Managing diabetes with a targeted approach
Individualizing treatment based on a patient's risk factors and preferences is the key to incorporating the updated 2022 AACE guidelines into clinical practice.
Early intensive therapy to reach glycemic goals as soon as possible is central to the newly updated type 2 diabetes clinical practice guideline from the American Association of Clinical Endocrinology (AACE) (available at pro.aace.com).1 Released in September 2022, the guideline covers every aspect of comprehensive care, from microvascular and cardiovascular risk management to obesity treatment and tailored patient education.
Along with your clinical judgment, this practical resource can help you and your patients make decisions based on their individual needs. Here, AACE experts offer recommendations for providing evidence-based care.
Start with lifestyle therapy
Adopting and maintaining healthy habits is the foundation of diabetes management. The AACE guideline covers several areas, including overweight/obesity, nutrition, physical activity, sleep, behavioral support and smoking cessation. “This combination lays a strong foundation to help patients be successful in achieving their glycemic and other health goals,” says Karl Nadolsky, DO, FACE, who is a Clinical Assistant Professor of Medicine at Michigan State University and Chair of the AACE Obesity & Nutrition Disease State Network. “There is also a risk stratification component of lifestyle therapy, so clinicians can more effectively target each patient’s needs.” (See Figure 1 below.) Dr. Nadolsky suggests some things to keep in mind:
Weight management. Close to 90% of patients with type 2 diabetes are overweight (BMI of 25 to 29.9) or have obesity (BMI of 30 or higher).2 Excess body fat worsens insulin resistance and hyperglycemia, which is why the AACE has identified preventing weight gain and promoting weight loss as high priorities. “A goal of 10% to 15% weight loss, primarily through diet, is the foundational treatment for type 2 diabetes,” says Dr. Nadolsky.
A personalized eating plan. Identifying a diet that considers a patient’s preferences will promote adherence. Ask patients to describe what they consume on a typical day and try to identify potential problems. “Especially sugary beverages and foods with a high glycemic load, such as refined starches and carbohydrates—foods that are not only contributing a lot of calories, but also make their blood sugars rise,” says Dr. Nadolsky. He also notes that a variety of weight-loss plans have proven effective in clinical trials, though he often encourages a Mediterranean-style diet, which has demonstrated benefits for management of obesity, diabetes and cardiovascular disease. For patients who are especially motivated to lose weight, liquid meal replacements, in addition to a low-fat diet, resulted in significant weight loss and improved glycemic control in patients with type 2 diabetes.3
Increased physical activity. AACE guidelines recommend that patients strive for a goal of at least 150 minutes of aerobic exercise (such as brisk walking) per week. Those who have been previously sedentary should start slowly and gradually increase activity and intensity levels, preferably spreading out exercise over most days. Using wearable technologies such as smartphones and smartwatches with activity trackers, or even a pedometer, can provide motivation to increase daily movement.
Also encourage patients to include strength training as part of their regimen, says Dr. Nadolsky. “I tell them that their muscle cells are like little sugar- and fat-burning factories, and we have to get them engaged,” he says. Dr. Nadolsky advises patients to perform strength training exercises, working all major muscle groups, on at least 2 or 3 days a week. Patients may use weights, exercise bands or other forms of resistance exercise, such as leg squats and push-ups.
Adequate sleep. Dr. Nadolsky asks patients how many hours they sleep on a typical night, whether they have been told they snore, whether they wake up feeling refreshed or feel drowsy during the day. All are clues of potential obstructive sleep apnea (OSA), a common comorbidity in type 2 diabetes. An effective treatment is weight loss: The Sleep AHEAD trial found that type 2 diabetes patients with obesity who lost weight with an intensive lifestyle program improved OSA symptoms more than a control group.4 In addition, the AACE cautions that sleep deprivation from any cause can worsen insulin resistance, hyperglycemia, hypertension and dyslipidemia.1
Figure 1.
Lifestyle therapy: Intensifying stages of treatment based on burden of disease1
Individualize A1C goals
The AACE recommends an A1C goal of 6.5% or less for most patients, based on the results of large trials indicating that people with type 2 diabetes who achieve and maintain that threshold reduce their risk for microvascular complications, including nephropathy, neuropathy and retinopathy.1,5,6 However, those same trials and others have also offered clear evidence that aggressive lowering of blood glucose with pharmacotherapy is not appropriate for all patients.
“Studies show that too tight control can cause hypoglycemia, which is associated with an increased risk for morbidity and mortality,” says Rachel Pessah-Pollack, MD, FACE, who is a Clinical Associate Professor at NYU Langone Health’s Division of Endocrinology, Diabetes and Metabolism and a member of the AACE Board of Directors.
She stresses the importance of tailoring goals for blood glucose reduction to the individual patient by considering factors such as advanced age, comorbidities and, especially important, the risk of hypoglycemia. “We want to make sure that a patient is achieving their target A1C with a low hypoglycemic risk. If the patient is at high risk for hypoglycemia, then their A1C target should be higher.” Hypoglycemic events are not only potentially dangerous, but they can also interfere with how effectively patients manage their diabetes. “Once a patient has a low glucose level, they may become scared and won’t want to adhere to the treatment they were prescribed,” says Dr. Pessah-Pollack.
