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Medtronic reports first real-world data on smart insulin pen system

March 20, 2025 By Sean Whooley

Medtronic Simplera CGM InPen Smart MDI system (1)
The Smart MDI system featuring the InPen and Simplera systems. [Image courtesy of Medtronic]
Medtronic (NYSE:MDT) today announced real-world data supporting the use of its smart insulin pen and CGM sensor combination.

The data evaluated Medtronic’s Smart MDI system, which combines the InPen with the Simplera continuous glucose monitor (CGM). Data showed how the system, designed for people with diabetes using multiple daily injections (MDI) when used as intended, helps users get closer to the internationally recommended 70% time in range (TIR) target.

Medtronic shared data today at the 18th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD) in Amsterdam. The medtech giant says it aims for its system to minimize the frequency of glucose highs for those on MDI.

According to a news release, less than 30% of people with diabetes using CGM achieve the glycemic target of HbA1c < 7%. Studies show that MDI, alongside regular blood glucose monitoring, achieves a TIR of only 45%. MDI accompanied by intermittently scanned CGM brings TIR to 51%, still well short of the 70% target.

Medtronic’s Smart MDI system became the first on the market to recommend corrections for missed or inaccurate insulin doses last fall. The company received FDA approval for Simplera in August 2024 as well.

In 2023, company officials explained the benefits of the brand-new form factor for the Smart MDI offering.

A look at the Medtronic Smart MDI data

Medtronic’s evaluation included 1,852 Smart MDI system users across Europe who self-reported living with type 1 diabetes. The mean percentage of TIR came in at 55.7%. Individuals who used Smart MDI as intended, reacting to >75% of Missed Dose or Correct High Glucose alerts with a bolus, had a higher average TIR of 67.2% and 71.5% respectively, highlighting that the system’s actionable alerts helped users achieve better glycemic outcomes.

The company says its Smart MDI helps reduce guesswork and simplify diabetes management with real-time, personalized insights. Data showed that 52.6% of injections came after recommendations from the dose calculator.

Medtronic presently offers the Smart MDI system in 16 countries across Europe, the Middle East and Africa. It plans to initiate a limited rollout in the U.S., beginning with standalone CGM and InPen customers. Then it plans for a broad commercial launch.

“For people with diabetes on multiple daily injections, the mental gymnastics of calculating insulin doses every day can be a challenge. This first snapshot of how the Medtronic Smart MDI system with Simplera CGM is simplifying the burden in real life is very promising,” said Dr. Ohad Cohen, senior global medical affairs director at Medtronic Diabetes. “The information provides us with an insight into the behaviors of users on MDI therapy. By analyzing the features that are contributing most to better outcomes and focusing on education efforts we believe better outcomes will be seen in future longitudinal analysis.”

Filed Under: Clinical Trials, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring, Technology Tagged With: ATTD 2025, Medtronic

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.

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