Development and validation of a prediction model for self-reported hypoglycemia risk in patients with type 2 diabetes: A longitudinal cohort study.

AIMS/INTRODUCTION: To develop and validate a simple prediction model for hypoglycemia risk in patients with type 2 diabetes. MATERIALS AND METHODS: We prospectively analyzed the data of 1,303 subjects in a third-class hospital in Tianjin and followed up their hypoglycemia events at 3 and 6 months. The hypoglycemia risk prediction models for 3 and 6 months were developed and the model performance was evaluated. RESULTS: A total of 340 (28.4%) patients experienced hypoglycemia within 3 months and 462 (37.2%) within 6 months during the follow-up period. Age, central obesity, intensive insulin therapy, frequency of hypoglycemia in the past year, and hypoglycemia prevention education entered both model3month and model6month. The area under the receiver operating characteristic curve of model3month and model6month were 0.711 and 0.723, respectively. The Youden index was 0.315 and 0.361, while the sensitivities were 0.615 and 0.714, and the specificities were 0.717 and 0.631. The calibration curves showed that the models were similar to reality. The decision curves implied that the clinical net benefit of the model was clear. CONCLUSIONS: The study developed 3 and 6 month hypoglycemia risk prediction models for patients with type 2 diabetes. The discrimination and calibration of the two prediction models were good, and might help to improve clinical decision-making and guide patients to more reasonable self-care and hypoglycemia prevention at home.

Development and validation of a risk prediction model for the recurrence of foot ulcer in type 2 diabetes in China: A longitudinal cohort study based on a systematic review and meta-analysis.

AIMS: To develop and validate a risk prediction model for Chinese patients with type 2 diabetes with the recurrence of diabetic foot ulcers (DFUs) based on a systematic review and meta-analysis. METHODS: A prospective analysis was performed with 1333 participants and followed up for 60 months. Three models were analysed using a derived cohort. The risk factors were screened using meta-analysis and logistic regression, and the missing variables were interpolated by multiple imputation. The internal validation was performed using the bootstrap procedure, and the validation cohort was applied to the external validation. The performance of the model was evaluated in the area under the discrimination Receiver Operating Characteristic Curve (ROC). Calibration and discrimination methods were used for the validation cohort. The variables were selected according to their clinical and statistical importance to construct the nomograms. RESULTS: Three models were developed and validated. Model 1 included seven social and clinical indicators like sex, diabetes mellitus duration, previous DFU, location of ulcer, smoking, history of amputation, and foot deformity. Model 2 included four more indicators besides those in Model 1, which were statin agents used, antiplatelet agents used, systolic blood pressure, and body mass index. Model 3 added further laboratory indicators to Model 2, such as LDL-C, HbA1C, fibrinogen, and blood urea nitrogen. In the derivation cohort, 20.1% (206/1027) participants with DFU recurred as compared to the validation cohort, which was 38.2% (117/306). The areas under the curve in the derivation cohort for Models 1-3 were 0.781 (0.744-0.817), 0.843 (0.813-0.873), and 0.899 (0.876-0.922), respectively. The Youden indexes for Models 1-3 were 0.430, 0.559, and 0.653, respectively. Model 3 showed the highest sensitivity and specificity. All models performed well for both discrimination and calibration. CONCLUSIONS: Models 1-2 were non-invasive, which indicate their role in general screening for patients at a high risk of recurrence of DFU. However, Model 3 offers a more specific screening due to its best performance in predicting the risk of DFU recurrence amongst the three models.

Incidence of accidental falls and development of a fall risk prediction model among elderly patients with diabetes mellitus: A prospective cohort study.

