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PL Detail-Document #281208
This PL Detail-Document gives subscribers
additional insight related to the Recommendations published in
PHARMACISTS LETTER / PRESCRIBERS LETTER
December 2012

Self-Monitoring of Blood Glucose in Patients with Type 2 Diabetes

Introduction
Self-monitoring of blood glucose is routine for
many patients with diabetes. While the role of
self-monitoring is well-established in patients
with type 1 diabetes, its role in patients with type
2 diabetes, especially those who are not receiving
insulin, is less clear.
1
This document reviews the
role of self-monitoring of blood glucose in
patients with type 2 diabetes.

Current Guidelines
Guideline recommendations regarding self-
monitoring of blood glucose in patients with type
2 diabetes are vague. The American Diabetes
Association recommends that for patients using
multiple daily doses of insulin or patients using an
insulin pump, self-monitoring of blood glucose
should be carried out at least three times a day.
They state that for patients who use less frequent
insulin or noninsulin medications, self-monitoring
of blood glucose may be useful as a guide to
management, but the recommendations do not
quantify the number of times patients should
monitor their glucose nor do they specify which
patients should monitor. Instead, the guidelines
suggest that the optimal frequency and timing of
self-monitoring of blood glucose is unclear.
2

The Canadian Diabetes Association notes that
the benefits and optimal frequency of self-
monitoring of blood glucose in patients with type
2 diabetes are less clear than for type 1 diabetes.
3

The guidelines point to contradictory evidence
and studies with methodological and conceptual
limitations. However, the guidelines highlight
that self-monitoring of blood glucose in those who
are recently diagnosed, regardless of treatment, is
beneficial.
3
In general, the guidelines
acknowledge the role of self-monitoring in
patients with type 2 diabetes using insulin, and
suggest that in others, testing should be
individualized based on glycemic control and the
potential for hypoglycemia associated with
noninsulin therapies.
3

In 2009, the Canadian Agency for Drugs and
Technologies in Health concluded that in patients
with type 2 diabetes using insulin, self-monitoring
of blood glucose should be used. In most patients
who only use long-acting insulin, testing up to 14
times a week is sufficient. Patients using oral
agents only do not require routine self blood
glucose monitoring. However, monitoring should
be considered for patients with unstable glucose
levels, acute illness, changes in their drug therapy
regimen, those at risk of hypoglycemia, during
pregnancy, or in those with jobs where
hypoglycemia poses danger.
4

With such vague guidelines and
recommendations, it is difficult to decide in whom
self-monitoring of blood glucose is warranted.

Clinical Trials
Malanda and colleagues conducted a
systematic review to assess the effects of self-
monitoring of blood glucose on glycemic control,
quality of life and well-being, patient satisfaction,
and hypoglycemic episodes in patients with type 2
diabetes who were not using insulin.
5
Inclusion
criteria for the studies included randomized,
controlled studies that investigated the
effectiveness of self-monitoring of blood glucose
compared with usual care. Studies that compared
self-monitoring of blood glucose to urine glucose
monitoring were also included. All studies were
required to use at least one outcome measure such
as A1C, fasting plasma glucose, hypoglycemic
episodes, quality of life, well-being, or patient
satisfaction.
The authors identified twelve randomized
controlled trials that included and evaluated
outcomes in 3259 randomized patients with type 2
diabetes who were not using insulin. Based on
these studies, the authors concluded that when the
duration of diabetes is greater than one year, the
overall effect of self-monitoring of blood glucose
on glycemic control is small during the six months
(reduction in A1C 0.3%; 95% CI -0.4 to -0.1;
(PL Detail-Document #281208: Page 2 of 4)
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2324 participants, nine trials) after initiation but
subsided after 12 months (reduction in A1C 0.1%;
95% CI -0.3 to 0.04; 493 participants, two trials).
Based on the existing literature, the authors
concluded that more research is needed to
determine the psychological impact of self-
monitoring and the impact on diabetes-specific
quality of life and well-being. Additionally, it is
not known how self-monitoring of blood glucose
affects the rate of hypoglycemia and diabetes
complications in patients with type 2 diabetes.
5
Farmer and colleagues conducted a meta-
analysis of randomized, controlled trials in
patients with type 2 diabetes who were not using
insulin to compare self-monitoring of blood
glucose with clinical management and no self-
monitoring. Trials published from the year 2000
and later with at least 80 participants were
included.
6
There were a total of 2552 patients in the six
included trials. At six months, the mean pooled
reduction in A1C was 0.88% in those who self-
monitored blood glucose compared with 0.69% in
the usual care group. The mean difference in
reduction in A1C between groups was 0.18% at
three months (p=0.001, five trials) and 0.23% at
12 months (p=0.002, three trials). The difference
in A1C between groups was consistent across age,
baseline A1C, sex, and duration of diabetes,
although the numbers of older and younger people
and those with A1C >10% were insufficient to
make any definitive conclusions. The authors
concluded that although self-monitoring of blood
glucose was statistically significantly better,
evidence does not support a clinical benefit of
self-monitoring blood glucose by noninsulin using
type 2 diabetes patients.
6,7


