Systematic review and Meta-analysis of efficacy and safety of Tangmaikang Granules in treatment of diabetic peripheral neuropathy / 中国中药杂志

This study aimed to explore the efficacy and safety of Tangmaikang Granules in the treatment of diabetic peripheral neuropathy(DPN). PubMed, Cochrane Library, EMbase, SinoMed, CNKI, Wanfang and VIP were retrieved for randomized controlled trial(RCT) of Tangmaikang Granules in the treatment of DPN. Cochrane handbook 5.3 was used to evaluate the quality of the inclu-ded studies, and RevMan 5.4.1 and Stata 15.1 were employed to analyze data and test heterogeneity. GRADEpro was used to assess the quality of each outcome index. Clinical effective rate was the major outcome index, while the improvement in numbness of hands and feet, pain of extremities, sluggishness or regression of sensation, sensory conduction velocity(SCV) and motor conduction velocity(MCV) of median nerve and peroneal nerve, fasting blood glucose(FBG), 2 h postprandial blood glucose(2hPBG), and glycated hemoglobin(HbA1c) and incidence of adverse reactions were considered as the minor outcome indexes. A total of 19 RCTs with 1 602 patients were eventually included. The Meta-analysis showed that the improvements in clinical effective rate(RR=1.45, 95%CI[1.32, 1.61], P<0.000 01), pain of extremities(RR=1.70, 95%CI[1.27, 2.27], P=0.000 3), MCV of peroneal nerve(MD=4.08, 95%CI[3.29, 4.86], P<0.000 01) and HbA1c(SMD=-1.23, 95%CI[-1.80,-0.66], P<0.000 1) of Tangmaikang Granules alone or in combination in the experimental group were better than those in the control group. Compared with the conditions in the control group, numbness of hands and feet(RR=1.42, 95%CI[1.12, 1.80], P=0.003), sluggishness or regression of sensation(RR=1.41, 95%CI[1.05, 1.91], P=0.02), SCV of median nerve(MD=4.59, 95%CI[0.92, 8.27], P=0.01), SCV of peroneal nerve(MD=4.68, 95%CI[3.76, 5.60], P<0.000 01) and MCV of median nerve(MD=5.58, 95%CI[4.05, 7.11], P<0.000 01) of Tangmaikang Granules in combination in the experimental group were improved by subgroup analysis. The levels of FBG(MD=-0.57, 95%CI[-1.27, 0.12], P=0.11) and 2hPBG(MD=-0.69, 95%CI[-1.70, 0.33], P=0.18) in the experimental group were similar to those in the control group after treatment with Tangmaikang Granules alone or in combination. There was no difference in the safety(RR=1.28, 95%CI[0.58, 2.82], P=0.54) of Tangmaikang Granules in the treatment of DPN between the experimental group and the control group. Tangmaikang Granules could significantly increase clinical effective rate and nerve conduction velocity as well as improve symptoms of peripheral nerve and blood glucose level, and no serious adverse reactions were identified yet. Further validation was needed in future in large-sample, multicenter, high-quality RCTs.

Associations between glycated hemoglobin and glucose indicators in adults in areas at different altitude in China / 中华流行病学杂志

Objective: To explore the associations of glycated hemoglobin (HbA1c) with FPG and oral glucose tolerance test 2-hour (OGTT-2 h) in areas at different altitude in China. Methods: Subjects who participated in 2018-2019 China Chronic Disease and Risk Factor Surveillance and had no prior type 2 diabetes diagnosis were included. Subsequently, they were categorized into three groups based on altitude of living area (<2 000, 2 000- and ≥3 000 m). With adjustment for intracluster correlation, multivariable linear regression analysis was performed to evaluate the associations of HbA1c with FPG and OGTT-2 h in the context of HbA1c was normal (<5.7%) or abnormal (≥5.7%). Furthermore, the shape of relationships between HbA1c and glucose indicators was examined using restricted cubic spline. Finally, receiver operating characteristic curve was used to evaluate the diagnostic performance of HbA1c for diabetes. Results: A total of 157 277 subjects were included in the analysis. While FPG and OGTT-2 h levels gradually decreased with increase of altitude, HbA1c level was similar among the three groups. When HbA1c was <5.7%, its association with FPG and OGTT-2 h was weak and no obvious difference was observed among the three groups. When HbA1c was ≥5.7%, the FPG and OGTT-2 h increased by 15.45% (95%CI:14.71%- 16.18%) and 24.54% (95%CI:23.18%-25.91%) respectively per one standard deviation increase in HbA1c in group in area at altitude <2 000 m. However, the FPG and OGTT-2 h increased by 13.08% (95%CI:10.46%-15.76%) and 21.72% (95%CI:16.39%-27.31%), respectively, in group in area at altitude 2 000- m, and increased by 11.41% (95%CI:9.32%-13.53%) and 20.03% (95%CI:15.38%- 24.86%), respectively, in group of altitude ≥3 000 m. The restricted cubic spline indicated that the curve showing the association of HbA1c with FPG and OGTT-2 h was flat when HbA1c was <5.7%, but showed a positive linear relationship when HbA1c was ≥5.7%. The area under curve for detecting diabetes was 0.808 (95%CI:0.803-0.812) in group of altitude <2 000 m and 0.728 (95%CI:0.660-0.796, P=0.022) in group of altitude ≥3 000 m. The relevant optimal cutoff value of HbA1c was 5.7%, with a sensitivity of 65.4% and a specificity of 83.0%, and 6.0%, with a sensitivity of 48.3% and a specificity of 93.7%, respectively. Conclusions: When HbA1c was ≥5.7%, the association between HbA1c and glucose indicators became weaker as the increase of altitude. In the area at altitude ≥3 000 m, it may not be appropriate to use HbA1c in the diagnosis of diabetes.

