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

Last updated: May 27, 2025
Sponsor: G2e Co., Ltd
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes Prevention

Treatment

Smart Coaching Insulin Pen

Clinical Study ID

NCT07004153
P8_S201
  • Ages 19-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age between 19 and 75 years old.

  2. Diagnosis of type 1 or type 2 diabetes for at least 1 year prior to screening

  3. Continuous use of MDI therapy for at least 3 months prior to screening, defined asone of the following regimens:

  • Long-acting insulin plus rapid-/short-acting insulin

  • Mixed insulin (e.g., insulin aspart/insulin degludec) plus rapid-/short-actinginsulin

  • Mixed insulin ≥3 times per day

  1. HbA1c of 7.5% to 12.0% at screening.

Exclusion

Exclusion Criteria:

  1. Diabetes mellitus secondary to pancreatic resection.

  2. Use of corticosteroids exceeding a prednisolone-equivalent dose of 5 mg/day within 3months prior to screening (Subjects on a stable dose for ≥3 months prior toscreening may be eligible).

  3. eGFR <15 mL/min at screening or those receiving dialysis

  4. Pregnant or lactating women

Study Design

Total Participants: 152
Treatment Group(s): 1
Primary Treatment: Smart Coaching Insulin Pen
Phase:
Study Start date:
June 01, 2025
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Samsung Medical Center

    Seoul, Gangnam-gu 06351
    Korea, Republic of

    Site Not Available

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