Cintia Gonzalez1,2, María José Picón3, Monica Tomé3, Isabel Pujol1, Jose Carlos Fernández-García3, Ana Chico1,2. 1. 1 Endocrinology and Nutrition Department, Hospital Santa Creu i Sant Pau , Barcelona, Spain . 2. 2 Biomedical Research Networking Center in Bioengineering, Biomaterials and Nanomedicine, Autonomous University of Barcelona , Barcelona, Spain . 3. 3 Department of Endocrinology and Nutrition, Hospital Virgen de la Victoria, Hospital Complex of Málaga , Málaga, Spain .
Abstract
OBJECTIVE: This study was designed to assess the impact of the use of an automated bolus advisor (ABA) on glycemic control, quality of life, and satisfaction in adult patients with type 1 diabetes mellitus treated with multiple daily injections of insulin. MATERIALS AND METHODS: A crossover, prospective, randomized, controlled, multicenter study of 36 weeks duration was conducted. Patients were randomized to start in either control phase (CP) using a traditional blood glucose meter to calculate insulin doses (Accu-Chek(®) Aviva Nano; Roche Diagnostics, Indianapolis, IN) or intervention phase (IP) using an ABA meter (Accu-Chek Aviva Expert; Roche Diagnostics) and switched to the other phase after a washout period. Each phase was 12 weeks in duration. RESULTS:Significant glycated hemoglobin (HbA1c) reduction was observed in both phases (CP, initial HbA1c of 8.05 ± 0.7%, final HbA1c of 7.59 ± 0.7% [P < 0.001]; IP, initial HbA1c of 8.13 ± 1%, final HbA1c of 7.61 ± 0.8% [P < 0.001]). Although the trend was to a higher HbA1c reduction in IP, no statistically significant differences were observed between phases (CP, HbA1c -0.39%; IP, HbA1c -0.52% [P = 0.8]). During IP, the number of daily glucose measurements was greater (4.28 ± 1.2 vs. 4.01 ± 1.1 [P < 0.006]), the rate of postprandial hypoglycemia was lower, and an improvement in quality of life and higher satisfaction were observed. CONCLUSIONS: In this first crossover study comparing the use of an ABA with the standard usual care, the use of an ABA was effective and well accepted. Furthermore, reduction in hypoglycemic events, improvement in adherence and quality of life, and higher treatment satisfaction were observed.
RCT Entities:
OBJECTIVE: This study was designed to assess the impact of the use of an automated bolus advisor (ABA) on glycemic control, quality of life, and satisfaction in adult patients with type 1 diabetes mellitus treated with multiple daily injections of insulin. MATERIALS AND METHODS: A crossover, prospective, randomized, controlled, multicenter study of 36 weeks duration was conducted. Patients were randomized to start in either control phase (CP) using a traditional blood glucose meter to calculate insulin doses (Accu-Chek(®) Aviva Nano; Roche Diagnostics, Indianapolis, IN) or intervention phase (IP) using an ABA meter (Accu-Chek Aviva Expert; Roche Diagnostics) and switched to the other phase after a washout period. Each phase was 12 weeks in duration. RESULTS: Significant glycated hemoglobin (HbA1c) reduction was observed in both phases (CP, initial HbA1c of 8.05 ± 0.7%, final HbA1c of 7.59 ± 0.7% [P < 0.001]; IP, initial HbA1c of 8.13 ± 1%, final HbA1c of 7.61 ± 0.8% [P < 0.001]). Although the trend was to a higher HbA1c reduction in IP, no statistically significant differences were observed between phases (CP, HbA1c -0.39%; IP, HbA1c -0.52% [P = 0.8]). During IP, the number of daily glucose measurements was greater (4.28 ± 1.2 vs. 4.01 ± 1.1 [P < 0.006]), the rate of postprandial hypoglycemia was lower, and an improvement in quality of life and higher satisfaction were observed. CONCLUSIONS: In this first crossover study comparing the use of an ABA with the standard usual care, the use of an ABA was effective and well accepted. Furthermore, reduction in hypoglycemic events, improvement in adherence and quality of life, and higher treatment satisfaction were observed.