Bolus Calculator Reduces Hypoglycemia in the Short Term and Fear of Hypoglycemia in the Long Term in Subjects with Type 1 Diabetes (CBMDI Study)

Background: In a previous study we demonstrated improvement in metabolic control and reduction in hypoglycemia in people with type 1 diabetes on multiple daily injections, after having used a bolus calculator for 4 months. Objective: To demonstrate whether (1) extending its use (2) or introducing it in the control group, previously subjected to treatment intensification, could further improve metabolic control and related psychological issues. Methods: After the previous clinical trial, in which the subjects were randomized either to treatment with the calculator or to control group for 4 months, both groups used the calculator during an additional 4-month period. Results: In the previous control group, after using the device, HbA1c did not improve (7.86% +/- 0.87% vs. 8.01% +/- 0.93%, P 0.215), although a significant decrease in postprandial hypoglycemia was observed (2.3 +/- 2 vs. 1.1 +/- 1.2/2 weeks, P 0.002). In the group in which the treatment was extended from 4 to 8 months, HbA1c did not improve either (7.61 +/- 0.58 vs. 7.73 +/- 0.65, P 0.209); however this group had a greater perceived treatment satisfaction (12.03 +/- 4.26 vs. 13.71 +/- 3.75, P 0.007) and a significant decrease in fear of hypoglycemia (28.24 +/- 8.18 basal vs. 25.66 +/- 8.02 at 8 months, P 0.026). Conclusions: The extension in the use of the calculator or its introduction in a previously intensified control group did not improve metabolic control, although it did confirm a decrease in hypoglycemic episodes in the short term, while the extension of its use to 8 months was associated with a reduction in fear of hypoglycemia and greater treatment satisfaction.