Self monitoring of blood glucose in type 2 diabetes

Letter to the Editor

Dear Sir,

We would like to make a few points in response to the two recent
articles regarding the usage of self blood glucose monitoring in Type 2
diabetes. Opinion on this subject has always been divided.

Patients in the DiGEM (ref. 1) study had initial education and 1-3
monthly follow up appointments to discuss their results. None of these
patients had 24 hour decision support available to them.

O’Kane et al (ref. 2) had 78 out of the 98 patients at 1 year on none
or only one drug. Given their treatment algorithm we would thus expect
that the majority of these newly diagnosed people with diabetes on just
one drug would be on Metformin, hence the incidence of hypoglycaemia would
be minimal in these patients. Hypoglycaemia has major implications in
patients who drive patients in certain professions and those who undertake
exercise. SBGM plays a valuable part in the daily management of their
diabetes and their safety.

We would expect that up to 50% of the patients with type 2 diabetes
will progress to insulin therapy in 6 years ( ref 3) and by introducing
the culture of SBGM monitoring and its implications will surely only serve
to benefit both the patient and HCP.

If we were to advocate the cessation of HBGM where is the evidence of
non- maleficience? Is it possible that patients may come to harm if they
do not test? For example, the Sulfonylurea or insulin treated patient may
run higher glucose levels to avoid hypoglycaemia if they lacked the
assurance of HBGM results and thus be at increased risk of long term
complications. By contrast might rates of severe hypoglycaemic episodes
increase in this group of patients.

There is evidence that linking HBGM to decision support is beneficial
in Type 2 Diabetes (refs.4,5) There are also existing Health informatics
solutions that offer a cost effective link between decision support and
HBGM (refs 6,7). In some systems, access to data is supported by online
structured patient education with assessment of educational outcomes and
further targeting of additional education as appropriate (refs 8,9)

The point of evidence based medicine is to advance the quality of
clinical care and outcomes until non-maleficience is demonstrated it may
be premature to withdraw HBGM in type 2 diabetes.
We would encourage RCT’s in health informatics decision support systems.

Conflict of interests- none

Prof G A Thomson, Consultant Diabetologist
Sherwood Forest Hospitals Foundation NHS Trust
Email: george.Thomson@sfh-tr.nhs.uk

Buddhike Mendis, Specialist Registrar
Sherwood Forest Hospitals Foundation NHS Trust
Email: buddmen@yahoo.com

References

1. Cost effectiveness of self monitoring of blood glucose in patients
with non- insulin treated type 2 diabetes: economic evaluation of data
from the DiGEM trial. Simon J, Gray A, Clarke P, Wade A, Neil A, Farmer A.
BMJ 2008 0: 39526.674873

2. .Efficacy of self monitoring of blood glucose in patients with
newly diagnosed type 2 diabetes (ESMON study): randomised controlled trial
Maurice J O’Kane, Brendan Bunting, Margaret Copeland, Vivien E Coates on
behalf of the ESMON study group.
BMJ 2008 0: 395345716

3. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-
glucose control with sulphonylureas or insulin compared with conventional
treatment and risk of complications in patients with type 2 diabetes
(UKPDS 33).
Lancet 1998;352:837-53

4. M-healthcare for patient self-management: a case for diabetics

CocosilaM, Cousaris C, Yuan Y

Int J Electronic Healthcare 2004;1(2):221-41

5. Home blood glucose prediction: validation, safety, and efficacy
testing in clinical diabetes
Albisser AM, Baidal, Alejandro R, Ricordi C

6. A graphical user interface for diabetes management that integrates
glucose prediction and decision support
Diabetes Technol Ther. 2005 Apr;7(2):264-73
Albisser AM

7. Task delegation and computerized decision support reduce coronary
heart disease risk factors in type 2 diabetes patients in primary care
Diabetes Technol Ther. 2007 Oct;9(5):473-81.
Cleveringa FG, Gorter KJ, van den Donk M, Pijman PL, Rutten GE.

8. Defining a comprehensive, streaming, e-education engine for
chronic diseases: The development of a Virtual Diabetes Centre
L Telemed Telecare 2006; 12:48-50
Thomson GA, Fernando DJS, Bushby P et al

9. Future patient management enhancements: Developing the virtual
health provider
Hosp Healthcare Eur 2008
Thomson GA

Competing interests:
None declared

Dear Editor, thanks a million.

