Page 14 - Glucose Monitoring Devices

The evidence base for SMBG in type 2 diabetes 9

care alone. In the study, 453 participants with mean baseline HbA1c levels of 7.5%
and median duration of diabetes of 3 years were randomized to one of three inter-
ventions: no SMBG, SMBG standardized with advice to contact their doctor for
interpretation of results, and SMBG that involved additional training of participants
in interpretation and application of the results into self-care. The differences in
HbA1c levels between the three groups were not significant at 12 months. Investiga-
tors concluded that SMBG has little effect on glycemic control in people with stable,
near-target metabolic control. In an economic evaluation of the DiGEM study [75],
SMBG was significantly more expensive than standardized usual care for
noninsulin-treated T2D. As there were no significant differences in HbA1c, the anal-
ysis implied that SMBG is unlikely to be cost-effective if added to standardized
usual care in insulin-independent T2D. The efficacy of SMBG in patients with newly
diagnosed T2D was assessed in the ESMON study [76]; the prospective randomized
controlled trial assessed the effect of SMBG on glycemic control and psychological
indices in 184 individuals with newly diagnosed T2D over 12 months. Subjects were
recruited soon after the diagnosis of T2D and randomized to SMBG or non-SMBG
(control) group. Intensive education and treatment resulted in a decrease of mean
HbA1c levels after 12 months in both groups; however, there were no significant dif-
ferences in HbA1c between groups at any time point. Moreover, SMBG was asso-
ciated with a 6% higher score on the depression subscale of the well-being
questionnaire. In the Monitor Trial [77]da pragmatic randomized controlled trial
conducted in 15 primary care practicesd450 participants with noninsulin-treated
T2D and HbA1c between 6.5% and 9.5% were randomized to one of three interven-
tions: no SMBG, once-daily SMBG, or once-daily SMBG with enhanced patient
feedback that featured automatic tailored messages delivered via the meter. At base-
line, >85% of study participants had been receiving care for diabetes for >1 year
and the mean HbA1c level was about 7.5%. After a year of follow-up, no significant
differences in HbA1c levels among the three groups were reported. In addition, there
were no significant differences between the study groups in terms of health-related
quality of life and adverse events such as hypoglycemia frequency, nor was there any
difference in insulin initiation. The authors concluded that routine SMBG does not
significantly improve HbA1c levels or quality of life for most individuals with
noninsulin-treated T2D. However, the trial evaluated once-daily SMBG, which
may not provide sufficient information about daily glucose excursions.
Many trials looking at the clinical effectiveness of SMBG in noninsulin-treated
people with T2D did not include structured SMBG regimens. Structured SMBG is a
systematic approach in which SMBG is performed periodically, according to
a defined regimen, such as before and after meals or exercise. Blood glucose values
provide feedback to make appropriate treatment decisions and lifestyle adjustments
[78]. Randomized controlled trials that have utilized structured SMBG as an inter-
vention reported greater HbA1c reduction compared with programs without struc-
tured SMBG. The Structured Testing Program study [79] was a randomized
prospective trial that evaluated the efficacy of two strategies of SMBG in persons
with noninsulin-treated T2D in a primary care setting. In the study, 483 poorly