Diabetes Mellitus, Type 2PDFNCT04932928
Patient-Driven Lifestyle Modification Using FreeStyle Libre in Type 2 Diabetes Patients
A study testing FreeStyle Libre and Blood glucose meter in people with Diabetes Mellitus, Type 2 and Lifestyle Risk Reduction, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
We aim to provide medical nutritional therapy to patients with type 2 diabetes who are on oral hypoglycemic agents or on basal insulin only and monitor the glycemic response with flash glucose monitoring or self-monitoring of blood glucose. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Lifestyle Risk Reduction
- What is being tested?
- FreeStyle Libre and Blood glucose meter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Mar 2021to 23 Mar 2023
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19-80
- Diagnosed with type 2 diabetes mellitus (DM)
- Uncontrolled type 2 DM: HbA1c 7.0-10.0%
- Signed informed consent
Who cannot join
- Diagnosed with other types of diabetes mellitus (i.e. Type 1 DM)
- Use of prandial insulin
- Change in diabetes medication in the preceding 3 months
- Pregnant/lactating women
- Addiction to drugs and alcohol
- Use of medications that result in drug-induced hyperglycemia (i.e. steroid)
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- Severe liver disease
- End-stage renal disease (i.e. on dialysis)
- Unable to wear CGM devices due to dermatologic side effects (i.e. severe burn, inflammation, active skin infection, severe skin reactions, hypertrichosis, etc.)
- Conditions that impact the stability of HbA1c measurement
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Young Min Cho, MD, PHD, 82-2-2072-1965, ymchomd@snu.ac.kr
About this study
We aim to provide medical nutritional therapy to patients with type 2 diabetes who are on oral hypoglycemic agents or on basal insulin only and monitor the glycemic response with flash glucose monitoring or self-monitoring of blood glucose.
Specifically, this is a randomized, open-label, controlled study where half of the study participants will have FreeStyle Libre device on for 12 weeks and compare the change in glycated hemoglobin (HbA1c) value with the patients in the control group.
Read the detailed description
Subjects: 126 patients with type 2 diabetes mellitus Scheme: Multi-center, Randomized, open-label, controlled study
This study is referred to as the "Patient-Driven lifestyle modification using FreeStyle Libre in type 2 diabetes patients", also known as the PDF study.
It will assess potential benefits of using Continuous Glucose Monitoring (CGM) versus Self Monitoring of Blood Glucose (SMBG) when combined with personalized education on lifestyle modification in people with type 2 diabetes. Specifically, we will investigate patients who have an elevated HbA1c between 7.0 - 10.0% who are not using prandial insulin.
Potential participants will be screened from routine outpatient clinic visits, will be randomized to either the CGM or SMBG group in a 1:1 ratio. Participants from both groups will receive education on lifestyle modification and will be reminded every 4 weeks with structured phone visits. Study will be completed at the visit on 12 weeks of follow up with the same laboratory examinations (including HbA1c) and survey from the baseline.
- Being tested
- FreeStyle Libre, Blood glucose meter
- Medical subject headings
- Diabetes Mellitus, Type 2, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FreeStyle LibreDevice
Also called Education on lifestyle modification
Flash glucose monitoring + Education on lifestyle modification
Blood glucose meterDevice
Also called Education on lifestyle modification
Self monitoring of blood glucose + Education on lifestyle modification
| Study group | Role | What they receive |
|---|---|---|
| FreeStyle Libre (CGM) Group | Experimental | Device: FreeStyle Libre (ver 1.0) Education on lifestyle modification Receives: Device: FreeStyle Libre |
| Self Monitoring of Blood Glucose (SMBG) Group | Active comparator | Device: Blood glucose meter Education on lifestyle modification Receives: Device: Blood glucose meter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Between group differences (CGM and SMBG) for the change in HbA1c from baseline to Month 3
Measured: Baseline to Month 3
Secondary outcomes (6)
Change in mean fasting glucose
Between group differences (CGM and SMBG) for the change in fasting glucose from baseline to Month 3
Measured: Baseline to Month 3
Change in body weight
Between group differences (CGM and SMBG) for the change in body weight from baseline to Month 3
Measured: Baseline to Month 3
Change in blood pressure
Between group differences (CGM and SMBG) for the change in blood pressure from baseline to Month 3
Measured: Baseline to Month 3
Change in waist circumference
Between group differences (CGM and SMBG) for the change in waist circumference from baseline to Month 3
Measured: Baseline to Month 3
Change in lipid level
Between group differences (CGM and SMBG) for the change in lipid level (total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol) from baseline to Month 3
Measured: Baseline to Month 3
Change in the Korean Version of Revised Summary of Diabetes Self-Care Activities Questionnaire (SDSCA-K) survey score
Between group differences (CGM and SMBG) for the change in survey score from baseline to Month 3
Measured: Baseline to Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start23 Mar 2021
- Primary completion23 Sep 2022 (estimated)
- Study completion23 Mar 2023 (estimated)
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 Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Inje University, Kangbuk Samsung Hospital
- Responsible party
- Sponsor
- Investigators
- Young Min Cho, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932928
- Sponsor's protocol ID
- H-2011-062-117
- Acronym
- Status last verified
- Mar 2021
- First submitted
- 13 Jun 2021
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Choe HJ, Rhee EJ, Won JC, Park KS, Lee WY, Cho YM. Effects of Patient-Driven Lifestyle Modification Using Intermittently Scanned Continuous Glucose Monitoring in Patients With Type 2 Diabetes: Results From the Randomized Open-label PDF Study. Diabetes Care. 2022 Oct 1;45(10):2224-2230. doi: 10.2337/dc22-0764.
