Coverage from the July 11, 2019, meeting of the Institute for Value-Based Medicine®, an initiative of The American Journal of Managed Care®. The meeting took place in Arlington, Virginia.
The chart on the screen tracked the patient’s blood glucose with a red line and insulin levels in blue. There was a noticeable bump shortly after 4 p.m., and Stephen C. Clement, MD, director of Endocrine Services at Inova Fairfax Hospital in Annandale, Virginia, challenged his audience to guess why.
The answer: the study was from England, and it was tea time! Servings of tea with sugar and milk, or perhaps a scone, were showing up in the data.1
Clement’s question illustrated his point: environment has everything to do with a person’s blood glucose and insulin patterns, and in the United States we haven’t done the best job of creating or sustaining healthy environments for good diabetes management. In fact, some native populations have seen their environments destroyed, followed by the population-wide devastation of their health because they were no longer working farmland or gathering their own food. For example, the Pima people, who live in southern Arizona, have the highest rate of type 2 diabetes (T2D) in the world at 38%, even though genetically similar people living in Mexico have rates of (T2D) of nearly 7%. around 6.9%.2
Reversing the population health mistakes of recent decades will not be easy, but failing to do so will be deadly and cost more in the long run, according to the panel of experts that Clement convened at the Institute for Value-Based Medicine®, an initiative of The American Journal of Managed Care®. The July 11 session, in Arlington, Virginia, featured:
As Clement explained, the body’s regulation of blood glucose is highly complex; the body is designed to use glucose through exercise and store what it doesn’t use for another time.
“When everything is working great, what’s left in the blood is glucose in a very narrow range,” he said; ideally, Donner explained later, that range is around 80 mg/dL to 180 mg/dL over the course of the day.3
People with T1D no longer produce insulin to regulate blood glucose, including converting it to energy; the inability to regulate blood glucose leads to a host of other complications.
“Those of us who care for people with diabetes know that it’s the leading cause of adult blindness, ESRD [end-stage renal disease], the leading cause of amputations, and the leading cause of heart attack and stroke,” he said.
Because a person with T1D must self-administer insulin—with calculations that factor in food intake, exercise, and sleep—the process of also keeping blood glucose in a narrow range that prevents complications can be overwhelming. As Donner noted, the injections hurt. The math is difficult. It’s not always convenient.
“What if you’re at a restaurant?” he asked, giving a nod to the stigma that many with T1D have described about administering insulin in public.
That’s where insulin pump therapy and continuous glucose monitoring (CGM) technology can make a huge difference. Pumps can be adjusted to administer more or less insulin at different times of the day; for example, it’s known that stress hormones activate between around 4 to 5 a.m., and a normal pancreas would make more insulin to counteract those hormones. “With a pump, we can program the pump to give more insulin,” Donner said.
CGM systems, meanwhile, not only read blood glucose throughout the day, but tell which direction it’s heading, he said. And while pumps and CGM have been around for several years, recently the technology has made significant strides. Donner discussed several innovations and shared photos with the audience:
Donner said he is starting to see higher use of the Freestyle Libre among patients with T2D who are on insulin. “They tend to be pretty well-covered,” by insurance.
Besides designs that are increasingly smaller and more discrete, new features can upload a user’s data to a physician, sparing the patient the need to record daily blood glucose readings. “It’s great for us, as clinicians or nurse practitioners, to see what times of day are our problem areas,” Donner said.
Moreover, remote monitoring features—which let parents or spouses see blood glucose readings in real time—can prevent a trip to the hospital or worse. Donner shared the story of a mother who monitored her son’s blood glucose as it took a nose dive while he slept in his college dorm room. When neither her son or his roommate answered her calls, she finally called security to wake him.
Donner discussed the “artificial pancreas” systems that FDA has approved and those under development. One attendee asked if Donner was familiar with patients who try the “do-it-yourself” systems with shared software on the internet. He did not advocate using something that had not been tested (FDA has recently issued a warning about such systems).5 However, he saidthose who are using such systems “are pushing the companies to advance things more quickly.”
