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| Name | Class |
|---|---|
| i-SENS, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Sequential CGM Application (Blinded followed by Unblinded) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous glucose monitoring | Device | 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:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 1 and Week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 1 and Week 2 |
| Change in Percentage of Time Below Range (TBR) <70 mg/dL From Week 1 (Blinded) to Week 2 (Unblinded) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kangbuk Samsung Hospital | Seoul | Jongro-Ku | 03181 | South Korea |
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|
Percentage of time glucose readings are below 70 mg/dL, indicating hypoglycemia. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Week 1 and Week 2 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |
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