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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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 Details — Status: Completed

Administrative data

• NCT number: NCT04926623
• Other study ID #: DWFSL-P401
• Status: Completed
• Phase: N/A
• Start date: June 17, 2021
• Est. completion date: April 4, 2023

Study information

• Verified date: June 2021
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: April 4, 2023
• Est. primary completion date: October 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Type 2 diabetes patients aged 19 and under 75 years.

2. Multiple insulin injections at the time of screening (at least one base insulin and two fast-acting insulin) or those who have been using an insulin pump for at least 12 weeks

3. HbA1c of not less than 7.5% and not more than 12.0% at the time of screening

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Device:
• FreeStyle Libre
FreeStyle Libre flash sensor-based glucose monitoring system (FSGM; Abbott Diabetes Care, Witney, Oxon, UK)

Other:
• SMBG
Self-Monitoring of Blood Glucose

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c (%) changes at 24 weeks compared to baseline		6 months after randomization