Study: Structured Self-Monitoring of Blood Glucose Significantly Reduces A1C Levels in Poorly Controlled, Noninsulin-Treated Type 2 Diabetes

This week I got word about this study:

To assess the effectiveness of structured blood glucose testing in poorly controlled, noninsulin-treated type 2 diabetes.

This 12-month, prospective, cluster-randomized, multicenter study recruited 483 poorly controlled (A1C ≥7.5%), insulin-naïve type 2 diabetic subjects from 34 primary care practices in the U.S. Practices were randomized to an active control group (ACG) with enhanced usual care or a structured testing group (STG) with enhanced usual care and at least quarterly use of structured self-monitoring of blood glucose (SMBG). STG patients and physicians were trained to use a paper tool to collect/interpret 7-point glucose profiles over 3 consecutive days. The primary end point was A1C level measured at 12 months.

The 12-month intent-to-treat analysis (ACG, n = 227; STG, n = 256) showed significantly greater reductions in mean (SE) A1C in the STG compared with the ACG: −1.2% (0.09) vs. −0.9% (0.10); Δ = −0.3%; P = 0.04. Per protocol analysis (ACG, n = 161; STG, n = 130) showed even greater mean (SE) A1C reductions in the STG compared with the ACG: −1.3% (0.11) vs. −0.8% (0.11); Δ = −0.5%; P < 0.003. Significantly more STG patients received a treatment change recommendation at the month 1 visit compared with ACG patients, regardless of the patient’s initial baseline A1C level: 179 (75.5%) vs. 61 (28.0%); <0.0001. Both STG and ACG patients displayed significant (P < 0.0001) improvements in general well-being (GWB).

Appropriate use of structured SMBG significantly improves glycemic control and facilitates more timely/aggressive treatment changes in noninsulin-treated type 2 diabetes without decreasing GWB.

Self-monitoring of blood glucose (SMBG) is widely recognized as a core component of effective diabetic self-management (1–3). Although most evidence indicates that SMBG contributes to good glycemic control among type 1 (4,5) and type 2 diabetic (6,7) patients, it remains uncertain whether SMBG use is efficacious in insulin-naïve type 2 diabetic patients. Current evidence in this latter population is mixed, with some studies pointing to significant glycemic benefits resulting from SMBG use (8–10), while others have shown no significant benefits (11–13). Given the growing cost of current type 2 diabetic care, it is important to determine whether resources devoted to SMBG in the insulin-naïve population are justified and are effectively applied.

Inconsistent findings seen in studies of insulin-naïve type 2 diabetic patients may be due, in part, to differences in key design issues, such as subject selection criteria (e.g., whether or not patients had poor glycemic control at study entry), critical content differences in the actual SMBG intervention (e.g., whether physicians were privy to patient SMBG data), fidelity of treatment delivery (e.g., the same physicians cared for patients from multiple study groups), and/or intervention adherence (e.g., whether patients actually completed the SMBG study protocol as directed). A review of these issues was published previously (14). We developed a comprehensive, structured SMBG intervention package that addresses these design issues and encourages patients and physicians to work collaboratively to collect, interpret, and appropriately use structured SMBG data. Our study was designed to investigate the effect of this intervention on glycemic control in poorly controlled, insulin-naïve type 2 diabetic patients compared with enhanced usual care. Additionally, we assessed the effect of this intervention on SMBG frequency, timing and intensity of treatment modification, and general well-being (GWB).

In short, people with type 2 diabetes who are not on insulin (called “insulin-naïve” in the study -not a happy term, it seems to me) were scientifically proved to have an improved A1c after 12 months if they tested regularly (just over twice a day, on average) provided that they get physician feedback: what the numbers mean.

It may seem intuitive if you test as often or more often than this, but this tells me one thing we must know as PWD: data we can understand helps us make more informed decisions and this ultimately leads to an improvement in our diabetes management.

Full disclosure:
I received the information from Roche Diagnostics. In the study it clearly states:
“Funding for the study was provided by Roche Diagnostics, Indianapolis, Indiana. W.H.P., D.A.H., and C.G.P. have worked as consultants for Roche Diagnostics and Abbott Diabetes Care. L.F., C.H.S., and Z.J. have worked as consultants for Roche Diagnostics. B.P., M.S., and R.S.W. are employed by Roche Diagnostics. No other potential conflicts of interest relevant to this article were reported.”

It would be interesting to compare a group getting “physician feedback” with a group getting “message board feedback”. “Holy smokes don’t eat that and hit golf balls at your doctor’s office”

That would be phenomenal to see! Closest thing we have to that nowadays would be the things we’ve begun to find through TuAnalyze:
(clearly not such a controlled study, but…)

I think that is a very good step in the right direction! I can see that it would be hard to quantify any sort of ‘result’ in such a way that would be meaningful to the Medical Insurancical Complex (MICEX, a term I have stumbled upon today…) though, or those elements therein “working” to “manage” (sic) diabetes on 6.67 strips/ day.

