I want to make a couple of comments. First of all, Dr. Gavin told us we do have a problem and the problem is not getting better; it's getting worse. We have more people with diabetes, and with all the drugs we have today, the hemoglobin A1C levels (A1Cs) are getting worse instead of better. Dr. Blonde gave us guidelines -- there are guidelines for everything today -- and told us a little bit about some of the importance of home glucose monitoring. And Dr. Gerich told us about the importance of postprandial hyperglycemia, patients he sees who know that if they do blood sugars and they have a big meal with pasta that the blood sugars will go up. There is a study with pizza, but some of the guidelines are backward. If you listen to what Dr. Blonde told you, you're going to do more blood sugars; if you're going to intensify insulin, you're going to do more blood sugars. If you're going to add oral agents, how do you know you need to add oral agents unless you have blood sugars? Common sense needs to prevail.

Self-monitoring of blood glucose (SMBG) is an educational tool; if we use it properly, the patients can actually intervene. If we're going to help in the management and better control of diabetes, then we need to educate our patients. You're going to see what happens. We tell them to do blood sugars; we don't tell them what to do with them and many times they come back to us, and we don't even see the blood sugars. Then we need to have specific recommendations on frequency and timing. We need to identify hypoglycemic and hyperglycemic patterns, and it is very important for us to make changes. So we really need to get going and educate people a lot better than we're doing now.

All patients who have diabetes should be able to perform SMBG. I think they're entitled to that. Monitoring should be individualized to the patient needs and to the therapies, and the therapies adapted to SMBG; not the other way around. The data should be allowed to be used by the patient and by us to make decisions. Simply doing SMBG is not going to take the patient from an A1C of 8% to 7%; they need to know what to do with the information. And patients with diabetes have the right to know their glucose levels.

Access to supplies, availability, is a problem. In Texas, we have a law that for patients who have the diagnosis of diabetes, managed care and insurance companies have to pay for home glucose monitoring out-of-pocket expenses. Obviously we need to translate that to some of the things you heard earlier. You saw from Dr. Gerich one study in which SMBG could lower the A1C by 1%. How much is 1% per patient per year -- the cost of 1% better A1C per patient per year? How much can we save? We save almost $1000 per patient. But $1000 per patient per year, isn't it worth it for Cigna or Blue Cross/Blue Shield or anybody else? It is worth it. We need to be proactive.

Language is a barrier for some things. A lot of our patients are low in terms of socioeconomics; many of them are new immigrants who know very little English. When we tell them to do more blood sugars and you tell them why, you should take the time and give some of the translation; the idea is that it is much better. And the education and the techniques that we use and the time we spend with patients are worth our while because they do better.

If we look at access, obviously if somebody gives it to you free and you know why to do it, you're going to use it more and you can see what happens to the A1C. Here you see the months, and you can see that the number of tests per day, if there is no cost to the patient, increases. On the other hand, what happened to the A1C? You see a difference; those people who get the strips at no cost have better A1C than those who don't get them because it's costly.

Then we usually blame the patient; it's so simple to tell the patient, "You don't do it; it's your fault; it's nobody else's." Here you see 40% of patients with diabetes still are adherent to the recommendations. And why? Because if we have a good healthcare team, we take the time to educate the patients; if they know what to do, I think they will do it more. But 60% are still not adhering, and we need to find out the reasons. Just to let them go and not do it, it makes no sense to me.

We need to educate them on the importance of glycemic control, why fasting, why postprandial, why preprandial, and what the targets are; for them to recognize a pattern and call us to make the changes; we can tell them ahead of time. But I cannot make a change on insulin and then start doing home glucose monitoring because I made the change; I will do the change based on the glycemic values.

You need to do profiles, either by meals or by days; you need to be cost-effective, and obviously depending on the patient, with the frequency. If I have somebody on intensive insulin therapy and I'm not adjusting doses, I need to do a lot more SMBG than in somebody who I'm going to start on metformin. But nevertheless, I want to tell you that metformin also has an effect on postprandial. Some of the drugs such as thiazolidinediones (TZDs) have an effect on postprandial. Then there are specific drugs that target postprandial, but that doesn't mean that they are the only ones.

