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Original Articles
Drug/Regimen
Safety and Effectiveness of Dulaglutide in the Treatment of Type 2 Diabetes Mellitus: A Korean Real-World Post-Marketing Study
Jeonghee Han, Woo Je Lee, Kyu Yeon Hur, Jae Hyoung Cho, Byung Wan Lee, Cheol-Young Park
Received February 3, 2023  Accepted July 10, 2023  Published online February 2, 2024  
DOI: https://doi.org/10.4093/dmj.2023.0030    [Epub ahead of print]
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AbstractAbstract PDFSupplementary MaterialPubReader   
Background
To investigate the real-world safety and effectiveness of dulaglutide in Korean adults with type 2 diabetes mellitus (T2DM).
Methods
This was a real-world, prospective, non-interventional post-marketing safety study conducted from May 26, 2015 to May 25, 2021 at 85 Korean healthcare centers using electronic case data. Data on patients using dulaglutide 0.75 mg/0.5 mL or the dulaglutide 1.5 mg/0.5 mL single-use pens were collected and pooled. The primary objective was to report the frequency and proportion of adverse and serious adverse events that occurred. The secondary objective was to monitor the effectiveness of dulaglutide at 12 and 24 weeks by evaluating changes in glycosylated hemoglobin (HbA1c ), fasting plasma glucose, and body weight.
Results
Data were collected from 3,067 subjects, and 3,022 subjects who received ≥1 dose (of any strength) of dulaglutide were included in the safety analysis set (53% female, mean age 56 years; diabetes duration 11.2 years, mean HbA1c 8.8%). The number of adverse events reported was 819; of these, 68 (8.3%) were serious adverse events. One death was reported. Adverse events were mostly mild in severity; 60.81% of adverse events were considered related to dulaglutide. This study was completed by 72.73% (2,198/3,022) of subjects. At 12/24 weeks there were significant (P<0.0001) reductions from baseline in least-squares mean HbA1c (0.96%/0.95%), fasting blood glucose (26.24/24.43 mg/dL), and body weight (0.75/1.21 kg).
Conclusion
Dulaglutide was generally well tolerated and effective in real-world Korean individuals with T2DM. The results from this study contribute to the body of evidence for dulaglutide use in this population.
Drug/Regimen
Safety and Effectiveness of Empagliflozin in Korean Patients with Type 2 Diabetes Mellitus: Results from a Nationwide Post-Marketing Surveillance
Jun Sung Moon, Nam Hoon Kim, Jin Oh Na, Jae Hyoung Cho, In-Kyung Jeong, Soon Hee Lee, Ji-Oh Mok, Nan Hee Kim, Dong Jin Chung, Jinhong Cho, Dong Woo Lee, Sun Woo Lee, Kyu Chang Won
Diabetes Metab J. 2023;47(1):82-91.   Published online June 20, 2022
DOI: https://doi.org/10.4093/dmj.2021.0356
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AbstractAbstract PDFSupplementary MaterialPubReader   ePub   
Background
To evaluate the safety and effectiveness of empagliflozin in routine clinical settings, we collected and assessed the clinical profiles of Korean patients with type 2 diabetes mellitus.
Methods
This was a post-marketing surveillance study of empagliflozin 10 and 25 mg. Information on adverse events and adverse drug reactions (ADRs) was collected as safety data sets. Available effectiveness outcomes, including glycosylated hemoglobin (HbA1c) level, fasting plasma glucose, body weight, and blood pressure, were assessed.
Results
The incidence rate of ADRs was 5.14% in the safety dataset (n=3,231). Pollakiuria, pruritis genital, and weight loss were the most common ADRs. ADRs of special interest accounted for only 1.18%, and there were no serious events that led to mortality or hospitalization. In the effectiveness data set (n=2,567), empagliflozin significantly reduced the mean HbA1c level and body weight during the study period by –0.68%±1.39% and –1.91±3.37 kg (both P<0.0001), respectively. In addition, shorter disease duration, absence of dyslipidemia, and higher baseline HbA1c levels were identified as the clinical features characteristic of a “responder” to empagliflozin therapy.
Conclusion
Empagliflozin is a safe and potent glucose-lowering drug in routine use among Korean patients with type 2 diabetes mellitus. It is expected to have better glycemic efficacy in Korean patients with poorly controlled type 2 diabetes mellitus.