Cons of Routine Self-Monitoring of Blood
Glucose
Critics of self-monitoring of blood glucose
claim that it has not been proven to be beneficial.
Lack of benefit may be due to a number of
factors.
To be beneficial, monitoring and recording of
blood glucose concentrations require actions
based on the recorded readings. Often, blood
glucose values are checked and recorded, but
these data are not shared with a health care
professional, and no action is taken to adjust diet,
medications, and exercise regimens. In order to
be beneficial, a health care professional must
review the glucose reading and provide a clear
action plan.
1

In addition, the effectiveness of self-
monitoring of blood glucose relies on the proper
use of the equipment in order to obtain accurate
results.
1,8,9
Health care providers should evaluate
a patients monitoring technique initially and then
at periodic intervals.
1
Cost of self-monitoring is also an issue.
Diabetes is a chronic illness that affects millions
of people. Critics claim that millions of dollars
are spent on self-monitoring (for strips, lancets,
lancing devices, meters, batteries, calibration
solutions) by patients with type 2 diabetes
receiving oral medications, yet the benefits are not
proven.
8-10

Critics also point out that home blood glucose
monitoring has a negative effect on quality of life,
with monitoring leading to distress, worry, and
depressive symptoms.
8,9
For example, in one
study of self-monitoring in newly diagnosed
patients with type 2 diabetes, those who were
assigned to self-monitor blood glucose had a
higher depression scale score than those who did
not monitor.
11


Pros of Routine Self-Monitoring of Blood
Glucose
Proponents of blood glucose self-monitoring
point out that it empowers patients to have control
of their disease. Through self-monitoring, they
can see the real-time effects of dietary habits and
medication compliance. In addition, they are able
to objectively see the beneficial effects of
exercise. It is hoped that by seeing these
beneficial effects, patients will be motivated to
comply with medication, dietary, and exercise
regimens.
1,12,13

While critics cite the results of studies by
Malanda and others as a reason not to advocate
routine self-monitoring in noninsulin using type 2
diabetes patients, proponents note the benefits
seen in that trial. They highlight the 0.3%
reduction in A1C values as beneficial. While the
benefits appear small, ongoing education of
patients and health care providers regarding better
utilization of documented blood glucose values
may lead to even greater improvements in A1C
values.
13,14

While proponents of self-monitoring recognize
the expense, they point out that if self-monitoring
prevents or delays the development of long-term
(PL Detail-Document #281208: Page 3 of 4)
More. . .
Copyright 2012 by Therapeutic Research Center
3120 W. March Lane, Stockton, CA 95219 ~Phone: 209-472-2240 ~Fax: 209-472-2249
www.PharmacistsLetter.com ~www.PrescribersLetter.com ~www.PharmacyTechniciansLetter.com
complications of diabetes, ultimately, there will be
a cost savings.
12
However, there are little
evidence-based data at this time to support this
claim.

Conclusion
The role of self-monitoring of blood glucose in
patients with type 2 diabetes who are not
receiving insulin has not been fully elucidated. So
far, evidence does not point to a significant
benefit in most of these patients [Evidence level
A; high-quality meta-analysis].
5,6

There are a number of situations, however,
when home blood glucose monitoring may be
justified for noninsulin using patients with type 2
diabetes. Monitoring should be considered for
patients with acute illness, unstable glucose levels,
new diabetes diagnosis, changes in medications,
hypoglycemia risk, during pregnancy, and if
postprandial hyperglycemia is a concern. In
addition, patients taking oral sulfonylureas may
benefit from blood glucose self-monitoring since
these agents can cause hypoglycemia.
1,4,5,13,15
In order to definitively answer the question of
whether routine self-monitoring of blood glucose
is beneficial in all noninsulin using patients with
type 2 diabetes, large randomized controlled trials
to assess the long-term benefits should be
conducted.


