Continuous glucose monitoring for high-risk type 2 diabetes patients in the hospital
Continuous Glucose Monitoring for High-Risk Type 2 Diabetes in the Hospital: Cloud-Based Real-Time Glucose Evaluation and Management System (Cyber GEMS)
This study tests if using a continuous glucose monitor in hospitals can help high-risk type 2 diabetes patients manage their blood sugar better and avoid complications.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 554 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Scripps Whittier Diabetes Institute Academic / other |
| Locations | 1 site (Chula Vista, California) |
| Trial ID | NCT05307237 on ClinicalTrials.gov |
What this trial studies
This research investigates a continuous glucose monitoring (CGM) system integrated into hospital settings to improve glucose management for high-risk type 2 diabetes patients. The study employs a digital dashboard for real-time monitoring, allowing healthcare teams to prioritize interventions and detect dangerous blood sugar levels. By utilizing the Dexcom G6 device, the trial aims to enhance glycemic control and reduce complications associated with poor blood sugar management during hospitalization. It is a randomized controlled trial designed to establish the efficacy and effectiveness of this innovative approach.
Who should consider this trial
Good fit: Ideal candidates include hospitalized patients with a documented diagnosis of type 2 diabetes and elevated blood sugar levels.
Not a fit: Patients who are expected to stay in the hospital for less than 24 hours or those in the ICU may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve blood sugar control and reduce complications for hospitalized patients with type 2 diabetes.
How similar studies have performed: Other studies have shown promise in using continuous glucose monitoring in outpatient settings, but this specific application in hospitalized patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Documented previous or current Type 2 Diabetes (T2D) diagnosis as defined by either diagnosis in the chart or an HbA1c \> or = to 6.5% in the last 90 days * Either on subcutaneous (SQ) insulin orders, or greater than two serum or Point of Care (POC) glucose \> or = 200 mg/dL in most recent 24 hours of admission Exclusion Criteria: * Anticipated length of stay \< 24 hours; * Current or anticipated ICU placement; * Does not speak English or Spanish; * Known allergy to adhesives; * Current participation in any medication or device research study; * Pregnant; * Any other condition that Multiple Principal Investigator (MPI) Philis-Tsimikas or the attending physician deems contraindicated
Where this trial is running
Chula Vista, California
- Scripps Mercy Hospital — Chula Vista, California, United States (Recruiting)
Study contacts
- Principal investigator: Athena Philis-Tsimikas, MD — Scripps Whittier Diabetes Institute
- Study coordinator: Fortmann Addie, PhD
- Email: fortmann.adelaide@scrippshealth.org
- Phone: 858-678-7059
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.