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September 29, 2021
Individuals with diabetes are at increased risk for COVID-19, the illness caused by the SARS-CoV-2 virus. As federal officials loosen restrictions on in-hospital use of personal glucose meters by COVID patients, clinical labs and institutions can take critical steps to support patients with diabetes or metabolic disease in the hospital setting. Among other steps, “laboratories should consult with the endocrinologists and diabetologists involved in the care of inpatient diabetics,” James H. Nichols, PhD, DABCC, FAACC, professor of pathology, microbiology, and immunology and medical director for clinical chemistry and point-of-care testing at Vanderbilt University Medical Center in Nashville, told CLN Stat.
Several studies underscore vulnerabilities in this population. One analysis of 1,122 COVID-19 adult patients in 88 U.S. hospitals found that patients with diabetes and/or uncontrolled hyperglycemia had higher mortality rates and longer hospital stays than patients without these conditions. Other research from China indicates that COVID-19 diabetes patients are at higher risk for severe pneumonia, dysregulation of glucose metabolism, and other complications that weaken their prognosis. “COVID-19 with diabetes has much more potential to progress rapidly with acute respiratory distress syndrome and septic shock, which may be eventually followed by multiple organ failure,” according to one commentary.
The U.S. Food and Drug Administration (FDA) has issued guidance permitting home-use blood glucose meters in the hospital setting for patients with COVID-19. The agency has also allowed two continuous glucose monitoring (CGM) devices—the Dexcom G6 and Abbott FreeStyle Libre—for use in hospitals during the pandemic, even though neither has been approved for hospital use.
This is a departure from current practice, which bases treatment and insulin dosage on using glucose meters that undergo daily quality controls and have been previously validated, Nichols said. Patients now have access to glucose meters that have no validation or quality control checks and balances. For this reason, labs and institutions should tread carefully in implementing the FDA guidance, he said. Although this practice is being promoted to conserve personal protective equipment, “there are a number of challenges and risks involved in use of home glucose meters in the hospital inpatient setting.”
Patients may have considerable experience self-managing glucose at home. However, as an inpatient, “the patient’s physiology will be different, the medications the patient receives will be different, and the effects of the immune response to the virus can alter metabolism as well as circulation,” Nichols noted. Patients who are intubated or admitted to intensive care are also unlikely to have the capacity to perform glucose self-management.
Labs can do their part by speaking with endocrinologists and diabetes management specialists at their institutions to raise awareness of the risks of patients self-managing with unvalidated meters. Institutions in turn should involve their risk management departments and possibly require patients to sign waivers outlining their responsibilities as participants in their healthcare, Nichols said. “They should also define when self-management must be discontinued due to procedures, anesthesia, medications, transfer to OR or ICU settings, intubation, and other situations when a patient is not capable of performing glucose self-management or conditions where the meter performance may be affected,” he said.
Hospitals assume even greater risk when they dispense a home use meter to a diabetic patient who might not have experience with operating the meter or a history of self-managing insulin with this device. “There are thus a number of practical concerns that should be discussed before patients are allowed to use their own glucose meters in the hospital,” Nichols suggested.
Clinicians should be aware of the potential analytical limitations of using glucose meters in a COVID-positive population and define those situations in which a patient can or cannot self-manage, Nichols said. “Institutions should be aware that the patient may run out of home testing supplies and test strips, which would not be stocked by hospitals and must therefore be brought by the patient on admission.” They should also document results in the patient’s medical record in a way that distinguishes that glucose result from other results such as blood gas analyzers and the hospital’s professional glucose meter tests, he suggested. “Otherwise, there can be clinical confusion with the interpretation of these results,” Nichols said.