Continuous Glucose Monitoring for Diabetes

Overseen By Cynthia Flores

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor Research Institute

Must not be taking: High-dose Tylenol

Disqualifiers: Pregnancy, Surgery, ICU, Organ transplant, Severe conditions, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Dexcom Generation 6 Continuous Glucose Monitor (CGM) to determine if it can help manage blood sugar levels in hospitalized patients with diabetes. The goal is to assess whether using this CGM reduces the risk of dangerously low blood sugar compared to usual finger-stick tests. Participants in the treatment group will have their blood sugar levels continuously monitored by the CGM, while the control group will not. Individuals with Type 1 or Type 2 diabetes who expect to be hospitalized for at least two days might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance diabetes care in hospitals.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you must avoid using high doses of acetaminophen (more than 4 grams per day).

What prior data suggests that this continuous glucose monitoring device is safe for inpatient use?

Research has shown that the Dexcom Generation 6 Continuous Glucose Monitor (CGM) is safe for use. One study found that over 99% of the readings from the Dexcom G6 fell within a safe range, indicating it reliably measures blood sugar levels without causing harm. Another study demonstrated that the Dexcom G6 is accurate and safe for pregnant women with diabetes.

Despite examining different groups, these studies consistently found that the Dexcom G6 is well-tolerated. No serious side effects were reported. The FDA has also approved the device for managing diabetes, further confirming its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about continuous glucose monitoring (CGM) with the Dexcom Generation 6 device because it offers real-time tracking of blood sugar levels for people with diabetes, providing a more dynamic and comprehensive view than traditional finger stick tests. Unlike the standard care, which relies on periodic blood sugar checks, this CGM system allows for continuous, real-time glucose monitoring, helping patients and healthcare providers make more informed decisions about diabetes management. This technology has the potential to improve glucose control, reduce the risk of hypoglycemia, and ultimately enhance the quality of life for individuals managing diabetes.

What evidence suggests that continuous glucose monitoring is effective for diabetes?

Research shows that the Dexcom Generation 6 Continuous Glucose Monitoring (CGM) system provides accurate blood sugar readings. In this trial, participants in the Treatment Group will manage their glucose levels using readings from the CGM device. Studies have shown that this approach significantly reduces A1C levels, a measure of long-term blood sugar control, by an average of 2.4% over six months. This improvement leads to better overall diabetes management. Additionally, the system lowers the risk of long-term diabetes complications, making it cost-effective for patients. Overall, the Dexcom G6 CGM improves blood sugar control and quality of life for people with diabetes. ^{1 4 5 6 7}

Who Is on the Research Team?

Tresa McNeal, MD

Principal Investigator

Baylor Scott & White Medical Center - Temple

Are You a Good Fit for This Trial?

This trial is for adults with diabetes who are hospitalized and expected to stay at least two more days. Participants must be willing to wear a CGM device and not use high doses of acetaminophen. It's not for pregnant or lactating women, those planning surgery within 48 hours, patients with certain skin conditions or allergies, active substance abusers, organ transplant recipients, or those with severe medical conditions.

Inclusion Criteria

Subjects willing to avoid using high dose acetaminophen (defined as greater than 4 gm per day)

You have either Type 1 or Type 2 diabetes.

Subjects willing to wear CGM device

Exclusion Criteria

Female subjects who are pregnant or lactating at the time of enrollment into the study. Females with childbearing potential will be queried about the possibility of pregnancy and a serum pregnancy test will be performed

You have taken more than 4 grams of Tylenol in a 24-hour period.

You have skin conditions or injuries in areas where the device needs to be placed that could affect its accuracy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are hospitalized and wear a CGM device for glucose monitoring, with management guided by either continuous monitoring or standard care

Up to 10 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dexcom Generation 6 CGM

Trial Overview The study tests the Dexcom Gen6 continuous glucose monitoring (CGM) device in hospitalized diabetic patients outside the ICU. The goal is to see if this newer CGM technology can improve blood sugar control and reduce hypoglycemic events compared to older devices.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 Intervention

Treatment Group subjects will wear the CGM device during their hospitalization, up to 10 days, and glucose readings WILL be continuously monitored. Treatment Group subjects will have their glucose management guided by readings from the CGM device and standard of care finger sticks.

Group II: Control Group Active Control 1 Intervention

Control Group subjects will wear the CGM device during their hospitalization, up to 10 days, but glucose readings will NOT be continuously monitored. Control Group subjects will have their glucose management guided by routine standard of care finger sticks. The readings from the CGM device are recorded and reviewed retrospectively, but not used for glucose management during the hospital stay.

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials

210

Recruited

205,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7757524/

Performance of the Dexcom G6 Continuous Glucose ... This study demonstrated that the Dexcom G6 CGM System provided accurate readings in comparison to reference YSI blood glucose values and that sensors were well ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7957382/

Real-World Evidence and Glycemic Improvement Using ... Optional features of continuous glucose monitoring (CGM) systems empower patients and caregivers to understand and manage diabetes in new ways.

3. provider.dexcom.com provider.dexcom.com/dexcom-community-glucose-monitoring-project-six-month-results-using-continuous-glucose-monitoring

Six-Month Results Using Continuous Glucose Monitoring ... Participants using a glucose sensor (n=237) showed clinically meaningful and statistically significant (p<0.001) decrease in A1C of 2.4%+1.9% at 6 months.

4. tandfonline.com tandfonline.com/doi/full/10.2147/CEOR.S304395

Full article: Evaluation of the Long-Term Cost-Effectiveness ... The Dexcom G6 RT-CGM system improves glycemic control and reduces the risk of costly long-term diabetes-related complications, providing a cost- ...

5. link.springer.com link.springer.com/article/10.1007/s13300-020-00959-y

Long-Term Cost-Effectiveness the Dexcom G6 Real-Time ... The G6 RT-CGM system was associated with an incremental gain in quality-adjusted life expectancy of 1.38 quality-adjusted life years (QALYs) ...

6. liebertpub.com liebertpub.com/doi/10.1177/15209156251368934

Accuracy of Dexcom G6 Pro and G7 Continuous Glucose ... For the G6 Pro, the MARDs of 21.2% and %20/20 of 63% are consistent with several previous studies of CGM accuracy in dialysis. A 2024 study of ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1530891X24005056

Continuous Glucose Monitoring Using the Dexcom G6 in ... This current study shows that >99% of the CGM readings by the Dexcom G6Pro CGM system fall within the zones considered clinically safe based upon the Clarke ...