Publication
Article
Evidence-Based Diabetes Management
Author(s):
Robert Kritzler, MD, wears 2 hats: He has been a practicing physician for more than 30 years; with a specialty in pediatric endocrinology, he has seen the rise of obesity and diabetes and its effects on the healthcare system. Today, as a leader in a health plan associated with a major academic institution, he is also part of the national conversation on how to control rising costs, as more patients gain access to the system under the Affordable Care Act.
Evidence-Based Diabetes Management:
Robert Kritzler, MD:
Have you observed progress in the community’s efforts to address diabetes mellitus in children as a public health problem? There has been some progress, but we need to break the progress down into type 1 and type 2 diabetes mellitus. Pediatric endocrinologists see more type 1 disease, and I think there’s been a lot of progress in terms of technology. As a clinician, many more of my young patients are using insulin pumps than in the past. Some of my patients are now using continuous glucose sensors (for continuous glucose monitoring, or CGM). As a managed care medical director, I can say that we’re seeing many more requests for insulin pumps and CGM monitors. That technology is changing how we treat the patient with type 1 disease. Alone, it is, however, not the whole answer. Our bigger concern right now is how we treat the many new young patients with type 2 diabetes, caused by the current epidemic of obesity in the community. We’ve seen a huge rise in the incidence of type 2 diabetes, particularly among teenagers. The obesity epidemic is throughout the United States, but it is hitting harder in the South, and Maryland’s numbers are rising. To an extent, community efforts have resulted in some progress, if not awareness. Clearly, First Lady Michelle Obama’s Let’s Move program has helped to address physical fitness and obesity, as have several other community-based programs. Overall, we’re still moving in the wrong direction with respect to type 2 diabetes.
EBDM:
Dr Kritzler:
What is the missing element from these efforts? Is it a matter of coordination? Is it a real motivation and commitment to participate in these efforts? You hit the nail on the head. For type 2 diabetes, tied to the obesity epidemic, there have been fits and starts—not one concerted effort. The effort needs to work down to things like school lunches, convenience foods, and fast foods, and work at the main reasons our population as a whole is gaining weight.
It’s seen by folks in the field, but not by the general public, as a public health emergency. I question whether all medical professionals consider it the public health emergency that it really is.
EBDM:
Dr Kritzler:
It’s hard to say. The data are already there. We see today the increased incidence of type 2 diabetes in teenagers and young adults. The data on the long-term costs of diabetes to the system are also there. Beyond that my crystal ball is as cloudy as everyone else’s.
From my perspective as a managed care medical executive, we’re trying to conquer the cost of medical care by weeding out unnecessary high-tech imaging and focusing on how much we pay for each individual service, but we don’t pay enough attention to the major public health problem that’s right in front of us.
EBDM:
Dr Kritzler:
You had mentioned the increased use of pumps and sensor devices for type 1 diabetes. What’s your view on our progress toward the artificial pancreas? It’s interesting that you asked me that, because not a day goes by when I’m not asked by one of my patients whether the artificial pancreas is right around the corner. To some extent, the answer is no, although patients and their families desperately want this solution. Today, we have smart pumps that are hooked up to sensors. It even looks achievable with today’s computer technology.
What people don’t fully understand is that glucose regulation involves more than just injecting insulin. We have known for a very long time that glucose regulation involves many hormones beyond insulin. A true artificial pancreas would have to regulate, to some extent, many of those hormones. It’s a more complicated construct than people think. Trials are under way, mostly in Europe, testing multi-channel pumps.
Today’s smart insulin pumps connected with continuous glucose monitoring is a way station towards a more functional artificial pancreas. We’re making progress, but a true artificial pancreas, enabling something approaching more rational glucose control, is further away. I believe this will occur before we see everyday islet cell transplants or that sort of thing. That’s looking into my own crystal ball.
EBDM:
Dr Kritzler:
And a true synthetic pancreas, constructed through some type of regenerative tissue engineering? How far away are we, realistically, from that? We’re a long way from this. Some pretty good research is ongoing, but we’re not anywhere near clinical utility.
