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Diabetes Core Update
Diabetes Core Update February 2016
00:24:42
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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- [00:04]
A
Welcome to the American Diabetes Association Diabetes Core Update, where we will regularly keep you up to date on the latest clinically relevant articles from the American Diabetes Association's core science and medical journals Diabetes, Diabetes Care, Clinical Diabetes and Diabetes Spectrum. Joining us for this program are Dr. Neal Skolnick, who is a Professor of Family Medicine at Temple University School of Medicine and Associate Director in the Family Medicine Residency Program at Abington Memorial Hospital. Welcome Dr. Skolnick.
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B
Thank you. It's a pleasure to be here.
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And Dr. John Russell, who is a Professor of Family Medicine at Temple University School of Medicine and Director in the Family Medicine Residency Program at Abington Memorial Hospital.
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C
Thank you. I'm looking forward to going over this week's articles.
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And now for the articles.
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B
We have another excellent issue this week, beginning with an exciting article on intranasal glucagon published in Diabetes Care, followed by a discussion of an article from Diabetes Care on the relationship between adherence to prescribed diabetes medicines and A1C outcomes, then an article on liraglutide in moderate renal failure, followed by a review of the new position statement of the American Diabetes association on the management of diabetes in long term care and skill nursing facilities, then a discussion of an article from Diabetes Spectrum on group medical visits, and finally a discussion of liraglutide reducing CNS activation in response to visual food cues, also published in Diabetes Care. Our first article is from Diabetes Care on intranasal glucagon for the treatment of insulin induced hypoglycemia in adults with type 1 diabetes. This study looked at a needle free intranasal glucagon preparation and it was compared to the standard intramuscular glucagon for treatment of insulin induced hypoglycemia. It was a randomized crossover non inferiority trial conducted involving 75 adults with type 1 diabetes with a mean age of 33 years, mean duration of diabetes of 18 years. To compare intranasal versus versus intramuscular glucagon for the treatment of hypoglycemia induced by intravenous insulin. Success in this study was defined as an increase in plasma glucose to greater than 70mg per deciliter or greater than 20mg per deciliter from the glucose nadir within 30 minutes after receiving the glucagon. Mean plasma glucose at the time of glucagon administration was was 48 milligrams per deciliter. Success criteria were met at all but one intranasal visit and at all intramuscular visits for a success rate of 99% versus 100%. It should be noted that the one person who did not achieve success with the intranasal glucagon actually just missed the predefined criteria and within five minutes of the end of that 30 minute criteria period the did increase their glucose to greater than 70 milligrams per deciliter. Meantime to success was 16 minutes for intranasal glucagon and 13 minutes for intramuscular glucagon. Head and facial discomfort was reported during 25% of intranasal and 9% of intramuscular dosing visits. Nausea occurred in 35 and 38% of visits respectively.
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John so when we talk about what is the best practices in healthcare, we really look for that triple aim. And the triple aim is high quality, low cost and very high patient safety. And I think when we're talking about insulin we're walking that line between someone having really good diabetic control with someone being in an entirely safe situation for the loved ones of folks who have type 1 diabetes who might experience hypoglycemia. Not everyone feels super comfortable giving a needle. I think a lot of our patients and their families kind of overthink things and I think people having something that's just a nasal spray and I think everyone can wrap their head around administering a nasal spray is a very good safety method for people for dealing with hypoglycemia. The show's efficacy is pretty much the same and I really do not think a patient's family member is going to have the qualms with spraying some rescue drug up someone's nose to the same extent that some of them might have with giving a needle. Our next article is from Diabetes Care and it looks at adherence to oral glucose lowering therapies in association with one year a 1c a retrospective cohort analysis in a large primary care database so to investigate the impact of taking oral glucose lowering medicines, the researchers conducted a large retrospective cohort study that used community acquired United Kingdom data. They looked at the prevalence of non adherence to treatment for type 2 diabetes and looked how this impacts A1C. Data was extracted for patients treated over a 10 year period from 2004 to 2014 who were newly prescribed either metformin, a sulfonylurea, a TZD or a DPP4 inhibitor. They were able to obtain this prescription for over one year. Overall, they found that roughly 13% in one arm and 15% in another arm of the patients respectively were non adherent. Proportions of non adherent patients varied by the oral Glucose medicine that was being used. The lowest amount of non adherence was in the tzds. The highest amount was with metformin. In looking at the non adherent versus the adherent patients, the non adherent patients had roughly a third lower impact of a 1C reduction in the folks who are regularly taking their medicines. Neil.