Consider agents with benefits beyond glucose lowering
Over the last decade, newer classes of medication have been approved that allow clinicians to address both elevated blood glucose and several related complications. “It’s a really exciting time to be treating people with diabetes,” says Dr. Pessah-Pollack, noting the availability of agents that not only lower blood glucose, but also offer important benefits, including reducing the risk of cardiovascular events and heart failure hospitalization and slowing progression of chronic kidney disease. The AACE guidelines recommend using these classes—specifically, GLP-1 agonists and SGLT2 inhibitors—in appropriate patients regardless of baseline A1C. (For more on this, see box.)
Choose a regimen based on A1C and intensity of control
Metformin (or another single agent) monotherapy combined with lifestyle changes was long the usual approach to treating patients newly diagnosed with type 2 diabetes. Monotherapy with lifestyle changes and ongoing glucose monitoring remains an acceptable strategy for new patients who have an A1C of 7.5% or lower and no other major risk factors, says Dr. Pessah-Pollack. However, patients with established CVD, stage 3 chronic kidney disease and/or heart failure are candidates for a GLP-1 agonist or SGLT2 inhibitor with proven efficacy independent of glycemic control, in combination with metformin or instead of metformin if not tolerated.
Patients who present with higher A1C levels require a more aggressive approach with initial therapy, per AACE guidelines. “When a patient has an A1C of 7.5% to 9%, that’s when you will want to consider starting with dual therapy, and then even increasing to triple therapy if needed,” says Dr. Pessah-Pollack. A patient with an entry A1C over 9% requires dual or triple therapy, with the addition of insulin if they have symptoms such as polyuria (excessive urine production), polydipsia (excessive thirst) and weight loss. “If somebody comes to my office with a significantly elevated A1C, for example, 10% or higher, I’m going to put them on numerous medications, and that’s frequently going to include insulin,” says Dr. Pessah-Pollack. However, certain older medications, while effective as antihyperglycemics, should be used with caution. Notably, sulfonylureas and glinides are associated with hypoglycemia, weight gain and increased risk for cardiovascular events.7
Establish a CVD risk profile
The need for controlling CV risk factors in patients with type 2 diabetes cannot be overstated. Of course, counseling patients on dietary and lifestyle changes is key, along with optimizing glycemic control. In addition, AACE guidelines recommend the following:
Blood pressure: Goal of <130/80 mmHg is reasonable for most patients.
LDL cholesterol: Goal is based on CV and other risk factors:
- Extreme risk: desirable level <55 (diabetes plus established clinical CVD)
- Very high risk: desirable level <70 (diabetes plus other major CVD risk factor(s) such as hypertension, low HDL cholesterol, family history of CVD, chronic kidney disease 3/4, smoking)
- High risk: desirable level <100 (diabetes but no other major risk factors and/or age <40)
Triglycerides: If higher than 150 on maximally tolerated statins, consider adding icosapent ethyl if very high risk (diabetes plus two or more ASCVD risk factors).
When it comes to assessing a patient’s cardiovascular risk, Suneil Koliwad, MD, Chief of the Division of Endocrinology at UCSF Diabetes Center, recommends this approach: “First, I would phenotype my patient as carefully as possible. That means taking into consideration their family history, their body shape and weight, their ethnicity and the presence or absence of other features that are most associated with diabetes and its consequences,” he says. “The second step would be to access an online risk calculator, and input the data to get a 10- or 20-year cardiovascular disease risk assessment profile,” says Dr. Koliwad, who recommends using the tool at cvriskcalculator.com. “That information can go in the person’s chart from the get-go and be used as talking points during exams,” he says.
“The next step is to optimize medications, such as cholesterol-lowering and blood pressure medications, in terms of the intensity of control you want for that particular patient in alignment with their risk,” says Dr. Koliwad. For example, a hypertensive patient with a 10-year CVD risk >8.5% should be treated aggressively until the target is achieved (e.g., increasing dose, prescribing additional antihypertensives, switching to BID dosing, etc.).
—Timothy Gower
Diabetes agents with cardiometabolic and renal benefits
The availability of two classes—GLP-1 agonists and SGLT2 inhibitors—with proven benefits beyond glucose lowering has dramatically changed the treatment landscape, says Rachel Pessah-Pollack, MD, FACE, Clinical Associate Professor at NYU Langone Health’s Division of Endocrinology, Diabetes and Metabolism. “Some of the most exciting recent developments in the treatment of type 2 diabetes are the oral medications and injectable medications, other than insulin, that we now have available,” says Dr. Pessah-Pollack. “Independent of glycemic control, we now have agents that reduce the risk of cardiovascular disease, kidney disease, heart failure and mortality in people with type 2 diabetes. This is why there’s a push to tailor treatment for diabetes to the patient and determine not only their A1C, but also, what are their other established risk factors?” The AACE recommends the following agents as top choices for management of type 2 diabetes:
GLP-1 receptor agonists: This class is proven to reduce the risk of major adverse cardiovascular events (MACE) and all-cause mortality. Therefore, the AACE recommends using these agents in appropriate high-risk individuals regardless of baseline or target A1C. In addition, because of their mechanism of action, these agents also promote weight loss via hypothalamic satiety pathways and are associated with the most weight loss of any drug yet tested. “GLP-1 receptor agonists work on several different areas of type 2 diabetes pathophysiology,” says Karl Nadolsky, DO, FACE, Clinical Assistant Professor of Medicine at Michigan State University. “These medications improve pancreatic beta-cell function, block glucagon effects on the liver and slow gastric emptying.” The AACE also notes GLP-1 agonists have potential renal benefits, and a meta-analysis of cardiovascular outcome trials suggests they may be particularly beneficial for reducing macroalbuminuria.8
NOTE: For the purposes of this discussion, certain attributes of GLP-1 agonists may also apply to the recently approved dual GIP/GLP-1 agonist, but at this time the drug’s FDA-approved indication does not include CV risk reduction.
SGLT2 inhibitors: This class is also proven to reduce the risk of MACE and all-cause mortality. As such, the AACE recommends using these agents in appropriate high-risk individuals regardless of baseline or target A1C. In addition, these agents are indicated for patients with or without diabetes but with: 1) heart failure, including both HFrEF and HFpEF, to reduce incident HF, HF hospitalization and CV death, and 2) chronic kidney disease to reduce CKD progression. This class also helps aid weight loss due to its mechanism of action via the kidneys, preventing reabsorption of glucose into the bloodstream and facilitating its excretion in the urine, resulting in an estimated loss of 100-300 calories a day, depending on the dose.
References
1. Blonde L, et al. American Association of Clinical Endocrinology (AACE) 2022 clinical practice guideline for type 2 diabetes [e-pub at pro.aace.com], and Garber AJ, et al. AACE diabetes management algorithm. Endocr Pract. 2020;26(1):107-139.
2. Daousi C, et al. Prevalence of obesity in type 2 diabetes in secondary care: association with cardiovascular risk factors. Postgrad Med J. 2006;82(966):280-284.
3. Lean MEJ, et al. Primary care-led weight management for type 2 diabetes (DiRECT). Lancet. 2018;391(10120):541-551.
4. Foster GD, et al. A randomized study on the effect of weight loss on obstructive sleep apnea among obese patients with type 2 diabetes. Arch Intern Med. 2009;169(17):1619-1626.
5. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008;358:2560-2572.
6. Gerstein HC, et al. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008;358:2545-2559.
7. Lv W, et al. Mechanisms and characteristics of sulfonylureas and glinides. Curr Top Med Chem. 2020;20(1):37-56.
8. Giugliano D, et al. GLP-1 receptor agonists and cardiorenal outcomes in type 2 diabetes: an updated meta-analysis of eight CVOTs. Cardiovasc Diabetol. 2021;20:189. [e-pub]
Partnering with African-American patients to improve disparities in care
Type 2 diabetes is a growing health concern in the United States, and research shows that non-Hispanic African-American adults are 60% more likely than non-Hispanic White adults to have the disease. In addition, African-American patients are more likely to experience worse diabetes control and complications, including blindness, kidney disease and amputations. The reasons for the disparities are numerous, with one study citing factors such as a clinician’s cultural awareness, unconscious bias, suboptimal healthcare delivery, a patient’s knowledge of the disease, socioeconomic status, nutritional preferences and more.1,2
Joshua Joseph, MD, Assistant Professor of Medicine in the Division of Endocrinology, Diabetes and Metabolism at The Ohio State University Wexner Medical Center in Columbus, leads a research group dedicated to understanding risk factors for the development of type 2 diabetes in diverse populations. He notes that more systemic solutions focusing on individual communities and upstream policies are needed to address the disparities in diabetes care. Along with that challenge, a recent poll found that 7 in 10 African-American adults say they are treated unfairly by the healthcare system, and more than half say they distrust it, according to a study by The Commonwealth Fund.3
Despite these hurdles, there is much you can do as a clinician to promote optimal health and reduce disparities among African-American patients with diabetes, Dr. Joseph says. It starts with understanding the unique cultural differences and promoting culturally sensitive, patient-centered care. “Trust is a big part of diabetes care,” Dr. Joseph says. “I think it’s important to listen and connect with African-American patients to understand the individual challenges they’re facing.” Here, Dr. Joseph and Chinenye Usoh, MD, Assistant Professor of Endocrinology and Metabolism, Wake Forest School of Medicine, and endocrinologist at Wake Forest Baptist Health, Winston-Salem, NC, offer ways to build such a bridge.
Stress they are the captain of their care team.
Dr. Joseph believes in using a team-based, patient-centered approach to help African-American patients better manage their condition and avoid complications. “I see my patients as superstars working to hit home runs,” Dr. Joseph says. “My role is to serve as their coach and to offer the support and resources they need to reach their goals and achieve positive outcomes.” Along with discussing diabetes medications and how they work, Dr. Joseph emphasizes the need to combine them with lifestyle changes. “When I talk to patients about how to best meet their goals and stay healthy, I compare successful diabetes management to a four-legged chair,” he says. “I explain how sleep, nutrition, physical activity and stress are each a leg on the chair and if one of the legs is missing, the chair falls.”
Dispel misconceptions.
“Many people still experience a sense of shame and fear when they receive a type 2 diabetes diagnosis,” says Dr. Usoh. Knowing this, she strives to empower her patients with knowledge. “I work to explain ‘the why’ behind what we’re doing, what their A1C level means and how they can be proactive in managing their diabetes to prevent complications.”
