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

NCT07004153 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2025-06-04

No results posted yet for this study

Summary

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

Conditions

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.

Sponsors & Collaborators

  • G2e Co., Ltd

    lead INDUSTRY

Principal Investigators

  • TAEMIN LEE · G2e Co., Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2026-07-31
Completion
2026-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07004153 on ClinicalTrials.gov