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Diabetes Core Update
Standards of Care - Diabetes Core Update Special Editon January 2015
00:24:48
Diabetes Core Update is a monthly podcast that presents and discusses the latest clinically relevant articles from the American Diabetes Association’s four science and medical journals – Diabetes, Diabetes Care, Clinical Diabetes, and...
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- [00:02]
A
Welcome to the American Diabetes Association Core Update. While we usually go over the most important articles from the core journals published by the American Diabetes association, today we will cover the American Diabetes Association Standards of Care published in the January 2015 issue of Diabetes Care. Joining us today will be our usual host, Dr. Neal Skolnick, as well as the chair of the committee, Dr. Richard Grant. Dr. Skolnick thank you, Amy. And welcome to this special edition of Diabetes Core Update where we are going to be discussing the new standards of care, which were published in the January issue of Diabetes Care. Each year in the January issue of Diabetes Care, the American Diabetes association publishes the Standards of medical Care and Diabetes, which essentially establishes the ongoing standard of care nationwide. The committee serving to put together the standards meets early in the fall and reviews new evidence that's been published over the previous year and then discusses and formulates any changes that are necessary based on the evidence. Joining us today is the chair of the committee that developed the new guidelines, Dr. Richard Grant. Dr. Grant is a research scientist and director of the Delivery Science Fellowship at Kaiser Permanente Division of Research and is an adjunct associate professor in the Department of Epidemiology and Biostatistics at the University of California in San Francisco. Welcome, Dr. Grant.
- [01:36]
B
Thank you. Pleasure to be here.
- [01:39]
A
Since we only have about 20 minutes to discuss the standards, we'll restrict our discussion to highlights of the guidelines. We encourage our listeners to go to the American Diabetes association website at www. Diabetes.org to download and read the full standards of Care. For first question for first question, Richard, can you give us an overview of the process that's used to create the standards? It's a mystery form most people, and it would be interesting for listeners to hear how the standards are actually developed.
- [02:09]
B
Oh, yeah, sure. I'd be happy to explain that. So we have a committee that meets twice a year, and on that committee is representatives from different aspects of diabetes care. We have endocrinologists and primary care physicians, nurses, pharmacists and diabetes educators. We have about it varies somewhere around 12 to 15 committee members and they serve a two year term. So every year half of our members are new. And what we do is basically take the prior year standards and sort of assign sections to groups of committee members. And then the task is to look through the most recent literature of the past couple of years and see if there have been any significant advances or changes and whether the strength of the evidence to support prior recommendations has changed. And then we each go off and do our homework and we have phone calls and meetings in between and then we all meet together for a long weekend in September and basically decide what's changed from the prior year, either in new studies or new ways of looking at data or other new developments. And then we try to update our recommendations and text based on that. And one of the things that we really focused on is making sure that all of our recommendations, all of our bulleted recommendations in the guidelines are accompanied by a level of evidence so that the reader knows is this A level randomized controlled trial evidence, down to E level expert opinion evidence.
- [03:47]
A
What I've always found fantastic about the way the American Diabetes association does things with regard to the standards is that it's meticulously done, but yet it's still updated every year. And unlike some other guidelines out there, like we were all waiting for years for JNC aid or ATP4, this is actually done consistently every year and it gives us all across the country current evidence based guidance for what we're doing. Moving on to the standards themselves, can you first discuss with us which tests are recommended for making the diagnosis of diabetes and some of the differences between using fasting glucose, the A1C or A2 hour oral glucose tolerance test?
- [04:35]
B
Yeah, so those are the three tests and there haven't been any dramatic changes in the recommendations based on those. Each test has its advantages and disadvantages. And so I think one of the themes you'll hear throughout this discussion and throughout the standards is there's evidence and then there's practice. And the job of the clinician is to figure out how to fit the evidence into their practice. So A1C, for example, it's a bit more expensive than glucose testing, but it can be gotten in a non fasting state and many physicians are used to using it. So it's a very useful test. There are some caveats. It's based on red blood cell turnover, so if someone has a hemoglobinopathy or other issues, then it might be less reliable. And it also needs to be done in a qualified lab. So we actually don't recommend point of care A1C testing, since it may not be at the same reliability as from a lab. And then there's the fasting glucose, which is cheap but of course requires fasting, and the two hour plasma glucose test, which requires more time. The interesting thing is that if you were to give all three tests to the same group of patients, you wouldn't identify exactly the same set of patients with diabetes because these three tests are not directly completely replicable. So the recommendation is that if you have one abnormal to repeat that same type of test to confirm the diagnosis.
- [06:11]
A
And then who should we be testing or screening for diabetes?
- [06:17]
B
Well, the off the cuff answer is everybody. But we actually have criteria and it's as you would expect, patients with obesity, patients with a family history, and they're all listed in the, in the guidelines. One thing I will highlight as a change is that based on developing evidence, we've changed the BMI threshold for Asian Americans. So anyone with a BMI over 25 should be tested. And then for Asian Americans, we lowered that to 23 kilograms per meter squared. So that's the one notable change in.
- [06:56]
A
Our criteria that's helpful to know. And a lot of people remember the screening criteria as just people over 45, but of course, that's not correct. It's younger in people who have a BMI over 25 and any risk factor for diabetes.
- [07:16]
B
And as you know, there are more and more people being diagnosed with type 2 diabetes at a younger age because of our obesity epidemic.
- [07:24]
A
Right. Can you discuss, speaking of the obesity epidemic and along with it, the increase in diabetes and prediabetes, can you talk a little bit about that category of prediabetes and what that means?
- [07:41]
B
Yeah. So, you know, we recognize that sugar or glucose dysregulation occurs over a spectrum, and it's a continuous variable. And so somebody has to come in and set thresholds to create a diagnosis. And so we have thresholds for diagnosing diabetes, and those are based on older data related to risk of developing retinopathy and such. But someone who doesn't quite meet that threshold but does not have normal glucose metabolism, we know is at an increased rate for progression to diabetes, and also of all the associated risk factors that go with diabetes. So this is why there's this category of prediabetes, which is people that, unless they make changes to their lifestyle and weight, already are showing signs of being on the pathway to diabetes. And so anyone who meets those criteria, which would be, for example, an A1C between 5.7 and 6.4, we strongly recommend that they engage in a lifestyle change program involving exercise and weight loss. And in fact, we recommend that that should probably be paid for because it's so important to prevent the onset of diabetes.
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A
I think that's one of the greatest opportunities for us as primary care physicians to adequately screen and find patients, which now is roughly a third of United States adults who have prediabetes and to be able to really aggressively address those risk factors and encourage lifestyle modifications. How about when it comes to we're going to move on to patients with diabetes and recommendations for self monitoring of blood glucose. Does everyone need to self monitor or is that more parsed out?
- [09:36]
B
You know, that's a great question and I think it's unnecessarily controversial, but let's talk about it. So one thing that we did in this year's standards is for patients like with type 1 diabetes or type 2 and complicated insulin regimens, we wanted to sort of emphasize the fact that some patients, especially around times of making adjustments, really need multiple sugar testing. They need different times of day, different circumstances, before and after meals. And so this sort of old idea of testing three times a day is really inflexible. And there will be certain patients like the ones I described who for a period of time might benefit from multiple testing during the day. On the other hand, for patients with type 2 diabetes that are not prescribed insulin, there's less risk of hypoglycemia. And so self monitoring of blood glucose has to be prescribed in a thoughtful way. I mean, we all know that self monitoring of blood glucose does not lower your A1C levels. It's a tool to provide information, but it doesn't itself. It's not at all therapeutic. And there's been research done that shows that there are some patients who monitor their glucose but don't look at the results or the results are not used by their providers to make any changes. And so we would say for those patients, clearly it's not necessary to be self monitoring. And really the take home message is that for patients not on insulin, self monitoring really has to go hand in hand with a, a planned educational program. It has to be used in a way that the patient changes what they do. Short of that, it's really actually not necessary because it's not going to change outcomes. So if you have a patient on metformin who's overweight and is focusing on lifestyle changes every three month, A1C is a perfectly reasonable way to monitor their diabetes. If you have another person who's really interested in knowing how their food intake relates to their sugar levels, then that would be a great candidate for self monitoring. And the last point in these kind of patients is that self monitoring of glucose is not a lifelong sentence. It's this kind of thing that needs to be used in context. And so it might be very useful, especially early in diagnosis, it might be useful around times of change, but this old fashioned idea of every single patient has to be sticking their fingers every single day doesn't take into account the Variation and the use of this tool to its greatest effect, we really have.
- [12:14]
A
Moved toward it from a one size fits all toward a more personalized approach, both with monitoring as well as with choosing anti hyperglycemic medications and even in setting A1C goals. A common misconception is that everyone with diabetes should have an A1C goal less than 7%. And that's such a common misconception that many of our practices are graded by insurance companies and payment attached to achieving specific A1C goals. Dr. Grant, can you clarify for us what does the standards recommend with regard to setting A1C goals for patients?
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B
Sure. This is an area that in my time on the practice committee, I think we've really been making a lot of progress, which is just as you say, how do you individualize care for the patient sitting in front of you and getting away from this one size fits all. So our approach has been to look at evidence when evidence is available and look at the larger context when it's not. We know from some of the large studies of early intervention and tight control that probably tight glycemic control right at the initial time of diagnosis in younger patients before they have a lot of complications, will probably do better than less tight control. On the other hand, for elderly patients who have decreased lifespan, and in fact the benefits that come from tight control would occur decades later, there's really not a good justification for tight control, especially if it comes at the risk of hypoglycemia, which in an elderly person could have all kinds of untoward consequences. And so we've tried in these standards to give some guidance into what's sort of the ideal patient to maybe try for a little bit lower than seven and other kinds of patients where seven is a reasonable goal, and then other patients where maybe you want to loosen it to 8 or 9%. And it's really an integration of sort of the pathophysiology that early glycemic control has long term effects, and also the recognition that patients are complex, they have many other conditions, many other medications, and some of them have limited lifespans. And so we tried to lay out a landscape where the clinician could make reasonable decisions about how tightly to control or what a 1C threshold to look for. In fact, for the readers who are willing to go and look at the website, there's a very nice picture with a range of different types of criteria, like how difficult it is to control how much comorbidity lifespan, where you can sort of see where tighter control or left tight control is recommended.
- [15:11]
A
That really is a wonderful diagram and I really would encourage people to take a look at it. We won't take time on today's podcast to discuss pharmacologic management other than to say that the standards are in agreement with the recent position statement put out by the American Diabetes association on the management of hyperglycemia and type 2 diabetes. And that statement, as is true of setting A1C goals, talks about a personalized, individualized, patient centered approach that takes into account patient preferences, cost, side effects, effect on weight and hypoglycemic risk. And just so our audience knows, we, there is a podcast that has just come out a little While ago with Dr. Ainzucci that discusses that recent position statement and I'd refer our listeners to listen to that. Let's move on to some other things now talked about in the standards of care. Can you talk a little bit about the increasing improvement that's been placed on recognition and management of hypoglycemia?
- [16:25]
B
Yes. So we've always known that hypoglycemia is a bad outcome to be avoided. What's changed, I think, is the publication of large cohort studies that 1 emphasize the higher prevalence of hypoglycemia than maybe was previously recognized. So it's quite common, particularly in older patients. And there's another body of research that's evolving that has shown that hypoglycemic events predict future cognitive decline. And so those two sort of the evidence from those two areas has led us to want to emphasize the fact that it's very important to monitor for and ask about hypoglycemia for our next question.
- [17:09]
A
Cardiovascular disease is an important and common consequence of diabetes. Control of risk factors is essential. About two years ago, the standards changed the recommendations regarding systolic blood pressure goals. This year the recommendation changed with regard to diastolic goals. Can you update us on what the new goals are and the rationale for the change?
- [17:32]
B
Yes, and I think this is actually a very important point to discuss. So blood pressure control remains and has always been an incredibly important part of diabetes management. In fact, effective blood pressure control probably has more benefit than effective glycemic control. So it's super important. The changes we've made are basically going back and reassessing the data to make sure that we're providing the highest level of evidence. So this year we changed the diastolic target from 80 milligrams of mercury to 90. So that doesn't mean that diastolic blood pressure control is any less Important. But if you look at the randomized controlled trials in the target set, in those trials, the highest level of evidence, or a level evidence, corresponds to 90. That doesn't mean that trying to achieve a level of 80 is a mistake. And in fact, if it can be achieved without undue burden on the patient, meaning very complicated medical regimens or episodes of hypotension, then that's reasonable. But by the strict letter of the evidence, we moved from 80 to 90. So that we can say this is a level recommendation that makes sense. And it really aligns our care of patients with diabetes with that of the general population, which I think also makes it in some ways easier, and particularly easier, because it often means the difference between using an additional medicine or not when we're trying for those lower goals. And if there's no evidence that it helps, then probably using less medicines has an advantage. Can you also speak to the new recommendations on lipid management? Yes. In some ways, this was the most controversial change, and we spent an awful lot of time on the committee discussing it. And it was driven by the fact that the American College of Cardiology and American Heart association presented new lipid recommendations in 2013. And we, as a committee said that we're not necessarily going to follow what they said, but we need to think hard about what they said and decide if we should be in accordance with that or if we're going to differ what our rationale is for differing. So in my view, the major difference is this idea of adjusting statin dose in response to LDL level, which is how we've always practiced. You get your LDL level and you twist the dials on your statin dose to get it to the level that you want. If you go back and look at the evidence to support this practice, those randomized clinical trials did not do that. They set an initial statin dose, either a moderate or high intensity dose, and then look to see the differences. And clinical practice sort of adapted that idea, but was using the LDL level to titrate. So the ACC and the AHA said, well, the strongest evidence is to support what intensity of statin treatment to begin with, based on the patient's risk factors. And that's reasonable. In fact, Hedis has already gone ahead and made some changes in how they monitor cholesterol quality. And so the bottom line is that virtually all patients with diabetes are at increased cardiovascular risk. I say virtually because there hasn't been RCTs for every single type of age and risk factor level for everyone with diabetes. But we know that that's the general case. And so what our recommendations this year focus on is when do you start a statin and really at what dose do you start the statin? And virtually all patients with type 2 diabetes should be started on at least a moderate dose. And then a subset who are at higher risk, for example, if they've had prior cardiovascular disease, should be started on high intensity dose. We make recommendations for type 1, recognizing that there really aren't any RCTs that can guide treatment in type 1. But we, by analogy, we took the same approach.
- [22:01]
A
I personally thought it was wonderful that all the recommendations are now in alignment because it's just difficult when different organizations come out with different recommendations from the same evidence. So the evidence is solid. And I was thrilled to see that the American Heart association recommendations were taken up by the American Diabetes Association. For us in the trenches in primary care, that clarity is always helpful. Due to time constraints, we've been selective in going over the highlights and important changes in the standard of care. The full standards contain tons more information on a lot of other topics, including neuropathy, nephropathy, retinopathy, management during illness, during inpatient admissions, medical nutrition therapy, exercise, and lots of other aspects of diabetes care. For more details, I'd refer our audience to the online statement itself, available at www.diabetesjournals.org. download and read the full standards. Dr. Grant, thank you so much for joining us. We've covered a ton of material. You've covered a ton of material. To recap, we've talked about screening, we've talked about identification and management of prediabetes, individualizing A1C goals, hypoglycemia, and the changes in recommendations for blood pressure and cholesterol. Dr. Grant, I do want to, for all of our listeners. Listeners, thank you very much. It's been a pleasure talking with you.
- [23:38]
B
Thank you.
- [23:38]
A
Dr. Skolnick, for the American Diabetes Association, I'm Dr. Neal Skolnick, and thanks for listening.