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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: CGM system with glucose alerts off; Device: CGM system with both glucose predictive alerts and threshold alerts on; Device: CGM system with only glucose threshold alerts on

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 527
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jian Zhou, Dr.; Phone Number: +86 18930172033; Email: zhoujian@sjtu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CGM system with both glucose predictive alerts and threshold alerts on; 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).	Device: CGM system with both glucose predictive alerts and threshold alerts on; the cloud-based real-time continuous glucose monitoring and management system with both glucose predictive alerts and threshold alerts on
Experimental: CGM system with only glucose threshold alerts on; 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).	Device: CGM system with only glucose threshold alerts on; the cloud-based real-time continuous glucose monitoring and management system with only glucose threshold alerts on
Active Comparator: CGM system with glucose alerts off; 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).	Device: CGM system with glucose alerts off; the cloud-based real-time continuous glucose monitoring and management system with glucose predictive/threshold alerts off

What is the study measuring?

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 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)
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)

Other Outcome Measures

Outcome Measure	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)	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)

Collaborators and Investigators

• Sponsor: Shanghai 6th People's Hospital
• Investigators: Principal Investigator: Jian Zhou, Shanghai 6th People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 18, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: July 3, 2023
• First Submitted That Met QC Criteria: July 11, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 2023061201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes