TY - JOUR
T1 - Use of an automated bolus calculator in MDI-treated type 1 diabetes
T2 - the BolusCal Study, a randomized controlled pilot study
AU - Schmidt, Signe
AU - Meldgaard, Merete
AU - Serifovski, Nermin
AU - Storm, Camilla
AU - Christensen, Tomas Møller
AU - Gade-Rasmussen, Birthe
AU - Nørgaard, Kirsten
PY - 2012/5
Y1 - 2012/5
N2 - OBJECTIVE - To investigate the effect of flexible intensive insulin therapy (FIIT) and an automated bolus calculator (ABC) in a Danish type 1 diabetes population treated with multiple daily injections. Furthermore, to test the feasibility of teaching FIIT in a 3-h structured course. RESEARCH DESIGN AND METHODS - The BolusCal Study was a 16-week randomized, controlled, open-label, three-arm parallel, clinical study of 51 adults with type 1 diabetes. Patients aged 18-65 years in poormetabolic control (HbA 1c 8.0-10.5%) were randomized to the Control (n = 8), CarbCount (n = 21), or CarbCountABC (n = 22) arm. During a 3-h group teaching, the Control arm received FIIT education excluding carbohydrate counting. CarbCount patients were taught FIIT and how to count carbohydrates. CarbCountABC group teaching included FIIT and carbohydrate counting and patients were provided with an ABC. RESULTS - At 16 weeks, the within-group change in HbA1c was -0.1% (95% CI-1.0 to 0.7%; P = 0.730) in the Control arm, -0.8% (-1.3 to -0.3%; P = 0.002) in the CarbCount arm, and -0.7% (-1.0 to -0.4%; P<0.0001) in the CarbCountABCarm. The difference in change in HbA 1cbetween CarbCount and CarbCountABC was insignificant. Adjusting for baseline HbA 1c in a regression model, the relative change in HbA 1c was -0.6% (-1.2 to 0.1%; P = 0.082) in CarbCount and -0.8% (-1.4 to -0.1%; P = 0.017) in CarbCountABC. Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire (status version) improved in all study arms, but the improvement was significantly greater in CarbCountABC. CONCLUSIONS - FIIT and carbohydrate counting were successfully taught in 3 h and improved metabolic control and treatment satisfaction. Concurrent use of an ABC improved treatment satisfaction further.
AB - OBJECTIVE - To investigate the effect of flexible intensive insulin therapy (FIIT) and an automated bolus calculator (ABC) in a Danish type 1 diabetes population treated with multiple daily injections. Furthermore, to test the feasibility of teaching FIIT in a 3-h structured course. RESEARCH DESIGN AND METHODS - The BolusCal Study was a 16-week randomized, controlled, open-label, three-arm parallel, clinical study of 51 adults with type 1 diabetes. Patients aged 18-65 years in poormetabolic control (HbA 1c 8.0-10.5%) were randomized to the Control (n = 8), CarbCount (n = 21), or CarbCountABC (n = 22) arm. During a 3-h group teaching, the Control arm received FIIT education excluding carbohydrate counting. CarbCount patients were taught FIIT and how to count carbohydrates. CarbCountABC group teaching included FIIT and carbohydrate counting and patients were provided with an ABC. RESULTS - At 16 weeks, the within-group change in HbA1c was -0.1% (95% CI-1.0 to 0.7%; P = 0.730) in the Control arm, -0.8% (-1.3 to -0.3%; P = 0.002) in the CarbCount arm, and -0.7% (-1.0 to -0.4%; P<0.0001) in the CarbCountABCarm. The difference in change in HbA 1cbetween CarbCount and CarbCountABC was insignificant. Adjusting for baseline HbA 1c in a regression model, the relative change in HbA 1c was -0.6% (-1.2 to 0.1%; P = 0.082) in CarbCount and -0.8% (-1.4 to -0.1%; P = 0.017) in CarbCountABC. Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire (status version) improved in all study arms, but the improvement was significantly greater in CarbCountABC. CONCLUSIONS - FIIT and carbohydrate counting were successfully taught in 3 h and improved metabolic control and treatment satisfaction. Concurrent use of an ABC improved treatment satisfaction further.
U2 - 10.2337/dc11-2044
DO - 10.2337/dc11-2044
M3 - Journal article
C2 - 22344610
SN - 0149-5992
VL - 35
SP - 984
EP - 990
JO - Diabetes Care
JF - Diabetes Care
IS - 5
ER -
