Effects of an Electronic Medical Records-Linked Diabetes Self-Management System on Treatment Targets in Real Clinical Practice: Retrospective, Observational Cohort Study.

BACKGRUOUND: This study evaluated the effects of a mobile diabetes management program called "iCareD" (College of Medicine, The Catholic University of Korea) which was integrated into the hospital's electronic medical records system to minimize the workload of the healthcare team in the real clinical practice setting. METHODS: In this retrospective observational study, we recruited 308 patients. We categorized these patients based on their compliance regarding their use of the iCareD program at home; compliance was determined through self-monitored blood glucose inputs and message subscription rates. We analyzed changes in the ABC (hemoglobin A1c, blood pressure, and low-density lipoprotein cholesterol) levels from the baseline to 12 months thereafter, based on the patients' iCareD usage patterns. RESULTS: The patients comprised 92 (30%) non-users, 170 (55%) poor-compliance users, and 46 (15%) good-compliance users; the ABC target achievement rate showed prominent changes in good-compliance groups from baseline to 12 months (10.9% vs. 23.9%, P<0.05), whereas no significant changes were observed for poor-compliance users and non-users (13.5% vs. 18.8%, P=0.106; 20.7% vs. 14.1%, P=0.201; respectively). CONCLUSION: Implementing the iCareD can improve the ABC levels of patients with diabetes with minimal efforts of the healthcare team in real clinical settings. However, the improvement of patients' compliance concerning the use of the system without the vigorous intervention of the healthcare team needs to be solved in the future.

Clinical experiences and case review of angiotensin II receptor blocker-related angioedema in Korea.

Although angiotensin-converting enzyme inhibitor-related angioedema is well known, angiotensin II receptor blocker (ARB)-related angioedema has not been extensively studied because of its lower incidence. Therefore, ARB-related angioedema is likely to be overlooked in the clinical setting. We analysed the medical records of adults who had been prescribed ARB and diagnosed with angioedema between 2009 and 2015. All adults over the age of 18 years who were initially administered ARB between 1 January 2009 and 31 December 2015 were selected as participants in this study. To confirm whether the angioedema was actually due to the administration of ARB, we conducted a chart review. A total of 35 584 patients were prescribed ARB for the first time when visiting the Seoul St. Mary's Hospital during the study period. Twenty-four patients diagnosed with angioedema for other reasons prior to their first prescription of ARB were excluded from this study. ARB-related angioedema was suspected in six of 35 560 patients (0.02%) who were initially prescribed ARB during the study period. The manifestation of ARB-related angioedema ranged from several days (1/6 case) to several years (3/6 cases). Some patients continued taking ARB with intermittent antihistamine or steroid therapy. In such cases, angioedema symptoms improved but did not completely resolve. Its diagnosis can be delayed and the symptoms may be recurrent as symptoms improve with antihistamine use. In some cases, the same person had different reactions depending on the type of ARB. Definitively diagnosing ARB-related angioedema is difficult, and physicians often overlook angioedema without suspecting that it is an adverse effect of ARB. Close attention of physicians and improved patient education can reduce the incidence of ARB-related angioedema.

Long-term effects of various types of 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors on changes in glomerular filtration rate in Korea.

Few long-term follow-up studies have compared the changes in renal function according to the type of statin used in Korea. We compared the long-term effects of statin intensity and type on the changes in the glomerular filtration rate (GFR). We extracted data of patients who took statin for the first time. We analyzed whether or not different statins affect the changes in GFR at 3 months after baseline and 4 years after. We included 3678 patients and analyzed the changes in GFR. The GFR decreased by 3.2% ± 0.4% on average 4 years after the first statin prescription, indicating statistically significant deterioration (from 83.5 ± 0.4 mL/min/1.73 m2 to 79.9 0.4 mL/min/1.73 m2, P < 0.001). When comparing the GFR among different statins, significant differences were observed between atorvastatin and fluvastatin (-5.3% ± 0.7% vs. 1.2% ± 2.2%, P < 0.05) and between atorvastatin and simvastatin (-5.3% ± 0.7% vs. -0.7% ± 0.8%, P < 0.05). In pitavastatin (odds ratio [OR]= 0.64, 95% confidence interval [CI]= 0.46-0.87, P < 0.005) and simvastatin (OR = 0.69, 95% CI = 0.53-0.91, P < 0.008), the GFR rate that decreased by < 60 mL/min/1.73 m2 was significantly lower than that of atorvastatin. Regarding long-term statin intake, GFR changed with the type of statin. This work is the first in Korea to compare each statin in terms of changes in the GFR after the statin prescription.

