Comparison between a tubeless, on-body automated insulin delivery system and a tubeless, on-body sensor-augmented pump in type 1 diabetes: a multicentre randomised controlled trial.

AIMS/HYPOTHESIS: This study compares the efficacy and safety of a tubeless, on-body automated insulin delivery (AID) system with that of a tubeless, on-body sensor-augmented pump (SAP). METHODS: This multicentre, parallel-group, RCT was conducted at 13 tertiary medical centres in South Korea. Adults aged 19-69 years with type 1 diabetes who had HbA1c levels of <85.8 mmol/mol (<10.0%) were eligible. The participants were assigned at a 1:1 ratio to receive a tubeless, on-body AID system (intervention group) or a tubeless, on-body SAP (control group) for 12 weeks. Stratified block randomisation was conducted by an independent statistician. Blinding was not possible due to the nature of the intervention. The primary outcome was the percentage of time in range (TIR), blood glucose between 3.9 and 10.0 mmol/l, as measured by continuous glucose monitoring. ANCOVAs were conducted with baseline values and study centres as covariates. RESULTS: A total of 104 participants underwent randomisation, with 53 in the intervention group and 51 in the control group. The mean (±SD) age of the participants was 40±11 years. The mean (±SD) TIR increased from 62.1±17.1% at baseline to 71.5±10.7% over the 12 week trial period in the intervention group and from 64.7±17.0% to 66.9±15.0% in the control group (difference between the adjusted means: 6.5% [95% CI 3.6%, 9.4%], p<0.001). Time below range, time above range, CV and mean glucose levels were also significantly better in the intervention group compared with the control group. HbA1c decreased from 50.9±9.9 mmol/mol (6.8±0.9%) at baseline to 45.9±7.4 mmol/mol (6.4±0.7%) after 12 weeks in the intervention group and from 48.7±9.1 mmol/mol (6.6±0.8%) to 45.7±7.5 mmol/mol (6.3±0.7%) in the control group (difference between the adjusted means: -0.7 mmol/mol [95% CI -2.0, 0.8 mmol/mol] (-0.1% [95% CI -0.2%, 0.1%]), p=0.366). No diabetic ketoacidosis or severe hypoglycaemia events occurred in either group. CONCLUSIONS/INTERPRETATION: The use of a tubeless, on-body AID system was safe and associated with superior glycaemic profiles, including TIR, time below range, time above range and CV, than the use of a tubeless, on-body SAP. TRIAL REGISTRATION: Clinical Research Information Service (CRIS) KCT0008398 FUNDING: The study was funded by a grant from the Korea Medical Device Development Fund supported by the Ministry of Science and ICT; the Ministry of Trade, Industry and Energy; the Ministry of Health and Welfare; and the Ministry of Food and Drug Safety (grant number: RS-2020-KD000056).

Optimal Coefficient of Variance Threshold to Minimize Hypoglycemia Risk in Individuals with Well-Controlled Type 1 Diabetes Mellitus.

BACKGRUOUND: This study investigated the optimal coefficient of variance (%CV) for preventing hypoglycemia based on real-time continuous glucose monitoring (rt-CGM) data in people with type 1 diabetes mellitus (T1DM) already achieving their mean glucose (MG) target. METHODS: Data from 172 subjects who underwent rt-CGM for at least 90 days and for whom 439 90-day glycemic profiles were available were analyzed. Receiver operator characteristic analysis was conducted to determine the cut-off value of %CV to achieve time below range (%TBR)<54 mg/dL <1 and =0. RESULTS: Overall mean glycosylated hemoglobin was 6.8% and median %TBR<54 mg/dL was 0.2%. MG was significantly higher and %CV significantly lower in profiles achieving %TBR<54 mg/dL <1 compared to %TBR<54 mg/dL ≥1 (all P<0.001). The cut-off value of %CV for achieving %TBR<54 mg/dL <1 was 37.5%, 37.3%, and 31.0%, in the whole population, MG >135 mg/dL, and ≤135 mg/dL, respectively. The cut-off value for %TBR<54 mg/dL=0% was 29.2% in MG ≤135 mg/dL. In profiles with MG ≤135 mg/dL, 94.2% of profiles with a %CV <31 achieved the target of %TBR<54 mg/dL <1, and 97.3% with a %CV <29.2 achieved the target of %TBR<54 mg/ dL=0%. When MG was >135 mg/dL, 99.4% of profiles with a %CV <37.3 achieved %TBR<54 mg/dL <1. CONCLUSION: In well-controlled T1DM with MG ≤135 mg/dL, we suggest a %CV <31% to achieve the %TBR<54 mg/dL <1 target. Furthermore, we suggest a %CV <29.2% to achieve the target of %TBR<54 mg/dL =0 for people at high risk of hypoglycemia.

