The PRISMA randomized trial
Abstract
OBJECTIVE We aimed to evaluate the added value of intensive self-monitoring of blood glucose (SMBG), structured in timing and frequency, in noninsulin-treated patients with type 2 diabetes.
RESEARCH DESIGN AND METHODS The 12-month, randomized, clinical trial enrolled 1,024 patients with noninsulin-treated type 2 diabetes (median baseline HbA1c, 7.3% [IQR, 6.9–7.8%]) at 39 diabetes clinics in Italy. After standardized education, 501 patients were randomized to intensive structured monitoring (ISM) with 4-point glycemic profiles (fasting, preprandial, 2-h postprandial, and postabsorptive measurements) performed 3 days/week; 523 patients were randomized to active control (AC) with 4-point glycemic profiles performed at baseline and at 6 and 12 months. Two primary end points were tested in hierarchical order: HbA1c change at 12 months and percentage of patients at risk target for low and high blood glucose index.
RESULTS Intent-to-treat analysis showed greater HbA1c reductions over 12 months in ISM (−0.39%) than in AC patients (−0.27%), with a between-group difference of −0.12% (95% CI, −0.210 to −0.024; P = 0.013). In the per-protocol analysis, the between-group difference was −0.21% (−0.331 to −0.089; P = 0.0007). More ISM than AC patients achieved clinically meaningful reductions in HbA1c (>0.3, >0.4, or >0.5%) at study end (P < 0.025). The proportion of patients reaching/maintaining the risk target at month 12 was similar in ISM (74.6%) and AC (70.1%) patients (P = 0.131). At visits 2, 3, and 4, diabetes medications were changed more often in ISM than in AC patients (P < 0.001).
CONCLUSIONS Use of structured SMBG improves glycemic control and provides guidance in prescribing diabetes medications in patients with relatively well-controlled noninsulin-treated type 2 diabetes.
http://care.diabetesjournals.org/content/36/10/2887.short?rss=1
Graham
6 comments:
I was given a meter and test strips from the offset. I was also given a diary in which to record my readings so that "Dr can work out the appropriate medication". As I was also put under pressure to raise my carb intake and the fact that all that happened was that my meds continued to rise as did my HBA1C, I think the education part is very significant. If there is no connection with diet ie patients are not taught to check how different foods affect readings I am not sure that monitoring would make much difference. In fact I know many diabetics used to make up the nos before their reviews.
Not very helpful to anyone you would think.
Later when I had discovered how to use meters I always used to take a week or so's readings with me to many appts although they didn't want them. They could hardly refuse to listen and it often made a difference to my meds etc.
A couple of years ago I did the same at the hospital with a Dr on a visiting research fellowship. He was amazed at this "novel idea" and encouraged me to continue.
Test strips for all had only been phased out a short while previously. Makes you wonder....
Kath
Test strips for all diabetics should be mandatory. Type 1's it goes without saying but Type 2's especially in the early days when you are finding out about this illness you have is so important.
As with many illnesses it comes down to where you live which is so wrong but is the way it is. It needs changing
James
You need a meter and you need test strips and you need to use them and act on the results. If you don't do that you can't care about your diabetes, your life. Of course you need to get your hands on a reliable meter and test strips first. If your doctor or diabetic nurse HCP does not prescribe one then check ebay, check forums, get one and then check your readings. Yes James meters and test strips for all should be mandatory. Why aren't they Jeremy Hunt?
I agree with what your saying James but with all the cut backs in the NHS I think things will get worse, I've seen comments were even Type 1's are facing restrictions on the amount of test strips prescribed.
Thanks for your comment.
Cheers
Graham
Anonymous @23.22
Couldn't have put it better myself thanks for your comment much appreciated.
Cheers
Graham
The problem is how to make people aware of meters in the first place. They are not mentioned on diagnosis. I acquired a meter and test strips for an elderly friend but he can't be persuaded to use them because when he mentioned them to his Practice Nurse she was angry with him.
I have mentioned them to others who obviously thought I was crazy. Hardly surprising when young GPs including one who assists in a hospital diabetes clinic asked me "why would I want to stick pins in myself".
So we have two small but essential pieces of information - reduce starchy carbs and get a meter and strips and learn how to use them, which could save lives, but which are poo-poohed by many HCP's.
Kath
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