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Continuous Glucose Monitoring System

Continuous Glucose Monitoring for Type 2 Diabetes (Cyber GEMS Trial)

Phase 2 & 3
Recruiting
Led By Athena Philis-Tsimikas, MD
Research Sponsored by Scripps Whittier Diabetes Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately following intervention completion
Awards & highlights

Cyber GEMS Trial Summary

This trial plans to study an alternative, digitized approach to glucose management in the hospital in order to improve patient care.

Who is the study for?
This trial is for hospitalized individuals with Type 2 Diabetes who have high blood sugar levels or are on insulin. They must have a documented diagnosis of diabetes or an HbA1c level of at least 6.5%. Exclusions include current research study participants, short hospital stays, ICU patients, adhesive allergies, non-English/Spanish speakers, and pregnancy.Check my eligibility
What is being tested?
The Cyber GEMS trial tests a new continuous glucose monitoring (CGM) system against usual care in hospitals. It aims to improve blood sugar management using a digital dashboard for real-time remote patient monitoring and prioritization for interventions.See study design
What are the potential side effects?
While the trial does not involve drugs that typically cause side effects, potential issues may arise from wearing the CGM device such as skin irritation due to adhesives or discomfort at the sensor site.

Cyber GEMS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Type 2 Diabetes or my HbA1c level was at least 6.5% in the last 90 days.
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I use insulin injections or have had high blood sugar levels recently.

Cyber GEMS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately following intervention completion
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately following intervention completion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Infection Rate
Percent time in range
Percent time spent in hypoglycemia and percent time in severe hyperglycemia
Secondary outcome measures
Electronic Medical Record (EMR) - Derived Outcome: fasting POC blood glucose
Electronic Medical Record (EMR) - Derived Outcomes: HbA1C
Glucose Variability
Other outcome measures
Process Indicators (Adoption): Clinical perceptions of glucose management
Process Indicators (Adoption): Perceptions of CGM
Process Indicators (Efficacy): Impact of time on CGM
+9 more

Cyber GEMS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Continuous Glucose MonitoringExperimental Treatment1 Intervention
Research Assistants (RAs) will verbally administer baseline survey and insert Dexcom G6 CGM, before unveiling the group assignment. CGM data will be transmitted from bedside iPhone to web-based platforms for: (1) Real-Time Management (via iPad-based FOLLOW app used by bedside RN and Digital Dashboard used by remote monitoring team) and (2) Clinical Optimization (via CLARITY, a Diabetes RN Coordinator will conduct remote clinical management of patients from a central, Scripps Diabetes Hub). A post-CGM satisfaction survey will be administered and compensation provided when CGM is removed prior to discharge or within 2 weeks following discharge. The CGM readings will be used to make recommendations for insulin adjustment and glucose management. After discharge, CGM data will be downloaded from a HIPPA-compliant, web-based CGM data management tool, and saved in Excel. The Data Analyst, blinded to condition, will routinely screen CGM data and merge individual spreadsheets for analysis.
Group II: Usual CareActive Control1 Intervention
RAs will verbally administer a baseline survey and insert the Dexcom G6 CGM. before unveiling the group assignment. CGM data will be blinded and used for evaluation purposes only. Glucose will be monitored via the hospital's standard POC testing protocol (i.e., prior to meals and at bedtime for patients who are eating, and every 4-6 waking hours if not eating). Glucose management in UC is designed to minimize differences between groups, aside from CGM monitoring, A post-CGM satisfaction survey will be administered and compensation provided when the CGM is removed prior to discharge or within 2 weeks following discharge. After discharge, CGM data will be downloaded from a HIPPA-compliant, web-based CGM data management tool, and saved in individual Excel spreadsheets. The study Data Analyst, blinded to study condition, will routinely screen CGM data and merge individual spreadsheets for analysis.

Find a Location

Who is running the clinical trial?

Scripps Whittier Diabetes InstituteLead Sponsor
17 Previous Clinical Trials
4,835 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,949 Total Patients Enrolled
Athena Philis-Tsimikas, MDPrincipal InvestigatorScripps Whittier Diabetes Institute
13 Previous Clinical Trials
4,105 Total Patients Enrolled

Media Library

Dexcom G6 Continous Glucose Monitoring Management (Continuous Glucose Monitoring System) Clinical Trial Eligibility Overview. Trial Name: NCT05307237 — Phase 2 & 3
Type 2 Diabetes Research Study Groups: Continuous Glucose Monitoring, Usual Care
Type 2 Diabetes Clinical Trial 2023: Dexcom G6 Continous Glucose Monitoring Management Highlights & Side Effects. Trial Name: NCT05307237 — Phase 2 & 3
Dexcom G6 Continous Glucose Monitoring Management (Continuous Glucose Monitoring System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05307237 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients being accepted into this clinical trial at this time?

"Yes, the online clinicaltrials.gov registry currently has this trial listed as open and recruiting participants. This study was first made public on April 19th, 2022 and was edited most recently on August 8th, 2022. Up to 554 patients will be enrolled at a single site."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Scripps Mercy Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Continuous Glucose Monitoring for High-Risk Type 2 Diabetes in the Hospital (Cyber GEMS)
Athena Philis-Tsimikas 2022. "Continuous Glucose Monitoring for High-Risk Type 2 Diabetes in the Hospital (Cyber GEMS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05307237.
~283 spots leftby Jun 2026
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