Page 15 - Glucose Monitoring Devices

10 CHAPTER 1 Introduction to SMBG

controlled (mean HbA1c 8.9%) participants with noninsulin-treated T2D were
assigned to a structured testing group or an active control group. Both groups
received enhanced usual care. In addition, the structured testing group was
instructed to perform a seven-point SMBG profile on three consecutive days before
each scheduled study visit using the ACCU-CHEK 360 degrees View tool.
Structured SMBG data were at least quarterly interpreted and used for treatment
modifications. At 1 year, the intervention SMBG group showed a significantly
greater mean reduction in HbA1c. Furthermore, participants actively adherent to
the structured SMBG protocol experienced significantly greater improvements in
reported diabetes self-confidence and increases in general well-being with respect
to patients receiving enhanced usual care [80]. In the Role of Self-Monitoring of
Blood Glucose and Intensive Education in Patients with Type 2 Diabetes Not
Receiving Insulin (ROSES) trial [81], 62 participants were randomly assigned to
either SMBG with intensive education or no monitoring with usual care. The partic-
ipants in the intervention group received education on how to adjust nutrition and
physical activity according to SMBG readings. Participants received counseling
during additional monthly telephone contact. After 6 months, HbA1c reduction
was significantly greater in the intervention group compared with the control group
with a significant mean difference of 0.5%. Additionally, significantly greater reduc-
tions were observed in weight loss. In the prospective randomized trial, St. Carlos
study [82], 161 newly diagnosed T2D participants were assigned to either an
SMBG-based intervention or an HbA1c-based control group. The intervention group
used SMBG as an educational and therapeutic tool to promote lifestyle changes and
adjust pharmacological treatment. The control group received standard treatment
based on HbA1c values without SMBG. After 1 year of follow-up, the SMBG inter-
vention group showed a significant reduction in median HbA1c level and body mass
index (BMI). There was no change in median HbA1c or BMI in the control group.
The 12-month Prospective Randomized Trial on Intensive SMBG Management
Added Value in Noninsulin-Treated T2DM Patients study enrolled 1024 participants
with noninsulin-treated T2D with median baseline HbA1c of 7.3% [83]. The inter-
vention group performed structured monitoring with four-point SMBG profiles
3 days per week. The active control group performed four-point SMBG profiles at
baseline and at 6 and 12 months. At 1 year, the intervention SMBG group had a
greater HbA1c reduction compared to the control group with a between-group
difference of 0.12%. In the per-protocol population, consisting of all randomized
patients who completed the study without major protocol violations and were
compliant with the SMBG regimen, the between-group difference was 0.21%.
This study demonstrated that structured SMBG improved glycemic control in indi-
viduals with relatively well-controlled noninsulin-treated T2D. Furthermore,
psychosocial data analysis demonstrated that structured SMBG was not associated
with a deterioration of quality of life [84]. In a randomized controlled trial of 446
participants with established T2D not on insulin therapy and suboptimal glycemic
control (HbA1c 7.5%), the use of structured SMBG alone or with additional
monthly telecare support was compared to a control group receiving usual diabetes