C Maier1, D Mustapic, E Schuster, A Luger, R Eher. 1. Department of Medicine III, Clinical Division of Endocrinology and Metabolism, Medical University of Vienna, Austria. christina.maier@meduniwien.ac.at
Abstract
AIM: To evaluate whether a pocket-size tablet-dispensing device would improve adherence to therapy as judged by reduction of HbA(1c) levels in a large population of Type 2 diabetic patients. METHODS: The study design was prospective, randomized, open label with two parallel groups. Patients (2296) were recruited from general practitioners and internists and randomized to either receive a tablet dispenser (TD) or no intervention (control group, CO). Patients' characteristics and current oral therapy (including dosage) were recorded at baseline. HbA(1c) was compared between groups at baseline and after 6 months' intervention. RESULTS: Data were available in 2081 patients. Baseline characterisitcs, including age, body mass index (BMI), blood pressure and gender distribution were comparable between the two groups, as was HbA(1c)[7.9 (7.9-8.0), TD vs. 8.0 (7.9-8.0)%, CO, means (95% CI)]. After 6 months, HbA(1c) improved in both groups, but improvement was significantly greater in TD than in controls [-0.74 (0.67-0.80) vs. -0.53 (0.47-0.59)%, P < 0.0001]. Possession of a dispenser remained an independent predictor of improved control in a multiple regression model. In the subgroup analysis, the effect was significantly more pronounced (i) in patients receiving more medications and (ii) more diabetes medications per day (iii) in younger patients. CONCLUSION: In this large study population in a 'realistic' setting, a simple tablet-dispensing device led to a significant and clinically relevant improvement in HbA(1c) levels. Because patients with a more complex therapy regimen benefited more, we suggest that TD might have improved adherence to therapy.
RCT Entities:
AIM: To evaluate whether a pocket-size tablet-dispensing device would improve adherence to therapy as judged by reduction of HbA(1c) levels in a large population of Type 2 diabeticpatients. METHODS: The study design was prospective, randomized, open label with two parallel groups. Patients (2296) were recruited from general practitioners and internists and randomized to either receive a tablet dispenser (TD) or no intervention (control group, CO). Patients' characteristics and current oral therapy (including dosage) were recorded at baseline. HbA(1c) was compared between groups at baseline and after 6 months' intervention. RESULTS: Data were available in 2081 patients. Baseline characterisitcs, including age, body mass index (BMI), blood pressure and gender distribution were comparable between the two groups, as was HbA(1c)[7.9 (7.9-8.0), TD vs. 8.0 (7.9-8.0)%, CO, means (95% CI)]. After 6 months, HbA(1c) improved in both groups, but improvement was significantly greater in TD than in controls [-0.74 (0.67-0.80) vs. -0.53 (0.47-0.59)%, P < 0.0001]. Possession of a dispenser remained an independent predictor of improved control in a multiple regression model. In the subgroup analysis, the effect was significantly more pronounced (i) in patients receiving more medications and (ii) more diabetes medications per day (iii) in younger patients. CONCLUSION: In this large study population in a 'realistic' setting, a simple tablet-dispensing device led to a significant and clinically relevant improvement in HbA(1c) levels. Because patients with a more complex therapy regimen benefited more, we suggest that TD might have improved adherence to therapy.