EBDM:
Dr Kritzler:
Johns Hopkins is a major research institution. How involved is Hopkins in researching these types of new technologies? Researchers from Johns Hopkins University and the University of Maryland are partners in the JHU-UMD Diabetes Research Center. It is headed by Dr Fredric Wondisford, an adult endocrinologist and metabolism physician. The Center is involved in a tremendous number of studies, probably way more than I know.
EBDM:
Let me ask you to put on your managed care hat. I’d like to talk about young patients with type 2 diabetes or prediabetes and how they transition from adolescents to teens and young adults.
Dr Kritzler:
Coordination is a challenge, not specifically for Hopkins, but in general. Patients with type 1 diabetes primarily receive their care through endocrinologists. Patients with type 2 disease receive their care through a combination of primary care doctors— pediatricians, family physicians, and adult internal medicine—and endocrinology consulting. Coordination can be a real issue. And at some point, teenagers have to transition from a pediatric care system to an adult care system. That’s an issue, even for those with type 1 diabetes, and it’s something the medical community doesn’t do as well as we should.
As with any other hand-off in health care you’re handing off between one provider to another or in some cases between one group of providers, primary care, endocrinologists, to a different group of providers. We all have different styles and different approaches. As a clinician, I tend to continue to see my patients with type 1 diabetes through their college years. These patients are undergoing life transitions at the same time. At some point, we have to transition these patients from pediatric to adult care. As with any other transition in medical care, it can be a challenge.
EBDM:
Dr Kritzler:
What is the most difficult part? It really has very little to do with the medical care system itself. Part of the real challenge is the transition from being an adolescent to being an adult. They’re undergoing numerous life transitions themselves, including from having a parent overseeing their care (particularly in type 1 disease), to having to oversee it themselves. They go to college, out into the workforce, and they move out of the parent’s home. Suddenly they’re adults, or at least the world calls them adults, and they have to take on more responsibility and accountability. For many of us in pediatric endocrinology, one of the things we try to do, particularly with our type 1 patients, is to be sure the transition to self-care begins well before the transition between pediatric medicine and adult medicine. I have many 11-, 12-, and 13-year olds who pretty much know how to run their own pumps and how to reprogram and how to change their basal levels, without a lot of input from their parents. But I also have 16-year-olds who can’t. That becomes a problem. With young type 2 patients, our first interventions are generally exercise and promotion of weight loss before we start medication therapy, and that’s also a question of taking adult responsibility for themselves.
EBDM:
Dr Kritzler:
I can imagine this would be extremely challenging for a patient with type 1 disease who goes off to college. They’re exposed to an entirely new environment, new stresses, the same risks that face other teenagers, including excessive drinking, and different eating habits and eating options… Yes, everybody talks about the “freshmen 15”—new freshmen who gain 15 pounds on dormitory food. This is a bigger problem if you’re already overweight and have prediabetes or diabetes: the freshman 15 can easily be the “freshmen 30.”
EBDM:
Dr Kritzler:
Can you do any special preparation, other than reinforcement and education, to prepare these kids for major life change? It is one of the challenges. That’s why care for type 1 and type 2 diabetes is such a team effort. By team, I mean the physician, advanced practice nurse or other physician extender, clinical diabetes educator, nutrition educator, social worker, and psychologist.
By the time the patient is transitioned to an adult-care provider, we assume that he or she has already moved through these various changes. That’s why I believe the pediatric care system, which is more family oriented, probably does a bit of a better job in facilitating those transitions.
EBDM:
Dr Kritzler:
In terms of treating younger patients with type 2 diabetes, you mentioned that it is not usually an endocrinologist but family physicians. They don’t seem to be as comfortable treating these patients as children as they are as adults. Why does that seem to be the case? Overall, I find that very few primary care physicians are comfortable treating type 1 diabetes, whether they’re pediatricians or family physicians or internists. So those patients are left to the endocrinologist. As for type 2 diabetes, there are just too many people with type 2 disease for the number of specialists available. So our primary care colleagues have to treat them.
