152
Participants
Start Date
June 30, 2025
Primary Completion Date
July 31, 2026
Study Completion Date
December 31, 2026
Smart Coaching Insulin Pen
Subjects randomized to the intervention group will use the DIA:CONN P8 smart insulin pen with full functionality, including Setup Wizard, CGM-based insulin injection coaching, and a bolus calculator. During the 12-week application period, including the baseline visit, participants will visit the hospital up to 5 times. At the start of the period, initial basal and bolus doses will be determined using the Setup Wizard and reviewed by investigators. Throughout the study, subjects will receive real-time insulin dose recommendations and coaching via the DIA:CONN app based on CGM data, carbohydrate input, and insulin dosing history.
Samsung Medical Center, Seoul
G2e Co., Ltd
INDUSTRY