Citations

Citations to this article as recorded by  
  • Evaluation of Efficacy and Safety of Empagliflozin in Bangladeshi Patients with Type 2 Diabetes Mellitus (EFFISAEM Study)
    Mohammad Saifuddin, Ajit Kumar Paul, Sultana Marufa Shefin, Md. Jahangir Alam, Shahjada Selim, Sunjida Islam, Tanjina Hossain, Sadiqa Tuqan, Nusrat Sultana, Marufa Mustari, Ramen Chandra Basak, Kazi Ali Aftab, Indrajit Prasad, Mohammad Rafiq Uddin, Shoma
    Indian Journal of Endocrinology and Metabolism.2024;[Epub]     CrossRef
  • Comparison of the Pharmacokinetics, Safety, and Tolerability of Two Empagliflozin Formulations in Healthy Korean Subjects
    Xu Jiang, Sungyeun Bae, Deok Yong Yoon, Shin Jung Park, Jaeseong Oh, Joo-Youn Cho, Kyung-Sang Yu
    Drug Design, Development and Therapy.2023; Volume 17: 2137.     CrossRef
  • Comparative safety of different sodium-glucose transporter 2 inhibitors in patients with type 2 diabetes: a systematic review and network meta-analysis of randomized controlled trials
    Chun Xing Li, Li Yan Liu, Chen Xiao Zhang, Xu Hua Geng, Si Meng Gu, Yu Qiao Wang, Hua Liu, Qing Xie, Shuo Liang
    Frontiers in Endocrinology.2023;[Epub]     CrossRef
Corrigendum
Early Glycosylated Hemoglobin Target Achievement Predicts Clinical Outcomes in Patients with Newly Diagnosed Type 2 Diabetes Mellitus
Joonyub Lee, Jae Hyoung Cho
Diabetes Metab J. 2021;45(4):621-621.   Published online July 30, 2021
DOI: https://doi.org/10.4093/dmj.2021.0119
Corrects: Diabetes Metab J 2021;45(3):337
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Citations

Citations to this article as recorded by  
  • Dynamic Detection of HbA1c Using a Silicon Nanowire Field Effect Tube Biosensor
    Hang Chen, Lijuan Deng, Jialin Sun, Hang Li, Xiaoping Zhu, Tong Wang, Yanfeng Jiang
    Biosensors.2022; 12(11): 916.     CrossRef
Editorial
Early Glycosylated Hemoglobin Target Achievement Predicts Clinical Outcomes in Patients with Newly Diagnosed Type 2 Diabetes Mellitus
Joonyub Lee, Jae Hyoung Cho
Diabetes Metab J. 2021;45(3):337-338.   Published online May 25, 2021
DOI: https://doi.org/10.4093/dmj.2021.0078
Correction in: Diabetes Metab J 2021;45(4):621
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Citations

Citations to this article as recorded by  
  • Evaluation of Left Ventricular Function in Diabetes Patients with Microvascular Disease by Three-Dimensional Speckle Tracking Imaging
    青 周
    Advances in Clinical Medicine.2023; 13(12): 18908.     CrossRef
  • Association of long-term visit-to-visit variability of HbA1c and fasting glycemia with hypoglycemia in type 2 diabetes mellitus
    Chen Long, Yaling Tang, Jiangsheng Huang, Suo Liu, Zhenhua Xing
    Frontiers in Endocrinology.2022;[Epub]     CrossRef
  • Time to Reach Target Glycosylated Hemoglobin Is Associated with Long-Term Durable Glycemic Control and Risk of Diabetic Complications in Patients with Newly Diagnosed Type 2 Diabetes Mellitus: A 6-Year Observational Study (Diabetes Metab J 2021;45:368-78)
    Kyoung Jin Kim, Jimi Choi, Jae Hyun Bae, Kyeong Jin Kim, Hye Jin Yoo, Ji A Seo, Nan Hee Kim, Kyung Mook Choi, Sei Hyun Baik, Sin Gon Kim, Nam Hoon Kim
    Diabetes & Metabolism Journal.2021; 45(4): 617.     CrossRef
Original Article
Complications
Differences in Clinical Outcomes between Patients with and without Hypoglycemia during Hospitalization: A Retrospective Study Using Real-World Evidence
Jeongmin Lee, Tong Min Kim, Hyunah Kim, Seung-Hwan Lee, Jae Hyoung Cho, Hyunyong Lee, Hyeon Woo Yim, Kun-Ho Yoon, Hun-Sung Kim
Diabetes Metab J. 2020;44(4):555-565.   Published online May 8, 2020
DOI: https://doi.org/10.4093/dmj.2019.0064
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AbstractAbstract PDFSupplementary MaterialPubReader   ePub   
Background

