Huons announced on September 8 that clinical study results for its stage 4 smart insulin pen DIA:CONN P8 were published in the September issue of Diabetes & Metabolism Journal (DMJ), an international SCIE-indexed journal published by the Korean Diabetes Association. The paper, titled “Effectiveness of the Stage 4 Smart Insulin Pen DIA:CONN P8 for Glycemic Control in a Real-World Setting,” marks the first Korean trial to evaluate real-world outcomes with stage 4 smart insulin pens (SIPs).

The study was conducted by Professor So Yoon Kwon of Daegu Catholic University Medical Center, Diabetes Educator RN Hyoseon Kwak, and Professor Jae Hyeon Kim’s team at Samsung Medical Center. Researchers compared the DIA:CONN P8 with traditional insulin pens (TIPs) in 42 adults with type 1 or type 2 diabetes receiving multiple daily injection therapy.

After completing Diabetes Self-Management Education, patients were randomly assigned to SIP or TIP groups (21 each). Glycemic metrics were measured by continuous glucose monitoring before and two weeks after education.

Results showed significantly greater improvements in the SIP group:

• % Time in Range (TIR): +11.0% (P=0.046)

• % Time Below Range (<70 mg/dL): –2.6% (P=0.024)

• % Time Below Range (<54 mg/dL): –0.9% (P=0.027)

• Glycemic Risk Index (GRI): –18.2 (P=0.022)

Notably, SIP users achieved better glycemic control despite receiving less education time (3.4 hours vs. 4.2 hours for TIPs), countering concerns that smart pens might be harder to use.

Professor Kwon explained, “The superior outcomes stem from two features: a bolus calculator that integrates with CGM data to optimize dosing and prevent postprandial hyperglycemia, and insulin-on-board tracking, which reduces stacking and hypoglycemia risk.”

Professor Kim added, “This is the first Korean study confirming the real-world value of stage 4 SIPs. They provide insulin pump-like benefits at a fraction of the cost, making them a practical alternative for many patients.”

The DIA:CONN P8 is Korea’s first stage 4 pen-shaped insulin delivery device. It integrates CGM data, including Dexcom G7, to calculate bolus doses, account for active insulin, and minimize hypoglycemia risk. Huons signed an exclusive domestic contract with G2E in 2023 for its launch and distribution.