- βStage 5 connected insulin pens offer AI coaching and personalized dosing guidance beyond any current smart pen on the US market
- βThe trial targets HbA1c levels of 7.5%β12.0%, closely matching millions of US insulin users who struggle to meet ADA goals
- βPositive results could fast-track FDA consideration and insurance coverage of advanced smart pen technology for American patients
| Country | South Korea |
| Journal | Endocrinology and metabolism (Seoul, Korea) |
| Year | 2026 |
| Authors | Kim, Kim, Kwak |
| PMID | 41391451 |
A study from South Korea is putting one of the most advanced insulin delivery technologies to the test β and the results could reshape how millions of Americans manage their diabetes with daily injections.
Researchers at Samsung Medical Center in Seoul β one of Asia's leading diabetes institutions β have launched a clinical trial called the SMART-5 Study, evaluating what they call "Stage 5 Connected Insulin Pens" (CIPs). While this technology may sound futuristic, it builds on tools already entering the US market, making South Korea's rigorous testing process directly relevant to American patients.
What Is a Stage 5 Connected Insulin Pen?
Think of connected insulin pens as a ladder of sophistication:
- Stage 2β3: Basic smart pens that log your insulin doses and sync to your phone via Bluetooth
- Stage 4: Pens with a built-in bolus calculator that factors in your real-time continuous glucose monitor (CGM) readings, carbs eaten, and previous doses
- Stage 5: Everything above, plus AI-driven education modules, personalized coaching, a Setup Wizard for individualized settings, and advanced dosing guidance based on your own glucose and injection patterns
In simple terms, a Stage 5 pen doesn't just track what you do β it actively helps you make better insulin decisions, learns your patterns, and coaches you along the way.
How the Study Works
The trial will enroll 152 adults aged 19β74 with Type 1 or Type 2 diabetes who take multiple daily injections (MDI). To qualify, participants must have an HbA1c between 7.5% and 12.0% β a range that represents many Americans whose blood sugar is not yet well controlled.
Half will use a Stage 5 CIP paired with a CGM. The other half will use a basic tracking pen also paired with a CGM. After 12 weeks, researchers will measure the change in HbA1c levels to see which group improves more.
For reference, current American Diabetes Association (ADA) guidelines recommend an HbA1c below 7.0% for most adults. The average American with diabetes sits around 7.3β7.5%, meaning the study population closely mirrors a large portion of US patients who could benefit from this technology.
Why This Matters for US Patients
More than 7 million Americans use insulin daily, yet many still rely on manual logging and guesswork to time and dose their injections. Smart pen technology β already available in early forms through brands like NovoPen 6, Tempo Smart Button, and InPen β is gaining traction in the US, but Stage 5 features with AI coaching remain largely unproven in large clinical trials.
South Korea's healthcare system is known for rapid, high-quality technology adoption and rigorous academic research. A positive result from the SMART-5 Study would provide the clinical evidence US insurers, the FDA, and physicians need to recommend β and cover β these advanced devices for American patients who take injections but aren't candidates for insulin pumps.
If you currently take multiple daily insulin injections and struggle to hit your blood sugar targets, ask your endocrinologist about connected insulin pen options available today and what emerging technology may be on the horizon.
Source: Kim, Kim, & Kwak. "Efficacy and Safety of Stage 5 Connected Insulin Pens in Type 1 or Type 2 Diabetes: Randomized Controlled Trial Protocol (SMART-5 Study)." Endocrinology and Metabolism (Seoul, Korea), 2026. PMID: 41391451. DOI: 10.3803/EnM.2025.2579. Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.