Skip to main content
Top
Published in: BMC Medical Informatics and Decision Making 1/2020

Open Access 01-12-2020 | Artificial Intelligence | Study protocol

Validation of the effectiveness of a digital integrated healthcare platform utilizing an AI-based dietary management solution and a real-time continuous glucose monitoring system for diabetes management: a randomized controlled trial

Authors: Sung Woon Park, Gyuri Kim, You-Cheol Hwang, Woo Je Lee, Hyunjin Park, Jae Hyeon Kim

Published in: BMC Medical Informatics and Decision Making | Issue 1/2020

Login to get access

Abstract

Background

Despite the numerous healthcare smartphone applications for self-management of diabetes, patients often fail to use these applications consistently due to various limitations, including difficulty in inputting dietary information by text search and inconvenient and non-persistent self-glucose measurement by home glucometer. We plan to apply a digital integrated healthcare platform using an artificial intelligence (AI)-based dietary management solution and a continuous glucose monitoring system (CGMS) to overcome those limitations. Furthermore, medical staff will be performing monitoring and intervention to encourage continuous use of the program. The aim of this trial is to examine the efficacy of the program in patients with type 2 diabetes mellitus (T2DM) who have HbA1c 53–69 mmol/mol (7.0–8.5%) and body mass index (BMI) ≥ 23 mg/m2.

Methods

This is a 48-week, open-label, randomized, multicenter trial consisting of patients with type 2 diabetes. The patients will be randomly assigned to three groups: control group A will receive routine diabetes care; experimental group B will use the digital integrated healthcare platform by themselves without feedback; and experimental group C will use the digital integrated healthcare platform with continuous glucose monitoring and feedback from medical staff. There are five follow-up measures: baseline and post-intervention at weeks 12, 24, 36, and 48. The primary end point is change in HbA1c from baseline to six months after the intervention.

