The Current State of Individualized Diabetes Care

The diabetes epidemic continues to plague the United States, with more than 30 million Americans coping with the disease, according to data from the Centers for Disease Control and Prevention (CDC). Although about 9.4% of the US population has been diagnosed with diabetes, almost one-quarter of that group—23.8%—are as yet undiagnosed.

Physicians, medical teams, and researchers across the country are seeking new ways to manage the condition. One physician, Marilyn Tan, MD, the chief of the Stanford Endocrine Clinic and clinical assistant professor of endocrinology, gerontology, and metabolism, is involved in drug trials and is seeing 2 primary trends in diabetes care, both linked to personalized care—a trend beginning to appear in medicine.

“I think the 2 main themes in diabetes care are the technology, such as the new insulin pump which is available for type 1 diabetes, and this new idea of cardiovascular indications for medications for type 2 diabetes,” Tan said. “We're still waiting on a lot of the cardiovascular outcome trials for some of these medications, however; it doesn't seem like a slam dunk for cardiovascular benefits throughout the class of medications, and instead seems to be drug-specific based on the data that we currently have.”

Seth Martin, MD, MHS, is the co-director of the Advanced Lipid Disorders Center and an assistant professor of medicine at Johns Hopkins University in Baltimore, Maryland. In that role, he collaborates with endocrinologists as well as other cardiologists, working to help many diabetic patients to manage their care. Martin sees the inclusion of patient assessments in the personalized care plan from the start as essential to its success.

Dual Indication Therapies

“From the standpoint of personalizing care, the reality is that often when we see patients in our clinic, they're not coming in because they just have 1 problem,” Martin told MD Magazine^®. “They have multiple things going on, and it's a question of prioritization. We should be asking ourselves—and discussing with our patients—what is the next most important thing that we can do in your care to help you?”In the past year, several diabetes medications have received dual indications from the US Food and Drug Administration (FDA) for their ability to lower cardiovascular disease risk, in addition to managing glycemic control.

So, will doctors be prescribing these drugs more in 2018? Martin said that it is still an open question, and noted that it will depend on the extent of ownership that physicians are willing to take with the new therapies.

“I think, probably, a good number of folks will be prescribing these and have an interest in them,” Martin said. “However, I think a doctor's level of familiarity and comfort with the drugs will play an important role here. So, will the desire to deal with the burden of paperwork prior authorizations [outweigh their desire to try them]?”

There are other roadblocks to getting new dual-indication therapies widely used—according the price, Martin said. “These new drugs are expensive, and insurance companies put up firewalls to get them.”

Another struggle could be the location of the physician’s practice. If the patient only has access to a single physician and is not necessarily seeing multiple specialists for these multiple conditions—cardiovascular risk and diabetes—then the odds of getting the dual-indication therapies prescribed could decrease.

“If you're in a location where there's not as many specialists around and you are it, the patient's going to get it from you, or it's not going to happen,” Martin said.

Because some hurdles have to be cleared to get widespread utilization, it boils down to how effective these drugs are. But according to Tan, that's not an always an easy question to answer.

“We have a couple that have shown benefits, and then a couple that are neutral,” Tan said. “I think it's reassuring that none of them have shown increased cardiovascular risk, but I think we still have to tease out the effects; the studies weren't all designed the same way, so you can't really compare them. If you take a bunch of high risk people and then put them on the drugs, it's hard to know how it influences your control group, or whether patients are having worse outcomes because they're high risk.”

There is also an important difference between the existence of a benefit and the absolute reduction in risk, noted David Nathan, MD, the director of the Diabetes Center and Clinical Research Center at Massachusetts General Hospital, in Boston.

“They have their strengths, and they have their weaknesses,” Nathan told MD Magazine^®. “The benefit is real in terms of reducing heart disease, but the absolute reduction in risk is actually quite small—it's a couple of cases per 1000 patients treated. So, you know, we should keep the modesty of the absolute risk reductions in mind.”

In addition, patients must be invested in their treatment, or even the most advanced drug will fail them. No matter how exciting it is to have dual-indication therapies, there are still issues with medication adherence, especially for patients with diabetes.

“Because we've had longstanding problems with medication adherence in our patients with other drugs that have worked well in the past,” Martin said, “I think we need to really pay more attention to this issue of not just who is a good candidate for the drugs, but which patients understand why they would be taking the drug and why is it so important—and how it fits into their other drug regimen. The implementation piece is not straightforward.”

Moreover, these drugs won't be perfect for each patient—not least because they come with their own risks, including adverse effects.

New Technologies Personalizing Care

“As exciting as these new medications are, I think people often forget about the contraindications and the risks,” Tan said. “For example, for the Jardiance, there is an increased risk of kidney infection, yeast infections, diabetic ketoacidosis, acute kidney injury—all things that they list at the end of the commercial that people don't really listen to. It's not a one-size-fits all medication.”The use of Medtronic’s new insulin pump—which personalizes dosing based on patient history and partially automates administration—is expected to become widespread in 2018. This is just one example of the ways that newer, smarter technologies will be changing diabetes care in the immediate future.

“Technology-wise, the newest pump that people are most excited about is the Medtronic 670 G,” Tan said. “This is the one that can help to automatically adjust basal levels of insulin based on feedback from a continuous glucose monitor which is sensing blood sugar levels, including variabilities throughout the day.”

Normally, the patient would have to essentially guess at how much insulin in the correct dose, in an attempt to mimic what the body would do in terms of insulin production. The Medtronic 670 G pump does all of that for the patient.

“[It] uses algorithms and continuous glucose monitors to adjust and predict where the blood sugars might go and adjust basal insulin rates accordingly,” Tan noted.

In terms of how the Medtronic 670 G compares with other options that are on the market, Tan said that right now it is an advanced product, but may be misunderstood by patients. Some patients appear to be under the impression that the pump is a sort of artificial pancreas, she said.

“It's as close as you can get these days to having an automated pancreas in terms of adjusting insulin based on your blood sugar information, it's still not quite like an artificial pancreas,” Tan said. “For example, it can't help you determine how much insulin you need to counter your food; you still have to manually enter those values. You also still have to change out the sensors and infusion sets every couple of days.”

“In addition, the sensors usually require blood sugar calibration, so you still have to check finger sticks twice a day, at least. It requires a lot of work on the part of the person who's using it,” she added.

However, this is not to take away from the device’s importance. For Tan, it still is a better option than most of the available choices because it takes away a lot of the patient burden of needing to calculate or guess at dosing.

On the Horizon

“A lot of people want to be on it,” she said. “Looking at the data for people who have been on these new pumps, it definitely reduces the fluctuation of the blood sugars and the variability, and helps to better get them into the narrow range of ideal blood sugars that we're aiming for.”Personalized diabetes care is definitely on the horizon, and although experts have different ideas about what is coming first, that general assertion is certainly not in dispute.

Michael Greenfield, MD, a practicing endocrinologist at El Camino Hospital in Palo Alto, California, argued that diabetes care is “absolutely” well-positioned for a move toward even more personalized or precision care.

Glooko, where Greenfield works as the chief medical officer, created an FDA-approved software used to monitor diabetes remotely, marking another technical advancement that is making personalized care more accessible.

“Diabetes is a very metricized condition,” Greenfield explains. “People with diabetes are asked to check their blood sugar at least daily, and are often having tests that add more data to the coffer. Since diabetes is very data rich, that data can be used to uncover insights about an individual's behaviors and how those behaviors can impact the progression or improvement of their diabetes. This data can and is being used to help both people with diabetes and care teams make better decisions.”