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

Shanghai Jiao Tong University

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: CGM system with only glucose threshold alerts on; Device: CGM system with glucose alerts off; Device: CGM system with both glucose predictive alerts and threshold alerts on

Study type: Interventional

Funder types: Other

Identifiers

NCT05941286

2023061201

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 533 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males and females ≥ 18 years.
2. Type 1 or type 2 diabetes with suboptimal glucose control requiring hospitalization, as determined by endocrinologists following clinical guidelines.
3. Willingness and ability to comply with the clinical investigation plan.

Exclusion criteria

1. significant hyperglycemia or diabetic ketoacidosis requiring continuous intravenous insulin infusion.
2. Female subjects who are pregnant or have a plan of pregnancy at time of enrollment into the study.
3. Current users of real-time glucose monitoring sensors or flash-glucose monitoring.
4. 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.
5. Patients expected to require operation, admission to the ICU and MRI procedures during hospitalization.
6. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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533 participants in 3 patient groups

CGM system with both glucose predictive alerts and threshold alerts on

Experimental group

Description:

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).

Treatment:

Device: CGM system with both glucose predictive alerts and threshold alerts on

CGM system with only glucose threshold alerts on

Experimental group

Description:

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).

Treatment:

Device: CGM system with only glucose threshold alerts on

CGM system with glucose alerts off

Active Comparator group

Description:

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).

Treatment:

Device: CGM system with glucose alerts off