“Nobody dies from retinopathy,” Inova’s Cooper said, as she discussed the need for the care of people with diabetes to “really look at the whole patient,” so that attention is paid not just to disabling complications, but to those that can kill—namely, heart failure.
The integration between diabetes and cardiovascular care has been underway for more than a decade, and Cooper reviewed the transition that began in 2008 when FDA began requiring drug makers to conduct cardiovascular outcomes trials (CVOTs) for new diabetes therapies.6 The early trials to track major adverse cardiovascular events (MACE) have uncovered unexpected benefits for sodium glucose co-transporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists.
Now, attention is finally turning to the connection between diabetes and heart failure. Diabetes increases the risk of heart failure more than 2-fold in men and more than 5-fold in women.7 “We have known this since the Framingham Heart Study,” Cooper said, “We are finally getting there.”
Cooper presented a slide showing all the reported trials and upcoming CVOTs, which showed that while the first wave of trials did not have heart failure as a primary end point, a new wave involving SGLT2 inhibitors and heart failure—including some patients without diabetes—are concluding now (after July’s session, AstraZeneca announced that dapagliflozin had met its primary end points in the DAPA-HF study).8
FDA’s 2008 directive ended up revealing benefits from subsequent classes of T2D drugs that “have ushered in a new era of diabetes drug development.”
Not all the classes behaved the same way. For the dipeptidyl peptidase-4 (DPP-4) inhibitors, the MACE results were “pretty neutral,” Cooper said; with liraglutide, a GLP-1 receptor agonist, and empagliflozin, an SGLT2 inhibitor, there was a clear cardiovascular benefit.
“We finally have the holy grail of diabetes medications,” she said.
With empagliflozin, Cooper pointed to a figure from the EMPA-REG OUTCOME study9 and said, “Look how early these curves separate. Almost immediately you see a benefit.”
While the level of robustness varied among the SGLT2 inhibitors, the trials had one thing in common: results were largely driven by reduction in hospitalization for heart failure, which had long been one of the biggest cost drivers in healthcare.10
“More people should be on these drugs,” Cooper said. “If you can keep people out of the hospital, you are going to save money.”
The bottom line? Cardiologists and endocrinologists must work together to prescribe drugs that will reduce the risk of conditions that harm patients, even if they perceive that condition to fall outside their specialty. Recent prevention guidelines from the American College of Cardiology call for this.11
“We need to move away from referring to somebody else, and we all need to take responsibility,” Cooper said.
The way Jeffery sees it, a diagnosis of diabetes sets off a process that is very much like the stages of grief. Except it’s not linear. “Most of the time, this is a cyclic process,” the endocrinologist said, with patients going through denial and depression and back again.
“Regardless of where they are on that spectrum, it will impair their ability to manage their diabetes,” Jeffery said. “None of the treatment modalities will have any success until they get to acceptance.”
And for many of her patients, social determinants of health—lack of education, housing, or language barriers—must be addressed before acceptance is possible. Jeffery sees many patients who arrive in the emergency department due to diabetic ketoacidosis (DKA) and are diagnosed for the first time. Often, they are overwhelmed by the news itself, let alone the wave of instructions, tools, and new treatments. For those with T1D, Jeffery must explain that many of the drugs they’ve seen in ads on television are not for them.
Welcome to insulin. If patients cannot afford the newer analogs or have no insurance, it will be off to Walmart for the $25-per-vial isophane (NPH) variety, which will make glucose management that much more challenging.
Jeffery shared the stories of 2 very different patients with different outcomes: the first was a Sudanese immigrant sleeping on a cousin’s sofa, who arrived with DKA and glycated hemoglobin (A1C) above 14%, among other conditions. Jeffery went through all her instructions, despite the patient’s expressionless face.
“I feel like all my patients have a kicker,” she said. This patient’s twist? Everything had to be translated by an Arabic interpreter.
