Table 3.
Summary of Studies of Structured Self-Monitoring of Blood Glucose in Diabetes (Adapted from Parkin et al.13)
| Study | Study design | Intervention | Key results |
|---|---|---|---|
| Schwedes et al.37 | • Randomized • Standardized lifestyle program including SMBG versus nonstandardized program without SMBG • Non–insulin-treated T2DM (n=250) • Baseline HbA1c 8.4–8.5% (68–69 mmol/mol) • 6-month duration (+6 months follow-up) |
Experimental arm: • Blood glucose/eating diary, standardized counseling, provided with SMBG device • 6-point glucose profiles 2 times per week Control arm: • Nonstandardized counseling on diet and lifestyle |
• Significantly greater reduction in HbA1c (−1.0 vs. −0.5% [−11 vs. −6 mmol/mol]; P<0.01) • Marked improvement of general well-being, with significant improvements in the subitems Depression (P=0.032) and Lack of well-being (P=0.02) |
| Bonomo et al.59 | • Randomized • Simple SMBG program versus more intensive SMBG • Non–insulin-treated T2DM (n=273) • Baseline HbA1c 8.0–8.1% (64–65 mmol/mol) • 6-month duration |
• All subjects encouraged to increase diet/exercise compliance when fasting and/or postprandial glucose targets not reached • Treatment adjustments based on SMBG Experimental arm: • 4-point glucose profiles every 2 weeks Control arm: • 4-point glucose profiles monthly |
• Significant HbA1c reductions in compliant experimental subjects • Compliance significantly less in the experimental group (44% vs. 73%) |
| Durán et al.60 | • Randomized • SMBG-based educational/pharmacological intervention versus HbA1c-based treatment algorithm • Newly diagnosed T2DM (n=161) • Baseline HbA1c 6.6% (49 mmol/mol) • 12-month duration |
• All patients instructed in lifestyle interventions Experimental arm: • 6-point glucose profiles every 3 days • Treatment adjustments based on SMBG Control arm: • SMBG started when deemed appropriate—always with insulin treatment • Treatment adjustments based on HbA1c |
• Significantly higher rates of regression and remission in experimental subjects • Significantly greater reductions in median HbA1c and BMI in experimental subjects • Significantly more experimental subjects achieved lifestyle score of >12 • Treatment changes occurred earlier and more frequently in experimental subjects. |
| Kleefstra et al.61 | • Randomized • Structured SMBG added to usual care versus usual care alone • Non–insulin-treated T2DM (n=41) • Baseline HbA1c 7.5–7.6% (59–60 mmol/mol) • 12-month duration |
Experimental arm: • 4-point glucose profiles 2 times per week • Blood glucose diary • Extra measurement in cases of high/low glucose, with action if abnormal measures persist Control arm: • No SMBG |
• No significant differences in HbA1c, HRQoL, or treatment satisfaction • Significant worsening of health perception (SF-36 dimension "health change") in SMBG arm |
| Kempf et al.62 | • Interventional • Evaluated impact of SMBG-structured intervention on glucometabolic and health parameters • Non–insulin-treated T2DM (n=405) • Baseline HbA1c 6.7% (50 mmol/mol) • 12-week duration |
• 7-point glucose profiles every 4 weeks • Patients received tape measure, step counter, and manual that provides guidance for diet and exercise adjustments based on SMBG |
• Significant reductions in HbA1c, weight, BMI, systolic BP, diastolic BP, and LDL-cholesterol |
| Mohan et al.98 | • Randomized • Determined effect of treatment based on preprandial and postprandial SMBG on progression of CIMT and HbA1c change • Non–insulin-treated T2DM (n=200) • Baseline HbA1c 7.2–7.3% (55–56 mmol/mol) • 18-month duration |
