Intensive blood sugar control - dangerous in type 2 diabetes?
You may have seen the news about changes in the ACCORD Trial. This is a clinical study of adults with type 2 diabetes who are at a higher risk for cardiovascular disease.Some of the people in the trial were following an intensive approach to managing their blood sugar. The aim was to keep their A1C results below 6%. Others in the trial were following a 'standard treatment' with a target A1C between 7% and 7.9%. This second range is much closer to what most people with type 2 diabetes achieve.
Over 10,00 people were taking part in the trial. Over about a four year period 257 people in the intensive group died, compared to 203 people in the standard treatment group. This was equivalent to 3 additional deaths per 1,000 participants per year. And both of these death rates were lower than similar populations in other studies.
About half of the additional deaths were due to cardiovascular disease, the rest were from other issues such as cancer. But it's not clear why these happened.
Because of safety concerns about this increase, the NHLBI who sponsors the trial has decided to stop using the intensive treatment approach and have all participants use the standard one with it's less demanding A1C goals.
If you want more information about the trial and what has changed, the NHLBI has an excellent FAQ page.
And remember, if you have type 1 diabetes, these findings don't apply to you. You should still aim for the best blood glucose control you can safely achieve.
Update: Kelly Close of Close Concerns has a good blog post about this trial, it's also worth reading.
The ACCORD Trial has its own web site, which gives more details about what the study was attempting to find out. From this page you can see that 5,128 people were in the intensive blood glucose control group and 5,123 people were in the standard blood glucose control group.
If you'd like to see other coverage of this situation across the diabetes internet, the diabetes search engine returns a lot of interesting hits for "ACCORD trial".
Labels: diabetes, NHLBI, research, trial, type2
posted by Bernard @ 10:34 PM
7 Comments:
Do you think that tighter monitoring of blood sugars following enrollment and especially following changes to dosing would have prevented some of those deaths?
This post has been removed by the author.
Since the people in this study were considered at an already higher cardiovascular risk, I wonder if they took into account the treatment drugs and various combinations used in the trial. What if the deaths were caused from higher doses of Avandia to achieve tighter control. I have to wonder if it is the way they brought down the A1c, not the result of a lower a1c.
BTW Bernard, I've been getting a lot of Blogger errors trying to post to your site. Thought you should know
The ACCORD trial randomized patients with diabetes and vascular disease or multiple cardiovascular risk factors to an intensive treatment program targeting normal blood glucose values and an A1C less than 6 percent or a standard treatment program with an A1C between 7 percent and 7.9 percent. The intensive participants in ACCORD are now being switched to the standard treatment program because of an increased death rate in the intensive treatment program (14 deaths per 1000 patients per year versus 11 per 1000 patients per year in the standard treatment program; a difference of 0.3 deaths per 100 patients per year).
Hmmm? Not quite headline material by itself.
sorry - source for the last post is the ADA's website.
Kevin
One of the reasons I blogged about this issue is because there's so many reports being published that make it sound as if achieving tight control is really dangerous. And some of those reports don't clearly point out that this was in people with type 2.
Looking at the statistics, the increase for those under the intensive regime doesn't seem like a lot. I just hope they're able to figure out why it happened, otherwise there'll be a lot of people saying that a lower A1C is not desirable.
It's all very interesting when you consider that the ADA essentially says "Your goal should be to have A1C values less than 7%.". I wonder if they'll now revise this target.
I wonder if this might have something to do with it:
Folks with higher a1c values are not having very many hypoglycemic episodes. Therefore their counter-regulatory system is not very well-developed or is under-utilized. So when all of the sudden they started aiming for a1c values below 6, they were experiencing many more lows that they ever have. As we all know, the adrenaline response when our BG is low can be pretty strong, and I wonder if this response caused more catastrophic heart failure in those patients? Just a thought.
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