Use of an Automated Bolus Calculator in MDI-Treated Type 1 Diabetes

Abstract

OBJECTIVEdTo 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 METHODSdThe BolusCal Study was a 16-week random-ized, controlled, open-label, three-arm parallel, clinical study of 51 adults with type 1 diabetes. Patients aged 18–65 years in poor metabolic 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. Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire (status version) improved in all study arms, but the improvement was significantly greater in CarbCountABC. CONCLUSIONSdFIIT 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. T he 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 (1). 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 (2). The concept includes a 5-day structured program in which patients are taught to practice FIIT and to handle minor metabolic derange-ments themselves. Over the years, the approach has been adapted in several other countries (3–7). 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 (3). The group recently has reported sustained benefit of the teaching program after 44 months (8). In Denmark, national guidelines published in 2010 recommend FIIT, including the use of carbohydrate counting to all patients with type 1 diabetes (9). This is in line with American Diabetes Association guidelines (10). In many clinics, however, …

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