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

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Eversense AGP

AGP

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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

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