Rapid Responses to:

RESEARCH:
Maurice J O’Kane, Brendan Bunting, Margaret Copeland, Vivien E Coates on behalf of the ESMON study group
Efficacy of self monitoring of blood glucose in patients with newly diagnosed type 2 diabetes (ESMON study): randomised controlled trial
BMJ 2008; 336: 1174-1177 [Abstract] [Full text]
*Rapid Responses: Submit a response to this article

Rapid Responses published:

[Read Rapid Response] why self-monitoring patients might score higher in depression
Lucy M. Candib   (20 April 2008)
[Read Rapid Response] Mean weekly glycemia: a SMBG-derived method for near-real-time evaluation of glycemic control and of adequacy of treatment strategy
AUGUSTO PIMAZONI, MD   (20 April 2008)
[Read Rapid Response] Merely proves there is no point in home monitoring if you ignore the results
Ben L Balzer   (26 April 2008)
[Read Rapid Response] Ignoring the obvious
Patti D Evans   (24 August 2008)
[Read Rapid Response] Compliance and Contamination
James A Campbell   (16 November 2008)

why self-monitoring patients might score higher in depression 20 April 2008
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Lucy M. Candib,
Family doctor and trainer
Family Health Center of Worcester

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Re: why self-monitoring patients might score higher in depression

O'Kane et al suggest that the negative effect of self-monitoring of blood glucose in the intervention group might relate to "the enforced discipline of regular monitoring without any tangible gain." I would like to suggest an alternative possibility based on my own personal experience. Within the first few years of diagnosis, many people with type 2 diabetes do not really believe that they "have" diabetes since they feel well. The diagnosis is intangible and only emerges from blood tests. There is no experiential quality of being ill, especially in those with easily controlled disease who are unlikely to have polyuria and polydipsia. It is easy to take the pills and slip back into a belief that I don't really have it, I could get over it, it will go away if I exercise and eat better, etc. Self-monitoring of blood glucose throws it in your face. You can't deny that 2 pieces of pie did unmentionable things to your postprandial value. You must admit again and again that you have diabetes. The unmonitored group does not have this constant reality check.

In only 12 months of observation, the monitored group feels more depressed because they are confronting the reality of a chronic disease, while the unmonitored group can believe what they want as long as they follow the regimen. The real difference will come in the long run with the deterioration in their pancreatic function when, eventually, the unmonitored group will have to face the music too. At that point they may look "more depressed" while the long term monitoring group might be more at ease with their diagnosis. One year is too short to incorporate the reality of a chronic disease into one's mindset. Only a much longer project would validate the differences in depression and long term outcome.

Competing interests: None declared

Mean weekly glycemia: a SMBG-derived method for near-real-time evaluation of glycemic control and of adequacy of treatment strategy 20 April 2008
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AUGUSTO PIMAZONI, MD,
Coordinator, Diabetes Education and Control Group
Center of Hypertension and Cardiovascular Metabology - Kidney and Hypertension Hospital - Brazil

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Re: Mean weekly glycemia: a SMBG-derived method for near-real-time evaluation of glycemic control and of adequacy of treatment strategy

Papers by Simon et al. and O’Kane et al. dealt with ideal type 2 diabetic patients, followed every three months for a whole year. The study on efficacy of self monitoring of blood glucose (SMBG) by O’Kane et al. included only “five star” diabetic patients that we all would like to have as our patients: no comorbidities of any kind, no insulin treatment, no cognitive deficits, no serious diseases. The study on cost-effectiveness by Simons et al. only included patients from the DiGEM Study managed with diet or oral hypoglycemic agents alone, also excluding insulin treated patients. Conclusions of both studies are therefore applicable to this divine segment of “pure” diabetic population, which by no means reflect the real world situation.

The real danger of this rather simplistic analysis is the extrapolation of these conclusions to the diabetic population as a whole. Both studies present the same pitfall of utilizing a prefixed frequency of testing for the whole 12 months period of the studies (8 tests /week in the efficacy study and 6 tests/week in the cost effectiveness study), regardless of the level of glycemic control, which conflicts with the very basic concept of SMBG according to which the frequency of testing should never be predefined, except during the realization of 6 or 7 points glycemic profiles for a very short period of a few days. It seems a total nonsense to force patients with reasonably stable glycemic control to test themselves in a predetermined frequency for a whole year.

At the Diabetes Education and Control Group of the Kidney and Hypertension Hospital, Federal University of Sao Paulo, Brazil, we just started a proof-of-concept study on the use of Mean Weekly Glycemia (MWG) as a practical, point-of-care, low cost method for the near -real-time evaluation of glycemic control and of adequacy of therapeutic regimen. The majority of our population consists of diabetic low income, less educated type 2, insulin treated patients with different comorbidities, between 50 and 70 years, with A1C levels ranging from 8% up to 15% and with different degrees of renal failure. These patients are seen every week for educational activities and weekly adjustments of therapeutic strategy as needed. Patients receive a glucose meter and strips (Lifescan One Touch Ultra), with instructions to perform a full 6 points glycemic profile (7 points in insulinized patients) during three days in a week (Mondays, Tuesdays and Wednesdays). At each visit, results from glucose monitors are downloaded with the help of the One Touch Diabetes Management Software Pro v3.1.1. for calculations of mean glycemia and standard deviation of data from any specified period of time. Results from the three glycemic profiles per week are used as representative of MWG value. Results are projected in a screen and presented to each patient, showing and commenting on his/her successes and failures in the week, compared with their performance in previous weeks. Treatment adjustments are implemented as needed , with the reasons for changes fully explained to the patient, taking in consideration the glucose trend and the standard day data modes provided by the software.