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John, I really like studies on adherence because it speaks to what's true in our practices. So there's a difference that we often don't think about between efficacy and effectiveness. Efficacy is what we see in research studies. How well does a medication work under perfect conditions where patients take all of their medicines? Effectiveness is how well that medicine works in real life and adherence is part of the equation that goes into effectiveness. So here we are seeing that patients who take their medicines have A1Cs that are about 30% better than patients who don't. What's really interesting though in this study is you have to pay attention to the details to interpret this study correctly. So they actually only looked at adherence in patients who stayed on their medicines for more than a year. It misses the large portion of patients when we really talk about effectiveness, who were prescribed a medicine but actually never went and filled that prescription, which is anywhere from 20 to 30% of patients or patients who tried a medicine for a few weeks and then didn't continue that medicine. When we look at other studies on adherence, what we see is if we look at people kind of out the starting gate, Approximately anywhere from 50 to 70% of patients stay on their medicine at the end of the year. Interference and compliance with taking the medicines that we prescribe is a critical issue in medication management. And the difference that we're seeing between people who take their medicines and people who don't is in the range of the difference that we see when we add sometimes a new medicine versus not add a medicine. So what we're going to see over the next few years are a number of strategies about how to help patients adhere to their medicines. Last point I'll make is that that there are significant differences, as you pointed out, John, between different medicines. The TZDs had a nonadherence rate of only 8%. Metformin, which we use all the time and really is our go to medicine had twice the non adherence rate, most likely due to side effects of nausea and diarrhea. So when we think about what works for patients, we have to think about it from the patient's point of view. And part of thinking about it from the patient's point of view view is helping them to take the medicines that are prescribed. Our next trial from Diabetes Care is on the efficacy and safety of liraglutide versus placebo as add on to glucose lowering therapy in patients with type 2 diabetes and moderate renal impairment. Renal impairment is clearly an issue for many patients with type 2 diabetes. This trial was conducted to establish the efficacy and safety of liraglutide as add on to existing glucose lowering medications in patients with inadequately controlled type 2 diabetes and moderate renal impairment. It was a 26 week double blind trial that enrolled 279 patients with A1Cs from 7 to 10% and moderate renal impairment defined as a GFR of 30 to 59. They were randomized to once daily liraglutide, 1.8 mg or placebo. The estimated treatment difference in A1C from baseline to week 26 was an improvement of 0.66% in the liraglutide group. Compared to placebo. Fasting plasma glucose decreased more with liraglutide than with placebo. There was greater reduction in body weight with liraglutide, a decrease of 2.4 kg than there was with placebo, a decrease of 1 kg. There were no changes in renal function observed and the most common adverse effects were GI adverse effects with 37% of patients experiencing that in the liraglutide group and 17% in the placebo group.