Users of this PL Detail-Document are cautioned to use
their own professional judgment and consult any other
necessary or appropriate sources prior to making
clinical judgments based on the content of this
document. Our editors have researched the
information with input from experts, government
agencies, and national organizations. Information and
internet links in this article were current as of the date
of publication.


Project Leader in preparation of this PL Detail-
Document: Neeta Bahal OMara, Pharm.D.,
BCPS, Drug Information Consultant

References
1. Renard E. Monitoring glycemic control: the
importance of self-monitoring of blood glucose. Am
J Med 2005;118(Suppl 9A):12S-19S.
2. American Diabetes Association. Standards of
medical care in diabetes 2012. Diabetes Care
2012; 35(Suppl 1):S11-S63.
3. Canadian Diabetes Association. Clinical Practice
Guidelines Expert Committee. Monitoring glycemic
control. 2008 clinical practice guidelines for the
prevention and management of diabetes in
Canada. Can J Diabet 2008;32(Suppl 1):S32-S36.
4. Canadian Agency for Drugs and Technologies in
Health (CADTH). Summary report: optimal
prescribing and use of blood glucose test strips for
self-monitoring of blood glucose. 2009.
http://www.cadth.ca/media/pdf/C1109_bgts_summ
ary_report_e.pdf. (Accessed November 7, 2012).
5. Malanda UL, Welschen LM, Riphagen II, et al.
Self-monitoring of blood glucose in patients with
type 2 diabetes mellitus who are not using insulin.
Cochrane Database Syst Rev 2012;(1):CD005060.
6. Farmer A, Perera R, Ward A, et al. Meta-analysis
of individual patient data in randomised trials of self
monitoring of blood glucose in people with non-
insulin treated type 2 diabetes. BMJ
2012;344:e486. doi:10.1136/bmj.e486.
7. Willett LR. J ournal club review of Meta-analysis of
individual patient data in randomised trials of self
monitoring of blood glucose in people with non-
insulin treated type 2 diabetes. ACP Journal Club
2012:156:J C6-12.
8. Davidson MB, Castellanos M, Kain D, Duran P.
The effect of self-monitoring of blood glucose
concentrations on glycated hemoglobin levels in
diabetic patients not taking insulin: a blinded,
randomized trial. Am J Med 2005;118:422-5.
9. Davidson MB. Counterpoint: self-monitoring of
blood glucose in type 2 diabetic patients not
receiving insulin: a waste of money. Diabetes Care
2005;28:1531-3.
10. Cameron C, Coyle D, Ur E, Klarenbach S. Cost-
effectiveness of self-monitoring of blood glucose in
patients with type 2 diabetes mellitus managed
without insulin. CMAJ 2010;182:28-34.
11. OKane MJ , Bunting B, Copeland M, Coates VE, 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;336:1174-7.
12. American Association of Diabetes Educators.
AADE position statement. The American
Association of Diabetes Educators position
statement: self-monitoring of blood glucose. 2010.
www.diabeteseducator.org. (Accessed November
8, 2012).
13. Ipp E, Aquino RL, Christenson P. Point: self-
monitoring of blood glucose in type 2 diabetic
patients not receiving insulin: the sanguine
approach. Diabetes Care 2005;28:1528-30.
14. Bergenstal RM, Gavin J R 3rd. The role of self-
monitoring of blood glucose in the care of people
with diabetes: report of a global consensus
conference. Am J Med 2005;118 (Suppl 9A):1S-
6S.
15. Anon. Self-monitoring of blood glucose in type 2
diabetes (T2DM). August 2012.
http://www.rxfiles.ca/rxfiles/uploads/documents/CH
T-Diabetes-SMBG.pdf. (Accessed November 9,
2012).
(PL Detail-Document #281208: Page 4 of 4)

Levels of Evidence
In accordance with the trend towards Evidence-Based
Medicine, we are citing the LEVEL OF EVIDENCE
for the statements we publish.
Level Definition
A High-quality randomized controlled trial (RCT)
High-quality meta-analysis (quantitative
systematic review)
B Nonrandomized clinical trial
Nonquantitative systematic review
Lower quality RCT
Clinical cohort study
Case-control study
Historical control
Epidemiologic study
C Consensus
Expert opinion
D Anecdotal evidence
In vitro or animal study
Adapted from Siwek J , et al. How to write an evidence-based
clinical review article. Am Fam Physician 2002;65:251-8.

















Cite this document as follows: PL Detail-Document, Self-Monitoring of Blood Glucose in Patients with Type 2
Diabetes. Pharmacists Letter/Prescribers Letter. December 2012.


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Copyright 2012 by Therapeutic Research Center

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