Diabetes Mellitus, Type 2PERIODIC-CGMNCT07336329
Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use
A study testing FreeStyle Libre 2 Continuous Glucose Monitoring in people with Diabetes Mellitus, Type 2, run by Kangbuk Samsung Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- FreeStyle Libre 2 Continuous Glucose Monitoring
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jan 2026to 30 Jun 2027
- 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
- Adults aged 19 to 80 years at the time of informed consent
- Adults with type 2 diabetes not using insulin
- Patients treated with GLP-1 agonist, oral hypoglycemic agents, and/or lifestyle modifications
- Patients who have maintained stable diabetes treatment for at least 3 months without changes
- HbA1c between 7.5% and 10.0%
- Willing to wear personal continuous glucose monitoring device (CGM)
Show all 10Show fewer
- Willing to install and use CGM-linked app on personal smartphone with continuous access to WIFI or cellular data
- Able to read and write Korean as judged by investigator
- Willing to use medically acceptable contraception until end of study (sterile status, intrauterine device, or concurrent use of male/female barrier method with spermicide)
- Fully informed about the clinical trial and voluntarily consenting to participate
Who cannot join
- Type 1 diabetes mellitus
- Gestational diabetes mellitus
- History of pancreatectomy
- Continuous or intermittent insulin therapy for 7 days or more within 3 months
- Oral or IV steroid treatment within 1 month prior to informed consent
- Serious infection, surgery (scheduled or history), or severe trauma within 3 months prior to informed consent
Show all 16Show fewer
- History of malignancy within 1 year prior to informed consent (except thyroid cancer)
- On hemodialysis or peritoneal dialysis or eGFR < 30 mL/min/1.73m2
- Unable to avoid the following concomitant medications, devices, or treatments during the study: CGM other than study device, X-ray/MRI/CT scans, radiofrequency thermal therapy, implantable devices such as pacemakers, immunosuppressants, steroids, IV vitamin preparations, cancer treatment, hemodialysis/peritoneal dialysis, insulin therapy
- Uncontrolled thyroid disease or clinically significant severe endocrine disorders (Cushing's syndrome, pheochromocytoma, etc.)
- Severe allergic reaction to skin adhesives (e.g., dyspnea, severe rash, edema)
- Whole blood donation within 60 days, apheresis within 30 days, or blood transfusion within 90 days prior to device application
- Judged by investigator as unable to handle continuous glucose monitoring device
- Pregnant or lactating women
- Planning pregnancy within 1 year
- Otherwise judged by investigator as inappropriate for participation in this clinical trial
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
Kangbuk Samsung Hospital
Seoul, South Korea, 03181
Sun-Joon Moon, MD, PhD, +82-2-2001-1550, ipleat.m@gmail.com
About this study
Official title: Effectiveness of Periodic Use of Continuous Glucose Monitoring After Three Months of Continuous Use in Patients With Non-Insulin-Treated Type 2 Diabetes Patients: A Multicenter, Randomized, Parallel-Group, Open-Label, Non-Inferiority, Investigator-Initiated Trial
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:
- Does wearing CGM part-time (2 weeks per month) control blood sugar as well as wearing it continuously?
- How do the two wearing patterns compare for blood sugar levels throughout the day, weight, blood pressure, and patient satisfaction?
Read more
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:
- Wear a CGM device continuously for 3 months to learn how their blood sugar responds to different foods and activities
- Then be randomly assigned to wear CGM either part-time (2 weeks each month) or continuously for another 3 months
- Replace the CGM sensor on their arm every 2 weeks
- Use a smartphone app to track their blood sugar readings
- Visit the clinic 3 times for blood tests and check-ups
- Receive education on adjusting diet based on their CGM readings
- Keep their current diabetes medications unchanged during the study
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- FreeStyle Libre 2 Continuous Glucose Monitoring
- Keywords
- type 2 diabetes, continuous glucose monitoring
- 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 2 Continuous Glucose MonitoringDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Periodic CGM Use | Experimental | 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. Receives: Device: FreeStyle Libre 2 Continuous Glucose Monitoring |
| Continuous CGM Use | Active comparator | 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. Receives: Device: FreeStyle Libre 2 Continuous Glucose Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: At 6 months (V3)
Secondary outcomes (20)
Change in HbA1c
Adjusted change in glycated hemoglobin A1c (HbA1c) from month 3 to month 6, comparing periodic versus continuous CGM use groups.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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%.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start2 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- Model description
- This is a non-inferiority trial comparing periodic versus continuous use of CGM
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kangbuk Samsung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Joon, Moon, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336329
- Sponsor's protocol ID
- KBSMC 2025-07-031
- Acronym
- PERIODIC-CGM
- Status last verified
- Jan 2026
- First submitted
- 10 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Periodic Use of Continuous Glucose Monitoring After Three Months of Continuous Use in Patients With Non-Insulin-Treated Type 2 Diabetes Patients: A Multicenter, Randomized, Parallel-Group, Open-Label, Non-Inferiority, Investigator-Initiated Trial
- ClinicalTrials.gov ID
- NCT07336329
- Acronym / sponsor ID
- PERIODIC-CGM / KBSMC 2025-07-031
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- type 2 diabetes, continuous glucose monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Study start
- 2 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 Jan 2026 (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.
