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CompletedNCT04926623Updated Jun 14, 2024

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

An interventional study of FreeStyle Libre 24 weeks and SMBG (22 weeks) and blind CGM (2 weeks) in Type 2 Diabetes Mellitus, sponsored by Daewoong Pharmaceutical Co. LTD.. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-14.

Sponsored by Daewoong Pharmaceutical Co. LTD. · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
159
Allocation
Randomized
Ages
19 Years to 75 Years
Sex
All
01

Study 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

Read the 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).

02

Conditions studied

  • Type 2 Diabetes Mellitus
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 159 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Daewoong Pharmaceutical Co. LTD. is the lead sponsor of 196 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
159 participants (actual)

Study arms

  • Experimental
    CGM with Structured Education

    CGM with Structured Education

    Device: FreeStyle Libre 24 weeks

  • Active comparator
    CGM with Standard Education

    CGM with Standard Education

    Device: FreeStyle Libre 24 weeks

  • Active comparator
    SMBG with Standard Education

    SMBG and CGM with Standard Education

    Other: SMBG (22 weeks) and blind CGM (2 weeks)

Interventions

  • DeviceFreeStyle Libre 24 weeks

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

  • OtherSMBG (22 weeks) and blind CGM (2 weeks)

    Self-Monitoring of Blood Glucose and Continuous Glucose Monitoring

06

What researchers measure

Primary outcomes

  1. HbA1c (%) changes

    HbA1c (%) changes at 24 weeks compared to baseline

    Time frame: 24 weeks

Secondary outcomes

  1. HbA1c (%) changes

    HbA1c (%) changes at 12 weeks compared to baseline

    Time frame: 12 weeks

  2. 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

    Time frame: 24 weeks

  3. 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

    Time frame: 24 weeks

  4. 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

    Time frame: 24 weeks

  5. 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

    Time frame: 24 weeks

  6. Percentage of time in range (70 - 180mg/dL)

    Percentage of time in range (70 - 180mg/dL) at 24 weeks compared to baseline

    Time frame: 24 weeks

  7. Mean glucose changes

    Mean glucose changes at 24 weeks compared to baseline

    Time frame: 24 weeks

  8. Coefficient of variation(CV) changes

    Coefficient of variation(CV) changes at 24 weeks compared to baseline

    Time frame: 24 weeks

  9. Diabetes Treatment Satisfaction Questionnaire (DTSQ) changes

    Diabetes Treatment Satisfaction Questionnaire (DTSQ) changes at 12 weeks compared to baseline

    Time frame: 12 weeks

  10. Diabetes Treatment Satisfaction Questionnaire (DTSQ) changes

    Diabetes Treatment Satisfaction Questionnaire (DTSQ) changes at 24 weeks compared to baseline

    Time frame: 24 weeks

07

Study locations

1 site
  • Samsung Medical Center
    Seoul, 135-710, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04926623
Lead sponsor
Daewoong Pharmaceutical Co. LTD.
Responsible party
Sponsor
First posted
Jun 15, 2021
Start date
Jun 17, 2021
Primary completion
Oct 26, 2022
Completion
Apr 4, 2023
Last update
Jun 14, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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