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Rapid Responses: Rapid Responses published:
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Self monitoring of blood glucose: analytical and clinical issues should not be overlooked.
- Giuseppe Lippi, Martina Montagnana, Giovanni Targher, Gian Cesare Guidi. (26 June 2007)
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SBGM is not the issue. Frequency of SBGM is…
- AUGUSTO PIMAZONI (26 June 2007)
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plasma reading capillary glucose meters
- Andrew C Burden (26 June 2007)
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Testing the wrong thing?
- Nicola Moxey (27 June 2007)
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Unfair to Type 2 Patients
- Sarah Barakat (30 June 2007)
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Re: Unfair to Type 2 Patients
- L Sam Lewis (30 June 2007)
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Test, review, Adjust
- Alan J Shanley (1 July 2007)
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Re: Re: Unfair to Type 2 Patients
- Sarah Barakat (1 July 2007)
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Monitoring is not an intervention
- Matthew Cohen (2 July 2007)
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Response to Dr Lewis
- Nicola Moxey (2 July 2007)
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Response to Lewis
- gretchen becker (2 July 2007)
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In which patient is monitoring useful?
- Andrew Moore, Sheena Derry, Grace McGeogh (5 July 2007)
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Self monitoring of blood glucose in non-insulin treated type 2 diabetic patients: well-designed trials are needed
- Oliver Schnell, Oliver Schnell, Eberhard Standl (5 July 2007)
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Appropriate sample
- Rodolfo Jr L. Yuchongco, 1700 (6 July 2007)
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Structured Education vs Blood Glucose Self Monitoring
- Anthony J Lister (20 July 2007)
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Patient understanding and longer follow-up needed
- Urban Rosenqvist, Aniko Veg and Anna Sarkadi (22 July 2007)
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Self monitoring: chicken or egg
- Shahid Amin (23 July 2007)
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Unfair to type 2 diabetic patients
- Mohammad A. Al-Jubouri (25 July 2007)
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Dispiriting medical attitudes
- Patti D Evans (26 July 2007)
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Cost effectiveness of blood sugar testing
- Jenny Chapman (26 July 2007)
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Don't take my parachute away!
- Shirwan A. Mirza, MD, FACP, FACE (26 July 2007)
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A choice in costs.
- Paul F Simmonds (26 July 2007)
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Still no evidence for SMBG in patients with type 2 diabetes not taking insulin.
- Nanne Kleefstra, Susan J.J. Logtenberg, and Henk J.G. Bilo (26 July 2007)
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Testing is vital
- Roger Cawte (26 July 2007)
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Newly diagnosed T2s need to test
- Peter Handley (27 July 2007)
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Don't throw away your best and first response.
- Amanda F Rutter (27 July 2007)
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Adherence to self-monitoring of blood glucose
- Alexander G. Logan, Joseph A. Cafazzo (8 August 2007)
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The wrong takeaway message
- Charles Fox, Northampton General Hospital NN1 5BD (15 August 2007)
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Continued success
- Joan McClusky (15 August 2007)
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Self Monitoring of blood glucose in type 2 diabetes
- David Simmons (31 August 2007)
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Self-Monitoring is a Vital Self-Care Tool for Individuals with Diabetes
- Karen A Fitzner (1 September 2007)
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Looks like an excuse
- M Elting (16 October 2007)
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Why the DiGEM study does not help us decide the value of SMBG in people with type 2 diabetes not on insulin
- Charles M. Clark, Jr., William H. Polonsky and Jane Bridges (3 November 2007)
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Giuseppe Lippi, Associate Professor of Clinical Biochemistry Sez. Chimica e Microscopia Clinica, Dip. Scienze Morfologico-Biomediche, Verona University, Martina Montagnana, Giovanni Targher, Gian Cesare Guidi.
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A variety of studies show conflicting results for the effect of self -monitoring of blood glucose (SMBG). In particular, the recent article that no significant improvement in glycaemic control was found after 12 months in patients with non-insulin treated type 2 diabetes using self monitoring of blood glucose levels when compared to those not self monitoring (1). This is a very concerning finding, in that SMBG is currently recommended for most patients with diabetes (2), with considerable costs to health systems. Basically, the benefit of SMBG depends not only on the actions taken based on the results, but also on the analytical quality achieved by these disposals, an aspect which was apparently overlooked in the article of Farmer et al. In fact, patients allocated to the more intensive intervention were given training and support in timing, interpreting, and using the results of their blood glucose test to enhance motivation and to maintain adherence to diet, physical activity, and drug regimens, though no specific intervention to improve the analytical quality of glucose meters performance is reported (calibration of the meters was checked by the research nurses using a test aliquot only at baseline and at six months). Patients performing SMBG traditionally control their instruments in several ways: by comparing results from self-monitoring with results obtained in a hospital laboratory, a doctor’s office, or a pharmacy; by using control materials recommended by the manufacturer. Actually, there is strong evidence that the analytical quality of SMBG is not satisfactory, and the need for standardized control routines has been underscored. The lack of standard quality-control procedures is significantly associated with poor control routines (3). Accordingly, implementing traditional external quality assessment schemes (EQAS) similar to those designed for office laboratories among diabetes patients may improve the overall quality of SMBG and could be also convenient for motivated patients (3). Therefore, when concluding that “it might not be necessary to routinely recommend self monitoring of blood glucose in reasonably well controlled patients with non-insulin treated type 2 diabetes” (1), the Authors should also take into consideration the possibility that a more rigorous adherence to standardized controls could substantially improve the outcome and clinical usefulness of SMBG measurements. Moreover, it should also be considered that severe hypoglycemia often follows a specific blood glucose fluctuation pattern that is identifiable from SMBG. Thus, partial prediction of imminent hypoglycemia by SMBG would be possible and clinically meaningful, providing a potential tool to trigger self-regulatory prevention (4). This conclusion is also supported by the data provided by Farmer et al., emphasizing that the identification of hypoglycaemic episodes was substantially higher in the more intensive intervention group who more diffusely used the SMBG (p<0.001), when compared to the other groups that were asked not to use a blood glucose meter unless their doctor considered it essential (control group) or asked to record three values daily on two days during the week (less intensive intervention) (1). References 1. Farmer A, Wade A, Goyder E, Yudkin P, French D, Craven A, Holman R, Kinmonth AL, NeilA, Diabetes Glycaemic Education and Monitoring Trial Group. Impact of self monitoring of blood glucose in the management of patients with non-insulin treated diabetes: open parallel group randomised trial. BMJ 2007:392474474, doi:10.1136/bmj.39247.447431.BE. 2. American Diabetes Association. Standards of Medical Care in diabetes – 2007. Diabetes Care 2007;30:S4-S41. 3. Kristensen GB, Nerhus K, Thue G, Sandberg S. Results and feasibility of an external quality assessment scheme for self-monitoring of blood glucose. Clin Chem 2006;52:1311-7. 4. Cox DJ, Gonder-Frederick L, Ritterband L, Clarke W, Kovatchev BP. Prediction of severe hypoglycemia. Diabetes Care 2007;30:1370-3. Competing interests: None declared |
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AUGUSTO PIMAZONI, Managing Director, MED MARK Medical Marketing Consultants, Brazil Sao Paulo, Brazil
