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Introduction We evaluated the tolerability and efficacy of the addition of sitagliptin in Chinese patients with type 2 diabetes mellitus receiving stable insulin therapy alone or in combination with metformin. Materials and Methods A total of 467 patients with inadequate glycemic control on insulin (glycated hemoglobin [HbA1c] ≥7.5% and ≤11%) were randomized 1:1 to receive sitagliptin 100 mg once daily or a matching placebo for 24 weeks. Randomization was stratified based on metformin use (on or not on metformin) and type of insulin (pre-mixed vs intermediate-/long-acting) at screening. The primary end-point was the change from baseline at week 24 in HbA1c. Results The addition of sitagliptin led to a significantly ( P < 0.001) greater week 24 HbA1c reduction (0.7%) compared with the reduction (0.3%) with placebo. A significantly ( P = 0.013) greater proportion of patients taking sitagliptin (16%) had an HbA1c of <7.0% at week 24 compared with placebo (8%). The addition of sitagliptin significantly ( P < 0.001) reduced 2-h post-meal glucose by 26.5 mg/ dL (1.5 mmol/L) relative to placebo. Reductions from baseline in fasting plasma glucose were observed in both the sitagliptin (14.4 mg/ dL reduction) and placebo (10.7 mg/ dL reduction) groups; the between-group difference was not significant. A total of 64 (27.4%) patients taking sitagliptin and 51 (21.9%) taking placebo experienced adverse events of hypoglycemia (symptomatic or asymptomatic). Neither group had a significant change from baseline in bodyweight. Conclusions After 24 weeks, sitagliptin added to stable insulin therapy (±metformin) was generally well tolerated and improved glycemic control in Chinese patients with type 2 diabetes mellitus. [ABSTRACT FROM AUTHOR]

Aims/introduction: We proposed a novel continuous glucose monitoring (CGM)‐based metric, area under the curve in range (AucIR), for integrating both the amplitude and duration of dysglycemia, and further compared AucIR with the emerging key CGM‐derived metric, time in range (TIR). Materials and methods: A total of 2,030 adult patients with type 2 diabetes were enrolled during May 2020 to October 2021. AucIR and TIR were measured with 7‐day CGM data. Logistic regression analysis and the C‐statistic was carried out to assess the association of AucIR and TIR with diabetic retinopathy (DR). Results: Both AucIR (r = −0.89) and TIR (r = −0.95) were strongly correlated with mean glucose levels. Compared with TIR, AucIR showed a tighter relationship with parameters of glycemic variability, including the coefficient of variation (r = −0.56), standard deviation (r = −0.89) and mean amplitude of glycemic excursions (r = −0.70). For each absolute 10% decrease in AucIR, the risk of DR was increased by 7% (95% confidence interval 1.02–1.13) after adjustment for confounders. With respect to TIR, each absolute 10% decrease was associated with an 8% (95% confidence interval 1.03–1.14) increased risk of DR. The model discrimination for DR, as measured by C‐statistic, did not differ significantly between the two metrics (P > 0.05). Conclusions: AucIR did not provide added benefit over TIR in the assessment of DR risk among patients with type 2 diabetes. The potential value of AucIR needs to be explored in future studies. [ABSTRACT FROM AUTHOR]

Aims/Introduction: To define the target value for the percentage coefficient of variation for glucose (%CV) as a measure of glycemic variability (GV) in Chinese diabetes patients. Materials and Methods: This retrospective study included 3,007 diabetes patients who underwent continuous glucose monitoring for 3 days. Type 2 diabetes was divided into groups according to the received treatment: group 1, non‐insulinotropic agent (n = 138); group 2, insulinotropic agent (n = 761); group 3, basal insulin therapy (n = 100); group 4, premixed insulin (n = 784); and group 5, intensive insulin therapy (n = 612). Type 1 diabetes patients were included as group 6 (n = 612). %CV and percentage of time per day within, below (3.9mmol/L; TBR3.9) and above (10.0 mmol/L) the target glucose range (3.9–10.0 mmol/L) were computed. TBR3.9 ≥4% was defined as excessive hypoglycemia. Results: Type 2 diabetes with a premixed or intensive insulin regimen had an increased %CV compared with those receiving oral therapy or basal insulin. The upper limit of %CV in group 1 was 33%, which was adopted as the threshold to define excessive GV. For each treatment group, the percentage of people with TBR3.9 ≥4% was significantly greater in the subgroup with %CV >33% than ≤33% (P < 0.001). In participants who achieved TBR3.9 <4%, the time per day spent within the target glucose range of 3.9–10.0 mmol/L > 70% and time per day above 10.0 mmol/L <25%, the 95th percentile of %CV was 32.70%. Further receiver operating characteristic curve analysis showed that the cut‐off values of %CV for predicting TBR3.9 ≥4% varied by the type of diabetes and glycated hemoglobin categories. Conclusions: A %CV of 33% was set as the threshold for excess glucose variability in Chinese diabetes patients. Meanwhile, glycated hemoglobin and the type of diabetes should be considered for the goal‐setting of %CV. [ABSTRACT FROM AUTHOR]