Jeffery ran through this young man’s new reality: $50 a month just for insulin, plus the test strips, plus the meter. The young man had 2 more clinic visits before this charity care was exhausted. He was nowhere close to where he needed to be medically. Jeffery doubted his ability or willingness to care for himself, must less advocate for his needs.
The only good news?
“He hasn’t been readmitted for DKA.”
Then there’s Tony, a 19-year-old who was admitted with an A1C of 11.4% a few days before he was set to return to school in North Carolina. His mother and family rallied around him, as he learned how to care for himself, got an insulin pump, and joked with his family about what would come out of everyone’s diet.
Three months later when Jeffery saw him, Tony’s A1C had dropped to 7.4%.
Diabetes, she said, cannot be just an endocrinologists’ problem. There aren’t enough specialists to serve everyone with diabetes, so primary care doctors and nurses must be part of the solution to produce results like the one seen in Tony. “Getting people to change requires the family to accept your diagnosis, and finding a way to implement changes into your work day,” she said.
Too often, Jeffery said, there’s too much “decision inertia,” where primary care physicians see A1C numbers rise over many months before they add more therapies, especially insulin. “We’re using insulin almost as a form of punishment,” she said, as heads nodded around the room.
To be sure, the wariness may have to do with the cost of insulin. Jeffery said she didn’t feel she gained much by watching the insulin pricing hearings in Congress.
People with diabetes are spending twice as much on medication as an average person without diabetes, she said, and patients cannot be expected to manage their disease if a life-saving drug is being priced beyond their ability to pay.
“We are asking our patients to do a lot, and we are not giving them the resources to do it,” she said.
Miller, of the MidAtlantic Business Group, discussed a resource he says is underutilized: wellness programs offered by employers.
Purchasing alliances, he said, have banded together to address rising healthcare costs, and much of that starts with diabetes and obesity. Going after obesity in the workplace, Miller said, deals with healthcare costs “upstream,” before a condition manifests itself as an amputation or an expensive prescription or a disability claim.
Part of Miller’s job is to get his members to see the connection between investing in value-based care and the long-term savings they will realize they can prevent obesity from turning into T2D, or a knee replacement, or a heart attack. “Value is the real point here,” he said, citing the example of not asking people with diabetes to cut back on test strips if it means more of them end up in the ED because they lacked adequate access to testing.
And that’s meant treating obesity as a disease, a designation the American Medical Association made in 2013, but one that has been slow to translate into better reimbursement of obesity drugs on formulary.12
“We’ve been looking at it as a personal failing we’re trying to outgrow that,” Miller said. No one would hesitate to treat someone with an A1C of 11%, but “a BMI of 33 is not looked at in the same objective fashion,” he said.
The first step was to get employers and health plans to create support systems for people with obesity. Well, Miller said, that’s happened, but now the challenge is to work with health plans connect the right patients with those programs.
“Physicians are only talking to 50% of the patients who are obese,” he said. “We find patients and members are not involved in the programs. … They’re all dressed up with no place to go.”
Stigma is one barrier, he said. Physicians fear upsetting their patients by raising the issue of obesity, so it goes unaddressed. But stigma’s not the only problem. The other problem is reimbursement.
If physicians spend time screening patients for obesity and promoting the use of wellness programs they should be paid for this, Miller said. If employers, as purchasers of insurance, end up paying for treatment of hypertension, diabetes, or other ailments associated with diabetes, “We should be paying for obesity management,” he said.
What are the keys to this shift? Miller said it will take better training of physicians so they learn how to have conversations about obesity with patients. It will take more conversations with health plans; in some cases, it means making sure the purchaser coalitions connect with physicians to ensure that they know obesity management programs are part of a health plan. And, it calls for health plans to include obesity management as part of the quality measures used to evaluate physicians.
Employers can and should weigh in with their health plans on this issue. After all, he said, for the most part, employers are the ones who are paying the bills. There’s a long way to go, he said, “but at least we’re beginning the conversation.”