Unknown Safety and Efficacy of Smartphone Bolus Calculator Apps Puts Patients at Risk for Severe Adverse Outcomes

Abstract

Manual calculation of bolus insulin dosages can be challenging for individuals treated with multiple daily insulin injections (MDI) therapy. Automated bolus calculator capability has recently been made available via enhanced blood glucose meters and smartphone apps. Use of this technology has been shown to improve glycemic control and reduce glycemic variability without changing hypoglycemia; however, the clinical utility of app-based bolus calculators has not been demonstrated. Moreover, recent evidence challenges the safety and efficacy of these smartphone apps. Although the ability to automatically calculate bolus insulin dosages addresses a critical need of MDI-treated individuals, this technology raises concerns about efficacy of treatment and the protection of patient safety. This article discusses key issues and considerations associated with automated bolus calculator use.

Mobile phone applications and self‐management of diabetes: A systematic review with meta‐analysis, meta‐regression of 21 randomized trials and GRADE

“…Although there is some indication that the use of diabetes apps is not associated with an excess of severe episodes of hypoglycaemia, current evidence concerning the safety of diabetes apps is scarce. Thus, future studies concerning diabetes apps should direct more attentions to safety issues, especially for apps with bolus calculator functionality …”

“…Thus, future studies concerning diabetes apps should direct more attentions to safety issues, especially for apps with bolus calculator functionality. 12 The population-wide implementation of diabetes apps requires the support of both clinicians and those financially responsible. For clinicians, the primary consideration is not only the clinical effect of using diabetes apps but, more importantly, whether the time spent to adapt the technology and send feedback justifies the perceived benefit.…”

Advances in Care for Insulin-Requiring Patients Without Closed Loop

“…This has led experts in the field to suggest the need for greater scrutiny and standards. 45,46 There has been a growing body of literature evaluating decision support interventions. Small pilot studies often have inconclusive results and lack follow-up.…”

Role of Automation/Technology in Day-to-Day Diabetes Care

“…Many smartphone applications are providing insulin bolus calculators to support self-management for T1D subjects on MDI. 12 A recent systematic assessment of 46 insulin bolus calculator applications on smartphones showed inaccuracies in recommending correct insulin bolus to manage blood glucose concentrations, with only one application being issue free based on criteria developed by the authors. 13 To conclude, insulin bolus remains a demanding aspect of diabetes self-management management for patients with T1D and some patients with type 2 diabetes on MDI.…”