Value of glycosylated hemoglobin A1c and apolipoprotein A-1 ratio on predicting outcome of patients with acute coronary syndrome / 中华心血管病杂志

Objective: To investigate the predictive value of glycosylated hemoglobin A1c/apolipoprotein A-1 (HbA1c/ApoA-1) ratio for major adverse cardiovascular events (MACEs) in patients with acute coronary syndrome (ACS). Methods: The present study is a retrospective cohort study. ACS patients who were hospitalized and underwent coronary angiography at Beijing Hospital from March 2017 to March 2019 were enrolled. Baseline information such as sex, age, previous history, Gensini score, HbA1c and ApoA-1 were analyzed. Patients were divided into two groups according to presence or absence of MACEs and the difference on HbA1c/ApoA-1 ratio was compared between the two groups. According to the tertiles of HbA1c/ApoA-1 levels, patients were divided into high (5.87-16.12), medium (4.50-5.83) and low (2.11-4.48) HbA1c/ApoA-1 groups. Cox proportional risk model was used to evaluate the differences in MACEs and all-cause mortality among the three groups. Kaplan-Meier survival analysis was used to compare the differences of MACEs between the various HbA1c/ApoA-1 groups. Results: A total of 366 ACS patients were included in this study. The mean age of the patients was (65.9±10.3) years. There were 59 MACEs and 10 all-cause deaths during the mean of (22.3±4.4) months follow-up. After adjusting for age, systolic blood pressure, history of diabetes and Gensini score, the incidence of MACEs was 2.45 times higher in the high HbA1c/ApoA-1 group than in the low HbA1c/ApoA-1 group (95%CI 1.16-5.18, P=0.019). There was no significant difference in all-cause mortality between the high and low HbA1c/ApoA-1 groups (P=1.000). Kaplan-Meier survival analysis showed that patients in the high HbA1c/ApoA-1 group had the highest risk of MACEs, while patients in the low HbA1c/ApoA-1 group had the lowest risk of MACEs (P<0.01). Spearman rank correlation analysis showed that HbA1/ApoA-1 ratio was positively correlated with Gensini score in ACS patients (r=0.274, P<0.01). Conclusion: High HbA1c/ApoA-1 ratio was an independent risk factor for MACEs in ACS patients. Patients with high HbA1c/ApoA-1 ratio had more severe coronary artery disease lesions. HbA1c/ApoA-1 ratio may be used as a potential risk stratification biomarker for ACS patients, it might be useful for the early identification of high-risk population and for predicting the incidence of MACEs among ACS patients.

A cohort study on the correlation between serum uric acid trajectory and the progression of renal function in patients with Type 2 diabetes mellitus / 中南大学学报(医学版)

OBJECTIVES@#Diabetic kidney disease is one of the most serious complications of diabetes mellitus (DM), and it is a main cause for chronic kidney disease and end-stage kidney disease (ESRD). It is important to find out the factors that cause the progression of renal function. The study aims to explore the relationship between serum uric acid (SUA) trajectory and the progression of renal function in patients with Type 2 diabetes mellitus (T2DM).@*METHODS@#A total of 846 patients with T2DM, who were admitted to the Department of Nephrology and Endocrinology, the Third Xiangya Hospital of Central South University, from January 2009 to December 2021 and met the criteria of baseline estimated glomerular filtration rate (eGFR)≥60 mL/(min·1.73 m2), were selected as the research subjects. The SUA data of multiple measurements were collected and identified as different SUA trajectories by group-based trajectory modeling (GBTM). According to the SUA trajectories, the patients were divided into a low trajectory group (105 cases), a middle trajectory group (396 cases), a middle high trajectory group (278 cases), and a high trajectory group (67 cases). Cox regression analysis was used to examine the effect of SUA trajectory on the progression of renal function in patients with T2DM. Subgroup analysis was performed by sex, age, course of disease, body mass index (BMI) and hemoglobin A1c (HbA1c).@*RESULTS@#The median follow-up was 4.8 years. At the end of follow-up, 158 patients had different degrees of decline in renal function. After adjusting for multiple confounding factors by Cox regression analysis, the risks of eGFR<60 mL/(min·1.73 m2), eGFR reduction rate≥50%, serum creatinine (Scr) doubling and composite endpoint (eGFR reduction rate≥50%, Scr doubling or ESRD) in the high trajectory group were significantly higher than those in the low trajectory group, with HR of 3.84 (95% CI 1.83 to 8.05), 6.90 (95% CI 2.27 to 20.96), 6.29 (95% CI 2.03 to 19.52), and 8.04 (95% CI 2.68 to 24.18), respectively. There was no significant difference in the risk of ESRD among the above 4 groups (all P>0.05). Subgroup analysis showed that: compared with the low trajectory group, the risks of eGFR<60 mL/(min·1.73 m2) in patients with high trajectory in the subgroup of male, female, age<65 years, course of disease<10 years, BMI≥24 kg/m2 and HbA1c≥7% were increased (all P<0.05). The SUA trajectory had no interaction with sex, age, course of disease, BMI and HbA1c (all interactive P>0.05).@*CONCLUSIONS@#The high SUA trajectory increases the risk for progression of renal function in patients with T2DM. Long-term longitudinal changes of SUA should be paid attention to.

HbA1c comparison and diagnostic efficacy analysis of multi center different glycosylated hemoglobin detection systems / 中华预防医学杂志

Objective: Compare and analyze the results of the domestic Lanyi AH600 glycated hemoglobin analyzer and other different detection systems to understand the comparability of the detection results of different detectors, and establish the best cut point of Lanyi AH600 determination of haemoglobin A1c (HbA1c) in the diagnosis of diabetes. Methods: Multi center cohort study was adopted. The clinical laboratory departments of 18 medical institutions independently collected test samples from their respective hospitals from March to April 2022, and independently completed comparative analysis of the evaluated instrument (Lanyi AH600) and the reference instrument HbA1c. The reference instruments include four different brands of glycosylated hemoglobin meters, including Arkray, Bio-Rad, DOSOH, and Huizhong. Scatter plot was used to calculate the correlation between the results of different detection systems, and the regression equation was calculated. The consistency analysis between the results of different detection systems was evaluated by Bland Altman method. Consistency judgment principles: (1) When the 95% limits of agreement (95% LoA) of the measurement difference was within 0.4% HbA1c and the measurement score was≥80 points, the comparison consistency was good; (2) When the measurement difference of 95% LoA exceeded 0.4% HbA1c, and the measurement score was≥80 points, the comparison consistency was relatively good; (3) The measurement score was less than 80 points, the comparison consistency was poor. The difference between the results of different detection systems was tested by paired sample T test or Wilcoxon paired sign rank sum test; The best cut-off point of diabetes was analyzed by receiver operating characteristic curve (ROC). Results: The correlation coefficient R2 of results between Lanyi AH600 and the reference instrument in 16 hospitals is≥0.99; The Bland Altman consistency analysis showed that the difference of 95% LoA in Nanjing Maternity and Child Health Care Hospital in Jiangsu Province (reference instrument: Arkray HA8180) was -0.486%-0.325%, and the measurement score was 94.6 points (473/500); The difference of 95% LoA in the Tibetan Traditional Medical Hospital of TAR (reference instrument: Bio-Rad Variant II) was -0.727%-0.612%, and the measurement score was 89.8 points; The difference of 95% LoA in the People's Hospital of Chongqing Liang Jiang New Area (reference instrument: Huizhong MQ-2000PT) was -0.231%-0.461%, and the measurement score was 96.6 points; The difference of 95% LoA in the Taihe Hospital of traditional Chinese Medicine in Anhui Province (reference instrument: Huizhong MQ-2000PT) was -0.469%-0.479%, and the measurement score was 91.9 points. The other 14 hospitals, Lanyi AH600, were compared with 4 reference instrument brands, the difference of 95% LoA was less than 0.4% HbA1c, and the scores were all greater than 95 points. The results of paired sample T test or Wilcoxon paired sign rank sum test showed that there was no statistically significant difference between Lanyi AH600 and the reference instrument Arkray HA8180 (Z=1.665,P=0.096), with no statistical difference. The mean difference between the measured values of the two instruments was 0.004%. The comparison data of Lanyi AH600 and the reference instrument of all other institutions had significant differences (all P<0.001), however, it was necessary to consider whether it was within the clinical acceptable range in combination with the results of the Bland-Altman consistency analysis. The ROC curve of HbA1c detected by Lanyi AH600 in 985 patients with diabetes and 3 423 patients with non-diabetes was analyzed, the area under curve (AUC) was 0.877, the standard error was 0.007, and the 95% confidence interval 95%CI was (0.864, 0.891), which was statistically significant (P<0.001). The maximum value of Youden index was 0.634, and the corresponding HbA1c cut point was 6.235%. The sensitivity and specificity of diabetes diagnosis were 76.2% and 87.2%, respectively. Conclusion: Among the hospitals and instruments currently included in this study, among these four hospitals included Nanjing Maternity and Child Health Care Hospital in Jiangsu Province (reference instrument: Arkray HA8180), Tibetan Traditional Medical Hospital of TAR (reference instrument: Bio-Rad Variant Ⅱ), the People's Hospital of Chongqing Liang Jiang New Area (reference instrument: Huizhong MQ-2000PT), and the Taihe Hospital of traditional Chinese Medicine in Anhui Province (reference instrument: Huizhong MQ-2000PT), the comparison between Lanyi AH600 and the reference instruments showed relatively good consistency, while the other 14 hospitals involved four different brands of reference instruments: Arkray, Bio-Rad, DOSOH, and Huizhong, Lanyi AH600 had good consistency with its comparison. The best cut point of the domestic Lanyi AH600 for detecting HbA1c in the diagnosis of diabetes is 6.235%.

