BACKGROUND: We evaluated intensive intervention in poorly controlled patients with type 2 diabetes mellitus involving weekly clinic visits and adjustment of therapy with analysis of three seven-point glucose profiles and intervention from an interdisciplinary staff. METHODS:Sixty-three patients were randomized to an intensive treatment group that obtained self-monitoring of blood glucose (SMBG) profiles (six or seven values per day, 3 days/week) and were seen in the clinic at Weeks 1-6 and 12. SMBG results were downloaded, analyzed using Accu-Chek(®) 360° software (Roche Diagnostics, Indianapolis, IN), and used to adjust therapy. Control group subjects obtained glucose profiles and had clinic visits only at Weeks 0, 6, and 12. RESULTS: There were highly statistically significant improvements in the intensive treatment group compared with the control group between Weeks 0 and 6 with greater reductions in weekly mean glycemia (WMG) (-76.7±8.9 mg/dL vs. -20.5±8.1 mg/dL), glycemic variability (SD) (-16.3±3.1 mg/dL vs. -5.0±3.1 mg/dL), and glycated hemoglobin (-1.82±0.16% vs. -0.66±0.22%) without significant changes in frequency of hypoglycemia or weight. Improvements were sustained in the intensive treatment group through Week 12. A minimal but statistically significant degree of improvement was seen in the control group at Week 12. CONCLUSIONS: This short-term pilot study of an intensive monitoring, educational, and pharmacological interventions program resulted in dramatic improvement of glycemic control within 6 weeks, and these effects are sustained through Week 12. SMBG glucose profiles, calculation of WMG and SD, and graphical displays of glucose data can improve the effectiveness of adjustment of therapy at weekly clinic visits when combined with intensive support from a multidisciplinary team.
RCT Entities:
BACKGROUND: We evaluated intensive intervention in poorly controlled patients with type 2 diabetes mellitus involving weekly clinic visits and adjustment of therapy with analysis of three seven-point glucose profiles and intervention from an interdisciplinary staff. METHODS: Sixty-three patients were randomized to an intensive treatment group that obtained self-monitoring of blood glucose (SMBG) profiles (six or seven values per day, 3 days/week) and were seen in the clinic at Weeks 1-6 and 12. SMBG results were downloaded, analyzed using Accu-Chek(®) 360° software (Roche Diagnostics, Indianapolis, IN), and used to adjust therapy. Control group subjects obtained glucose profiles and had clinic visits only at Weeks 0, 6, and 12. RESULTS: There were highly statistically significant improvements in the intensive treatment group compared with the control group between Weeks 0 and 6 with greater reductions in weekly mean glycemia (WMG) (-76.7±8.9 mg/dL vs. -20.5±8.1 mg/dL), glycemic variability (SD) (-16.3±3.1 mg/dL vs. -5.0±3.1 mg/dL), and glycated hemoglobin (-1.82±0.16% vs. -0.66±0.22%) without significant changes in frequency of hypoglycemia or weight. Improvements were sustained in the intensive treatment group through Week 12. A minimal but statistically significant degree of improvement was seen in the control group at Week 12. CONCLUSIONS: This short-term pilot study of an intensive monitoring, educational, and pharmacological interventions program resulted in dramatic improvement of glycemic control within 6 weeks, and these effects are sustained through Week 12. SMBG glucose profiles, calculation of WMG and SD, and graphical displays of glucose data can improve the effectiveness of adjustment of therapy at weekly clinic visits when combined with intensive support from a multidisciplinary team.
Authors: Peter Gaede; Pernille Vedel; Nicolai Larsen; Gunnar V H Jensen; Hans-Henrik Parving; Oluf Pedersen Journal: N Engl J Med Date: 2003-01-30 Impact factor: 91.245
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