One of the most common questions she hears: “Why did my blood sugar go up?” When educating patients, Dr. Usoh says she tries to dispel misconceptions they may have about their diagnosis and treatment while offering facts and resources. A few sites with information for patients and their providers: Denver’s Center for African-American Health (caahealth.org); the ADA’s cultural programs (diabetes.org/get-involved/community) and The Office of Minority Health (minorityhealth.hhs.gov).
Set them up for success.
Dr. Joseph knows a diagnosis can seem overwhelming, so rather than having his patients work on multiple lifestyle changes at once, he encourages them to set small, realistic goals. “I use the SMART acronym, a well-established goal-setting tool, to help patients set achievable goals,” he says (SMART stands for Specific, Measurable, Achievable, Realistic and Time-bound). “For example, patients with diabetes may decide to increase their physical activity by walking two days each week for 30 minutes at a time.” It’s an effective approach: A recent study showed that patients who set flexible, self-selected goals saw improvements in hyperglycemia even in the absence of substantial weight loss.4
“Trust is a big part of diabetes care. It’s important to listen and connect with African-American patients to understand the challenges they’re facing.”
—Joshua Joseph, MD
Help them gain access to healthy foods.
Research shows that predominantly African-American neighborhoods are less likely to have large supermarkets offering fresh, healthy food options and more likely to have convenience stores that sell processed, high-fat, sugary and salty foods.5 “Telling my patients with diabetes to eat healthier isn’t helpful if they don’t have access to nutritious food options,” Dr. Joseph says. He often refers patients to The Ross Heart Hospital Community Garden at Wexner Medical Center, where they can learn how to grow and harvest fruits and vegetables and participate in free weekly nutrition classes. “In addition, we have a mobile education kitchen that travels through central Ohio neighborhoods, educating the community on how a plant-based diet along with exercise can help with weight loss,” notes Dr. Joseph.
For patients who don’t have access to such community resources, experts at the American Diabetes Association note that many people can still get canned vegetables at Dollar Stores and convenience stores, so ask patients what they have available and work with that. One caveat: Alert patients to avoid produce canned with syrup and to rinse off sugary liquids. For more low-cost eating tips, see diabetesfoodhub.org.
Offer realistic dietary changes.
Dr. Usoh talks with her patients about simple ways to improve their eating habits. “It might be starting with giving up carbonated sodas,” she says. “I also refer newly diagnosed patients to a diabetes educator who can help with specific recommendations and offer substitutions on how to make their favorite meals healthier.” In addition, the nonprofit organization Oldways offers free nutritional programs such as the African Heritage Diet, which features classes across the country in-person and online, that demonstrate healthier ways to make traditional foods such as Cajun-style gumbo, succotash soup and more (visit oldwayspt.org).
Ask about financial barriers.
When a patient has blood sugar levels that are higher than normal, Dr. Usoh will ask if they’ve been missing doses of their medication. “Sometimes, because of cost, patients will ration their medication,” she says. “Others will hesitate to fill prescriptions.” By having an open, nonjudgmental conversation, Dr. Usoh says it’s possible to determine why patients aren’t taking their medication and find solutions. “We can ask our preauthorization team if there are other, more affordable medication options, or offer patients coupons to discount medication sites such as GoodRx.com,” Dr. Usoh says. In addition, most pharmaceutical websites offer patient-assistance programs.
“Prescribe” regular exercise.
Rather than just advising his patients to get more physical activity each week, Dr. Joseph prescribes the “Exercise is Medicine” program at Wexner Medical Center to help patients establish a regular workout routine. “The program meets each patient at their own starting point,” he says. “If they haven’t been physically active, or if they have an injury or limitation, they learn how to modify specific exercises to get the best results.” He says this often inspires patients to join their YMCA or continue an exercise program at home.
For people who are unable to attend a hospital-based program—for example, due to work conflicts or lack of transportation—Dr. Joseph recommends that his patients start by walking several times a week. For added motivation, encourage patients to join walking groups, such as those offered by local ADA chapters, African-American churches and GirlTrek, a nonprofit health organization for African-American women with chapters across the country. To date, the organization has more than 800,000 participants in their events (visit girltrek.org). —Linda Childers
“Many still experience a sense of shame and fear after they receive a diabetes diagnosis. I work to explain ‘the why’ behind what we’re doing.”
—Chinenye Usoh, MD
References
1. U.S. Department of Health and Human Services, Office of Minority Health. Diabetes and African Americans. Available at minorityhealth.hhs.gov.
2. Caballero AE. The “A to Z” of Managing Type 2 Diabetes in Culturally Diverse Populations. Front Endocrinol. Aug 2018;9:479. [e-pub]
3. The Commonwealth Fund. Understanding and Ameliorating Medical Mistrust Among Black Americans. January 14, 2021. Available at commonwealthfund.org.
4. Ritchie ND, et.al. Patient-centered goal setting in the national diabetes prevention program: a pilot study. Diabetes Care. Aug 2021; dc210677. [epub]
5. Bower KM, et al. The intersection of neighborhood racial segregation, poverty and urbanicity and its impact on food store availability in the United States. Preventive Medicine. 2014;58:33-39.
Overcoming barriers to adherence
by Alex Evans, PharmD, MBA
Despite enormous strides in treatment, nonadherence is one of the biggest factors associated with poor outcomes in patients with diabetes. Research estimates that in the United States, nonadherence to prescribed medications for chronic conditions results in about 125,000 preventable deaths and a 10% increase in hospitalizations each year.1 Studies looking at type 2 diabetes specifically reported these sobering findings:2,3
- One in three patients reported missing at least one dose of oral antihyperglycemic medication each month.
