An interventional study of FreeStyle Libre 2 Continuous Glucose Monitoring in Diabetes Mellitus, Type 2, sponsored by Kangbuk Samsung Hospital. Recruiting at 1 site in South Korea. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-13.
Sponsored by Kangbuk Samsung Hospital · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to test whether wearing a continuous glucose monitor (CGM) part-time works as well as wearing it full-time in adults with type 2 diabetes who do not use insulin. The main questions it aims to answer are:
Researchers will compare part-time CGM use to continuous CGM use to see if part-time use is just as effective for blood sugar control.
All participants will:
The study will last about 6 months total. Participants will use the FreeStyle Libre 2 CGM device, which is already approved for use in people with diabetes.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 150 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Kangbuk Samsung Hospital is the lead sponsor of 63 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants first wear FreeStyle Libre 2 CGM continuously for 12 weeks to establish baseline glucose patterns. Only those with at least 50% sensor active time proceed to randomization. After randomization, participants in this arm wear CGM intermittently for 2 weeks at weeks 2, 6, and 10 (±3 days each). Each sensor is worn for 14 days then removed. During non-wearing periods, no CGM is used. Participants receive education on diet adjustment based on postprandial glucose from CGM. Existing diabetes medications are maintained without changes throughout the study.
Device: FreeStyle Libre 2 Continuous Glucose Monitoring
All participants first wear FreeStyle Libre 2 CGM continuously for 12 weeks to establish baseline glucose patterns. Only those with at least 50% sensor active time proceed to randomization. After randomization, participants in this arm continue to wear CGM continuously for 12 weeks with sensor replacement every 14 days (total 6 replacements). Participants receive education on diet adjustment based on postprandial glucose from CGM. Existing diabetes medications are maintained without changes throughout the study.
Device: FreeStyle Libre 2 Continuous Glucose Monitoring
FreeStyle Libre 2 continuous glucose monitoring system consisting of a sensor worn on the upper arm that measures interstitial glucose levels continuously for up to 14 days. Data is transmitted to a smartphone app (FreeStyle LibreLink). The sensor is a Class 3 medical device approved by MFDS (Korea). Participants receive education on adjusting diet based on postprandial glucose patterns observed through CGM. Existing diabetes medications (oral agents and/or GLP-1 agonists) are maintained without changes throughout the intervention period.
Change in HbA1c from 3 to 6 months
Non-inferiority comparison of the adjusted change in glycated hemoglobin A1c (HbA1c) from month 3 (V2, randomization visit) to month 6 (V3, end of study). The non-inferiority margin is set at 0.3%. The periodic use group will be considered non-inferior to the continuous use group if the lower bound of the 97.5% one-sided confidence interval for the difference in HbA1c change (periodic minus continuous) is greater than -0.3%.
Time frame: At 6 months (V3)
Change in HbA1c
Adjusted change in glycated hemoglobin A1c (HbA1c) from month 3 to month 6, comparing periodic versus continuous CGM use groups.
Time frame: At 6 months (V3)
Change in Blood Pressure
Adjusted change in systolic and diastolic blood pressure from month 3 to month 6, comparing periodic versus continuous CGM use groups.
Time frame: At 6 months (V3)
At 6 months (V3)
Adjusted change in lipid parameters (LDL cholesterol, HDL cholesterol, total cholesterol, triglycerides) from month 3 to month 6, comparing periodic versus continuous CGM use groups.
Time frame: At 6 months (V3)
Change in Body Weight
Adjusted change in body weight (kg) from month 3 to month 6, comparing periodic versus continuous CGM use groups.
Time frame: At 6 months (V3)
Change in HOMA-IR
Adjusted change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) from month 3 to month 6, comparing periodic versus continuous CGM use groups.
Time frame: At 6 months (V3)
Change in Diabetes Treatment Satisfaction (DTSQ)
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score from month 3 to month 6, comparing periodic versus continuous CGM use groups. Higher scores indicate greater treatment satisfaction.
Time frame: At 6 months (V3)
Change in Diabetes Self-Efficacy (K-DMSES)
Change in Korean-Diabetes Management Self-Efficacy Scale (K-DMSES) score from month 3 to month 6, comparing periodic versus continuous CGM use groups. Higher scores indicate greater self-efficacy.
Time frame: At 6 months (V3)
Change in Diabetes Self-Care Activities (SDSCA-K)
Change in Summary of Diabetes Self-Care Activities Questionnaire-Korean (SDSCA-K) score from month 3 to month 6, comparing periodic versus continuous CGM use groups.
Time frame: At 6 months (V3)
Time in Range 70-180 mg/dL (Non-inferiority)
Non-inferiority comparison of percentage of time in glucose range 70-180 mg/dL between periodic and continuous CGM use groups. Non-inferiority margin is 6%.
Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months
Time in Range 70-180 mg/dL
Percentage of time in glucose range 70-180 mg/dL, comparing periodic versus continuous CGM use groups.
Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months
Time in Tight Range 70-140 mg/dL
Percentage of time in tight glucose range 70-140 mg/dL, comparing periodic versus continuous CGM use groups.
Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months
Time Above Range 180 mg/dL
Percentage of time above glucose range (\>180 mg/dL), comparing periodic versus continuous CGM use groups.
Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months
Time Above Range 250 mg/dL
Percentage of time above glucose range (\>250 mg/dL), comparing periodic versus continuous CGM use groups.
Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months
Time Below Range 70 mg/dL
Percentage of time below glucose range (\<70 mg/dL), comparing periodic versus continuous CGM use groups.
Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months
Time Below Range 54 mg/dL
Percentage of time below glucose range (\<54 mg/dL), comparing periodic versus continuous CGM use groups.
Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months
Glucose Standard Deviation (SD)
Standard deviation of glucose levels, comparing periodic versus continuous CGM use groups.
Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months
Glucose Coefficient of Variation (CV)
Coefficient of variation of glucose levels, comparing periodic versus continuous CGM use groups.
Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months
Mean Amplitude of Glycemic Excursions (MAGE)
Mean amplitude of glycemic excursions, a measure of glucose variability, comparing periodic versus continuous CGM use groups.
Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months
Glucose Management Indicator (GMI)
Glucose Management Indicator, an estimate of HbA1c derived from CGM data, comparing periodic versus continuous CGM use groups.
Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months
Mean Glucose
Mean glucose level (mg/dL), comparing periodic versus continuous CGM use groups
Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months
Plan to share: Yes — Individual participant data that underlie the results reported in articles resulting from this study will be made available after deidentification. This includes data supporting primary and secondary outcomes, demographic information, and adverse event data. Data will be provided in a format suitable for secondary analysis while protecting participant privacy.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Individual participant data will be available beginning December 2028, approximately 24 months after the primary completion date. Data will be available for 5 years following initial availability. Supporting documents (protocol, SAP, CSR) will be made available at the same time.
Access criteria: Data will be shared with researchers who provide a methodologically sound proposal for secondary analysis. Access will be granted at the discretion of the study investigators based on the scientific merit and feasibility of the proposed research.
No publications or documents are linked to this record.
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Kangbuk Samsung Hospital