New diabetes guideline reflects change in glucose therapy considerations
The American Diabetes Association recently published its 2020 Standards of Medical Care in Diabetes. Perhaps one of the most important updates in the guidance for primary care physicians is that medications that have evidence of improving cardiovascular and renal outcomes are now recommended in at-risk patients independent of the need for additional glucose lowering, an expert told Healio Primary Care.
The recommendations — given a grade of A, B, C or E, depending on the level of evidence behind each recommendation — also provide insight on managing CVD and strategies for following the chronic care model.
Data indicate that PCPs treat at least 90% of the 24 million patients in the United States with diabetes. Healio Primary Care interviewed several experts about the most important takeaways from the guideline for PCPs.
Adding glucose therapies
In the past, the ADA has recommended adding glucose-lowering therapies to regimens to lower A1C levels in patients who were at risk for CVD or renal disease, according to Joshua J. Neumiller, PharmD, chair of the ADA’s Professional Practice Committee, which oversees annual updates to the Standard of Care.
Now, use of additional glucose-lowering therapies “should be considered independently of baseline A1C or individualized A1C target and even if a patient has reached their A1C goal,” he told Healio Primary Care. “This change in guidance is based on recent evidence that suggests that the cardiovascular and renal outcome benefits of these medications are realized independent of a patient’s A1C level.”
Some other recommendations related to glucose assessment include:
- Standardized, single-page glucose reports with visual cues such as the Ambulatory Glucose Profile should be considered a standard printout for all continuous glucose monitoring devices. (E grade)
- The measure of time in range is associated with the risk for microvascular complications and should be a satisfactory endpoint for clinical trials and can be used to assess glycemic control. Additionally, time below target (< 70 and < 54 mg/dL) and time above target (> 180 mg/dL) are “useful parameters for reevaluation of the treatment regimen.” (E grade)
These recommendations are intended to provide PCPs with more tools to assess a patient’s glucose level, according to Kevin M. Pantalone, DO, an endocrinologist and the director of diabetes initiatives in the department of endocrinology, diabetes and metabolism at Cleveland Clinic.
“The ADA wants PCPs to look beyond the patient’s A1C in assessing the need for additional therapies,” he explained. “Simply put, a patient’s A1C does not always tell the whole story. Therefore, the ADA wants PCPs to use additional tools such as ambulatory glucose profile reports and glycemic variability.”
Neumiller added that the Standards of Care provides several tools to help PCPs with these recommendations.
“There's an example of an ambulatory glucose profile in the guidelines,” he said. “We also added in a table that describes important metrics to PCPs whose patients use continuous glucose monitors. These tools can help PCPs take what are often a lot of data to sort through and give them some definable metrics to look at when evaluating the patient's overall glycemic control.”
The 2020 guidance also includes several new CVD treatment recommendations:
- A SGLT2 inhibitor with demonstrated CV benefit is recommended to lower the risk for major adverse CV events and hospitalization for heart failure in patients with type 2 diabetes and established atherosclerotic CVD (ASCVD) and/or multiple ASCVD risk factors. (A grade)
- A GLP-1 receptor agonist with demonstrated CV benefit is recommended to lower the risk for major adverse CV events in patients with type 2 diabetes and established ASCVD and/or multiple ASCVD risk factors. (A grade)
- A SGLT2 inhibitor may be considered to reduce the risk for hospitalization from heart failure in patients with diabetes and established heart failure (C grade).
According to Pantalone, these recommendations reflect a “more global approach” of type 2 diabetes management.
“Before these changes, many PCPs were led to believe that only metformin and lifestyle modification should be initiated to manage most patients with a recent onset of diabetes and that additional therapies should be added only if a patient’s A1C remained above target,” Pantalone said. “But the new Standards of Care encourage physicians to introduce additionaltherapies that also reduce cardiovascular risk, particularly in patients with known CVD, even if they're meeting their A1c goals.”
“Most patients with type 2 diabetes will die from cardiovascular complications,” Pantalone continued. “Because many of the newer therapies for glucose lowering also reduce cardiovascular risk independent of those glucose lowering properties, all patients with type 2 diabetes who have known CVD, regardless of their present A1C level, should be considered eligible for the newer glucose lowering therapies.
