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 Background 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 bene...
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| Format: | Article |
| Language: | English |
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BMC
2017-07-01
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| Series: | BMC Medical Informatics and Decision Making |
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| Online Access: | http://link.springer.com/article/10.1186/s12911-017-0507-4 |
| _version_ | 1818672243099566080 |
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| author | Gyuri Kim Ji Cheol Bae Byoung Kee Yi Kyu Yeon Hur Dong Kyung Chang Moon-Kyu Lee Jae Hyeon Kim Sang-Man Jin |
| author_facet | Gyuri Kim Ji Cheol Bae Byoung Kee Yi Kyu Yeon Hur Dong Kyung Chang Moon-Kyu Lee Jae Hyeon Kim Sang-Man Jin |
| author_sort | Gyuri Kim |
| collection | DOAJ |
| description | Abstract Background 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. Methods 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. Discussion 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. Trial registration Clinicaltrials.gov NCT 03112343 . Registered on 12 April 2017. |
| first_indexed | 2024-12-17T07:36:48Z |
| format | Article |
| id | doaj.art-32612be0a89a4828847a630d89cbd4f7 |
| institution | Directory Open Access Journal |
| issn | 1472-6947 |
| language | English |
| last_indexed | 2024-12-17T07:36:48Z |
| publishDate | 2017-07-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Medical Informatics and Decision Making |
| spelling | doaj.art-32612be0a89a4828847a630d89cbd4f72022-12-21T21:58:17ZengBMCBMC Medical Informatics and Decision Making1472-69472017-07-0117111110.1186/s12911-017-0507-4An 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 trialGyuri Kim0Ji Cheol Bae1Byoung Kee Yi2Kyu Yeon Hur3Dong Kyung Chang4Moon-Kyu Lee5Jae Hyeon Kim6Sang-Man Jin7Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of MedicineDivision of Endocrinology and Metabolism, Department of Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of MedicineDepartment of Digital Health, SAIHST, Sungkyunkwan UniversityDivision of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of MedicineDepartment of Digital Health, SAIHST, Sungkyunkwan UniversityDivision of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of MedicineDivision of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of MedicineDivision of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of MedicineAbstract Background 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. Methods 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. Discussion 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. Trial registration Clinicaltrials.gov NCT 03112343 . Registered on 12 April 2017.http://link.springer.com/article/10.1186/s12911-017-0507-4Diabetes mellituseCRFICT-based clinical trialInsulinMobile applicationsPersonal health record |
| spellingShingle | Gyuri Kim Ji Cheol Bae Byoung Kee Yi Kyu Yeon Hur Dong Kyung Chang Moon-Kyu Lee Jae Hyeon Kim Sang-Man Jin 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 BMC Medical Informatics and Decision Making Diabetes mellitus eCRF ICT-based clinical trial Insulin Mobile applications Personal health record |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Diabetes mellitus eCRF ICT-based clinical trial Insulin Mobile applications Personal health record |
| url | http://link.springer.com/article/10.1186/s12911-017-0507-4 |
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