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.

The Calculating Boluses on Multiple Daily Injections (CBMDI) study: A randomized controlled trial on the effect on metabolic control of adding a bolus calculator to multiple daily injections in people with type 1 diabetes.

Background: Although the insulin bolus calculator is increasingly being used by people with type 1 diabetes (T1D) on multiple daily injection (MDI) therapy, few studies have investigated its effects on glycemic control. The aim of this study was to determine whether adding this device to therapeutic intensification could further improve metabolic control.

Methods: A 4-month randomized controlled clinical trial was performed comparing subjects undergoing therapeutic intensification and either using the bolus calculator (Cb group) or not (active control [Co] group).