The Benefits Of Continuous Glucose Monitoring In Pregnancy.

Previous studies have consistently demonstrated the positive effects of continuous glucose monitoring (CGM) on glycemic outcomes and complications of diabetes in people with type 1 diabetes. Guidelines now consider CGM to be an essential and cost-effective device for managing type 1 diabetes. As a result, insurance coverage for it is available. Evidence supporting CGM continues to grow and expand to broader populations, such as pregnant people with type 1 diabetes, people with type 2 diabetes treated only with basal insulin therapy, and even type 2 diabetes that does not require insulin treatment. However, despite the significant risk of hyperglycemia in pregnancy, which leads to complications in more than half of affected newborns, CGM indications and insurance coverage for those patients are unresolved. In this review article, we discuss the latest evidence for using CGM to offer glycemic control and reduce perinatal complications, along with its cost-effectiveness in pregestational type 1 and type 2 diabetes and gestational diabetes mellitus. In addition, we discuss future prospects for CGM coverage and indications based on this evidence.

Comparison of Glycemia Risk Index with Time in Range for Assessing Glycemic Quality.

Background: The glycemia risk index (GRI) is a novel composite continuous glucose monitoring (CGM) metric that gives greater weight to hypoglycemia than to hyperglycemia and to extreme hypo/hyperglycemia over less extreme hypo/hyperglycemia. This study aimed at validating the effectiveness of GRI and at comparing it with time in range (TIR) in assessing glycemic quality in clinical practice. Methods: A total of 524 ninety-day CGM tracings of 194 insulin-treated adults with diabetes were included in the analysis. GRI was assessed according to standard metrics in ambulatory glucose profiles. Both cross-sectional and longitudinal analyses were performed to compare the GRI and TIR. Results: The GRI was strongly correlated not only with TIR (r = -0.974), but also with the coefficient of variation (r = 0.683). To identify whether the GRI differed by hypoglycemia even with a similar TIR, CGM tracings were grouped according to TIR (50% to <60%, 60% to <70%, 70% to <80%, and ≥80%). In each TIR group, the GRI increased as time below range (TBR)<70 mg/dL increased (P < 0.001 for all TIR groups). In longitudinal analysis, as TBR<70 mg/dL improved, the GRI improved significantly (P = 0.003) whereas TIR did not (P = 0.704). Both GRI and TIR improved as time above range (TAR)>180 mg/dL improved (P < 0.001 for both). The longitudinal change was easily identifiable on a GRI grid. Conclusions: The GRI is a useful tool for assessing glycemic quality in clinical practice and reflects hypoglycemia better than does TIR.

Association Between Continuous Glucose Monitoring-Derived Glycemia Risk Index and Albuminuria in Type 2 Diabetes.

Background: The glycemia risk index (GRI) is a new composite metric derived from continuous glucose monitoring (CGM) data to assess the quality of glycemia. This study investigates the association between the GRI and albuminuria. Methods: Professional CGM and urinary albumin-to-creatinine ratio (UACR) data from 866 individuals with type 2 diabetes were retrospectively reviewed. Albuminuria and macroalbuminuria were defined as one or more UACR measurements ≥30 and ≥300 mg/g, respectively. Results: The overall prevalence of albuminuria and macroalbuminuria was 36.6% and 13.9%, respectively. Participants with a higher UACR had a significantly higher hyperglycemia component and GRI score than those with a lower UACR (all P < 0.001), although the hypoglycemia component did not differ among the groups. Multiple logistic regression analyses that adjusted for various factors affecting albuminuria revealed that the odds ratio (OR) of albuminuria was 1.13 (95% confidence interval [CI]: 1.02-1.27, P = 0.039) per increase in the GRI zone. The results were similar for the risk of macroalbuminuria (OR: 1.42 [95% CI: 1.20-1.69], P < 0.001), and that association remained after adjusting for glycated hemoglobin (OR: 1.31 [95% CI: 1.10-1.58], P = 0.004). Conclusions: GRI is strongly associated with albuminuria, especially macroalbuminuria, in type 2 diabetes.

Advances in Continuous Glucose Monitoring and Integrated Devices for Management of Diabetes with Insulin-Based Therapy: Improvement in Glycemic Control.

Continuous glucose monitoring (CGM) technology has evolved over the past decade with the integration of various devices including insulin pumps, connected insulin pens (CIPs), automated insulin delivery (AID) systems, and virtual platforms. CGM has shown consistent benefits in glycemic outcomes in type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) treated with insulin. Moreover, the combined effect of CGM and education have been shown to improve glycemic outcomes more than CGM alone. Now a CIP is the expected future technology that does not need to be worn all day like insulin pumps and helps to calculate insulin doses with a built-in bolus calculator. Although only a few clinical trials have assessed the effectiveness of CIPs, they consistently show benefits in glycemic outcomes by reducing missed doses of insulin and improving problematic adherence. AID systems and virtual platforms made it possible to achieve target glycosylated hemoglobin in diabetes while minimizing hypoglycemia, which has always been challenging in T1DM. Now fully automatic AID systems and tools for diabetes decisions based on artificial intelligence are in development. These advances in technology could reduce the burden associated with insulin treatment for diabetes.

Effect of structured individualized education on continuous glucose monitoring use in poorly controlled patients with type 1 diabetes: A randomized controlled trial.

AIM: We aimed to evaluate the efficacy of structured individualized education combined with real-time continuous glucose monitoring (rt-CGM) on glycemic outcomes in adults with type 1 diabetes. METHODS: This was a single-center, 3-month, randomized controlled trial of 47 adults with type 1 diabetes with HbA1c ≥ 7.0% (53 mmol/mol). Study participants were assigned randomly (1:1) to a structured education group or control group. The control group received the same education as the intervention group in a 3-month extension study. The primary outcome was the mean difference in time in range (TIR 70-180 mg/dL [3.9-10.0 mmol/L]) between groups. RESULTS: TIR was higher for the education group than the control group (63.4% vs. 44.5%), resulting in a between-group difference of 15.3% (95% CI 7.9 to 22.8, p < 0.001) at week 12. HbA1c decreased 0.5% (5.5 mmol/mol) more in the intervention group than the control group at week 12 (-0.1 to -1.0, p < 0.001). In the extension period, TIR increased significantly (8.9% [2.2 to 15.6], p = 0.01) in educated control group. CONCLUSIONS: In adults with type 1 diabetes, rt-CGM use with individualized education resulted in better TIR than rt-CGM alone, highlighting the importance of personalized structured education when using rt-CGM. (ClinicalTrials.gov, number NCT03794934).

Contralateral Suppression at Adrenal Venous Sampling Is Associated with Renal Impairment Following Adrenalectomy for Unilateral Primary Aldosteronism.

BACKGROUND: Adrenal venous sampling (AVS) is performed to distinguish the subtype of primary aldosteronism (PA). The clinical implication of contralateral suppression (CS; aldosterone/cortisolnondominant0.26 after adjusting for other factors. CONCLUSION: CS may not predict postoperative clinical and biochemical outcomes in subjects with unilateral aldosterone excess, but it is associated with postsurgical deterioration of renal function in subjects over 50 years with CSI ≤0.26.

Glucose Management Indicator for People with Type 1 Asian Diabetes Is Different from That of the Published Equation: Differences by Glycated Hemoglobin Distribution.

Background: We aimed to determine whether there are racial differences in glucose management indicator (GMI) equation for Asians and propose an adjusted GMI equation specific to Asians. Methods: This was a 24-week, prospective, observational study. A total of 106 Korean subjects with type 1 diabetes was included in the analyses. Continuous glucose monitoring (CGM: Dexcom G5) data and glycated hemoglobin (HbA1c) were obtained at the end of 3 months (n = 106) and 6 months (n = 70) of use of a CGM device. Full 3-month CGM data were collected from 176 patients. Results: Linear regression analysis between HbA1c and CGM-derived mean glucose (GMI [%] = 2.814 + 0.026 × mean glucose [mg/dL], R2 = 0.739, P < 0.001) showed significant correlation. An increase corresponding to each 25 mg/dL increase of mean glucose was higher with the Asian-Dexcom-specific GMI (0.7%) than with the published GMI (0.6%). The mean Asian-Dexcom-specific GMI was significantly lower than the published GMI (P = 0.022), especially in patients with HbA1c <7.0% (<6.0%: P = 0.003, 6.0%-6.9%: P = 0.001). Conclusions: The GMI equation specific for Asian Type 1 diabetes was different from the published GMI equation. For a given CGM-derived mean glucose, GMI calculated with the published equation could overestimate HbA1c in Asian subjects with HbA1c <7.0%. Although race partially explains the differences in GMI equation between published and Asian data, future research with larger databases is needed to develop a specific formula for Asian populations.

Association of Urinary N-Acetyl-ß-D-Glucosaminidase with Cardiovascular Autonomic Neuropathy in Type 1 Diabetes Mellitus without Nephropathy.

BACKGROUND: Cardiovascular autonomic neuropathy (CAN) is a common microvascular complication of diabetes and related to albuminuria in diabetic nephropathy (DN). Urinary N-acetyl-ß-D-glucosaminidase (uNAG) is a renal tubular injury marker which has been reported as an early marker of DN even in patients with normoalbuminuria. This study evaluated whether uNAG is associated with the presence and severity of CAN in patients with type 1 diabetes mellitus (T1DM) without nephropathy. METHODS: This cross-sectional study comprised 247 subjects with T1DM without chronic kidney disease and albuminuria who had results for both uNAG and autonomic function tests within 3 months. The presence of CAN was assessed by age-dependent reference values for four autonomic function tests. Total CAN score was assessed as the sum of the partial points of five cardiovascular reflex tests and was used to estimate the severity of CAN. The correlations between uNAG and heart rate variability (HRV) parameters were analyzed. RESULTS: The association between log-uNAG and presence of CAN was significant in a multivariate logistic regression model (adjusted odds ratio, 2.39; 95% confidence interval [CI], 1.08 to 5.28; P=0.031). Total CAN score was positively associated with loguNAG (ß=0.261, P=0.026) in the multivariate linear regression model. Log-uNAG was inversely correlated with frequency-domain and time-domain indices of HRV. CONCLUSION: This study verified the association of uNAG with presence and severity of CAN and changes in HRV in T1DM patients without nephropathy. The potential role of uNAG should be further assessed for high-risk patients for CAN in T1DM patients without nephropathy.

Primary aldosteronism subtyping in the setting of partially successful adrenal vein sampling.

BACKGROUND AND AIMS: Frequent failure of adrenal vein (AV) cannulation is a major obstacle to the universal use of adrenal vein sampling (AVS) for subtyping primary aldosteronism (PA). This study aimed to confirm and modify the value of a previously reported AVS parameter for PA subtyping in the case of cannulation failure on one side. METHODS: Successfully catheterized AVS studies in 157 patients (121 patients as a derivation cohort and 36 patients as a validation cohort) from two tertiary hospitals were retrospectively reviewed. The AV/inferior vena cava (IVC) index was defined by dividing the aldosterone/cortisol ratio (ACR) of AV by the ACR of the IVC. Cutoff values for lateralized PA were obtained from two methods: scatterplots and the values corresponding to Youden's index in receiver operating characteristic (ROC) curves, on the assumption of catheterization failure on one side. RESULTS: Due to multiple samplings in a single AVS procedure, 252 left AV/IVC ratios (LIRs) and 272 right AV/IVC ratios (RIRs) were calculated. Scatterplot cutoffs of LIR >5.4 or <0.5 predicted unilateral PA with a sensitivity of 42.1% and a specificity of 98.6%. Scatterplot cutoffs of RIR <0.5 or >7.0 showed a sensitivity of 55.1% and a specificity of 98.6%. ROC curve cutoffs of LIR ⩽0.8 or >3.1 predicted unilateral PA with a sensitivity of 82.5% and a specificity of 69.6%. ROC curve cutoffs of RIR ⩽0.8 or >3.9 resulted in 87.4% sensitivity and 80.7% specificity. CONCLUSION: In the case of unilateral AVS failure, the AV/IVC index may help in diagnosing PA subtype.

Relationship between low skeletal muscle mass, sarcopenic obesity and left ventricular diastolic dysfunction in Korean adults.

BACKGROUND: Heart failure with preserved ejection fraction is an emerging global health issue attributed to an ageing population. However, the association between low skeletal muscle mass, sarcopenic obesity, and left ventricular diastolic dysfunction remains unclear. In the current study, we aimed to investigate the relationship between low skeletal muscle mass, sarcopenic obesity, and diastolic dysfunction in a large cohort of Korean adults. METHODS: We conducted a cross-sectional study of 31 258 subjects who underwent health examinations at Samsung Medical Centre's Health Promotion Centre in Seoul, Republic of Korea. Relative skeletal muscle mass was calculated using the skeletal muscle mass index [SMI (%) = appendicular skeletal muscle mass (kg)/body weight (kg) × 100], which was estimated by bioelectrical impedance analysis. Cardiac structure and function were evaluated by echocardiography. RESULTS: Amongst the 31 258 subjects, 3058 (9.78%) were determined to have diastolic dysfunction. The odds ratio (OR) of diastolic dysfunction was 1.56 [95% confidence interval (CI): 1.31-1.85; p for trend <0.001] for the lowest SMI tertile relative to the highest SMI tertile following multivariable adjustment. Furthermore, the risk of diastolic dysfunction was much higher in the sarcopenic obesity (OR: 1.70, 95% CI: 1.44-1.99), followed by in the obesity-only (OR: 1.40, 95% CI: 1.21-1.62), and sarcopenia-only (OR: 1.32, 95% CI: 1.08-1.61) when compared with the nonobese, nonsarcopenic group. These results remained consistent amongst the elderly (age ≥ 65 years). CONCLUSIONS: Our findings demonstrate that lower skeletal muscle mass and sarcopenic obesity are strongly associated with diastolic dysfunction in middle-aged and older adults.

Mean and visit-to-visit variability of glycated hemoglobin, and the risk of non-alcoholic fatty liver disease.

AIMS/INTRODUCTION: We aimed to determine whether mean and visit-to-visit glycated hemoglobin (HbA1c) variability independently increase the incidence of non-alcoholic fatty liver disease (NAFLD) across the diabetic continuum from normal glucose tolerance (NGT) to established diabetes. MATERIALS AND METHODS: In a longitudinal cohort study, 21,123 participants underwent five or more annual health screening checkups. Participants were categorized into diabetes (n = 1,635), prediabetes (n = 6,650) and NGT (n = 12,838) groups. Mean, standard deviation (SD) and coefficient of variation data on HbA1c were obtained from three consecutive measurements. The associations between those data and incident NAFLD were analyzed using Cox regressions. RESULTS: Over a median follow-up period of 57 months, 3,860 (18.3%) participants developed NAFLD. The risk of NAFLD increased continuously, with the mean HbA1c beginning at 4.9%, even in the NGT group. We found a significant association between increasing HbA1c variability and incident NAFLD (coefficient of variation, adjusted hazard ratio 1.14, 95% confidence interval 1.01-1.29; standard deviation, adjusted hazard ratio 1.19, 95% confidence interval 1.05-1.36) in the diabetes group, but not in the NGT or prediabetes group. Consistent findings were observed when NAFLD patients with a low possibility of fibrosis were excluded. The association between the coefficient of variation of HbA1c and incident NAFLD in the diabetes group was significant only in those with an increasing trend of post-baseline HbA1c (adjusted hazard ratio 1.24, 95% confidence interval 1.01-1.52). CONCLUSIONS: Increased mean HbA1c levels elevated the risk of incident NAFLD, even with NGT. Increases in visit-to-visit variability of HbA1c independently elevated the risk of incident NAFLD, but only in the diabetes group.

C1q/TNF-related protein-9 attenuates palmitic acid-induced endothelial cell senescence via increasing autophagy.

Autophagy is an important process in the pathogenesis of atherosclerosis. C1q/tumor necrosis factor-related protein 9 (CTRP9) is the closest adiponectin paralog. CTRP9 has anti-aging and anti-atherogenic effects, but its roles in autophagy and endothelial senescence are currently unknown. This study aimed to evaluate whether CTRP9 prevents palmitic acid (PA)-induced endothelial senescence by promoting autophagy. After no treatment or pre-treatment of human umbilical vein endothelial cells with CTRP9 prior to PA treatment, the level of senescence was measured by senescence associated acidic ß-galactosidase staining and the level of hyperphosphorylated pRB protein. Autophagy was evaluated by LC3 conversion and the level of p62/SQSTM1, a protein degraded during autophagy. Autophagosome-lysosome fusion was detected by fluorescence microscopy. Pre-treatment with CTRP9 attenuated PA-induced endothelial senescence. CTRP9 increased the conversion of LC3-I to LC3-II and decreased p62 levels in a time- and dose-dependent manner. Although both CTRP9 and PA treatment increased LC3 conversion, treatment with PA increased the expression level of p62 and decreased the fusion of autophagosomes and lysosomes, which represented decreased autophagic flux. However, pre-treatment with CTRP9 recovered the autophagic flux inhibited by PA. AMP-activated kinase (AMPK) activation was involved in LC3 conversion and decreased p62 levels induced by CTRP9. CTRP9 inhibits PA-induced endothelial senescence by recovering autophagy and autophagic flux through AMPK activation.

Effects of low skeletal muscle mass and sarcopenic obesity on albuminuria: a 7-year longitudinal study.

We aimed to identify the association between low skeletal muscle, sarcopenic obesity, and the incidence of albuminuria in the general population using a longitudinal study. Data from 29,942 subjects who underwent two or more routine health examinations from 2006 to 2013 were retrospectively reviewed. Relative skeletal muscle mass was presented using the skeletal muscle mass index (SMI), a measure of body weight-adjusted appendicular skeletal muscle mass estimated by bioelectrical impedance analysis. The cumulative incidence of albuminuria was 981 (3.3%) during the 7-year follow-up period. The hazard ratio of incident albuminuria was 1.44 (95% CI: 1.22-1.71, p for trend <0.001) in the lowest SMI tertile relative to the highest SMI tertile after multivariable adjustment. After additionally adjusting for general and central obesity, the hazard ratio was 1.35 (95% CI: 1.13-1.61, p for trend = 0.001) and 1.30 (95% CI: 1.08-1.56, p for trend = 0.003), respectively. Furthermore, the risk of developing albuminuria was much higher in the sarcopenic obesity group (HR: 1.49, 95% CI: 1.21-1.81, p for trend <0.001) compared to the other groups. Sarcopenic obesity, as well as low skeletal muscle, may lead to albuminuria in general populations.

Association Between Continuous Glucose Monitoring-Derived Time in Range, Other Core Metrics, and Albuminuria in Type 2 Diabetes.

Background: As the use of continuous glucose monitoring (CGM) has increased, time in range (TIR) and other core CGM metrics are now emerging as the core metrics for clinical targets and assessing diabetic complications, beyond HbA1c. This study investigated the association between the CGM-derived TIR, hyperglycemia, hypoglycemia metrics, and albuminuria. Methods: A total of 866 subjects with type 2 diabetes who underwent 3 or 6 days of CGM and had urinary albumin-to-creatinine ratio (ACR) measurements were retrospectively reviewed. CGM metrics were defined according to the most recent international consensus. Albuminuria was defined as one or more of the ACR measurements being >30 mg/g. Results: The overall prevalence of albuminuria was 36.6%. The prevalence of albuminuria was lower in subjects who achieved the target of TIR 70-180 mg/dL, time above range (TAR) >180 mg/dL, and TAR >250 mg/dL, as recommended by international consensus (P < 0.001). Multiple logistic regression analysis revealed that the odds ratio of having albuminuria was 0.94 (95% confidence interval: 0.88-0.99, P for trend = 0.04) per 10% increase in TIR of 70-180 mg/dL, after adjusting for multiple factors, including glycemic variability. The results were similar for hyperglycemia metrics (TAR >250 mg/dL and TAR >180 mg/dL). Conclusions: TIR 70-180 mg/dL and hyperglycemia metrics are strongly associated with albuminuria in type 2 diabetes.