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:
- Does wearing CGM part-time (2 weeks per month) control blood sugar as well as wearing it continuously?
- How do the two wearing patterns compare for blood sugar levels throughout the day, weight, blood pressure, and patient satisfaction?
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:
- Wear a CGM device continuously for 3 months to learn how their blood sugar responds to different foods and activities
- Then be randomly assigned to wear CGM either part-time (2 weeks each month) or continuously for another 3 months
- Replace the CGM sensor on their arm every 2 weeks
- Use a smartphone app to track their blood sugar readings
- Visit the clinic 3 times for blood tests and check-ups
- Receive education on adjusting diet based on their CGM readings
- Keep their current diabetes medications unchanged during the study
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a non-inferiority trial comparing periodic versus continuous use of CGM
| Arm | Type | Receives |
|---|---|---|
| Periodic CGM Use | Experimental | Device: FreeStyle Libre 2 Continuous Glucose MonitoringAll 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. |
| Continuous CGM Use | Active comparator | Device: FreeStyle Libre 2 Continuous Glucose MonitoringAll 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. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adults aged 19 to 80 years at the time of informed consent
- Adults with type 2 diabetes not using insulin
- Patients treated with GLP-1 agonist, oral hypoglycemic agents, and/or lifestyle modifications
- Patients who have maintained stable diabetes treatment for at least 3 months without changes
- HbA1c between 7.5% and 10.0%
Key exclusion criteria (16 listed)
- Type 1 diabetes mellitus
- Gestational diabetes mellitus
- History of pancreatectomy
- Continuous or intermittent insulin therapy for 7 days or more within 3 months
- Oral or IV steroid treatment within 1 month prior to informed consent
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 2 Continuous Glucose MonitoringFreeStyle 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. | Device | Continuous CGM Use, Periodic CGM Use |
Primary outcome
Change in HbA1c from 3 to 6 months
Time frame: At 6 months (V3)
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%.
20 secondary outcomes
Change in HbA1c
Time frame: At 6 months (V3)
Change in Blood Pressure
Time frame: At 6 months (V3)
At 6 months (V3)
Time frame: At 6 months (V3)
Change in Body Weight
Time frame: At 6 months (V3)
Change in HOMA-IR
Time frame: At 6 months (V3)
Change in Diabetes Treatment Satisfaction (DTSQ)
Time frame: At 6 months (V3)
Change in Diabetes Self-Efficacy (K-DMSES)
Time frame: At 6 months (V3)
Change in Diabetes Self-Care Activities (SDSCA-K)
Time frame: At 6 months (V3)
Time in Range 70-180 mg/dL (Non-inferiority)
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
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
Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months
Time Above Range 180 mg/dL
Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months
Time Above Range 250 mg/dL
Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months
Time Below Range 70 mg/dL
Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months
Time Below Range 54 mg/dL
Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months
Glucose Standard Deviation (SD)
Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months
Glucose Coefficient of Variation (CV)
Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months
Mean Amplitude of Glycemic Excursions (MAGE)
Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months
Glucose Management Indicator (GMI)
Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months
Mean Glucose
Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months
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 13 Jan 2026.
- Individual participant dataSharing planned: 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.
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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.
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 2 Continuous Glucose Monitoring in people with Diabetes Mellitus, Type 2, run by Kangbuk Samsung 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 10 inclusion and 16 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 13 Jan 2026. 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 Sun-Joon Moon, MD, PhD (+82-2-2001-1550, ipleat.m@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c from 3 to 6 months (time frame: At 6 months (V3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2026.