AIMS: To investigate the incidence of accidental falls and develop a fall risk prediction tool in elderly patients with diabetes mellitus. BACKGROUND: The risk of fall in elderly patients with diabetes is higher than that in the general elderly, there is fewer fall assessment tools for elderly patients with diabetes. DESIGN: A prospective cohort study. METHODS: Between June and September 2019, a total of 1007 elderly patients with diabetes were enrolled from a tertiary specialist diabetes hospital in Tianjin and were prospectively followed up for 6 months to determine outcomes of accidental falls through telephone. Demographic and diseases related factors were collected at baseline. Incidence of falls was investigated, and a nomogram was developed based on logistic regression model. SPSS 21.0 and R 3.6.3 were used to analyse the data. The article was reported in accordance with STROBE guidelines. RESULTS: Among 1007 elderly patients, 950 finished the follow-up. A total of 133 falls occurred in 93 patients during the follow-up period, with a fall rate of 9.79%. Diabetic peripheral neuropathy, walking aids, depression, fall history, fatigue and sex were independent predictors of accidental fall in diabetes elderly patients. The sensitivity and specificity of the predictive model were 73.12% and 52.63%, respectively, and a fall risk prediction nomogram was developed based on the regression model. CONCLUSIONS: A nomogram including 6 easily available prediction factors (diabetic peripheral neuropathy, walking aids, depression, fall history within 1 year, fatigue, sex) was developed, and it can be used in safety management among Chinese elderly patients diagnosed with diabetes. RELEVANCE TO CLINICAL PRACTICE: Nomogram can be used to identify diabetic elderly patients at high risk of accidental falls.

Injection Technique Education in Patients with Diabetes Injecting Insulin into Areas of Lipohypertrophy: A Randomized Controlled Trial.

INTRODUCTION: The aim of this randomized controlled trial was to assess the impact of providing intensive injection technique (IT) education to patients routinely injecting insulin into sites of lipohypertrophy (LH). METHODS: Between November 2016 and May 2018, insulin-injecting patients with LH treated at Tianjin Metabolism Hospital (a public tertiary medical institution), Tianjin, China, were included in a 6-month prospective randomized controlled trial and randomized into either the intervention (the IT-education group) or the control (control group) arm. The control and IT-education groups were seen by different groups of trained nurses on different clinic days. IT education emphasized moving injections to normal tissue sites, within-and between-site injection rotation, an initial reduction of insulin total daily dose (TDD), and stopping needle reuse. Needles were provided to the IT group, while controls acquired needles in their usual way. Differences in changes in glycated hemoglobin (HbA1c) and insulin TDD were the primary and main secondary endpoints, respectively. RESULTS: The control (n = 104) and IT-education (N = 106) groups had similar demographic parameters (97% with type 2 diabetes) and baseline IT behavior. HbA1c reduction was similar in the IT-education and control group in the intention-to-treat (ITT) analysis (6-month between-group difference 0.16% [1.7 mmol/mol], 95% confidence interval [CI] - 0.11, 0.43 [- 1.2, 4.7]; p = 0.239) but was significant by the per-protocol (PP) analysis (difference 0.31% [3.4 mmol/mol], 95% CI 0.02, 0.60 [0.2, 6.6]; p = 0.038). Changes in TDD insulin in the IT-education group were approximately - 7 and - 8 IU by the ITT and PP analyses, respectively, versus - 1 IU (nonsignificant) in the controls (both between-group differences p ≤ 0.05). Despite the study design, IT education "contamination" (unplanned adoption of IT-intervention behaviors) was documented in 63 control patients. By post hoc analyses, HbA1c in "contaminated" controls decreased by 0.70% (7.7 mmol/mol) vs. 0.20% (2.2 mmol/mol) in "non-contaminated' patients (p = 0.019) at 6 months. CONCLUSIONS: Proper IT, including learning to not inject into sites of LH, proper within- and between site rotation, needle reuse reduction, and the use of 4-mm, 32-G needles in Chinese patients injecting into sites of LH enables a safe reduction of TDD insulin while maintaining overall glycemic control. TRIAL REGISTRATION: Trial registration: ChiCTR-IOR-16009270 in the Chinese Clinical Trials Registry.

Psychometric properties of the Chinese version of the Hypoglycemia Fear SurveyII for patients with type 2 diabetes mellitus in a Chinese metropolis.

