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Diabetes Core Update
Diabetes Core Update February 2015
00:18:54
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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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 four 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 and Associate Director in the Family Medicine Residency Program at Abington Memorial Hospital. Welcome Dr. Skolmik.
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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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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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We have another excellent issue this month, beginning with an article from Diabetes Care on community programs to health Latino patients with diabetes. Next, an article from Diabetes on exercise before and during pregnancy, preventing the deleterious effects of a poor diet. Then an article from JAMA on metformin in patients with type 2 diabetes and kidney disease. Then an article both from JAMA and Diabetes Care on the follow up 27 year follow up of DCCT trial and finally from Diabetes Care an article discussing hypoglycemia and the risk of cardiovascular disease and total mortality in a large national population.
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Our first article is from Diabetes Care, the February 2015 edition. We looked at the impact of a community health workers led structured program on blood glucose control among latinos with type 2 diabetes. Latinos with type 2 diabetes face major healthcare access and disease management disparities. In this particular study they looked at 211 adult Latinos with poorly controlled type 2 diabetes with a baseline A1C of approximately 9.5. They were randomly assigned to standard healthcare or community health worker groups. The community health worker intervention comprised 17 individual sessions delivered at home over a 12 month period. The sessions addressed type 2 diabetes complications, healthy lifestyle, nutrition, healthy food choices and diet for diabetes. It also include blood glucose monitoring and medication adherence. Patients were followed at 3, 6, 12 and 18 months for various parameters related to their diabetes. Overall they found relative to the control group, the community health worker group had a positive impact on net a 1C at 3 months, decrease in 0.42 at 6 months a decrease of 0.47, 12 months, a decrease of 0.57 and 18 months a decrease of 0.55. They overall had an overall significant effect on fasting blood glucose concentration. They found no significant effect on blood lipids, hypertension and weight.
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Neil John I find this study Very interesting because we often think we're doing a lot, we talk a lot, we see people back in the office. But this reminds us culturally sensitive message delivered to people by people, understand their lifestyle and understand the challenges can often be more effective than what we do in the office. The amount of improvement here was pretty remarkable. A decrease in 0.5%. A1C is in the same range that we get with a lot of the newer medicines, but here not because we added any additional medicines, but because we're able to teach people the things they needed to know in the manner that they needed to know them. The challenge for us all for this type of program is to figure out who gets the program, how to deliver the program, and when to use it. Our next article is from Diabetes on Exercise before and During Pregnancy Preventing the deleterious effects of maternal High Fat feeding on Metabolic health of male offspring what this study did was to determine the effects of maternal exercise during pregnancy on the metabolic health of offspring. They used a rat model and used 6 week old female mice who were fed a regular diet or a high fat, 60% fat diet and then divided into four subgroups. Those that were trained with running wheels for two weeks prior to conception and during gestation. Pre pregnancy trained, meaning they worked on a running wheel just prior to conception, gestation trained running wheel during gestation or completely sedentary. Male offspring were either fed a regular diet and studied from 8 weeks through 52 weeks of age. Offspring from chow fed or regular diet fed dams that trained both before and during gestation had improved glucose tolerance beginning at 8 weeks of age and continuing throughout the full first week of life at 52 weeks of age, had significantly lower serum insulin concentrations and percent body fat compared with all the other groups.
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JOHN so these animal studies are often often very interesting. You know, we probably could never reproduce this, right? So I don't think this is something that we can kind of take a, you know, large cohort of women and feed them a certain diet before they get pregnant and then kind of maintain them having to do a certain exercise thing. But I think if we're looking at any particular group that is most prone to make dramatic changes in their behavior, it's pregnant women. So, you know, we take care of lots of women who can't find any other reason to quit smoking but suddenly get pregnant and stop, or suddenly are very good about watching their blood sugar, suddenly very good about a lot of things. So I think the takeaway point could really be that, you know, some fitness and really trying to continue to get some exercise during pregnancy to continue to watch what you eat, to have mindfulness. Just like if you're going to stay away from soft cheeses during pregnancy, maybe you should stay away from Cheetos. So you're going to do some other particular things in pregnancy. Maybe some exercise can be part of that and maybe that would help us make some imprint on the babies that are going to be born and maybe they can have some genetic ability to be a little healthier.