Analyzing the distinguishing factors that affect childhood obesity in South Korea.

Understanding obesity in children is crucial because it can lead to adulthood obesity and result in fatal chronic diseases. Distinctive factors associated with obesity in adults have been described, but distinctive factors related to children remain unclear. We analyzed the correlation between the percentage of body mass index and lifestyle habits by conducting surveys on physical, nutritional, and psychological factors, and we used annual physical examination data to compare different traits among elementary school students (n = 197) and middle school students (n = 461). Our study revealed that the computing hours in elementary school students with overweight and obesity were significantly correlated with the percentage of body mass index (r = 0.29 on school days and r = 0.35 on days off, all P < 0.05). No statistically significant difference was found (all P > 0.05) in the computing hours of middle school students with overweight and obesity. Childhood obesity can cause depression and reduce children's quality of life because of their distorted body perception. In conclusion, physical factors directly affecting childhood obesity and psychological and environmental factors surrounding a child should be considered.

Change in ALT levels after administration of HMG-CoA reductase inhibitors to subjects with pretreatment levels three times the upper normal limit in clinical practice.

AIM: Prescription of statins to patients with chronic liver disease whose alanine transaminase (ALT) is over three times the upper normal limit (UNL) is not recommended. In this study, we attempted to evaluate patients with baseline ALT levels > 3 ×  UNL who were prescribed statins without ethical problems, using electronic medical records. METHODS: We enrolled subjects with ALT levels > 3 ×  UNL. The patients were divided into three groups consisting of those who had been taking agents affecting liver function (HEPA) and continued to do so after the statin prescription (HepCon), those who had not previously taken HEPA and began doing so after statin prescription (HepNew), and those who had never taken HEPA (HepNo). All ALT levels were determined within 3 months of statins administration, and changes were monitored. RESULTS: From January 2009 to December 2012, 61 patients with baseline ALT levels > 3 ×  UNL were prescribed statins for the first time. During the 3-month ALT monitoring, levels of the HepCon, HepNew, and HepNo groups decreased by 45 ± 8%, 64 ± 10%, and 42 ± 8%, respectively; however, intergroup differences were not significant (P = .386). All the subjects who were administered statins showed improvement or maintained their ALT levels, except for two subjects, which showed deterioration. However, the ALT levels of the two subjects subsequently remained stable. CONCLUSION: It is not clear whether it is safe to prescribe statins to patients with ALT > 3 times the UNL. Our study showed that prescription of statins in combination with HEPA did not cause deleterious effects, suggesting that ALT levels > 3 times the UNL do not have harmful effects.

Satisfaction Survey on Information Technology-Based Glucose Monitoring System Targeting Diabetes Mellitus in Private Local Clinics in Korea.