- Only 60% of patients taking insulin reported medication adherence.
- Poor medication adherence and missed clinical appointments were each independently associated with a 1.6-fold increase in all-cause mortality.
- Each 1-point drop in self-reported medication adherence (using the Morisky Medication Adherence Scale) was associated with an increase in physician (4.6%), emergency room (20.4%) and hospital (20.9%) visits.
- Poor adherence to medications used to treat diabetes, dyslipidemia and hypertension resulted in an estimated direct cost of $105.8 billion across 230 million patients with type 2 diabetes.
While there are numerous reasons patients don’t adhere to their medication regimens—and as a practicing pharmacist, I have seen my fair share of them—there are a few barriers that seem to account for much of treatment nonadherence. Here are three of the most common along with solutions to overcome them, which will ultimately help improve patient outcomes and quality of life.
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1. Lack of motivation
The patient’s motivation, or lack thereof, to take medication can come from a variety of sources. Often, they worry about side effects, don’t understand the seriousness of their condition, or possibly even have underlying depression or apathy toward their own health. Here are some top ways to keep your patients engaged:
Gauge their understanding and provide education
This sets the stage for good adherence, says George Grunberger, MD, Clinical Professor of Medicine, Wayne State University School of Medicine, Detroit. “I think it’s critical to sit down with the patient and negotiate treatment based on the targets you recommend. Get a feel for how far and how intensely they want to be managed,” suggests Dr. Grunberger. “In addition, I provide patients with a self-care chart from the American Association of Clinical Endocrinology that they can keep in a prominent place, such as on their refrigerator. The chart is a list of professional exams, lab work and self-care practices for prevention/early detection of complications, as well as desired frequency and results—similar to a car’s maintenance schedule. Patients should be praised for sticking to their plan.”
Put the patient in charge
A common reason patients lack motivation is because they feel powerless over their condition. In the case of type 2 diabetes, I tell them diet and exercise cannot only prevent poor outcomes, but might even help reduce the amount of medicine they take. While I ensure they don’t stop taking any medication without their provider’s involvement, I often see a shift in attitude once the patient realizes they have some control over their condition.
Help them identify tangible benefits
To improve adherence, Dr. Grunberger suggests finding their personal motivator. “The trick is to help patients see the real-life payoffs down the road if they take care of their diabetes today. Most of these problems—hyperglycemia, hyperlipidemia, hypertension—are asymptomatic, so patients are not going to feel ‘better’ if you put them on medication,” he notes. “So what is important for them? I might say, ‘If we achieve these mutually negotiated goals, you might get to dance at your daughter’s wedding,’ or ‘You might celebrate your 50th anniversary.’ Whatever it is, you need to be very concrete so they connect to it emotionally.”
2. Financial issues
Lack of insurance or inability to afford copays not only leads to unfilled prescriptions, but also to medications taken incorrectly. For example, I recently saw a patient who wanted to forgo taking medication because of the cost. Thankfully, I work for a nonprofit and was able to get it covered through our foundation. Since many practitioners may not have access to such a resource, here are other ways to help overcome financial barriers:
Apply for patient assistance programs
I’m often surprised at how few offices take advantage of such programs to ensure their patients are able to get on the therapy their provider truly wants them on. Offered by most pharmaceutical manufacturers, patient assistance programs allow eligible patients to receive their medications at little or no cost and get it delivered to their home or their provider’s office. Here are my best practices for maximizing these programs:
- The prescription has to come from the doctor’s office. The pharmacy is unable to transfer or send the prescription to the manufacturer; it must come directly from the provider’s office. I have seen this misunderstanding lead to delays in application processing.
- Write the prescription for a 90-day supply with three refills. The patient will need to call and request additional refills, and the manufacturers often will fill 90 days at a time for up to 1 year, so it’s important to prescribe the patient as much at one time as is allowed.
- Send all paperwork at once. For example, if the prescription is faxed one day, but the application is faxed the next, I have often seen manufacturers reject both for being incomplete. It makes sense to send everything at once, after the patient has filled out their portion, and keep the confirmation page with the application.
Take advantage of copay cards and free trials
Both are available from many manufacturers and can really help patients with financial issues. With copay cards, I bill their insurance first, then bill the copay card to bring down their share of the cost to a more affordable amount. With free trials, the manufacturer pays in full for the medication for a trial period, typically 30 days. Here are important things to know about them:
- Can be used with patient assistance programs: Patient-assistance applications take time to process, so in the meantime a free trial card can get the patient one month of the medication to bridge that gap until their application is approved.
- Government insurance: If the patient has a government plan (Medicare, Medicaid, Tricare, etc.), they are ineligible for copay cards, though they can use a free trial card.
- Maximum benefit: All the copay cards I’ve seen have a maximum benefit, often around $100 to $200, so if the patient’s copay is very high, their card will likely not cover the full amount.
Look into nonprofits
Dispensary of Hope is a nonprofit drug distributor that works with partner pharmacies to offer medications at no cost to eligible patients. It offers a wide range of generic medications and even insulin, and has been a tremendous asset to us as we work to address financial barriers. A list of participating pharmacies is available at dispensaryofhope.org.