PubMed 35984640
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Driven Lifestyle Modification Using FreeStyle Libre in Type 2 Diabetes Patients
- ClinicalTrials.gov ID
- NCT04932928
- Acronym / sponsor ID
- PDF / H-2011-062-117
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Inje University, Kangbuk Samsung Hospital
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 23 Sep 2022 (estimated)
- Study completion
- 23 Mar 2023 (estimated)
- First posted
- 21 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.
We aim to provide medical nutritional therapy to patients with type 2 diabetes who are on oral hypoglycemic agents or on basal insulin only and monitor the glycemic response with flash glucose monitoring or self-monitoring of blood glucose.
Specifically, this is a randomized, open-label, controlled study where half of the study participants will have FreeStyle Libre device on for 12 weeks and compare the change in glycated hemoglobin (HbA1c) value with the patients in the control group.
Detailed description
Subjects: 126 patients with type 2 diabetes mellitus Scheme: Multi-center, Randomized, open-label, controlled study
This study is referred to as the "Patient-Driven lifestyle modification using FreeStyle Libre in type 2 diabetes patients", also known as the PDF study.
It will assess potential benefits of using Continuous Glucose Monitoring (CGM) versus Self Monitoring of Blood Glucose (SMBG) when combined with personalized education on lifestyle modification in people with type 2 diabetes. Specifically, we will investigate patients who have an elevated HbA1c between 7.0 - 10.0% who are not using prandial insulin.
Potential participants will be screened from routine outpatient clinic visits, will be randomized to either the CGM or SMBG group in a 1:1 ratio. Participants from both groups will receive education on lifestyle modification and will be reminded every 4 weeks with structured phone visits. Study will be completed at the visit on 12 weeks of follow up with the same laboratory examinations (including HbA1c) and survey from the baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FreeStyle Libre (CGM) Group | Experimental | Device: FreeStyle LibreDevice: FreeStyle Libre (ver 1.0) Education on lifestyle modification |
| Self Monitoring of Blood Glucose (SMBG) Group | Active comparator | Device: Blood glucose meterDevice: Blood glucose meter Education on lifestyle modification |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 19-80
- Diagnosed with type 2 diabetes mellitus (DM)
- Uncontrolled type 2 DM: HbA1c 7.0-10.0%
- Signed informed consent
Key exclusion criteria (10 listed)
- Diagnosed with other types of diabetes mellitus (i.e. Type 1 DM)
- Use of prandial insulin
- Change in diabetes medication in the preceding 3 months
- Pregnant/lactating women
- Addiction to drugs and alcohol
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 LibreAlso: Education on lifestyle modificationFlash glucose monitoring + Education on lifestyle modification | Device | FreeStyle Libre (CGM) Group |
| Blood glucose meterAlso: Education on lifestyle modificationSelf monitoring of blood glucose + Education on lifestyle modification | Device | Self Monitoring of Blood Glucose (SMBG) Group |
Primary outcome
Change in HbA1c
Time frame: Baseline to Month 3
Between group differences (CGM and SMBG) for the change in HbA1c from baseline to Month 3
6 secondary outcomes
Change in mean fasting glucose
Time frame: Baseline to Month 3
Change in body weight
Time frame: Baseline to Month 3
Change in blood pressure
Time frame: Baseline to Month 3
Change in waist circumference
Time frame: Baseline to Month 3
Change in lipid level
Time frame: Baseline to Month 3
Change in the Korean Version of Revised Summary of Diabetes Self-Care Activities Questionnaire (SDSCA-K) survey score
Time frame: Baseline to Month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Derived from this study: PubMed 35984640Choe HJ, Rhee EJ, Won JC, Park KS, Lee WY, Cho YM. Effects of Patient-Driven Lifestyle Modification Using Intermittently Scanned Continuous Glucose Monitoring in Patients With Type 2 Diabetes: Results From the Randomized Open-label PDF Study. Diabetes Care. 2022 Oct 1;45(10):2224-2230. doi: 10.2337/dc22-0764.
- Individual participant dataSharing planned: No
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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.
Young Min Cho, MD, PhD principal investigator
Seoul National University Hospital
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 and Blood glucose meter in people with Diabetes Mellitus, Type 2 and Lifestyle Risk Reduction, run by Seoul National University Hospital 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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 21 Jun 2021. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hun Jee Choe, MD (82-2-2072-1965, hunjeechoe@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: Baseline to Month 3). 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 NCT04932928, 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 21 Jun 2021.