The Standards of Care also provide BP targets for patients with varying levels of CVD risk. However, Randy Wexler, MD, clinical and academic vice chair of the family medicine department at The Ohio State University Wexner Medical Center, expressed concern that not all medical societies concur on what those BP targets should be.
According to Wexler, the recommendations state that for individuals with diabetes and hypertension who are at higher CVD risk (existing ASCVD or 10-year ASCVD risk of greater than 15%), a blood pressure target of 130 mm Hg/80 mm Hg may be appropriate. The recommendations go on to say that for patients with diabetes and hypertension who are at lower risk for CVD (10-year ASCVD risk of less than 15%), clinicians should treat to a blood pressure target of 140 mm Hg/90 mm Hg.
“However, the American Heart Association hypertension guideline uses a 10% risk for CVD to determine when a blood pressure is considered high enough to start medication in some populations. Some European medical societies also have different targets. Furthermore, and depending on what chronic disease you are treating, a person’s CVD risk is sometimes 10%, and sometimes it is 15%,” Wexler continued. “The mix of blood pressure targets and varying ASCVD cut-offs that differ across organization guidelines adds confusion, which will exacerbate clinical inertia.”
Neumiller said that the ADA received the American College of Cardiology’s input as it developed the 2020 Standards of Care.
“For the second year in a row, the section on cardiovascular disease and risk management within the ADA’s Standards of Care was reviewed and endorsed by the ACC, with two ACC designated representatives participating in the update.”
Wexler still thought physicians might be confused by the various BP levels throughout the report.
“I recognize that recommendations tend to be done in conjunction with other guideline groups with respect to a specific disease process, the mix of blood pressure targets and varying ASCVD cut-offs that differ across organization guidelines adds confusion, which will exacerbate clinical inertia.”
Managing behavioral health
Pantalone said another important element of this year’s Standards of Care is the greater emphasis on patients having greater control over their own health and improving their psychological well-being. Some recommendations in this area include:
- The “key goals” of patient education are clinical outcomes, health status and well-being and should be gauged as part of routine care. (C grade)
- Patient education can be given in group or one-on-one settings and should be conveyed to a patient’s entire diabetes care team. (A grade)
“Diabetes treatment is not just about medication and nutrition,” Pantalone said. “There is a huge psychological component in the burden of chronic disease management that impacts patients with diabetes and their ability to get their diabetes under control.”
Implementing the chronic care model
The Standards of Care also recommend that approaches to diabetes management follow the Chronic Care Model. The A grade recommendation states that this model “emphasizes person-centered team care, integrated long-term treatment approaches to diabetes and comorbidities, and ongoing collaborative communication and goal setting between all team members.”
Dana E. King, MD, chair of the family medicine department at West Virginia University, said he already utilizes the chronic care model.
“We have a set of trained chronic care model nurses who keep track of our most vulnerable patients,” he said. “These nurses call patients on a monthly basis to make sure they’re keeping their appointments with me, any specialists and getting their lab work done. They answer questions about diet and provide medication reminders. In essence, they are coaching and coordinating care for the patients who are not having much trouble.”
King added that it is important not to let patients fall through the cracks.
“We want to know if a year goes by and we haven't seen this patient, or if they didn't get a particular diabetes-related exam this year. Stay in touch with your patients to ensure that they’re getting the care that they need,” he said.
Treating patients on case-by-case basis
An overarching theme throughout the Standards of Care recommendations is the need for individualized and personalized care, according to Neumiller.
“One-size-fits-all doesn't work in diabetes,” he said. “Find out what patients’ self-care capacities are, what their goals and therapies are, what their glycemic target should be and what their caregiver support is.”
Pantalone noted that the tailored approach to diabetes management also includes the use of technology — like newer meters, continuous glucose monitors and insulin pumps — He said he believes this prompted the Standards of Care authors to reorganize and expand a section on these types of tools.
“PCPs are trying to manage five or six chronic medical problems as well as acute issues during patient encounters,” he said. “Therefore, the ability of PCPs to have a great understanding of the reports that these technologies generate can be very challenging. With the Standards of Care, I hope that we can get past that.” – by Janel Miller
Disclosures: Pantalone reports receiving speaker honoraria from AstraZeneca, Merck and Novo Nordisk; research support from Merck and Novo Nordisk and consulting honoraria from Bayer, Merck and Novo Nordisk. King, Neumiller and Wexler all report no relevant financial disclosures.