Cardiac Structural and Functional Features in Patients With Type 2 Diabetes Mellitus and Heart Failure With Preserved Ejection Fraction:A Study Based on Propensity Score Matching / 中国医学科学院学报

Objective To investigate the cardiac structural and functional characteristics in the patients with heart failure with preserved ejection fraction (HFpEF) and type 2 diabetes mellitus (T2DM),and predict the factors influencing the characteristics. Methods A total of 783 HFpEF patients diagnosed in the Department of Geriatric Cardiology,the First Hospital of Lanzhou University from April 2009 to December 2020 were enrolled in this study.Echocardiography and tissue Doppler technique were employed to evaluate cardiac structure and function.According to the occurrence of T2DM,the patients were assigned into a HFpEF+T2DM group (n=332) and a HFpEF group (n=451).Propensity score matching (PSM)(in a 1∶1 ratio) was adopted to minimize confounding effect.According to urinary albumin excretion rate (UAER),the HFpEF+T2DM group was further divided into three subgroups with UAER<20 μg/min,of 20-200 μg/min,and>200 μg/min,respectively.The comorbidities,symptoms and signs,and cardiac structure and function were compared among the groups to clarify the features of diabetes related HFpEF.Multivariate linear regression was conducted to probe the relationship of systolic blood pressure,blood glucose,glycosylated hemoglobin,and UARE with cardiac structural and functional impairment. Results The HFpEF+T2DM group had higher prevalence of hypertension (P=0.001) and coronary heart disease (P=0.036),younger age (P=0.020),and larger body mass index (P=0.005) than the HFpEF group,with the median diabetic course of 10 (3,17) years.After PSM,the prevalence of hypertension and coronary heart disease,body mass index,and age had no significant differences between the two groups(all P>0.05).In addition,the HFpEF+T2DM group had higher interventricular septal thickness (P=0.015),left ventricular posterior wall thickness (P=0.040),and left ventricular mass (P=0.012) and lower early diastole velocity of mitral annular septum (P=0.030) and lateral wall (P=0.011) than the HFpEF group.Compared with the HFpEF group,the HFpEF+T2DM group showed increased ratio of early diastolic mitral filling velocity to early diastolic mitral annular velocity (E/e') (P=0.036).Glycosylated hemoglobin was correlated with left ventricular mass (P=0.011),and the natural logarithm of UAER with interventricular septal thickness (P=0.004),left ventricular posterior wall thickness (P=0.006),left ventricular mass (P<0.001),and E/e' ratio (P=0.049). Conclusion The patients with both T2DM and HFpEF have thicker left ventricular wall,larger left ventricular mass,more advanced left ventricular remodeling,severer impaired left ventricular diastolic function,and higher left ventricular filling pressure than the HFpEF patients without T2DM.Elevated blood glucose and diabetic microvascular diseases might play a role in the development of the detrimental structural and functional changes of the heart.

Relación de IMC con marcadores de inflamación y hemoglobina glicosilada en niños y jóvenes con diabetes mellitus 1 / Relationship of BMI with markers of inflammation and glycosylated hemoglobin in children and young adults with diabetes mellitus 1

La diabetes mellitus tipo 1 (DM1) es una enfermedad autoinmune que genera dependencia exógena de insulina de forma permanente, presenta inflamación subclínica crónica lo que conlleva a una elevación de marcadores de inflamación como factor de necrosis tumoral alfa (TNF-α), proteína C reactiva (PCR) e interleuquina 6 (IL-6). OBJETIVO: determinar la relación entre el IMC sobre los marcadores de inflamación y el control metabólico en niños y jóvenes con DM1 entre 5 a 15 años de edad. METODOLOGÍA: Se realizó un estudio clínico, observacional, exploratorio. A partir de La recolección de datos de fichas clínicas y muestras de sangre en el Instituto de Investigaciones Materno Infantil (IDIMI) del Hospital San Borja Arriarán de la Universidad de Chile. Clasificación del estado nutricional utilizando datos registrados en ficha clínica. Marcadores de inflamación por medio de ELISA, hemoglobina glicosilada mediante métodos estándares. El análisis estadístico incluyó correlaciones mediante test de Spearman y diferencia de medias mediante test de Kruskal-Wallis seguido de post hoc Dunns. RESULTADOS: Un 30% de los pacientes con DM1 presentaron malnutrición por exceso. Al analizar la relación entre los niveles de marcadores inflamatorios y Hb glicosilada se observó la existencia de asociacion positiva entre usPCR y HbA1c (r= 0,30; p=0,0352) y entre IL-6 y HbA1c (r= - 0,038; p=0,0352). CONCLUSIONES: este estudio describe una posible asociación entre parámetros clásicos de inflamación con la hemoglobina glicosilada en las categorias de sobrepeso y obesidad en pacientes con DM1.

