Timely News and Notes for Primary Care Providers from the American Diabetes Association

Glycemic and blood pressure control in people with diabetes has declined in the past decade in the United States, according to a major analysis published in the New England Journal of Medicine (Fang et al., doi.org/gkhdvv).

The cross-sectional analysis of National Health and Nutrition Examination Survey (NHANES) data suggests that glycemic control (i.e., A1C <7%) peaked in about 57% of survey participants in 2010 but then dropped back to ∼50% in 2018, the latest year included in the analysis. Similar patterns were evident for blood pressure and lipid control, which either declined or plateaued in recent years.

Few respondents managed to achieve these measures combined (i.e., glycemic, blood pressure, and lipid control). This proportion was just 9% in the 1999–2002 period, increasing to nearly 25% in 2007–2010, and then declining to ∼22% in 2015–2018.

“These are concerning indings,” the report’s senior author Elizabeth Selvin said. “There has been a real decline in glycemic control from a decade ago, and overall, only a small proportion of people with diabetes are simultaneously meeting the key goals of glycemic control, blood pressure control, and control of high cholesterol.”

The study used annually collected data from NHANES, which includes a combination of interview responses and medical examinations. A total of 6,653 participants were included in the analysis.

Medicare beneiciaries with diabetes have experienced high out-of-pocket expenses for medical care over the past two decades, according to a recent report by Park et al. in Diabetes Care (doi.org/gqnp). Furthermore, the authors found evidence of socioeconomic and racial/ ethnicity disparities, with low-income groups experiencing higher out-of-pocket costs than higher income groups and non-Hispanic Whites experiencing the highest burden.

According to the analysis, mean annual out-of-pocket costs rose 28%, from an estimated $3,609 in 1999 to $4,612 in 2017. Costs rose signiicantly in the 1999–2005 period, with an annual average increase of 4.9%. After that, costs leveled off. Between 57 and 72% of beneiciaries had costs that exceeded 10% of their annual income throughout the study period. Even more concerning, between 29 and 41% of beneiciaries had costs that exceeded 20% of their annual income.

The authors noted that, although inflation may have contributed to increases in prescription drug costs, other factors such as the availability of new and more expensive glucose-lowering medications likely also played a role. They noted that, between 2013 and 2015, prescription drug prices increased annually by 10%, or six times the rate of inflation. And they singled out the poster child of extraordinary drug pricing—insulin—as particularly contributing to high out-of-pocket costs, even after some coverage gaps were set to close under the Affordable Care Act.

Several recent developments have raised the prospect of a possible shake-up in the U.S. insulin market. First is a recent change in regulatory approval for Semglee, a long-acting insulin glargine from Mylan Pharmaceuticals/Viatris. First approved by the U.S. Food and Drug Administration (FDA) in mid-2020 for glycemic control in type 1 and type 2 diabetes, Semglee has now been approved as an “interchange- able biosimilar” for insulin glargine (Lantus, Sanofi) (bit.ly/3A9u2H5). This means Semglee is now considered by the FDA to have no “clinical meaningful differences” from the reference product (i.e., Lantus). In practical terms, it also means that Semglee can be swopped for Lantus in pharmacies without prescriber intervention, thus acting as a generic for insulin glargine, in the U.S. insulin market (where states allow).

“This is a momentous day for people who rely daily on insulin for treatment of diabetes, as biosimilar and interchangeable biosimilar products have the potential to greatly reduce health care costs,” Acting FDA Commissioner Janet Woodcock said in a July statement. “Today’s approval … furthers FDA’s longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective, and high-quality medications at potentially lower cost.”

Initial wholesale acquisition pricing was set at $147.98 per pack of five 3-mL pens and $98.65 per 10-mL vial of Semglee insulin glargine (bit.ly/3fwrkDv). By comparison, a 10-mL vial of Lantus insulin glargine is roughly $300 (bit.ly/3jp5jYp). However, discounts, rebates, and pharmacy benefit manager negotiations will likely alter final pricing, so time will tell how competitive Semglee insulin glargine turns out to be. Nevertheless, the entry of a new competitor in the tightly controlled insulin market could herald a long-awaited shake-up in insulin pricing.

In another development, Walmart has launched a private label version of insulin aspart (Novolog, Novo Nordisk) that is retailing at a substantial discount compared to the branded version (bit.ly/3xpJInZ). The move will help some patients with affordabil- ity, but it has also been labeled as a “band- aid” solution (bit.ly/3A8SHeS) to bigger problems in the U.S. insulin market.

