Clinical evaluation of an adaptive decision support system for insulin dose adjustment in type 1 diabetes

Abstract

The calculations required for insulin bolus dose adjustment in type 1 diabetes (T1D) may be complex. An automated standard bolus calculator has been shown to reduce dosing errors and decrease HbA1c although this may be at the expense of hypoglycaemia. It is not able to automatically adjust settings in response to changes in insulin sensitivity. The Advanced Bolus Calculator for Type 1 Diabetes (ACB4D) is an adaptive decision support system (DSS) comprising a real-time bolus calculator displayed on a smartphone application, used with realtime continuous glucose monitoring and a web-based clinician’s platform. The ABC4D app runs in adaptive bolus calculator (intervention) or non-adaptive bolus calculator (control) mode. This thesis outlines the clinical evaluation of the ABC4D in adults with T1D using multipledaily injections. Its safety and efficacy has been evaluated in an 8 month prospective randomised controlled non-inferiority crossover study. Participants underwent a 2 week run-in period, were randomised to intervention or control for 12 weeks, followed by a 6 week washout period and were crossed over to the other arm for the last 12 weeks. There were no differences in glycaemic outcomes between ABC4D and control. The increase in diabetes treatment satisfaction score from baseline was lower with ABC4D compared to control. Participants accepted a lower percentage of all and meal doses during the last 2 weeks of ABC4D compared to control, with a greater reduction in meal doses from that recommended. Whilst the ABC4D was safe, it did not demonstrate a glycaemic benefit compared to control. However ABC4D adaptations were performed automatically on participants’ smartphones without requiring approval by a healthcare professional, which could save time in routine clinic appointments to then focus on other areas of diabetes care. Further research is needed to explore the barriers in the uptake of and trust in DSSs.