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

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Systematic continuous glucose monitoring (CGM) is commonly provided as a treatment option to patients with diabetes in ambulatory care settings yet is rarely provided during hospitalization. CGM of inpatients has the potential to be the care delivery innovation that is feasible, cost effective and can improve glucose control, especially by reducing hypoglycemic events. Studies of CGM use in the ICU setting have been found to be helpful for reducing hypoglycemia in some studies while less so in others, however, these studies were performed with earlier generation glucose monitoring devices(5). ICU studies have confirmed accuracy of CGM measurements compared with capillary glucose even in settings with use of vasopressors and large-volume resuscitation. A limited number of studies have evaluated glycemic outcomes in the inpatient non-ICU setting. Studies of non-ICU patients (6-10) are limited by very small sample size, short study duration, and use of older CGM devices. There is, therefore, a critical need to systematically investigate the use of CGM in the inpatient care of patients with diabetes mellitus who are receiving care in a hospital setting that is typical of inpatient care.

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+