And there is proper technique, and meter calibration. Some patients wash their hands, and they leave a lot of water in the hands. That is a delusion; the blood sugar may not be correct. How about if the A1C doesn't match the home glucose monitoring? Remember, many, many labs have not standardized the A1C. So in your institution, you need to ask for A1C testing that is Diabetes Control and Complications Trial (DCCT)-standardized. In your offices, you can buy equipment that's standardized to DCCT that will give you better chances to get a real A1C. There are new machines coming up. In addition to that, some people with some hemoglobinopathies may have a low normal A1C, and then the glucose monitoring becomes more important. Then proper technique, alternate site monitoring, etc, is very important for people.

Common user errors include failure to store the strips properly (sometimes humidity may change it), insufficient blood, no controls, out-of-date solutions, and out-of-date strips. I have patients who have strips from a year and a half before, they find them, they use them, and it doesn't work that way; you need to be sure you tell them of the expiration time and so on. Match the strip code, and be sure that the meter is clean and that the patient knows how to use it.

We need to help the patients gain awareness of their bodies, understand the role of diet and carbohydrates, and get past discomfort of fingersticks; the new little lancets are not as painful as they used to be, and once they do it, they will continue to do it.

If people write down the blood sugars, the A1C, just by doing that and seeing them improve, they don't rely only on the meter memory because it doesn't give the pattern; writing them down is very important.

Establish preprandial and postprandial targets. Get them to get the data to you (medications, meal time, etc) and format the data to establish a good relationship. Remember, at the end of the day, if we don't do it right, all of us will pay.

And facilitate the pattern management. A systemic approach to identify glucose patterns and determine lifestyle and medication changes is needed to optimize control.

Pasta, pizza; there are some fruits such as watermelon that in some patients will increase the blood sugars from very normal to 250 mg/dL; there are some things that affect some people differently. We need to start looking more at glycemic index; the Europeans are ahead of us. It's important in postprandial; it's important in fasting. And we need to take the actions necessary.

Establish the goals, get pertinent data, identify the patterns, assess the influencing factor, and let's take action. I think we can do it. I think in spite of the fact that we don't have all the tools that we want to have, the medications together with home glucose monitoring today should allow us to get most of the patients under good control.

A pattern is a series of out-of-range glucose readings, and that could be hyperglycemia or hypoglycemia. If it's hyperglycemia, I will try to make changes in 3 to 4 days. And if it's hypoglycemia that repeats 2 to 3 days without the patient telling me that is his or her fault because they missed a meal, they were late, I will start doing the changes based on the glucose and not based on the therapy. Oral agents can give you hypoglycemia as well.

Influencing factors; are they sick and that's the reason they have the pattern? Then you need to adjust it for that period of time. Are they taking any new medication that may influence glycemic control? Have they changed their exercise activity and now they have hypoglycemia? Then we need to adjust the medication or change the time of exercise. But I will not decrease exercise; I believe that exercise in patients with type 2 diabetes and type 1 diabetes is extremely important.

Is a change necessary? Only we can make that decision. We can tell patients to do a few things, but the decisions are made with consistency of glucose monitoring and values that you have, and then we respond to those patterns. A new study came out last year in which they measured C-reactive protein (CRP), postprandial, and A1C, and at the same level of A1C, using drugs that actually target postprandial such as repaglinide, the lowering of the postprandial was better; the A1C was the same. They did carotid intima-media thickness (CIMT) and there was a decrease in the thickening of the CIMT, and there was also a significant decrease in CRP. All these patterns, we need to respond to them, and it doesn't take 3 months. If you see a patient every 3 months and they don't know what to do and they don't call or e-mail you the results, it will take a long time to get to the targets.

