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

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

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Device: FreeStyle Libre 24 weeks; Other: SMBG (22 weeks) and blind CGM (2 weeks)

Detailed 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 Type: Interventional
• Enrollment (Actual): 159
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 or more fast-acting insulin. However, one insulin aspart/insulin degludec + one insulin aspart or two or more insulin aspart/insulin degludec can be included.) 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
4. patients who agree to use FreeStyle Libre for medical care and research
5. patients who voluntarily signed a written consent form

Exclusion Criteria:

1. Those who have difficulty in education due to severe systemic diseases (e.g., terminal renal failure requiring dialysis, cirrhosis above Child-Pugh Class C), cognitive impairment, and mental illness.
2. Those who are taking drugs that may affect metabolism per screening time (e.g., adrenocortical hormones, immunosuppressants, etc.) (However, those who have taken the same dose for more than 12 weeks until screening time and who are not scheduled to change drug dose can participate in this study.)
3. Those with clinically significant cardiovascular diseases (heart failure, angina, myocardial infarction, cerebral infarction, etc.) within 24 weeks of screening.
4. Those who have a glomerular filtration rate (eGFR) of <15 mL/min.
5. A person with severe diabetes complications that deteriorate or newly occur within 3 months of screening and require emergency treatment.
6. Pregnant or lactating persons.
7. Pregnancy is planned during the study period, effective contraception (if condoms, oral contraceptives, intrauterine contraceptives, injections, transplants, contraceptives, or absolute abstinence, such as periodic abstinence (e.g., Krenda, ovulation, symptom body temperature) and resection are not considered as recognized contraceptives) for women or men.
8. Those who find other researchers inappropriate for participation in research.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CGM with Structured Education	Device: FreeStyle Libre 24 weeks; FreeStyle Libre flash sensor-based glucose monitoring system (FSGM; Abbott Diabetes Care, Witney, Oxon, UK)
Active Comparator: CGM with Standard Education	Device: FreeStyle Libre 24 weeks; FreeStyle Libre flash sensor-based glucose monitoring system (FSGM; Abbott Diabetes Care, Witney, Oxon, UK)
Active Comparator: SMBG with Standard Education; SMBG and CGM with Standard Education	Other: SMBG (22 weeks) and blind CGM (2 weeks); Self-Monitoring of Blood Glucose and Continuous Glucose Monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c (%) changes	HbA1c (%) changes at 24 weeks compared to baseline	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c (%) changes	HbA1c (%) changes at 12 weeks compared to baseline	12 weeks
Percentage of time in level 2 hypoglycemia (<54 mg/dL)	Percentage of time in level 2 hypoglycemia (<54 mg/dL) at 24 weeks compared to baseline	24 weeks
Percentage of time in level 1 hypoglycemia (<70- 54 mg/dL)	Percentage of time in level 1 hypoglycemia (<70- 54 mg/dL) at 24 weeks compared to baseline	24 weeks
Percentage of time in level 1 hypoglycemia (> 180 mg/dL)	Percentage of time in level 1 hypoglycemia (> 180 mg/dL) at 24 weeks compared to baseline	24 weeks
Percentage of time in level 2 hypoglycemia (> 250 mg/dL)	Percentage of time in level 2 hypoglycemia (> 250 mg/dL) at 24 weeks compared to baseline	24 weeks
Percentage of time in range (70 - 180mg/dL)	Percentage of time in range (70 - 180mg/dL) at 24 weeks compared to baseline	24 weeks
Mean glucose changes	Mean glucose changes at 24 weeks compared to baseline	24 weeks
Coefficient of variation(CV) changes	Coefficient of variation(CV) changes at 24 weeks compared to baseline	24 weeks
Diabetes Treatment Satisfaction Questionnaire (DTSQ) changes	Diabetes Treatment Satisfaction Questionnaire (DTSQ) changes at 12 weeks compared to baseline	12 weeks
Diabetes Treatment Satisfaction Questionnaire (DTSQ) changes	Diabetes Treatment Satisfaction Questionnaire (DTSQ) changes at 24 weeks compared to baseline	24 weeks

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2021
• Primary Completion (Actual): October 26, 2022
• Study Completion (Actual): April 4, 2023

Study Registration Dates

• First Submitted: June 10, 2021
• First Submitted That Met QC Criteria: June 10, 2021
• First Posted (Actual): June 15, 2021

Study Record Updates

• Last Update Posted (Actual): June 14, 2024
• Last Update Submitted That Met QC Criteria: June 13, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: DWFSL-P401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No