Some patients admitted to hospitals for glycemic control experience hypoglycemia despite regular meals and despite adhering to standard blood glucose control protocols. Different factors can have a negative impact on blood glucose control and prognosis after discharge. This study investigated risk factors for hypoglycemia and its effects on glycemic control during the hospitalization of patients in the general ward.

Methods

This retrospective study included patients who were admitted between 2009 and 2018. Patients were provided regular meals at fixed times according to ideal body weights during hospitalization. We categorized the patients into two groups: those with and those without hypoglycemia during hospitalization.

Results

Of the 3,031 patients, 379 experienced at least one episode of hypoglycemia during hospitalization (HYPO group). Hypoglycemia occurred more frequently particularly in cases of premixed insulin therapy. Compared with the control group, the HYPO group was older (61.0±16.8 years vs. 59.1±16.5 years, P=0.035), with more females (60.4% vs. 49.6%, P<0.001), lower body mass index (BMI) (23.5±4.2 kg/m2 vs. 25.1±4.4 kg/m2, P<0.001), and higher prevalence of type 1 diabetes mellitus (6.1% vs. 2.6%, P<0.001), They had longer hospital stay (11.1±13.5 days vs. 7.6±4.6 days, P<0.001). After discharge the HYPO group had lower glycosylated hemoglobin reduction rate (−2.0%±0.2% vs. −2.5%±0.1%, P=0.003) and tended to have more frequent cases of cardiovascular disease.

Conclusion

Hypoglycemia occurred more frequently in older female patients with lower BMI and was associated with longer hospital stay and poorer glycemic control after discharge. Therefore, clinicians must carefully ensure that patients do not experience hypoglycemia during hospitalization.

Citations

Citations to this article as recorded by  
  • Acute kidney injury: a strong risk factor for hypoglycaemia in hospitalized patients with type 2 diabetes
    Ana Carreira, Pedro Castro, Filipe Mira, Miguel Melo, Pedro Ribeiro, Lèlita Santos
    Acta Diabetologica.2023; 60(9): 1179.     CrossRef
  • Adherence to healthy lifestyle behaviors as a preventable risk factor for severe hypoglycemia in people with type 2 diabetes: A longitudinal nationwide cohort study
    Jae‐Seung Yun, Kyungdo Han, Yong‐Moon Park, Eugene Han, Yong‐ho Lee, Seung‐Hyun Ko
    Journal of Diabetes Investigation.2022; 13(9): 1533.     CrossRef
  • Predicting hypoglycemia in hospitalized patients with diabetes: A derivation and validation study
    Michal Elbaz, Jeries Nashashibi, Shiri Kushnir, Leonard Leibovici
    Diabetes Research and Clinical Practice.2021; 171: 108611.     CrossRef
  • Hospital care: improving outcomes in type 1 diabetes
    Schafer Boeder, Kristen Kulasa
    Current Opinion in Endocrinology, Diabetes & Obesity.2021; 28(1): 14.     CrossRef
  • Data Pseudonymization in a Range That Does Not Affect Data Quality: Correlation with the Degree of Participation of Clinicians
    Soo-Yong Shin, Hun-Sung Kim
    Journal of Korean Medical Science.2021;[Epub]     CrossRef
  • Letter: Differences in Clinical Outcomes between Patients with and without Hypoglycemia during Hospitalization: A Retrospective Study Using Real-World Evidence (Diabetes Metab J 2020;44:555-65)
    Sung-Woo Kim
    Diabetes & Metabolism Journal.2020; 44(5): 775.     CrossRef
  • Response: Differences in Clinical Outcomes between Patients with and without Hypoglycemia during Hospitalization: A Retrospective Study Using Real-World Evidence (Diabetes Metab J 2020;44:555-65)
    Jeongmin Lee, Hun-Sung Kim
    Diabetes & Metabolism Journal.2020; 44(5): 779.     CrossRef
  • Hypoglycaemia and Cardiovascular Disease Risk in Patients with Diabetes
    Niki Katsiki, Kalliopi Kotsa, Anca P. Stoian, Dimitri P. Mikhailidis
    Current Pharmaceutical Design.2020; 26(43): 5637.     CrossRef
Letter
Letter: Effects of High-Dose α-Lipoic Acid on Heart Rate Variability of Type 2 Diabetes Mellitus Patients with Cardiac Autonomic Neuropathy in Korea (Diabetes Metab J 2017;41:275-83)
Jeongmin Lee, Jae Hyoung Cho
Diabetes Metab J. 2017;41(5):417-419.   Published online October 24, 2017
DOI: https://doi.org/10.4093/dmj.2017.41.5.417
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Citations