On the surface every thing looks good. How good is good? How good is
plasma glucose screening? Statistical medicine, sold all over as very
scientific originates from scandal of poor research says Douglas G Altman,
head of the medical statistics, London. Plasma glucose screening was
recently proved to be disease mongering and selling sickness. Many studies
have consistently demonstrated that history taking and physical
examinations are the most important factors in arriving at correct
diagnosis, whereas lab tests play only minor role and too often palpably
illogical laboratory findings are accepted without question. The quotation
from a Cardiologist Mimi Guarneri “Beyond the power of most sophisticated
medical equipment is a physician’s humanity – the listening ear, the
healing touch, the devices of healers throughout time”, holds good at this
juncture

Health Care Providers from traditional system of medicines including
Majority of Ayurvedic physicians, having a great influence of poor
research based western medicine gradually are going away from clinical
symptoms of diseases in general and T2DM in particular based on laboratory
results / self monitoring blood glucose. If laboratory reports are
abnormal, asymptomatic healthy person is “medicalised and drugged or
operated upon”, irrespective of truth whether he or she is suffering or
not. It is unfortunate that such a great Science Ayurveda which has
existed for “Times out of mind” in India is also slowly deviating to
follow the Modern Medical System of Laboratory Diagnosis even in the
“Well” segment of the population. Even in the Western Medicine treatment
of asymptomatic Hyperglycemia has been shown to be futile, if not
dangerous. Even the newly invented disease in Western Medicine IGT or
Impaired glucose Tolerance has been shown to benefit more by life style
changes rather than modern medicine like Rosiglitasof in a large study.

“Euboxic” Ayurvedic doctors have been neglecting the definition of
disease defined in different classics of Ayurveda , as a “state in which
both the body and mind are subjected to pain and misery”. Chambers
Dictionary also defines disease which is similar to Ayurvedic definition
as “an unhealthy state of body or mind; a disorder, illness or ailment
with distinctive symptoms. The laboratory diagnostic criteria of Diabetes
Mellitus of western medical science which is flourishing with unscientific
practice should not be followed for diagnosis of Madhumeha, because "The
medical profession is being bought by the pharmaceutical industry, not
only in terms of the practice of medicine, but also in terms of teaching
and research," says Arnold Relman, a Harvard professor and former editor
of the New England Journal of Medicine.

Random glucose more than 200 mg/dl and Plasma glucose of 126 mg/dl or
higher after an overnight fast, documented more than one occasion with
associated symptoms are the essentials of Type 1 diabetes mellitus
diagnosis. The essentials of diagnosis of Type 2 diabetes are plasma
glucose of 126 mg/dl or higher after an overnight fast on more than one
occasion and after 75 gm oral glucose, diagnostic values are 200 mg/dl or
more 2 hours after the oral glucose. Polyuria, polydipsia. ketonuria and
weight loss generally are uncommon at time of diagnosis. Candidal
vaginitis in women and Belanophosthitis in men may be an associated
initial manifestation .Many patients have few or no symptoms. This so
called international diagnostic criterion with no symptoms takes liberty
of life and puts healthy individual into bottom less pit till last
respiration
Total body scan (TBS) including plasma glucose for T2DM has become a
routine among educated, economically rich people and national program in
developed countries. Whole body scanning is currently marketed in the
medical field to make healthy individual ill and who will rarely become
healthy as Professor Isan burg says. A study reported in Journal of the
National Cancer Institute says that routine screening for prostate cancer
using the prostate specific antigen (PSA) leads to over diagnosis. In
Netherland, in 1982 around 1000 children were referred to pediatrician
after a positive screening result which was shown to be false for
congenital hypothyroidism. More test, more false- positive result. This
type new born and children screening programs with false positive results
create potential parental stress

The Pap smear screening program for cervical cancer in Bristol to
prevent cancer, where in 13000 women needed to be screened over 20 years
to prevent one death. To prevent one cardiac event per year about 1000
patients needed to treat with newly introduced Polypill which is nothing
but old wine in new bottle. This is the use of screening which could
damage public health and nation treasure. The plasma glucose scanning will
show natural normalcy in asymptomatic person as abnormal and encourages
physicians with linear thinking to drug healthy mind and body by creating
ghost fear. Epidemiologists to cause epidemics predicted that Diabetes
affects one in 20 adults world wide and 333 million cases are predicted
world wide by 2025 and to sell drugs to increase mortality rate which has
been proved by recent clinical trail. Statistical science is one of the
leading causes of death in United States of America. To prevent and stop
disease mongering The Pew Charitable trust has given US$ 6 million
campaign by name ‘prescription project’ to reduce the influence of
pharmaceutical industry marketing on US physicians and doctors-in
–training

Professor B.M. Hegde Sir in his classic “What Doctors Don’t Get to
Study in the Medical School” says “The problems lie in medicine’s
difficulties in defining normality, the devil of “false positives”, and
our limited understanding of the natural history of disease. The most
common way of defining normal is that the measure lies within two standard
deviations of the mean”. So defining normal and abnormal plasma glucose
level in a dynamic non- linear human body which has the natural super
power to manage altered internal environment to great extent is impossible
by linear science.