3. Cultural differences and low health literacy
It’s estimated that 80 million Americans have low health literacy, struggling in skills such as accessing healthcare, interpreting test results, finding health information and communicating with healthcare providers. Patients with poor health literacy have been shown to have worse outcomes compared with those who have high health literacy.4
Cultural differences in the practice of medicine and administration of healthcare can also create barriers between providers and patients. Here are strategies to break down these walls:
- Use aids to improve understanding. Helpful strategies include using the following: graphics and illustrations, the teach-back method, using simple language, asking open-ended questions, and even using apps and patient portals, which can all improve patient understanding of their healthcare.5
- Ensure health education is in their native language. Nearly every health system has interpretation lines, and when I was a pharmacist in Maui, I met patients from nearly every continent and used that phone line every week. Unless you truly speak the patient’s native language, it is best to call an interpreter when communicating health information.
- Be aware of cultural differences. Whether it is hesitancy about taking Western medicine or the fact that a certain member of the household is typically the decision maker in that culture, it is critical to address cultural differences when treating patients. In Japan, for example, prescription refills don’t exist.6 That means a newcomer to our system likely won’t understand what “I’m giving you 90 days with three refills” means.
- Remember that some things are universal. Everyone understands what a smile means and what kindness looks like. There is nothing that closes a cultural gap faster than showing them you care and being honest and respectful.
Getting patients on board with a multidrug regimen
Asking a patient with type 2 diabetes to agree to take more than one medication is the first hurdle. Ensuring they take all their medications exactly as prescribed—and keep taking them—is another challenge all its own. The following tips can help increase your patients’ odds of success.
Explain how each medication works. “Patients often don’t understand how and why a drug is supposed to work,” says Veronica Brady, CDE, a diabetes nurse practitioner at the University of Nevada School of Medicine in Reno. Patients are less likely to skip doses if you explain how a drug lowers blood glucose and why that’s important. This is particularly true for patients who don’t have symptoms and may not see the point in taking medication. “Make sure the patient understands that diabetes is a progressive disease,” says Brady.
Consider combination or extended-release formulations. Some patients complain that taking several drugs is confusing, and studies show that fixed-dose combination pills improve adherence. Taking one pill instead of two also eliminates a copay, notes Brady. In addition, Carol Wysham, MD, an endocrinologist at Rockwood Clinic in Spokane, WA, has found that combination products containing extended-release metformin, which is only taken once a day, seems to mitigate the GI side effects. “We all recognize how important metformin is as the foundation of pharmacologic therapy for type 2 diabetes,” says Dr. Wysham. “Most of my patients that have previously been intolerant of metformin do better on this formulation. The metformin in these products is the Depo-Med technology, which is associated with much greater tolerability.”
Use reminders. Patients who forget to take medications should leave pill bottles by toothbrushes or coffee mugs—wherever they won’t be overlooked. Setting reminders on smartphones also helps. Brady says that one of her patients has even programmed an Amazon Echo (a voice-controlled “smart” speaker) to call out reminders to take her meds.
Make it convenient. Research has found that type 2 diabetes patients were more likely to take drugs as directed if they received the medications by mail. Also, users of injectable drugs were less likely to miss doses if they used a pen-style injector instead of a syringe.3
Supervise the first injection. If you’ve prescribed an injectable medication, have the patient take the first dose in your office, suggests Florida diabetologist Frank Lavernia, MD. “That first injection will not happen at home, because a patient will think it’s going to be painful,” says Dr. Lavernia, who adds that most patients are surprised to learn that the fine-gauge needles used today produce little pain.
References
1. Kini V, et al. Interventions to improve medication adherence: a review. JAMA. 2018;320:2461-2473.
2. McGovern A, et al. Systematic review of adherence rates by medication class in type 2 diabetes: a study protocol. BMJ Open. 2016;6:e010469.
3. Polonsky WH, et al. Poor medication adherence in type 2 diabetes: recognizing the scope of the problem and its key contributors. Patient Preference and Adherence. 2016;10:1299-1307.
4. Berkman ND, et al. Low health literacy and health outcomes: an updated systematic review. Ann Intern Med. 2011;155(2):97-107.
5. 8 Ways to Improve Health Literacy. Institute for Healthcare Improvement. Available at ihi.org.
6. Akaba Y, et al. Challenges of instituting a prescription refill system in Japan. RSMP. 2019;9(2):69-78.
Case Study
PATIENT: Isabel, a 57-year-old Hispanic woman,
was diagnosed with type 2 diabetes 5 years ago.
“Isabel needed a
therapy that fit with
her lifestyle and preferences”
PHYSICIAN:
Carol H. Wysham, MD,
Clinical Professor of Medicine,
University of Washington;
and an endocrinologist at the
Rockwood Clinic in Spokane
Treatment History:
At our first visit, Isabel had an A1C of 8.1%, BMI of 35 and a blood pressure of 134/80. She was taking metformin, an SGLT2 inhibitor, atorvastatin and lisinopril. She had previously been treated with glipizide but stopped taking it after experiencing hypoglycemia at work. As a busy emergency room nurse, it was very embarrassing to have symptoms (e.g., feeling dizzy and faint) and need to ask coworkers to cover for her while she left to treat her hypoglycemia with juice.
