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
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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
patients diagnosed with T1DM, T2DM, and/or post-transplant DM
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
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18
- Maximum age
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69
- Newborns
- Twins
- Countries
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- South Korea
- Ethnic Origin
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- Health Status
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- Subjects diagnosed with type 1 DM, type 2 DM, and/or post-transplant DM
Recruitment
- Sources of recruitment
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- 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
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2017
- End Date
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2017
- Data sources
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Mobile data collection
- Mobile phone
- Smartphone
- Smartphone apps
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Mobile data collection