Sometimes you see a study published that is so poorly conceived it leaves you wondering how lab chimpanzees were able to take over the department that ran the study and how they got into the journal office that published it.
The most recent study that falls into this category was published in this month's Diabetes Care.
Effects of Prandial Versus Fasting Glycemia on Cardiovascular Outcomes in Type 2 Diabetes: The HEART2D trial
It is very important that you pay attention to what is wrong with this study, because it is yet another study whose outcome is going to be used to justify denying you the care that could prevent you from developing complications.
The idea behind this study was to see if lowering post-meal blood sugars would be more effective in preventing heart attacks than using a strategy of lowering fasting blood sugar alone.
Okay. That sounds reasonable. Why am I trashing this study?
Here's why: The study took a group of people who had already had a heart attack. It assigned them to two groups. One received three shots a day of Humalog (Lispro). The other received either 2 shots a day of NPH or one shot of Lantus.
Do you see the problem with this study? Of course you do! They gave no basal insulin to the people who were given the post-meal insulin. But all these people started out with very high A1cs which tells you that their fasting blood sugar control was shot. So when those three shots of fasting insulin wear off, their blood sugar will go right back up.
That, apparently, is exactly what happened. At the time the study was stopped both groups of patients had nearly the same average A1cs: 7.7 ± 0.1 (Humalog) and 7.8 ± 0.1% (basal insulin.) The people using fast acting only would have had their blood sugars rise any time they were in the fasting state. The people using basal only had their blood sugars shoot up any time they were in the post-meal state.
No group was given insulin to control their blood sugars in both states. Brilliant, eh?
Endocrinologists do not prescribe post-meal insulin alone. They prescribe it in combination with basal insulin. That researchers in a major study involving 1,115 patients were so ignorant that they set up their experiment in a way that violated everything doctors know about blood sugar control is criminal. That the editors of Diabetes Care considered this study worthy of publication is even more so.
Criminal? That's a strong word. But it is probably not strong enough. Because you can be certain this study will be used by insurance companies as "Evidence Based Medicine" that justifies withholding expensive fast acting insulin from patients.
In fact, all this study really proved is that if you maintain your blood sugar at levels high enough to produce a 7.7% A1c and already have severe heart disease you have a one in three chance of having another heart attack.
This is not news. EPIC-Norfolk data already showed conclusively, drawing on a huge number of study subjects, that people with A1cs well over 7% have three times the risk of heart attack as those with an A1c of 5.5%-6% and between 4 and 5 times higher than those with an A1c of 4-5.4%.
So in addition to proving that using fast acting insulin without basal insulin is ineffective in people with very high blood sugars. this study also proves only that allowing patients who have already had a heart attack to maintain average blood sugars at levels known to quadruple cardiovascular risk in anyone will not change their risk.
But try telling that to your insurer when they tell you they are no longer paying for your fast acting insulin because "studies show it doesn't do anything.
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