Isabel’s job and family life also made it difficult to manage her blood sugar. She worked the 3 to 11 pm shift and sometimes had no time to eat, yet there were always snacks around, which were easy to grab on her breaks. In addition, she was divorced, with her youngest of three kids still at home. Plus, she comes from a large, close-knit family and food is part of her culture, making it hard to avoid eating traditional meals.
Isabel was also concerned about her family history. Her father and brother had diabetes as well as cardiovascular and kidney problems. Her goals were to lose weight, avoid hypoglycemia and prevent complications.
Initiating treatment:
I recommended that Isabel start a GLP-1 agonist, which could help her achieve all three of her goals: It has a low risk of hypoglycemia, could help her lose weight by controlling her appetite and help lower her risk of cardiovascular disease. She was eager to start it but expressed a preference for oral medication. Before prescribing it, I told Isabel that the most common side effects were nausea and other gastrointestinal symptoms. However, I assured her we could minimize them by starting at a low dose and slowly titrating as needed. I also advised her that eating smaller meals with a lower fat content and eating slowly can help minimize symptoms.
I instructed Isabel to take her tablet first thing upon awakening with no more than 4 oz. of plain water and to wait at least 30 minutes before taking other medications and eating. I told her waiting even longer might help increase absorption of the oral medication. In addition, we discussed lifestyle changes. I encouraged her to join Weight Watchers or similar group, take healthy snacks to work and keep a food journal to get a better idea of what was driving her eating. If it was hunger, the GLP-1 agonist should help with this. If she ate due to stress or boredom, I suggested trying other behaviors, such as taking a brisk walk or doing meditation. I also encouraged her to work on increasing her leisure-time physical activity.
We started Isabel on the oral GLP-1 agonist at 3 mg daily for 1 month, then increased to 7 mg. At her 3-month follow up, Isabel had lost 8 lbs., her A1C dropped to 7.0% and her blood pressure was 130/75. She reported mild nausea when starting the oral GLP-1 agonist, which resolved after about 2 weeks. She also noted a reduction in her appetite and was not eating snack foods, and she had joined a weight-loss group at her church. Isabel was motivated to continue her regimen and felt she was on the road to better health.
Considerations:
Controlling Isabel’s glucose was imperative given her A1C, weight and family history of diabetes and cardiorenal disease. When deciding on a regimen, her work schedule and problems with hypoglycemia also needed to be considered. A GLP-1 agonist could address all these issues, and the oral form offers similar benefits as the injectable in a convenient once-daily pill. For patients like Isabel who are hesitant about taking an injection, being able to offer them an oral version is a welcome option that may encourage them to try this class of medication.
Q&A
Managing type 2 diabetes
Determining A1C goals
Q: How do you individualize a patient’s A1C goal?
A: Many factors are taken into account. There are general goals set by the AACE and ADA, but it’s also very important to individualize such targets based on the patient’s characteristics and other factors. For example, people with newly diagnosed diabetes and those with longer life expectancy may benefit from more stringent efforts to lower their A1C. In those instances, I think it’s beneficial to treat aggressively to reach those goals, as long as it can be done safely.
However, we need to be careful in preventing hypoglycemia and other side effects related to escalating therapy. I believe once the decision is made with this in mind, there should be a clear plan of treatment in order to achieve the agreed upon goal. When patients are motivated to keep their goal, I would recommend spending time explaining how to manage side effects and ways to minimize risks rather than de-intensifying therapy. On the other hand, in patients with severe complications or comorbidities, the A1C goal could be less stringent. Regardless of age or comorbidities, any treatment decision should take into account the patient’s preference and the available resources and support.
—Joanna Mitri, MD,
Research Associate, Joslin Diabetes Center, Boston; Instructor in Medicine, Harvard Medical School
Resistance to pharmacotherapy
Q: What’s your strategy when patients resist add-on medication or want to use only diet and exercise?
A: I see my role as a consultant or partner in a shared decision-making process with people living with diabetes. I discuss with my patients the evidence available to support or go against the need to use a certain add-on medication. It is important to me that we have the time necessary to have an informed conversation and spend the time to come together on the decision-making process. I see that once patients are made aware of how their medications work and what to expect, they are more open to add on medications or other interventions.
Also, I am always open to have a conversation with patients about a treatment plan using only diet and exercise, when appropriate. Diet and exercise remain vital in the management of diabetes for all patients regardless of their medication regimen. I feel the need to remind my patients that medications are not alternatives to lifestyle changes.
—Nuha Ali El Sayed, MD,
MMSc; staff physician, Joslin Diabetes Center; Instructor in Medicine, Harvard Medical School
Avoiding hypoglycemia
Q: How do you help patients avoid hypoglycemia? Which patients are especially prone to this problem?
A: First, it is important to establish that any patient complaining of hypoglycemia truly has low blood sugar, as many people feel these symptoms for a variety of reasons; hunger, fatigue, anxiety, hypotension and other illnesses may all present as “hypoglycemia.” A confounding factor in the patient with diabetes is that they may become habituated to higher blood glucose values and feel symptoms of hypoglycemia at normal or even high blood glucose values. They may also perceive rapid changes in blood glucose as hypoglycemia. This is especially true in patients on insulin. Those on oral secretagogues like sulfonylureas may note that they feel hypoglycemic when their medications peak, even though they may in fact experience only normalization of blood glucose. This is important as perception of hypoglycemia is an aversive sensation and many patients will eat in response, fueling weight gain and higher blood glucose.