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  • Efficacy and safety of oral alpha-lipoic acid supplementation for type 2 diabetes management: a systematic review and dose–response meta-analysis of randomized trials
    Aliyu Tijani Jibril, Ahmad Jayedi, Sakineh Shab-Bidar
    Endocrine Connections.2022;[Epub]     CrossRef
  • Long-Term Sleep Deprivation-Induced Myocardial Remodeling and Mitochondrial Dysfunction in Mice Were Attenuated by Lipoic Acid and N-Acetylcysteine
    Fei Song, Jiale Lin, Houjian Zhang, Yuli Guo, Yijie Mao, Zuguo Liu, Gang Li, Yan Wang
    Pharmaceuticals.2022; 16(1): 51.     CrossRef
Original Articles
Others
Satisfaction Survey on Information Technology-Based Glucose Monitoring System Targeting Diabetes Mellitus in Private Local Clinics in Korea
Hun-Sung Kim, So Jung Yang, Yoo Jin Jeong, Young-Eun Kim, Seok-Won Hong, Jae Hyoung Cho
Diabetes Metab J. 2017;41(3):213-222.   Published online June 21, 2017
DOI: https://doi.org/10.4093/dmj.2017.41.3.213
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AbstractAbstract PDFPubReader   
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.

Citations

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  • Exploring Quantitative Methodologies for Assessing the Environmental, Social, and Economic Impacts of Telemedicine: A Literature Review
    Anna Savoldelli, Daniele Landi, Caterina Rizzi
    Sustainability.2024; 16(6): 2438.     CrossRef
  • Telemedicine for Diabetes Mellitus Management in Older Adults: A Systematic Review
    Luca Schiliró Tristão, Guilherme Tavares, Francisco Tustumi, Wanderley Marques Bernardo, Márcio Luis Duarte, Maria Stella Peccin, Lucas Ribeiro dos Santos
    Current Diabetes Reviews.2023;[Epub]     CrossRef
  • The effectiveness of mobile application for monitoring diabetes mellitus and hypertension in the adult and elderly population: systematic review and meta-analysis
    Emily de Souza Ferreira, Fernanda de Aguiar Franco, Marina Marilac dos Santos Lara, André Amaral Levcovitz, Mateus Araújo Dias, Tiago Ricardo Moreira, Ary Henrique Morais de Oliveira, Rosângela Minardi Mitre Cotta
    BMC Health Services Research.2023;[Epub]     CrossRef
  • Effects of the Physician–Primary-Healthcare Nurse Telemedicine Model (P-NTM) on Medication Adherence and Health-Related Quality of Life (HRQoL) of Patients with Chronic Disease at Remote Rural Areas
    Mi Young Kwak, Eun Jeong Hwang, Tae Ho Lee
    International Journal of Environmental Research and Public Health.2021; 18(5): 2502.     CrossRef
  • Lessons from Use of Continuous Glucose Monitoring Systems in Digital Healthcare
    Hun-Sung Kim, Kun-Ho Yoon
    Endocrinology and Metabolism.2020; 35(3): 541.     CrossRef
  • Apprehensions about Excessive Belief in Digital Therapeutics: Points of Concern Excluding Merits
    Hun-Sung Kim
    Journal of Korean Medical Science.2020;[Epub]     CrossRef
  • Peripartum Management of Gestational Diabetes Using a Digital Health Care Service: A Pilot, Randomized Controlled Study
    Ji-Hee Sung, Da Young Lee, Kyoung Pil Min, Cheol-Young Park
    Clinical Therapeutics.2019; 41(11): 2426.     CrossRef
  • Mobile Phone–Based Telemedicine Practice in Older Chinese Patients with Type 2 Diabetes Mellitus: Randomized Controlled Trial
    Chenglin Sun, Lin Sun, Shugang Xi, Hong Zhang, Huan Wang, Yakun Feng, Yufeng Deng, Haimin Wang, Xianchao Xiao, Gang Wang, Yuan Gao, Guixia Wang
    JMIR mHealth and uHealth.2019; 7(1): e10664.     CrossRef
Clinical Care/Education
Physician-Directed Diabetes Education without a Medication Change and Associated Patient Outcomes
Hun-Sung Kim, Hyunah Kim, Hae-Kyung Yang, Eun Young Lee, Yoo Jin Jeong, Tong Min Kim, So Jung Yang, Seo Yeon Baik, Seung-Hwan Lee, Jae Hyoung Cho, In Young Choi, Hyeon Woo Yim, Bong-Yun Cha
Diabetes Metab J. 2017;41(3):187-194.   Published online May 12, 2017
DOI: https://doi.org/10.4093/dmj.2017.41.3.187
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AbstractAbstract PDFPubReader   
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.