Type 1 diabetes mellitus (T1D) is an autoimmune disease that generates permanent exogenous insulin dependence, accompanied by chronic subclinical inflammation that leads to an elevation of inflammation markers such as tumor necrosis factor-alpha (TNF-α), C-reactive protein (CRP) and interleukin-6 (IL-6). OBJECTIVE: To determine the relationship between BMI on markers of inflammation and metabolic control in children and young people with T1D between 5 and 15 years of age. METHODOLOGY: A clinical, observational and exploratory study was carried out, based on the collection of data from clinical records and blood samples of children and adolescents with DM1 at the Instituto de Investigaciones Materno Infantil (IDIMI) of the Hospital San Borja Arriarán of the Universidad de Chile. Nutritional status, levels of inflammation markers and glycosylated hemoglobin were determined by standardized methods. Statistical analysis included correlations by Spearman test and mean difference by Kruskal-Wallis test followed by post hoc Dunns test. RESULTS: A total of 56 patients with T1D were analyzed, 30% of whom presented excess malnutrition. Those children or adolescents with obesity presented significantly higher usPCR levels compared to underweight patients or patients at risk of malnutrition (p=0.039). In addition, HbA1c levels were determined which were negatively associated with usPCR (r= 0.30; p=0.0352) and IL-6 (r= - 0.038; p=0.0352) levels. CONCLUSIONS: This study points out that nutritional status is associated with usPCR levels, in agreement with what is described in the literature and shows a possible association between classical parameters of inflammation with glycosylated hemoglobin in children and adolescents with nutritional diagnosis of overweight or obesity.

Relación de la calidad de sueño, adherencia al tratamiento, hemoglobina glucosilada en mujeres con diabetes / Relationship of sleep quality, adherence to treatment, glycated hemoglobin in women with diabetes

Introducción: La Diabetes Tipo 2 es considerado un problema de salud pública que afecta principalmente a las mujeres, que sumado a una mala adherencia al tratamiento terapéutico y, a una falta de calidad de sueño, aumentan la problemática de salud. Objetivo: Determinar las interrelaciones existentes entre la Calidad de Sueño, la Adherencia al Tratamiento Terapéutico y los valores de HbA1c en Mujeres con DT2, perteneciente a una comunidad de la ciudad de Puebla. Materiales y Métodos: El diseño del estudio fue de tipo descriptivo, correlacional y de corte transversal. La muestra se calculó con un nivel de significancia de .05, un coeficiente de correlación .30 y un poder estadístico del 90%, obteniendo una n=110. Los instrumentos utilizados fueron: una cédula de datos personales, el Índice de calidad de sueño de Pittsburgh (PSQI), el Cuestionario de Adherencia Terapéutica MBG (Martín-Bayarre-Grau) y el dispositivo Eclipse A1c. Resultados: Se encontró una relación negativa y significativa para la calidad de sueño con los niveles de HbA1c (rs=-.355; p=.001); no así para con la variable de adherencia al tratamiento terapéutico. Discusión: La información obtenida concuerda con otros estudios, al reafirmar de manera indirecta, las reacciones bioquimicas que ocurren durante la privación del sueño. Conclusiones: Los resultados descubiertos contribuyen al fortalecimiento científico de enfermería, orientando en la mejora de cuidados, que servirá para el diseño de intervenciones que favorezcan a la salud de las mujeres con Diabetes Tipo 2.

Introduction: Type 2 Diabetes is considered a public health problem that mainly affects women, which, added to poor adherence to therapeutic treatment and a lack of quality sleep, increase health problems. Objective: To determine the existing interrelations between Sleep Quality, Adherence to Therapeutic Treatment and HbA1c values in Women with T2D, belonging to a community in the city of Puebla. Materials and Method: the study design was descriptive, correlational and cross-sectional. The sample was calculated with a significance level of .05, a correlation coefficient of .30 and a statistical power of 90%, obtaining n = 110. The instruments used were: a personal data card, the Pittsburgh Sleep Quality Index (PSQI), the MBG Therapeutic Adherence Questionnaire (Martín-Bayarre-Grau) and the Eclipse A1c device. Results: a negative and significant relationship was found for sleep quality with HbA1c levels (rs = -. 355; p = .001); not so for the variable of adherence to therapeutic treatment. Discussion: The information obtained agrees with other studies, indirectly reaffirming the biochemical reactions that occur during sleep deprivation. Conclusions: the results discovered contribute to the scientific strengthening of nursing, guiding the improvement of care, which will serve to design interventions that favor the health of women with Type 2 Diabetes.

Introdução: A diabetes tipo 2 é considerada um problema de saúde pública que afeta principalmente as mulheres, o que somado a uma má aderência ao tratamento terapêutico e, a falta de qualidade do sono, aumenta o problema de saúde. Objetivo: Determinar as inter-relações entre a qualidade do sono, a adesão ao tratamento terapêutico e os valores de HbA1c nas mulheres com DT2, pertencentes a uma comunidade da cidade de Puebla. Materiais e Métodos: O desenho do estudo foi descritivo, correlacional e transversal. A amostra foi calculada com um nível de significância de 0,05, um coeficiente de correlação de 0,30 e um poder estatístico de 90%, obtendo-se uma n=110. Os instrumentos utilizados foram: um formulário de dados pessoais, o Índice de Qualidade de Sono de Pittsburgh (PSQI), o Questionário MBG para Avaliar Adesão Terapêutica (Martín-Bayarre-Grau) e o dispositivo Eclipse A1c. Resultados: Foi encontrada uma relação negativa e significativa da qualidade do sono com os níveis de HbA1c (rs=-.355; p=.001); este não foi o caso para a variável de aderência ao tratamento terapêutico. Discussão: As informações obtidas concordam com outros estudos, reafirmando indiretamente as reações bioquímicas que ocorrem durante a privação do sono. Conclusões: Os resultados descobertos contribuem para o fortalecimento científico da enfermagem, orientando a melhoria dos cuidados, que servirão para o desenho de intervenções que favoreçam a saúde das mulheres com diabetes tipo 2.

