Authors

  1. Molyneux, Jacob

Abstract

Despite practical and policy barriers, new technologies support the case for greater flexibility.

 

Article Content

When patients with diabetes are admitted to the hospital, they must often turn over every aspect of their diabetes management to a rotating roster of physicians, nurses, dietitians, and nurse's aides. These clinicians are in turn guided by a variety of protocols governing the particulars and timing of meals, insulin delivery, and blood glucose testing. Some of these patients may have type 1 diabetes and extensive experience in glucose self-management aimed at improving quality of life and reducing the long-term risks of retinal, kidney, and cardiovascular damage associated with poor blood glucose control. The process involves monitoring blood glucose; titrating insulin dose according to glucose level and nutritional intake; eating a low glycemic index diet; and accounting for other factors that can affect blood glucose levels, such as exercise, stress, and illness.

  
Figure. A CGM reader... - Click to enlarge in new windowFigure. A CGM reader (or smartphone app) receives data, such as current glucose level, from a sensor affixed to the patient's abdomen or back of the arm; alarms can be set to warn patients or clinicians of hypo- or hyperglycemic events (see reader at left). The reader can also be used to reveal glucose averages and patterns of fluctuation, as well as a record of past hypo- or hyperglycemic events (see reader at right).

These patients may be skilled at avoiding hyper- or hypoglycemic incidents and at quickly treating them when they occur. Many will have adopted wearable technologies for measuring glucose that warn of harmful or dangerous highs and lows with preset alarms (continuous glucose monitors [CGMs]) or for delivering insulin (continuous subcutaneous insulin infusion [CSII, or insulin pumps]), sometimes even linking the two in a "closed-loop" system in the effort to approximate the subtle work of a functioning human pancreas in real time.

 

The sudden loss of autonomy and control in the hospital may be a source of profound anxiety for the patient. It may also increase the patient's chance of experiencing sustained hyperglycemia or dangerous hypoglycemic incidents, both of which are common in hospitalized patients with diabetes and can increase length of stay and mortality. Hospital policies often hew closely to a conservative approach to diabetes management, in which patients are seen as passive participants rather than as partners in their own care. These policies may be influenced by factors including liability concerns, protocols that don't reflect recent practice guidelines, and practical limitations in hospital staffing and resources.

 

In a recent online discussion forum thread about the hospital experiences of patients with type 1 diabetes, participants reported having insulin pens confiscated, being given special "diabetic" meals heavy with high glycemic index carbohydrates like white pasta, being refused unscheduled correction shots between meals despite a blood glucose level over 300 mg/dL and potential ketoacidosis, being given rapid-acting insulin up to an hour or more before meal delivery, and so on.

 

Those who reported being allowed to maintain some role in their own glucose management sometimes had to renegotiate this right with each nurse who came on shift. Those who used CSIIs sometimes reported faring better, because some institutions had guidelines in place supporting their continued use by patients who were well enough to care for themselves. Several commenters suggested arriving with legal waivers absolving the hospital of liability if they were allowed to manage their own glucose levels.

 

INCREASED SCRUTINY OF INPATIENT DIABETES CARE

According to the Centers for Disease Control and Prevention, there are over 21 million people in the United States with diagnosed type 2 diabetes and over 1.3 million with type 1. The COVID-19 pandemic drove home the vulnerability of this population; a 2020 meta-analysis of observational studies published in Nutrition, Metabolism and Cardiovascular Diseases found that patients with preexisting diabetes had up to a "threefold greater risk of in-hospital mortality associated with COVID-19."

 

The twin goals of in-hospital diabetes care are to avoid prolonged hyperglycemia or hypoglycemic episodes. It's well established that keeping glucose levels within lower target ranges can significantly improve patient outcomes such as wound healing and reduce inpatient mortality as well as cost and length of stay. At the same time, hypoglycemic events are among the most common adverse drug events in the hospital and can lead to disorientation, seizures, coma, and death. Reflecting the growing awareness in health care that in-hospital diabetes management needs improvement, the Centers for Medicare and Medicaid Services' 2022 final rule includes two new electronic clinical quality measures for management of inpatient diabetes in the hospital setting; these will allow reporting on rates of severe hyperglycemia or hypoglycemia, and affect hospital quality rankings.

 

Many hospitalized patients with diabetes are in critical care, are unable to eat, or have other clinical factors affecting glucose management. But as more attention is given to improving in-hospital glucose management, are we doing enough to determine and support the subset of patients who might wish to and be able to play an effective role in diabetes self-management?

