Table 2.
References | Study design | Objectives | Results |
---|---|---|---|
Maurizi et al. [34] | 3- to 6-month randomized trial comparing patients using an ABC to a control group | Effect of an ABC on metabolic control at 3 and 6 months | At 3 months: nonsignificant improvement in HbA1c levels (−0.61%) |
40 consecutive adult type 1 diabetes patients | At 6 months: significant improvement in HbA1c levels (−0.85%; P < 0.05) | ||
Schmidt et al. [35] (The BolusCal study) | 16-week randomized, controlled, open-label, three-arm parallel trial | Effect of FIIT and an ABC on metabolic control | Significant improvement of HbA1c in the arm of CarbCountABC (P < 0.0001) |
51 adult MDI-treated type 1 diabetes patients | Effect of FIIT and an ABC on treatment satisfaction | Significant improvement in treatment satisfaction (DTSQs and DTSQc) in the arm of CarbCountABC (P < 0.001) | |
Garg et al. [36] | 1-year open-label, randomized, controlled trial | Improvement of HbA1c values | HbA1c improvement by >0.6% at 12 months (P < 0.02) |
123 adult type 1 diabetes patients randomized on a 1:1 basis to either an ABC or control group | Higher proportion of ABC users achieving HbA1c <7.5% (P < 0.01) | ||
Within-target values higher among ABC users | |||
Without weight gain or changes in insulin dosages | |||
More severe hypoglycemia among ABC users (P = 0.04) | |||
Lepore et al. [37] | 1-year prospective observation study | Improvement of HbA1c values | Significant improvement in HbA1c (P < 0.007) |
30 CSII-treated type 1 diabetes patients already trained to CH counting and ISF and invited to use an insulin pump with an ABC | Significant improvement of postprandial BG levels (P < 0.05) | ||
Significant improvement of daily glucose variability (P < 0.005) | |||
Improved aptitude to calculate proper dose of insulin bolus | |||
No increased frequency of hypoglycemia | |||
Klupa et al. [38] | Observational study | Improvement of HbA1c values when using an ABC (in an insulin pump) | No significant improvement in HbA1c values |
18 CSII-treated type 1 diabetes patients | Significant decrease in 2-h postprandial values (P < 0.05) | ||
Enander et al. [39] | 1-year multicenter study involving 40 CSII-treated type 1 diabetes patients in three arms: control, CC, CC plus ABC (in an insulin pump) | Improvement in HbA1c levels and in meal-related BG levels | No difference in HbA1c values |
Decreased BG levels fluctuations and increase in postmeal BG levels within target (P = 0.014) | |||
Błazik and Pańkowska [40] | 3-month randomized, open-label study | Changes in HbA1c, postprandial glucose and glucose variability | No change in HbA1c values |
48 CSII-treated type 1 diabetic children randomly allocated to a group using diabetics software, and a control group using caloric tables and mental calculations | Significant decrease in 2-h postprandial BG levels and in glucose variability parameters (P < 0.05) |
ABC automated bolus calculator, BG blood glucose, CC carbohydrate counters, CSII continuous subcutaneous insulin infusion, DTSQc and DTSQs diabetes treatment satisfaction questionnaires (change and status versions, respectively), FIIT flexible intensive insulin therapy, HbA 1c glycated hemoglobin, IDC insulin dosage calculation, ISF insulin sensitivity factor, MDI multiple daily injection