I think the diversity of experiences reflected in people posting here is only a portion of the people with diabetes but it might represent a group who could perhaps be thought of as having “The Right Stuff”, at least pushing the envelope by signing up to yak with strangers on the internet and going “I had that brand of rice and my BG was ok” to help each other have a dialogue that, at least in my experience, has sort of been lacking in my medical teams? Or maybe that’s just because I don’t ask them for much? Since the people are here, something ought to be done with them. A long term study to see what sort of hazards there are for people running in the 4s and 5s w/ their A1C? I think that some people have been doing it for a long time but the MICEX seems to refuse to recognize that as a rational goal? Who knows? Maybe they are correct however without a suitable study, I would question whether or not they are actually correct?

Given the fiscal strains the economy is under, I would think that doctors and patients and insurers (gasp) should perhaps be looking for ways to improve the exchange of information? Doctors’ time is very valuable and expensive but, at the same time, I have t think that there are people who are ‘gun shy’ about deviating from whatever their doctor told them who can benefit from someone saying “if my BG were low every day, all day, I would take less basal insulin”, particularly when demand for endos is escalating and some people have to wait weeks or even months before their next shot at medical advice? Of course, the standard is to talk to your medical team but they can’t hang out on message boards because 1) they can’t charge for it and 2) there’d be all sorts of sinister malpractice implications that could come up.

I am actually surprised this study got a positive result. This study suffered from the fundamental flaw in virtually all the previous studies of self monitored blood sugar. I’ll get to that flaw in a moment, but first I’d like to comment on why this and similar studies matter. Public health recommendations and insurance company coverage for numbers of test strips is based on studies like this. Almost across the board, these studies have found it matters little how much type 2 diabetics test. That is a terrible shame.

And now we get to the central flaw, and that is when you have patients test their blood sugar, you need to test them to “do something” with the result. But unfortunately, the medical profession is in total denial. It turns out type 2 patients are not advised to make thieir own decisions about treatment based on test results. They are not told to decrease their carb intake if they have high blood sugars, and they are not told to adjust anything else in their treatment regime. So what is the point of testing? That is a valid question.

So as Jenny Ruhl has always pointed out, diabetics should test so that they can make informed decisions about their treatment and the most elementary of those decisions for a type 2 diabetics involves dietary carbs. Until the medical establishment “gets a clue,” we will continue to have “stupid” studies of self monitored blood sugars being inneffective. This study showed a positive results, but it is probably just dumb luck, my doctors won’t even look at my logs.

This is all very interesting. Given the time contraints and pressures of the doctor - (except an ENDO) do you feel that those primary care and internists treating diabetes have the proper training/skills to quickly analyse a BG chart over time to make the appropriate course corrections to their patients therapy (those on insulin and those not)

Some very good points there, bsc! It is possible one flaw could be the very intent the doctors involved in the study could have in giving the right information, i.e. the patient population may be randomly selected but the doctors they were seeing weren’t… So we need two things to happen:

  1. All patients to test regularly;
  2. All doctors to behave as the doctors in this study!

Very true, but if you read the study, the patients reported their blood sugar reading to the doctors. And the doctors made the recommendations on changes to medication and lifestyle. The blood sugar readings had ZERO value to the patients self management. In my opinion, that is the serious flaw.

I am sure the people that put together the report are reading this, so it’s a useful feedback!

Your constant and consistent optimism is an inspiration to all of us. The primary author is William Polonsky, author of Diabetes Burnout. I have a lot of respect for him. This study at least looked at changing treatment based on SMBG. But given the previous track record, I remain a hopeful skeptic.

If William Polonsky or any of the authors are listening. I would be happy to help design an important study which gets to the real heart of matter. Can SMBG help type 2 patients make daily decisions about their treatment and in particular can they these test results help them determine how many carbs they can tolerate at meals?

BSC= right stuff!

SMBG works for many of us on this site. The key would be to integrate it with diabetes education.

Part of the problem is that the standard protocol for T2 is to test once or twice a day. Since you are getting no feedback how can you adjust your diet, exercise etc. Of course this won’t work for everyone, but I have to believe more testing in the overall population would result in lower average A1C’s and less complications. Or said another way, being so stingy with strips causes a rise in overall costs.

I often base meal choices on my pre meal reading. If it’s good I may have a few more carbs. Without the extra test I’m shooting in the dark.

Good points, BadMoon.

