Continuous Glucose Monitoring for Type 1 Diabetes

Overseen By Guillermo Umpierrez, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Must be taking: Insulin

Must not be taking: Immunosuppressive agents

Disqualifiers: ICU, Type 2 diabetes, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 10 days

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that you are treated with insulin therapy. It might be best to discuss your specific medications with the trial coordinators.

What data supports the effectiveness of the treatment Dexcom G7 for continuous glucose monitoring in type 1 diabetes?

Research shows that continuous glucose monitoring (CGM) systems like the Dexcom G6 can improve blood sugar control in people with type 1 diabetes by reducing A1c levels and minimizing low blood sugar events. This suggests that the Dexcom G7, as a newer model, may offer similar benefits. ^{1 2 3 4 5}

Is the Dexcom G7 continuous glucose monitor safe for use in humans?

The Dexcom G7 continuous glucose monitor has been shown to be safe in adults with diabetes, with no serious adverse events reported during a study of its use over 10.5 days. Some users have reported issues with sensor accuracy, but these did not lead to serious safety concerns. ^{6 7 8 9 10}

How is the Dexcom G7 treatment different from other treatments for type 1 diabetes?

The Dexcom G7 is a continuous glucose monitoring (CGM) system that provides real-time glucose readings with high accuracy, allowing for better management of blood sugar levels in people with type 1 diabetes. Unlike traditional methods that require frequent finger pricks, the G7 offers a more convenient and less invasive way to monitor glucose levels continuously. ^{8 11 12 13 14}

What is the purpose of this trial?

This study aims to compare inpatient glycemic control by measuring the percentage of time in the range of 70-180 mg/dl and the frequency of hypoglycemia between Dexcom G7 Continuous Glucose Monitoring (CGM) and Point of Care (POC) Blood Glucose Testing in poorly controlled subjects with Type 1 Diabetes Mellitus. The main question it aims to answer is: -Whether there is a difference between POC testing (standard of care) and Real-time CGM in glycemic control and hypoglycemic events during hospitalization:

Research Team

Guillermo Umpierrez, MD

Principal Investigator

Emory University

Eligibility Criteria

This trial is for people with poorly controlled Type 1 Diabetes Mellitus. Participants should be hospitalized or recently discharged and need to manage their blood sugar levels. Specific criteria for joining or reasons you can't join are not provided here.

Inclusion Criteria

Expected length of hospital stay > three days at the time of randomization

I have Type 1 Diabetes and am on insulin therapy.

I was diagnosed with Type 1 Diabetes and have high blood sugar or HbA1c over 7%.

Exclusion Criteria

Patients expected to require MRI procedures during hospitalization

Subjects using CGM technology before admission

I am currently admitted to the ICU.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are hospitalized and receive either POC testing or Dexcom G7 CGM for glucose monitoring and insulin therapy adjustment

Up to 10 days

Daily monitoring during hospitalization

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Dexcom G7

Trial Overview The study compares two ways of monitoring blood sugar: the Dexcom G7 Continuous Glucose Monitoring (CGM) system versus traditional fingerstick tests that measure at specific times (POC). It looks at how well each method keeps blood sugar within a safe range and prevents low blood sugar episodes in the hospital.

Participant Groups

Group I: Dexcom CGM Experimental Treatment 1 Intervention

Severe hyperglycemia will be managed by primary care professionals (Hospitalist Service) intravenously with subcutaneous insulin therapy. Subjects will be invited to participate in the study after the resolution of severe hyperglycemia (BG \< 400 mg/dl). Subjects will wear a real-time Dexcom G7 CGM for up to 10 days. Insulin therapy will be titrated based on daily CGM reports, including mean glucose, glycemic excursions, hypoglycemia, and severe hyperglycemia \> 180 and \>250 mg/dl values. Participants will wear a Dexcom rtCGM for up to 10 days during hospitalization.

Group II: Standard of Care Active Control 1 Intervention

Severe hyperglycemia will be managed by primary care professionals (Hospitalist Service) with intravenous or subcutaneous insulin therapy. Subjects will be invited to participate in the study after the resolution of severe hyperglycemia (BG \< 400 mg/dl). Glucose monitoring by POC testing will be performed before meals and at bedtime. Results will be uploaded to the electronic medical record (EMR) system. The research team, together with the Primary care (PCP) team, will adjust daily insulin orders based on POC readings (standard of care). In addition, subjects will wear a 'blinded' CGM (no results will be visualized by patients, nursing staff, medicine, or research teams) during hospitalization for up to 10 days.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

DexCom, Inc.

Industry Sponsor

Trials

151

Recruited

35,700+

Kevin Sayer

DexCom, Inc.

Chief Executive Officer since 2015

Bachelor’s and Master’s degrees in Accounting and Information Systems from Brigham Young University

Dr. Shelly Lane

DexCom, Inc.

Chief Medical Officer since 2023

MD from University of California, San Diego

Findings from Research

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]

In a study involving 11 patients with type 1 diabetes, the Dexcom G5 Mobile (DG5) continuous glucose monitor demonstrated significantly better accuracy than the Eversense (EVS) implantable sensor during controlled clinical conditions, particularly when blood glucose levels were decreasing.