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Our next article is from JAMA on Metformin in patients with type 2 diabetes and kidney A systematic Review Metformin is widely used as the initial pharmacologic option and in diabetes. However, it's contraindicated in many individuals with impaired renal function because of concerns of lactic acidosis. What the authors of this systematic review did is essentially reviewed all of the English language literature to look at the data supporting the lack of use and the FDA regulation against use of metformin in kidney disease and what they found was that although metformin is renally clear, drug levels generally remain within the therapeut range and lactate concentrations are not substantially increased when used in patients with mild to moderate chronic kidney disease, that is with an estimated GFR of 30 to 60. The overall incidence of lactic acidosis in metformin users varies across studies from approximately 3 per 100,000 person years to 10 per 100,000 person years and is generally indistinguishable from the background rate in the overall population with diabetes. Data suggesting an increased risk of lactic acidosis in metformin treated patients with chronic kidney disease is limited and no randomized controlled trials have been conducted to test the safety of metformin in patients with significantly impaired renal function. Population based studies demonstrate that metformin may be prescribed counter to prevailing guidelines suggesting a renal risk in up to one in four patients with type 2 diabetes, but in most reports it's not been associated with increased rates of lactic acidosis. Observational studies suggest a potential benefit from metformin on macrovascular outcomes, even in patients with renal contraindications to its use.
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John I thought this was a pretty amazing article and I think this is probably something that anyone who's taking care of folks with diabetes probably should try to download and take a look at this article. When you think about metformin, it certainly is our workhorse drug. It's going to be the drug that most primary care doctors are going to use the most with diabetes. Most of the guidelines recommended as a first line choice for taking care of our folks with diabetes. But there's always been this kind of boogeyman of lactic acidosis and looking at these creatinines of 1.5 and 1.4, and I think it certainly drives a lot of our patients off Metformin to choices that aren't necessarily as good choices that have a little bit more true safety issues, like hypoglycemia, which we're going to talk about later in the program. So, you know, having to abandon metformin sometimes prematurely for lactic acidosis. And if you've taken care of diabetes for a long time, and this is a side effect we're worried about, we probably all should have seen it more. And it's just not something that people are seeing. And I think this study really comes to point out that, you know, just because someone has lactic acidosis and they're on metformin, oftentimes there were other cases of things that led people to lactic acidosis. So certainly I don't think for our folks who have GFRs under 30, this is a medicine we should be using. But I think in our folks who are between 30 and 60, we can have some mindful use of Metformin. It might include more frequent monitoring, it might include more frequent lowering of doses to do this. But I think that this is kind of an interesting thing. And if you look at some of the information at the end of the article, it's really not worldwide. This 1.5, 1.4 creatinine for not using it in males and females and other places have it based on gfr. So I think as GFR becomes more readily available, it might be something that we're going to kind of have a little bit of wiggle room for for our patients with diabetes. Next, we're going to review two separate articles looking at the DCCT trial. One was from diabetes, February 2015, one was from January edition of JAMA, both looking at the DCCT trial. Overall, it was that first seminal trial that really looked at tight control in diabetes and its impact. In the Diabetes article from February, it looked at what happened with retinopathy in following people who were in this trial 18 years later. What they found was that the people who were in the trial, even though they had six and a half years of initial tight control, that there was some metabolic memory, and the folks who were initially had tight control over that first six and a half years, ended up having less retinopathy and less diabetic eye disease going on for 18 years. Not quite linear but as time passed, they still had a cumulative incidence of lower retinal outcomes. The other trial was looking at mortality in the same population that was in jama and overall in this particular arm, they looked at the folks who would receive the intensive therapy of about 711 folks versus conventional therapy, which was 730 folks. Overall. Looking at the over 1400 people, there were 107 deaths, 604 in the conventional and 43 in the intensive group. The overall risk reduction, we had a lower mortality cause of 0.67. In the tightly controlled group, the primary causes of death were cardiovascular disease, cancer, acute diabetes, complications and accidents of suicide. Higher level of hemoglobin A1Cs were associated with all cause mortality as well as the development of albuminoria.
