More Bad News for the BGM Market
Over the past few items Diabetic Investor has written on the blood glucose monitoring (BGM) market, we’ve been warning everyone it’s only a matter of time before reimbursement for glucose testing supplies undergoes a dramatic change. Our premise has been with the number of studies showing there is little credible evidence that non-insulin using patients achieve better outcomes even when they are monitoring their glucose levels, insurers would begin changing or even eliminating reimbursement for non-insulin using patients.
Two studies published in the most recent issue of the respected British Medical Journal will only add credibility to our belief. In the first study, “Cost effectiveness of self monitoring of blood glucose in patients with non-insulin type 2 diabetes: economic evaluation from the DiEGM trial”, the authors concluded; “Self monitoring of blood glucose with or without additional training in incorporating the results into self care was associated with higher costs and lower quality of life in patients with non-insulin treated type 2 diabetes. In light of this, and no clinically significant differences in other outcomes, self monitoring of blood glucose is unlikely to be cost effective in addition to standardized usual care.”
The second study, “Efficacy of self monitoring of blood glucose in patients with newly diagnosed type 2 diabetes (ESMON study): randomized controlled trial” the authors concluded; “In patients with newly diagnosed type 2 diabetes self monitoring of blood glucose concentration has no effect on glycemic control but is associated with higher scores on a depression subscale.”
Talk about piling on, not one but two studies conclude BGM is of little value and actually makes patients more depressed. Diabetic Investor hates to say we told you so, but we did. While we could go into our rant on why these results are just one more example of the poor state of patient education or how the major BGM companies really have no one but themselves to blame for this situation, let’s take a closer look at both studies before we rant on.
In the first study 453 patients were divided into three groups; “Briefly, consenting people with type 2 diabetes who had hemoglobin A1c of 6.2% or more and who were not using self monitoring more than once a week were allocated to one of three groups: standardized usual care (control group, n=152), use of a blood glucose meter with advice for participation to contact their doctor for interpretation of results (less intensive self monitoring group, n=150), and use of a blood glucose meter with training in self interpretation and application of the results to diet, physical activity, and drug adherence (more intensive self monitoring group, n=151).”
Besides finding no major benefits in outcomes, the study did reveal some interesting points:
1. “Ninety nine (67%) of those receiving the less intensive intervention and 79 (52%) of those receiving the more intensive intervention continued to use the meter at least twice a week for the 12 months of the study.”
2. “The control group showed no significant change in mean utility per patient during the trial. By contrast, patients in both self monitoring groups showed reductions in quality of life, which reached statistical significance for the more intensive self monitoring group.”
3. “This study therefore provides no convincing evidence for routinely recommending self monitoring to patients with non-insulin treated type 2 diabetes.”
(Just in case your wonder where all those moans are coming from look no further than Milpitas, CA, Libertyville, IL, Indianapolis, IN and Tarrytown, NY. )
In the second study with newly diagnosed patients , one group of patients “were asked to monitor four fasting and four postprandial capillary blood glucose measurements each week. They were advised on appropriate responses to high or low readings. Such advice included the need for dietary review or the suggestions of exercise (such as walking) in response to high readings. At each clinic visit, concordance with self monitoring regimen was verified by downloading meter readings.”
“Patients in the no monitoring group (control) were asked not to acquire a meter or perform monitoring for the duration of the study.”
“Patients in both groups underwent an identical structured education programme involving diabetes nurse practitioners, dieticians, podiatrists and medical staff. All patients were reviewed by the doctor, diabetes nurse practitioner , and dietician at three monthly intervals for one year. At each visit all aspects of glycemic control (HbA1c for both groups and self monitoring results for the self monitoring group). Patients in the self monitoring group received ongoing advice and support in the appropriate interpretation of and response to their capillary results.”
Some notable findings:
1. “An interesting finding in our study was that monitoring was associated with a 6% higher score on depression subscale and a trend towards increased anxiety, although satisfaction with treatment was unchanged.”
2. “Although HbA1c fell within each group, there was no significant differences between the groups at any time point, with mean (SD) values at 12 months of 6.9 (0.8)% v 6.9 (1.2)% for the self monitoring versus control groups.” It should be noted that the baseline A1c at the beginning of the study was 8.8% for the self monitoring group and 8.6% for the control group.
3. “The value of self monitoring in patients with a new diagnosis is an important practical issue given that in UK clinical practice patients are often introduced to monitoring at an early stage after diagnosis. Our results suggest it is not associated with any improvement in glycemic control in such patients and might be associated with reduced wellbeing.”
At least the second study with its strong emphasis on education proves the benefits of education with solid improvements in outcomes. A message that should not go unnoticed when one looks at the first study that carried little education or intervention. Equally important is not just that the patients in the second study received education rather they received on a regular and ongoing basis. This is one of the most misunderstood aspects about education and one of the reasons why most companies just don’t get it.
Education cannot simply be delivered with a pamphlet or web site on an occasional basis. To be truly effective education must be on-going and involve the patients entire health care support system. To believe that patients can learn anything about their diabetes management from a once in a while education session is about as ludicrous as believing patients can gain anything from measuring their glucose levels once a week or eight times a week.
The fact is patients are improperly educated on the benefits of glucose monitoring from the first day of their diagnosis. This obsession with point to point measurements and little explanation of what the numbers mean is one of the main reasons for patients experiencing increased anxiety and depression. In the eyes of patients their daily regimen of measuring glucose is filled with trepidation as they see these measurements as a test which carries a pass or fail grade at the end.
It’s time for a change in which patients are taught of that each measurement is part of a larger picture or trend. The fact is for a non-insulin using patient one individual glucose measurement means very little. However, a series of data points can provide valuable even life saving information. By looking at a series of data points the patient and health care team can get a much clearer picture and more effectively manage the patients diabetes. One data point higher than normal means nothing, however consistent readings that are high is warning sign that something needs to be done. It could be as simple as a change in diet or that a change in medication is required. There is absolutely no way this type of decision can be made with once weekly measurements or even quarterly A1c tests.
The problem with A1c isn’t the number it’s the frequency with which the test is performed. While A1c measurements should be performed quarterly this is far from reality. In the real world only a minor percentage of patients actually have A1c measured quarterly, semi-annual or annual measurements are more the norm. This being the case regular glucose measurements take on an even greater importance.
Unfortunately the major glucose monitoring companies have wasted an opportunity when times were good, when they could have easily afforded to push an education agenda. Instead they spent considerable resources on developing new monitors with fancy features that hardly anyone uses. All this time the patient population was exploding and diabetes related healthcare costs were rising. It’s not surprising that studies were initiated to gauge the effectiveness of glucose monitoring, a multi-billion dollar expense.
Given the poor state of education no one should be shocked or surprised that the majority of these studies showed little evidence between improved outcomes and glucose monitoring, particularly with non-insulin using type 2 patients. Diabetic Investor has little doubt with healthcare costs rising faster than inflation combined with the exploding type 2 diabetes population, insurers will use these studies to justify changes or elimination of reimbursement for glucose testing supplies for non-insulin using patients.
Then that moaning which is getting loader with each study that’s released will extend beyond glucose monitoring companies to medical supply companies like Medco (NYSE:MHS) the new owners of Liberty Medical Supply, CCS Medical, Access and Byram Healthcare. Not to mention retailers like Walgreens (NYSE:WAG), CVS/Caremark (NYSE:CVS) and Rite-Aid (NYSE:RAD) who would see their pharmacy traffic drop dramatically.
When this change in reimbursement becomes reality, notice we said when not if, there will be the usual finger pointing and blame. There will be lots of noise, physicians will start screaming that the bad ole insurance companies are once again hurting the patient in favor of profits. The reality is all these critics claiming to have the best interest of the patient in mind are just as responsible as the bad ole insurance companies. Companies who unfortunately have plenty of documented evidence to justify any move they make.
The bottom line here is the old saying “An opportunity lost is an opportunity missed” applies to the BGM market.