NCT07004153

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
7mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Jun 2025Dec 2026

First Submitted

Initial submission to the registry

May 27, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

June 4, 2025

Status Verified

May 1, 2025

Enrollment Period

1.1 years

First QC Date

May 27, 2025

Last Update Submit

May 27, 2025

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c(%) at 12 weeks compared to baseline

    Descriptive statistics (sample size, mean, standard deviation, median, minimum, and maximum) are provided for the change in HbA1c (%) from baseline to the 12-week time point, stratified by group.

    from baseline to the 12-week time point

Study Arms (2)

Investigational Group

EXPERIMENTAL

Basal and bolus insulin injection using an electric smart insulin pen (DIA:CONN P8); equipped with a Setup-wizard, CGM-based Advanced insulin injection Coaching and a Bolus calculator \- Providing education on Carb Counting(carbohydrate measurement) and Methods for adjusting insulin bolus calculator

Device: Smart Coaching Insulin Pen

Control group

NO INTERVENTION

Basal and bolus insulin injection using only the injection and recording functions of DIA:CONN P8 \- Subjects manually enter and inject their insulin doses without using the bolus calculator or coaching functions

Interventions

Smart Coaching Insulin PenDEVICE

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.

Investigational Group

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 19 and 75 years old.
  • Diagnosis of type 1 or type 2 diabetes for at least 1 year prior to screening
  • Continuous use of MDI therapy for at least 3 months prior to screening, defined as one of the following regimens:
  • Long-acting insulin plus rapid-/short-acting insulin
  • Mixed insulin (e.g., insulin aspart/insulin degludec) plus rapid-/short-acting insulin
  • Mixed insulin ≥3 times per day
  • HbA1c of 7.5% to 12.0% at screening.

You may not qualify if:

  • Diabetes mellitus secondary to pancreatic resection.
  • Use of corticosteroids exceeding a prednisolone-equivalent dose of 5 mg/day within 3 months prior to screening (Subjects on a stable dose for ≥3 months prior to screening may be eligible).
  • eGFR \<15 mL/min at screening or those receiving dialysis
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, Gangnam-gu, 06351, South Korea

Location

Related Publications (1)

  • Kim JY, Kim NH, Kwak SH, Jung CH, Kang ES, Moon JS, Moon SJ, Kwon SY, Yoo JH, Kim Y, Lee TM, Yang CI, Kim JH, Jin SM. Efficacy and Safety of Stage 5 Connected Insulin Pens in Type 1 or Type 2 Diabetes: Randomized Controlled Trial Protocol. Endocrinol Metab (Seoul). 2025 Dec 12. doi: 10.3803/EnM.2025.2579. Online ahead of print.

    PMID: 41391451DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • TAEMIN LEE

    G2e Co., Ltd

    STUDY DIRECTOR

Central Study Contacts

SOOHYUN YOON

CONTACT

+82-10-3352-4744soohyun.yoon@g2e.co.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2025

First Posted

June 4, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

June 4, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)