Citations

Citations to this article as recorded by  
  • Management Status of Patients with Type 2 Diabetes Mellitus at General Hospitals in Korea: A 5-Year Follow-Up Study
    Jin Hee Jung, Jung Hwa Lee, Hyang Mi Jang, Young Na, Hee Sun Choi, Yeon Hee Lee, Yang Gyo Kang, Na Rae Kim, Jeong Rim Lee, Bok Rye Song, Kang Hee Sim
    The Journal of Korean Diabetes.2022; 23(1): 64.     CrossRef
  • Effect of Voluntary Participation on Mobile Health Care in Diabetes Management: Randomized Controlled Open-Label Trial
    Da Young Lee, Seung-Hyun Yoo, Kyong Pil Min, Cheol-Young Park
    JMIR mHealth and uHealth.2020; 8(9): e19153.     CrossRef
  • Developing a multi-center clinical data mart of ACEI and ARB for real-world evidence (RWE)
    Hun-Sung Kim, Sue Hyun Lee, Tong Min Kim, Ju Han Kim
    Clinical Hypertension.2018;[Epub]     CrossRef
Editorial
Clinical Care/Education
Potential of OneTouch Diabetes Management Software System in Real Field for Korean Type 2 Diabetes Patients
Borami Kang, Jae Hyoung Cho
Diabetes Metab J. 2016;40(2):115-117.   Published online April 25, 2016
DOI: https://doi.org/10.4093/dmj.2016.40.2.115
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Original Articles
The Insulin Resistance but Not the Insulin Secretion Parameters Have Changed in the Korean Population during the Last Decade
Hae Kyung Yang, Jin Hee Lee, In-Young Choi, Hyuk Sang Kwon, Jeong Ah Shin, Seung Hee Jeong, Seung-Hwan Lee, Jae Hyoung Cho, Ho Young Son, Kun Ho Yoon
Diabetes Metab J. 2015;39(2):117-125.   Published online April 20, 2015
DOI: https://doi.org/10.4093/dmj.2015.39.2.117
  • 4,554 View
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AbstractAbstract PDFPubReader   
Background

This study aimed to compare the patterns of insulin secretion and resistance between Korean subjects in the 1990s and 2000s.

Methods

Insulin secretion and resistance indices were calculated from subjects who underwent 75-g oral glucose tolerance tests in the year 1997 to 1999 and 2007 to 2011 at the Seoul St. Mary's Hospital, Korea.

Results

A total of 578 subjects from the 1990s (mean age, 48.5 years) and 504 subjects from the 2000s (mean age, 50.2 years) were enrolled. Compared with the subjects from the 1990s, those from the 2000s exhibited increased insulin resistance (increased homeostatic model assessment for insulin resistance), and reduced insulin sensitivity (reduced Matsuda index and quantitative insulin sensitivity check index), regardless of their glucose tolerance status. However, insulinogenic index did not reveal significant differences between the 2 decades in subjects with or without diabetes. A distinct relationship was confirmed between Matsuda index and total area under the curve (insulin/glucose) in each glucose tolerance group. The mean product of the Matsuda index and the total area under the curve (insulin/glucose) as well as the oral disposition index, was lower in subjects with normal glucose tolerance from the 2000s than in those from the 1990s.