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The study by Andrews Farmer et al. on the impact of self blood glucose monitoring (SBGM) in type 2 diabetes suffers from the same flaws of many other published papers on this matter: the misconception that SBGM might have miraculous therapeutic properties in terms of providing a better glycemic control all by itself. SBGM is obviously a diagnostic tool that helps diabetic patients to evaluate their level of glycemic control and not a magic resource to promote glycemic control. Therefore, the basic question is not whether SBGM is or is not indicated for the evaluation of glycemic control in type 2 diabetes but, yes, the frequency of tests of glycemia that should be recommended for each patient at any particular moment in the natural evolution of his/her diabetes. The recommended frequency of glucose testing for type 2 diabetes might vary from 4 to 6 tests per day in very special circumstances to none at all in a well controlled, cooperative and stable patient for who follow up testing every 1 to 3 months would suffice. It is obvious that in this particular study population of well controlled, non insulin treated type 2 diabetic patients the need for traditional SBGM is not applicable, but we should all bear in mind that diabetes can progress to chronic complications without any symptoms and this is the main reason why we should be very careful in interpreting results from studies on SBGM in such a way as to diminish the paramount importance of this tool for the prevention of chronic complications. Final message: SBGM is not the issue. Frequency of SBGM is… AUGUSTO PIMAZONI, MD Medical Marketing Consultant, Brazil - E-mail: pimazoni@uol.com.br Competing interests: Medical Marketing Consultant for the Health Care Industry |
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Andrew C Burden, Community Diabetologist Heart of Birmingham tPCT, Diabetes Care, Peel place, Carver Street, Birmingham B1 3AS
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This study showed a surprising result: that hypoglycaemia was more common in the individuals performing self testing. Whilst the authors may be correct in their assertion that this was because of finding low test results; another explanation might have been that patients were recommended a low fasting plasma capillary glucose level: 4mmol/l. This value has been traditionally taught when using whole blood glucose meters, but for plasma reading meters will be expected to be associated with symptomatic hypoglycaemia, at least in those patients on sulphonylurea therapy. I suspect that the hypoglycaemia may have also weakened the enthusiasm of patients to self test, and to self modulate their therapy. Competing interests: None declared |
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Nicola Moxey, Type 2diabetic Ipswich
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"previous studies have found that trying to understand blood glucose measurements may lead to frustration when results do not fall into a pattern, or cease to be of interest when they are entirely predictable." I suspect that this is the crux of why they failed to find any improvement from the testing pattern they chose. If they're not using that testing information to inform their meal choice, and drive those readings down by modifying their carb intake next time round - OF COURSE the readings are going to cease to be of interest, or relevance! I, and many, many other T2s on the alt.support.diabetes and alt.support.diabetes.uk newsgroups, have achieved and maintained sub-6% A1c readings for several years by testing at the 1-hour point, and changing our diet to get one with as few blood glucose spikes as possible. The 1-hour reading allows us to capture the glucose peak; getting that into a normal range gives you a good chance that the 2-hour marker will be close to your pre-meal reading. The resulting diet is lower in carbs than the standard NHS diet, and concentrates the mind on low-GI carbs and making best use of a carb budget; non-starchy vegetables become a staple. It makes me very angry when the PCT, and my GP, use this kind of research in order to restrict access to test strips. In my opinion, what this research was testing was the boredom and / or depression thresholds of the study cohort. Without the freedom to test effectively, and modify diet as a direct result of that testing, this study was yet another waste of money and resources, and may well cost us dearly down the line as more people who should be testing are told not to do so. Competing interests: None declared |
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Sarah Barakat, Teacher Not working at the moment
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As a Type 2 patient, I'm frankly disappointed to come upon such a study at a time when diabetes has become an epidemic around the world. I can only talk from my own personal experience, ofcourse; I dare to write this letter to such a prestigious magazine only because of my concern as a diabetic patient and what it could mean to so many thousands of Type 2 patients, who like me, have managed to control their diabetes with a lot of hard work and persistence. To all of us, our glucose meters have been our live savers. Two years ago I was diagnosed as a Type 2 with an A1c of 6.8, with already protein in my urine and shortly after the diagnosis, started to have severe muscle spasms in both of my feet. My doctors eventually came to the consensus that it was diabetic neuropathy. My total cholesterol two years ago was 294, LDL/192, Trig/245 and HDL/53. I decided to go on a lifestyle change instead of going on oral medications. I've lost about 30 lbs over these last two years, my total cholesterol has come down to 170, LDL/87, Trig/72 and HDL 69 and my A1c is 5.9. This has been done with very intensive glucose monitoring. In fact, without my glucose meter, it would have been impossible to come down to an A1c of 5.9. I've been on Lipitor and Cozaar all this time. After the first six months, instead of testing myself, 2 hours after meals, I started to do so after an hour. Everything was done very much with the encouragement of my doctor, who, ofcourse, got me the glucose monitor. A study like this is bound to influence health insurance companies; many of us cannot afford the very expensive test strips without our insurance companies paying for them. I pose this question to Dr Farmer and co. and to doctors and the general public who may read this letter. Would it better to spend money on glucose monitors/test strips for Type 2, who may have controlled their diabetes to a certain point, so that they can continue to do or stop doing this and have them go back to uncontrolled diabetes and be more of a burden to society as a whole? I know from my own experience, that the moment I stop being careful, my A1c will shoot back to what it was before. This is my encouragement to constantly use my glucose meter and I'm sure it must be also for thousands of other patients like me. Type 2 patients, not on insulin/oral medications, I feel, need to be as careful as diabetic patients who are. Before I end, a couple more questions: are 450 patients anough for a trial as important as this? Is twice a week checking, "intensive therapy"? Sincerely, Sarah Competing interests: None declared |
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L Sam Lewis, GP Surgery, Newport, Pembrokeshire SA42 0TJ
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You make an impassioned defence of your intensive Blood Glucose monitoring - and it obviously appears to work for you.. But I notice that you return to your A1c , Cholesterol, and Triglyceride parameters as the proof of benefit. I believe that knowledge of a spot blood glucose is sometimes very useful in a type II diabetic. But I would NOT normally adjust therapy on spot glucose, without knowing the overview picture, provided easily and reliably by regular HbA1c. So tell me, apart from keeping your attention firmly fixed on frequent monitoring of blood glucose, how did it assist you to adjust your treatment, where periodic HbA1c would not. Did you suffer any harms ? Competing interests: cost and harms vs benefit |
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Alan J Shanley, Patient, Type 2 diabetes Pottsville NSW Australia