When should we start treating and using SMBG in diabetes? We have 41 million people with prediabetes. Why monitor patients at this stage? Prediabetes is a progressive disease; from the Diabetes Prevention Program (DPP), you know that they are going to progress to diabetes if they do nothing. Second, even if they do something, a significant number of people continue the progression, and in most cases, the main glucose elevation is the postprandial. Then monitoring postprandial will allow the patient and healthcare team to properly intervene with education, nutrition, exercise, and eventually the proper pharmacologic therapy.

The American Diabetes Association (ADA) recognizes impaired glucose tolerance (IGT) as a cardiovascular risk factor. Again, we need to use common sense. What is IGT? Is it a normal fasting with an abnormal postprandial? And if that increases cardiovascular risk -- and cardiovascular risk problems in diabetes are a big problem -- why shouldn't we intervene?

If we want to decrease the risk of cardiovascular events, we need to look at postprandial. If you look at glucose levels, the elevation of postprandial is 5 to 7 years before you see an elevation in the fasting, and in the United States, we made the diagnosis of diabetes 7 to 14 years too late. Why? Because if we rely only on fasting elevation, you're going to waste that important period of time where we can do interventions.

If you see something like this where fasting glucose and preprandials are normal, but you see the postprandial elevation between 140 and 160, what can you do? First, the patient can exercise; second, they can look at the diet.

You start looking at this pattern, you control this, and you can see this patient is doing something. You have a 101 to 163; you have a previous pattern from the previous week, you start intervening with a little exercise after breakfast, lowering the carbohydrate load for that meal, and now you have a postprandial that is normal. Then what's the next step? This patient has IGT; you just decreased the risk of cardiovascular disease.

Then you go to the next one; this patient may not want to do and you may not want them to do 6 glucoses a day. Control one pattern, the next week you go to lunch, the next week you go to supper; sometimes when we do that, we see that the postprandial lunch is not a real problem. The next big problem is postprandial after supper because usually we tend to eat a bigger meal at that time.

Then you fix that and you continue, and type 2 diabetes continues the progress.

You heard from Dr. Gerich what influences postprandial and what influences fasting.

This is from Monnier. What I want to tell you is whenever you are getting closer to normal, like he says 7.5 or below, look at the contribution of the postprandial. Here the contribution of the postprandial below 7.3 is almost 80%. If you only monitor preprandial and you want to get to the new target, which is 6.5, you're not going to do it unless you start looking at where the postprandial elevation is and intervene properly to get it there. And we have new treatments; it's not that we don't have tools.

Dr. Gerich told you about short-acting insulin secretagogues such as meglitinide, repaglinide, but we have also rapid-acting insulin analogs, which work very well in postprandial. Rapid-acting analog premixed preparations, some patients will do very well with them. Obviously when you go more intensified, you need to know when to adjust insulin. And we have all these combinations between rapid-acting secretagogues, sensitizers. Using those combinations, we did a study and the most important part of the study was that we actually lowered postprandial significantly and we got a lot of the patients to target.

And you're going to continue having new agents. Today, the incretin mimetics, the glucagon-like peptide-1 (GLP-1) analogs, they affect postprandial. They have been approved in combination with secretagogues such as sulfonylureas. If you use them, you increase the risk of hypoglycemia in some of the patients, and glucose monitoring to adjust the sulfonylurea, not necessary the GLP-1 analog, is very important.

Let's look at the DCCT and hypoglycemia. In the DCCT, in Dallas, Texas, home glucose monitoring was very important. Severe hypoglycemia events occurred at triple the rate in the intensively treated patients compared with the conventional group, but that doesn't mean the conventional group didn't have hypoglycemia. The rate was 62 episodes per hundred patient-years vs 19. But over the time, we learn how to prevent these episodes, and after the first 3 years, we were able to decrease the risk of hypoglycemia. The only way it can be done is by doing home glucose monitoring.

