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DIA:CONN P8(Smart Insulin Pen) Study in Diabetes Patients
Sponsor: G2e Co., Ltd
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
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.
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