Individual Study / Kim et al.; BMC Med Inform Decis Mak. 2017

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

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

Initiatives -
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. Note: All published information has been collected from the article referenced in the Marker Paper box below. Therefore, there may be variations with more advanced versions of the study.
Start Year
2017
Funding
The study is supported by the Ministry of Trade, Industry, & Energy (MOTIE, Korea) under the Industrial Technology Innovation Program (No. 10059066).

Design

Study design
Clinical trial cohort

Marker Paper

Kim G, Bae JC, Yi BK, et al. 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 [published correction appears in BMC Med Inform Decis Mak. 2017 Dec 12;17 (1):169]. BMC Med Inform Decis Mak. 2017;17(1):109. Published 2017 Jul 18. doi:10.1186/s12911-017-0507-4

PUBMED 28720103

Number of participants

Number of participants
96
Number of participants with biosamples

Access

Availability of data and biosamples

Data
Biosamples
Other

Timeline

Population

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.
Selection Criteria
Minimum age
18
Maximum age
69
Newborns
Twins
Countries
  • South Korea
Ethnic Origin
Health Status
  • Subjects diagnosed with type 1 DM, type 2 DM, and/or post-transplant DM

Recruitment

Sources of recruitment
  • Clinical patients

Number of participants

Number of participants
96
Number of participants with biosamples
Data Collection Event
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.
Start Date
2017
End Date
2017
Data sources
  • Mobile data collection
    • Mobile phone
    • Smartphone
    • Smartphone apps