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I am not a doctor. I am a type 2 diabetic patient who has a keen interest in patient self-management of diabetes, and who has spent far too much time over the past four years discussing this with other diabetics around the world on the net and personally. My only relevant publication is a patient's view online at http://loraldiabetes.blogspot.com/ This is not the first poorly performed study of blood glucose testing techniques published in the past twelve months, including one in my own country. All have suffered from the same basic flaw. SMBG is pointless – as is any testing of any sort – if the results are not used to either confirm that things are as expected or to assess what changes need to be made to improve the results next time. However, if SMBG is used systematically to assess the success of past treatments and to then make changes in those treatments, in a continuously iterative method, it can be spectacularly successful. I accept that BMJ readers will consider anything I say as anecdotal; however I have seen it happen hundreds of times over the past five years. This study was a waste of time and effort because the patients in the “most intensive” group were given no training in evaluating their test results with a view to improvement. In fact the basic premises of their training doomed them to failure: “They were also given training and support in timing, interpreting, and using the results of their blood glucose test to enhance motivation and to maintain adherence to diet, physical activity, and drug regimens.” That was the worst thing they could have done - to maintain adherence to their present regimens, particularly diet. In fact they maintained it so well that they hardly changed their poor HbA1c levels at all. As an aside, for the authors to consider A1c's in the mid 7's as "reasonably well controlled" is appalling to me. I would refer the authors to the EPIC Norfolk study which found that "HbA1c was continuously related to subsequent all cause, cardiovascular, and ischaemic heart disease mortality through the whole population distribution, with lowest rates in those with HbA1c concentrations below 5%. An increase of 1% in HbA1c was associated with a 28% (P<0.002) increase in risk of death " BMJ 2001;322:15 [Full] ( 6 January ) Now, back to SMBG. The single most important thing that the patient can do at home is modify diet. They should not change medications without doctor’s advice, there are realistic limits to the exercise they can add to their routine – but they can make dramatic changes in blood glucose levels with a diet modified by feed-back from post-prandial peak blood glucose levels. I, and many of my friends around the world, have been following a systematic testing regimen that works for some years now. It is intensive in the initial stages, then becomes much more relaxed once individuals have created their own personal databases of foods and activities, so we know what foods and activities will cause blood glucose spikes (at the peak, not necessarily at two hours), and which won’t. It’s as simple as that. I challenge the authors of this paper – or any other researchers for that matter, to repeat the study but train the “most intensive” group as follows: Eat, then test after eating at your peak spike time and if blood glucose levels are too high then review what you ate and change the menu next time. Then do that again, and again, and again until what you eat doesn’t spike you. You will get some surprises, particularly at breakfast time. The so-called "heart-healthy" breakfast is NOT for most type 2's. Similarly, you will find variations through the day - the same thing will have different effects at breakfast, lunch, dinner and supper As you gradually improve your blood glucose levels, review the resulting way of eating to ensure adequate nutrition, fibre etc are included and adjust accordingly. Test, review, adjust until you have a flexible and interesting menu that is nutritious but does not “spike” your post-prandial blood glucose; a menu you can follow for the rest of your life. Studies such as the one in question are meaningless if the SMBG is not performed systematically and with a defined purpose. Alan Shanley, Australia Competing interests: None declared |
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Sarah Barakat, Teacher Not working at the moment
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Thank you Dr. Lewis. Again, I'm only writng as a layperson, who's been determined to stay off medicines for Type 2, because of so many side effects, that may occur because of them.
I gave my cholesterol/ triglycerides parameters before I got to an A1c of 5.9 to give an idea of how "serious" a patient I was and still could be since all this runs in the family. The after parameters give an idea, ofcourse, of how much "healthier" I am now. The way, I understand things, is that BP and cholesterol are very much tied to our glucose levels.
In the first six months, inspite of having lost weight etc, my A1c hadn't made too much of a budge. I was still testing 2 hours after eating and although, the numbers were lower, not low enough to bring my A1c under 6.5, which was the goal. I discussed this with my doctor, who told me that my highest glucose levels might be at the 1 hour point. So I decided to do this and we saw the clear difference in the A1c three months later. It dropped from a 6.8 to 6.3.
I had been so frustrated at not seeing a change in my A1c that at that point, I started to check my glucose levels with all the various foods I was eating, so that I could stick to a lifestyle eating plan that I could comfortably stick to for the rest of my life. This sometimes meant 5/6 times testing per day. One of the most important things I learned from this way was, how important portion control was to get to a lower glucose level. This could not have possible without my glucose meter at hand close by.
The A1c test done every 2/3 months can't tell me this at all. How can it? It's an overall picture, it doesn't tell me how to eat every day. I, as a Type 2, since I decided that I didn't want to rely on medication could only change what I was eating. We, as Type 2, need to know for instance how much fruit we can eat safely. I checked this with my glucose meter and understood things much better.
I didn't mention my foot drop I had last August; my A1c went from a 6.1 back to 6.6, because of not being able to walk/ exercise for about three months. And I saw the rising numbers clearly on the meter. Once I could start walking again, I again had to use my glucose meter to bring myself back to an acceptable A1c. This time I had the constraints of not over walking so as not to risk another foot drop. In May, I found my A1C was 5.9.
Now having had a foot drop, I have to be even more careful about my glucose levels and thus am still checking regularly with the meter, certainly not 5/6 times a day; sometimes, just once per day, sometimes up to thrice.
I know, I very clearly rely on my glucose meter to tell me the story and would be very upset if my doctors or the insurance company decided that I didn't need it any more. It would cause me stress and that alone would raise my glucose levels, as the medical community knows well.
Dr. Lewis, you ask me about any harms. Do you mean harms from frequent testing? I, personally have not suffered any harms from frequent testing, only benefits.
As I see it: a diabetic needs both a regular A1c test every 3/4 months, as well as regular glucose testing done at home. I think most diabetic patients just don't understand how important both these things are.
Thank you again, Dr. Lewis for asking me your question and letting me have a bit more of a spot. I thank the BMJ editor, as a concerned Type 2.
Sincerely,
Sarah
Competing interests: None declared |
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Matthew Cohen, Director Medical Services International Diabetes Institute, 250 Kooyong Rd, Caulfield 3162, Australia
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Farmer et al have made the fundamental error of subjecting a method of monitoring to a trial designed for an intervention. Self blood glucose monitoring (SBGM) is just that – monitoring. It is not a treatment that can or should be expected, by itself, to alter blood glucose levels. Subjecting the thermometer or the INR test to a similar trial might equally well not be expected to show any benefit. It is the action required by people with diabetes, and their doctors, that may affect outcomes. A second problem is that although patients in this study were provided with education, it was left to the treating GP to alter oral anti -diabetic medication, and it is not known how intensively this was carried out. When I am adjusting doses, particularly of sulphonylureas, I want to know how close my patients BG levels are to hypoglycemia. Just knowing the HbA1c level is not enough. A pattern of BG levels such as 13 mmol/l before breakfast and 4 before dinner would require different action than BG levels of 9 mmol/l throughout the day, even though the HbA1c levels may the same in each case. Third, anyone with an HbA1c above 6.2% was eligible for the study, and I am unsure how much more improvement could be expected in this group. Even I, who first described the use of in T2D in the early 1980s (1,2) and am still an enthusiastic proponent, do not suggest that everyone with T2D needs to perform SBGM. But there are subgroups in whom SBGM may be of benefit, eg those not “reasonably well controlled” ie above 7.5% HbA1c. The authors promise a subgroup analysis, and it will be of interest to see the result in those with the highest HbA1c levels. Another subgroup are those treated with sulphonylureas and who are thus at risk of hypoglycemia, (which is often asymptomatic.) In fact, this trial demonstrates that hypoglycemia was detected more frequently in the intensively (43 patients) and less intensively (33) monitored groups than the unmonitored group (14). One patient in the control group, but none in the monitored group had severe hypoglycemia, ie needing third party assistance. In my opinion, some bravado is needed if one attempts to achieve the recommended HbA1c targets by adding or increasing a sulphonylurea without the safety measure of SBGM to detect hypoglycemia, particularly in the elderly. Adjusting medication to avoid hypoglycemia might not be expected to lower HbA1c levels, yet this is an important safety outcome. I could discuss the role of SBGM in other subgroups, and as an educational tool to encourage healthy eating and exercise, (noting that the monitoring group lowered their cholesterol compared to controls) but I have to return a phone call from a patient I saw 2 weeks ago. For some reason, her blood glucose levels at home have increased to around 15 mmol/l for the last few days. Luckily, she wasn’t in the trial’s “control group” or she might have waited until her next HbA1c level, due in 3 months. 1. Cohen M & Zimmet P. Home monitoring of blood glucose: a new advance in management of diabetes. Aust Fam Phys 1980;9:53. 2. Cohen M & Zimmet P. Self-monitoring of blood glucose levels in non -insulin dependent diabetes mellitus. Med J Aust 1983;2:377.-380. Competing interests: None declared |
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Nicola Moxey, T2 diabetic Ipswich
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Dr Lewis has missed the value of SMBG for a T2 diabetic. Whilst he would be quite right not to adjust treatment on the value of a spot reading, the patient can do exactly that - by taking exercise to bring down a high reading, and/or by modifying the diet to lessen the spike next time. Using just such a method has helped me to find a diet and exercise regime that exactly suits my lifestyle and the state of my diabetes progression. No-one disputes that SMBG without applying some intelligence to the readings is a waste of time and resources - but the practice of testing at the one hour mark, and acting on the readings, empowers the patient to make positive contributions to their care. Competing interests: None declared |
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gretchen becker, writer/editor Halifax, VT 05342
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Dr Lewis said, "But I would NOT normally adjust therapy on spot glucose, without knowing the overview picture, provided easily and reliably by regular HbA1c." Of course not. But patients are the ones who "adjust therapy" the most often, when by "adjusting therapy" I mean modifying their diet and exercise. Informed patients know the overall picture. If they have meters and strips and test after meals, they'll likely notice that pizza followed by chocolate cake makes their blood glucose levels soar. If they're motivated, they'll stop eating pizza and chocolate cake. This will be more effective in many cases than adding yet-another expensive diabetes medication. In the long run, it will save the health care system money. "So tell me, apart from keeping your attention firmly fixed on frequent monitoring of blood glucose, how did it assist you to adjust your treatment, where periodic HbA1c would not." I can't answer for the previous poster, but I think that's answered in a general case by the previous paragraph. Furthermore, A1c measures only AVERAGE blood glucose. You could be going extremely high after meals and then very low, and the A1c would look fine, but some people are now saying that postprandial levels and even fluctuations in blood glucose are more important than the A1c. The A1c depends on many factors, including methodology and the patient's own physiology. I've had A1c tests done at different labs from blood taken the same day (research studies), and the results were different. What you physicians need to do is to teach patients HOW to use the results of their meters to find a diet that works for them. This will undoubtedly require more time at first, but it will lower expenses in the long run. Competing interests: None declared |
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Andrew Moore, Editor, Bandolier Pain Research, The Churchill, Oxford OX3 7LJ, Sheena Derry, Grace McGeogh
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The most useful light to view the results of the randomised trial of self-monitoring of blood glucose [1] should not be whether the intervention works (acknowledging for a moment the difficulties of defining what works means in this context), but rather in which patient this intervention is useful. The conclusion of the randomised trial is very sensible: that self- monitoring has no measurable improvement in glycaemic control in reasonably well controlled patients with type 2 diabetes. This result is exactly in line with a recent systematic review of randomised trials (1,000 patients, three trials) and observational studies (60,000 patients, 13 studies) [2], which demonstrates that only when the average starting HbA1c is above 8% do studies consistently show benefit of self-monitoring. The inference that self-monitoring may be beneficial where control is poor is just common sense. That it is difficult to show benefit when control is already pretty good is also common sense – there is no sensitivity to show a difference even if there were one. What would be interesting would be a different way of reporting results of trials like this. Our interest is not in the average patient, since few patients are average: what we require is to know the number of patients who showed improvement (however defined, or perhaps at several levels of HbA1c) vs the number showing no change or an increase in HbA1c, as has been done before [3]. What should be avoided is making generalised policy decisions based on data like this. Farmer and colleagues suggest that, in light of their results, cost per QALY of SMBG has previously been underestimated. Extrapolating averages from trials into health economic models does disservice to patients and professionals in several ways, which include unthinking restriction of useful interventions, and the caustic erosion of professional skill and responsibility. A more useful approach would be some operational and other research to identify those patients who would benefit most from self-monitoring and the best way to engage them in actively helping themselves. This would build on professional skill and responsibility. Self monitoring of blood glucose in type 2 diabetes is one of the best examples where so-called evidence has been misused in restrictive policy to the detriment of real improvements. It is sobering to remember that where doctors make their own decisions, the results have been terrific, especially in clinical outcomes with major consequence. They did it by deciding which patients with type 2 diabetes would benefit from self -monitoring, and prescribing self-monitoring in those patients [4]. Simple, really. Andrew Moore (andrew.moore@pru.ox.ac.uk) Sheena Derry Grace McGeogh References: 1. Farmer A, Wade A, Goyder E, Yudkin P, French D, Craven A, Holman R, Kinmonth AL, Neil A; Diabetes Glycaemic Education and Monitoring Trial Group. Impact of self monitoring of blood glucose in the management of patients with non-insulin treated diabetes: open parallel group randomised trial. BMJ 2007 Jun 25; [Epub ahead of print]. 2. McGeoch G, Derry S, Moore RA. Self-monitoring of blood glucose in type-2 diabetes: what is the evidence? Diabetes Metab Res Rev. 2007 May 30; [Epub ahead of print]. 3. Guerci B, Drouin P, Grange V, et al. Self-monitoring of blood glucose significantly improves metabolic control in patients with type 2 diabetes mellitus: the Auto-Surveillance Intervention Active (ASIA) study. Diabetes Metab. 2003; 29: 587-594. 4. Martin S, Schneider B, Heinemann L, et al. Self-monitoring of blood glucose in type 2 diabetes and long-term outcome: an epidemiological cohort study. Diabetologia. 2006; 49: 271-278. Competing interests: We have written a recently-published systematic review on this topic |
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Oliver Schnell, Professor of Medicine Diabetes Research Institute, 85764 Neuherberg / Munich, Oliver Schnell, Eberhard Standl