BACKGROUND: Private local clinics in Korea have little experience with information technology (IT)-based glucose monitoring (ITGM). Our aim is to examine user satisfaction and the possibility of using ITGM service practically. METHODS: Patients sent their blood glucose levels to physicians in local clinics. The physicians reviewed the blood glucose values online and provided personal consultations through text messaging or phone calls. Thereafter, a satisfaction survey on the ITGM service, the modified Morisky scale, and patient assessment of chronic illness care were administered. RESULTS: One hundred and seventy patients from seven private local clinics used the ITGM. Overall satisfaction, including that about the ITGM service, the device, and its usefulness, was rated higher than "mostly satisfied" (score 4.2±0.8 out of 5.0) and even higher among the elderly. Satisfaction was positively associated with age, especially in those older than 60 years. The main reason for intent for future use of the service was the time/place flexibility. Highly motivated patients tended to answer positively regarding information satisfaction (P=0.0377). CONCLUSION: Our study is the first to investigate ITGM satisfaction in private local clinics. The feasibility of users utilizing ITGM should be clarified, and future clinical research on the service's clinical effects and cost-benefit analysis is needed.

Physician-Directed Diabetes Education without a Medication Change and Associated Patient Outcomes.

BACKGROUND: When patients with diabetes mellitus (DM) are first referred to a hospital from primary health care clinics, physicians have to decide whether to administer an oral hypoglycemic agent (OHA) immediately or postpone a medication change in favor of diabetes education regarding diet or exercise. The aim of this study was to determine the effect of diabetes education alone (without alterations in diabetes medication) on blood glucose levels. METHODS: The study was conducted between January 2009 and December 2013 and included patients with DM. The glycosylated hemoglobin (HbA1c) levels were evaluated at the first visit and after 3 months. During the first medical examination, a designated doctor also conducted a diabetes education session that mainly covered dietary management. RESULTS: Patients were divided into those who received no diabetic medications (n=66) and those who received an OHA (n=124). Education resulted in a marked decrease in HbA1c levels in the OHA group among patients who had DM for <1 year (from 7.0%±1.3% to 6.6%±0.9%, P=0.0092) and for 1 to 5 years (from 7.5%±1.8% to 6.9%±1.1%, P=0.0091). Those with DM >10 years showed a slightly lower HbA1c target achievement rate of <6.5% (odds ratio, 0.089; P=0.0024). CONCLUSION: For patients who had DM for more than 5 years, higher doses or changes in medication were more effective than intensive active education. Therefore, individualized and customized education are needed for these patients. For patients with a shorter duration of DM, it may be more effective to provide initial intensive education for diabetes before prescribing medicines, such as OHAs.

The differences in the incidence of diabetes mellitus and prediabetes according to the type of HMG-CoA reductase inhibitors prescribed in Korean patients.

BACKGROUND: Very few studies conducted in Korea have investigated the relationship between statins and the incidence of diabetes. Therefore, we analyzed the progression from normal blood glucose to prediabetes and then to diabetes mellitus (DM) according to the type, intensity, and dose of statin prescribed. METHODS: Data of patients who were first prescribed statins between 2009 and 2011 were extracted from electronic medical records. Patients with normal blood glucose or prediabetes were observed for 4 years after initiation of statin therapy. RESULTS: A total of 2890 patients were included in our study and analyzed on the basis of the first statin they were prescribed. The incidence rate of DM in patients with prediabetes was 1.72 times that of patients with normal glucose levels (odds ratio = 1.72, 95% confidence interval = 1.41-2.10, P < .001). Regarding progression from normal blood glucose to prediabetes, the incidence rate of prediabetes was significantly lower in patients prescribed pitavastatin (odds ratio = 0.62, 95% confidence interval = 0.40-0.96, P = .031) compared to that in patients prescribed atorvastatin. Regarding the progression from normal blood glucose or prediabetes to DM, there were no significant differences among all statins. CONCLUSIONS: Lower DM incidence in patients prescribed pitavastatin appears to be primarily because of the lower rate of progression from normal blood glucose to prediabetes. These findings indicate that avoiding statins because of DM risk is unjustified and that clinicians should prescribe statins from the appropriate potency group.

Development of Clinical Data Mart of HMG-CoA Reductase Inhibitor for Varied Clinical Research.

