An interventional study of Continuous glucose monitoring in Continuous Glucose Monitoring and Type 2 Diabetes, sponsored by Kangbuk Samsung Hospital. Active, not recruiting at 1 site in South Korea. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by Kangbuk Samsung Hospital · Not applicable, Interventional, and Treatment
This study evaluates the effect of using a real-time continuous glucose monitoring (CGM) system on blood sugar control in people with type 2 diabetes who do not use insulin.
Participants will wear a CGM device (CareSens Air) for a total of two weeks. During the first week, the device will be set to "blinded mode," meaning participants cannot see their glucose readings. During the second week, the device will be switched to "unblinded mode," allowing participants to view their glucose levels and trends in real-time.
The study aims to determine if simply seeing real-time glucose data can help patients improve their blood sugar control (such as increasing the time their blood sugar is in the target range) without receiving additional structured education on diet or exercise. Researchers will compare the glucose data collected during the blinded week with the data from the unblinded week.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 120 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Kangbuk Samsung Hospital is the lead sponsor of 59 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single arm consisting of adults with non-insulin-treated type 2 diabetes. All participants undergo a 2-week prospective observation using a real-time CGM device (CareSens Air), transitioning from a blinded baseline period to an unblinded intervention period to evaluate glycemic changes.
Device: Continuous glucose monitoring
All participants are adults with non-insulin-treated type 2 diabetes. Participants will wear a real-time continuous glucose monitoring (rt-CGM) device (CareSens Air) for a total of two weeks. The intervention consists of two consecutive phases: 1. Week 1 (Blinded Mode): Participants wear the CGM but cannot view their glucose readings. This period establishes baseline glycemic data. 2. Week 2 (Unblinded Mode): The same CGM session continues, but the mode is switched to "unblinded." Participants can view their real-time glucose levels and trend arrows. Throughout the study, no additional structured education (e.g., diet or exercise coaching) or medication adjustments by the investigators are provided. The study evaluates the effect of data visibility alone on glycemic metrics.
Change in Percentage of Time in Range (TIR) 70-180 mg/dL From Week 1 (Blinded) to Week 2 (Unblinded)
Percentage of time glucose readings are within the target range of 70-180 mg/dL.
Time frame: Week 1 and Week 2
Change in Percentage of Time in Tight Range (TITR) 70-140 mg/dL From Week 1 (Blinded) to Week 2 (Unblinded)
Percentage of time glucose readings are within the tight target range of 70-140 mg/dL.
Time frame: Week 1 and Week 2
Change in Percentage of Time Below Range (TBR) <70 mg/dL From Week 1 (Blinded) to Week 2 (Unblinded)
Percentage of time glucose readings are below 70 mg/dL, indicating hypoglycemia.
Time frame: Week 1 and Week 2
Change in Percentage of Time Below Range (TBR) <54 mg/dL From Week 1 (Blinded) to Week 2 (Unblinded)
Percentage of time glucose readings are below 54 mg/dL, indicating clinically significant hypoglycemia.
Time frame: Week 1 and Week 2
Change in Percentage of Time Above Range (TAR) >140 mg/dL From Week 1 (Blinded) to Week 2 (Unblinded)
Percentage of time glucose readings are above 140 mg/dL. This metric assesses exposure to hyperglycemia, including mild elevations.
Time frame: Week 1 and Week 2
Change in Percentage of Time Above Range (TAR) >180 mg/dL From Week 1 (Blinded) to Week 2 (Unblinded)
Percentage of time glucose readings are above 180 mg/dL, indicating hyperglycemia.
Time frame: Week 1 and Week 2
Change in Percentage of Time Above Range (TAR) >250 mg/dL From Week 1 (Blinded) to Week 2 (Unblinded)
Percentage of time glucose readings are above 250 mg/dL, indicating severe hyperglycemia.
Time frame: Week 1 and Week 2
Change in Mean Glucose Concentration From Week 1 (Blinded) to Week 2 (Unblinded)
Average glucose concentration (mg/dL) measured by the CGM device.
Time frame: Week 1 and Week 2
Change in Glucose Standard Deviation (SD) From Week 1 (Blinded) to Week 2 (Unblinded)
Standard Deviation (SD) of glucose readings, measuring glycemic variability.
Time frame: Week 1 and Week 2
Change in Glucose Coefficient of Variation (CV) From Week 1 (Blinded) to Week 2 (Unblinded)
Coefficient of Variation (CV) calculated as (SD / Mean Glucose) \* 100, measuring glycemic variability.
Time frame: Week 1 and Week 2
Change in Glucose Management Indicator (GMI) From Week 1 (Blinded) to Week 2 (Unblinded)
GMI is an estimated HbA1c level calculated from the mean glucose concentration derived from CGM data.
Time frame: Week 1 and Week 2
Plan to share: No
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This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Kangbuk Samsung Hospital