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DIA:CONN P8(Smart Insulin Pen) Study in Diabetes Patients

NCT06406439 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-07-31

No results posted yet for this study

Summary

A Multicenter, Open label, Randomized, Comparative Study to Evaluate the Efficacy and Safety of Electric Smart Insulin Pen DIA:CONN P8 in patients with Type 1, Type 2 or Pancreatogenic Diabetes Mellitus under Multiple Dose Insulin Therapy

Conditions

  • Diabetes (Insulin-requiring, Type 1 or Type 2)
  • Pancreatogenic Diabetes Mellitus

Interventions

DEVICE

Smart Insulin Pen

During the 12-week, for basal insulin, the treatment group will input and inject the dosage using the DIA:CONN P8, using only the insulin injection and injection recording functions, same as the blind CGM period. For bolus insulin, when the carbohydrate counting is entered or the type of meal is selected into the DIA:CONN P8 application, the insulin dosage is automatically calculated and set using the entered information and other indicators. Subjects inject the insulin at that calculated dosage using the DIA:CONN P8.

DEVICE

Injection of bolus insulin via conventional therapy using insulin pen

During the 12-week, the control group will use DIA:CONN P8 to manually input and inject the dosage of both basal and bolus insulin, only using the insulin injection and injection recording functions, same as the blind CGM period.

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
2024-05-21
Primary Completion
2025-04-02
Completion
2025-04-02

Countries

  • South Korea

Study Locations

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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 NCT06406439 on ClinicalTrials.gov