Clinical Safety and Feasibility of the Advanced Bolus Calculator for Type 1 Diabetes Based on Case-Based Reasoning: A 6-Week Nonrandomized Single-Arm Pilot Study
File(s)ReddyManuscript_revised_30.04.16.pdf (183.53 KB)
Accepted version
Author(s)
Type
Journal Article
Abstract
Background: The Advanced Bolus Calculator for Diabetes (ABC4D) is an insulin bolus dose decision support system based on case-based reasoning (CBR). The system is implemented in a smartphone application to provide personalized and adaptive insulin bolus advice for people with type 1 diabetes. We aimed to assess proof of concept, safety, and feasibility of ABC4D in a free-living environment over 6 weeks.
Methods: Prospective nonrandomized single-arm pilot study. Participants used the ABC4D smartphone application for 6 weeks in their home environment, attending the clinical research facility weekly for data upload, revision, and adaptation of the CBR case base. The primary outcome was postprandial hypoglycemia.
Results: Ten adults with type 1 diabetes, on multiple daily injections of insulin, mean (standard deviation) age 47 (17), diabetes duration 25 (16), and HbA1c 68 (16) mmol/mol (8.4 (1.5) %) participated. A total of 182 and 150 meals, in week 1 and week 6, respectively, were included in the analysis of postprandial outcomes. The median (interquartile range) number of postprandial hypoglycemia episodes within 6-h after the meal was 4.5 (2.0–8.2) in week 1 versus 2.0 (0.5–6.5) in week 6 (P = 0.1). No episodes of severe hypoglycemia occurred during the study.
Conclusion: The ABC4D is safe for use as a decision support tool for insulin bolus dosing in self-management of type 1 diabetes. A trend suggesting a reduction in postprandial hypoglycemia was observed in the final week compared with week 1.
Methods: Prospective nonrandomized single-arm pilot study. Participants used the ABC4D smartphone application for 6 weeks in their home environment, attending the clinical research facility weekly for data upload, revision, and adaptation of the CBR case base. The primary outcome was postprandial hypoglycemia.
Results: Ten adults with type 1 diabetes, on multiple daily injections of insulin, mean (standard deviation) age 47 (17), diabetes duration 25 (16), and HbA1c 68 (16) mmol/mol (8.4 (1.5) %) participated. A total of 182 and 150 meals, in week 1 and week 6, respectively, were included in the analysis of postprandial outcomes. The median (interquartile range) number of postprandial hypoglycemia episodes within 6-h after the meal was 4.5 (2.0–8.2) in week 1 versus 2.0 (0.5–6.5) in week 6 (P = 0.1). No episodes of severe hypoglycemia occurred during the study.
Conclusion: The ABC4D is safe for use as a decision support tool for insulin bolus dosing in self-management of type 1 diabetes. A trend suggesting a reduction in postprandial hypoglycemia was observed in the final week compared with week 1.
Date Issued
2016-05-19
Date Acceptance
2016-05-01
Citation
Diabetes Technology & Therapeutics, 2016, 18 (8), pp.487-493
ISSN
1557-8593
Publisher
Mary Ann Liebert
Start Page
487
End Page
493
Journal / Book Title
Diabetes Technology & Therapeutics
Volume
18
Issue
8
Copyright Statement
© 2016 Mary Ann Liebert, Inc. The final publication is available from Mary Ann Liebert, Inc., publishers http://dx.doi.org/10.1089/dia.2015.0413.
Sponsor
Imperial College Healthcare NHS Trust- BRC Funding
Grant Number
N/A
Subjects
Science & Technology
Life Sciences & Biomedicine
Endocrinology & Metabolism
Publication Status
Published