Paper Info
Title
An information and communication technology-based centralized clinical trial to determine the efficacy and safety of insulin dose adjustment education based on a smartphone personal health record application: a randomized controlled trial.
Abstract
A Personal Health Record (PHR) is an online application that allows patients to access, manage, and share their health data. PHRs not only enhance shared decision making with healthcare providers, but also enable remote monitoring and at-home-collection of detailed data. The benefits of PHRs can be maximized in insulin dose adjustment for patients starting or intensifying insulin regimens, as frequent self-monitoring of glucose, self-adjustment of insulin dose, and precise at-home data collection during the visit-to-visit period are important for glycemic control. The aim of this study is to examine the efficacy and safety of insulin dose adjustment based on a smartphone PHR application in patients with diabetes mellitus (DM) and to confirm the validity and stability of an information and communication technology (ICT)-based centralized clinical trial monitoring system.This is a 24-week, open-label, randomized, multi-center trial. There are three follow-up measures: baseline, post-intervention at week 12, and at week 24. Subjects diagnosed with type 1 DM, type 2 DM, and/or post-transplant DM who initiate basal insulin or intensify their insulin regimen to a basal-bolus regimen are included. After education on insulin dose titration and prevention for hypoglycemia and a 1-week acclimation period, subjects are randomized in a 1:1 ratio to either an ICT-based intervention group or a conventional intervention group. Subjects in the conventional intervention group will save and send their health information to the server via a PHR application, whereas those in ICT-based intervention group will receive additional algorithm-based feedback messages. The health information includes level of blood glucose, insulin dose, details on hypoglycemia, food diary, and step count. The primary outcome will be the proportion of patients who reach an optimal insulin dose within 12 weeks of study enrollment, without severe hypoglycemia or unscheduled clinic visits.This clinical trial will reveal whether insulin dose adjustment based on a smartphone PHR application can facilitate the optimization of insulin doses in patients with DM. In addition, the process evaluation will provide information about the validity and stability of the ICT-based centralized clinical trial monitoring system in this research field.Clinicaltrials.gov NCT 03112343 . Registered on 12 April 2017.
Year
DOI
Venue
2017
10.1186/s12911-017-0507-4
BMC Med. Inf. & Decision Making
Keywords
Field
DocType
Diabetes mellitus,Hypoglycemia,ICT-based clinical trial,Insulin,Mobile applications,Personal health record,eCRF
Regimen,Diabetes mellitus,Emergency medicine,Knowledge management,Randomized controlled trial,Clinical trial,Insulin,Health informatics,Medicine,Hypoglycemia,Glycemic
Journal
Volume
Issue
ISSN
17
1
1472-6947
Citations 
PageRank 
References 
0
0.34
0
Authors
8
Name
Order
Citations
PageRank
G Kim100.68
Ji Cheol Bae200.68
Byoung-Kee Yi301.01
Kyu Yeon Hur400.68
Dong Kyung Chang500.34
Moon-Kyu Lee61046.62
Jae Hyeon Kim700.68
Sang-Man Jin801.69