Feasibility and Efficiency of a Novel Bolus Calculator (IF-DIABETE) for Patients With Type 1 Diabetes: A Nonrandomized Single-Arm Pilot Study

Abstract

Background The IF-DIABETE system is an insulin bolus dose support, considered as the first bolus calculator dedicated to people with type 1 diabetes, designed in the Arabic language, and adapted to the large Arabic food culture. Our aims were to assess the proof of concept and efficiency of the IF-DIABETE system in improving clinical and metabolic outcomes in individuals with type 1 diabetes. Methods This is a prospective nonrandomized single-arm pilot study. Our patients used the IF-DIABETE smartphone application as a novel bolus calculator. Over six months period of the study, the primary outcome considered was hemoglobin glycated (HbA1c), and we identified hypoglycemic events, body mass index (BMI), and the frequency of blood glucose measurements as secondary outcomes. Results Twenty-one patients with type 1 diabetes were enrolled. The average age was 21 ± 3 years. Over a six months’ period of the study, the mean HbA1c level decreased from 8.3 ± 0.8% to 7.0 ± 0.5 % with a reduction in mild hypoglycemic events’ frequency from 5 ± 3 to 1 ± 0.7 episodes/3 months. We did not observe any change in BMI and the frequency of the blood glucose testing improved from 2 ± 0.5 to 5 ± 1 tests per day. Conclusion The IF-DIABETE system was safe and effective to support individuals who have type 1 diabetes to improve their metabolic control. At six months, patients were able to improve their glycemic control without increasing the risk of hypoglycemic events.