Efficacy of Bolus Calculation and Advanced Carbohydrate Counting in Type 2 Diabetes: A randomized clinical trial

Background: Carbohydrate counting and use of automated bolus calculators (ABCs) can help reduce HbA 1c in type 1 diabetes but only limited evidence exists in type 2 diabetes. We evaluated the efficacy of advanced carbohydrate counting (ACC) and use of an ABC compared with manual insulin bolus calculation (MC) in persons with type 2 diabetes. Materials and Methods: A 24-week open-label, randomized clinical study was conducted in 79 persons with type 2 diabetes treated with basal-bolus insulin (mean age 62.5 ± 9.6 years, HbA 1c 8.7% ± 1.0% [72 ± 11 mmol/mol], diabetes duration 18.7 ± 7.6 years). Participants were randomized 1:1 into two groups: ABC group received training in ACC and use of an ABC; MC group received training in ACC and manual calculation of insulin bolus. Participants wore blinded continuous glucose monitors for 6 days at baseline and at study end. Primary endpoint was change in HbA 1c. Results: After 24 weeks, HbA 1c decreased 0.8% (8.8 mmol/mol) in ABC group and 0.8% (9.0 mmol/mol) in MC group with no between-group difference ( P  = 0.96) and without increase in time in hypoglycemic range (sensor glucose <3.9 mmol/L). Glycemic variability decreased significantly in both groups, whereas the total insulin dose and body mass index (BMI) remained unchanged during the study. Treatment satisfaction increased significantly in both groups after 24 weeks. Conclusion: ACC is an effective, low-cost tool to reduce HbA 1c and glycemic variability in persons with basal-bolus insulin-treated type 2 diabetes without increase in hypoglycemia or BMI. Similar effects were seen with use of an ABC and with use of manual bolus calculation. Trial registration: ClinicalTrials.gov NCT02887898.