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. 2013 Nov 1;7(6):1575–1584. doi: 10.1177/193229681300700618

Table 1.

Summary of Clinical Studies Assessing Pattern Management

First author Number of study participants, study duration Comparators Main outcomes
Polonsky16
  • 483 poorly controlled insulin naive T2DM (from 34 U.S. practices)

  • Study duration: 12 months

Cluster randomized to structured testing using a paper tool and seven-point testing + education or active control receiving routine care (ACG)
  • Significant reduction in HbA1c in both groups, but effect was larger in the STG (-1.2 ± 0.09% versus -0.9 ± 0.10% in insulin tolerance test analysis; -1.3 ± 0.11% versus -0.8 ± 0.11% in per protocol analysis)

  • STG: significant reductions in seven-point SMBG profile, more treatment change recommendations, greater general wellbeing

Polonsky26
  • 483 poorly controlled insulin naive T2DM (from 34 U.S. practices)

  • Study duration: 12 months

Cluster randomized to structured testing (STG) using a paper tool and seven-point testing + education or active control receiving routine care (ACG)
  • Greater treatment modifications in the STG

  • Greater reduction in HbA1c in the STG versus ACG (-1.2% versus -0.9%)

  • Two times more patients started on insulin in the STG

Polonsky27 36 primary care professionals and 25 internists
  • Evaluation of clinician ability to identify patterns

  • Analysis of case studies of patients with T2DM reviewing HbA1c and episodic SMBG to identify patterns and evaluate decision making

  • 78% of primary care professionals correctly identified glucose patterns

  • 53% of primary care professionals found SMBG data of equal value than that of HbA1c, and 33% found them of greater value

  • Three-day, seven-point glucose profile and standard log book most favorable formats (78.7%)

Lalic28
  • 266 individuals with T1DM or T2DM with baseline HbA1c >8.0%; 38 individuals had a baseline HbA1c <8.0%

  • Study duration: 3 months

Structured glucose monitoring and lifestyle adjustments: seven-point SMBG profile on three consecutive days prior to baseline and months 1, 2, and 3; routine BG test (>1 test per day); use of Accu-Chek 360o
  • Significant reduction in mean HbA1c (-1.2 ± 1.6%; p < .001)

  • Significant reduction in mean BG (-36.4 ± 52.5 mg/dl; p < .001)

  • Significant changes in seven-point BG values, lipid parameters, and blood pressure

  • Significant diference between T1DM and T2DM individuals in changes in weight, body mass index, and blood pressure but not in HbA1c reduction

  • Accu-Chek 360o acceptance was high among participants (>80%) and HCPs (87.5%)

Rodbard29 288 clinicians: 40% family physicians, 38% internists, and 22% nurse practitioners Review of 30 cases with either: structured SMBG data, structured SMBG with decision support tool, structured SMBG with DVD, or structured SMBG with decision support tool + DVD
  • More clinicians correctly identified the pattern and glucose abnormality and selected the appropriate therapeutic option with the decision support tool + DVD or both than in the control group

Cox30
  • 100 individuals with T1DM and 79 with T2DM

  • Duration: 6 months (for participants with T1DM

Retrospective evaluation of SMBG data to look for prediction of severe hypoglycemia events
  • Severe hypoglycemia associated with increase in low BG index in 24 h prior to severe hypoglycemia in both participants with T1DM and T2DM

  • Algorithm predicted 58-60% of imminent episodes of severe hypoglycemia; this increased if five readings per day were present

Kempf31
  • 327 individuals with T1DM_

  • Study duration: 12 weeks

SMBG + lifestyle intervention: seven-point SMBG profile at baseline and at weeks 4, 8, and 12; healthy diet and physical activity; make changes to lifestyle based on SMBG results
  • Significant reduction in weight (-2.3 kg; p < .001) and HbA1c (-0.3%; p < .001)

  • Significant improvement in cardiovascular disease risk factors

  • Significant increase in quality of diet, physical activity, general wellbeing, and physical and mental health

  • Correlation between weight reduction and change in HbA1c: each kilogram of weight loss associated with a mean HbA1c reduction of 0.05%

Hansen32 1076 individuals with T1DM
  • Retrospective evaluation of SMBG data

  • Adherence, and characteristics associated with adherence, to SMBG

  • Questionnaire included SMBG frequency, motives for performing SMBG, hypoglycemia experience and awareness, demography, lifestyle

  • Suboptimal adherence to SMBG: 3% did not perform SMBG at all, 33% did not perform routine tests, 61% did not do the test on a daily basis

  • Association between higher test frequency and age, insulin regimen, lower HbA1c, and hypoglycemia awareness