Family physicians need to have a much wider span of knowledge to treat so many disorders appropriately and in so many age groups. I know some family physicians who are very good with kids and teenagers, and I know some who certainly don’t like to treat younger kids and are uncomfortable with teenagers. Then consider the specialty of adolescent medicine, in which youre primary training could be in any one of the pediatrics, family medicine, or internal medicine. This has become a larger subspecialty over the years, for the exact reason that adolescents are not children or adults. They are an entity unto themselves.
EBDM:
Dr Kritzler:
Well, if you have primarily family physicians treating these children with type 2 diabetes, at what point do you feel it’s appropriate that they should be referred to specialists? What becomes the tipping point? For type 2 diabetes in children, most family physicians and pediatricians are comfortable when they’re just dealing with diet and exercise, and the glycemic levels are not widely abnormal. At that point, some are comfortable starting—certainly adult primary care physicians are—the first couple of oral antidiabetic drug steps for their patients. Pediatricians and family physicians may be less so in those younger than 18, because the higher incidence of type 2 diabetes in these patients is a pretty new phenomenon.
Many of the pediatricians are not trained in medical school in the use of these oral antidiabetes drugs. I was trained as a general pediatrician, and I was never trained in the use of oral antidiabetic medications. This has changed recently, because of the necessity of it.
I believe it can be helpful to refer to a specialist for one or two consultations, as glycemic levels demand, when beginning medications. Personally, I see a number of young patients with type 2 diabetes in order to start their medication therapy, because the general pediatrician or family practitioner is not as comfortable doing that. But they’re comfortable enough managing the patient once the medication regimen is started and glucose levels are controlled. This may be different in an integrated system, where general pediatricians may be more comfortable dealing with diabetes, even type 1 to some extent. They usually have specialists more available for phone and E-consults.
EBDM:
Dr Kritzler:
Is this supported through your regular diabetes disease management programs? At JHHC, we don’t do disease management much anymore; instead, we focus on embedded, nonspecific case management. As a health plan, we’re most interested in chronic disease.
EBDM:
Dr Kritzler:
If you could change one diabetes-related Health Effectiveness Data and Information Set (HEDIS) measure, what would it be and how would you change it? (HEDIS consists of 75 measures of healthcare quality and service.) I think that most of the HEDIS measures on diabetes are directionally correct. I think one of the things that people forget about HEDIS measures are that they are population health measures, not individual patient measures.
Consider that there still is no consensus among the professional societies as to whether the goal A1C measure should be 7.0% or 6.5% (guidelines of the American Diabetes Association and the American Association of Clinical Endocrinologists, respectively). And diabetes blood pressure targets have just been changed, which would affect a large number of patients. The HEDIS measures are really just averages for what the population-wide target should be. Health care professionals can get caught up thinking, “I have patient Sally Smith in front of me, and she needs to meet all of these measures and all of these targets.” That’s not the intent of HEDIS.
I don’t really have any beefs with any of the HEDIS diabetes measures as long as people remember the context in which they’re meant to be used. For example, an elderly patient with type 2 diabetes who has had previous hypoglycemia should not have a target A1C of below 8.0%. An average A1C level of 7.5% among 5000 patients is very reasonable. I don’t think there’s a right answer.
EBDM:
Dr Kritzler:
On that same note, would you like to add a HEDIS measure for the future, one that might be helpful as an additional guide? Keeping in mind that it’s a population-wide measure, I think the existing HEDIS measures on diabetes are about right. I don’t think there’s much we need to add. Some people talk about measuring long-term outcomes in type 2 diabetes, such as amputations, renal failure, those types of things. But I wouldn’t add anything right now to HEDIS with regard to diabetes care.
EBDM:
Dr Kritzler:
Let me ask you a question about current therapies. A new class of therapies has just been introduced—the SGLT-2 inhibitors for type 2 diabetes. As a medical director, you’ve probably been involved in some coverage decision making on these agents and the previous categories of drugs. What’s your overall opinion not necessarily of just the SGLT-2 inhibitors but of the recent new oral diabetes therapies that have come along in the last 5 years? It’s an exciting area. For type 2 diabetes, exercise and weight loss are still the mainstays of treatment. Metformin is still the first medication choice, but there has been so much exciting research and many new medication choices, whether you’re talking about the DPP-4s, GLP-1s, or the newest classes. And I’m sure that a year from now, we’ll see yet another class.
From a managed care point of view, you’re absolutely right. We look at a cost benefit in terms of where we’ll place it on our formularies, what agents may have to be stepped through in order to cover the drug, and what we’ll ask the patients to pay for them, assuming they are more expensive than the last class of treatments introduced. As each new class comes along or within a class, a medication may be introduced in a once-weekly injection instead of a oncedaily injection, which can lead to better adherence. Each time something new comes out, we have to evaluate the gain versus the cost—the value.
The number of new options has resulted in the professional societies loosening their relatively rigid guidelines, recognizing what we in managed care are also recognizing, that one size doesn’t fit every patient. There are a number of possible permutations and combinations, and we on the managed care side try to make those available within reason to our patients and to our clinicians.
That being said, I believe that insulin is not utilized as much as possible in patients with type 2 diabetes. Insulin’s not new or sexy, but there are new formulations, there are new delivery systems, and there are pumps. Very few patients with type 2 disease are using insulin pumps, although we’re starting to see an occasional request for them. Insulin is still an important therapy for type 2 diabetes, and it is underutilized.
EBDM:
Dr Kritzler:
For many years, needle phobia has been cited as a principal reason why the transition to insulin has been so difficult. Do you think there are certain things that are just so difficult to overcome; cultural, social, in terms of the insulin use that we’re never really going to get that number where it needs to be in terms of equalization? I’ve been practicing 30 years, give or take, and during that time, the insulin needles have become progressively smaller, to the point now that it’s not the kind of needle phobia that existed when my grandmother took insulin in 1955. It’s a little bit overrated as a barrier. You could point out that the many GLP-1s are given by injection, not as frequently administered as basal insulin, but you’re still giving them with a needle.
There are clearly people who can’t adjust to using needles, particularly some of the elderly. However, every one of my patients with type 1 diabetes use needles because they really have no choice—they’re either on multiple injections a day or they’re on a pump, which involves a needle. Everybody adjusts to a needle if they need to.
EBDM:
Dr Kritzler:
We alluded to the shortage of endocrinologists earlier. Do you see any action in payment reform that might someday attract more doctors to the endocrinology field? Endocrinology in general is like most of the cognitive specialties; it is on the lower end of the pay scale. Of my medical school class in 1977, two-thirds went into primary care. Of last year’s graduates, maybe 8% or 10% went into primary care. As a cognitive specialty, endocrinologists don’t do many procedures other than thyroid biopsies. People just aren’t attracted to it as a profession, because it carries pay that is relatively low. To the degree that we value endocrinologists, we’ll see more people go into the specialty.
Let me make a related comment: There’s a very nice set of programs out of the University of Connecticut where the provider is taking risk for diabetes care, especially type 1. The provider accepts global payments for care and then has to sort it out within their own system, taking some risk for performance. That sort of payment reform is very exciting to me, in terms of any chronic disease.
EBDM:
Dr Kritzler:
Is that program based on the patient-centered medical home concept? I don’t think they call it a patient-centered medical home, but rather a diabetes home. A patient-centered medical home for kids with type 1 diabetes pretty much describes the model. This and other similar experiments around the country will do little to attract more people to endocrinology, but what it will do is support the team care concept. On a fee-for-service basis, some of the non-physician team members don’t always get reimbursed very well. If you think primary care physicians and endocrinologists are not reimbursed well, diabetic nurse educators and nutritionists are paid far less. A diabetic medical home allows caring for more patients with a multidisciplinary team, which I think in some ways may be as important as some of the technological advances, at least in the short run for type 1 diabetes care, anyway. EBDM
What might it take to raise that level of alarm?