Therefore, MWG is a practical option for short term, near-real –time evaluation of glycemic control that allows a fully rational approach to adjustments in therapy on a weekly basis, instead of having to wait 3 months as suggested by almost all international guidelines on the treatment of diabetes. A1C is the gold standard for long term evaluation of glycemic control, but does not provide the need information on what kind of pharmacological agents would be more indicated for each particular patient at any particular time and situation. MWG, on the other hand, has the advantage of being able to provide these very crucial information and thus give a definite contribution to combat therapeutic inertia. Correlations between MWG and A1C levels at weeks 0,4, 6 and 8 after the implementation of the MWG evaluation method will be carried out. Patients who do respond to this approach (an average of 60% of our patients) will achieve within normal range glucose readings in 4 to 6 weeks. After this period, patients are instructed to perform tests only occasionally, 2 times per week, in different times of the day, or when they feel that something is wrong.

AUGUSTO PIMAZONI, MD
Coordinator, Diabetes Education and Control Group
Center of Hypertension and Cardiovascular Metabology, Kidney and Hypertension Hospital, Federal University of Sao Paulo, Brazil
E-mail: pimazoni@uol.com.br

Competing interests: None declared

Merely proves there is no point in home monitoring if you ignore the results 26 April 2008
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Ben L Balzer,
General Practitioner
Beverly Hills 2209 NSW Australia

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Re: Merely proves there is no point in home monitoring if you ignore the results

The paper itself shows that the home BG readings were totally ignored in deciding the therapy for each individual. So even if home BG readings were elevated, they were not used to change therapy, as the treatments were solely determined by HbA1c readings. The patients might as well have done daily iridology. These authors might get the Nobel prize for the bleeding obvious. The only real conclusion that can be made from this data is "We have proven that there is no point in home monitoring if your doctor ignores the results, just as we have done". Indignantly yours Ben Balzer

http://www.bmj.com/cgi/content/full/bmj.39534.571644.BEv1

We used an identical treatment algorithm for dietary and pharmacological management of glycaemia for both groups based on HbA1c targets (figure 1)Go. Blood concentrations of HbA1c, lipids, and electrolytes were measured at or before each clinic and results were discussed with patients in the context of the treatment targets. Measurement of HbA1c was performed in the local hospital laboratory with a diabetes control and complications trial (DCCT) aligned HbA1c assay.2 All laboratories participated in HbA1c external quality assurance, which was satisfactory for the duration of the study. All other laboratory tests were also performed in the local hospital laboratory, where staff were blinded to treatment allocation.

Competing interests: None declared

Ignoring the obvious 24 August 2008
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Patti D Evans,
Administrator
Penzance, TR18 3PE

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Re: Ignoring the obvious

It is indeed obvious that testing, without the wherewithal to influence the results of said tests, will cause depression. Although the study states that participants were given "a structured education programme", from anecdotal and personal experience of such "education" programmes, little practical advice on how to influence blood sugars is given. The dietary advice dispensed on such education programmes is, if followed to the letter, almost guaranteed to result in high blood sugar levels, since it advocates the "eatwell plate", and advises:- "plenty of bread, rice, potatoes, pasta and other starchy foods – choose wholegrain varieties whenever you can". It is a simple biological fact that carbohydrates turn to sugars in the blood stream. Hence for diabetics on oral medication or diet and exercise, even if the low GI versions are eaten, the result will be high BGs post prandially.

However, members of diabetes-support.org.uk have significantly improved their results (and hence their Hba1cs) by learning the affect of carbohydrates on their own bodies and managing their intake to minimise them. A structured regime of testing for a few weeks will quickly show what foods can be tolerated on an individual basis, because oddly, each person has a different tolerance level to different foods. The effect of exercise in reducing any resulting spike in BG levels can also be demonstrated in a practical way and this in itself can be a motivation to improve both diet and exercise regimes.

These findings are repeated over and over in every single diabetic forum on the internet. Yet Doctors are refusing to prescribe test strips in what can only be regarded as a short-sighted and cost conscious fashion. Whilst those who can afford it can purchase the test strips to educate themselves, those who cannot are simply being denied a very simple means of being in charge of their own health and preventing future complications.

Competing interests: Patients welfare

Compliance and Contamination 16 November 2008
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James A Campbell,
Medical Student
Auckland City Hospital 1023

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Re: Compliance and Contamination

"Of the 96 participants in the self-monitoring group, 63 carried out more than 80% of the requested blood glucose monitoring (that is, four fasting and four postprandial readings a week)."

Compliance is possibly a systematic problem in this study. There is 65.6% compliance to the intervention, even with the laxity in intervention compliance - "defined" as >80% of the monitoring expected.

Thus, with the compliance laxity, the worst case scenario gives 34.4% contamination from self-monitoring to no monitoring.

Competing interests: None declared