Continuous Glucose Monitoring for Type 2 Diabetes

(Cyber GEMS Trial)

Overseen by Athena Philis-Tsimikas, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Recruiting

Sponsor: Scripps Whittier Diabetes Institute

Disqualifiers: Icu placement, Pregnancy, Others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Given the known serious consequences of uncontrolled blood sugars during hospitalization, this research plans to study an alternative seamlessly integrated continuous glucose monitoring (CGM) system in the hospital to test a dynamic and digitized, team-based approach to glucose management in an underserved and understudied, yet high-risk population. A digital dashboard will facilitate real-time, remote monitoring of a large volume of patients simultaneously; automatically identify and prioritize patients for intervention; and will detect any and all potentially dangerous hypoglycemic episodes in a hospital environment. The study will focus on clinical metrics of glucose control and infection that are in-line with patient priorities and US hospital quality initiatives.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Dexcom G6 Continuous Glucose Monitoring Management for Type 2 Diabetes?

Research shows that using continuous glucose monitoring (CGM) systems like the Dexcom G6 can help people with diabetes improve their blood sugar control. Features of the Dexcom G6 that alert users to potential blood sugar issues have been linked to better blood sugar management, and reviewing CGM data regularly can improve quality of life and health outcomes. ^{1 2 3 4 5}

Is continuous glucose monitoring safe for humans?

Continuous glucose monitors (CGMs) like the Dexcom G6 have been associated with some safety concerns, including sensor inaccuracies that can lead to serious outcomes. In 2022, there were over 281,000 adverse events reported, highlighting the need for improved safety procedures. ^{3 6 7 8 9}

How is the Dexcom G6 Continuous Glucose Monitoring treatment different from other treatments for type 2 diabetes?

The Dexcom G6 Continuous Glucose Monitoring system is unique because it provides real-time glucose level tracking without the need for fingerstick calibration, offering a more convenient and less invasive way to manage blood sugar levels compared to traditional methods. ^{1 4 5 8 10}

Research Team

Athena Philis-Tsimikas, MD

Principal Investigator

Scripps Whittier Diabetes Institute

Addie Fortmann, PhD

Principal Investigator

Scripps Whittier Diabetes Institute

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with Type 2 Diabetes or my HbA1c level was at least 6.5% in the last 90 days.

I use insulin injections or have had high blood sugar levels recently.

Exclusion Criteria

Anticipated length of stay < 24 hours

The study's lead investigator or your doctor thinks that you have a condition that makes it unsafe for you to participate in the study.

I do not speak English or Spanish.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive continuous glucose monitoring using the Dexcom G6 device, with data transmitted for real-time management and clinical optimization.

During hospitalization

Continuous monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including post-CGM satisfaction survey and data analysis.

Up to 2 weeks following discharge

Data Analysis

CGM data is downloaded and analyzed to assess glucose variability, infection rates, and other clinical outcomes.

Immediately following intervention completion

Treatment Details

Interventions

• Dexcom G6 Continous Glucose Monitoring Management (Continuous Glucose Monitoring System)
• Usual Care - Blinded Continuous Glucose Monitoring Management (Continuous Glucose Monitoring System)

Trial Overview 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.

Participant Groups

Group I: Continuous Glucose Monitoring Experimental Treatment 1 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 Care Active Control 1 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.

Who Is Running the Clinical Trial?

Scripps Whittier Diabetes Institute

Lead Sponsor

Trials

19

Recruited

5,400+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Executive Officer since 2007

MD, M.A.C.P.

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Medical Officer since 2007

MD, M.A.C.P.

Findings from Research

Regularly reviewing weekly continuous glucose monitoring (CGM) reports is linked to improved quality of life (QoL) and glycemic outcomes in adults with diabetes, with 73.1% reporting better A1C levels and 75.9% feeling more confident about managing hypoglycemia.

Engaging with the report, especially by discussing it with family or friends, positively impacts QoL and perceived glycemic control, while doing nothing with the report's information is associated with poorer glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Retrospective Data Review in the Personal Use of Real-Time Continuous Glucose Monitoring: Perceived Impact on Quality of Life and Health Outcomes. Polonsky, WH., Soriano, EC., Fortmann, AL.[2022]

A study of 47,784 users of the Dexcom G6 continuous glucose monitoring system over 6 months found that more than 75% of users across various regions utilized alert features, which significantly improved glycaemic control.

Enabling Low and Urgent Low Soon alerts was linked to less time spent below target glucose levels, while High alerts were associated with more time in the target range and less time above it, indicating that proper use of these alerts can enhance diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

G6 continuous glucose monitoring system feature use and its associations with glycaemia in Europe. Acciaroli, G., Parkin, CG., Thomas, R., et al.[2023]

In a study involving 34 adults with type 1 diabetes, the Guardian, Navigator, and Glucoday continuous glucose monitors (CGMs) showed comparable numerical accuracy, particularly excelling in hypoglycemic conditions, while the DexCom had significantly larger numerical errors.

