Hospitalized patients with Type 2 diabetes who wore a wireless continuous glucose monitoring (CGM) device during their admission saw significantly better control of their blood sugar levels compared with similar patients who didn’t wear the device, according to newly published research from the Scripps Whittier Diabetes Institute.
The report, which appeared today in the online version of the medical journal Diabetes Care, highlights results from the first large-scale, randomized and controlled clinical trial showing that the same types of CGM technologies which have been available for home use for nearly 20 years can benefit some hospitalized patients in similar ways.
“Tracking vital signs is routine in many hospitalized patients,” said Athena Philis-Tsimikas, M.D., corporate vice president of Scripps Whittier and the senior author of the report. “This study demonstrates that blood sugar should be considered the fifth vital sign for hospitalized diabetes patients, joining temperature, pulse, respiration and blood pressure, as a potentially crucial metric for delivering the highest quality care.”
The findings are significant because blood sugar levels in hospitalized patients with diabetes are often poorly managed when relying on the more traditional method of periodic finger sticks. Other conditions, such as stress, unpredictable timing of tests and procedures, new medications, and the medical staff’s focus on the patient’s primary reason for hospitalization, can make glucose management even more difficult.
It is essential to properly and continuously manage blood sugar levels in people with diabetes to ensure their long-term health. When blood sugar is too high (a common effect of diabetes known as hyperglycemia) for too long of a period, it can cause serious problems such as heart disease or heart attack, stroke, and damage to the kidneys, nerves and eyes.
The clinical trial results also speak to the ongoing coronavirus pandemic.
In March, the U.S. Food and Drug Administration (FDA) issued emergency authorization for the use of CGM devices in hospitals as a way to reduce the number of times nurses go into the rooms of COVID-19 patient, which in turn would conserve more of the personal protective equipment needed to prevent the spread of the infection.
Scripps in May became one of the first health systems to take advantage of the FDA’s decision by launching a CGM program at its Scripps Mercy Hospital San Diego. The move was made possible because of the hospital’s use of the technology as part of an earlier clinical trial.
“The current pandemic environment has greatly accelerated the need to find safe and effective ways to monitor the blood sugar of hospitalized patients without interfering with the necessary and often intensive interventions to treat COVID-19,” said Addie Fortmann, Ph.D., director of the diabetes service line at Scripps and the lead author of the paper. “Our study clearly demonstrates the value of CGM in community hospitals, and it offers a model for other health systems that are looking to use this technology in similar ways.”
Study recruited 110 participants
As part of the study, researchers recruited 110 adult patients with Type 2 diabetes who were admitted to a medical/surgical floor at Scripps Mercy San Diego over a 4-year period. The patients were randomized to be fitted with a Dexcom G6 CGM device or to receive the current standard for hospital glucose management – three pin-prick blood sugar tests conducted every 24 hours.
Participants ranged in age from 30 to 89 years old, 56.6% were women and 80.8% were Hispanic.
The G6 CGM system, which is made by San Diego-based Dexcom, is made up of several elements – a small sensor and transmitter attached to the patient’s lower abdomen; a cell phone placed next to the hospital bed that picks up the transmitter’s signal via Bluetooth through an app; and a tablet or computer used by doctors and nurses to track real-time glucose readings from their patients over a secure cloud data storage system.
Each of the wireless sensors placed on the 57 patients assigned to the device group generated a glucose reading every five minutes, and the monitoring system sent out alerts when blood sugar levels moved outside acceptable levels, allowing doctors and nurses to track trends and respond with rapid treatment when needed.
Patients with a CGM device recorded an average glucose level of 220 mg/dL, compared with 238 mg/dL among patients receiving standard care. The amount of time spent in hyperglycemia (with a blood sugar reading greater than 250 mg/dL) was 11% lower in the CGM group than it was in the standard care group.
Researchers reported that the CGM device did not interrupt patients as they slept or cause them any discomfort. Other issues, such as persistent sensor signal loss and sensor detachment, were extremely rare.
One barrier to the adoption of CGM devices more broadly in hospitals could be their cost, the study noted. For the clinical trial, researchers relied on a CGM support team in the hospital to help manage the technology system, an expenditure not required when delivering the current standard care. Over time, the financial burden of such a team could be offset, at least in part, by the falling cost of CGM technology. Further cost benefits could come from the continued use of the CGM system as a patient moves from the hospital to a post-discharge setting if such monitoring helps to prevent future hospital readmissions, which are more common among people with diabetes.
Funding for the study was provided by the Confidence Foundation, Diabetes Research Connection and the National Center for Advancing Translational Science. DexCom also provided the G6 devices used in the trial.
The full journal article is available here.