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Dear Editor, The benefit of self monitoring of blood glucose in the management of type 2 diabetic patients, who are not receiving insulin, has been observed in the Kaiser Permanente Northern California Medical Care Program (1) and the ROSSO Study (2). Furthermore, a meta-analysis of 1307 non-insulin treated patients demonstrated a 0,42 % lower HbA1c level in non-insulin treated diabetic patients, who performed self monitoring of blood glucose as compared to those, who did not apply self monitoring of blood glucose (3). In contrast to results from these large study populations (1-3), the diabetes glycaemic education and monitoring (DiGEM) study (4,5) was unable to demonstrate that self monitoring of blood glucose alone or with with additional instructions translates into an improvement of glycaemic control in non-insulin treated patients with type 2 diabetes (4,5). Several limitations of the study need to be considered, which may have counteracted a potential benefit for the patients. In the DiGEM study, the patients` eligibilty for randomisation included an HbA1c level of monitoring of blood glucose in non-insulin treated type 2 diabetic patients with HbA1c levels of >= 6,2 % and the mean HbA1c values of the groups ranged from 7,41 to 7,53 %. The relatively low HbA1c level at entry into the study might have attenuated the need for a modification or intensification of treatment within any of the three groups. This view is supported by the observation, that hypoglycemic drugs were increased only in less than one third of the patients (5). In both the less intensive and the more intensive intervention group, hypoglycemic drugs were not increased more frequently as compared with the control group (29 and 32% vs 30%; 5). The fact that the Body Mass Index of the patients, whose mean BMI was > 30 kg/m2 at inclusion, remained unchanged during the follow-up of one year, supports the view that the effects of the "intervention protocol", which included motivation, interpretation of readings and training to apply goals for lifestyle changes and adherence to physical activity (4,5), were rather minor. In overweight type 2 diabetic patients, life style intervention has been demonstrated not only to be associated with weight loss, but also with a significant decrease in HbA1c from 7,2 % to 6,6 % (6). The use of self-monitoring of glucose was somehow blurred: In the DiGEM Study, nearly on third of the patients had performed self monitoring of blood glucose prior to inclusion into the study (4,5). The authors mention that 31,6 % of the patients, who were even allocated to the control group, had previously been using a glucose meter up to once weekly (5). In the less and more intensive self monitoring groups, 26,7% and 32,5 % had been using glucose meters respectively (5). In the study, adherence to self monitoring was generally low. The fact that patients, who were allocated to less intensive self monitoring were somehow more likely to continue the use of the meter (67%) as compared to those receiving a more intensive intervention (52%) does not support the view, that an effective intervention concept was applied (4). Therefore, the results of the DiGEM study do not further contribute to the current knowledge on the effects of self monitoring of blood glucose. The limitations of the study design might have largely outweighed potential benefits, which had been previously documented for self monitoring of blood glucose in non-insulin treated diabetic patients. To further analyze the potential beneficial effects of self-monitoring of blood glucose in these patients, large and well-designed randomised controlled trials are required. Literature: 1. Karter AJ, Parker MM, Moffet HH, Spence MM, Chan J, Ettner SL, Selby JV. Longitudinal study of new and prevalent use of self-monitoring of blood glucose. Diabetes Care 2006; 29:1757-63 2. Martin S, Schneider B, Heinemann L, Lodwig V, Kurth HJ, Kolb H, Scherbaum WA. Self-monitoring of blood glucose in type 2 diabetes and long -term outcome: an epidemiological cohort study. Diabetologia 2006;49:271- 8. 3. Sarol JN, Nicodemus NA, Tan KM, Grava MB. Self-monitoring of blood glucose as part of a multi-component therapy among non-insulin requiring type 2 diabetes patients: a meta-analysis (1966-2004). Curr Med Res Opin2005;21:173-84 4. Farmer A, Wade A, French DP, Goyder E, Kinmonth AL, Neil A. The DiGEM trial protocol--a randomised controlled trial to determine the effect on glycaemic control of different strategies of blood glucose self- monitoring in people with type 2 diabetes. BMC Fam Pract 2005;6:25 5. Farmer A, Wade A, Goyder E, Yudkin P, French D, Craven A, Holman R, Kinmonth AL, Neil A; Diabetes Glycaemic Education and Monitoring Trial Group. Impact of self monitoring of blood glucose in the management of patients with non-insulin treated diabetes: open parallel group randomised trial. BMJ 2007 Jun 25; [Epub ahead of print] 6. Look AHEAD Research Group, Pi-Sunyer X, Blackburn G, Brancati FL, Bray GA, Bright R, Clark JM, Curtis JM, Espeland MA, Foreyt JP, Graves K, Haffner SM, Harrison B, Hill JO, Horton ES, Jakicic J, Jeffery RW, Johnson KC, Kahn S, Kelley DE, Kitabchi AE, Knowler WC, Lewis CE, Maschak-Carey BJ, Montgomery B, Nathan DM, Patricio J, Peters A, Redmon JB, Reeves RS, Ryan DH, Safford M, Van Dorsten B, Wadden TA, Wagenknecht L, Wesche- Thobaben J, Wing RR, Yanovski SZ. Reduction in weight and cardiovascular disease risk factors in individuals with type 2 diabetes: one-year results of the look AHEAD trial. Diabetes Care 2007;30:1374-1383 Competing interests: None declared |
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Rodolfo Jr L. Yuchongco, Physician Paranaque, Philippines, 1700
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What may be the more appropriate sample of patients for me in this study would be those who have not achieved adequate glycemic control and the Hb A1C percentage level would be above or way above the normal line. Using the same parameters as in the study like type 2 DM patients under OHA or diet, 25 or more at time of diagnosis and are independent in their daily living and could include patients that are using insulin in their management. I believe that the difference would be more prominent and the challenge of monitoring and managing the glycemic control of these patients would more challenging. This study can also expound on the effect of glycemic control through SMBG with on the other conditions such hypertension in DM type 2 patients, weight, total cholesterol level, ratio of total cholesterol to HDL, and BMI. Competing interests: None declared |
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Anthony J Lister, GP Old Palace Medical Practice, 148 Old Palace Road, Norwich NR2 4JA
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The article by Farmer et alia reinforces our experiences in practice. We have not prescribed testing strips routinely to stable type 2 diabetic patients for the last 3 years. Aggressive diabetic management based on principles of patient education, development of trust between diabetic trained nurses and the patient and early use of oral agents to achieve target HbA1c levels has led to gratifyingly good outcome measures in our 3000 patient urban practice. We actively discourage the use of self- monitoring for several reasons: expense of testing strips and equipment, the anxiety generated by small variations in results and the subsequent medical time pressures in dealing with these, equipment failure and the lack of evidence of any benefit. We have had pressure from hospital consultants, patients themselves and pressure groups to provide testing strips, but have firmly stuck to our guns. In the present state of knowledge, nothing would persuade us to go back to encouraging or supporting routine self-monitoring in stable type 2 diabetic patients. Our results are too good to justify the change. Competing interests: None declared |
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Urban Rosenqvist, M.D. Ph.D. Dpt of Public health and caring science, Uppsala university, 751 85 Uppsala, Sweden, Aniko Veg and Anna Sarkadi
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Many studies of type 2 patient education use a too short follow-up. We recently published a RCT were the patients were followed two years after the start of a one year intervention. Significant lowering of HbA1c were noted 6 and 24 months after the start (1). We were subsequently able to show that patients who managed to lower and maintain ther HbA1c values understood their role in a more mature way than those who did not succeed (2). These findings indicate that the training should focus on how patients understand their role in the treatment and how to go about it. Furthermore, the study might be more informative if the follow-up is longer. 1. Sarkadi, A. and U. Rosenqvist, Experience-based group education in type 2 diabetes - A randomised controlled trial. Patient Education and Counseling, 2004. 53(3): p. 291-298. 2. Veg, A., Rosenqvist, U. and Sarkadi, A., Sel-management profiles and metabolic outcome in type 2 diabetes. J Adv Nurs 2006. 56(1): 44-54. Competing interests: None declared |
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Shahid Amin, GP Rectory House Surgery Lucas Road High Wycombe HP13 6QG
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As past of Medicines Management project for Wycombe PCT our
pharmacuetical adviser suggested reviewing the prescibing of blood glucose
stix to type 2 diabetics in 2003/2004 because of their dubious cost
benefits. Following a review of glucose stix repeat prescibing I
decided to change the prescribing instructions to glucose profile once
weekly ie 4 tests in one day 3 pre-prandially and one before bedtime.
Talking to patients who were on repeat prescibing for blood glucose stix
in whom I felt scripts could be stopped the folowing emerged.