BACKGROUND: The increasing use of electronic medical record (EMR) systems for documenting clinical medical data has led to EMR data being increasingly accessed for clinical trials. In this study, a database of patients who were prescribed statins for the first time was developed using EMR data. A clinical data mart (CDM) was developed for cohort study researchers. METHODS: Seoul St. Mary's Hospital implemented a clinical data warehouse (CDW) of data for ~2.8 million patients, 47 million prescription events, and laboratory results for 150 million cases. We developed a research database from a subset of the data on the basis of a study protocol. Data for patients who were prescribed a statin for the first time (between the period from January 1, 2009 to December 31, 2015), including personal data, laboratory data, diagnoses, and medications, were extracted. RESULTS: We extracted initial clinical data of statin from a CDW that was established to support clinical studies; the data was refined through a data quality management process. Data for 21,368 patients who were prescribed statins for the first time were extracted. We extracted data every 3 months for a period of 1 year. A total of 17 different statins were extracted. It was found that statins were first prescribed by the endocrinology department in most cases (69%, 14,865/21,368). CONCLUSION: Study researchers can use our CDM for statins. Our EMR data for statins is useful for investigating the effectiveness of treatments and exploring new information on statins. Using EMR is advantageous for compiling an adequate study cohort in a short period.

Use of Moderate-Intensity Statins for Low-Density Lipoprotein Cholesterol Level above 190 mg/dL at Baseline in Koreans.

The ACC/AHA 2013 guideline recommends high-intensity statin therapy for a decrease in low-density lipoprotein cholesterol (LDL-C) level by >50% among patients with baseline values of ≥190 mg/dL (approximately 4.872 mmol/L); however, this value should be modified before applying it to Korean populations. We investigated the statin-specific LDL-C-lowering effects in Korean patients with baseline LDL-C value ≥4.872 mmol/L. Data of patients prescribed a statin for the first time from January 2009 to December 2013 were assessed. In patients with baseline LDL-C value ≥4.872 mmol/L, laboratory data for a maximum of 6 months from the date of first statin prescription were collected. Among 33,721 patients who were prescribed a statin for the first time, 655 patients had a baseline LDL-C value ≥4.872 mmol/L (1.9%). Of these, 179 patients were analysed. Patients receiving moderate-intensity statins were divided into two groups based on LDL-C reduction rate (p = 0.0002), defined as moderate-high-intensity (atorvastatin 20 mg, rosuvastatin 10 mg, simvastatin 20 mg) and moderate-low-intensity (atorvastatin 10 mg, pitavastatin 2 mg, pravastatin 40 mg) statin groups. LDL-C reduction rates did not significantly differ between the moderate-high- and high-intensity statin groups (p = 0.4895). We found that some moderate-intensity statins demonstrated a LDL-C-lowering effect of more than 50% in Korean patients with a baseline LDL-C value ≥4.872 mmol/L. Our results reflect the need of a large-scale, randomized, controlled trial on partial reclassification of statins for patients with baseline LDL-C value ≥4.872 mmol/L before adopting ACC/AHC guidelines in Korea.

Social Networking Services-Based Communicative Care for Patients with Diabetes Mellitus in Korea.

OBJECTIVES: Social networking services (SNS)-based online communities are good examples of improving quality of care by incorporating information technology into medicine. Therefore, we created an SNS-based community care webpage for communication among patients with diabetes mellitus (DM). We aimed to identify what diabetic patients wanted to know and were interested in by analyzing their posts and classified content in which users were interested. METHODS: As opposed to the existing physician-focused health information websites, we built a patient-focused experience exchange website, "I love insulin (http://www.iloveinsulin.co.kr)." The DM communication webpage was divided into "My Web-Chart," "My community-free board," and "Life & Health." The contents analysis targeted users' postings, and replies were classified by theme from May 2012 to June 2013. The data included number of questions asked, answers, and question-to-answer (QA) ratio in each category. RESULTS: A total of 264 patients registered on the "I Love Insulin" website. The most frequent topic of posts classified as questions were about diabetes itself (23%), diet (22%), and glucose levels (19%). Conversely, most answers and information provided by users were about daily life with no relationship to diabetes mellitus (54%). While there were many questions about diet, there were very few answers (2%). Whereas there was much provision of knowledge about general DM, sharing diet information was rare. The ratios of answers to questions on diet (ratio=0.059, 1/17), glucose level (ratio=0.067, 1/15), insulin regulation (ratio=0.222, 2/9) and webpage (ratio=0.167, 1/6) were significantly low compared to DM itself (all p < 0.001). DISCUSSION: Patients in Korea with DM tend to have insufficient knowledge about diet and insulin regulation; continuously providing diet and insulin regulation information are desirable. It is hoped that the patients would be motivated to participate actively by "knowledge sharing." Through this process, patients learn about their diseases not from the physicians but from among themselves.