In the United Kingdom Prospective Diabetes Study (UKPDS), there were more hypoglycemic events with all types of intensive treatment regimens, including oral agents such as sulfonylureas, metformin, and the combination of metformin and sulfonylureas. But hypoglycemia in the UKPDS was reported in people not using pharmacologic therapy. How will you make a change in therapy if a patient tells you, "I have symptoms," and they don't have a glucose level? Even in these studies, people who were not pharmacologically treated had hypoglycemia.

Looking at hypoglycemia in the UKPDS, we don't use chlorpropamide in this country any more, or very rarely. You have a lot more hypoglycemia with this drug based on the number of patients. There were no deaths with chlorpropamide; there were no deaths with glibenclamide, which is what we call glyburide in the United States. And there was 1 death with insulin. That means the type 1s don't have a risk for hypoglycemia? They do.

If we look at many studies, and I have done that in the last few months, hypoglycemia in type 2 diabetes is mainly a problem in the elderly. When you see a patient who is 70 years of age, you are going to say, "He's too old to do home glucose monitoring." Well, that patient really needs it. If they're in a nursing home, we want to be sure they do it. Sometimes they have erratic eatings, not only the timing but the quantities. The meals come late; they give them the medication, they have hypoglycemia. Also, in people 65, 70 years of age and older, sometimes the creatinine is not that good a reflection of renal function. Some of these drugs may accumulate for a longer period of time and cause more hypoglycemia. And the older the patient is, the higher the risk of hypoglycemia. I reviewed some recent studies from Europe in nursing homes, and once we get somebody 80 years of age, they can actually achieve very good control, but hypoglycemia is a significant problem. Don't forget the elderly patient.

In hypoglycemia, the documentation of glucose levels is extremely important. Hypoglycemic symptoms do not always correlate with very low glucose levels. A sudden drop in glucose may cause the same symptoms. Unless you know the blood sugars, you cannot adjust the therapy. SMBG is a critical tool in the decision making process to determine true glucose values. If they call you and they tell you, "I have the symptoms," in order to make adjustments in therapy, we need to see if there is a pattern.

In summary and conclusion, diabetes and prediabetes are associated with microvascular and macrovascular complications. Both complications are truly a problem for us, and not only in terms of retinopathy. Remember, a patient with hyperglycemia has a risk equivalent to somebody who already had a myocardial infarction (MI). Improved glycemic control decreases the onset of complications, and remember, as shown in the Epidemiology of Diabetes Interventions and Complications (EDIC), the continuation of the DCCT, metabolic memory that stays because we treat people intensively from day 1 is very important. And recently I heard that the same happens to be true in the observational part of the UKPDS; that is, we have not only type 1, but now we are starting to have data in patients with type 2 diabetes.

Optimal control is more difficult to achieve in the clinical setting outside controlled clinical trials. But I do clinical trials, many of you do clinical trials, and what's the difference? Do we need to treat them differently? I think a patient is in a clinical trial if they have diabetes the rest of their lives and it's our clinical trial.

SMBG is valuable to adjust therapy because you don't change the therapy based on A1C; you change the A1C based on blood sugars and you adjust the therapy for those blood sugars. And that's common sense, you need to adjust the blood sugars; you need to adjust the therapy to get a better A1C. It provides a real-time feedback; it detects abnormal glycemic profiles. It facilitates appropriate medication and management; it acts as both an educational and motivational tool. Some patients do abuse home glucose monitoring, but not having the right to do it is worse.

SMBG should be performed at various times of the day depending on the needs of the patients. If fasting and preprandial SMBGs are controlled but A1Cs are above target, postprandial glucose control should be emphasized. You cannot just forget about postprandials because once you get close to normal, that's what really is needed to get to the new targets, and it's doable.

SMBG is an educational tool that should be used in conjunction with a diabetes management action plan and that should include patient education in techniques and targets, and specific recommendations on frequency and timing. The healthcare team will dictate what they need to do; if the patient knows what they're doing it for and how to use it, they're going to achieve a lot more than 40% adherence. It helps you identify hyperglycemic and hypoglycemic patterns, and healthcare follow-up based on the results with additional education will be appropriate for some of these people.