Teaching and training patients to check blood glucose properly takes a lot of time and effort. Asking the right question and doing the right study in relation to cost benefits of blood glucose monitoring in type 2 diabetes is not easy ; but I suspect if you look at the big picture it is cost effective. Competing interests: None declared |
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Mohammad A. Al-Jubouri, Consultant Chemical Pathologist Department of Chemical pathology, Whiston Hospital, Prescot, Merseyside L35 5DR
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I truly sympathise with all diabetic patients who are motivated by self monitoring of their blood glucose levels to help them comply with lifestyle changes and use of their medications. However, healthcare spending in this area is substantial and therefore it is only appropriate that healthcare professionals examine ways to utilise these finite resources to maximise benefits for patients based on good quality research evidence. A randomized trial is usually set to answer one question relevant to clinical practice. Therefore, Farmer et al were right to investigate the effectiveness of widespread use of glucose self monitoring in non-insulin treated type 2 diabetic patients as they represent a substantial section of the diabetic population. With the ever rising number of newly diagnosed type 2 diabetes, the expenses incurred by such monitoring is going to be huge and cost benefit analysis has to be applied to such practice. The other questions posed by readers are equally valid and each warrants a randomised trial to provide the answer that is evidence based to justify the cost of such practice. Using self testing of blood glucose to motivate such patients is hugely expensive way that may work for some but not for others. Also, the argument of using the glucometers for opportunistic screening of friends and relatives has no evidence base to justify the cost. Moreover, glucometer readings must not be used to diagnose diabetes. Competing interests: None declared |
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Patti D Evans, Administrator The Lescudjack Centre, TR18 3PE
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As has been pointed out by several responders, the trial was flawed in that those in the "intensive testing" group were not given the information to act on the results of their tests in order to bring their BG down (i.e. take exercise) nor were they encouraged to use the results of the test to modify their diets to achieve greater control. On the contrary they were encouraged to maintain their regimes. Therefore I find the contention that SMBG is not beneficial and the attitude of some of the medical profession towards their diabetic patients extremely arrogant and ill founded. It led me to think about how I would feel if I were refused strips and treated like a child with the DSN precribing my regime - in effect, it would take away my "ownership" of the disease and I can only say that it would considerably diminish my motivation in maintaining control. This is from a Type 2 diabetic who has had an Hba1c under 6 for the last three years which I have been able to attain and consistently maintain due to my ability to test and to use the results of that testing to modify my own regime. Prior to my discovering the method of gaining this knowledge I was scrupulously following the advice of the NHS dietician and my Hba1c was over the 7.5 limit where complications are more likely to set in. As many diabetics will confirm, we are all individuals who have differing reactions to various foods and situations e.g. exercise/stress and the knowledge that we are able to gain regarding our own bodies is only possible through a testing regime. The DNS cannot possibly know or understand how each of her charges reacts physically to different foods because of the very individuality of our responses. The testing regime is often intense initially to find out about different foods, but once this knowledge is gained, it can be relaxed considerably. Surely it is possible for Doctors to prescribe for motivated patients who will take advantage of the strips to modify their regimes accordingly and prove the worth of the prescription by saving the NHS money in the long run. There will, of course, be many patients who cannot cope with the necessary hard work (because believe me, it is hard work) and who would prefer to have their diabetes managed by the medical profession, but PLEASE do not deny the wherewithal to those who are both motivated and able to use the results! Competing interests: None declared |
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Jenny Chapman, Type 1 Diabetic Coventry CV1 3PJ
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If a newly diagnosed diabetic of any Type, sort or kind, doesn't do fairly intensive testing, how on earth can the medics decide what's going on with 'em and how to proceed with whatever medication they prescribe? If an ancient one like myself suddenly has blood sugar going from around 30 to 1.8 and back again like gun-fire, my overall HbA1c was still only in the mid 8's so that wasn't too bad, was it? Just a bit of tweaking here and there, then - NOT! I may be completely naive but I always thought prescribing any medicine was based on information, information and information. Quite a lot of it specialist information - that I haven't got because I haven't had the appropriate training. So how wrong am I? Many of the medics responding here seem to be telling me they just stick their finger in the air and guess, with T2's at least, because the PCT say it's too expensive to actually get the information. Well fine - it isn't them that runs the risk of going blind, having a limb amputated or being on dialysis or worse. And I don't suppose any of that kind of unfortunate result would have to be paid for by the GP's practice budget, so double OK for the GP then. So that's alright then, is it? I know very well that there are many many diabetic patients out there both T1 and T2 who don't test or if they test they don't do anything with the results. What do you expect, when nobody bothers to educate them properly in the first place or makes any attempt to update that education on an ongoing basis? (Do doctors never need to go on refresher courses? Do they never have to receive training in something 'new' or 'different'? Do they miraculously 'just know everything, for ever' from Day 1?) For those of us who have taken the effort to try to educate ourselves, and have to live with this insidious unpredictable condition every day of our lives - please try to treat us with the RESPECT we deserve, just as we try to respect you - even though we are well aware on many occasions that we know one hell of a lot more about our condition, than a lot of you seem to!!! Competing interests: None declared |
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Shirwan A. Mirza, MD, FACP, FACE, Clinical Assistant Professor/Consultant Diabetologist Auburn, New York
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In this week's BMJ Farmer and colleagues report the results of their trial in well-controlled type 2 diabetes who were not taking insulin. They claim no benefit of an effect of self-monitoring of blood glucose (SMBG) on glycemic control, with and without diabetes education, compared with usual care. This study reminds me of a previous study published in BMJ: Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomized controlled trials Smith GC et al. BMJ 2003;327:1459-1461, that asserted that the effectiveness of parachutes has not been subjected to rigorous evaluation by using randomized controlled trials. What is wrong with the academicians these days? Have we exhausted all research areas of medicine and we are turning against the well-established medical milestones of the past half century of research. If we applied the message of this study, we would not have had DCCT or UKPDS trials. Those 2 trials are considered the jewels and of all diabetes trials. They clearly showed that intensive treatment (which is impossible to do without intensive monitoring) clearly reduces risks of diabetes complications. Why do we want to steal from our patients the empowerment of knowledge about their glucose values? Without measurement of blood glucose, we will never know when our patients have nocturnal hyper-, or hypoglycemia, postprandial hyper- or hypoglycemia. For example: when I see persistent morning hyperglycemia, I would know that my patient has nocturnal hepatic glucose production. This would guide me to add metformin or insulin to night-time antidiabtes regimen. When my patient has severe hyperglycemia throughout the day, I would suspect either inadequate doses of oral agents or insulin deficiency. SMBG readings will guide my next therapeutic steps. The patient would also know the effect of food items, and physical activity on own blood glucose readings and develop a sense of empowerment. By claiming that SMBG is of no value just because it will save some short- term costs, we will put blindfolds on both patients and physicians; and then we ask them to accomplish the unattainable, namely, glycemic control in the dark. Parachutes work to save life, whether there were randomized double-blind clinical trials to prove it or not. Doing studies to prove it would end a few lives. Competing interests: None declared |
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Paul F Simmonds, Communications Engineer: Type 2 "County" of London
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As a lay-person, albeit from a technical background, I cannot say that the report says much that isn't new. I would dispute that the findings prove anything conclusive from my point of view, that being, and I quote: "I'm not in the "business" I *am* the business." What I will do is ask a simple, non-technical, question of those who sponsored this trial and those respondents who have argued in favour of the results..... What would work out more cost-effective? 1) Continued relatively frequent testing, with periodic
interpretation and advice from local "specialists" (DSN's etc..)
