Abstract
BackgroundA 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.MethodsThis 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.DiscussionThis 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 registrationClinicaltrials.gov NCT 03112343. Registered on 12 April 2017.
Highlights
A Personal Health Record (PHR) is an online application that allows patients to access, manage, and share their health data
Kim et al BMC Medical Informatics and Decision Making (2017) 17:109 (Continued from previous page). 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 diabetes mellitus (DM)
Evaluation of the stability of information and communication technology (ICT)-based centralized clinical trial monitoring At week 12 and 24 clinic visits, the clinical research coordinator (CRC) will identify the frequency of hypoglycemia, insulin dose, body weight, and blood pressure in the face-to-face interview; analyze the consistency of the data examined by the CRC and transmitted data from the PHR app, including the hypoglycemia diary; and verify the efficacy of the ICTbased centralized clinical trial monitoring
Summary
A Personal Health Record (PHR) is an online application that allows patients to access, manage, and share their health data. 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. Due to the failure of insulin dose titration and fear of hypoglycemia, insulin treatment is perceived as a complex and reluctant therapy by both patients and doctors [4, 5]. To overcome these barriers, frequent and intensive selfmonitoring of glucose and detailed feedback on insulin dosage are critical [6]. Until the safety of automated insulin dose calculator applications is sufficiently documented, there is a clinical need for mobile applications to enhance patient education around insulin dose adjustment
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