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

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus

• Registration Number: NCT05941286
• Lead Sponsor: Shanghai 6th People's Hospital

Brief 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.

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 Timeline

• Study First Submitted: 2023-07-03
• Study First Submitted QC: 2023-07-11
• Study First Posted: 2023-07-12
• Study Start: 2024-04-18
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-09
• Primary Completion: 2025-08-01
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 527

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time in range (3.9~10.0mmol/L, %)	Through study completion (during hospitalization, 5-7 days)	Percentage of time within glucose level of 3.9-10.0 mmol/L (70-180 mg/dL) measured by CGM.

Secondary Outcome Measures

Name	Time	Method
Coefficient of variation (CV)	Through study completion (during hospitalization, 5-7 days)	Standard deviation divided by mean glucose level measured by CGM.
Glycemia risk index (GRI)	Through study completion (during hospitalization, 5-7 days)	Glycemia risk index (GRI) was calculated according to the following equation: GRI = (3.0×VLow) + (2.4×Low) + (1.6×VHigh) + (0.8×High).
Time above range (>10.0mmol/L, %)	Through study completion (during hospitalization, 5-7 days)	Percentage of time above glucose level of 10.0 mmol/L (180 mg/dL) measured by CGM.
Time in range (3.9~7.8mmol/L, %)	Through study completion (during hospitalization, 5-7 days)	Percentage of time within glucose level of 3.9-7.8 mmol/L (70-140 mg/dL) measured by CGM.
Mean sensor glucose (MSG)	Through study completion (during hospitalization, 5-7 days)	Mean of daily continuous 24-h blood glucose.
Time above range (>13.9mmol/L, %)	Through study completion (during hospitalization, 5-7 days)	Percentage of time above glucose level of 13.9 mmol/L (250 mg/dL) measured by CGM.
Time below range (<3.0mmol/L, %)	Through study completion (during hospitalization, 5-7 days)	Percentage of time below glucose level of 3.0 mmol/L (54 mg/dL) measured by CGM.
Standard deviation (SD)	Through study completion (during hospitalization, 5-7 days)	Standard deviation of blood glucose measurements during CGM.
Time below range (<3.9mmol/L, %)	Through study completion (during hospitalization, 5-7 days)	Percentage of time below glucose level of 3.9 mmol/L (70 mg/dL) measured by CGM.

Trial Locations

Locations (1)

Shanghai Sixth People's Hospital; 🇨🇳 Shanghai, Shanghai, China