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John so overall we've got lots and lots of our patients who are finding themselves in that CKD3 group, especially as our population ages. So if we have a new onset diabetic or a diabetic whose control is not as well as we would like it to be, where do we go? Well, certainly we've talked several times about metformin and I think all clinicians who use metformin know that that's a little bit of a caveat. Some of the sulfonylureas like glyburide, it's really problematic if someone's kidney function gets worse, the glyburide hangs around longer and longer and longer. Several of the DPP4s we need to adjust doses based on renal funct. So where are we and what do we want to do? Well, I think this study would actually tell us that this particular GLP1 is a medicine that is not going to affect someone's kidney function. So that is a good thing and actually has decent control in lowering someone's a 1C. So I think that this is something that might move a little to the front of our list as saying what are our non insulin based medicines that we can use for someone with diabetes and someone who has CKD3 4 next up is from Diabetes care and it's management of diabetes in long term care and skilled nursing facilities. This is a position statement in the American Diabetes association so going through this we're going to highlight some recommendations in different areas in our general overall approach to care. Management of diabetes among older adults related to residing in long term care facilities should have careful evaluation of comorbidities and overall health as needed before developing goals and treatment strategies for diabetes and its management. Diabetic management in these long term care patients requires different approaches and unique challenges faced by a population and working in long term care facilities. Overall goals and strategies should be Hypoglycemia risk is the most important risk factor in determining glycemic goals. Due to the catastrophic consequences in this population, we should have simplified treatment regimens which are preferred and better tolerated. The sole use of sliding scale insulin should be avoided. Liberal diet plans have been associated with improvement in food and beverage intake in this population, so to avoid dehydration and unintentional weight loss, restrictive and therapeutic diet should be minimized. Overall, when we look in the areas of transition of care, care transitions are found to be important times to revisit our diabetic management plans. We should perform medication reconciliation, we should provide patient and caregiver education, we should re evaluate the patient's ability to perform diabetes self care behaviors and we should have close communication between the transferring and receiving care teams to ensure patient safety and reduce readmission rates when a patient is admitted to a facility. This transitional care documents should include meal plan activity levels, prior treatment regimen, prior self care education, lab tests including A last A1C last lipids, last renal function, hydration status and whether the patient has had previous episodes of hypoglycemia.
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Neil John this is a position statement where if you live your professional life taking care of geriatric patients, nothing in here is surprising. If you occasionally take care of geriatric patients, this becomes an incredibly important set of recommendations to follow. And it starts with setting appropriate A1C goals. People remember the general A1C goal of 7% but often forget that part of the standards of care says to individualize treatment and individualized goal setting. And for patients who are older, as is true of most of our patients in long term care and who have many comorbidities, we ought to have a less rigorous A1C goal. So an A1C goal of 8, even 8.5 is considered appropriate in doing this. That then lets us avoid hypoglycemia, which is, as you pointed out, one of the most critical risks for our older patients. If someone who is young or middle aged gets hypoglycemia, they eat a little bit and their hypoglycemia improves. When you are 80 to 90, 95 years of age, you often don't recognize the symptoms of hypoglycemia. It's harder to communicate when you do recognize that, and the consequences such as falling and breaking a hip are potentially catastrophic. So it starts with picking the correct A1C goal. And that's important for both physicians to understand and to communicate clearly to families who have become used to aiming for lower goals. Next thing that you pointed out, which is worth emphasizing, is the complexity of insulin regimens. So often in long term care facilities there are many patients, all of whom are scheduled to get their medicines at the exact same time. And of course they can't get them at the exact same time. Complicated regimens don't work well in long term care facilities. They're often unnecessary with appropriate goal setting and they actually often interfere interfere with additional adjustments of insulin, sliding scale insulins, interfere with our adjustment of our basal insulin and getting the right data to know how to address it. It also increases the risk of hypoglycemia. And I can't tell you how often I see patients come out of the hospital on four time a day insulin basal bolus regimens with sliding scales attached who are 90 years of age and above. And that's something we should really try to avoid. Last thing I want to emphasize is diet. A critical issue for many of these patients really is nutrition. And having restricted diets, which is talked about in this position statement is never a good idea because weight loss, frailty is often an issue that is more difficult to manage than their blood sugars. So a very helpful position statement and I'd recommend that our listeners actually go to the statement and read in more detail. Our next study is from Diabetes Spectrum on group medical appointments. Group medical appointments are a new model of care where patients are seen in a group and have the opportunity to discuss issues with each other as well as their professionals during visits. This study looked at 104 patients in the VA system who received group medical appointments and compared them with a larger sample of patients who did not. Group medical appointments were organized with an interprofessional team composed of nurse practitioner who is also a certified diabetes educator and was board certified in advanced diabetes management. A Pharmacist, a health psychologist and a licensed vocational nurse. Patients with type 2 diabetes with an A1C greater than 8% were referred to the group medical visits by their primary care physicians. What the results of the study showed was that data from the usual primary care Cohort showed that 19% of patients reached their A1C goal, where in the group medical appointment cohort, 50% reached their goal.