PURPOSE: To evaluate the psychometric properties of the Chinese version of the Hypoglycemia Fear SurveyII (HFS-II) in patients with type 2 diabetes mellitus from Tianjin City. METHODS: The original HFS-II was translated and adapted to Chinese.350 inpatients from five hospitals of Tianjin completed the Chinese HFS-II. We examined the validity (content and construct validity) and reliability (internal consistency and test-retest reliability) of the scale. Content validity was evaluated by the content validity index (CVI) and the average agreement CVI(S-CVI/Ave). The construct validity was assessed by exploratory factor analysis. Reliability was measured by intraclass correlation coefficient (ICC) and Cronbach's alpha. RESULTS: The mean age of the 350 patients was 55.5±9.3years. The CVI was 0.71~1.0 and S-CVI/Ave was 0.92 respectively. By exploratory factor analysis, four factors were extracted which accounted for 52.15% of the total variance in the 23-item scale. The Chinese HFS-II displayed good internal consistency (Cronbach's alpha = 0.90) and test-retest reliability (ICC = 0.96). CONCLUSIONS: The Chinese version of HFSII had excellent psychometric properties and it could provide a useful tool for clinicians and nursing staff to assess the fear of hypoglycemia.

The Development of a Standardized Framework for Primary Nurse Specialists in Diabetes Care in China: A Delphi Study.

BACKGROUND: The number of patients with diabetes has been increasing rapidly according to a 2017 report by the International Diabetes Federation. Diabetes has become one of the most challenging public health problems, and there will be an estimated 143 million patients with diabetes in China by 2035. This puts considerable pressure on nurses who specialize in the care of patients with diabetes in China and increases related social and financial burdens. Clinical practice has proven that strengthening the core competencies of nurses and establishing an evaluation system of core competencies improve both healthcare quality and patient quality of life. However, no core-competence system framework currently addresses the unique characteristics of nurses in China. PURPOSES: The purpose of this study was to construct a core-competence system framework for primary nurse specialists in diabetes care. METHODS: A brainstorming approach was conducted that worked to conceptualize the core competencies of nurse specialists in diabetes care in China. Next, a study group organized this information and conducted a seminar; 50 experts and patients with diabetes were invited to develop the first draft of the framework. Afterward, 50 experts were selected to participate in the Delphi survey. Most indicators were retained after a three-round Delphi process, and the superiority chart was used to determine the weights of the six dimensions. RESULTS: Forty-seven experts completed the consultation. The experts' rate of response ranged from 94% to 100%, the authority coefficient was .91, and the Kendall's coefficients of concordance in Grades 1-3 were .793, .418, and .542, respectively. An increasingly detailed, three-grade system framework was developed, including six first-grade indicators (diabetes professional knowledge, diabetes-related knowledge, communication skills and health education ability, specialized skills, clinical judgment, and specialty development capacity), 23 second-grade indicators, and 87 third-grade indicators. The weights of the six first-grade indicators were .221, .149, .192, .209, .160, and .069, respectively. CONCLUSIONS: The core-competence system framework includes six core competencies, which represent the main characteristics of primary nurse specialists in diabetes care who are highly recommended by experts. It is important to keep in mind that this is only a theoretical framework and thus must be further tested in clinical practice settings in China.

Reliability and validity of the Chinese version of the new fear of hypoglycemia scale: FH-15.

OBJECTIVE: This study aimed to evaluate the reliability and validity of the Chinese version of the Fear of Hypoglycemia scale with 15 items (FH-15). METHODS: After obtaining the original author's authorization, the English version of the FH-15 scale was translated, back translated, and culturally debugged to obtain the Chinese version of FH-15. A convenient sampling method was used to extract patients with type 2 diabetes from four tertiary hospitals in Tianjin. A total of 408 patients with type 2 diabetes were investigated in the hospital to test the reliability and validity of Chinese version FH-15 scale. RESULTS: The content validity index of the scale was 0.92, and the content validity index of each item was 0.8-1.0. The exploratory factor analysis extracted three common factors (fear, avoidance, and interference), which contained 15 items, and the cumulative variance contribution rate was 71.245%. The confirmatory factor analysis results showed that the model fit was better at 1.981 χ 2/df, GFI = 0.901, CGI = 0.962, TLI = 0.952, and RMSEA = 0.070. The cut-off value for the total hypoglycemia fear scale was 30.5. The Cronbach's α coefficient of the three dimensions of the scale was 0.918, the Cronbach's α coefficient of each dimension is 0.876-0.916, the test-retest reliability was 0.903, and the test-retest reliability of each factor was 0.733-0.930. CONCLUSION: The Chinese version of the FH-15 scale can be considered reliable and valid. The item expression is concise, clear, and easy to understand. It is suitable for clinical practice as an initial screening tool to identify and evaluate the severity of fear of hypoglycemia in patients with type 2 diabetes.

