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.

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). Metabolic control, fear of hypoglycemia, and treatment acceptance were evaluated. RESULTS: In all, 70 people completed the study (42 in the Cb group, 28 in the Co group). There was a significant decrease in HbA1c in both the Cb and Co groups (-7 mmol/mol [-0.7 %] vs -4 mmol/mol [-0.4 %], respectively). There were no significant differences in HbA1c at baseline or the end of the study, or in the decrease in HbA1c, glycemia, or changes in blood glucose levels at the end of the study between the two groups. There was a significant increase in the number of participants with good metabolic control (HbA1c <58 mmol/mol [7.5 %]) in the Cb group (from 16.7 % to 40.5 %), but not in the Co group. The incidence of hypoglycemic events was reduced slightly but significantly only in the Cb group. There was no change in the fear of hypoglycemia at the end of the study. The bolus calculator was well accepted. CONCLUSIONS: In T1D, adding a bolus calculator to intensive MDI resulted in a significant improvement in metabolic control and slightly decreased the number of hypoglycemic episodes. Metabolic control also improved in the Co group.