Smart Pen Integration with CGM

Smart Pen Integration with Continuous [Glucose Monitoring](/) (CGM)

Smart pen integration puts two records side by side: the insulin doses a connected pen logs, and the glucose readings a continuous glucose monitor (CGM) sends. For people on multiple daily injections (MDI), standard pens keep no record of what was injected and when, a gap a 2026 review says connected pens were designed to close [1]. The "smart" part isn't really the pen. It's the app that reads both records together, and as of October 2026 that pairing works only with specific pens and sensors [1][2].

Connected pen or smart pen: the data flow decides

The clearest definition we found comes from that review, a 2026 white paper in Diabetologia. Its authors argue that the same pen can sit in a "dumb" system or a smart one, depending on what happens to its data after the injection [1]. A connected pen sends data one way, to an app or clinic platform, showing missed or late doses without taking CGM readings into account [1].

A smart pen system pairs the pen with a CGM through a phone app and adds decision support, typically a dose calculator, reminders and tracking of insulin on board (IOB), meaning insulin from earlier doses that is still working [1]. IOB tracking matters more than it sounds. The authors say a system that counts recent doses helps prevent "insulin stacking", where a new dose lands on top of insulin that hasn't finished acting [1]. Caps and clip-on devices form a third group, adding some of these functions to ordinary pens, including disposable ones [1].

How a pen knows what dose was taken

The most detailed answer we found was in an FDA filing. The 510(k) summary for Mallya, a clip-on device for Sanofi's SoloStar pens, compares it with MiniMed's InPen: both turn the rotation of the dose knob into units dialed, though the summary notes different hardware ("magnet vs. electronic rotational encoder") [3]. Mallya senses the knob's position at the end of the injection to mark the dose complete, and both send the dose and its time to a phone app over Bluetooth Low Energy [3].

Here's what surprised us: these devices log the dose that was set, not insulin measured leaving the pen; the summary calls the recorded dose "calculated based on dose set" for both [3]. Power differs too. The InPen's battery can't be recharged and is rated for one year of use, while Mallya recharges over USB and is rated for two years [3].

Novo Nordisk's NovoPen 6 takes a different route. It stores the date, time and units of each injection, has a five-year battery, and shares its log by near field communication (NFC), a very short-range wireless link [4]. The user holds the pen against the NFC spot on a phone, and the pen keeps the last 800 doses, which Novo Nordisk puts at three months of use or more [5].

The systems we could verify (as of October 2026)

MiniMed InPen and the MiniMed Go system

The FDA first cleared the InPen in July 2016 for Companion Medical; later InPen app clearances, including one in November 2024, list Medtronic MiniMed [6]. As of October 2026, MiniMed's US site sells the InPen as part of its MiniMed Go system, paired with either the Simplera CGM (adults 18 and older) or the Instinct sensor, made by Abbott, and says no other sensors are compatible [2]. The pen connects by Bluetooth Low Energy and NFC and must be replaced when its one-year battery runs out [2].

MiniMed's own comparison table shows what integration adds. The InPen can be used alongside a Dexcom sensor, but then the CGM data sits in a separate app with a one-hour delay, without MiniMed Go's missed-dose and high-glucose alerts [2]. That's a manufacturer's comparison, not an independent test.

NovoPen 6 and NovoPen Echo Plus

Novo Nordisk's product page lists the apps that can read these pens, market by market. A direct connection with the Dexcom G7 is listed for seven countries, including Germany, Japan and Spain; other apps, such as Glooko and mySugr, are listed mostly for European markets [5]. The page lists no FreeStyle Libre app and names no US market [5].

The FDA's 510(k) database lists the older NovoPen Echo but neither of these pens [7]. That alone isn't proof, because US insulin pens can also be regulated as drug-device combination products [1]. As of October 2026, we couldn't confirm that the NovoPen 6 is sold in the US.

Mallya for SoloStar pens

The FDA cleared Biocorp's Mallya in December 2022 for SoloStar pens of Lantus, Toujeo, Admelog, Apidra and Soliqua 100/33. It records and transmits doses but plays no part in delivering insulin [3].

What the studies show so far

The best-known outcome study for a connected pen followed 94 adults with type 1 diabetes at 12 Swedish clinics who used CGM and started the NovoPen 6. Time in range (TIR), the share of the day glucose stays inside a target band, rose by about 1.9 hours a day, and missed mealtime doses fell by 43% [4]. The study was observational. Novo Nordisk funded it, and three of its five authors were Novo Nordisk employees [4].

For a full smart pen system, a 2025 analysis followed 1,852 people with type 1 diabetes in 21 countries using MiniMed's "Smart MDI system" (the InPen, the Simplera CGM and the InPen app). Mean TIR was 55.7%, and people who responded within an hour to more than three-quarters of alerts had higher TIR [8]. The authors, who include Medtronic Diabetes staff, say the data can't show cause and effect [8]. How to act on any alert or reading is a decision for each person and their care team.

Where integration still falls short

Cost is the first hurdle the 2026 review names: a smart pen system usually costs USD 100 to 250 per device, against USD 20 to 40 for a conventional disposable pen [1]. Uptake reflects that. The review cites a 2025 report finding that fewer than 20% of insulin-treated people in Europe use connected pens, while CGM and pump use tops 60% in several European markets [1].

Compatibility is the second. Reusable smart pens take specific cartridges (NovoRapid Penfill for the NovoPen 6 and Echo Plus; the InPen needs its own), so an insulin shortage or a switch to a biosimilar can leave a pen unusable [1]. Getting pen data into clinic records also depends on different manufacturers' systems working together, a problem our article on data ecosystems and remote monitoring covers in more depth. Users add battery life and Bluetooth problems to the list [1].

The review also suggests some clinicians may skip the smart pen and move a person straight to automated insulin delivery (AID), where a pump and CGM work together [1]. The biggest open question is evidence. The authors expect smart pen systems to help, but say high-quality clinical and health-economic studies are still needed before payers accept them widely [1]. Until then, whether a given pen talks to a given CGM depends more on the country than on the pen [5].