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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05941286
• Other study ID #: 2023061201
• Status: Recruiting
• Phase: N/A
• Start date: April 18, 2024
• Est. completion date: September 30, 2025

Study information

• Verified date: May 2024
• Source: Shanghai 6th People's Hospital
• Contact: Jian Zhou, Dr.
• Phone: +86 18930172033
• Email: zhoujian[@]sjtu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 527
• Est. completion date: September 30, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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
• 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
• CGM system with glucose alerts off
the cloud-based real-time continuous glucose monitoring and management system with glucose predictive/threshold alerts off

Locations

Country	Name	City	State
China	Shanghai Sixth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 6th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	Length of hospital stay (days)	The total length of hospital stay.	Through study completion (during hospitalization, 5-7 days)
Other	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)
Other	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)
Other	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Mean sensor glucose (MSG)	Mean of daily continuous 24-h blood glucose.	Through study completion (during hospitalization, 5-7 days)
Secondary	Coefficient of variation (CV)	Standard deviation divided by mean glucose level measured by CGM.	Through study completion (during hospitalization, 5-7 days)
Secondary	Standard deviation (SD)	Standard deviation of blood glucose measurements during CGM.	Through study completion (during hospitalization, 5-7 days)