I would respectfully suggest that the former would be better option for all concerned. Competing interests: None declared |
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Nanne Kleefstra, MD Diabetes Centre, Isala Clinics, PO Box 10400, 8000 GK Zwolle, The Netherlands, Susan J.J. Logtenberg, and Henk J.G. Bilo
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Dear editor, - A systematic review regarding the effect of self-monitoring of blood glucose (SMBG) in patients with type 2 diabetes who are not using insulin, was recently published in Diabetes Care and in the Cochrane Library (1,2). This review included 6 randomised clinical trials (RCTs), four of them of poor methodological quality. In his response to this review (3), the editor of Diabetes Care stated that statistical significance was found in 2 of the 6 RCTs only, with a drop-out rate of 40 -48% in the first study; and a difference in counselling, probably attributing to the reported improved glycaemic control, in the second study (4,5). Both trials were amongst those labelled as of limited methodological quality by the authors of the systematic review (1,2). This led to the conclusion that the available evidence to date does not show that SMBG in diabetic patients not taking insulin leads to lower HbA1c levels. - Results from a RCT regarding this topic are published in the current issue of the BMJ (6). The authors conclude that SMBG does not significantly improve glycaemic control. There are some concerns with the design of the study we would like to discuss. HbA1c is the primary outcome measure, and the study was powered to detect a difference in HbA1c of 0.5%. It should be noted however, that well controlled patients were also included in the trial. What further improvement over 12 months can be expected a priori from SMBG in patients with a baseline HbA1c of 6.2%, when current treatment guidelines target at HbA1c between 6.5% and 7.5% (7)? We look forward to the subgroup analyses of different levels of glycaemic control. Maybe SMBG has different effects in patients with moderate or poor glycaemic control compared to patients with good control. Such patients might be more motivated to lifestyle change. Analysis of a subgroup of patients on maximal doses of oral blood glucose lowering agents, who possibly regard SMBG as a last option in order to avoid insulin therapy, would be interesting as well. Secondly, clinicians were allowed to change treatment at their own discretion, and in one in every three patients treatment was indeed intensified. This change in treatment regimen makes it impossible to identify the effect on HbA1c of SMBG alone. - The conclusion reached in Diabetes Care still stands, i.e. that the available evidence regarding the use of SMBG in type 2 diabetes patients not taking insulin does not lead to lower HbA1c levels. Therefore, SMBG should not be used when its goal is to improve glycaemic control in this patient category. Of course, SMBG could be used in individual patients for other reasons than improving glycaemic control, like assessing the possible occurrence of hypoglycaemic episodes in patients taking sulphonylureas. - References: 1. Welschen LMC, Bloemendal E, Nijpels G, Dekker JM, Heine RJ, Stolman WAB, Bouter LM: Self-monitoring of blood glucose in patients with type 2 diabetes who are not using insulin: a systematic review. Diabetes Care 2005;28:1510–1517 2. Welschen LM, Bloemendal E, Nijpels G, Dekker JM, Heine RJ, Stalman WA, Bouter LM: Self-monitoring of blood glucose in patients with type 2 diabetes who are not using insulin. Cochrane Database Syst Rev 2005;2:CD005060 3. Davidson MB. Self-monitoring of blood glucose in patients with type 2 diabetes who are not using insulin: response to Welschen et al. and Kleefstra et al. Diabetes Care 2005;28(10):2597 4. Guerci B, Drouin P, Grange V, Bougneres P, Fontaine P, Kerlan V, Passa P, Thivolet C, Vialettes B, Charbonnel B: Self-monitoring of blood glucose significantly improves metabolic control in patients with type 2 diabetes mellitus: the Auto-Surveillance Intervention Active (ASIA) study. Diabete Metab 2003;29:587–594 5. Schwedes U, Siebolds M, Mertes G for the SMBG Study Group: Meal- related structured self-monitoring of blood glucose: effect on diabetes control in non-insulin-treated type 2 diabetic patients. Diabetes Care 2002;25:1928–1932 6. Farmer A, Wade A, Goyder E, Yudkin P, French D, Craven A, Holman R, Kinmonth AL, Neil A; Diabetes Glycaemic Education and Monitoring Trial Group. Impact of self monitoring of blood glucose in the management of patients with non-insulin treated diabetes: open parallel group randomised trial. BMJ 2007 Jun 25; [Epub ahead of print] 7. National Institute for Clinical Excellence. Management of type 2 diabetes: management of blood glucose. London: NICE, 2002. Competing interests: None declared |
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Roger Cawte, retired None OX11 7BN
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There would seem to be some flaws in the logic here. Firstly the patients who tested intensively in the study seem to have been encouraged not to alter their exercise or diet regimes. This totally negates the whole purpose of testing. All patients react differently to different foods. I am well aware of the effect of certain food stuffs on my own system such as white bread and potatoes. By avoiding these I have managed to bring my own results down significantly from diagnosis. At one stage my doctor encouraged me to significantly reduce my testing and that I did only to find that I needed increased medication to return to my former levels. By use of a more intensive regime I got back to better levels and am now on a reduced level again both of testing and of medication. The testing is more relaxed than orginally as I have more idea of what I am doing. Blanket studies of this nature are generally of limited value as they seek to relect a diverse collection of patients and then draw overall and, often, erroneous generalised conclusions. As a diabetic myself I do find it disturbing that the medical profession appears to be saying, smugly, that self management of a chronic condition should be left solely to them. I fear that my local practice would be very concerned at having to see me often enough to make that a viable alternative! I feel that if a patient is prepared to put in the hard work (and it is not pleasant) to achieve better results then that patient should be encouraged to test. Yes, it is expensive, but the long term consequences are even more expensive and need to be considered. Competing interests: None declared |
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Peter Handley, IT Manager Portsmouth PO8
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As a newly diagnosed Type 2, I believe it is essential for me to understand what is happening to my BG on a regular basis, in order that I can successfully manage MY condition. As I understand the trial, only 15% of the people who were approached to take part in the trial actually agreed to participate. Human nature says these are probably the type of person who is already keen to manage their condition, and so it is no surprise that no significant difference was seen. I also understand that the results were deemed 'inconclusive', which is not the same as proving there is no need for self-testing. While I understand a GP's need to balance their books, it seems obvious to me that good self management can help to avoid life threatening complications in later life, which will also prove a costly burden to the NHS. Maybe testing strips should come out of a central budget, i.e. the same budget that would pay for dealing with the major complications? Competing interests: None declared |
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Amanda F Rutter, Incident & Emergencies Section Exeter, EX2 7LQ