In yet another development, the state of Mississippi has filed a lawsuit against insulin manufacturers and pharmacy benefit managers over the price of insulin.

“As the mother of a diabetic, I know the emotional, physical, and financial toll the un- conscionable price of insulin has on families,” the state’s Attorney General Lynn Fitch said in a statement (bit.ly/2TTrIo6). “I filed this lawsuit on behalf of every Mississippian who relies on this medication to survive. These companies are exploiting the vulnerable. I’m fighting back because you should never have to decide between paying the ever- increasing price of insulin or compromising your care.”

The complaint, submitted to Chancery Court of Hinds County, MS, on 8 June 2021, is available at bit.ly/3fvCUip.

Know Diabetes by Heart (KDBH), a joint initiative of the American Heart Association (AHA) and the American Diabetes Association (ADA), has produced several new resources that focus on the intersection of diabetes, cardiovascular disease (CVD), heart failure, and chronic kidney disease.

“The Know Diabetes by Heart resources highlight key issues clinicians face daily when treating people with diabetes,” Robert Gabbay, MD, PhD, ADA’s Chief Science and Medical Officer said. “In the past few months, we’ve focused on critical topics such as mental health, older adults, and renal disease and how they all relate to diabetes and CVD. These resources have been created in such a way that busy health care professionals can easily access them on the go.”

The following is a list of recent KDBH webinars and podcasts, which health care professionals can access online free of charge.

This virtual salon, co-hosted by Scientific American, features Kenneth E. Freedland, PhD, Lawrence Fisher, PhD, ABPP, and Paula M. Trief, PhD, in a discussion focusing on the latest research linking mental health, diabetes, and CVD, as well as interventions in the clinic and community that can ease the burden on people with diabetes. It can be viewed at bit.ly/3ykvZQt.

Panelists Darren K. McGuire, MD, MSc, Medha Munshi, MD, Neil Skolnik, MD, and Tracey Taveira, PharmD, CDOE, talk about the medical, psychological, functional, and social domains that need to be considered when treating older adults with diabetes and CVD. The recorded discussion is available for viewing at bit.ly/3fvpH9s.

Jennifer Green, MD, Sanjay, Kaul, MD, FACC, FAHA, and Neda Rasouli, MD, participate in a robust discussion of new science related to CVD and renal risk management, including how these new findings can be incorporated into clinical practice to improve patient outcomes. The recorded conversation can be viewed at bit.ly/3io3BHJ.

Robert Eckel, MD, revisits some of the most frequently asked questions from previous webinars on managing renal disease in patients with heart failure and type 2 diabetes. Access this podcast at bit.ly/3iueisp.

George L. Bakris, MD, FAHA, FASN, Cecilia C. Low Wang, MD, FACP, and Neda Rasouli, MD, highlight updates made to the ADA’s Standards of Medical Care in Diabetes—2021 related to metformin use and considerations for when the guidelines recommend use of a sodium–glucose cotransporter 2 inhibitor or a glucagon-like peptide 1 receptor agonist independent of A1C or metformin use. Listen to the discussion at bit.ly/3xm8bKF.

The ADA’s new Professional Education Portal offers health care professionals a wealth of interactive webcasts, bundled pricing for continuing education courses, and integration with the American Board of Internal Medicine and the Accreditation Council for Continuing Medical Education’s Program and Activity Reporting System for recording Maintenance of Certification credits. A new search option makes it easier than ever to find downloadable PowerPoint presentations, lecture recordings, and educational resources. Learners can test their knowledge of diabetes care through the ADA’s case-based self-assessment programs and participate in live webinars featuring diabetes experts. For all of your diabetes-related professional education and development needs, visit the new portal at professionaleducation.diabetes.org.

Two studies published in the Journal of the American Medical Association suggest that individuals with type 2 diabetes who use basal insulin may benefit from the use of a continuous glucose monitoring (CGM) system. And, according to an accompanying editorial by Monica Peek and Celeste Thomas (doi.org/gkcjvx), these findings suggest that CGM use may provide benefits in a much wider group of individuals with type 2 diabetes, even though current recommendations in the United States are limited only to those who use basal and mealtime bolus insulin. The editorial authors suggest that changes might be needed to Medicare and private insurance coverage policies to widen access to CGM. Such changes could result in significant improvements to diabetes care, particularly in vulnerable groups who have traditionally not had access to the technology.