Glucemia en ayunas entre 100 y 109 mg/dL versus prediabetes según hemoglobina glicosilada / Fasting blood glucose between 100 and 109 mg/dL versus prediabetes according to glycosylated hemoglobin

Introducción: algunos estudios han señalado que valores de glucemia en ayunas entre 100 y 109 mg/dL se asocian con frecuencias elevadas de prediabetes cuando el criterio de clasificación son los valores de HbA1c. La Sociedad Argentina de Diabetes (SAD) sostiene a 110 mg/dL como valor a partir del cual se clasifica a un paciente como portador de glucemia en ayunas alterada; la frecuencia de individuos posiblemente clasificados en forma incorrecta, según este criterio, aún no se conoce en la población argentina. Objetivos: establecer la frecuencia con que se presenta prediabetes según HbA1c en una población sin diagnóstico de diabetes mellitus (DM) con glucemias en ayunas entre 100 y 109 mg/dL; correlacionar las dos variables y cuantificar la probabilidad de que esto ocurra respecto de otros con glucemias en ayunas <100 mg/dL. Materiales y métodos: se incluyeron 1.002 muestras de igual número de sujetos desde 45 laboratorios de análisis clínicos de la Asociación de Laboratorios de Alta Complejidad (ALAC), con procesamiento local de glucemia y centralizado de HbA1c por high performance liquid chromatography (HPLC). Análisis estadístico: chi cuadrado, odds ratio, coeficiente de correlación y determinación de Pearson, y correlación serial de Durbin-Watson. Resultados: frecuencia de HbA1c ≥5,7% en la población estudiada con glucemias de ayunas entre 100 y 109 mg/dL=29,7%; test de chi cuadrado: p<0,001; odds ratio de tener HbA1c ≥5,7% entre la población con glucemias en ayunas de 100 a 109 mg/dL vs aquella con valores <100 mg/dL=4,328 (IC 95% 2,922-6,411); r=0,852, r2 = 0,727, Durbin-Watson=1,152. Conclusiones: la prediabetes diagnosticada por HbA1c resultó cuatro veces más frecuente en la población estudiada con glucemias en ayunas entre 100 y 109 mg/dL, que en aquella con valores por debajo de 100 mg/dL.

Introduction: some studies have shown that fasting blood glucose values between 100 and 109 mg/dL are associated with high rates of prediabetes when the classification criteria are HbA1c values. The Argentine Diabetes Society still maintains 110 mg/dL as the value from which a patient is classified as having impaired fasting blood glucose; the frequency of individuals possibly incorrectly classified, according to this criterion, is not yet known in any Argentine population. Objectives: to establish the frequency in a population without a diagnosis of diabetes mellitus with fasting blood glucose levels between 100 and 109 mg/dL in which prediabetes occurs according to HbA1c, to correlate both variables and to quantify the probability that this predicts with respect to others with fasting blood glucose levels <100 mg/dL. Materials and methods: 1.002 samples from the same number of subjects from 45 clinical laboratories belonging to ALAC, with local processing of blood glucose and centralized processing of HbA1c by high performance liquid chromatography (HPLC). Statistical analysis: chi square, odds ratio, Pearson correlation coefficient, coefficient of determination and Durbin-Watson serial correlation. Results: frequency of HbA1c ≥5.7% in the studied population with fasting blood glucose levels between 100 and 109 mg/ dL = 29.7%, chi square test: p<0.001; odds ratio of having HbA1c ≥5.7% between the population with fasting blood glucose levels of 100 to 109 mg/dL vs that one with values <100 mg/dL=4.328 (95% CI 2.922-6.411); r=0.852, r2 =0.727, DurbinWatson=1.152. Conclusions: prediabetes diagnosed by HbA1c was four times more frequent in the studied population with fasting glucose values between 100 and 109 mg/dL than in that one with values below 100 mg/dL.

Efectos de los agonistas del receptor de péptido similar al glucagón tipo 1 como tratamiento en pacientes con obesidad y diabetes mellitus tipo 2 / Effects of glucagon-like peptide-1 receptor antagonist in the treatment of patients with obesity and Type 2 diabetes mellitus

Introducción: Recientemente se han descubierto nuevos medicamentos para el tratamiento de la diabetes tipo 2, con novedosos mecanismos de acción y menos efectos adversos. Dentro de ellos tenemos los análogos del péptido similar al glucagón tipo 1. Objetivo: Explicar la evidencia existente sobre los efectos del tratamiento con agonistas del receptor del péptido similar al glucagón tipo 1 en las personas con obesidad y diabetes mellitus tipo 2. Material y Métodos: Se realizó una revisión sistemática que incluyó estudios de los efectos de los agonistas del receptor del péptido similar al glucagón tipo1 como tratamiento en personas mayores de 12 años con obesidad y diabetes tipo 2. Se realizó una síntesis narrativa formal de los datos recogidos, no se realizó una síntesis estadístico formal. La calidad de evidencia para cada desenlace se determinó, según la metodología Grading of Recommendations Assessmet, Developmet and Evaluation. Resultados: La evidencia disponible demuestra que los agonistas del receptor del péptido similar al glucagón tipo 1, lograron una mayor disminución del peso corporal (-7,0 por ciento vs -2 por ciento) y de las cifras de hemoglobina glucosilada (HbA1c) (-0,40 por ciento vs -0,10 %) respecto al grupo placebo. Además, de una mayor reducción de la cintura abdominal. Conclusiones: La evidencia analizada muestra que los fármacos del tipo agonistas del receptor del péptido similar al glucagón tipo 1 tienen efectos beneficiosos en el tratamiento de las personas con obesidad y diabetes, disminuyendo el peso corporal y los valores de glucemia(AU)

Introduction: New drugs with novel mechanisms of action and fewer adverse effects have recently been discovered for the treatment of type 2 diabetes. Among them are glucagon-like peptide-1 analogues. Objective: To explain the existing evidence of the effects of treatment with glucagon-like peptide-1 receptor agonists in people with obesity and type 2 diabetes mellitus. Material and Methods: We conducted a systematic review that included studies on the effects of glucagon-like peptide -1 receptor agonists for the treatment of people older than 12 years with obesity and type 2 diabetes. A formal narrative synthesis of the collected data was performed, whereas a formal statistical synthesis was not performed. The quality of evidence for each outcome was determined according to the Grading of Recommendations Assessment, Development and Evaluation method. Results: The available evidence shows that glucagon-like peptide -1 receptor agonists achieved a greater reduction in body weight (-7,0 percent vs -2 percent) and glycosylated hemoglobin (HbA1c) (-0,40 percent vs -0,10 percent) compared to the placebo group. In addition, there was a greater reduction in abdominal waist circumference. Conclusions: The evidence analyzed shows that glucagon-like peptide -1 receptor agonists have beneficial effects in the treatment of people with obesity and diabetes, reducing body weight and glycemia values(AU)

The importance of optimal 25-hydroxyvitamin D levels in the glycemic control of older adults with type 2 Diabetes Mellitus: Data from the study on aging and longevity EELO

