Automated Bolus Calculator in MDI-treated Type 1 Diabetes
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 poor metabolic control (HbA1c 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 CarbCountABC arm. The difference in change in HbA1c between CarbCount and CarbCountABC was insignificant. Adjusting for baseline HbA1c in a regression model, the relative change in HbA1c 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.
The importance of near normalization of blood glucose (BG) in preventing microvascular long-term complications of diabetes was demonstrated in the Diabetes Control and Complications Trial. In the trial, strict glycemic control was achieved by flexible intensive insulin therapy (FIIT) with multiple daily insulin injections adjusted according to BG, carbohydrate intake, and exercise to mimic insulin secretion in healthy individuals. The therapy was closely supervised by the health care team and, although effective, the therapy was caregiver-dependent and resource demanding. For >3 decades, a patient-empowering approach to FIIT has been practiced in Germany. The concept includes a 5-day structured program in which patients are taught to practice FIIT and to handle minor metabolic derangements themselves. Over the years, the approach has been adapted in several other countries. The DAFNE (Dose Adjustment for Normal Eating) Study Group in the U.K. performed the first randomized study testing the efficacy of the approach and documented significant improvements in glycemic control and diabetes-related quality of life. The group recently has reported sustained benefit of the teaching program after 44 months.
In Denmark, national guidelines published in 2010 recommend FIIT, including the use of carbohydrate counting to all patients with type 1 diabetes. This is in line with American Diabetes Association guidelines. In many clinics, however, it is yet to be implemented. It is our experience that insulin pump patients adapt well to FIIT, whereas few multiple daily injection (MDI)-treated patients do. This could rely on the different techniques used for bolus estimation by the two groups. The pump users have the advantage of bolus calculator functions integrated in their insulin pump, whereas MDI-treated patients are left with mental calculations or more simple algorithms. The calculations can be somewhat complicated, especially when the premeal BG is out of the desired range.
A BG meter with an integrated bolus calculator function (Accu-Chek Aviva Expert; Roche Diagnostics, Mannheim, Germany) recently was launched, offering MDI-treated patients the same advantages as pump patients. We hypothesized that a Danish type 1 diabetic population in poor metabolic control would achieve better metabolic control, treatment satisfaction, and quality of life from FIIT and that the benefits could be further improved with the concurrent use of the Accu-Chek Aviva Expert automated bolus calculator (ABC). The BolusCal Study was a pilot study testing these hypotheses and the feasibility of teaching the principles of FIIT during a 3-h structured course.
Abstract and Introduction
Abstract
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 poor metabolic control (HbA1c 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 CarbCountABC arm. The difference in change in HbA1c between CarbCount and CarbCountABC was insignificant. Adjusting for baseline HbA1c in a regression model, the relative change in HbA1c 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.
Introduction
The importance of near normalization of blood glucose (BG) in preventing microvascular long-term complications of diabetes was demonstrated in the Diabetes Control and Complications Trial. In the trial, strict glycemic control was achieved by flexible intensive insulin therapy (FIIT) with multiple daily insulin injections adjusted according to BG, carbohydrate intake, and exercise to mimic insulin secretion in healthy individuals. The therapy was closely supervised by the health care team and, although effective, the therapy was caregiver-dependent and resource demanding. For >3 decades, a patient-empowering approach to FIIT has been practiced in Germany. The concept includes a 5-day structured program in which patients are taught to practice FIIT and to handle minor metabolic derangements themselves. Over the years, the approach has been adapted in several other countries. The DAFNE (Dose Adjustment for Normal Eating) Study Group in the U.K. performed the first randomized study testing the efficacy of the approach and documented significant improvements in glycemic control and diabetes-related quality of life. The group recently has reported sustained benefit of the teaching program after 44 months.
In Denmark, national guidelines published in 2010 recommend FIIT, including the use of carbohydrate counting to all patients with type 1 diabetes. This is in line with American Diabetes Association guidelines. In many clinics, however, it is yet to be implemented. It is our experience that insulin pump patients adapt well to FIIT, whereas few multiple daily injection (MDI)-treated patients do. This could rely on the different techniques used for bolus estimation by the two groups. The pump users have the advantage of bolus calculator functions integrated in their insulin pump, whereas MDI-treated patients are left with mental calculations or more simple algorithms. The calculations can be somewhat complicated, especially when the premeal BG is out of the desired range.
A BG meter with an integrated bolus calculator function (Accu-Chek Aviva Expert; Roche Diagnostics, Mannheim, Germany) recently was launched, offering MDI-treated patients the same advantages as pump patients. We hypothesized that a Danish type 1 diabetic population in poor metabolic control would achieve better metabolic control, treatment satisfaction, and quality of life from FIIT and that the benefits could be further improved with the concurrent use of the Accu-Chek Aviva Expert automated bolus calculator (ABC). The BolusCal Study was a pilot study testing these hypotheses and the feasibility of teaching the principles of FIIT during a 3-h structured course.
Source...