Page 13 - Glucose Monitoring Devices

8 CHAPTER 1 Introduction to SMBG

for 3.5e5.6 years [63e65] and ACCORD was halted due to the increased rate of
mortality in the intensive glycemic control group [66]. Thus ADA’s Standards of
Medical Care in Diabetes emphasize individualization of blood glucose and glyce-
mic targets, suggesting that less stringent goals may be appropriate for some individ-
uals with T2D [67]. Two observational studies investigated the association of SMBG
with clinical outcomes. Data from the Fremantle Diabetes Study showed no inde-
pendent cross-sectional relationship between HbA1c and SMBG frequency
regardless of treatment [68]. In addition, assessment of longitudinal data over a
5-year period revealed that SMBG was not independently associated with improved
survival and, after adjustment, cardiac mortality was even higher in SMBG users not
treated with insulin [69]. On the other hand, the Self-monitoring of Blood Glucose
and Outcome in Patients with Type 2 Diabetes (ROSSO) study, which followed
participant from diagnosis of T2D with a mean follow-up period of 6.5 years,
reported a lower total rate of nonfatal (micro- and macrovascular) as well as fatal
events in the SMBG group in comparison with the non-SMBG group [70]. In the
large observational Kaiser Permanente study, SMBG performed at least daily was
associated with lower HbA1c levels among individuals with pharmacologically
treated T2D compared to less frequent monitoring. In nonpharmacologically treated
participants, SMBG at any frequency was associated with lower HbA1c compared to
no SMBG [49]. A longitudinal study with a 4-year follow-up found evidence for
improvements in HbA1c with more frequent monitoring in new SMBG users regard-
less of diabetes therapy and among pharmacologically treated prevalent users [71].
In an observational retrospective study of 657 individuals with T2D, targeted HbA1c
values of <7% were associated with greater use of SMBG test strips in the
noninsulin-treated group. Of interest, there were no significant differences in the
insulin-treated group [72]. Data from the DPV database showed that more frequent
SMBG was associated with HbA1c reduction of 0.16% for one additional SMBG per
day in individuals with T2D treated with insulin, while no benefit on metabolic
control was observed in those not treated with insulin [51]. In a cross-sectional study
of 1480 participants with T2D, increased frequency of SMBG was related to
increased HbA1c and a higher proportion of insulin users. However, within each
treatment category, there was no relationship between the frequency of SMBG
and HbA1c for those treated with insulin, oral agents, or diet alone [73].
Although SMBG has been found to be effective in the management of T1D and
insulin-treated T2D, the clinical benefits of SMBG have been debated for nearly
75% of people living with T2D, who are not using insulin and manage their disease
with lifestyle modification and oral medications. Several randomized trials and
meta-analyses have been conducted to evaluate the clinical benefit and cost-
effectiveness of routine SMBG in noninsulin-treated people with T2D. The effect
of SMBG in noninsulin-treated T2D has not been consistent in randomized control
trials, and many studies have found no clinically relevant effect of SMBG on glyce-
mic control. The Diabetes Glycemic Education and Monitoring (DiGEM) random-
ized controlled trial [74] assessed the effectiveness of two strategies of SMBG in
improving glycemic control in noninsulin-treated individuals with T2D versus usual