The value of blood-glucose monitoring
May/13/09 09:17 Filed in: Medical devices | Healthcare Policy | Medical products | Evidence based medicine
One of the paradigms of managing patients with Type II diabetes includes regular home testing of blood glucose levels using one of the widely available blood glucose monitors. The American Diabetes Association, one of the leading organizations that advocate for and provide information about diabetes, recommends home glucose monitoring for patients who have diabetes and are:
These are probably good recommendations, based on good evidence. Controlling blood glucose in those patients with Type 2 diabetes has strong positive benefits for reducing risks of chronic and acute diseases, such as peripheral artery disease, hypertension, diabetic dyslipidemia, heart attack and stroke.
Recently, a clinical trial published in the British Medical Journal analyzed the medical usefulness of home blood glucose monitoring in patients with Type II diabetes. The trial was well designed enrolling 184 individuals with recently diagnosed type 2 diabetes mellitus. The patients were randomized into two groups: one that utilized a monitor and one that did not. The patients were observed for one year.
The results of the trial were somewhat surprising:
The authors of the study make this conclusion:
That’s a pretty solid conclusion. And that calls into question the value of providing blood glucose monitors to patients. In the United States, it’s almost a standard of care that physicians will authorize and third-party payers (including managed care organizations) will pay for these products. Are they gathering dust? With these results, it’s fair to state that providing blood glucose monitors to patients is a significant waste of money for the health care system. There are approximately 17.9 million individuals with diagnosed diabetes, which probably means that the total cost of monitors for this group exceeds $1 billion annually. That’s a significant healthcare expenditure that seems to have a marginal usefulness.
I was personally surprised by these results. I would recommend further studies including whether there is a subset of Type 2 diabetes patients who might benefit from the monitors. For example, someone who has a strong desire to reduce blood sugar may, instead of being depressed, may be motivated by knowing that their diet and exercise maintains appropriate levels of blood glucose. I have a difficult time reconciling these poor results with the obvious value of accurate monitoring of glucose levels given the long-term consequences of not doing so.
I have also been troubled by the design and ergonomics of medical devices, especially blood glucose monitors. There has to be a lower cost, yet easier to use, product that can be designed. Everything from using the lancets, to placing a drop on a strip to actually using the monitors makes it a challenge for a patient to be compliant.
We need to find out if these results have changed physician and third-party payer attitudes.
By Michael W Simpson
- taking insulin or diabetes pills
- on intensive insulin therapy
- pregnant
- having a hard time controlling your blood glucose levels
- having severe low blood glucose levels or ketones from high blood glucose levels
- having low blood glucose levels without the usual warning signs
These are probably good recommendations, based on good evidence. Controlling blood glucose in those patients with Type 2 diabetes has strong positive benefits for reducing risks of chronic and acute diseases, such as peripheral artery disease, hypertension, diabetic dyslipidemia, heart attack and stroke.
Recently, a clinical trial published in the British Medical Journal analyzed the medical usefulness of home blood glucose monitoring in patients with Type II diabetes. The trial was well designed enrolling 184 individuals with recently diagnosed type 2 diabetes mellitus. The patients were randomized into two groups: one that utilized a monitor and one that did not. The patients were observed for one year.
The results of the trial were somewhat surprising:
- Monitoring was associated with a 6% higher score on the depression subscale of the well-being questionnaire. In other words, there was a significant (p=.01) increase in depression for those who used a blood glucose monitor. We can speculate on the reasons, but it probably resulted from a constant reminder of their health status.
- There were no baseline differences in mean hemoglobin A1c (a blood marker that provides information about a patient’s blood glucose levels over the past three months) between those who monitored themselves and those who did not.
The authors of the study make this conclusion:
In patients with newly diagnosed type 2 diabetes self monitoring of blood glucose concentration has no effect on glycaemic control but is associated with higher scores on a depression subscale.
That’s a pretty solid conclusion. And that calls into question the value of providing blood glucose monitors to patients. In the United States, it’s almost a standard of care that physicians will authorize and third-party payers (including managed care organizations) will pay for these products. Are they gathering dust? With these results, it’s fair to state that providing blood glucose monitors to patients is a significant waste of money for the health care system. There are approximately 17.9 million individuals with diagnosed diabetes, which probably means that the total cost of monitors for this group exceeds $1 billion annually. That’s a significant healthcare expenditure that seems to have a marginal usefulness.
I was personally surprised by these results. I would recommend further studies including whether there is a subset of Type 2 diabetes patients who might benefit from the monitors. For example, someone who has a strong desire to reduce blood sugar may, instead of being depressed, may be motivated by knowing that their diet and exercise maintains appropriate levels of blood glucose. I have a difficult time reconciling these poor results with the obvious value of accurate monitoring of glucose levels given the long-term consequences of not doing so.
I have also been troubled by the design and ergonomics of medical devices, especially blood glucose monitors. There has to be a lower cost, yet easier to use, product that can be designed. Everything from using the lancets, to placing a drop on a strip to actually using the monitors makes it a challenge for a patient to be compliant.
We need to find out if these results have changed physician and third-party payer attitudes.
By Michael W Simpson