Effect of Continuous Glucose Monitoring System Alerts on Diabetes Management in the Hospital: a Randomised Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus
- Sponsor
- Shanghai 6th People's Hospital
- Enrollment
- 533
- Locations
- 1
- Primary Endpoint
- Time in range (3.9~10.0mmol/L, %)
- Status
- Completed
- Last Updated
- 4 months ago
Overview
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.
Investigators
Jian Zhou
Principal Investigator, Professor, Chief Physician, Deputy Director
Shanghai 6th People's Hospital
Eligibility Criteria
Inclusion Criteria
- •Males and females ≥ 18 years.
- •Type 1 or type 2 diabetes with suboptimal glucose control requiring hospitalization, as determined by endocrinologists following clinical guidelines.
- •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 or have a plan of pregnancy 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.
Outcomes
Primary Outcomes
Time in range (3.9~10.0mmol/L, %)
Time Frame: 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 Outcomes
- Coefficient of variation (CV)(Through study completion (during hospitalization, 5-7 days))
- Glycemia risk index (GRI)(Through study completion (during hospitalization, 5-7 days))
- Time below range (<3.0mmol/L, %)(Through study completion (during hospitalization, 5-7 days))
- Standard deviation (SD)(Through study completion (during hospitalization, 5-7 days))
- Time above range (>10.0mmol/L, %)(Through study completion (during hospitalization, 5-7 days))
- Time in range (3.9~7.8mmol/L, %)(Through study completion (during hospitalization, 5-7 days))
- Mean sensor glucose (MSG)(Through study completion (during hospitalization, 5-7 days))
- Time above range (>13.9mmol/L, %)(Through study completion (during hospitalization, 5-7 days))
- Time below range (<3.9mmol/L, %)(Through study completion (during hospitalization, 5-7 days))