Effect of Continuous Glucose Monitoring System Alerts on Diabetes Management in the Hospital

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Effect of Continuous Glucose Monitoring System Alerts on Diabetes Management in the Hospital: a Randomised Controlled Trial

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: CGM system with glucose alerts on
* Device: CGM system with glucose alerts off


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females ≥ 18 years. Type 1 or type 2 diabetes who requires intensive insulin therapy during hospitalization. Willingness and ability to comply with the clinical investigation plan. Exclusion Criteria: significant hyperglycemia or diabetic ketoacidosis requiring continuous intravenous insulin infusion. Female subjects who are pregnant at time of enrollment into the study. Current users of real-time glucose monitoring sensors or flash-glucose monitoring. Participants were unable to tolerate tape adhesive around sensor placement area, or with medically documented allergy towards the adhesive (glue) of plasters, or with serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) around sensor placement area. Patients expected to require operation, admission to the ICU and MRI procedures during hospitalization. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CGM system with glucose alerts on<br>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. In addition, patients will undergo POC testing at least 4 times per day (usually before meals and bedtime). Intensive insulin therapy will be titrated based on daily CGM and POC printouts. | Device: CGM system with glucose alerts on<br>* the cloud-based real-time continuous glucose monitoring and management system with glucose predictive/threshold alerts on<br>|
| Active Comparator: CGM system with glucose alerts off<br>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). Intensive insulin therapy will be titrated based on daily CGM and POC printouts. | Device: CGM system with glucose alerts off<br>* the cloud-based real-time continuous glucose monitoring and management system with glucose predictive/threshold alerts off<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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, %) | 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) | 
| 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) | 
| Mean amplitude of glycemic excursions (MAGE) | Valid glycemic excursion is defined as more than 1 SD during 24-h CGM. Amplitude of glycemic excursion is calculated based on the direction of first valid excursion. Mean amplitude of glycemic excursions (MAGE) is the average value of all amplitude of glycemic excursions. | 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) | 
| 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) |