So let's get down to some of the meat of it which is simply, "Is SMBG useful in the treatment of non-insulin treated diabetes" I say non-insulin treated diabetes because that's where I'm focusing my talk.
The DPPP and the UKPDS has really shown that in Type 1 diabetics and for even Type 2 diabetes patients who use insulin, it clearly shows that SMBG is effective for patients.
Why is that? Again, as we kind of go through the presentation.
A lot of reasons come to the fact that they're utilizing those numbers and those readings to take an action or to realize how they need to adjust something.
As we kind of go through and I give you some, hopefully constructive, clinical guidelines on how to do that, you'll realize that that's key.
But there's a lot of debate on the effectiveness of whether SMBG as a tool in self-management of patients with Type 2 Diabetes who are not using insulin is useful.
So, what I'd like to do is just review some of the information that we have on that.
There were six randomized controlled trials.
We have an additional six randomized controlled trial that have come out.
So, what the Cochrane Group does is they have various requirements to determine whether a study is valid enough to be included in their review with the very rigorous design that they look at in terms of their protocol, but they identified these 12 studies which included 3,259 patients.
The intervention duration for these studies ranged anywhere from 6 months to 12 months.
So again, these are randomized controlled trials.
So these are actually proactive trials where people were randomized to particular groups.
So of the 12, nine compared SMBG with the usual care without monitoring at all.
One compared SMBG to self-monitoring of urine glucose.
One had three arms comparing SMBG to SMUG and then to usual care, and one had three arms where they actually did a more intensive monitoring to a less intensive monitoring to usual care.
So this is a forethought of comparison of a few or most of the studies that were included.
The thing that I want to draw your attention to is that this is actually looking at people who were followed or were randomized to either self-monitoring of blood glucose or to control, and this is at six months of follow-up.
If you stay on the forethought, the left where my arrow is, it's favoring SMBG and the right is favoring the control.
So if you'll look at this, you'll notice that almost all of the studies actually showed that for six months, it actually did have usefulness in hemoglobin A1c up to 1% or 2% in some aspects for the monitoring of those patients.
What they went on to say in the review was that in newly diagnosed Type 2 patients who are not using insulin, that they found that during the first year, there was some benefit in the lowering of the hemoglobin A1c and the use of the SMBG.
What they also found was that once you got over a year in newly diagnosed diabetics that they no longer found a lot of benefit or use to the monitoring, to the use of SMBG.
What they also showed was that for folks who had had diabetes for greater than one year's duration, in folks that are non-insulin treated again, that really the glycemic control benefit of the use of SMBG was small up to 6 months and again, subsided after 12 months.
So they really made the differentiation that, well, what they found was using it in newly diagnosed was useful up until a year.
Using it in people that had had diabetes for longer than a year, you may get some initial benefit during the first six months of intent or using it but that benefit subsided in terms of glycemic control after a year.
The other things that they noted in some of these randomized controlled trials was that even despite possible beneficial glycemic effect, that the monitoring had no relevant effect on general well-being and health-related quality of life.
So various ones of these studies looked at various health-related questionnaires and other things, and whether patients felt secure or not so secure in using the monitoring system and they really didn't see that it had any effect on that.
They also saw in these control trials that people who use SMBG were just as satisfied with their treatments as those people not using SMBG.
As one would expect, they actually did find that you had increased reporting of hypoglycemic episodes with folks who were using SMBG on a regular basis.
You can have hypoglycemia without being symptomatic.
So if you're not checking, you may be hypoglycemic and not know about it.
So of course, you're going to find more episodes of hypoglycemia if you're checking on a regular basis.