• All patients instructed in meal planning, but no specific instructions for addressing elevated fasting or postprandial glucose Study Arm 1 (FP): • 3 fasting glucose measurements per week • Instructions for adjusting medication based on SMBG Study Arm 2 (PP): • 3 postprandial glucose measurements per week • Instructions for adjusting medication based on SMBG |
• Significant reductions in CIMT and HbA1c in PP but not FP subjects • Significant improvements in BMI, waist circumference, systolic BP, and serum cholesterol in PP subjects but not FP subjects |
| Shiraiwa et al.63 | • Randomized • Determined effect of occasional postprandial SMBG on glycemic control • Non–insulin-treated T2DM (n=71) • Baseline HbA1c 6.7% (50 mmol/mol) • 4-month duration |
Experimental arm: • 10 postprandial glucose measurements per month • Recorded eating and exercise habits Control • No SMBG |
• Significant reductions in HbA1c (P=0.028) and body weight (P<0.01) in experimental subjects versus control subjects • 94% of experimental subjects reported making lifestyle changes • No medication changes made in either study group |
| Franciosi et al.64 | • Randomized • Assessed the efficacy of SMBG-based disease management strategy • T2DM treated with OAs (n=62) • Baseline HbA1c 7.9% (63 mmol/mol) • 6-month duration |
Experimental: • ‘‘Staggered’’ SMBG regimen • Instructed in lifestyle interventions based on SMBG • Treatment adjustments based on SMBG Control: • Standard instruction in diet/exercise • No SMBG • Treatment adjustments based on HbA1c |
• Significantly greater reduction in HbA1c (−1.2% vs. −0.7% [−13 vs. −8 mmol/mol]; P=0.04) |
| Khamseh et al.65 | • Interventional • Evaluate the effect of structured SMBG on patient self-management behavior and metabolic outcomes • T2DM (n=30) • Baseline HbA1c 8.4% (68 mmol/mol) • 3-month duration |
• 7-point glucose profiles over 3 consecutive days per month • Education on device use and data collection using a paper tool • Basic core education to use SMBG to alter diet and physical activity |
• Significant reductions in HbA1c and mean, fasting, and postprandial glucose (all subjects combined) • Significant reductions in HbA1c and mean and postprandial glucose in poorly controlled subjects (HbA1c ≥8% [64 mmol/mol] at baseline) • No significant metabolic improvements in subjects with relatively good control at baseline (HbA1c <8%) |
| Kato and Kato66 | • Randomized • Determined effect of structured SMBG versus routine SMBG • T1DM and insulin-treated T2DM (n=86) • Baseline HbA1c 7.9% (63 mmol/mol) • 6-month duration |
Experimental arm: • 7-point glucose profiles over 3 consecutive days per month • Treatment adjustments made by clinicians based on SMBG Control arm: • Usual "random" SMBG • Treatment adjustments made by clinicians based on SMBG |
• Significant reductions in HbA1c in experimental subjects versus control subjects |
| Polonsky et al.67 | • Randomized • Assessed impact of structured SMBG intervention on glycemic control • Non–insulin-treated T2DM (n=483) • Baseline HbA1c 8.9% (74 mmol/mol) • 12-month duration |
Experimental arm: • 7-point glucose profiles over 3 consecutive days, every 3 months • Instructed in lifestyle interventions based on SMBG • Treatment adjustments based on SMBG and/or HbA1c Control arm: • Usual care |
• Significantly greater improvement in mean HbA1c, glucose levels at all preprandial and postprandial time points, and MAGE in experimental subjects • Treatment changes occurred earlier and more frequently in experimental subjects. |
BMI, body mass index; BP, blood pressure; CIMT, carotid intimal-medial thickness; HRQoL, health-related quality of life; LDL, low-density lipoprotein; MAGE, mean amplitude of glycemic excursions; OA, oral (glucose-lowering) agent; SF-36, 36-item Short Form; SMBG, self-monitoring of blood glucose; T1DM/T2DM, (type 1/type 2) diabetes mellitus.