INTRODUCTION: Optimal serum levels of vitamin D are of great importance, especially in populations with comorbidities such as Diabetes Mellitus (DM). OBJECTIVE: The study evaluated the relationship between hypovitaminosis D and glycemic control in older adults with type 2 DM. METHODS: Cross-sectional and prospective study, part of the EELO project (Study on Aging and Longevity), conducted in Southern Brazil. Glycated hemoglobin (diabetes ≥6.5%) and serum levels of vitamin D (25(OH)D) were evaluated. Hypovitaminosis D was determined using cutoff points <20 and <30 ng/mL). Multivariate logistic regression was used to assess the risk of having uncontrolled DM. RESULTS: Of the 120 older adults included in the study, aged between 60 and 87 years, 74.2% were women, 66.7% used hypoglycemic medications and 75.8% exhibited uncontrolled diabetes. An inverse correlation was observed between the levels of 25(OH) D and glycated hemoglobin (rS=-0.19, p=0.037), suggesting that low levels of vitamin D are associated with poor glycemic control in diabetic individuals. The prevalence of hypovitaminosis D when using the cutoff points of <20 and <30 ng/mL were 34.2% and 75.0%, respectively. The odds ratio (OR) analysis showed that individuals with 25(OH)D<20ng/mL have almost 4 times more risk of having uncontrolled DM (OR:3.94; CI95%:1.25-12.46, p=0.02) when compared to the older adults with sufficient levels of vitamin D. CONCLUSION: The results indicate that the optimal serum levels currently recommended for 25(OH)D should preferably be 30 ng/mL or higher to contribute to better glycemic control in older adults with type 2 DM.

INTRODUÇÃO: Os níveis séricos ideais de vitamina D são de grande importância, especialmente na população com comorbidades como o Diabetes Mellitus (DM). OBJETIVO: O estudo avaliou a relação entre hipovitaminose D e controle glicêmico em idosos com DM tipo 2. MÉTODOS: Estudo transversal e prospectivo, parte do projeto EELO (Estudo sobre Envelhecimento e Longevidade), no Sul do Brasil. A hemoglobina glicada (diabetes ≥6,5%) e os níveis séricos de vitamina D (25(OH)D) foram avaliados. Hipovitaminose D foi determinada usando ponto de corte <20 e <30 ng/mL. Regressão logística multivariada foi utilizada para avaliar o risco de ter DM descompensado. RESULTADOS: Dos 120 idosos incluídos no estudo, idade entre 60 a 87 anos, 74,2% eram mulheres, 66,7% faziam uso de medicamentos hipoglicemiantes e 75,8% apresentavam diabetes descompensada. Uma correlação inversa foi observada entre os níveis de 25(OH)D e hemoglobina glicada (rS=-0,19; p=0.037), sugerindo que baixos níveis de vitamina D está associado a um pior controle glicêmico em diabéticos. A prevalência de hipovitaminose D quando se utiliza ponto de corte <20 e <30 ng/mL foi de 34,2% e 75,0%, respectivamente. A análise Odds ratio (OR) mostrou que indivíduos com 25(OH)D<20 ng/mL tem quase 4 vezes mais risco de ter DM descompensado (OR:3,94; IC95%:1,25­12,46; p=0,02) quando comparado aos idosos com níveis suficientes de vitamina D. CONCLUSÃO: Os resultados indicam que os níveis sérios ideais atualmente recomendados para 25(OH)D maior ou igual a 30 ng/ml contribuem para o melhor controle glicêmico na população idosa com DM tipo 2.

Dose-ranging effects of SGLT2 inhibitors in patients with type 2 diabetes: a systematic review and meta-analysis

ABSTRACT The lowest dosage of empagliflozin (10 mg) showed similar benefits on glycated hemoglobin (HbA1c) level, body weight, blood pressure, and total and cardiovascular mortality in comparison with the highest available dose (25 mg) in the EMPAREG trial. These findings have not been clearly demonstrated for canagliflozin and dapagliflozin. The objective was to compare the effect of different doses of SGLT2 inhibitors commercially available in Brazil on HbA1c and body weight of patients with type 2 diabetes. MEDLINE, Cochrane and Embase databases were searched from inception until 11th October 2021 for randomized controlled trials of SGLT2 inhibitors in type 2 diabetes patients, lasting at least 12 weeks. HbA1c and body weight variations were described using standard mean difference. We performed direct and indirect meta-analysis, as well as a meta-regression with medication doses as covariates. Eighteen studies were included, comprising 16,095 patients. In the direct meta-analysis, SGLT2 inhibitors reduced HbA1c by 0.62% (95% CI −0.66 to −0.59) and body weight by 0.60 kg (95% CI −0.64 to −0.55). In the indirect meta-analysis, canagliflozin 300 mg ranked the highest regarding reductions in HbA1c and body weight. The remaining medications and dosages were clinically similar, despite some statistically significant differences among them. Canagliflozin 300 mg seems to be more potent in reducing HbA1c and body weight in patients with type 2 diabetes. The remaining SGLT2 inhibitors at different doses lead to similar effects for both outcomes. Whether these glycemic and weight effects are reflected in lower mortality and cardiovascular events is still uncertain and may be a topic for further studies.

Prescription of DPP4 inhibitors: Indication and effect on glycosylated hemoglobin in a primary care institution of Colombia / Prescripción de inhibidores de la DPP-4: indicación y efecto sobre la hemoglobina glicosilada en un primer nivel de Colombia

Abstract Introduction and objective: In Colombia, Dipeptidyl-Peptidase IV (DPP4) inhibitors are recommended as second-best choice for type 2 diabetes mellitus treatment. However, no evaluation of the accomplishment or impact of this recommendation was performed. The objective was to determine the prescription of the DPP4 inhibitor according to the Colombian Clinicial Practice Guide regarding type 2 diabetes mellitus treatment, and its effects on glycosylated hemoglobin (HbAlc). Materials and methods: A descriptive study that included patients with type 2 diabetes mellitus who attended a first level between 2016 and 2018, had a prescription for DPP4 inhibitor and at least two control appointments. Variables included were sociodemographic, clinics, treatment and comorbidities. The unadjusted prescription was defined as the lack of accomplishment of Colombian guidelines. Descriptive statistics and X2 test were used for the comparison of categorical variables. A binary logistic regression model was applied. Results: 112 out of 207 patients accomplished inclusion criteria, of which 77 were women (68.8%). Also, 68.8% of the patients had an unadjusted prescription of the iDPP4. There was a 0.21% total reduction in HbA1c levels, with a mean of 198.2 ± 124 days between the first and second control measurement (reduction of 0.55% when the prescription was adjusted to the guidelines and 0.05% if it was unadjusted). Conclusion: There is a limited impact of DPP4 inhibitors regarding the reduction of HbA1c and metabolic control, and there is a slight follow-up to the Colombian guidelines in patients who attend a first level.