Aims/Introduction: The relationship between glycemic variability (GV) and diabetic complications has gained much interest and remains under debate. Furthermore, the association of GV with diabetic complications has not been examined in latent autoimmune diabetes of the adult (LADA). Therefore, we evaluated the relationships among several metrics of GV with diabetic retinopathy (DR) in patients with LADA and type 2 diabetes mellitus. Materials and Methods: A total of 192 patients with LADA and 2,927 patients with type 2 diabetes mellitus were enrolled. After continuous glucose monitoring for 72 h, three metrics of GV including standard deviation, coefficient of variation and mean amplitude of glycemic excursions were calculated. DR was assessed by fundus photography performed with a digital non‐mydriatic camera. Results: The prevalence of DR was 20.3 and 26.4% in LADA and type 2 diabetes mellitus patients (P < 0.001), respectively. Generally, LADA patients had fewer cardiometabolic risk factors than type 2 diabetes mellitus patients, and all GV metrics were significantly higher in LADA than in type 2 diabetes mellitus. In the multivariate logistic regression analysis, no metrics for GV were identified as independent risk factors of DR (standard deviation: P = 0.175; coefficient of variation: P = 0.769; mean amplitude of glycemic excursions: P = 0.388) in LADA. However, the standard deviation was significantly associated with DR (OR 1.15, P = 0.017) in patients with type 2 diabetes mellitus after adjusting for confounders. The independent relationships of coefficient of variation and mean amplitude of glycemic excursions with DR (P = 0.194 and P = 0.251, respectively) did not reach statistical significance in type 2 diabetes mellitus. Conclusions: GV is more strongly associated with DR in type 2 diabetes than in LADA, suggesting that different glucose‐lowering strategies should be used for these two types of diabetes. [ABSTRACT FROM AUTHOR]

Abstract: Aims/Introduction: The present study aimed to investigate the performance of a new real‐time continuous glucose monitoring system. Materials and Methods: Interstitial glucose levels were monitored for 7 days in 63 patients with type 1 or type 2 diabetes using the Medtrum A6 TouchCare® CGM System. Venous blood was collected on a randomized day of the wear period. Plasma glucose levels were measured as reference values. Results: Among 1,678 paired sensor–reference values, 90.5% (95% confidence interval 89.1–91.9%) were within ±20%/20 mg/dL of the reference values, with a mean absolute relative difference of 9.1 ± 8.7% (95% CI: 8.9–9.2%). The percentages of paired sensor–reference values falling within zone A and B of the Clarke error grid analysis (EGA) and the type 1 diabetes consensus EGA were 99.1 and 99.8%. Continuous EGA showed that the percentages of accurate readings, benign errors, and erroneous readings were 89.9, 6.3 and 3.8%, respectively. Surveillance EGA showed that 90.6, 9.2, and 0.2% of sensor–reference values with no, slight and lower moderate risk, respectively. The mean absolute relative difference was 16.6, and 96.0% of the sensor values fell within zones A and B of the consensus EGA for hypoglycemia. More than 85% of sensor values were within ±20%/20 mg/dL of reference values, the mean absolute relative difference was <11, and >99.5% of the sensor values fell in zones A and B of the consensus EGA. Conclusions: The Medtrum real‐time continuous glucose monitoring system was numerically and clinically accurate over a large glucose range across 7 days of wear. [ABSTRACT FROM AUTHOR]