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Sean so I found this to be a very interesting study with the caveat that it only had 50 people in the study. So group visits have been talked about over the last 10 years and it's really nice to see a very significant difference in outcome with group visits. And certainly we are comfortable with group visits in perimedical things like Weight Watchers or Alcoholics Anonymous. But what about in our own offices? I've always been a little bit of a skeptic on this and that, you know, we're going to bring in 10 or 12 people and we're going to get 10 or 12 office visits coded in a relatively short period of time. And is this just a new way to generate income? But if you look at in the context that people get better diabetic control, maybe it is the thing where we are going and that being able to bring in our colleagues who are dietitians, our colleagues who are behavioral health consultants, maybe this is the way and maybe we can look at this, things like Weight Watchers and things like Alcoholics Anonymous and say having some peer group sharing some ability to work as a group might be where we're going. I think the coding of this is going to be an interesting place for primary folks care folks to go. If you go to the American Academy offamily physicians afp.org and put in group visits, there is a nice section on how to go about trying to to code these in your office. Our next article is from Diabetes Care and it looked at liraglutide and its impact on CNS activation in response to visual food cues after short term treatment in patients with type 2 diabetes. The researchers performed a randomized crossover study in 20 obese patients who had type 2 diabetes. The patients had a mean age of 59 years of age and a mean BMI of 32. The study consisted of two 12 week periods of treatment where they either got liraglutide or insulin glargine. Patients were followed using functional MRIs when they determine the effects of treatment on the CNS response to viewing food pictures in a fasted condition after 30 minutes after a meal intake. After 12 weeks, the decrease in A1C was larger in the patients with liriglutide versus insulin glargine A minus 0.7 versus 0.2 body weight decreased in the liraglutide versus insulin glargine, a loss of 3.3 kilos versus a gain of 0.8 kilos after 10 days. The patients treated with liraglutide compared with the insulin glargine showed decreased response to food pictures in the insula and the putamen of the brain. In addition, lariglutide enhanced the satiating effect of meal intake on responses in the putamen amygdala.
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Neil John I love these studies using functional MRI to look at the issue of satiety Any of us who have stayed awake late at night and eaten probably as many calories late at night as they ate the whole rest of the day understands that one of the core pieces that contribute to weight gain or loss is is satiety and our ability to not just use self control to overcome satiety, but just whether or not we're driven to eat more. A study that we looked at about a year ago looked at functional MRI and the differential effect on areas of the brain of visual food cues in obese versus lean people and what we saw was that obesity individuals had more lighting up of the areas of the brain that would drive one to get food in response to visual cues of tasty food than did lean people. Here this is an incredibly sophisticated way of looking at why do people seem to eat less and therefore lose more weight on liraglutide than on insulin for instance? What's interesting here is during the period of largest weight loss, the initial period after startin liraglutide, clearly there was decreased activation. There was more satiety shown on functional MRI decreased activation those areas of the brain in response to visual food cues. So you don't have to use as much self control in order to not eat as much. What was equally interesting here is that seemed to decrease over time. At the 12 week part of the study there was not a difference in functional MRI indicators of satiety in the two groups, although in fairness the authors do say that it might be that the differences are so subtle at that point in time that they are enough to maintain the weight loss that occurs early on when the effect on satiety was greater. Clearly it shows that GLP1s in general, particularly liraglutide, have an effect not just on slowing gastric emptying, which we would expect to lead to decreased food intake, but also a very real and significant effect on satiety, which makes it easier for people not to eat more and in total then makes it easier for people to lose weight, one of the core features that make use of GLP1s attractive. For more information and links to the articles that we discussed in this issue, just go to www.diabetesjournals.org. until next week, keep listening and keep learning. Sa.