Randomized, Open-Label, Parallel Group Study to Evaluate the Effect of Internet-Based Glucose Management System on Subjects with Diabetes in China.

OBJECTIVE: Large amounts of time and effort are needed to implement an Internet-based glucose monitoring system (IBGMS) in the clinical setting. This study was designed using research experience that was developed while implementing an IBGMS in Korea, and the research platform was modified to evaluate the efficacy of an IBGMS in controlling blood sugar in the Chinese population. METHODS: A randomized, open-label, parallel group design was used to evaluate the efficacy of an IBGMS among Chinese subjects with type 2 diabetes. Over a 6-month period, 182 subjects were evaluated in the IBGMS (n = 92) or control (n = 90) groups. RESULTS: After 3 months, the control group's HbA1c levels were reduced from 8.0% ± 0.8% to 7.3% ± 1.2% (p < 0.001) and the IBGMS group experienced a reduction from 7.9% ± 0.8% to 6.9% ± 0.7% (p < 0.001); the IBGMS group's end value was significantly lower (p = 0.014). The intragroup changes in the control and IBGMS groups were significant at the 3-month (p = 0.002) and 6-month (p < 0.01) follow-ups. Over this period, the HbA1c levels in the control group increased slightly (7.3% ± 1.1% to 7.4% ± 1.3%, p = 0.605), and the HbA1c levels in the IBGMS group decreased slightly (6.9% ± 0.7% to 6.7% ± 0.7%, p = 0.081). CONCLUSIONS: The IBGMS was effective in improving blood sugar levels among patients with diabetes. Therefore, IBGMS experience can be effectively transferred between institutions and countries.

Efficacy of the smartphone-based glucose management application stratified by user satisfaction.

BACKGROUND: We aimed to assess the efficacy of the smartphone-based health application for glucose control and patient satisfaction with the mobile network system used for glucose self-monitoring. METHODS: Thirty-five patients were provided with a smartphone device, and self-measured blood glucose data were automatically transferred to the medical staff through the smartphone application over the course of 12 weeks. The smartphone user group was divided into two subgroups (more satisfied group vs. less satisfied group) based on the results of questionnaire surveys regarding satisfaction, comfort, convenience, and functionality, as well as their willingness to use the smartphone application in the future. The control group was set up via a review of electronic medical records by group matching in terms of age, sex, doctor in charge, and glycated hemoglobin (HbA1c). RESULTS: Both the smartphone group and the control group showed a tendency towards a decrease in the HbA1c level after 3 months (7.7%±0.7% to 7.5%±0.7%, P=0.077). In the more satisfied group (n=27), the HbA1c level decreased from 7.7%±0.8% to 7.3%±0.6% (P=0.001), whereas in the less satisfied group (n=8), the HbA1c result increased from 7.7%±0.4% to 8.1%±0.5% (P=0.062), showing values much worse than that of the no-smartphone control group (from 7.7%±0.5% to 7.7%±0.7%, P=0.093). CONCLUSION: In addition to medical feedback, device and network-related patient satisfaction play a crucial role in blood glucose management. Therefore, for the smartphone app-based blood glucose monitoring to be effective, it is essential to provide the patient with a well-functioning high quality tool capable of increasing patient satisfaction and willingness to use.