NCT07004153

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

A Multicenter, Open Label, Randomized, Comparative Confirmatory Study to Evaluate the Efficacy and Safety of Electric Smart Insulin Pen (DIA:CONN P8) Including Setup Wizard, Advanced Insulin Injection Coaching and Bolus Calculator With Analysis Function Based on Continuous Glucose Monitoring Data in Patients With Type 1 or Type 2 Diabetes Mellitus Under Multiple Dose Insulin Therapy

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: G2e Co., Ltd · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This study evaluates the efficacy and safety of the DIA:CONN P8, an electric smart insulin pen equipped with a Setup Wizard, CGM-based insulin injection coaching, and a bolus calculator. The device is designed to support patients with type 1 or type 2 diabetes who are on multiple daily insulin injections (MDI). The study compares the outcomes of patients using these advanced features to those using only the injection and recording functions of the device. The rationale stems from previous research showing that structured education in combination with CGM improves glycemic control in patients with diabetes. The DIA:CONN P8 aims to replicate the benefits of such structured education through app-based coaching and algorithm-driven recommendations, potentially reducing the burden of complex insulin dose calculations in routine care. Participants will undergo a run-in period using DIA:CONN P8 with injection-only functionality to assess compliance. Eligible subjects will then be randomized into either the investigational group (using all device functions) or the control group (injection and recording only). Over 12 weeks, the primary endpoint is the change in HbA1c. Secondary outcomes include CGM-based metrics such as Time in Range (TIR), Time Below Range (TBR), and insulin dosing behavior. The study is designed as a multicenter, open-label, randomized, comparative confirmatory trial conducted at six sites. A total of 152 subjects will be enrolled.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-07-01
• Completion: 2026-12-01
• First posted: 2025-06-04
• Last updated: 2025-06-04

Locations

1 site across 1 country: South Korea