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| Name | Class |
|---|---|
| Powder (Guangzhou) Pharmaceuticals Limited | UNKNOWN |
| Powder Pharmaceuticals (HK) Co., Ltd | UNKNOWN |
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Subjects in the upper arm group will have a sensor of the CGM System inserted on each arm (left and right upper arm). Subjects in the abdomen group will have 2 sensors inserted, one on each side of the abdomen (left and right abdomen) The sensors will be placed for 29 days. After sensor insertion, the CGM system should be calibrated with capillary blood glucose readings from a self-monitoring blood glucose meter。
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the upper arm group on Day 2 | Other | The upper arm group to perform Visit 3 venous blood glucose measurement on Day 2. |
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| the upper arm group on Day 15±1 day | Other | The upper arm group to perform Visit 3 venous blood glucose measurement on Day 15±1 day. |
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| the upper arm group on Day 29±1 day | Other | The upper arm group to perform Visit 3 venous blood glucose measurement on Day 29±1 day. |
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| the abdomen group on Day 2 | Other | The abdomen group to perform Visit 3 venous blood glucose measurement on Day 2. |
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| the abdomen group on Day 15±1 | Other | The abdomen group to perform Visit 3 venous blood glucose measurement on Day 15±1. |
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| the abdomen group on Day 29±1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| continuous glucose-monitoring | Device | Continuous glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients with diabetes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| %20/20 agreement between the test device readings and the EKF readings: %20/20 = A + B | A = the proportion of the CGM system values that were within ±20% of paired EKF values >4.4mmol/L (>80 mg/dL) B = the proportion of the CGM system values that were within ±1.1mmol/L (20mg/dL) of paired EKF values ≤4.4mmol/L (≤80mg/dL) | up to 29 days |
| Proportion of readings in Region A + Region B of Clarke Error Grid | Analyze the proportion of readings in each region (Region A, B, C D and E). Readings in Region A are clinically accurate, while readings in Region B are of clinically acceptable accuracy. Readings in C, D and E are inaccurate to various degrees. | up to 29 days |
| Proportion of readings in Region A + Region B of Consensus Error Grid | Analyze the proportion of readings in Region A and Region B. | up to 29 days |
| the percentage of MARD (Mean Absolute Relative Difference) | Analyze the proportion of readings in MARD <18% (95%CI<20%). | up to 29 days |
| Measure | Description | Time Frame |
|---|---|---|
| Alarm success rate1 | Hypoglycemia alarm success rate and failure rate (sensitivity) | up to 29 days |
| Alarm success rate2 | Hypoglycemia detection rate and missed detection rate (specificity) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elaine Chow, Prof. | Contact | (852) 3505 1642 | e.chow@cuhk.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Elaine Chow, Prof. | Prince of Wales Hospital, the Chinese University of Hong Kong | Principal Investigator |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| 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 |
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| Other |
The abdomen group to perform Visit 3 venous blood glucose measurement on Day 29±1. |
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| up to 29 days |
| Alarm success rate 3 | Hyperglycemia alarm success rate and failure rate | up to 29 days |
| Alarm success rate 4 | Hyperglycemia detection rate and missed detection rate | up to 29 days |
| Sensor Stability | Compare the accuracy of the sensor between Day 2(22h~48h after insertion), Day 15±1day, Day 29±1day to evaluate sensor. | up to 29 days |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |