Endocrinology and Metabolism

Original Articles

Diabetes, obesity and metabolism
Efficacy and Safety of Stage 5 Connected Insulin Pens in Type 1 or Type 2 Diabetes: Randomized Controlled Trial Protocol (SMART-5 Study): Ji Yoon Kim, Nam Hoon Kim, Soo Heon Kwak, Chang Hee Jung, Eun Seok Kang, Jun Sung Moon, Sun Joon Moon, So Yoon Kwon, Jee Hee Yoo, Younghoon Kim, Tae-min Lee, Chung-il Yang, Jae Hyeon Kim, Sang-Man Jin; Endocrinol Metab. 2026;41(3):393-404. Published online December 12, 2025; DOI: https://doi.org/10.3803/EnM.2025.2579

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Abstract PDF PubReader ePub: Background
Stage 2 or 3 connected insulin pens (CIPs) refer to tracking insulin pens that are capable of transmitting insulin dose data via cloud connectivity. Stage 4 CIPs feature a bolus calculator that determines appropriate insulin doses based on real-time continuous glucose monitoring (CGM) data, carbohydrate intake, previous dosing history, and preset parameters. Stage 5 CIPs additionally offer advanced decision-support features, such as education modules and coaching. However, the efficacy and safety of stage 5 CIPs have not yet been established.
Methods
In this prospective, open-label, parallel-group, multicenter, randomized controlled trial, we will include adults aged ≥19 and <75 years with type 1 or type 2 diabetes receiving multiple daily insulin injections (MDI) and having glycosylated hemoglobin (HbA1c) levels of 7.5% to 12.0%. In total, 152 participants will be randomized in a 1:1 ratio to receive either stage 5 CIPs with CGM or tracking insulin pens with CGM. Stage 5 CIPs include a Setup Wizard that recommends individualized initial settings and an algorithm that provides advanced insulin dosing guidance based on analyses of each participant’s CGM and insulin injection data. The primary outcome will be the change in HbA1c levels from baseline to week 12 (ClinicalTrials.gov, NCT07004153).
Conclusion
This trial (Stage 5 connected insulin pen for MDI with Advanced decision support in a Randomized Trial [SMART-5 Study]) will determine whether stage 5 CIPs are superior to tracking insulin pens in improving glycemic control among adults with type 1 or type 2 diabetes treated with MDI. Overall, this study may offer a promising strategy for enhancing the management and outcomes of patients with diabetes.

Diabetes, obesity and metabolism
Impact of Carbohydrate Intake Fluctuations on Glucose Profiles: Insights from Continuous Glucose Monitoring-Based Patient Clustering: Hyun Ah Kim, Kyung Hee Kim, Young Lee, Yoon-Ju Song, Joon Ho Moon, Sung Hee Choi, Tae Jung Oh; Endocrinol Metab. 2026;41(1):152-161. Published online December 12, 2025; DOI: https://doi.org/10.3803/EnM.2025.2486

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Abstract PDF PubReader ePub: Background
Continuous glucose monitoring (CGM) is widely applied in daily glucose management. However, its potential to categorize individuals based on glucose profiles is not fully established. This study employed CGM-based patient clustering and examined nutritional factors influencing glucose patterns.
Methods
This prospective observational study enrolled 34 individuals with diabetes. Retrospective professional CGM was conducted over 7 days, during which food intake was recorded. K-means clustering was performed using CGM-derived coefficient of variation (CV) and time in range. Macronutrient intake and its fluctuations were compared across clusters.
Results
Participants were grouped into cluster 1 (well-controlled), cluster 2 (highest CV), and cluster 3 (highest mean glucose). Baseline clinical characteristics, daily energy intake (kcal), and macronutrient intake did not differ significantly among clusters. However, carbohydrate intake fluctuations were greater in cluster 3 (CV 41.0%±32.1%, standard deviation [SD] 502.1±363.4 kcal) than in cluster 1 (CV 21.9%±9.0%, SD 260.2±94.1 kcal) and cluster 2 (CV 19.2%±9.1%, SD 250.2±126.1 kcal) (P=0.123 for CV; P=0.024 for SD). The SD (kcal) of carbohydrate intake was positively correlated with mean glucose levels (rho=0.88, P=0.023).
Conclusion
CGM enables categorization of individuals based on glucose profiles, and higher carbohydrate intake fluctuations are associated with poorer glycemic control. Personalized dietary strategies, particularly stabilizing carbohydrate intake, may support better glucose management in individuals with high mean glucose and low CV.

Review Article

Diabetes, obesity and metabolism
Advances in Continuous Glucose Monitoring: Clinical Applications: So Yoon Kwon, Jun Sung Moon; Endocrinol Metab. 2025;40(2):161-173. Published online April 8, 2025; DOI: https://doi.org/10.3803/EnM.2025.2370

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Continuous glucose monitoring (CGM) has revolutionized diabetes management, significantly enhancing glycemic control across diverse patient populations. Recent evidence supports its effectiveness in both type 1 and type 2 diabetes management, with benefits extending beyond traditional glucose monitoring approaches. CGM has demonstrated substantial improvements in glycemic control across multiple metrics. Studies report consistent glycosylated hemoglobin reductions of 0.25%–3.0% and notable time in range improvements of 15%–34%. CGM effectively reduces hypoglycemic events, with studies reporting significant reductions in time spent in hypoglycemia. CGM also serves as an educational tool for lifestyle modification, providing real-time feedback that helps patients understand how diet and physical activity affect glucose levels. While skin-related complications remain a concern, technological advancements have addressed many initial concerns. High satisfaction rates and long-term use suggest that device-related issues are manageable with proper education and support. Despite high initial costs, CGM’s prevention of complications and hospitalizations ultimately reduces healthcare expenditures. With appropriate training and support, CGM represents a transformative technology for comprehensive diabetes care.

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Efficacy and Safety of Stage 5 Connected Insulin Pens in Type 1 or Type 2 Diabetes: Randomized Controlled Trial Protocol (SMART-5 Study)
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Original Article

Diabetes, obesity and metabolism
Plasma C-Peptide Levels and the Continuous Glucose Monitoring-Defined Coefficient of Variation in Risk Prediction for Hypoglycemia in Korean People with Diabetes Having Normal and Impaired Kidney Function: So Yoon Kwon, Jiyun Park, So Hee Park, You-Bin Lee, Gyuri Kim, Kyu Yeon Hur, Jae Hyeon Kim, Sang-Man Jin; Endocrinol Metab. 2025;40(2):268-277. Published online February 27, 2025; DOI: https://doi.org/10.3803/EnM.2024.2083

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Background
We aimed to investigate the predictive values of plasma C-peptide levels and the continuous glucose monitoring (CGM)-defined coefficient of variation (CV) in risk prediction for hypoglycemia in Korean people with diabetes with normal and impaired kidney function.
Methods
We analyzed data from 1,185 participants diagnosed with type 1 and type 2 diabetes who underwent blinded professional CGM between January 2009 and May 2021 at outpatient clinics. We explored correlations among CGM-defined CV, plasma C-peptide levels, and time below range at <70 and 54 mg/dL across different kidney function categories.
Results
In patients with chronic kidney disease (CKD) stages 1–2 (n=934), 89.3% who had a random plasma C-peptide level higher than 600 pmol/L exhibited a CV of ≤36%. Among those in CKD stage 3 (n=161) with a random plasma C-peptide level exceeding 600 pmol/L, 66.7% showed a CV of ≤36%. In stages 4–5 of CKD (n=90), the correlation between random C-peptide levels and CV was not significant (r=–0.05, P=0.640), including cases with a CV greater than 36% despite very high random plasma C-peptide levels. Random plasma C-peptide levels and CGM-assessed CV significantly predicted hypoglycemia in CKD stages 1–2 and 1–5, respectively.
Conclusion
The established C-peptide criteria in Western populations are applicable to Korean people with diabetes for hypoglycemic risk prediction, unless kidney function is impaired equivalent to CKD stage 3–5. The CGM-defined CV is informative for hypoglycemic risk prediction regardless of kidney function.

Citations

Citations to this article as recorded by

Continuous glucose monitoring in high-risk individuals
Zhiyue Chen, Yinbei Zhang, Lin Sun, Weiying Guo
Clinica Chimica Acta.2026; 580: 120733. CrossRef
The evolution of C-peptide's role in diabetes care
Laura Briggs, Alexander Read, Sarah Darch, Emma L. Williams, Wann Jia Loh, Julia S. Kenkre
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Antidiabetic Potential of Brewed Arabica Coffee: Modulation of GLUT4, Insulin, and Glucagon in STZ‐Induced Rats
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Journal of Nutrition and Metabolism.2026;[Epub] CrossRef
Recent Advances in the Application of C-Peptide in Type 2 Diabetes Management: From Biomarker to Clinical Decision Tool
茜许
Advances in Clinical Medicine.2026; 16(04): 3314. CrossRef
High-Amplitude and Prolonged Glucose Excursions as a Key Determinant of Discordance Between Glucose Management Indicator and Glycated Hemoglobin in Type 1 Diabetes
Soojin Park, So Hyun Cho, Seohyun Kim, Sang Ho Park, Ji Yoon Kim, Rosa Oh, Myunghwa Jang, You-Bin Lee, Gyuri Kim, Kyu Yeon Hur, Jae Hyeon Kim, Sang-Man Jin
Diabetes Care.2026; 49(7): 1221. CrossRef
Plasma C-Peptide Level and Continuous Glucose Monitoring-Derived Coefficient of Variation as a Predictable Risk Factor for Hypoglycemia in Koreans with Diabetes
Seung-Hyun Ko
Endocrinology and Metabolism.2025; 40(2): 198. CrossRef
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Marie Ticha, Ondrej Sobotka, Pavel Skorepa, Lubos Sobotka
Diabetology.2025; 6(6): 47. CrossRef

Review Article

Stepwise Approach to Problematic Hypoglycemia in Korea: Educational, Technological, and Transplant Interventions: Sang-Man Jin; Endocrinol Metab. 2017;32(2):190-194. Published online June 23, 2017; DOI: https://doi.org/10.3803/EnM.2017.32.2.190

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Abstract PDF PubReader

Impaired awareness of hypoglycemia has been found to be prevalent in 20% to 40% of people with type 1 diabetes. If a similar prevalence exists in Koreans with type 1 diabetes, at a minimum, thousands of people with type 1 diabetes suffer at least one unpredicted episode of severe hypoglycemia per year in Korea. For patients with problematic hypoglycemia, an evidence-based stepwise approach was suggested in 2015. The first step is structured education regarding multiple daily injections of an insulin analog, and the second step is adding a technological intervention, such as continuous subcutaneous insulin infusion or real-time continuous glucose monitoring. The next step is a sensor-augmented pump, preferably with a low glucose suspension feature or very frequent contact, and the final step is islet or pancreas transplantation. In Korea, however, none of these treatments are reimbursed by the National Health Insurance, and thus have not been widely implemented. The low prevalence of type 1 diabetes means that Korean physicians are relatively unfamiliar with the new technologies in this field. Therefore, the roles of new technologies and pancreas or islet transplantation in the treatment of problematic hypoglycemia need to be defined in the current clinical setting of Korea.

Citations

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Protective and risk factors of impaired awareness of hypoglycemia in patients with type 1 diabetes: a cross-sectional analysis of baseline data from the PR-IAH study
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Original Article

Clinical Study
1,5-Anhydro-D-Glucitol Could Reflect Hypoglycemia Risk in Patients with Type 2 Diabetes Receiving Insulin Therapy: Min Kyeong Kim, Hye Seung Jung, Soo Heon Kwak, Young Min Cho, Kyong Soo Park, Seong Yeon Kim; Endocrinol Metab. 2016;31(2):284-291. Published online May 27, 2016; DOI: https://doi.org/10.3803/EnM.2016.31.2.284

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Abstract PDF PubReader

Background

The identification of a marker for hypoglycemia could help patients achieve strict glucose control with a lower risk of hypoglycemia. 1,5-Anhydro-D-glucitol (1,5-AG) reflects postprandial hyperglycemia in patients with well-controlled diabetes, which contributes to glycemic variability. Because glycemic variability is related to hypoglycemia, we aimed to evaluate the value of 1,5-AG as a marker of hypoglycemia.

Methods

We enrolled 18 adults with type 2 diabetes mellitus (T2DM) receiving insulin therapy and assessed the occurrence of hypoglycemia within a 3-month period. We measured 1,5-AG level, performed a survey to score the severity of hypoglycemia, and applied a continuous glucose monitoring system (CGMS).

Results

1,5-AG was significantly lower in the high hypoglycemia-score group compared to the low-score group. Additionally, the duration of insulin treatment was significantly longer in the high-score group. Subsequent analyses were adjusted by the duration of insulin treatment and mean blood glucose, which was closely associated with both 1,5-AG level and hypoglycemia risk. In adjusted correlation analyses, 1,5-AG was negatively correlated with hypoglycemia score, area under the curve at 80 mg/dL, and low blood glucose index during CGMS (P=0.068, P=0.033, and P=0.060, respectively).

Conclusion

1,5-AG level was negatively associated with hypoglycemia score determined by recall and with documented hypoglycemia after adjusting for mean glucose and duration of insulin treatment. As a result, this level could be a marker of the risk of hypoglycemia in patients with well-controlled T2DM receiving insulin therapy.

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