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COMPLETED
NCT06406439
NA

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

Sponsor: G2e Co., Ltd

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

19 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-05-21

Completion Date

2025-04-02

Last Updated

2026-07-30

Healthy Volunteers

No

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.

Locations (9)

Chung-Ang University Gwangmyeong Hospital

Gwangmyeong, Deokan-ro, South Korea

Kyung Hee University Hospital

Seoul, Dongdaemun-gu, South Korea

Kyung Hee University Hospital at Gangdong

Seoul, Gangdong-gu, South Korea

Samsung Medical Center

Seoul, Gangnam-gu, South Korea

National Health Insurance Service Ilsan Hospital

Goyang-si, Ilsandong-gu, South Korea

Kangbuk Samsung Hospital

Seoul, Jongno-gu, South Korea

Samsung Changwon Hospital

Changwon, Masanhoewon-gu, South Korea

Seoul St. Mary's Hospital

Seoul, Seocho-gu, South Korea

Severance Hospital

Seoul, Seodaemun-gu, South Korea