Time in Range from Continuous Glucose Monitoring: A Novel Metric for Glycemic Control.

Glycosylated hemoglobin (HbA1c) has been the sole surrogate marker for assessing diabetic complications. However, consistently reported limitations of HbA1c are that it lacks detailed information on short-term glycemic control and can be easily interfered with by various clinical conditions such as anemia, pregnancy, or liver disease. Thus, HbA1c alone may not represent the real glycemic status of a patient. The advancement of continuous glucose monitoring (CGM) has enabled both patients and healthcare providers to monitor glucose trends for a whole single day, which is not possible with HbA1c. This has allowed for the development of core metrics such as time spent in time in range (TIR), hyperglycemia, or hypoglycemia, and glycemic variability. Among the 10 core metrics, TIR is reported to represent overall glycemic control better than HbA1c alone. Moreover, various evidence supports TIR as a predictive marker of diabetes complications as well as HbA1c, as the inverse relationship between HbA1c and TIR reveals. However, there are more complex relationships between HbA1c, TIR, and other CGM metrics. This article provides information about 10 core metrics with particular focus on TIR and the relationships between the CGM metrics for comprehensive understanding of glycemic status using CGM.

Clinical parameters affecting the therapeutic efficacy of empagliflozin in patients with type 2 diabetes.

We aimed to investigate the clinical factors affecting the therapeutic effectiveness of the sodium-glucose cotransporter-2 inhibitor empagliflozin in patients with type 2 diabetes mellitus (T2DM). We reviewed the medical records of 374 T2DM patients aged between 20 and 75 years who were prescribed empagliflozin 10 mg or 25 mg as add-on therapy for more than 90 consecutive days. Changes in hemoglobin A1c (HbA1c) from baseline levels and the reduction in body weights of the study participants were assessed. We found that younger patients (≤ 50 years), patients with the highest levels of HbA1c (>9%) at baseline, patients with an estimated glomerular filtration rate (eGFR) of >90 mL/min/1.73 m2, and patients with a shorter duration of T2DM (< 10 years) were more likely to exhibit a better glycemic response. Multivariate linear regression analysis revealed that a shorter duration of T2DM, higher baseline levels of HbA1c, and higher eGFR were positively associated with HbA1c reduction. Higher BMI and lower HbA1c levels were predictors of a more significant reduction in body weight among patients taking empagliflozin. The glucose-lowering effect of empagliflozin was more evident in T2DM patients with higher baseline HbA1c levels, better renal function, and shorter duration of T2DM.

Clinical Efficacy and Parameters Affecting the Response to Dulaglutide Treatment in Patients with Type 2 Diabetes: A Retrospective, Real-World Data Study.

INTRODUCTION: This study aimed to investigate the efficacy and clinical factors affecting the glycemic response to dulaglutide in type 2 diabetes (T2D) in a real-world clinical setting. METHODS: We conducted a retrospective study of 234 patients at the Asan Medical Center, Republic of Korea, who had T2D and initiated dulaglutide from June 2016 to December 2017. The primary outcome was the change in glycated hemoglobin (HbA1c) concentration between baseline and 6 months after the initiation of therapy. Multivariate regression analysis was used to determine the clinical parameters contributing to a superior glycemic response to dulaglutide. RESULTS: The mean age of the patients was 53, and 50% were male. Their mean baseline HbA1c, body mass index and duration of diabetes were 8.8%, 27.6 kg/m2 and 10.2 years, respectively. The change in HbA1c between baseline and 6 months was - 0.92% (95% CI: - 1.1% to - 0.74%, p < 0.001). The reduction in body weight over the same period was -2.1 kg (95% CI: - 2.9 to - 1.3 kg, p < 0.001). Using multivariate regression analysis, baseline HbA1c was found to be a significant predictor of superior glycemic response to dulaglutide. CONCLUSION: The use of dulaglutide was associated with a significant reduction in HbA1c and body weight over a 6-month period in a real-world clinical setting. T2D patients with higher baseline HbA1c concentrations were more likely to demonstrate good clinical responses to dulaglutide.