Clinical accuracy during euglycemia was high for all CGMs, but the Navigator and Glucoday performed better in detecting hypoglycemia, indicating their potential for better patient safety in critical situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the numerical and clinical accuracy of four continuous glucose monitors. Kovatchev, B., Anderson, S., Heinemann, L., et al.[2022]

In a real-world setting, the blinded Dexcom G6 Pro continuous glucose monitor (CGM) demonstrated a mean absolute relative difference (MARD) of 11.0% over a median wear time of 50 hours, indicating reliable accuracy for glucose monitoring in individuals with type 1 diabetes.

The accuracy of the Dexcom G6 Pro improved after the first 12 hours of use, stabilizing at around 10.1% MARD thereafter, which aligns with previous laboratory-based accuracy findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing the Real-World Accuracy of the Dexcom G6 Pro CGM During the Insulin-Only Bionic Pancreas Pivotal Trial. Marak, MC., Calhoun, P., Damiano, ER., et al.[2023]

Continuous glucose monitors (CGMs) have been associated with over 25,000 complaints of sensor inaccuracy reported to the FDA since 2015, highlighting significant safety concerns regarding their reliability for insulin dosing.

Despite evidence of sporadic and unpredictable errors in CGMs, the FDA approved the Dexcom G5 for nonadjunctive use, indicating a need for improved safety procedures rather than removing existing safeguards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonadjunctive Use of Continuous Glucose Monitors for Insulin Dosing: Is It Safe? Shapiro, AR.[2018]

The FDA is considering a nonadjunctive label claim for the DEXCOM G5 Mobile continuous glucose monitoring (CGM) system, which would allow users to make insulin dosing decisions based solely on CGM data without needing confirmatory blood glucose tests.

If approved, this change could enhance diabetes management by providing real-time glucose readings every 5 minutes, along with alerts and trending information, potentially reducing the risk of hypoglycemia and improving overall patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulation Catches Up to Reality. Edelman, SV.[2019]

The Dexcom G6 continuous glucose monitoring system maintained its functionality and data integrity after exposure to simulated x-ray and MRI procedures, indicating it is safe to use during these medical imaging processes.

During MRI simulations, the devices experienced minimal displacement force, heating of less than 2°C, and low induced currents, suggesting they are unlikely to be dislodged or damaged during standard MRI scans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Functional Integrity of Continuous Glucose Monitoring Components After Simulated Radiologic Procedures. Thomas, C., Welsh, JB., Lu, S., et al.[2021]

In 2022, there were 281,963 reported adverse events related to continuous glucose monitors (CGMs), highlighting a significant safety concern for people with diabetes.

The analysis of adverse events for four CGM products revealed that common issues included inaccuracy and device malfunctions, indicating a need for improved monitoring and device reliability to enhance user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Event Causes From 2022 for Four Continuous Glucose Monitors. Krouwer, JS.[2023]

The Dexcom G6 continuous glucose monitoring (CGM) system demonstrated a mean absolute relative difference (MARD) of 7.7% in accuracy when compared to laboratory blood glucose measurements, indicating high reliability for monitoring glucose levels in children and adolescents with type 1 diabetes.

With 96.2% of estimated glucose values falling within 20% of the reference values, the G6 system's accuracy supports its potential to enhance glycemic control and encourage consistent use among young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of a Factory-Calibrated, Real-Time Continuous Glucose Monitoring System in Pediatric Participants With Type 1 Diabetes. Welsh, JB., Zhang, X., Puhr, SA., et al.[2020]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Comparing the accuracy of transcutaneous sensor and 90-day implantable glucose sensor. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

The Role of Retrospective Data Review in the Personal Use of Real-Time Continuous Glucose Monitoring: Perceived Impact on Quality of Life and Health Outcomes. [2022]

3. England pubmed.ncbi.nlm.nih.gov

G6 continuous glucose monitoring system feature use and its associations with glycaemia in Europe. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Comparison of the numerical and clinical accuracy of four continuous glucose monitors. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Testing the Real-World Accuracy of the Dexcom G6 Pro CGM During the Insulin-Only Bionic Pancreas Pivotal Trial. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Nonadjunctive Use of Continuous Glucose Monitors for Insulin Dosing: Is It Safe? [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Regulation Catches Up to Reality. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Safety and Functional Integrity of Continuous Glucose Monitoring Components After Simulated Radiologic Procedures. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Adverse Event Causes From 2022 for Four Continuous Glucose Monitors. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Performance of a Factory-Calibrated, Real-Time Continuous Glucose Monitoring System in Pediatric Participants With Type 1 Diabetes. [2020]