Resumen Introducción y Objetivo: En Colombia se recomiendan los inhibidores de la Dipeptidil Peptidasa-IV (iDPP4) como segunda opción para el manejo de la diabetes mellitus tipo 2. No se ha evaluado el cumplimiento e impacto de esta recomendación. Como objetivo se buscó determinar la prescripción de los iDPP4 según las recomendaciones de la Guía de Práctica Clínica colombiana, y su efecto sobre la hemoglobina glicosilada (HbA1c). Materiales y métodos: Estudio descriptivo que incluyó pacientes con diabetes mellitus tipo 2 que consultaron a un primer nivel entre 2016 y 2018, y tenían formulado un iDPP4, con al menos dos consultas de seguimiento. Se incluyeron variables sociodemográficas, clínicas, tratamiento y comorbilidades. La prescripción no ajustada se definió como la falta de cumplimento de la recomendación de la guía colombiana. Se empleó estadística descriptiva y pruebas X2 para la comparación de variables categóricas. Se aplicó un modelo de regresión logística binaria. Resultados: Hubo 207 pacientes de los cuales 112 cumplieron criterios de inclusión, 77 eran mujeres (68,8%). El 68,8% de los pacientes presentaron una prescripción no ajustada del iDPP4. Hubo una reducción total de 0,21%, con una media de 198,2±124 días entre la primera y segunda medición de HbA1c de control (reducción de 0,55% cuando la prescripción se ajustaba a la guía colombiana y 0,05% cuando no). Conclusión: Hay un limitado impacto de los iDPP4 frente a la reducción de HbA1c y poco seguimiento de la guía colombiana en pacientes de primer nivel de atención.

Assessment of electrolytes, markers of glycaemic control and renal dysfunction among adult Nigerians recently diagnosed with type 2 diabetes mellitus

Background: Diabetes mellitus is a chronic and progressive endocrine disorder that may result in macro and microvascular complications. Objective: This study assessed some biochemical analytes in Nigerians who were recently (≤ 6 months) diagnosed with Type 2 diabetes mellitus (T2DM). Methods: 160 T2DM and 90 non-diabetic control participated in this study. Blood samples were collected and analyzed for Heart-type fatty acid-binding protein (HFABP), high sensitivity C-reactive protein (hs-CRP), electrolytes, lipid and renal profile parameters, glycated haemoglobin (HBA1C) and fasting blood glucose (FBG), using standard guidelines. Result: The body mass index (BMI) of the T2DM volunteers was higher than control (P <0.001). The lipid profile, potassium, glucose, HBA1C, urea and creatinine values were elevated (P <0.001) while estimated glomerular filtration rate (eGFR) was lower (P<0.05) in diabetes. The median HFABP and hs-CRP were raised (P <0.05) in T2DM. Positive associations existed between FBG and urea (P <0.001), Creatinine and HBAIC (P <0.001). A logistic regression analysis, shows that an increased BMI, HBA1C, FBG, Cholesterol, urea and creatinine were associated with higher odds (p<0.001) of cardiovascular and renal complications. Conclusion: Elevated hs-CRP, glycated haemoglobin, urea and creatinine among T2DM increase the odds of cardiovascular and renal insults in this population

Family-integrated diabetes education for individuals with diabetes in South-west Niger

Objectives: This study aimed to determine the effects of family-integrated diabetes education on diabetes knowthe ledge of patients and family members, as well as its impact on patients' glycosylated haemoglobin (A1C). Design: The design was a two-group Pretest Posttest quasi-experimental. Setting: The study took place at the diabetes clinics of two tertiary hospitals in southwestern Nigeria. Participants: People Living with Diabetes (PLWD) and family members aged 18 years and over and without cognitive impairment were placed, as clusters, into either a control group (CG) or an intervention group (IG) The CG comprised 88 patients and 88 family members while IG comprised 82 patients and 82 family members. Of these, 78 and 74 patients completed the study in CG and IG, respectively. Interventions: PLWD in IG along with their family members were given an educational intervention on diabetes management and collaborative support with an information booklet provided. This was followed by three (3) complimentary Short Messaging Service (SMS).Main outcome measures: A1C and diabetes knowledge. Results: Over half (52.4%) and about a fifth (18.2%) of family members and patients, respectively, had never had diabetes education. There was a statistically significant increase in the knowledge of patients and family members in IG. Unlike CG, the A1C of patients in IG improved significantly at three and six-month post-intervention, (p<0.01). Regression showed an independent effect of family members' knowledge on IG's A1C. Conclusions: Improved family members' diabetes knowledge positively impacted patients' glucose level. There is a need to integrate family members into diabetes care better.

Comparison of initial periodontal therapy and its correlation with white blood cell level in periodontitis patients with or without diabetes mellitus / 北京大学学报(医学版)

OBJECTIVE@#To compare the clinical efficacy of initial periodontal therapy in periodontitis patients with or without type 2 diabetes mellitus and its correlation with white blood cell counts.@*METHODS@#In this study, 32 chronic periodontitis patients without systemic disease (CP group) and 27 chronic periodontitis patients with type 2 diabetes mellitus (CP+DM group) were enrolled. At admission, all the patients went through periodontal examination and fasting blood examination(baseline). Probing depth (PD), attachment loss (AL), bleeding index (BI), plaque index (PLI), white blood cells (WBC) counts and fasting blood glucose (FBG) were recorded respectively, while hemoglobin A1c (HbA1c) was recorded only in CP+DM group. After that, initial periodontal therapy was performed. All the tests were repeated 3 and 6 months after treatment. The changes of periodontal clinical indexes and WBC levels were compared between the two groups before and after treatment, and the correlation between WBC and periodontal clinical indexes and glucose metabolism indexes were analyzed by generalized linear mixed model.@*RESULTS@#At baseline, the periodontal inflammation and destruction were similar in CP and CP+DM group, but the WBC level was significantly higher in CP+DM groups [(6.01±1.26)×109/L vs. (7.14±1.99)×109/L, P=0.01]. After 3 and 6 months of initial periodontal therapy, the mean PD, AL, BI, and PLI in CP+DM and CP groups were significantly lower than the baseline, and the PD in CP+DM group was further decreased by 6 months compared with 3 months [(3.33±0.62) mm vs. (3.61±0.60) mm, P < 0.05]. However, none of these periodontal indexes showed significant difference between the two groups by 3 or 6 months. In CP+DM group, HbA1c at 3 months and 6 months were significantly lower than the baseline [(7.09±0.79)% vs. (7.64±1.16)%, P < 0.05; (7.06±0.78)% vs. (7.64±1.16)%, P < 0.05], and FBG was significantly lower than the baseline by 6 months [(7.35±1.14) mmol/L vs. (8.40±1.43) mmol/L, P < 0.05]. The WBC level in CP group was significantly lower than the baseline level by 3 months [(5.35±1.37)×109/L vs. (6.01±1.26)×109/L, P < 0.05], while that in CP+DM group was significantly lower than the baseline level by 6 months [(6.00±1.37)×109/L vs. (7.14±1.99)×109/L, P < 0.05]. The analysis of genera-lized linear mixed model showed that WBC level was significantly positively correlated with PD and FBG (P < 0.05).@*CONCLUSION@#Initial periodontal therapy can effectively improve the periodontal clinical status of patients with or without type 2 diabetes mellitus, and have benefits on glycemic control in diabetic patients. However, the response of periodontal indexes and WBC level to initial therapy were relatively delayed in diabetic patients. WBC plays an important role in the correlation between diabetes mellitus and periodontitis.

