Simplera CGM Approved in Europe
By April Hopcroft
Medtronic's Simplera is the latest CGM for people with diabetes ages 2 and up. Under FDA review for approval in the U.S., Simplera is sleek, disposable, and requires no fingersticks.
A new continuous glucose monitor (CGM) from Medtronic called Simplera is now approved in Europe. Simplera is not yet approved by the FDA, but is expected to be greenlit by spring 2024.
Available for people with diabetes aged 2 years and older, Simplera is a major upgrade from the Guardian 4 sensor. This new device is half the size, disposable, and does not require fingersticks. It also has a streamlined two-step insertion process, which means there’s less chance for error.
Simplera’s flat design, white color, and simple insertion are similar to that of the Dexcom G7 and Freestyle Libre 3. With the approval of Simplera, people with diabetes can choose between three options for a discrete CGM.
Key features
Simplera is the first major redesign of a Medtronic CGM. Key features include:
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Smaller size: Simplera is half the size of the Guardian 4 sensor and is completely flat. The sensor is square, rather than a clamshell shape, and can be worn on the back of the upper arm.
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No fingersticks: Simplera requires no fingerstick calibrations. After the two-hour warm-up period, you’re good to go.
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Simple, two-step insertion process: The sensor itself is in the middle of the Simplera device (unlike the Guardian 4), making it easier to align for insertion.
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All-in-one disposable device: Simplera is Medtronic’s first fully disposable CGM, with the sensor and transmitter combined into one device.
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No overtape required: This means that the overall “footprint” of the device is much smaller than that of the Guardian 4. Simplera’s adhesive is made from an anti-lint material and designed to prevent sweat and water from reaching the sensor.
Medtronic also preserved some of the key features from the Guardian 4 for Simplera, including:
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Two-hour warm-up time
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Seven-day lifespan: While this is shorter than other CGMs on the market, a seven-day lifespan can be helpful for those who like to have a regular routine, such as changing their sensor every Sunday morning.
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InPen smart insulin pen integration: InPen provides personalized dosing guidance for people on multiple daily injections of insulin through the InPen app. The app offers a bolus calculator based on carb ratios, meal estimations, the amount of insulin onboard, and fixed dosing regimens. Together, Simplera and InPen form Medtronic’s Smart MDI system.
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Compatibility with Apple iOS and Android, including notifications on the Apple Watch.
When will Simplera integrate with the MiniMed 780G?
Ali Dianaty, senior vice president of product innovation and operations at Medtronic, said they’re also looking ahead to “further integration [of Simplera] with the MiniMed 780G.” Integrating Simplera with Medtronic’s MiniMed 780G AID system is currently under regulatory review in Europe.
The clinical trial for MiniMed 780G with Simplera has finished recruiting and is expected to finish in December 2023. The data from this trial will be important for approvals of Simplera in both Europe and the U.S. – stay tuned.
Learn more about the latest CGMs here:
