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Type 1

The Goals Ahead: Sitting Down with ADA President Richard Bergenstal, MD

by sanjay trehan and kelly close

We were thrilled to speak recently with Dr. Richard M. Bergenstal, the President, Medicine & Science of the American Diabetes Association (ADA), and a leading endocrinologist and Executive Director at the International Diabetes Center at Park Nicollet (IDC) in Minneapolis, Minnesota. Dr. Bergenstal has been involved in diabetes for just over 30 years, serving as a principal investigator for landmark trials, chairing several diabetes organizations, and receiving numerous awards, including the ADA's Outstanding Physician Clinician Award. During our discussion, Dr. Bergenstal stressed the importance of delivering patient-centered team-based healthcare, in which the primary care physician and/or endocrinologist work with a certified diabetes educator (CDE). He said that the ADA is working hard to support provisions for team-based care and the prevention of diabetes in the US government's healthcare reform. Until then, he urged that patients search for such a team that is willing to coordinate among physicians and communicate between visits. Regarding new therapies, Dr. Bergenstal was saw a definite place for ultra rapid-acting insulins and longer-acting GLP-1 agonists; he specifically supported the early use of GLP-1 agonists in appropriate patients. As a major advocate of insulin therapy as one important strategy to optimize glycemic control, Dr. Bergenstal addressed the misleading perception of insulin as a rescue therapy only meant for a “severe form of diabetes.” He expressed interest in a new age of insulin patch pumps that could potentially smooth the transition to insulin or a more intensive insulin regimen. Finally, in the next few years, he hopes a telecommunication-based healthcare system will be implemented such that patients can receive care via wireless communication between office visits. Dr Bergenstal looks at this year as President for Medicine and Science for the ADA (a volunteer role that he will juggle with his ongoing leadership of the IDC) as a real privilege to be able to advocate for those with type 1 and type 2 diabetes and the professionals that care for them as the ADA works with others to STOP DIABETES.

Sanjay Trehan: Dr. Bergenstal, thank you so much for taking the time to speak with us today. To start, we would love to get a sense of what motivated you to take this position with the ADA and what you hope to accomplish in the year ahead.

Dr. Richard Bergenstal: I have been in involved in diabetes for 31 years and what I really value most is my contact with patients. Although taking this position with the ADA has forced me to spend less time with patients, I can't give it up. The ADA represents an opportunity to help improve the lives of people with diabetes and make a difference on a much larger scale. The ADA has been helpful to me as have other organizations, so this is also a chance for me to give back to the community and reach more people than I can through day-to-day care in the office.

As you may know, I am a big advocate of team-based care and allowing the patient to have access to a skilled team of diverse healthcare professionals. So for my year as president anything I can do to facilitate this aspect of diabetes care becoming the accepted norm and standard of care will be a great accomplishment, whether it comes through healthcare reform, new innovations in technology, or other ways. I think people with diabetes deserve to have this team available and properly funded so that they can be supported by team members that can help them live well with their disease. This requires a team that can call or communicate in other ways with patients between visits. Since the world is moving towards electronic communication, I think it’s important to embrace these mediums of communication to improve patient care. All of this will take some healthcare reform or some health policy changes – healthcare providers must get reimbursed for these communications so that the team can have a chance to learn and use new technologies. Currently, sometimes a new technology is approved and reimbursed and is beneficial for the patient, but since the system is not organized to encourage providers to learn the value of these technologies, they don’t reach patients nearly as often as they can or should. I strongly endorse translational research that both shows new drugs or technology are effective but also goes the next step to show to implement these advances in practice in a cost-effective manner. Then everyone benefits.

Another goal for this year will be to reform healthcare. If you forced me to pick three aspects of the healthcare system that must be reformed, I would choose: 1) the pre-existing condition rule that denies patients insurance based on previous conditions; 2) the donut hole (a range of total prescription drugs for which elderly patients on Medicare receive no coverage); and 3) overall access to team care for diabetes patients. In addition, I would like to see some provision for prevention, such as the Franken and Lugar Prevention Bill, and a provision for funding team-based care more appropriately. If I can help move these issues in the right direction, then I will feel I have contributed something.

Sanjay: Thank you. On a related note, can you talk a little more about what we need from healthcare reform and what the ADA’s role has been in these discussions?

Dr. Bergenstal: I think the ADA has been a major player in healthcare reform particularly since they are the major voice of what is best for the person with diabetes. The three aspects of healthcare reform I mentioned earlier greatly affect people with diabetes – these were written for people with diabetes. The ADA has worked very hard with the CDC (Center for Disease Control and Prevention) and with Franken and Lugar on the Prevention Bill; I hope the bill gets more press, especially since it is either cost-neutral or cost-saving. I don’t see how anybody could argue against community-based efforts at diabetes prevention as we are faced with a diabetes epidemic. I think we need to keep healthcare reform moving in one way or another. We hope it could be a big package; if not, we have to proceed bill by bill and try to generate as much support as possible. Aside from these current issues, the ADA has been very supportive of legislation that continues type 1 diabetes funding and funding for the Indian Health Service (to focus on helping one of the very highest risk populations for diabetes and its complications). These special funding initiatives t must be continually renewed and we all must advocate for general funding for NIH (National Institute of Health) and CDC to continue basic science advances and translation research on a national and international level.

dr. bergenstal’s take on drugs and devices

Kelly Close: You’ve done some notable research on drugs in development. How are you feeling about the field these days, with more and more calls for personalized medicine, optimized care, and less “one size fits all” approach for patients? We’re at the point where three drugs (exenatide once-weekly and ultra-rapid acting insulin VIAject) are currently being reviewed by the FDA, with a number of drugs in later stage trials. Broadly, can you share with us which drugs or drug classes you are most excited about in terms of their potential to effectively treat diabetes?

Dr. Bergenstal: I am definitely excited that there are some new entries into the more rapid-acting insulin arena since continuous glucose monitoring (CGM) has shown us all that an even faster onset mealtime insulin is really needed. I think it’s important we continue to go down the path of finding faster acting insulins, which I understand is not an easy task. I have had experience with Afrezza and know about Biodel and am excited that we will sort out if they are going to ultimately help us have a more rapid-acting insulin. I do hope we have others as well.

On the long-acting GLP-1 agonists, for which I include once-daily liraglutide (Victoza) and once-weekly exenatide and taspoglutide (still in development), I think they will be a major addition for achieving the kind of goals we look for in type 2 diabetes. I am really optimistic on the GLP-1 therapy class of drugs – I think there are still barriers to overcome, such as the required injection, but to me, it should not be an insurmountable barrier given the positive benefits. I also think we are looking more and more beyond just the A1c when considering drugs and taking into account the drug’s effect on weight and hypoglycemia. I think this class of drugs could play a major role, and we’re all going to have to work, both patients and primary providers, to find a way around the injection barrier.

Sanjay: Focusing on GLP-1 therapy, we are encouraged to see recently-approved Victoza and other candidates advance through the stages of drug development. How do you see GLP-1’s fitting into the treatment paradigm? Do you think they should be used closer to the time of diagnosis for patients with type 2? If so, what are the challenges and how can we overcome these challenges?

Dr. Bergenstal: I think they should be put much earlier in the treatment paradigm as a central consideration. If you look at our International Diabetes Center treatment algorithm, we advocate early use of GLP-1 agonists or DPP-4 inhibitors in certain patient profiles, and it turns out that a majority of patients may fit this profile. Meaning, if you're on metformin and follow a diet/exercise regimen and there is room for improvement in weight, A1c, and minimizing hypoglycemia, then it makes sense for GLP-1 therapies to be very early in the treatment algorithm.

Kelly: Can you comment on the range of drug classes as you can see them today? Some say there are too many to choose from, while others note that there are still many patients not in good control – upwards of 40% in the US. Are there any classes you would support taking off the market?

Dr. Bergenstal: When I look at all the currently available drugs as well as the new classes of drugs in development (glucokinase activators, SGLT2 inhibitors, etc.), I try to decide which ones are best for what I am trying to achieve. I am not really against or for one particular class of drugs, but we need a range due to the various challenges patients have (insulin resistance, poor insulin secretion, sensitivity to hypoglycemia, major struggle with weight control, etc.). For example, if we're trying to achieve optimal glucose control with minimal hypoglycemia and no weight gain, then it helps me to say, “I think sulfonylureas are less likely to get us there because of their effects on hypoglycemia and weight gain. However, I think agents like GLP-1 agonists, DPP-4 inhibitors, and metformin are the most likely to achieve those goals.” So instead of saying I would eliminate sulfonylureas, I would rather say that I am less likely to use them if I am concerned with hypoglycemia and weight gain. I would use sulfonylureas when cost is the #1, #2, and #3 reason - in other words, when nothing else is affordable. Unfortunately, until we get healthcare reform through, there are some patients who can only afford sulfonylureas, so I can't be in the eliminating business. But I remain focused on the objectives I mentioned. As you may know, I am also a big insulin advocate, but I think we have to be more innovative and start looking at insulin in conjunction with GLP-1 agonists or DPP-4 inhibitors because insulin is associated with weight gain that can be neutralized or offset by using agents like GLP-1, DPP-4, or metformin. So I think we have to be more creative in deciding our goals and determining which drugs will get us to those goals (glucose control and beyond). Another reason I am a big fan of insulin is because I am deeply committed to improving the lives of people with type 1 diabetes and insulin is obviously life saving in this population. But again, we have to be committed to innovations in insulin delivery and glucose monitoring so more individuals can take advantage of these strategies.

Kelly: Moving to devices, there are more and more devices being developed for type 2 diabetes on the insulin delivery side. Can you comment on this?

Dr. Bergenstal: I think patch pumps have a lot of potential for type 2 patients, and they deserve much more attention. Broadly, I believe that more people with type 2 diabetes should be on insulin than are currently, because so many people can't reach the right A1c on other drugs. I am not necessarily saying insulin should be a first-line drug, but more people should be on it and we should be developing easier ways for them to do that - and easier ways for their doctors to teach them how to take it. You have already heard my preference of trying GLP-1 therapies first, but a lot of people will eventually require insulin because their beta cell function will eventually decline. Insulin is very effective if delivered appropriately, meaning more patients with type 2 diabetes on a basal/bolus insulin regimen. We all recently learned from my friend Dr. Rury Holman in his 4T research study that starting with a long acting background (basal) insulin and quickly advancing to add mealtime insulin appears to the approach that works best for many with type 2 diabetes who require insulin. I don't think we have done a great job with our injection therapy - we delay starting it and we do not work as a team to keep steadily adjusting and fine tuning the insulin. So, I look forward to seeing if patch pumps or other patient- provider communication technology can promote greater general acceptance of insulin and help move more people toward effective use of basal/bolus insulin therapy.

Sanjay: Dr. Bergenstal, what do you perceive as the biggest barriers for people with diabetes receiving proper care today?

Dr. Bergenstal: First, is the lack of access to a team, and reimbursement for healthcare provider time outside the visit, and second is inadequate insurance. There are too many patients on good medications that reach the donut hole and stop. (Note from diaTribe- per Medicare rules, after the government pays $2250 for drugs or technology, patients themselves must take over the costs themselves - at which point many patients stop taking the drug or technology until the next year when coverage kicks in again.) It's really difficult for people without good insurance to pay co-pays from $50 to several hundred dollars per month. We need to figure out how to fix this system. I think we also must educate people to focus not just on the A1c but also in addition to other factors, such as weight and hypoglycemia and possibly glucose fluctuations. Very high up and down movement of blood glucose certainly makes life miserable for many people with diabetes and research is ongoing to see if minimizing these fluctuations might also reduce the risk of complications of diabetes. Similarly, we must find a way around the barrier of injections (for insulin as well as GLP-1 therapies). There seems to be the impression that any injectable medicine is only used for an extremely serious form of diabetes, which is not true. We need better approaches to education and training to overcome this perception.

Kelly: In terms of the general perception of diabetes, what do you feel needs to be changed, from the perspective of a patient as well as that of a physician, specifically primary care? We’re especially interested in hearing this from you because your model at the International Diabetes Center (IDC) combines primary care and specialist care so well.

Dr. Bergenstal: Well, I think the perception in the public is that diabetes is not a very serious condition and therefore, does not deserve that much attention or that much funding for research. One thing I've learned in my tenure with the ADA through this “Stop Diabetes” campaign is that, after a lot of research, they found that people really don't understand diabetes. So I think it is a serious condition, but it's manageable and that we can accomplish a lot in primary care if we're willing to support primary care. There are too many people with type 2 diabetes that only see an endocrinologist. I'm a huge supporter of endocrinologists seeing the appropriate patient, but we need to support primary care. In our model, we embed a Certified Diabetes Educator (CDE) in a primary care practice where the CDE is actually works alongside the primary care provider as part of their team. But the CDE is still connected to the endocrinologist or in our case the IDC for ongoing training and support around the latest advances in therapy and technology that would benefit patients in the primary care setting. .. It is a model that deserves much more attention and research because it's a way, in my view, to support primary care to be able to get insulin started when it's needed and to move new technology and medications into primary care. Educators know the medicines and can help follow the algorithms and get the ball rolling and are in easy and frequent contact with endocrinology as well. It is a model we have to move towards, and I hope we and other centers who are testing it can show that it is an effective model the patient who we are really concerned about gets the best of all worlds a primary care provider for day to day needs and to coordinate their care needs, a diabetes educator team to be sure they are very up to date on management and an endocrinologist (maybe in the background initially but available at a moment's notice to the CDE or primary care provider and for a consult when appropriate. In addition the endocrinologist helps the team study their model and make refinements to improve care and communications).

the advantages of early and effective insulin treatment

Kelly: A few years ago, the CDC estimated that about 47% of people with diabetes were not in good glucose control (meaning, an A1c of under 7%). Can you discuss where we are today and your perspective on where we should go?

Dr. Bergenstal: Let’s go to the numbers first. I think we’ve made progress. I think there are more people in control now than there were five years ago than there were ten years ago. I don’t think the general community may be doing quite as well as those numbers suggest. I say “well” but it is really bad if the number continues to hover around 40-some percent. If you were a skeptic, you might say “look at the data – it says that the people on insulin are doing the worst so why would we want more people on insulin, right?” But this is backwards thinking. To me, it says we are doing one of two things wrong. Either we are starting insulin too late or we don’t really know how to use insulin effectively. I think it is evenly split, in terms of how many physicians are starting insulin too late and how many aren’t using insulin appropriately. When I say “starting insulin too late,” I mean that many people are using insulin too much as a rescue therapy when someone has an A1c of 9% or 10%. We would do much better if we kept intervening with therapies at 7.1% and 7.3% instead of waiting until patients are extremely out of control and then initiating insulin.

Sanjay: Do you think the 4-T trial that you mentioned (a trial investigating various insulin regimens – see Conference Pearls from diaTribe #19 for more details) will cause people to advance to insulin more aggressively, i.e. to move to mealtime and correction insulin when basal only isn’t working?

Dr. Bergenstal: The 4-T trial was a great study and just reinforced our decade-old philosophy at the IDC of starting with basal insulin and moving quickly to a basal/bolus regimen. The basal insulin alone was not much better than any other therapy. Same with pre-mixed or mealtime insulin; you realize that whatever insulin you start, you really do need to move to basal/bolus insulin. So for the last decade, our philosophy has been to move to basal/bolus insulin when a patient reaches 0.5 to 0.7 units per kilogram of basal insulin (which translates to 40-50 units per day). But people don’t make this transition. I think the 4-T trial has reinforced the message of moving from basal to basal/bolus insulin, but I am also looking forward to new technologies, such as the patch pumps, to improve acceptance.

Kelly: Do you think delaying insulin therapy is more patient-driven or physician-driven? How can we overcome this model?

Dr. Bergenstal: I think it takes much more focused education on both sides - patients and physicians should understand that insulin is not the enemy, hyperglycemia and other metabolic abnormailites are the enemies There are so many barriers that educational programs need to address - not just encouraging insulin use when appropriate, but also instructions on how to properly start and adjust insulin. If the doctor will accept it and be positive about its benefits, it is amazing. Our nurses and CDEs will probably take a shot themselves three or four times a day to show the patients and then do it with the patient. To me, we really need to break it down and focus on that kind of training and demonstration and teaching for physicians.

final comments

Kelly: Dr. Bergenstal, it’s been really something to speak to you. One of our last questions is what you see as the major areas of progress in 2009 and what you look forward to the next few years.

Dr. Bergenstal: Three things come to mind in 2009. I think continuous glucose monitoring (CGM) has really come front and center in the past few years. I won't say that it has taken over the market but it has certainly taken over the imagination in terms of what's possible. It has also helped us better understand diabetes and medications. For example, our needs for a super rapid-acting insulin that we discussed earlier only came about because of CGM. Now we understand exactly how rapid-acting insulins are superior to regular insulin. I hope we will continue to learn to use CGM to help us make better clinical decisions regarding the adjustment of insulin delivery or selecting appropriate therapy in T2DM.

The second major advance in 2009 is the multi-factorial treatment of diabetes - now we realize we need to treat glucose, lipids, and blood pressure to target I think the fact that we need to be much stronger on treating all of these related conditions has also come front and center in 2009. While I'm happy to have a stronger emphasis on blood pressure and cholesterol, I am not willing to give up on the importance of blood glucose which we know minimizing eye, kidney and nerve disease.

Finally, and again some love this and some hate this, but more and more we will be paying for performance. We are all working to define and agree on the optimal targets of care (A1c, minimal hypoglycemia, weight reduction or maintenance, BP and Lipid control, not smoking and use of ASA in appropriate high risk patients). We desperately need consensus on the science based targets and then we need to develop consensus on how to measure the performance of a doctor, or health system in working with their patients to reach these targets, in the right patients, in a safe way. Then it is appropriate to move away from just paying for visits and procedures to paying for accepted measures of patient-centered optimal team care.

Going forward, I think more research needs to be conducted on the central nervous system effects of diabetes. While I am not an expert in this area depression and dementia in diabetes really worries me - we don't understand as much as we should. In addition, in the next five to ten years, I would love to see the telecommunication-based care that I referred to earlier be implemented. I am optimistic about using the cell phone and wireless communication in general to facilitate patient care. We may be looking back ten years from now saying, “They weren't using cell phones? What were they thinking?”

Sanjay: And, Dr. Bergenstal, do you have some final words of advice for diaTribe readers and other patients with diabetes?

Dr. Bergenstal: I want people to know they can do it; just ask for help and keep looking for that healthcare team that is willing to work with them. They really can do it, and they should not get discouraged. There are too many good providers, good technologies, and good information for them to give up. People with diabetes and loved ones of people with diabetes are lucky to have resources like diaTribe, American Diabetes Association, Juvenile Diabetes Research Foundation, International Diabetes Center and others to keep them up to date and motivated. If they keep searching, and keep seeking information and education, they can live an amazing life with diabetes.

Sanjay: Thank you so much Dr. Bergenstal!

Kelly: Yes, thank you enormously! You have helped diaTribe so much in being on our advisory board and in reviewing articles and being so open to assisting patients and translating important findings for us. We can’t thank you enough for all your service to patients with diabetes. Appreciation all around, Dr. Bergenstal.