EOPLUS Completes Clinical Trial of Korea's First Wearable Insulin Pump 'EOPatch'

[Asia Economy Reporter Eunmo Koo] IoFlow announced on the 3rd that it has completed clinical trials for EOPatch, the first wearable insulin patch pump in Korea.

From December last year to July this year, IoFlow conducted a study at Samsung Seoul Hospital and Asan Medical Center targeting patients with type 1 diabetes. The study compared the four weeks before wearing the EOPatch and the four weeks after wearing it to evaluate the product's efficacy, satisfaction, side effects, safety, and effectiveness.

In terms of efficacy, the clinical trial results showed that the EOPatch was effective in managing blood glucose levels in diabetic patients who had difficulty controlling their blood sugar. At all times, blood glucose levels remained within the target range (70?180 mg/dL) longer after wearing the EOPatch compared to before wearing it.

The incidence of level 2 severe hypoglycemia (below 54 mg/dL), which can cause symptoms such as tremors, anxiety, confusion, palpitations, hunger, loss of consciousness, seizures, and coma, was significantly reduced after wearing the device. It was especially effective in preventing severe hypoglycemia during nighttime hours (P-value<0.01). Additionally, the incidence of sensor glucose levels between 180 and 250 mg/dL decreased, indicating effectiveness in preventing hyperglycemia as well.

In the clinical trial satisfaction survey, 7 out of 9 respondents expressed satisfaction with ease of wearing, and 8 showed satisfaction with daily life after wearing the device. Regarding whether the patch pump reduced concerns about insulin injections, all 9 respondents answered affirmatively, indicating relatively high satisfaction with the EOPatch.

Regarding side effects, mild cases of skin rash, needle site pain, and itching?already well-known side effects of continuous glucose monitors or insulin pumps?occurred once each, but there were no serious adverse reactions. However, it was noted as a limitation that the 4-week follow-up period of this study did not show significant changes in glycated hemoglobin and glycated albumin levels.

Jaejin Kim, CEO of IoFlow, stated, “We are pleased that the excellence of the first wearable insulin patch pump in Korea has been verified through this clinical trial. Having secured product competitiveness, we will accelerate domestic and international commercialization to achieve meaningful sales growth and profit generation.” He added, “We will continue to strive to achieve good results with wearable artificial pancreas devices to be introduced through diverse and active research activities.”