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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

Must not have

Does not speak English or Spanish

Current or anticipated ICU placement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately following intervention completion

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not speak English or Spanish.

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I am currently in or expected to be in the ICU.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately following intervention completion

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Infection Rate

Percent time in range

Percent time spent in hypoglycemia and percent time in severe hyperglycemia

Secondary study objectives

Electronic Medical Record (EMR) - Derived Outcome: fasting POC blood glucose

Electronic Medical Record (EMR) - Derived Outcomes: HbA1C

Glucose Variability

Other study objectives

Process Indicators (Adoption): Clinical perceptions of glucose management

Process Indicators (Adoption): Perceptions of CGM

Process Indicators (Efficacy): Impact of time on CGM

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 4Eligibility criteria met