Huons’ smart insulin pen DIA:CONN P8 improves glycemic control in clinical study

Huons announced on Monday that the results of a clinical study for its stage-4 smart insulin pen, DIA:CONN P8, regarding glycemic control in a real-world setting were published in the September issue of Diabetes & Metabolism Journal (DMJ).

DMJ is an international journal, indexed in the Science Citation Index Expanded (SCIE) and published by the Korean Diabetes Association. The study was titled “Effectiveness of the Stage 4 Smart Insulin Pen DIA:CONN P8 for Glycemic Control in a Real-World Setting.”

Professor Kwon So-yoon at Daegu Catholic University Medical Center, Certified Diabetes Educator and Registered Nurse (RN) Kwak Hyo-seon, and a research team led by Professor Kim Jae-hyeon at Samsung Medical Center jointly conducted the study.

The joint research team evaluated whether a stage 4 smart insulin pen (SIP) provides superior glycemic control compared with a traditional insulin pen (TIP) in individuals with intensively insulin-treated diabetes. The study involved 42 adult patients with diabetes (including both type 1 and type 2) who were on Multiple Daily Injection (MDI) therapy.

All participants first received Diabetes Self-Management Education (DSME). They were then divided into two groups: a TIP group (comprising 21 patients) and a SIP group (also comprising 21 patients). Glycemic metrics were assessed using Continuous Glucose Monitoring (CGM) before and two weeks after DSME.

The results showed differences in glycemic outcomes between the SIP and TIP groups. The differences between the groups in percent TIR, percent TBR <70 mg/dL, percent TBR <54 mg/dL, and GRI were significantly greater in the SIP group (11.0 percent, P=0.046; –2.6 percent, P=0.024; –0.9 percent, P=0.027; –18.2, P=0.022, respectively).

According to the clinical study results, the SIP group showed better improvements in glycemic control despite receiving an average of 3.4 hours of education, which was less than the TIP group's 4.2 hours. This finding runs counter to some users' concerns that smart insulin pens might be more difficult to use than traditional insulin pens.

“The superior glycemic outcomes of smart insulin pens come from two key features: the bolus calculator, which works in conjunction with a CGM, enables more precise insulin dosing and helps prevent postprandial hyperglycemia,” Professor Kwon said. “The calculator also incorporates insulin-on-board tracking, which helps prevent insulin stacking and thus reduces the risk of hypoglycemia.”

Professor Kim said, “This study is significant as it is the first in Korea to evaluate the real-world use of stage-4 SIPs in Korea. Smart insulin pens can be a practical alternative for patients, offering the benefits of an insulin pump at a much lower cost.”

The DIA:CONN P8 is Korea’s first stage-4 pen-shaped insulin delivery device for diabetic glucose management. The application integrates CGM data, such as Dexcom G7, to automatically incorporate current glucose levels, active insulin time, and trends into dose calculations. It also helps prevent hypoglycemia by automatically calculating the insulin needed after a meal (bolus insulin), allowing for precise insulin delivery.

Huons signed an exclusive domestic contract with G2E in 2023 to launch and distribute DIA:CONN P8.