C-reactive protein/oxidised low-density lipoprotein/ß2-glycoprotein I complex promotes atherosclerosis in diabetic BALB/c mice via p38mitogen-activated protein kinase signal pathway.

BACKGROUND: The aim of this study was to investigate the effect of C-reactive protein/oxidised low-density lipoprotein/ß2-glycoprotein I (CRP/oxLDL/ß2GPI) complex on atherosclerosis (AS) in diabetic BALB/c mice. METHODS: BALB/c mice were fed high-fat and normal diet. Eight weeks later, the mice fed with high-fat diet were injected with streptozotocin (STZ) to induce diabetes. The diabetic mice were respectively injected twice monthly with 20 µg oxLDL, 20 µg ß2GPI, 40 µg oxLDL/ß2GPI complex, 44 µg CRP/oxLDL/ß2GPI complex, and PBS. Aortas were stained with Sudan IV to investigate lipid plaque formation. The infiltration condition of smooth muscle cells (SMCs), macrophages, and T cells in the aortas were determined by immunohistochemistry (IH). The mRNA expressions of receptors associated with lipid metabolism were quantified by real-time PCR. The phosphorylation of p38 mitogen-activated protein kinase (p38MAPK) and MKK3/6 in aorta tissues were assessed by Western blot. The expression of inflammation cytokines was evaluated by protein chip. RESULTS: The lipid plaques were more extensive, the lumen area was obviously narrower, the ratio of intima and media thickness were increased, and the normal internal elastic lamia structure and endothelial cell disappeared (P < 0.05) in the oxLDL and CRP/oxLDL/ß2GPI groups (P < 0.05). CRP/oxLDL/ß2GPI complex dramatically promoted infiltration of SMCs, macrophages, and T cells, improved the mRNA expression of ABCA1 and ABCG1, but reduced the mRNA expression of SR-BI and CD36 and increased the phosphorylation of p38MAPK and MKK3/6 (all P < 0.05). The highest expression levels of IL-1, IL-9, PF-4, bFGF, and IGF-II were detected in the CRP/oxLDL/ß2GPI group (P < 0.05). CONCLUSIONS: CRP/oxLDL/ß2GPI complex aggravated AS in diabetic BALB/c mice by increasing lipid uptake, the mechanism of which may be mediated by the p38MAPK signal pathway.

Health-related quality of life among Tianjin Chinese patients with type 2 diabetes: a cross-sectional survey.

The purpose of this study was to examine factors that influence the quality of life among Tianjin Chinese living with type 2 diabetes. In this study, the quality of life was assessed in 174 participants. The dependent variables included demographic and clinical data, depressive symptoms and lifestyle behavioral factors. Chi-square tests and logistic regression analysis were conducted to identify significant factors. Using multiple regression analyses, the odds ratios (ORs) of having low quality of life were 4.53 (95% confidence interval (CI) = 1.89-10.87), 2.83 (95% CI = 1.21-6.63), and 2.48 (95% CI = 1.03-5.96) for patients with microvascular complications, diabetic neuropathy, and peripheral vascular disease, respectively. Coronary heart disease, depression, and unhealthy eating habits were also found to have significant negative effects on quality of life. In addition, multiple regression analysis showed that regular exercise (OR = 0.29, 95% CI = 0.12-0.71) was a protective factor for health-related quality of life. The identification of these influencing factors will assist nurses to provide continuous care to people living with diabetes, thus to postpone or avoid complications as well as improve their quality of life.

