Glucose Self-Monitoring in
Non-Insulin Treated Patients
with Type 2 Diabetes Does Not
Improve Glycemic Control
JAMA Internal Medicine
Take-home message
•
Patients with non–insulin treated
type 2 diabetes managed in pri-
mary care were randomized to no
self-monitoring of blood glucose
(SMBG), once-daily SMBG, or once-
daily SMBG with enhanced patient
feedback; the goal was to evaluate
the impact of SMBG on HbA1c levels
and health-related quality of life
(HRQOL). After 52 weeks, the HbA1c
level was not significantly different
among the three groups. HRQOL
was also similar in all three, as was
the rate of key adverse events.
•
Patients with non–insulin treated
type 2 diabetes receive no benefit
from SMBG.
Abstract
IMPORTANCE
The value of self-monitoring of blood
glucose (SMBG) levels in patients with non-insu-
lin-treated type 2 diabetes has been debated.
OBJECTIVE
To compare 3 approaches of SMBG
for effects on hemoglobin A1c levels and
health-related quality of life (HRQOL) among
people with non-insulin-treated type 2 diabe-
tes in primary care practice.
DESIGN, SETTING, AND PARTICIPANTS
The Mon-
itor Trial study was a pragmatic, open-label
randomized trial conducted in 15 primary care
practices in central North Carolina. Participants
were randomized between January 2014 and
July 2015. Eligible patients with type 2 non-insu-
lin-treated diabetes were: older than 30 years,
established with a primary care physician at
a participating practice, had glycemic control
(hemoglobin A1c) levels higher than 6.5% but
lower than 9.5% within the 6 months preced-
ing screening, as obtained from the electronic
medical record, and willing to comply with the
results of random assignment into a study group.
Of the 1032 assessed for eligibility, 450 were
randomized.
INTERVENTIONS
No SMBG, once-daily SMBG, and
once-daily SMBG with enhanced patient feed-
back including automatic tailored messages
delivered via the meter.
MAIN OUTCOMES AND MEASURES
Coprimary out-
comes included hemoglobin A1c levels and
HRQOL at 52 weeks.
RESULTS
A total of 450 patients were randomized
and 418 (92.9%) completed the final visit. There
were no significant differences in hemoglobin
A1c levels across all 3 groups (P=.74; estimated
adjustedmean hemoglobin A1c difference, SMBG
with messaging vs no SMBG, -0.09%; 95% CI,
-0.31% to 0.14%; SMBG vs no SMBG, -0.05%; 95%
CI, -0.27% to 0.17%). There were also no signifi-
cant differences found in HRQOL. There were
no notable differences in key adverse events
including hypoglycemia frequency, health care
utilization, or insulin initiation.
CONCLUSIONS AND RELEVANCE
In patients with
non-insulin-treated type 2 diabetes, we observed
no clinically or statistically significant differences
at 1 year in glycemic control or HRQOL between
patients who performed SMBG compared with
those who did not perform SMBG. The addi-
tion of this type of tailored feedback provided
through messaging via a meter did not provide
any advantage in glycemic control.
Glucose self-monitoring in non-insulin-treated
patients with type 2 diabetes in primary care
settings: a randomized trial.
JAMA Intern Med
2017 Jun 10;[EPub Ahead of Print], LA Young, JB
Buse, MA Weaver, et al.
www.practiceupdate.com/c/54625COMMENT
By Deborah Wexler
MD
I
n this pragmatic randomized controlled
trial conducted in 15 primary care
practices, 450 patients with non–
insulin treated diabetes and A1c 6.5%
to 9.5% were randomly assigned to
no self-monitoring of blood glucose
(SMBG), once-daily SMBG, or once-
daily self-monitoring of blood glucose
with enhanced patient feedback, which
consisted of tailored messages delivered
via the glucose meter. Most patients were
treated with metformin and sulfonylurea,
and over 90% of the patients had used
SMBG in the past. Mean baseline A1c was
roughly 7.5%. There was no change in
glycemic control or health-related quality
of life after 1 year of follow-up. There
was a very modest difference between
the testing arms and the no-testing arm
of 0.33% favoring the testing arm at 6
months. Rates of daily testing decreased
over time in both testing groups.
An important study to review in
comparison with Young et al is a 1-year
evaluation of structured self-monitoring
of blood glucose.
1
In the Polonsky study,
483 patients with poorly controlled
non–insulin treated type 2 diabetes
were randomly assigned to enhanced
usual care vs enhanced usual care plus
structured SMBG. The structured testing
arm participants performed 7-point SMBG
profiles on 3 days prior to each scheduled
study visit, recording medications,
food, and activity in relation to SMBG.
Importantly, providers were trained to
interpret the structured SMBG profiles
and were provided with an algorithm
of potential treatment strategies to use
depending on the pattern identified.
Baseline mean A1c was 8.9%. In the
Polonsky study, both treatment arms
improved over time, with 12-month A1c
results favoring the structured testing
group by 0.3% in the intention-to-treat
analysis and 0.5% in the per-protocol
analysis. Participants in the structured
testing group had more medication
changes made at their study visits.
Taking into account the balance of the
evidence, routine daily SMBG in patients
with non–insulin treated, reasonably well-
controlled type 2 diabetes is probably a
low-value activity on a population level.
However, patients with less–well controlled
type 2 diabetes, or those who are using the
information in a targeted fashion to gain
behavioral insight or to make treatment
decisions, probably do derive modest
benefit in terms of overall glycemic control,
especially when their care providers review
and act on the information.
Reference
1. Polonsky WH, Fisher L, Schikman CH, et al.
Structured self-monitoring of blood glucose
significantly reduces A1C levels in poorly
controlled, noninsulin-treated type 2 diabetes:
results from the Structured Testing Program
study.
Diabetes Care
2011;34(2):262-267.
Dr Wexler is Associate
Professor of Medicine at
Harvard Medical School,
Boston, Massachusetts, the
Associate Clinical Chief of
the MGH Diabetes Unit, and
Co-Clinical Director of the
MGH Diabetes Center.
DIABETES
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VOL. 1 • NO. 2 • 2017