Aims/Introduction It has not been reported whether chronic hepatitis B virus infection ( CHB) is associated with a specific type of diabetes. We sought to investigate the prevalence of CHB status in different diabetes subtypes among a Chinese population. Materials and Methods This was a cross-sectional study. A total of 381 patients with adult-onset autoimmune diabetes, 1,365 patients with type 2 diabetes and 1,365 non-diabetic controls were recruited from June 2005 to February 2014. The exclusion criteria included: (i) hepatitis C virus antibody positive; (ii) hepatic cirrhosis; and (iii) malignant neoplasm and severe renal dysfunction (serum creatinine >450 μmol/L). Patients were grouped as hepatitis B virus-negative and CHB status. Results Patients with type 2 diabetes had a higher prevalence of CHB than the controls in the overall population (13.5 vs 10.0%, P = 0.004) and among patients with normal hepatic function (13.3 vs 8.8%, P = 0.002). There was no difference in the prevalence of CHB status between patients with adult-onset autoimmune diabetes and the controls. Multiple logistic regression analysis showed that the odds ratio of CHB increased by ~1.5-fold in patients with type 2 diabetes than in the control group after adjustment for age, sex and body mass index, regardless of hepatic function status. Conclusions CHB status was more prevalent in patients with type 2 diabetes than in individuals with adult-onset autoimmune diabetes and the controls among the Chinese population. Further research is required to ascertain whether CHB status increases the risk of developing type 2 diabetes, or whether type 2 diabetes, but not adult-onset autoimmune diabetes, increases the risk of CHB. [ABSTRACT FROM AUTHOR]

Aims/Introduction Individuals with type 2 diabetes mellitus are vulnerable to micro- and macrovascular complications in the presence of microalbuminuria. Adipocyte fatty acid-binding protein (A-FABP) was proposed as an indicator for albuminuria in patients with diabetes. The present study aimed to explore the associations between serum A-FABP levels and microalbuminuria in the hyperglycemic population. Materials and Methods Serum A-FABP levels were detected using sandwich enzyme-linked immunosorbent assay. Microalbuminuria was identified by urinary albumin-to-creatinine ratio (UACR), when the value was between 30-300 mg/g. The participants were divided into the subgroups based on sex and the status of impaired glucose regulation or newly diagnosed type 2 diabetes mellitus. Results A total of 939 participants, consisting of 436 men and 503 women, were enrolled. Serum levels of A-FABP were much higher in participants with microalbuminuria than those without microalbuminuria. This result held true for all subgroups (all P < 0.05). For Spearman's correlation analyses, serum A-FABP levels showed a positive relationship with the UACR in men and women (both P < 0.01). Multiple stepwise regression analysis showed that serum A-FABP levels were independently and positively correlated with UACR in both sexes (men: standardized β = 0.256, P < 0.001; women: standardized β = 0.155, P = 0.001). This relationship remained significant in every subgroup (all P < 0.01). Conclusions For hyperglycemic individuals, serum A-FABP levels increased in the presence of microalbuminuria. Serum A-FABP levels were identified as an independent factor positively associated with the UACR. [ABSTRACT FROM AUTHOR]

Aims/Introduction Patients with type 2 diabetes are known to show elevated serum levels of carbohydrate antigen 19-9 ( CA19-9). The aim of the present study was to investigate the possible relationships of CA19-9 with metabolic control, insulin resistance ( IR), and pancreatic β-cell function in patients with obesity and type 2 diabetes who underwent Roux-En-Y gastric bypass ( RYGB). Materials and Methods The present study included 81 healthy volunteers, and 33 patients diagnosed with obesity and type 2 diabetes who underwent RYGB. Anthropometry, serum levels of CA19-9, glucose and lipid metabolic profiles, and serum insulin levels were determined at baseline and at 12 weeks after RYGB. Results Changes in CA19-9 were significantly and positively correlated with changes in fasting plasma glucose ( r = 0.552, P = 0.001), 2-h post-challenge plasma glucose levels ( r = 0.623, P = 0.000), glycated hemoglobin levels ( r = 0.819, P = 0.000), glycated albumin levels ( r = 0.711, P = 0.000), total cholesterol ( r = 0.449, P = 0.009) and the Homeostasis Model of Assessment- IR index ( r = 0.407, P = 0.019). Furthermore, a multiple stepwise regression analysis showed that the changes in serum levels of CA19-9 were independently and significantly associated with changes in glycated hemoglobin (β = 0.598, P = 0.000), fasting plasma glucose (β = 0.309, P = 0.000) and Homeostasis Model of Assessment- IR (β = 0.235, P = 0.010) after adjusting for confounding factors. Conclusions CA19-9 could be an effective indicator of IR, and glycemic and lipid metabolism in patients with obesity and type 2 diabetes after rapid metabolic control by RYGB. Additionally, CA19-9 might be a marker with which to evaluate the short-term effects of glycolipid toxicity on IR in these patients. [ABSTRACT FROM AUTHOR]