The Endocrine Society has issued an updated clinical practice guideline on the prevention and management of hypoglycemia in patients with diabetes who are at at high risk, addressing the wide variety of treatment advances, such as insulin pumps and continuous glucose monitoring (CGM) systems, that have appeared since the publication of the society’s last guideline on hypoglycemia, in 2009.
“CGM and insulin pumps have been much more commonly used in the last decade among people with diabetes including children, and there are new forms of glucagon available,” said Anthony L. McCall, MD, PhD, chair of the panel that wrote the guideline.
“We had to update our guideline to match these developments in the diabetes field,” noted McCall, University of Virginia in Charlottesville, in a press statement.
The new guideline, developed by a multidisciplinary panel of clinical experts and published this week in the Journal of Clinical Endocrinology and Metabolism, addresses 10 key clinical questions regarding current issues relevant to hypoglycemia prevention and treatment in adult or pediatric patients with either type 1 or type 2 diabetes in the outpatient or inpatient setting.
Key Guideline Recommendations
The recommendations are based on factors including critical outcomes, implementation feasibility, and patient preferences.
Key guideline recommendations that are considered “strong,” based on evidence, include:
The use of CGM rather than self-monitoring of blood glucose by fingerstick for patients with type 1 diabetes receiving multiple daily injections.
The panel underscores that “comprehensive patient education on how to use and troubleshoot CGM devices and interpret these data is critically important for maximum benefit and successful outcomes.”
The use of a structured program for patient education versus unstructured advice for adult and pediatric outpatients with type 1 diabetes or type 2 diabetes receiving insulin therapy.
Structured education on how to avoid repeated hypoglycemia is critical, and this education should be performed by experienced diabetes clinicians,” the panel asserts. “Moreover, insurance coverage for education should be available for all insulin-using patients.”
The use of glucagon preparations that do not have to be reconstituted, as opposed to those that do (ie, available as a powder and diluent) in the treatment of outpatients with severe hypoglycemia.
Guideline recommendations that received conditional recommendations include:
Use of real-time CGM and algorithm-driven insulin pumps in people with type 1 diabetes.
Use of CGM for outpatients with type 2 diabetes at high risk for hypoglycemia.
Use of long-acting and rapid-acting insulin analogs for patients at high risk for hypoglycemia.
Noting that there is “moderate-certainty” evidence for severe hypoglycemia reduction as an outcome in those using long-acting analog insulins versus human neutral protamine Hagedorn (NPH) insulin, the panel cautions that “most studies of long-acting analog insulins do not assess for significant adverse effects including cardiovascular outcomes, and that many studies were designed to demonstrate noninferiority of analog insulin compared with human NPH insulin.”
Initiation of and continuation of CGM for select inpatient populations at high risk for hypoglycemia.
Hypoglycemia: One of Top 3 Preventable Adverse Drug Reactions
The updated guidelines are especially important considering the common incidence of hypoglycemia, which the US Department of Health and Human Services has determined to be one of the top 3 preventable adverse drug reactions, the panel says.
They note that between January 2007 and December 2011, emergency department visits for therapy-associated hypoglycemia among Medicare beneficiaries resulted in more than $600 million in spending.
Meanwhile, many people with type 1 or 2 diabetes may not experience or recognize the symptoms of hypoglycemia, which in severe cases, can lead to unconsciousness or seizures, in addition to affecting quality of life, social life, work productivity, and ability to drive safely.
Key to accurate diagnosis of those patients is assessment of the three levels of hypoglycemia, described in a 2018 consensus statement:
Level 1: Glucose < 70 mg/dL (3.9 mmol/L) and ≥ 54 mg/dL (3.0 mmol/L). This level of hypoglycemia should alert patients that they may need to ingest carbohydrate to prevent progressive hypoglycemia.
Level 2: Glucose < 54 mg/dL (3.0 mmol/L). This level of hypoglycemia is associated with increased risk for cognitive dysfunction and mortality.
Level 3: A severe event characterized by altered mental and/or physical status requiring assistance. This level of hypoglycemia is life-threatening and requires emergent treatment typically with glucagon.
Ultimately, “new technology and medications will help reduce hypoglycemia, and [clinicians] can better treat patients now with new, easier glucagons,” McCall told Medscape Medical News.
“People with diabetes, their caregivers, and diabetes specialists will all benefit from our guideline with a better understanding of best practices and interventions,” the panel notes.
Disparities Still Exist in Access to Insulin Pumps
Separately, new research shows that while use of insulin pumps to manage type 1 diabetes has grown over 20 years, there has been no improvement in racial, ethnic, and socioeconomic disparities in their use in the United States. The findings are reported in Diabetes Technology & Therapeutics.
Using data from the SEARCH for Diabetes Youth Study across four time periods between 2001 and 2019, the researchers show that by the end of the period studied, insulin pump use was 67% among non-Hispanic Whites, 41% among Hispanics, 29% among Blacks, and 46% among other racial and ethnic groups.
In addition, 70% of people with bachelor’s degrees or higher used the pumps, compared with 56% among those with some college, 40% among holders of high school degrees, and 18% among those with no high school education. By income level, 74% of those with household incomes of $75,000 or more, 66% with $50,000 to $74,999, 51% with $25,000 to $49,999, and 41% with less than $25,000, used the pumps.
“Diabetes technology has numerous benefits for patients with type 1 diabetes, but the problem is that there is a huge divide in who actually has access to these technologies,” said study lead Estelle Everett MD, assistant professor of medicine in the division of endocrinology, diabetes & metabolism at the David Geffen School of Medicine at UCLA.
McCall had no disclosures to report.
J Clin Endocrinol Metab. Published December 7, 2022. Full text
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