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I was diagnosed with T2 diabetes just 8 weeks ago. There has been no mention that I will ever see a DSN, nor a consultant. I have seen the practice nurse who [apparently] specialises in diabetes], just once. She gave no advice, other than to eat lots of bread, pasta, rice, potatoes etc, which I have since found to be quite wrong and caused my BG levels to be too high. As I am finding it necessary to educate myself I am adjusting my diet accordingly and testing to see how I respond to different foods, fortunately I am able to SMBG, although on a very limited basis. The GP whose list I am on has allowed me to monitor, but the strips/lancets prescribed mean I can only test once approx every third day. However this has already enabled me to find that what I was first told to eat is absolutely wrong, with BG’s of around 9.8. Now that I am able to SMBG I have brought my BG’s down into the 5.3 kind of range, 2/24 after starting a meal. I still need to find out how I respond to different foods and can only do that by self-testing. If I don’t control my BG levels, then quite frankly who will? It isn’t as though I will see a GP or Practice Nurse very often. I will have an Hba1c every few months, quite how long an interval in between I have yet to find out, but the thought of not being able to self monitor means that I would be blind. If as I was first told – that I did not need to self monitor, and I had eaten as advised to, then for months I would have been up in the 9 range or conceivably higher. What would that have done to my health, what problems over a period of time would that have caused, and at what cost to the NHS? Many T2’s will not wish to monitor, or will be unable to deal with self monitoring, but for those of us who wish to “own” our T2 and be in control, with the Health Centre providing occasional support, then it surely has to be in both the patient’s and NHS’s interest? Better understanding [albeit self-taught, as I have been offered no education by the NHS] can only be a good thing. If I am motivated to keep as tight control as I can, by diet/exercise [pilates/gym/swimming/walking, which I started upon diagnosis] then surely and hopefully I will at least postpone some of the many complications that come with this disease, and that has to save the NHS money. Don’t take away what is such a valuable tool from people who do use SMBG sensibly and who need it to keep their levels tight from day to day. To rely on an Hba1c every few months is simply ridiculous, incredibly short sighted and narrow minded. Rather spend money on educating youngsters on the dangers of the food they eat, and the dangers of not exercising. Educate the parents and teachers so they can also help with today’s youngsters, diabetes in the young has increased, and a lot of it is to do with lack of exercise and poor diet. Spend money there and save money later. But realise that T2’s who do SMBG and therefore keep tight control are money in the bank for the NHS, and they should be grateful that there are people like us out there. Competing interests: None declared |
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Alexander G. Logan, Professor of Medicine University of Toronto, 435-600 University Avenue, Toronto, Canada M5G 1X5, Joseph A. Cafazzo
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The results of the Farmer et al paper on self-glucose monitoring1 are particularly disappointing to advocates of participatory decision making and patient self-care, which includes the authors of this letter. The use of home monitoring as a means to improve health outcomes, however, must effectively address the issue of adherence to the monitoring procedure itself. Not all patients want to be actively engaged in self-care activities2 and their reluctance may manifest itself as non-adherence to the monitoring schedule. In the Farmer et al study, a quarter of subjects in the intensive group were not adhering to the minimal levels of self- monitoring after 2 months and nearly half by 1 year. The low adherence rate indicates that the efficacy as opposed to effectiveness of self- monitoring of blood glucose has not been ruled out, and it would be premature to dismiss the procedure as a useful management tool in this patient population. For self-monitoring to be adopted by patients, there is an expectation that the process of monitoring will result in timely changes in treatment. Otherwise the activity may be perceived as futile. In the Farmer et al study, the proportion of patients prescribed an increase in hypoglycaemic medications during the study was virtually identical among the three groups and there was no significant difference in the HbA1C levels at follow-up. In addition, the markedly elevated HbA1C values in the two intervention groups at the end of the trial suggest that the physicians did not act on the information being collected by the patients, a phenomenon called clinical inertia3. Possibly they had concerns about the reliability of reporting of self-monitoring of blood glucose and were reluctant to make treatment decisions on the basis of patient-generated information4. Studies have repeatedly documented significant omission of blood glucose readings and addition of phantom results5. These problems can now be largely mitigated by a telemonitoring system that automatically transmits all readings to a central server, which records the time and date of testing and activates an automated messaging system when too few results are received6. It is our belief that an effective, reliable self- monitoring system will enhance patient self-care and improve health outcomes. References 1. Farmer A, Wade A, Goyder E, Yudkin P, French D, Craven A, Holman R, Kinmonth AL, Neil A. Impact of self monitoring of blood glucose in the management of patients with non-insulin treated diabetes: open parallel group randomised trial. BMJ. 2007;335:132-139. 2. Levinson W, Kao A, Kuby A, Thisted RA. Not all patients want to participate in decision making. A national study of public preferences. J Gen Intern Med. 2005;20:531-535. 3. Phillips LS, Branch WT, Cook CB, Doyle JP, El-Kebbi IM, Gallina DL, Miller CD, Ziemer DC, Barnes CS. Clinical inertia. Ann Intern Med. 2001;135:825-834. 4. Halifax NV, Cafazzo JA, Irvine MJ, Hamill M, Rizo CA, McIssac WJ, Rossos PG, Logan AG. Telemanagement of hypertension: a qualitative assessment of patient and physician preferences. Can J Cardiol. 2007;23:591-594. 5. Kendrick JM, Wilson C, Elder RF, Smith CS. Reliability of reporting of self-monitoring of blood glucose in pregnant women. J Obstet Gynecol Neonatal Nurs. 2005;34:329-334. 6. Logan AG, McIsaac WJ, Tisler A, Irvine MJ, Saunders A, Dunai A, Rizo CA, Feig DS, Hamill M, Trudel M, Cafazzo JA. Mobile phone-based remote patient monitoring system for management of hypertension in diabetic patients. Am J Hypertens 2007 (in press). Competing interests: None declared |
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Charles Fox, Consultant diabetologist Diabetes Centre, Northampton General Hospital NN1 5BD
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Andrew Farmer and colleagues have produced a thoughtful piece of work, which shows that in groups of people with relatively well controlled type 2 diabetes, home blood glucose monitoring makes little difference to the HbA1c. The accompanying editorial by Simon Heller is equally reflective. These detached scientific articles have been greeted by a torrent of long and detailed responses from people with type 2 diabetes, nearly all of whom believe that taking HBGM away would be an assault on their human rights. In simplistic terms, diabetes is a condition in which a raised blood glucose concentration leads to dangerous consequences in the long term. People with diabetes have made the case with passion that they can correct any abnormalities in blood glucose by taking action. But they can do nothing without knowing the actual value - a urine test doesn't quite provide the same information. So the polarised debate continues between the scientists and those who are doing their best to reduce the very real risks of living with diabetes. These opposing views are summed up in two of the letters published in the Journal on 11th August. Dr Lister banns his patients with type 2 diabetes from measuring their blood glucose and nothing will persuade him to change his mind. Dr Lister uses this research project to support his unswerving views. Patti Evans no doubt finds this attitude "arrogant and ill founded". Sadly PCT pharmacy advisers throughout the country will now state with confidence that blood glucose monitoring is of no proven value in type 2 diabetes without understanding the limitations that Andrew Farmer et al spell out in the electronic account of their work but which are omitted in the paper version. It is an important study but will be misinterpreted by those responsible for managing tight budgets, who believe that most of the money spent on glucose strips is wasted. Competing interests: None declared |
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Joan McClusky, medical writer New York, NY 10003
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If people have been doing pretty well at controlling their type 2 diabetes based on A1c for 3 years, it's not surprising that they'd continue to do well based on the same measurement. People are not going to suddenly take bad care of themselves because they can monitor their own blood glucose levels--but in essence, that's what this study was evaluating. Perhaps the question should have been how many people with poorly controlled diabetes based on A1c do a better job in terms of this long term measurement if they can see the patterns on a daily basis? SMBG levels change during a given day based on exercise, diet, illness, and a host of other things. Someone doing a poor job at this is going to have A1c levels that reflect that. Competing interests: None declared |
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