The FDA recognizes that home-use blood glucose meters may be used by patients with diabetes who are hospitalized due to COVID-19 to check their own blood glucose levels and provide the readings to the health care personnel caring for them.
As part of efforts to help protect health care providers and patients from exposure to COVID-19 to the extent possible during this pandemic, this page provides answers to frequently asked questions that health care providers and other personnel at health care settings may have on patients’ use of these devices.
1. Can patients self-test using blood glucose meters labeled for home use while they are in the hospital during the COVID-19 pandemic?
A. Yes. The FDA recognizes that home-use blood glucose meters may be an option to provide relief and support to health care professionals in hospital settings seeking to reduce interactions between patients and health care providers, thereby limiting exposure to COVID-19, and conserving personal protective equipment (PPE), whenever possible.
In addition, some home-use blood glucose meters have built-in wireless data transmission capabilities, which can facilitate remote patient monitoring. Therefore, the FDA encourages hospitals to consider policies to allow patients to self-test using home-use blood glucose meters, which may include leveraging patients’ own home-use blood glucose meters or dispensing a home-use blood glucose meter upon in-patient admission to the hospital. Utilization of strategies in which hospitalized patients may conduct their own blood glucose testing, while allowing wireless access to results by health care professionals, may limit the number of necessary patient contacts, thereby reducing risk of viral transmission and preserving a hospital’s limited supply of PPE.
2. What are the factors that health care providers caring for a COVID-19 patient can consider before allowing patients to self-test using a home-use blood glucose meter?
A. In considering whether to allow in-patients to self-test using home-use blood glucose meters, health care providers caring for COVID-19 patients can take into consideration the availability of other equipment in their hospitals to get timely and accurate blood glucose readings that can be easily transferred or logged into the patient’s medical record. Health care providers can also take into consideration whether the patient is well enough or sufficiently lucid to properly conduct their own self testing and whether the patient is comfortable with using an unfamiliar home-use blood glucose meter, if one was dispensed by the hospital. While a patient may be used to getting blood glucose readings using their own meter, the patient may not be as successful using an unfamiliar model.
In the case of home-use blood glucose meters, health care professionals in hospitals may choose to have patients utilize home-use meters to monitor blood glucose levels of patients when they have already been hospitalized due to COVID-19. In addition, self-testing by patients, even while in the hospital, is already within the authorized FDA-labeling for home-use meters.
3. Can COVID-19 patients with diabetes bring their own blood glucose monitors to the hospital if they need to be hospitalized?
A. Yes. Self-management of diabetes by a patient using their own devices, even in a hospital setting, is consistent with device labeling.
4. If a hospital chooses to dispense home-use blood glucose meters to in-patients, can that meter be used for multiple patients?
A. No. All blood glucose meters labeled “for single patient use only,” whether dispensed by the hospital to a patient or brought in to a hospital by a patient, may only be used by the individual patient. Blood glucose meters labeled “for single patient use only” may not be shared among multiple patients. This limitation is necessary to prevent transmission of infection between individuals as these types of glucose meters are not adequately robust to withstand the cleaning and disinfection that would be necessary to enable multiple patient use. Any home-use blood glucose meter dispensed to an admitted patient should either be taken home by that patient or disposed of upon the patient’s discharge from the hospital.