Type 2 Diabetes MellitusNCT04926623
Freestyle Libre-based Education on MDI in T2DM (FreEdoM-2)
A study testing FreeStyle Libre 24 weeks and SMBG (22 weeks) and blind CGM (2 weeks) in people with Type 2 Diabetes Mellitus, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
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 Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- FreeStyle Libre 24 weeks and SMBG (22 weeks) and blind CGM (2 weeks)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jun 2021to 4 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes patients aged 19 and under 75 years.
- 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.
- HbA1c of not less than 7.5% and not more than 12.0% at the time of screening
- patients who agree to use FreeStyle Libre for medical care and research
- patients who voluntarily signed a written consent form
Who cannot join
- 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.
- 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.)
- Those with clinically significant cardiovascular diseases (heart failure, angina, myocardial infarction, cerebral infarction, etc.) within 24 weeks of screening.
- Those who have a glomerular filtration rate (eGFR) of <15 mL/min.
- A person with severe diabetes complications that deteriorate or newly occur within 3 months of screening and require emergency treatment.
- Pregnant or lactating persons.
- 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.
- Those who find other researchers inappropriate for participation in research.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- FreeStyle Libre 24 weeks, SMBG (22 weeks) and blind CGM (2 weeks)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FreeStyle Libre 24 weeksDevice
FreeStyle Libre flash sensor-based glucose monitoring system (FSGM; Abbott Diabetes Care, Witney, Oxon, UK)
SMBG (22 weeks) and blind CGM (2 weeks)Other
Self-Monitoring of Blood Glucose and Continuous Glucose Monitoring
| Study group | Role | What they receive |
|---|---|---|
| CGM with Structured Education | Experimental | CGM with Structured Education Receives: Device: FreeStyle Libre 24 weeks |
| CGM with Standard Education | Active comparator | CGM with Standard Education Receives: Device: FreeStyle Libre 24 weeks |
| SMBG with Standard Education | Active comparator | SMBG and CGM with Standard Education Receives: Other: SMBG (22 weeks) and blind CGM (2 weeks) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c (%) changes
HbA1c (%) changes at 24 weeks compared to baseline
Measured: 24 weeks
Secondary outcomes (10)
HbA1c (%) changes
HbA1c (%) changes at 12 weeks compared to baseline
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 24 weeks
Percentage of time in range (70 - 180mg/dL)
Percentage of time in range (70 - 180mg/dL) at 24 weeks compared to baseline
Measured: 24 weeks
Mean glucose changes
Mean glucose changes at 24 weeks compared to baseline
Measured: 24 weeks
Coefficient of variation(CV) changes
Coefficient of variation(CV) changes at 24 weeks compared to baseline
Measured: 24 weeks
Diabetes Treatment Satisfaction Questionnaire (DTSQ) changes
Diabetes Treatment Satisfaction Questionnaire (DTSQ) changes at 12 weeks compared to baseline
Measured: 12 weeks
Diabetes Treatment Satisfaction Questionnaire (DTSQ) changes
Diabetes Treatment Satisfaction Questionnaire (DTSQ) changes at 24 weeks compared to baseline
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start17 Jun 2021
- Primary completion26 Oct 2022
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926623
- Sponsor's protocol ID
- DWFSL-P401
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2021
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kim JY, Jin SM, Sim KH, Kim BY, Cho JH, Moon JS, Lim S, Kang ES, Park CY, Kim SG, Kim JH. Continuous glucose monitoring with structured education in adults with type 2 diabetes managed by multiple daily insulin injections: a multicentre randomised controlled trial. Diabetologia. 2024 Jul;67(7):1223-1234. doi: 10.1007/s00125-024-06152-1. Epub 2024 Apr 19.
PubMed 38639876
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04926623
- Acronym / sponsor ID
- DWFSL-P401
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 15 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CGM with Structured Education | Experimental | Device: FreeStyle Libre 24 weeksCGM with Structured Education |
| CGM with Standard Education | Active comparator | Device: FreeStyle Libre 24 weeksCGM with Standard Education |
| SMBG with Standard Education | Active comparator | Other: SMBG (22 weeks) and blind CGM (2 weeks)SMBG and CGM with Standard Education |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetes patients aged 19 and under 75 years.
- 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.
- HbA1c of not less than 7.5% and not more than 12.0% at the time of screening
- patients who agree to use FreeStyle Libre for medical care and research
- patients who voluntarily signed a written consent form
Key exclusion criteria (8 listed)
- 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.
- 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.)
- Those with clinically significant cardiovascular diseases (heart failure, angina, myocardial infarction, cerebral infarction, etc.) within 24 weeks of screening.
- Those who have a glomerular filtration rate (eGFR) of <15 mL/min.
- A person with severe diabetes complications that deteriorate or newly occur within 3 months of screening and require emergency treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FreeStyle Libre 24 weeksFreeStyle Libre flash sensor-based glucose monitoring system (FSGM; Abbott Diabetes Care, Witney, Oxon, UK) | Device | CGM with Standard Education, CGM with Structured Education |
| SMBG (22 weeks) and blind CGM (2 weeks)Self-Monitoring of Blood Glucose and Continuous Glucose Monitoring | Other | SMBG with Standard Education |
Primary outcome
HbA1c (%) changes
Time frame: 24 weeks
HbA1c (%) changes at 24 weeks compared to baseline
10 secondary outcomes
HbA1c (%) changes
Time frame: 12 weeks
Percentage of time in level 2 hypoglycemia (<54 mg/dL)
Time frame: 24 weeks
Percentage of time in level 1 hypoglycemia (<70- 54 mg/dL)
Time frame: 24 weeks
Percentage of time in level 1 hypoglycemia (> 180 mg/dL)
Time frame: 24 weeks
Percentage of time in level 2 hypoglycemia (> 250 mg/dL)
Time frame: 24 weeks
Percentage of time in range (70 - 180mg/dL)
Time frame: 24 weeks
Mean glucose changes
Time frame: 24 weeks
Coefficient of variation(CV) changes
Time frame: 24 weeks
Diabetes Treatment Satisfaction Questionnaire (DTSQ) changes
Time frame: 12 weeks
Diabetes Treatment Satisfaction Questionnaire (DTSQ) changes
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Derived from this study: PubMed 38639876Kim JY, Jin SM, Sim KH, Kim BY, Cho JH, Moon JS, Lim S, Kang ES, Park CY, Kim SG, Kim JH. Continuous glucose monitoring with structured education in adults with type 2 diabetes managed by multiple daily insulin injections: a multicentre randomised controlled trial. Diabetologia. 2024 Jul;67(7):1223-1234. doi: 10.1007/s00125-024-06152-1. Epub 2024 Apr 19.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FreeStyle Libre 24 weeks and SMBG (22 weeks) and blind CGM (2 weeks) in people with Type 2 Diabetes Mellitus, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (%) changes (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04926623, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.