Safety and efficacy of an adaptive bolus calculator for Type 1 diabetes: a randomised control cross over study
File(s)ABC4D.pdf (1.36 MB)
Accepted version
Author(s)
Type
Journal Article
Abstract
Background The Advanced Bolus Calculator for Type 1 Diabetes (ABC4D) is a decision support system employing the artificial intelligence technique of case-based reasoning to adapt and personalise insulin bolus doses. The integrated system comprises a smartphone application and clinical web portal. We aimed to assess safety and efficacy of the ABC4D (intervention) compared to a non-adaptive bolus calculator (control). Methods This was a prospective randomised controlled crossover study. Following a 2-week run-in period, participants were randomised to ABC4D or control for 12 weeks. After a 6-week washout period, participants crossed over for 12 weeks. The primary outcome was difference in percentage (%) time in range (TIR) (3.9-10.0 mmol/L (70-180mg/dL)) change during the daytime (07:00-22:00) between groups. Results 37 adults with type 1 diabetes on multiple daily injections of insulin were randomised, median (IQR) age 44.7 (28.2-55.2) years, diabetes duration 15.0 (9.5-29.0) years, HbA1C 61.0 (58.0-67.0) mmol/mol (7.7 (7.5-8.3)%). Data from 33 participants were analysed. There was no significant difference in daytime %TIR change with ABC4D compared to control (median (IQR) +0.1 (-2.6 to + 4.0)% versus +1.9 (-3.8 to + 10.1)%; p = 0.53). Participants accepted fewer meal dose recommendations in the intervention compared to control (78.7 (55.8-97.6)% versus 93.5 (73.8-100)%; p = 0.009) with a greater reduction in insulin dosage from that recommended. Conclusion The ABC4D is safe for adapting insulin bolus doses and provided the same level of glycaemic control as the non-adaptive bolus calculator. Results suggest that participants did not follow ABC4D recommendations as frequently as control, impacting its effectiveness.
Date Issued
2023-04-05
Date Acceptance
2023-02-08
Citation
Diabetes Technology and Therapeutics, 2023, 25 (6), pp.414-425
ISSN
1520-9156
Publisher
Mary Ann Liebert
Start Page
414
End Page
425
Journal / Book Title
Diabetes Technology and Therapeutics
Volume
25
Issue
6
Copyright Statement
Copyright © Mary Ann Liebert, Inc.
This is the accepted version of the following article: 'Safety and Efficacy of an Adaptive Bolus Calculator for Type 1 Diabetes: a Randomised Control Cross over Study', which has now been formally published in final form at Diabetes Technology & Therapeutics at https://doi.org/10.1089/dia.2022.0504. This original submission version of the article may be used for non-commercial purposes in accordance with the Mary Ann Liebert, Inc., publishers’ self-archiving terms and conditions.
This is the accepted version of the following article: 'Safety and Efficacy of an Adaptive Bolus Calculator for Type 1 Diabetes: a Randomised Control Cross over Study', which has now been formally published in final form at Diabetes Technology & Therapeutics at https://doi.org/10.1089/dia.2022.0504. This original submission version of the article may be used for non-commercial purposes in accordance with the Mary Ann Liebert, Inc., publishers’ self-archiving terms and conditions.
Identifier
https://www.liebertpub.com/doi/10.1089/dia.2022.0504
Publication Status
Published
Date Publish Online
2023-04-05