fitbit or other fitness tracker.

When’s it coming? Dexcom planned on launching G7 in “early 2021,” but with most clinics placing new trials on hold, Dexcom is expecting a “minimum delay of approximately six months.” It’s difficult to know when clinics will be able to conduct trials (and when people will feel comfortable enrolling in trials), but assuming a six-month delay, G7 could be on the US market sometime in the second half of 2021.

Medtronic “Project Zeus” CGM

Abbott FreeStyle

Image source: Medtronic

What’s new? Medtronic’s next CGM, referred to as “Project Zeus,” will reduce the number of required fingerstick calibrations and have improved accuracy (compared to its current offering, Guardian Sensor 3). The new CGM will require day-one calibration (unclear on the number of fingersticks that will be required on day one), compared to Guardian Sensor 3, which requires at least two fingerstick calibrations every day. Medtronic expects Project Zeus to launch with a “non-adjunctive” indication, meaning users will be able to bolus insulin based on CGM reading alone, and not have to perform a confirmatory fingerstick. the new CGM will keep the same seven-day wear, size and shape, and reusable transmitter component as the Guardian Sensor 3 (pictured above).

When’s it coming? The trial for Project Zeus began in June 2019 and is expected to wrap up within the next month. Medtronic expects to submit the CGM to the FDA by the “end of the summer.”

Senseonics Eversense XL (180-day)

Eversense XL

Image source: Eversense XL

What’s new? The “XL” extended life-version of Senseonics’ Eversense in the U.S. will have the same size and features as the original Eversense, but the Eversense XL is implanted for 180 days, rather than the 90-day Eversense. As a reminder, the Eversense sensor is implanted in the users’ upper arm in a clinic and remains there for the sensor duration; a silver-dollar sized on-body transmitter is worn on the outside of the arm to deliver readings to a smartphone. Senseonics is targeting reducing calibrations from 2 per day to 1 per day with same non-adjunctive indication.

When’s it coming? Eversense XL is already available in Senseonics’ European markets. The trial for Eversense XL in the US wrapped up in late March, and Senseonics has previously aimed for FDA clearance in “late” 2020. We aren’t sure whether that timeline has been pushed back due to COVID-19, but the fact that the trial has already completed is encouraging.

Source: diabetesdaily.com

New Implantable Device Gains Attention

We have seen major advancements in the world of continuous glucose monitors in recent years, including Eversense, the first implantable device. This implanted device is able to monitor blood glucose, as well as alert the person when their levels get too low or high. One issue with implantable devices is how to continuously power them. Excitingly, a new prototype was recently developed that can power itself by using our own glucose.

With implantables being the way of the future, having to remove the device to charge is counterproductive. Researchers at King Abdullah University of Science and Technology (KAUST) created this device that is able to directly utilize the energy within our bodies. It is made up of n-type semiconducting polymer along with the enzyme glucose oxidase. When the glucose oxidase detects glucose in its surroundings, it removes electrons and transports them through the connected polymer. The device can detect glucose levels in saliva and likely other bodily fluids, while the same polymer also helps convert glucose and oxygen into electrical power, which runs the device.

While more research is needed to see if this method is practical and safe, so far it has shown to be promising. According to the recent press release,

“This fuel cell is the first demonstration of a completely plastic, enzyme-based electrocatalytic energy generation device operating in physiologically relevant media,” says Sahika Inal, principal investigator of the study. “Glucose sensing and power generation are only two examples of the applications possible when a synthetic polymer communicates effectively with a catalytic enzyme-like glucose oxidase. Our main aim was to show the versatile chemistry and novel applications of this special water-stable, polymer class, which exhibits mixed conduction (ionic and electronic).

Have you considered an implantable device? If insertions were minimal due to this new technology, would it pique your interest?

Source: diabetesdaily.com

Search

+