The National Institutes of Health Tuesday awarded a $3.1 million grant to the Scripps Whittier Diabetes Institute to study the use of wireless continuous glucose monitoring devices among hospitalized patients with type 2 diabetes in hope of better controlling their blood sugar during their admission.
The study is intended to build on earlier research conducted by Scripps Whittier and on the subsequent use of CGM devices among diabetes patients in Scripps Health hospitals during the COVID-19 pandemic.
“Our new study gives us the opportunity to test CGM in the acute-care setting under rigorous, gold-standard research conditions,” said Addie Fortmann, director of the diabetes service line at Scripps and study co- principal investigator. “The data we gather will greatly expand our understanding of the safety, effectiveness and value of using this technology to improve the care and outcomes of hospitalized patients with diabetes.”
Early in the pandemic, the Food and Drug Administration cleared the way for hospitals to use the devices to reduce the number of times a nurse must go into a patient’s room for more conventional finger pricks. Without CGM, nurses typically enter a patient’s room four to six times a day to check blood glucose levels.
CGM devices have been approved for outpatient use since 1999, but their use in the hospital setting remains limited to research efforts and the special conditions allowed during the pandemic.
It is essential to manage blood sugar levels properly and continuously 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 a period, it can cause serious problems such as heart disease or heart attack, stroke, and damage to the kidneys, nerves and eyes.
Moving CGM technology permanently into the acute-care setting could be significant, Scripps researchers say, because this would equip care teams with 288 measurements a day to guide treatment decisions.
In what is touted as the largest study of its kind to date, Scripps Whittier researchers plan to enroll 554 patients with type 2 diabetes who are admitted into Scripps Mercy Hospital Chula Vista over the three-and-a-half-year recruitment period of the randomized controlled trial.
All study participants will be fitted with a CGM device. However, only data from one half of the participants will be continuously monitored by nurses using real-time dashboards on iPads and computers, allowing them to track blood sugar trends and respond to urgent changes with insulin or other treatments.
The other half will undergo the periodic finger pricks and metering that is part of the current standard of care. Data from CGM devices worn by the second group will be used only for overall evaluation.
Researchers hope to start enrolling patients in the study in early 2022.
In the earlier clinical trial, Scripps Whittier researchers recruited 110 adult patients with type 2 diabetes who were admitted to Scripps Mercy Hospital San Diego over a four-year period. Reporting in the medical journal Diabetes Care last August, the researchers said patients wearing CGM devices saw better control of their blood sugar levels, and time spent in hyperglycemia was 11% lower than in patients who received the standard care finger pricks.
Under the special allowance by the FDA during the pandemic, Scripps has outfitted about 500 additional patients — a third of whom were infected with the new coronavirus — with CGM devices.
“Patients accustomed to using these devices outside the hospital are relieved to use one once they are admitted,” Fortmann said. “For nurses, being able to access glucose data remotely without entering a patient’s room saves personal protective equipment, lowers the risk of exposure to infection, saves time and reduces burden for care team members who have been heavily taxed by pandemic patient volumes.”
–City News Service