Effectiveness of quality of care for patients with type 2 diabetes in China: findings from the Shanghai Integration Model (SIM) / 医学前沿

This cross-sectional study aimed to investigate the quality of care of diabetes in Shanghai, China. A total of 173 235 patients with type 2 diabetes in 2017 were included in the analysis. Profiles of risk factors and intermediate outcomes were determined. The patients had a mean age of 66.43 ± 8.12 (standard deviation (SD)) years and a mean diabetes duration of 7.95 ± 5.53 (SD) years. The percentage of patients who achieved the target level for HbA1c (< 7.0%) was 48.6%. Patients who achieved the target levels for blood pressure (BP) < 130/80 mmHg and low-density lipoprotein-cholesterol (LDL-c) < 2.6 mmol/L reached 17.5% and 34.0%, respectively. A total of 3.8% achieved all three target levels, and the value increased to 6.8% with an adaptation of the BP target level (< 140/90 mmHg) for those over 65 years. Multivariable analysis identified the factors associated with a great likelihood of achieving all three target levels: male, young age, short diabetes duration, low body mass index, macrovascular complications, no microvascular complications, prescribed with lipid-lowering medication, and no prescription of antihypertensive medication. In conclusion, nearly 50% and one-third of the patients with diabetes met the target levels for HbA1c and LDL-c, respectively, with a low percentage achieving the BP target level. The percentage of patients who achieved all three target levels needs significant improvement.

Factors associated with glycemic variability in children with type 1 diabetes mellitus based on flash glucose monitoring system / 中南大学学报(医学版)

OBJECTIVES@#Patients with classical type 1 diabetes mellitus (T1DM) require lifelong dependence on exogenous insulin therapy due to pancreatic beta-cell destruction and absolute insulin deficiency. T1DM accounts for about 90% of children with diabetes in China, with a rapid increase in incidence and a younger-age trend. Epidemiological studies have shown that the overall glycated haemoglobin (HbA1c) and compliance rate are low in Chinese children with T1DM. Optimal glucose control is the key for diabetes treatment, and maintaining blood glucose within the target range can prevent or delay chronic vascular complications in patients with T1DM. Therefore, this study aims to investigate the glycemic control of children with T1DM from Hunan and Henan Province with flash glucose monitoring system (FGMS), and to explore factors associated with glycemic variability.@*METHODS@#A total of 215 children with T1DM under 14 years old were enrolled continuously in 16 hospitals from August 2017 to August 2020. All subjects wore a FGMS device to collect glucose data. Correlation of HbA1c, duration of diabetes, or glucose scan rates with glycemic variability was analyzed. Glucose variability was compared according to the duration of diabetes, HbA1c, glucose scan rates and insulin schema.@*RESULTS@#HbA1c and duration of diabetes were positively correlated with mean blood glucose, standard deviation of glucose, mean amplitude of glucose excursions (MAGE), and coefficient of variation (CV) of glucose (all P<0.01). The glucose scan rates during FGMS wearing was significantly positively correlated with time in range (TIR) (P=0.001) and negatively correlated with MAGE and mean duration of hypoglycemia (all P<0.01). Children with duration ≤1 year had lower time below range (TBR) and MAGE when compared with those with duration >1 year (all P<0.05). TIR and TBR in patients with HbA1c ≤7.5% were higher (TIR: 65% vs 45%, TBR: 5% vs 4%, P<0.05), MAGE was lower (7.0 mmol/L vs 9.4 mmol/L, P<0.001) than those in HbA1c >7.5% group. Compared to the multiple daily insulin injections group, TIR was higher (60% vs 52%, P=0.006), MAGE was lower (P=0.006) in the continuous subcutaneous insulin infusion group. HbA1c was lower in the high scan rates (≥14 times/d) group (7.4% vs 8.0%, P=0.046), TIR was significantly higher (58% vs 47%, P<0.001), and MAGE was lower (P<0.001) than those in the low scan rate (<14 times/d) group.@*CONCLUSIONS@#The overall glycemic control of T1DM patients under 14 years old in Hunan and Henan Province is under a high risk of hypoglycemia and great glycemic variability. Shorter duration of diabetes, targeted HbA1c, higher glucose scan rates, and CSII are associated with less glycemic variability.

Efficacy and Safety of Mulberry Twig Alkaloids Tablet for Treatment of Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Study / 中国结合医学杂志

OBJECTIVE@#To assess the efficacy and safety of mulberry twig alkaloids (Sangzhi alkaloids, SZ-A) for treatment of type 2 diabetes in a randomized, double-blind, placebo-controlled multicenter clinical trial.@*METHODS@#A total of 200 patients were randomized to receive SZ-A (n=100) or placebo (n=100) for 16 weeks. The data analysis system for electronic data capture clinical trial central randomization system was used for randomization and dispensing of drugs. The primary outcome was the change in glycosylated hemoglobin (HbA1c) level. The secondary outcome included the proportions of cases with HbA1c <7.0% and HbA1c <6.5%, fasting blood glucose (FBG), postprandial blood glucose (PBG), area under curve for the PBG (AUC0-2h), body weight, and body mass index (BMI). Adverse events (AEs), severe adverse events (SAEs), treatment-related adverse events (TAEs), gastrointestinal disorders (GDs), blood pressure, routine blood tests, and liver and kidney function were monitored.@*RESULTS@#Compared with baseline, the change of HbA1c at week 16 was -0.80% (95% CI: -0.98% to -0.62%) and -0.09% (95% CI: -0.27% to 0.09%) in SZ-A group and placebo group, respectively. The proportion of patients with HbA1c <7% and <6.5% was higher in the SZ-A group than in the placebo group (46.8% vs. 21.6% and 29.9% vs. 10.8%). The observed values and changes in FBG, 1 h-PBG, 2 h-PBG, and AUC0-2h differed significantly between groups (P<0.001), but differences were not significant in body weight and BMI (P>0.05). The incidence rates of AEs, TAEs, and GDs differed significantly between groups (P=0.010, P=0.005, and P=0.006, respectively), whereas the incidence rates of SAEs showed no significant differences between groups (P=1.000).@*CONCLUSION@#SZ-A are effective and safe for treatment of type 2 diabetes. The protocol was registered in http://www.chictr.org.cn/showproj.aspx?proj=60117 (ChiCTR2000038550).