Impact of glucose monitoring alerts on diabetes management in hospitals
Effect of Continuous Glucose Monitoring System Alerts on Diabetes Management in the Hospital: a Randomised Controlled Trial
This study is testing if alerts from continuous glucose monitors can help hospitalized patients with type 1 or type 2 diabetes manage their blood sugar better while they receive intensive insulin therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 527 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai 6th People's Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT05941286 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of continuous glucose monitoring (CGM) alerts in improving glycemic control for hospitalized patients with type 1 or type 2 diabetes requiring intensive insulin therapy. It compares three groups: one receiving predictive and threshold alerts, another with only threshold alerts, and a third with alerts turned off. By continuously measuring glucose levels every 5 minutes, the study aims to determine if the alerts significantly enhance patient outcomes compared to standard point-of-care glucose testing. The goal is to clarify the role of alerts in managing glycemic events during hospitalization.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with type 1 or type 2 diabetes requiring hospitalization due to suboptimal glucose control.
Not a fit: Patients with significant hyperglycemia, diabetic ketoacidosis, or those currently using real-time glucose monitoring systems may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved glycemic control and reduced adverse events for hospitalized diabetes patients.
How similar studies have performed: Previous studies have shown promise in using continuous glucose monitoring systems for diabetes management, but the specific impact of alert features remains to be fully validated.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai, Shanghai
- Shanghai Sixth People's Hospital — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Jian Zhou — Shanghai 6th People's Hospital
- Study coordinator: Jian Zhou, Dr.
- Email: zhoujian@sjtu.edu.cn
- Phone: +86 18930172033
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.