Adding insulin substantially increases the risk of hypoglycemia and therefore must be used judiciously. Patients need to be aware that their blood sugar may become too low and educated regarding the symptoms of hypoglycemia. If patients do have hypoglycemia, we work to identify precipitating events, like missing a meal, exercising or drinking alcohol. We then devise a plan to modify behavior or medication dosing to reduce risk of low blood sugar.
—Susan Herzlinger, MD,
Joslin Diabetes Center; Division of Endocrinology, Beth Israel Deaconess Medical Center, Boston
Addressing mental health
Q: Depression and other mental health issues are common in patients with diabetes. What is your approach to screening and management?
A: Patients are more likely to take care of their diabetes when they are feeling well mentally and physically. The American Association of Clinical Endocrinology (AACE) recommends screening for depression in all patients because of the effects on disease management, including difficulty following a healthy eating and exercise plan and adhering to medications. I try to assess a patient’s mood at each visit, such as asking them to describe how their mood is currently and how the past few months have been for them. In addition, I encourage patients to bring family members or close friends to their office visit, since often a loved one may notice mood-related changes that the patient has not yet been able to vocalize. My goal is to ensure patients have an adequate support system with access to resources, and I refer them as necessary. It is important for patients with diabetes to feel they can reach out to different healthcare professionals, including for help with depression, anxiety and personal issues. This in turn helps them manage all aspects of their diabetes and ultimately facilitates better overall health and well-being.
—Rachel Pessah-Pollack, MD,
Clinical Associate Professor, NYU Langone Health, and member of the AACE Board of Directors
Expert Insight
Oral GLP-1 agonists:
Optimizing use in clinical practice
1. What is the significance of an oral GLP-1 agonist being available?
As a class, GLP-1 receptor agonists treat multiple metabolic risk factors. Not only do they lower glucose levels, but they also facilitate weight loss, improve liver steatosis, lower blood pressure, decrease lipid levels and inflammatory markers and, for some of the agents in this class, reduce the risk of major cardiovascular (CV) events. Despite these benefits, it is estimated that less than 15% of eligible patients are prescribed GLP-1 agonists. One reason is that they were first available only as an injection, and while it is easy to use and virtually painless, most patients’ initial reaction would be to shy away from an injectable therapy. Practitioners find it time consuming to provide additional education to ease patient concerns, teach them how to use the device and follow up to ensure adequate injection technique. As such, many providers don’t even offer this option, perpetuating the treatment gap and withholding from patients a potentially useful therapy. Oral GLP-1 agonists were developed to bridge this gap and make this class available to more people who would benefit from them. Oral semaglutide is the first GLP-1 agonist available as a pill, with others in the pipeline.
2. How does it compare with other glucose-lowering medications?
Oral semaglutide has demonstrated effectiveness in a range of patients, including those with early diabetes, those on multiple glucose-lowering agents, including insulin, and those with CV complications. In addition, oral semaglutide was compared with other glucose-lowering agents, including an SGLT2 inhibitor, a DPP-IV inhibitor and two injectable GLP-1 agonists (liraglutide and dulaglutide). In all studies, oral semaglutide at a dose of 14 mg showed similar or superior reductions in glucose and greater reductions in weight vs. the comparator drugs. There has been no head-to-head study comparing the injectable and oral forms of semaglutide. The injectable form of semaglutide was shown to reduce major CV events in those with pre-existent CVD in the SUSTAIN 6 trial. Oral semaglutide showed a similar trend in the smaller PIONEER 6 trial and is currently being evaluated in a large CV outcomes trial called SOUL.
3. You coauthored a study on real-world use of oral semaglutide. What were the findings?
The IGNITE study is a retrospective, observational, real-world practice study in which we evaluated the characteristics of the patients who were prescribed oral semaglutide shortly after its approval, along with the changes in their glycemic control over the first 6 months of use. We identified 782 patients in an electronic health record database who were prescribed oral semaglutide, in most cases by their primary care provider. These patients were more likely to have obesity than patients enrolled in the clinical trials, suggesting that practitioners perceive a greater benefit in those with a higher weight. In addition, many patients were not up-titrated to the full dose of 14 mg. Despite this, there were still significant reductions in A1C of 0.9%. While we were not able to understand the reasons behind this apparent underdosing, it is concerning that patients will not be able to experience the full benefit of the therapy.
The main takeaway: It was great to see that PCPs were comfortable prescribing oral semaglutide, which hopefully will eventually bridge the gap discussed above. However, prescribers should be educated about the need for up-titration to the full tolerated dose of oral semaglutide to maximize the outcomes from this therapy.
OUR EXPERT: Ildiko Lingvay, MD, MPH, MSCS, endocrinologist and Professor of Medicine, University of Texas Southwestern Medical Center, Dallas
Clinical Minute:
Test your knowledge of type 2 diabetes treatment
Special thanks to our medical reviewer:
Mihail Zilbermint, MD, FACE, Associate Professor of Clinical Medicine, Division of Endocrinology, Diabetes and Metabolism, Johns Hopkins School of Medicine
Reviewed by:
Thanks to the American Association of Clinical Endocrinology for their review of this publication.
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