Twentieth century great physician, Lord Platt a great teacher of
medicine at the university, in 1949 wrote that “If you listen to your
patient long enough, s/he will tell you what is wrong with her/him”. Later
his students did prove that with a very well executed prospective, double
blind, randomized, hi-tech based (even PET scanner) study of the role of
history taking, physical examination, and investigations in medical
diagnosis. The study showed that 80% of the final accurate diagnosis and
100% of the future management strategies could be arrived at the end of
listening to the patient and reading the GP‘s referral letter. This is
refined slightly by examination and investigations!
Diabetic Medicine 1999 published a revolutionary study report on the
effect of insulin on symptomatic and asymptomatic hyperglycemic patients.
Quality of life and plasma glucose in insulin treated diabetics clearly
showed real relief only in those patients who were symptomatic before
treatment. Asymptomatic hyperglycemic patients experienced more problems
with social functioning and pain with treatment. This is the proof for
efficacy of drugs in symptomatic hyperglycemia and adverse effect of
medicalisation.

T2DM needs a good Physician to understand T2DM, not a machine. In
other words of Sir William Osler, “It is a safe rule to have no teaching
without a patient for a text, and the best teaching is that taught by the
patient himself”

References:
Douglas G Altman. The scandal of poor medical research. BMJ 1994; 308:283-
28, Sushruta Samhita of Sushrita with Nibandhasangraha Commentary of Sri
Dallnacharya edited by Vaidhya Jadavji Trikamji Acharya and Narayanaram
Acharya,Sixth Edition 1997, 6-1/23, Richard Smith. Unscientific practice
flourishes in science. BMJ 1998; 316:1036, Elizabeth A, Gurian, Danial D.
Exapanded Newborn screening for biochemical disorders: The effect of a
False- Positive Result. Pediatrics 2006; 117:1915-1921, M Thompson, R
Perera. Prevention of diabetes. BMJ 2006; 333:764-765

Competing interests:
None declared

Simon et al1 used data from the DiGEM2 study done on 453 patients
with non-insulin treated type 2 diabetes and a mean haemoglobin A1c of
7.5%. The ESMON study utilized 184 newly diagnosed diabetics3. Diabetes is
more often than not associated with partners of the metabolic syndrome
such as hypertension, dyslipidaemia, obesity, hyperuricaemia and renal
function insufficiency, none of which were described in the O’Kane and
Simon study populations. Diabetics in the community commonly have HbA1c
levels over the 8.8 reported in the O’Kane study. Self monitoring of blood
glucose (SMBG) allows patients to monitor and quantify their disease
progression. As with asthma, objective assessments which patients can see
avoids over-rating disease control and encourages them to take
responsibility for and control of their disease.

In Trinidad, patients
proudly present their SMBG records with explanations for deviations and
positive results after initiating corrective measures. Rather than being a
drain on the purse or the psyche, SMBG avoids complications of co-morbid
diabetes, and enables patients who may not be able to travel to do an
HbA1c estimation, to call their health care provider and seek assistance
to correct SMBG values. The expense to the health exchequer for SMBG would
be expected to be more economical than the burden of hyper and or
hypoglycaemia which urine testing cannot offer. The wisdom of extending
these findings to diabetics in general must be viewed with sobriety.

Controlled diabetics doing SMBG will keep running to stay in the same
place.

1. Simon J, Gray A, Clarke P, Wade A, Neil A, Farmer A. Cost
effectiveness of self monitoring of blood glucose in patients with non-
insulin treated type 2 diabetes: economic evaluation of data from the
DiGEM trial. BMJ 2008 0: 39526.674873

2. Farmer A, Wade A, Goyder E, Yudkin P, French D, Craven A, et al. Impact
of self-monitoring of blood glucose in the management of patients with non
-insulin treated diabetes: open parallel group randomised trial. BMJ
2007;335:132-9.

3. Efficacy of self monitoring of blood glucose in patients with newly
diagnosed type 2 diabetes (ESMON study): randomised controlled trial
Maurice J O’Kane, Brendan Bunting, Margaret Copeland, Vivien E Coates on
behalf of the ESMON study group. BMJ 2008 0: 395345716

Competing interests:
None declared

The potential for diabetics to self-monitor their blood glucose
should be self-evident. However, the reality is that people often find
excuses for not adhering to the diet and treatment regimens that should be
a part of any self-testing routine. It doesn’t have to be that way. I
recently met with the CEO of a disease management firm that relies on self
-testing. The diabetic's blood glucose monitor is Bluetooth enabled to
automatically send readings through a computer or PDA to the physician’s
office. If the diabetic fails to test on schedule – or if blood sugar has
spiked – a diabetic nurse educator calls on the phone to inquire why the
test was not done or which foods recently eaten may have caused a spike in
blood sugar. It’s not the self-testing that controls diabetes. Rather it’s
using the information to adjust and adhere to treatment goals. I cannot
imagine how any program to successfully manage chronic diabetes would not
include some type of self-testing between office visits.

Competing interests:
None declared