Freestyle Libre-based Education on MDI in T2DM (FreEdoM-2)

Status Completed

Clinical Trial Summary

Multicenter, Open-label, Randomized Trial to Compare the Effectiveness of Structured Education and Safety of FreeStyle Libre or Self-Monitoring of Blood Glucose (SMBG) in patients with type 2 Diabetes Mellitus using Multiple Daily Injections or Insulin Pumps

Clinical Trial Description

All subjects must participate in Blind Continuous Glucose Monitoring(CGM) for two weeks prior to Visit 2 visit (random assignment). Subjects who meet the selection/exclusion criteria in Visit 2 visits are randomly assigned to the test group (personal in-depth education and FreeStyle Libre) or control 1 (standard education and FreeStyle Libre) or control 2 (standard education and SMBG) at a 1:1:1 ratio. In the test group, personal in-depth education is conducted at baseline (Visit 2), 4 weeks (Visit 3), 8 weeks (Visit 4), 12 weeks (Visit 5), and 18 weeks (Visit 6), and the time required for education and preparation time required for patient education are checked. Control groups 1 and 2 conduct routine insulin basic injection training as standard education at baseline (Visit 2) and 12 weeks (Visit 5). After randomization, FreeStyle Libre is applied to the test group and control group 1 for 24 weeks, and SMBG is performed for 22 weeks and Blind CGM is applied for 2 weeks at 22 weeks (Visit 7). Blood glucose measurements collected from FreeStyle Libre are collected through the reader program, and are checked in real time by researchers and used for education, research, and analysis. Prior to the implementation of FreeStyle Libre for the collection of real-time blood sugar collected through FreeStyle Libre, the subject is given consent to disclose blood sugar information. All subjects visit baseline (Visit 2), 12 weeks (Visit 5), and 24 weeks (Visit 8) to conduct surveys on physical examinations, blood tests and urine tests (Central Lab), and treatment satisfaction questionnaire (DTSQ). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04926623
Study type	Interventional
Source	Daewoong Pharmaceutical Co. LTD.
Contact
Status	Completed
Phase	N/A
Start date	June 17, 2021
Completion date	April 4, 2023

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