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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FreeStyle Libre 2 Continuous Glucose Monitoring | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | At 6 months (V3) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Adjusted change in glycated hemoglobin A1c (HbA1c) from month 3 to month 6, comparing periodic versus continuous CGM use groups. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sun-Joon Moon, MD, PhD | Contact | +82-2-2001-1550 | ipleat.m@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kangbuk Samsung Hospital | Recruiting | Seoul | South Korea | 03181 | South Korea |
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.
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.
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.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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This is a non-inferiority trial comparing periodic versus continuous use of CGM
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| 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. | 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. | 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. | 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. | 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. | 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. | 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%. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months |
| D004700 | Endocrine System Diseases |