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Neil John it's hard to even remember the time when we didn't know that better control of diabetes clearly led to better outcomes. And the DCCT trial was the first trial to establish that intensive care led to improvement in particularly microvascular disease. The long term follow up of this study published in Diabetes that you just reviewed shows that there is a legacy effect, meaning even though both there was a difference between both groups for an average of six and a half years, almost 20 years later there's still as a result of that intensive treatment, an improvement in retinopathy. And in the JAMA article that you reviewed, again we see a legacy effect. But here in both macrovascular disease and microvascular diseases, in the diabetes trial that we see 27 years later, a decrease and a large decrease, a 33% decrease in mortality as a result of approximately six and a half years of intensive treatment. The other interesting thing to think about is the intensive treatment here achieved a one Cs of seven. So this is different than the ACCORD trial where even lower levels of blood glucose were the target. And remember, at lower levels than seven, even though even in this trial we did have a greater amount of hypoglycemia in the intensive treated group. And even though this trial focused on patients with type 1 diabetes, what we saw in the ACCORD trial is you don't get something for nothing. And we're going to talk about in our next article issues around hypoglycemia and that whole controversy of how hard to treat. Lastly, the important thing to remember here is that even though we've known for quite some time that an A1C in patients with type 1 diabetes of 7 or less yields a clearly better outcome, it's a reminder that there are many patients in the United states with type 1 diabetes who still have trouble getting to an A1C of less than 7. And it's once again further encouragement to continue to work with our patients. We saw earlier in this podcast the different ways of working with patients, healthcare workers going out to patients homes in a Latino community that there are lots of creative ways as well as standard ways to help patients achieve the goals we all have. Our next article is from Diabetes Care on hypoglycemia and risk of cardiovascular disease and all cause mortality in insulin treated people with type 1 and type 2 diabetes. This study assessed whether in a nationally representative population there is an association between hypoglycemia, the risk of cardiovascular events and all cause mortality among insulin treated people. This retrospective cohort study used data from the Clinical Practice Research Datalink database and included all insulin treated patients greater than 30 years of age with diabetes. In patients who experienced hypoglycemia, hazard ratios for cardiovascular events in people with type 1 diabetes were 1.51 and 1.61 respectively for those with and without a history of cardiovascular disease. In people with type 2 diabetes, the hazard ratios for patients with and without a history of Cardiovascular disease was 1.6 and 1.49 respectively. For all cause mortality, hazard ratios in people with type 1 diabetes were 1.98 and 2.03 respectively for those with and without a history of cardiovascular disease. Among people with type 2 diabetes, hazard ratios were 1.74 and 1 and 2.48.
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John so I love studies like this that come from the United Kingdom because I think it's so powerful because you really can't exclude people in the population. If everyone is part of the healthcare system, it is a great way to get some information. This study echoes so many different studies that we've looked at that have looked at mortality related to hypoglycemia. And certainly people having hypoglycemia can cause a significant increase in the chance of people having a cardiovascular event or a death. So I think we really need to be mindful now. Remember, this is a population in Britain that was already selected to be on insulin, so a patient population whose diabetes is going to be a bit worse anyway. But for us as clinicians, I think when we have patients on insulin, we need to be mindful that we kind of teach people how to respond to hypoglycemia, the signs and symptoms of hypoglycemia, or what to do on sick days, et cetera, et cetera. For our patients who are on medicines such as sulfonylureas that can cause significant hypoglycemia. I think we need to be mindful as our patient population gets older, what is our A1C target and the medicines that cause hypoglycemia? Again, does that population know how to identify hypoglycemia, how to respond to it?
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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.