While both devices showed similar accuracy during home monitoring, DG5 had a lower median absolute relative difference (ARD) of 7.91% compared to EVS's 11.4% during glucose excursions in a clinical setting, indicating it may be more reliable for detecting rapid changes in glucose levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the accuracy of transcutaneous sensor and 90-day implantable glucose sensor. Boscari, F., Vettoretti, M., Amato, AML., et al.[2021]

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]

The Eversense continuous glucose monitoring (CGM) system demonstrated long-term safety with no related serious adverse events reported among 3023 patients over multiple sensor insertion-removal cycles, totaling 1260 patient-years of follow-up.

The most common minor adverse events included site infections and irritation, but these occurred at low rates, indicating that the Eversense CGM system is generally well-tolerated in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Safety of an Implantable Continuous Glucose Sensor Over Multiple Cycles of Use: A Post-Market Registry Study. Deiss, D., Irace, C., Carlson, G., et al.[2020]

The analysis of adverse events for the Medtronic 670G insulin pump revealed that users experienced more hypoglycemic events when the auto mode was activated compared to when it was turned off.

For the Dexcom continuous glucose monitors, complaints about inaccuracies were most common when the readings fell within the acceptable range (B zone), indicating potential confusion among users regarding the reliability of the device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Analysis of 2019 FDA Adverse Events for Two Insulin Pumps and Two Continuous Glucose Monitors. Krouwer, JS.[2022]

The seventh generation (G7) Dexcom continuous glucose monitor (CGM) demonstrated high accuracy in glucose readings, with mean absolute relative differences (MARD) of 8.2% for arm sensors and 9.1% for abdomen sensors, based on data from 316 participants over 10.5 days.

No serious adverse events were reported during the study, indicating that the G7 CGM is safe for use in adults with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy and Safety of Dexcom G7 Continuous Glucose Monitoring in Adults with Diabetes. Garg, SK., Kipnes, M., Castorino, K., et al.[2022]

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 Guardian™ continuous glucose monitoring (CGM) system showed good accuracy in measuring glucose levels in children and adolescents with type 1 diabetes, with a mean absolute relative difference of about 10.9% for the Guardian Connect system and 11.1% for the Glucose Sensor Recorder.

The system was safe, with only one minor adverse event reported (contact dermatitis) and no serious device-related complications, supporting its use for diabetes management in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of a Fourth-Generation Continuous Glucose Monitoring System in Children and Adolescents with Type 1 Diabetes. Slover, RH., Tryggestad, JB., DiMeglio, LA., et al.[2018]

Continuous glucose monitoring (CGM) is becoming a standard tool for managing type 1 diabetes, with advancements that may lead to its integration into closed-loop artificial beta-cell systems.

The review highlights the accuracy and performance of the two currently approved CGM devices, discussing their clinical trial results, limitations, and best practices for use in diabetes care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring in type 1 diabetes. Weinzimer, SA., Tamborlane, WV., Chase, HP., et al.[2019]

The SEVEN PLUS System, a new continuous glucose monitoring device, demonstrated a median absolute relative difference of 13.0% compared to laboratory reference measurements, indicating good accuracy in glucose tracking for the 53 participants, mostly with type 1 diabetes.

The device showed improved sensor life, with 89% of sensors lasting the full 7 days, and no serious adverse events were reported, highlighting its safety and reliability for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New features and performance of a next-generation SEVEN-day continuous glucose monitoring system with short lag time. Bailey, T., Zisser, H., Chang, A.[2009]

References

1. 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]

2. Netherlands pubmed.ncbi.nlm.nih.gov

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

3. Switzerland pubmed.ncbi.nlm.nih.gov

Benefits of a Switch from Intermittently Scanned Continuous Glucose Monitoring (isCGM) to Real-Time (rt) CGM in Diabetes Type 1 Suboptimal Controlled Patients in Real-Life: A One-Year Prospective Study &#167;. [2021]

4. 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]

5. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Use of continuous glucose monitoring in patients with type 1 diabetes. [2022]

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

Real-World Safety of an Implantable Continuous Glucose Sensor Over Multiple Cycles of Use: A Post-Market Registry Study. [2020]

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

An Analysis of 2019 FDA Adverse Events for Two Insulin Pumps and Two Continuous Glucose Monitors. [2022]

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

Accuracy and Safety of Dexcom G7 Continuous Glucose Monitoring in Adults with Diabetes. [2022]

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

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

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

Accuracy of a Fourth-Generation Continuous Glucose Monitoring System in Children and Adolescents with Type 1 Diabetes. [2018]

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

Accuracy of a Seventh-Generation Continuous Glucose Monitoring System in Children and Adolescents With Type 1 Diabetes. [2023]

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

Analysis of "Accuracy of a Seventh-Generation Continuous Glucose Monitoring System in Children and Adolescents With Type 1 Diabetes". [2023]

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

Continuous glucose monitoring in type 1 diabetes. [2019]

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

New features and performance of a next-generation SEVEN-day continuous glucose monitoring system with short lag time. [2009]