[High D-glucose alters PI3K and Akt signaling and leads to endothelial cell migration, proliferation and angiogenesis dysfunction].

OBJECTIVE: To investigate the effects of high D-glucose on migration, proliferation, and angiogenesis of endothelial cells and to make sure whether PI3K and Akt signaling pathway plays an important role in the pathogenesis of diabetic vascular complications. METHODS: Human umbilical vein endothelial cells (HUVECs) were cultured. D-glucose of the concentrations of 5 mmol/L, 15 mmol/L, and 30 mmol/L and mannitol of the concentrations of 5 mmol/L, 15 mmol/L, and 30 mmol/L were added in to the medium, the migration rate of the cells was measured by wound healing test and the cell proliferation was examined with CellTiter 96 AQ(ueous) One Solution cell proliferation assay. Matrigel was spread on 96-well plate, and culture of HUVECs with D-glucose and mannitol of different concentrations were added. Microscopic photography was used to calculate the total area of vascular bed, average vessel length, vessel number, branch points, so as to observe the angiogenesis. Immuno-precipitation was used to detect the expression of p85/PI3K. Western blotting was used to detect the protein expression of p85/PI3K, p-PI3K, GSK3beta (downstream kinase of Akt), p-Akt (Threonine308) and p-GSK3beta. LY294002, a PI3K inhibitor, of the concentrations of 0.1 micromol/L, 1 micromol/L, and 10 micromol/L was added into the culture fluid with 5 mmol/L D-glucose, then the endothelial cell migration, proliferation number, total area of blood bed, etc were observed. RESULTS: The migration rate of the 5 mmol/L D-glucose group was 100 +/- 23/microm2, and D-glucose dose-dependently decreased the migration rate, e.g. the migration rates of the 15 mmol/L and 30 mmol/L D-glucose groups were 77 +/- 18/microm2 and 46 +/- 18/microm2 respectively, both significantly lower than that of the 5 mmol/L D-glucose group (both P < 0.01). LY294002 of the concentrations of 0.1 micromol/L, 1 micromol/L, and 10 micromol/L dose-dependently decrease the endothelial cells migration rates to 68 +/- 16/microm2, 36 +/- 12/microm2, and 13 +/- 3/microm2 respectively (all P < 0.01) The cell proliferation rate of the 5 mmol/L, 15 mmol/L) and 30 mmol/L D-glucose groups were 59,128 +/- 7415/well, 33,144 +/- 9082/well, and 11,625 +/- 4196/well respectively, showing that D-glucose dose-dependently decreased the cell proliferation (all P < 0.01). LY294002 of the concentrations of 0.1 micromol/L, 1 micromol/L, and 10 micromol/L dose-dependently decrease the endothelial cell proliferation to 42,560 +/- 4213/well, 17,688 +/- 7198/well, and 5704 +/- 558/well respectively (all P < 0.01). 15 mmol/L and 30 mmol/L D-glucose decreased the numbers of total area of vascular bed, average tubule length, number of capillaries, and number of vessel branch pint formed on the Matrigel. LY294002 dose-dependently inhibited the angiogenesis (P < 0.05 or P < 0.01) 15 mmol/L and 30 mmol/L D-glucose dose-dependently inhibited the phosphorylation of p85/P13K and Akt (P < 0.05 and P < 0.01). However, D-glucose did not influence the protein expression of p85/PI3K and Akt. Mannitol did not influence the cell proliferation, angiogenesis, and the expression of p85/PI3K, phosphorylated p85/PI3K, Akt, phosphorylated Akt (Thr308), and phosphorylated GSK3beta. CONCLUSION: Hyperglycemia-impaired PI3K-Akt signaling may lead to migration, proliferation and angiogenesis dysfunction of endothelial cells in diabetes patients, which is likely to contribute to the pathogenesis of diabetic vascular complications.