- βStage 5 pens offer personalized AI dosing guidance plus built-in education β a potential game-changer for MDI users
- βThe trial pairs smart pens with CGM, making full use of real-time glucose data to inform every injection decision
- βIf proven effective, this technology could significantly improve HbA1c without switching to an insulin pump
| Journal | Endocrinology and metabolism (Seoul, Korea) |
| Year | 2026 |
| Authors | Kim, Kim, Kwak |
| PMID | 41391451 |
What Is This Study About?
Researchers in South Korea are running a clinical trial called the SMART-5 Study to find out whether a new generation of 'smart' insulin pens can improve blood sugar control better than standard connected pens. This matters because millions of people with type 1 and type 2 diabetes take multiple daily insulin injections (MDI), and getting the dose right every time is genuinely hard.
The Evolution of Smart Insulin Pens
Not all connected insulin pens are created equal. Think of them in generations:
- Stage 2β3 pens simply record and transmit your insulin doses to an app or cloud.
- Stage 4 pens go further β they calculate suggested doses using your real-time continuous glucose monitor (CGM) readings, carbohydrate intake, and past dosing history.
- Stage 5 pens add a layer of intelligence on top: personalized coaching, education modules, a Setup Wizard that recommends your starting settings, and an algorithm that learns from your unique CGM and injection patterns over time.
Stage 5 pens are the newest and most advanced, but until now no rigorous clinical trial has confirmed whether they actually work better than simpler options.
How the Trial Works
The study will enroll 152 adults aged 19β74 with type 1 or type 2 diabetes whose HbA1c (a 3-month blood sugar average) sits between 7.5% and 12.0% β meaning their control has room to improve. Participants are split into two groups:
- Group 1: Stage 5 connected pen + CGM
- Group 2: Standard tracking pen + CGM
After 12 weeks, researchers will compare HbA1c levels between the two groups to see whether the AI-powered coaching and dosing guidance made a meaningful difference.
What This Could Mean for Patients
If Stage 5 pens prove superior, it could be a turning point for people on multiple daily injections who aren't yet using an insulin pump. Instead of guessing at doses or relying solely on memory, users would get personalized, data-driven suggestions every time they inject β plus ongoing education to build their own diabetes management skills.
For anyone already using CGM sensors alongside their injections, pairing that data with a smart pen's recommendations could close one of the biggest gaps in MDI therapy: acting on the information your CGM is already giving you. At MDS Diabetes, we stock a range of CGM supplies and insulin pen accessories to support patients exploring connected diabetes technology.
Important Caveats
This is a trial protocol β the research plan, not the results. We won't know whether Stage 5 pens work better until the study is completed and published. The trial is also open-label, meaning participants know which device they're using, which can influence behaviour.
Bottom Line
The SMART-5 Study is one of the first rigorous trials to test AI-coached insulin pens against standard connected pens for people taking multiple daily injections. Results β expected after the 12-week intervention period β could help determine whether this smarter technology deserves a place in everyday diabetes care. Watch this space.