A Study of DIA:CONN P8 Smart Insulin Pen With CGM-Based Coaching in Patients With Type 1 or Type 2 Diabetes

NANot yet recruitingINTERVENTIONAL
Enrollment

152

Participants

Timeline

Start Date

June 30, 2025

Primary Completion Date

July 31, 2026

Study Completion Date

December 31, 2026

Conditions
Diabetes Mellitus
Interventions
DEVICE

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.

Trial Locations (1)

06351

Samsung Medical Center, Seoul

All Listed Sponsors
lead

G2e Co., Ltd

INDUSTRY