Discussion

This trial will verify the effectiveness of a digital integrated healthcare platform with an AI-driven dietary solution and a real-time CGMS in patients with T2DM.
Literature
2.
go back to reference Management L. Standards of medical Care in Diabetes-2019. Diabetes Care. 2019;42(Suppl 1):S46–s60. Management L. Standards of medical Care in Diabetes-2019. Diabetes Care. 2019;42(Suppl 1):S46–s60.
3.
go back to reference Norris SL, Lau J, Smith SJ, Schmid CH, Engelgau MM. Self-management education for adults with type 2 diabetes: a meta-analysis of the effect on glycemic control. Diabetes Care. 2002;25(7):1159–71.CrossRef Norris SL, Lau J, Smith SJ, Schmid CH, Engelgau MM. Self-management education for adults with type 2 diabetes: a meta-analysis of the effect on glycemic control. Diabetes Care. 2002;25(7):1159–71.CrossRef
4.
go back to reference An KH, Han KA, Sohn TS, Park IB, Kim HJ, Moon SD, et al. Body fat is related to sedentary behavior and light physical activity but not to moderate-vigorous physical activity in type 2 diabetes mellitus. Diabetes Metab J. 2020;44(2):316–25.CrossRef An KH, Han KA, Sohn TS, Park IB, Kim HJ, Moon SD, et al. Body fat is related to sedentary behavior and light physical activity but not to moderate-vigorous physical activity in type 2 diabetes mellitus. Diabetes Metab J. 2020;44(2):316–25.CrossRef
5.
go back to reference Cui M, Wu X, Mao J, Wang X, Nie M. T2DM self-Management via smartphone applications: a systematic review and meta-analysis. PLoS One. 2016;11(11):e0166718.CrossRef Cui M, Wu X, Mao J, Wang X, Nie M. T2DM self-Management via smartphone applications: a systematic review and meta-analysis. PLoS One. 2016;11(11):e0166718.CrossRef
6.
go back to reference Doupis J, Festas G, Tsilivigos C, Efthymiou V, Kokkinos A. Smartphone-Based Technology in Diabetes Management. Diab Ther : Res Treat Educ Diab Relat Disord. 2020. Doupis J, Festas G, Tsilivigos C, Efthymiou V, Kokkinos A. Smartphone-Based Technology in Diabetes Management. Diab Ther : Res Treat Educ Diab Relat Disord. 2020.
7.
go back to reference Kim EK, Kwak SH, Jung HS, Koo BK, Moon MK, Lim S, et al. The effect of a smartphone-based, patient-centered diabetes care system in patients with type 2 diabetes: a randomized, controlled trial for 24 weeks. Diabetes Care. 2019;42(1):3–9.CrossRef Kim EK, Kwak SH, Jung HS, Koo BK, Moon MK, Lim S, et al. The effect of a smartphone-based, patient-centered diabetes care system in patients with type 2 diabetes: a randomized, controlled trial for 24 weeks. Diabetes Care. 2019;42(1):3–9.CrossRef
8.
go back to reference Martinez-Perez B, de la Torre-Diez I, Lopez-Coronado M. Mobile health applications for the most prevalent conditions by the World Health Organization: review and analysis. J Med Internet Res. 2013;15(6):e120.CrossRef Martinez-Perez B, de la Torre-Diez I, Lopez-Coronado M. Mobile health applications for the most prevalent conditions by the World Health Organization: review and analysis. J Med Internet Res. 2013;15(6):e120.CrossRef
11.
go back to reference Lim S, Kang SM, Shin H, Lee HJ, Won Yoon J, Yu SH, et al. Improved glycemic control without hypoglycemia in elderly diabetic patients using the ubiquitous healthcare service, a new medical information system. Diabetes Care. 2011;34(2):308–13.CrossRef Lim S, Kang SM, Shin H, Lee HJ, Won Yoon J, Yu SH, et al. Improved glycemic control without hypoglycemia in elderly diabetic patients using the ubiquitous healthcare service, a new medical information system. Diabetes Care. 2011;34(2):308–13.CrossRef
12.
go back to reference Agarwal P, Mukerji G, Desveaux L, Ivers NM, Bhattacharyya O, Hensel JM, et al. Mobile app for improved self-Management of Type 2 diabetes: multicenter pragmatic randomized controlled trial. JMIR mHealth uHealth. 2019;7(1):e10321.CrossRef Agarwal P, Mukerji G, Desveaux L, Ivers NM, Bhattacharyya O, Hensel JM, et al. Mobile app for improved self-Management of Type 2 diabetes: multicenter pragmatic randomized controlled trial. JMIR mHealth uHealth. 2019;7(1):e10321.CrossRef
13.
go back to reference Boushey CJ, Spoden M, Zhu FM, Delp EJ, Kerr DA. New mobile methods for dietary assessment: review of image-assisted and image-based dietary assessment methods. Proc Nutr Soc. 2017;76(3):283–94.CrossRef Boushey CJ, Spoden M, Zhu FM, Delp EJ, Kerr DA. New mobile methods for dietary assessment: review of image-assisted and image-based dietary assessment methods. Proc Nutr Soc. 2017;76(3):283–94.CrossRef
14.
go back to reference Dobson R, Whittaker R, Jiang Y, Maddison R, Shepherd M, McNamara C, et al. Effectiveness of text message based, diabetes self management support programme (SMS4BG): two arm, parallel randomised controlled trial. BMJ. 2018;361:k1959.CrossRef Dobson R, Whittaker R, Jiang Y, Maddison R, Shepherd M, McNamara C, et al. Effectiveness of text message based, diabetes self management support programme (SMS4BG): two arm, parallel randomised controlled trial. BMJ. 2018;361:k1959.CrossRef
Metadata
Title
Validation of the effectiveness of a digital integrated healthcare platform utilizing an AI-based dietary management solution and a real-time continuous glucose monitoring system for diabetes management: a randomized controlled trial
Authors
Sung Woon Park
Gyuri Kim
You-Cheol Hwang
Woo Je Lee
Hyunjin Park
Jae Hyeon Kim
Publication date
01-12-2020
Publisher
BioMed Central
Published in
BMC Medical Informatics and Decision Making / Issue 1/2020
Electronic ISSN: 1472-6947
DOI
https://doi.org/10.1186/s12911-020-01179-x

Other articles of this Issue 1/2020

BMC Medical Informatics and Decision Making 1/2020 Go to the issue