Conclusion

After rapid economic growth and changes in lifestyle patterns, insulin resistance has worsened across the glucose tolerance status; however, the insulin secretory function remained unchanged, which resulted in an increase in the susceptibility to the development of type 2 diabetes mellitus among Korean subjects without diabetes. We could not rule out the potential selection bias and therefore, further studies in general Korean population are needed.

Citations

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  • Longitudinal Changes in Insulin Resistance, Beta-Cell Function and Glucose Regulation Status in Prediabetes
    Chul-Hee Kim, Hong-Kyu Kim, Eun-Hee Kim, Sung-Jin Bae, Jaewon Choe, Joong-Yeol Park
    The American Journal of the Medical Sciences.2018; 355(1): 54.     CrossRef
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    Hyunah Kim, Hyunyong Lee, Hyeon Woo Yim, Hun-Sung Kim
    Primary Care Diabetes.2018; 12(1): 59.     CrossRef
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    Diabetes, Obesity and Metabolism.2018; 20(5): 1121.     CrossRef
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    Kei Takahashi, Hidetaka Nakamura, Hiroshi Sato, Hideto Matsuda, Kazuo Takada, Tomiko Tsuji
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    In‐Kyung Jeong, Choon Hee Chung, Zhiguang Zhou, Jeong Hee Han, Ran Duan, Diana M. Edralin, Angel Rodriguez
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    Jong-Dai Kim, Won-Young Lee
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    Min-Ji AHN, Sin-Gu JEONG, Goang-Won CHO
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Incidence of Diabetic Foot and Associated Risk Factors in Type 2 Diabetic Patients: A Five-year Observational Study.
Shin Ae Park, Seung Hyun Ko, Seung Hwan Lee, Jae Hyoung Cho, Sung Dae Moon, Sang A Jang, Hyun Shik Son, Ki Ho Song, Bong Yun Cha, Ho Young Son, Yu Bae Ahn
Korean Diabetes J. 2009;33(4):315-323.   Published online August 1, 2009
DOI: https://doi.org/10.4093/kdj.2009.33.4.315
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AbstractAbstract PDF
BACKGROUND
The frequency of lower extremity amputation due to diabetic foot has been increasing in type 2 diabetic patients. The aim of this study was to observe the incidence, clinical aspects and associated risk factors for diabetic foot. METHODS: We evaluated the incidence of diabetic foot through a five-year observation of type 2 diabetic patients who presented to St. vincent's Hospital between January and December 2003. To identify the risk factors for diabetic foot, we evaluated mean glycosylated hemoglobin A1c (HbA1c) every six months and assessed renal function based on the existence of proteinuria and estimated glomerular filtration rate (GFR) using the Modification of Diet in Renal Disease (MDRD) equation. Patients were also evaluated for retinopathy, peripheral neuropathy and autonomic neuropathy using Ewing's method. RESULTS: From an initial pool of 613 patients, the observational study of 508 patients (82.9%) was completed. The mean age, duration of diabetes and HbA1c were 50.3 +/- 10.6 yrs, 7.2 +/- 6.5 yrs and 8.8 +/- 2.1%, respectively. Diabetic foot occurred in 32 patients (6.3%). The incidence of diabetic foot increased when diabetic retinopathy (OR = 6.707, 2.314~19.439), peripheral neuropathy (OR = 2.949, 1.075~8.090), and autonomic neuropathy (OR = 3.967, 1.476~10.660) were present and when the MDRD GFR (OR = 5.089, 1.712~15.130) decreased. Mean HbA1c (OR = 12.013, 1.470~98.179) was found to be an independent risk factor for diabetic foot. CONCLUSION: The present study confirmed the importance of intensive glycemic control and the role of autonomic dysfunction in the development of diabetic foot. In addition, diabetic retinopathy and impaired renal function proved to be factors associated with the occurrence of diabetic foot. Therefore, intensive glycemic control, as well as periodic examination of renal function, are essential for the prevention of diabetic foot.

Citations

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  • Microbiological, Clinical and Radiological Aspects of Diabetic Foot Ulcers Infected with Methicillin-Resistant and -Sensitive Staphylococcus aureus
    Maria Stańkowska, Katarzyna Garbacz, Anna Korzon-Burakowska, Marek Bronk, Monika Skotarczak, Anna Szymańska-Dubowik
    Pathogens.2022; 11(6): 701.     CrossRef
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The Effects of Exendin-4 on IRS-2 Expression and Phosphorylation in INS-1 Cells.
Ji Hyun Kim, Ji Won Kim, Sung Yoon Jeon, Heon Seok Park, Dong Sik Ham, Young Hye You, Seung Hwan Lee, Jae Hyoung Cho, Mi Ja Kang, Kang Woo Lee, Hyuk Sang Kwon, Kun Ho Yoon, Bong Yun Cha, Kwang Woo Lee, Sung Koo Kang, Ho Young Son
Korean Diabetes J. 2008;32(2):102-111.   Published online April 1, 2008
DOI: https://doi.org/10.4093/kdj.2008.32.2.102
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AbstractAbstract PDF
BACKGROUND
Insulin receptor substrate 2 (IRS-2) is a key regulator of beta cell proliferation and apoptosis. This study was aimed to investigate effect of the glucolipotoxicity on apoptosis in INS-1 cell, and the effect of Exendin-4, a GLP-1 receptor agonist, on IRS-2 expression in the glucolipotoxicity induced INS-1 cell. The goal was to discover the new action mechanism and function of Exendin-4 in beta cell apoptosis. METHOD: INS-1 cells were cultured in glucolipotoxic condition for 2, 4 or 6 days and were categorized as G groups. Another group in which 50 nM Exendin-4 was added to INS-1 cells, cultured in glucolipotoxic condition, were named as Ex-4 groups. We investigated the expression of IRS-2 by RT-PCR, phosphorylated IRS-2 and phosphorylated Akt protein levels by western blot. We measured the apoptosis ratio of INS-1 cell in glucolipotoxic condition by TUNEL staining in both groups. RESULT: IRS-2 expression of INS-1 cells decreased with correlation to the time of exposure to glucolipotoxic condition. pIRS-2 and pAkt protein levels decreased in the similar pattern in glucolipotoxicity group. However, this effect of glucolipotoxicity on INS-1 cell was inhibited by the Exendin-4 treatment. In the Ex-4 groups, IRS-2 expression, pIRS-2 and pAkt protein levels remained at the similar level to low glucose condition state. Also, apoptosis induced by glucolipotoxicity was suppressed by Exendin-4 treatment significantly. CONCLUSION: We showed that the long-term treatment of Exendin-4 inhibited the apoptosis of beta cells significantly in glucolipotoxic condition and that this effect of Exendin-4 was related with IRS-2 and Akt among the beta cell's intracellular signal transduction pathway.
Clinical Trial
Perspectives of "Ubiquitous Health Care System" for Diabetes Management.
Jae Hyoung Cho, Hyuk Sang Kwon, Kun Ho Yoon
Korean Diabetes J. 2006;30(2):87-95.   Published online March 1, 2006
DOI: https://doi.org/10.4093/jkda.2006.30.2.87
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AbstractAbstract PDF
Although clear evidences of the beneficial effects of tight glycemic control on diabetic patients had been already made, the past decade has not seen any noticeable improvement in terms of glycemic control. "Ubiquitous health care system", which is one of the developing fusion technologies of IT, BT and NT, could give us new solutions in future. We established the Internet based glucose monitoring system (IBGMS) and conducted prospective, randomized short-term and long-term clinical trials using the system which can guide the patients with diabetes by mobile technology anytime and anywhere. The mean HbA1c and HbA1c fluctuation index (SD of mean HbA1c) during the whole study period was significantly lowered by the intervention, suggesting more improved state in both HbA1c level and glucose stability. Appropriate physician's advises to the patients' questions and problems at the right time through the IBGMS were the major interventions. Although many unsolved problems still exist, the Internet-based bidirectional communication system developed by the advanced information technology can contribute to the foundations to tomorrow's or ubiquitous medicine

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Randomized Controlled Trial
Establishment of Blood Glucose Monitoring System using Internet.
Hee Soo Kim, Jae Hyoung Cho, Hyuk Sang Kwon, Jin Hee Lee, Bok Re Song, Jung A Oh, Kun Ho Yoon, Ho Young Son
Korean Diabetes J. 2003;27(3):280-287.   Published online June 1, 2003
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AbstractAbstract PDF
BACKGROUND
The internet has been used world wide as a communication tool. To improve the quality of glucose control, the effectiveness of an Internet-based Blood Glucose Monitoring System (IBGMS), on changes in HbA1c levels, was investigated. RESEARCH DESIGN AND METHODS: A randomized clinical trial, involving 110 patients who had visited outpatient's clinic at the Kangnam St. Mary's Hospital diabetes center for 3 months, was conducted. The study subjects were treated with IBGMS for 12 weeks, with a control group receiving the usual outpatient management for the same period. HbA1C and other laboratory tests were performed at the baseline and at the end of the study. RESULTS: There were no significant differences found between the two groups at the baseline measurements, with respect to age, sex, diabetes duration, body mass index, blood pressure, HbA1C and other laboratory data. In the follow up tests, the study group showed a significant reduction in the HbA1C level, by 7.1% (0.54% absolute, p=0.001), while the control group showed an increased HbA1C level (p=0.054). Moreover, there was an 11.1% reduction (0.92% absolute, p<0.001) in the HbA1C level in the patients with HbA1C levels > or =7.0% at baseline in the study group, but those with HbA1C levels <7.0% maintained good HbA1c levels, 6.32%, by the end of the study. CONCLUSIONS: This new IBGMS resulted in a significant reduction in the HbA1C levels during the study period. We propose this IBGMS as a new method for glycemic control.
Original Article
Selective beta-Cell Loss and alpha-Cell Expansion in Islets of Type 2 Diabetic Patients.
Jae Hyoung Cho, In Kyu Lee, Kun Ho Yoon, Seung Hyun Ko, Sun Hee Suh, Jung Min Lee, Sung Rae Kim, Yoo Bae Ahn, Jong Min Lee, Hyun Shik Son, Moo Il Kang, Bong Yun Cha, Kwang Woo Lee, Ho Young Son, Sung Koo Kang
Korean Diabetes J. 2001;25(2):164-177.   Published online April 1, 2001
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AbstractAbstract PDF
BACKGROUND
It has been reported that a decrease in the beta-cell mass, may play a major role in the development of type 2 diabetes. Some stimuli that cause beta-cell loss can stimulate neogenesis from precursors as well as replication of matured beta-cells. In an animal-based studies reported that alpha-cells can also be produced in the course of alpha-cell neogenesis, after being treated with streptozotocin. Through this research, we attempted to determine the change of beta-cell mass according to the changes in alpha-cell mass and to characterize the size of the beta-cell nucleus observed in type 2 diabetes. METHOD: To estimate the relative fraction of alpha- and beta-cell mass in the pancreas, we counted beta-cells and alpha-cells by point count method. We also performed a double immunohistochemical staining with glucagon and insulin antibodies to calculate the ratio between these two cells area in the pancreas (A/B ratio). In order to measure the size of the beta-cell nucleus, an immunofluorescence staining of the nucleus and insulin was carried out. Data were gathered from type 2 diabetic subjects (n=19) and normal controls (n=8). RESULTS: Although there was no statistical difference, we observed the tendency of decrease of beta-cell mass and increase of alpha-cell mass in the pancreas of type 2 diabetic patients. The ratio of alpha-to beta-cell area in islet (A/B ratio) increased to 0.81+/-0.76 in diabetic patients compared to control with 0.26+/-0.25 (p<0.01). The mean of the A/B ratios of the islets more than 22,000 micro m2 was 1.64+/-1.10, whereas that of the islets less than 22,000 micro m2 was 0.73+/-0.67 in type 2 diabetic patients (p<0.01). The size of the beta-cell nucleus in both diabetic subjects and normal controls was bigger than that of exocrine cells (p<0.05) and 2.9% of beta-cells in type 2 diabetic subjects showed substantially enlarged nuclei more than M+5SD (M and SD means the average and standard deviation of nucleus size of exocrine cells, respectively) whereas this type of nucleus was found in only 0.5% of beta-cells in normal controls (p<0.05). CONCLUSION: The islet pathology in type 2 diabetes could be characterized by an expansion of alpha-cells associated with the selective loss of beta-cells. Some beta-cells found in diabetes showed a significant increase in size of the nucleus. Through the results from this study, we postulate that enlarged beta-cell nucleus and reverse of A/B ratio in the islets could be a marker of early senescence of beta-cells in patients with type 2 diabetes mellitus.

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