The first study, by Martens et al. (doi.org/gkcprv), was a randomized controlled trial showing that CGM usage over 8 months significantly improved glycemic control compared to traditional blood glucose monitoring in patients on basal-only insulin therapy. Patients who used CGM had a significantly greater change in A1C (−1.1%) compared to those using traditional blood glucose monitoring (−0.6%), for an adjusted difference of −0.4%. Notably, the patients received care in primary care settings with support from endocrinologists, suggesting that the approach could be widely implemented.

“Until now, we were unsure of the benefit for people with type 2 diabetes who were on less complicated background insulin regimens,” lead author Thomas Martens said. “This data expands the number of people who could benefit from these devices and points to a possible future in which CGMs are common in primary care clinics across the U.S.”

The second study, a retrospective cohort study by Karter et al. (doi.org/gkcprw), looked at glycemic control in insulin-treated patients with type 2 diabetes who did or did not use CGM. Those who used CGM achieved significantly better glycemic control, reducing A1C from 8.17 to 7.76% over the study period, compared to a decrease from 8.28 to 8.19% in those not using CGM, yielding a significant adjusted difference of −0.4%.

“The improvement in blood sugar control was comparable to what a patient might experience after starting a new diabetes medication,” lead author Andrew J. Karter said. “Selective prescribing of continuous glucose monitors may partially explain the benefits we saw in these patients with type 2 diabetes. Doctors appeared to have preferentially prescribed monitors to patients with a history of hypoglycemia or at high risk of hypoglycemia.”

According to senior author Richard Dlott, the next step is to identify other patients with type 2 diabetes who might benefit from using the technology.

“This study found that patients who used continuous glucose monitors had very good results compared to those who continued only with intermittent testing using fingersticks,” he said. “We now need to determine whether there are other patients who might also benefit, even if they don’t meet all of the Medicare criteria. The newest technology isn’t always better for everybody. We need to identify the people who are most likely to benefit.”

The American Diabetes Association’s 81st Scientific Sessions, presented virtually 25–29 June 2021, had a huge new topic to chew over this year: coronavirus disease 2019 (COVID-19) and diabetes.

The meeting included more than a dozen sessions on various aspects of the pandemic relating to diabetes. One of the standout features of the COVID-19 pandemic has been the perhaps surprising but certainly impressive amount of epidemiological data generated in the relatively brief time since the disease emerged. The task of summarizing the epidemiological situation was handed to Edward Gregg of Imperial College London.

“To me, the overall picture is one of variation,” Gregg said. “It’s a story of variation by time. It depends on when you look, where you look, what segment of the population you look at, and that makes it very difficult to quantify the epidemiology.”

He added that, although it is encouraging to see so much epidemiological data come out in such a short amount of time, it is still information that is quite narrow, with most data coming from hospital settings.

“We need a broader view of the epidemiology,” he said in an ADA Meeting News interview (bit.ly/3lKpl2H). “We need population denominators to understand the full cascade of risk. We need a full range of indirect effects of the pandemic to understand factors in care, management, and behavior that were most dramatically affected. And, we need to understand the unintended benefits that may have occurred from the rapid innovation of care.”

The results of the controversial DARE-19 (Dapagliflozin in Respiratory Failure in Patients With COVID-19) trial were also released at the Scientific Sessions. That study looked at potential protective effects of the sodium–glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin against organ failure and death due to COVID-19. However, it found the drug to be no better than placebo at protecting patients and that it did not aid recovery. The full results have been published in The Lancet Diabetes & Endocrinology (doi.org/gqnw).

In addition to all of the COVID-19 news, several major trials reported results at the conference. The GRADE study reported early data suggesting that there are few clinical differences among the various classes of diabetes medications, although SGLT2 inhibitors were not included (bit.ly/3rSbKHx). The SOLOIST and SCORED trials reported strong data in support of sotagliflozin for significant cardiovascular benefits in patients with cardiovascular issues and type 2 diabetes (bit.ly/3ikp7gq). Additionally, results from four SURPASS trials of the “twincretin” tirzepatide were presented, showing superior A1C reduction, fasting glucose improvements, and weight loss benefits (bit.ly/2WWGmfB). Full results of SURPASS-1 and SURPASS 2 have been published in The Lancet (doi.org/gqnx) and the New England Journal of Medicine (doi.org/gkzkzv), respectively.

To learn more about ADA’s continuing education opportunities, including Diabetes Is Primary events in your community, please visit professional.diabetes.org/ce.