Also the lack of testing is just one issue. Even with more testing, we all know that the official advice for diet actually makes blood sugar management worse…

And now we get to the central flaw, and that is when you have patients test their blood sugar, you need to test them to "do something" with the result. But unfortunately, the medical profession is in total denial. It turns out type 2 patients are not advised to make thieir own decisions about treatment based on test results. They are not told to decrease their carb intake if they have high blood sugars, and they are not told to adjust anything else in their treatment regime. So what is the point of testing? That is a valid question.

You apparently did not read p. 263, column 2, paragraph 1 after subtitle Intervention. It reads:

STG participants used the Accu-Chek 360° View blood glucose analysis system (Roche Diagnostics), a validated tool (16) that enabled patients to record/plot a 7-point SMBG profile (fasting, preprandial/2-h postprandial at each meal, bedtime) on 3 consecutive days prior to each scheduled study visit (months 1, 3, 6, 9, and 12), to document meal sizes and energy levels, and to comment on their SMBG experiences. STG participants received training in the use of the Accu-Chek system, including instructions for how to identify problematic glycemic patterns and how best to address such problems through changes in physical activity, portion sizes, and/or meal composition. STG patients and physicians reviewed the completed form at each of the scheduled visits and noted areas of needed medication and lifestyle change. Completion of the Accu-Chek system was prompted via a telephone call from their physician’s office one week prior to their next appointment. ACG subjects did not receive the Accu-Chek system. ACG patients were instructed to use their meter following their physicians’ recommendations but received no additional SMBG prompting, training, or instruction.

The experimental group WAS, in fact, taught how to use that data to make changes in activity, portion sizes AND OR MEAL COMPOSITION – i.e. change the proportion of fat:protein:carbohydrate, ALL OF WHICH IMPACT BLOOD GLUCOSE LEVELS, NOT JUST CARBOHYDRATE CONSUMPTION.

Sorry to shout, but you are incorrect.

This is actually a hopeful study. They tested 7 times per day which is what I do. My doc was surprised at how quickly I was able to bring my numbers down but, never made the connection between frequent testing and better numbers. He still seems bemused at how much I test.

Perhaps this will make it into the ADA guidelines for treatment. The average lowering of A1C was 1.5% which is more than a lot of expensive drugs do (thinking of the ACCORD study for instance)

That report was pretty dense and hard to decipher but it wasn’t written for people like me.

That is not how I read the study. The next paragraph read:

STG physicians/staff received training on interpreting the structured data and were provided with an algorithm that described various pharmacologic/lifestyle treatment strategies that could be used in response to the specific SMBG patterns identified.

It was the physicians that downloaded meter readings and made recommendations on medication and lifestyle changes. Later in the paper it was further noted that:

ITT analysis showed that patients in both study groups who received a treatment change recommendation (pharmacologic and/or lifestyle) at the month 1 visit experienced significantly (P < 0.0005) greater reductions in A1C than patients who did not receive a treatment change recommendation at the month 1 visit.

This was a study of how much improvement there was when physicians made decisions when informed by SMBG. This was not about how patients who made SMBG informed treatment decisions improved. Although the study does note that

… the PP analyses show that the glycemic advantage occurred only among the STG patients who adhered to the intervention. Therefore, physician training alone does not sufficiently explain these findings.

So at least the study recognizes that patient has a role in the outcome.

And I am sometimes incorrect, and we will know it even if you don’t shout.

I have to admit I test a lot more than my doctor recommends. He wants me to test 2 x per week. I probably test 2-3 times most days. As Brian said, I do something with the results. I learned this on online forums, not from my dietician or doctor. In fact if I had followed my CDE’s advice I would probably be on tons of meds by now. She told me 180 after meals was fine. I have now fine tuned my diet so I am around 110 after meals and back to high 70’s before my next meal. I don’t know why doctors don’t teach their patients to eat to their meters. I know insurance companies want to limit our strip use but in the long run by keeping our bgs low we have fewer complications that cost them much more money.

That is FANTASTIC, especially because there was a study in the UK several years ago that said that BG monitoring had no effect at all on control in Type 2’s. Which led some insurance companies, and probably Medicare, to greatly limit the amount of test strips Type 2’s could get.

I sure hope this will encourage the holders of the key to effective treatment (money) to liberalize rules on supplies for Type 2’s!

An idea I’ve had for years (and which my close CDE friend agrees with) but which the AADE is bitterly against is the idea of a Certified Peer Mentor. That means US. Those of us who have had diabetes for a long time have much to offer the newly diagnosed, even if it is only ideas to bring back to their medical professionals. We wouldn’t want to step on any professional toes by telling someone if and how much to increase their basal (would we?), but we can certainly talk about food, and about treating lows (juice or Coke?), and not to panic over a number that may not be as horrific as a newbie might think. Or just to talk about feelings – emotions run rampant when a person is newly diagnosed.

We are a WONDERFUL, but totally unrecognized resource!