Clinical performance of Hedia Diabetes Assistant bolus calculator for diabetes management: a real-world retrospective cohort study

Abstract

Introduction: Individuals living with type 1 diabetes are at risk of long-term complications related to chronic hyperglycemia. Tight glycemic control is recommended but can increase the risk of iatrogenic hypoglycemia. Hedia Diabetes Assistant (HDA) is a bolus calculator that provides users with bolus insulin recommendations based on personalized settings. We aimed to investigate the effects of HDA on a known risk index of hypoglycemia.

Methods: New users from 2019 to 2021 were included if they fulfilled the following criteria: age ≥18 years, ≥5 logs/1st week of use, and ≥1 log for glucose, carbohydrate, and insulin. User data was extracted from the HDA database. The prespecified primary endpoint was change in the Low Blood Glucose Index (LBGI) after 12 weeks of use. Secondary endpoints were changes in the High Blood Glucose Index (HBGI) and eA1c. An exploratory endpoint was to maintain potential improvements in LBGI after 25 weeks. A repeated-measures mixed model with a log-transformation was used.

Results: A total of 1,342 users were included. The mean age was 43.4 years (SD 14.7) with 52.3% being female. After 12 weeks, LBGI significantly improved from 0.73 to 0.61 (17% decrease, P < 0.001) with no significant changes in HBGI, and eA1c. From week 12 to 25, LBGI decreased from 0.61 to 0.55 (10%, P = 0.107).

Conclusions: Users of HDA experienced statistically significant improvement in LBGI after 12 weeks with no changes in HBGI and eA1c, which was successfully maintained after 25 weeks. These results suggest a decreased risk of hypoglycemia when using HDA.

Keywords: bolus calculator; digital technologies; glycemic control; hypoglycemia; type 1 diabetes mellitus.

Figure 1

Flow-chart of user inclusion. eA1c, estimated A1c; HBGI, high blood glucose index; LBGI, low blood glucose index.

Figure 2

Trajectories of LBGI, eA1c, and HBGI from week 0 to week 25. Trajectories of LBGI, eA1c, and HBGI from week 0 to week 25. The figure shows values over time for LBGI (A), HBGI (B), and eA1c (C) Bold week numbers and black points indicate time points of interest, and error bars indicate 95% confidence intervals. The values are geometric means. eA1c, estimated A1c; HBGI, high blood glucose index; LBGI, low blood glucose index.