 

THE ADA POSITION ON SELF-MANAGEMENT

According to the American Diabetes Association (ADA) Standards of Medical Care in Diabetes-2022,

 

"Diabetes self-management in the hospital may be appropriate for . . . both adolescent and adult patients who successfully conduct self-management of diabetes at home and whose cognitive and physical skills needed to successfully self-administer insulin and perform self-monitoring of blood glucose are not compromised. In addition, they should have adequate oral intake, be proficient in carbohydrate estimation, use multiple daily insulin injections or [CSII], have stable insulin requirements, and understand sick-day management. If self-management is to be used, a protocol should include a requirement that the patient, nursing staff, and physician agree that patient self-management is appropriate."

 

Assessing a patient's self-management competence. While many non-critically ill patients with type 1 diabetes who practice self-management may fit the ADA's description, their competence can only be verified by performing a glycated hemoglobin (HbA1c) test at time of admission and by contacting the patient's diabetes care provider, according to the ADA.

 

Further insight can be derived from direct discussion with a patient, but here the question of staff knowledge about diabetes becomes relevant. While some medical centers have glucose management teams to offer staff training and support patient assessment, many hospitals do not, and nurses' experience with current diabetes technologies and practices can differ widely. In addition, not all hospitals have adopted ADA recommendations. These include a target glucose range of 140 to 180 mg/dL (7.8 to 10 mmol/L) for the majority of patients and the use of an insulin regimen "with basal, prandial, and correction components" for non-critically ill hospitalized patients (a sliding-scale insulin regimen "is strongly discouraged"). The ADA also recommends careful coordination of glucose monitoring, insulin dosing, and mealtimes.

 

These standards are likely to agree with the daily self-care practices of many experienced patients with type 1 diabetes. Yet most hospitals that have adopted up-to-date ADA inpatient practice recommendations like those above are still far from developing comprehensive policies for patient self-management.

 

Technology as a force for change? The ADA states that "patients using diabetes devices should be allowed to use them in an inpatient setting when proper supervision is available." Regarding the use of insulin pumps, they add that "hospital policy and procedures delineating guidelines for CSII therapy, including the changing of infusion sites, are advised." But while research has shown no decline in glucose control in patients transitioned from out-of-hospital to in-hospital CSII therapy, and many people with type 1 diabetes have significantly lowered HbA1c levels through CSII home use, the existence of policies and staff training enabling CSII support is inconsistent.

 

Home CGM use is even more ubiquitous than CSII use, and its potential benefits for the inpatient population are increasingly recognized, though regulatory obstacles remain. The ADA 2022 standards note that CGM monitoring

 

"provides frequent measurements of interstitial glucose levels as well as the direction and magnitude of glucose trends. Even though CGM has theoretical advantages over POC [point-of-care] glucose testing in detecting and reducing the incidence of hypoglycemia, it has not been approved by the FDA [Food and Drug Administration] for inpatient use. Some hospitals with established glucose management teams allow the use of CGM in selected patients . . . , provided both the patients and the glucose management team are well educated in the use of this technology."

 

However, as with the use of telehealth, the COVID-19 pandemic may have speeded adoption of this technology and made clear its advantages for detecting hyper- and hypoglycemia and alerting patients and staff to important glucose trends. As Laura Hieronymus, DNP, MSEd, RN, MLDE, BC-ADM, CDCES, FADCES, vice president, health care programs, science and health care, at the ADA told AJN: "At the start of the pandemic, one of the ways that hospitals sought to cut down on potential COVID spread was to allow patients with diabetes to keep on their CGM while in the inpatient setting . . . so nurses did not have to keep coming into the hospital room to consistently check blood glucose levels."

 

Although the FDA does not normally allow CGM use in the hospital, according to Hieronymus the agency agreed not to enforce this rule during the public health emergency. In addition, she says, the ADA "has since spoken to . . . the FDA about making this a permanent change, and they recommended that device sponsors should make a formal request" to this effect.

 

Should the FDA relax its opposition to in-hospital CGM use, current increased regulatory scrutiny of the poor outcomes associated with inadequate glucose control among inpatients, plus the increasing awareness that technologies like CGMs can save staff time and labor while providing real-time actionable data, may eventually lead to their use with much larger numbers of inpatients. Such a sea change in one central glucose management practice for hospitalized patients with diabetes could inevitably lead to other changes, including clearer policies that allow greater freedom for some patients to self-administer insulin to maintain a steadier glucose level. But this remains to be seen.-Jacob Molyneux, senior editor