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Current continuous glucose monitoring (CGM) devices provide features that alert for current and impending adverse glycemic events.This trial aims to examine whether these glucose alerts provided added benefit on glycemic outcomes in patients with type 1 or 2 diabetes who required intensive insulin therapy during hospitalization.
Glycemic management for patients with diabetes during hospitalization is highly challenging, especially for those requiring intensive insulin therapy. For those patients, hypoglycemia is a common adverse event, which is associated with adverse clinical outcomes. Bedside capillary point-of-care (POC) glucose monitoring is the standard of care to assess glycemic control in the hospital. However, POC glucose testing only provides glucose measurements at specific time points, leading to missed information important for glycemic control. Continuous glucose monitoring (CGM) measures interstitial glucose every 5 min, thus providing a more complete glycemic profile during a 24 h period compared with standard POC glucose testing.
The cloud-based real-time continuous glucose monitoring (RT-CGM) and management system was previously observed to be safe and effective in guiding intensive insulin therapy. Therefore, this CGM intergraded system holds promise for improving glucose control in patients with diabetes during hospitalization. However, it is currently unclear if alerts are the main reason for the better outcome in the RT-CGM groups, or rather the fact that sensor values are available in real-time. Moreover, the current system provided the feature of predictive threshold alerts that could alert before the onset of clinical hypoglycemia or hyperglycemia. Thus, this trial aims to examine whether these glucose alerts provided added benefit on glycemic outcomes in patients with type 1 or 2 diabetes who required intensive insulin therapy during hospitalization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGM system with both glucose predictive alerts and threshold alerts on | Experimental | Patients will wear a real-time CGM (The Guardian Connect CGM System with Guardian sensor 3, Medtronic), which provide glucose readings every 5 minutes for up to 7 days. High/low predictive/threshold alerts will be enabled in this group, with low glucose alert set at 3.9 mmol/L and high glucose alert set at 16.7 mmol/L. Notably, predictive threshold alerts are triggered when a high/low glucose value is predicted within the next 15 min. In addition, patients will undergo POC testing at least 4 times per day (usually before meals and bedtime). |
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| CGM system with only glucose threshold alerts on | Experimental | Patients will wear a real-time CGM (The Guardian Connect CGM System with Guardian sensor 3, Medtronic), which provide glucose readings every 5 minutes for up to 7 days. Only high/low threshold alerts will be enabled in this group, with the same high/low glucose alert set, which is 3.9 mmol/L and 16.7 mmol/L respectively. In addition, patients will undergo POC testing at least 4 times per day (usually before meals and bedtime). |
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| CGM system with glucose alerts off | Active Comparator | Patients will wear a real-time CGM (The Guardian Connect CGM System with Guardian sensor 3, Medtronic), which provide glucose readings every 5 minutes for up to 7 days. High/low predictive/threshold alerts will be off in this group. In addition, patients will undergo POC testing at least 4 times per day (usually before meals and bedtime). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CGM system with both glucose predictive alerts and threshold alerts on | Device | the cloud-based real-time continuous glucose monitoring and management system with both glucose predictive alerts and threshold alerts on |
| Measure | Description | Time Frame |
|---|---|---|
| Time in range (3.9~10.0mmol/L, %) | Percentage of time within glucose level of 3.9-10.0 mmol/L (70-180 mg/dL) measured by CGM. | Through study completion (during hospitalization, 5-7 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Time above range (>10.0mmol/L, %) | Percentage of time above glucose level of 10.0 mmol/L (180 mg/dL) measured by CGM. | Through study completion (during hospitalization, 5-7 days) |
| Time above range (>13.9mmol/L, %) |
| Measure | Description | Time Frame |
|---|---|---|
| Time taken to achieve target glucose (days) | Target glucose was defined as CGM-recorded TIR 3.9-10.0 mmol/L (70-180 mg/dL) more than 70%, with a maximum allowed time of 7 days. | Through study completion (during hospitalization, 5-7 days) |
| Length of hospital stay (days) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jian Zhou | Shanghai 6th People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Sixth People's Hospital | Shanghai | Shanghai Municipality | 200233 | China |
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| CGM system with only glucose threshold alerts on | Device | the cloud-based real-time continuous glucose monitoring and management system with only glucose threshold alerts on |
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| CGM system with glucose alerts off | Device | the cloud-based real-time continuous glucose monitoring and management system with glucose predictive/threshold alerts off |
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Percentage of time above glucose level of 13.9 mmol/L (250 mg/dL) measured by CGM.
| Through study completion (during hospitalization, 5-7 days) |
| Time below range (<3.9mmol/L, %) | Percentage of time below glucose level of 3.9 mmol/L (70 mg/dL) measured by CGM. | Through study completion (during hospitalization, 5-7 days) |
| Time below range (<3.0mmol/L, %) | Percentage of time below glucose level of 3.0 mmol/L (54 mg/dL) measured by CGM. | Through study completion (during hospitalization, 5-7 days) |
| Time in range (3.9~7.8mmol/L, %) | Percentage of time within glucose level of 3.9-7.8 mmol/L (70-140 mg/dL) measured by CGM. | Through study completion (during hospitalization, 5-7 days) |
| Glycemia risk index (GRI) | Glycemia risk index (GRI) was calculated according to the following equation: GRI = (3.0×VLow) + (2.4×Low) + (1.6×VHigh) + (0.8×High). | Through study completion (during hospitalization, 5-7 days) |
| Mean sensor glucose (MSG) | Mean of daily continuous 24-h blood glucose. | Through study completion (during hospitalization, 5-7 days) |
| Coefficient of variation (CV) | Standard deviation divided by mean glucose level measured by CGM. | Through study completion (during hospitalization, 5-7 days) |
| Standard deviation (SD) | Standard deviation of blood glucose measurements during CGM. | Through study completion (during hospitalization, 5-7 days) |
The total length of hospital stay. |
| Through study completion (during hospitalization, 5-7 days) |
| Total daily insulin dose (units/kg/day) | Total daily insulin dose per kilogram of body weight per day. | Through study completion (during hospitalization, 5-7 days) |
| Total daily basal insulin dose (units/kg/day) | Total daily basal insulin dose per kilogram of body weight per day. | Through study completion (during hospitalization, 5-7 days) |
| Total prandial insulin dose (units/kg/day) | Total prandial basal insulin dose per kilogram of body weight per day. | Through study completion (during hospitalization, 5-7 days) |
| 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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