EOFlow Announces First Patient Enrolled in the Pivotal Study of Two-Part Wearable Artificial Pancreas “EOPatch X” on People with Type 1 Diabetes in Korea

▶ “EOPatch X” is a two-part wearable artificial pancreas (AP) solution that automatically adjusts insulin delivery based on the user’s glucose level
▶ A multicenter trial that will be conducted at nine university-hospitals and will enroll over one hundred people with type 1 diabetes aims to validate the clinical efficacy and safety of “EOPatch X”

EOFlow Co., Ltd. (KOSDAQ: 294090) (EOFlow or the Company) today announced that the first patient has been enrolled in the pivotal study of two-part wearable artificial pancreas “EOPatch X” on people with type 1 diabetes in Korea.

According to the Company, the first “EOPatch X” patient was enrolled by Dr. Kim Jae Hyeon, department of Endocrinology and Metabolism, Samsung Medical Center, Sungkyunkwan University School of Medicine. This pivotal study of “EOPatch X” is a multicenter trial that will be conducted at nine university-hospitals and will enroll one hundred and four patients with type 1 diabetes. The study aims to validate the clinical efficacy and safety of “EOPatch X.”

The primary end point is Time-in-range (TIR) with and without EOFlow's artificial pancreas solution. With the use of CGM (Continuous Glucose Monitoring) in diabetes management, time-in-range emerged as a valuable blood glucose metric, ‘beyond HbA1c’ for a deeper insight into glycemic control in people with diabetes. TIR denotes the amount of time in percentage that a person's glucose level remains within the proposed target range (3.9–10.0 mmol/L or 70–180 mg/dL). It is advised that a type 1 or type 2 individual should spend more than 70% (16 h, 48 min) of a day in the target range while more than 50% (>12 h) is applicable for older and high-risk type 2 patients. An effective treatment should always target to increase TIR while reducing Time-below-range (TBR)*. The secondary endpoint is Improvement of glycosylated hemoglobin [HbA1c].

The pivotal study received approval of Investigational Device Exemption (IDE) application from Ministry of Food and Drug Safety of Korea (KMFDS) in December 2021. After thoroughly reviewed and approved by the Ethics Committees of each hospital, EOFlow held a clinical researcher meeting in February 2022. Starting from last April, the Company is holding initiation meetings.

Upon successful completion of the pivotal clinical trial, the Company intends to obtain medical device market approval from KMFDS. EOFlow aims to commercialize “EOPatch X” by the end of year 2023.

“EOPatch X” is a two-part wearable artificial pancreas (AP) solution that automatically adjusts basal insulin delivery based on the user’s glucose level. “EOPatch X” links its wearable pump “EOPatch”, which runs an AP algorithm, to a separate (third party) continuous glucose monitoring (CGM) sensor. This solution greatly increases user convenience by eliminating the need to check the blood glucose level as well as the need to monitor and adjust basal and correction insulin delivery throughout the day. The user is still expected to count carbohydrates per meal and deliver meal insulin doses.

* Saboo, B., Kesavadev, J., Shankar, A., Krishna, M. B., Sheth, S., Patel, V., & Krishnan, G. (2021). Time-in-range as a target in type 2 diabetes: An urgent need. Heliyon, 7(1), e05967. https://doi.org/10.1016/j.heliyon.2021.e05967