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Effects of Concomitant Administration of Sodium Glucose Co-transporter 2 Inhibitor with Insulin on Hemoglobin A1c, Body Mass Index and Serum Lipid Profile in Japanese Type 2 Diabetic Patients.
Kusunoki, M, Natsume, Y, Miyata, T, Tsutsumi, K, Oshida, Y
Drug research. 2018;(12):669-672
Abstract
In patients with type 2 diabetes mellitus who show suboptimal blood glucose control under insulin therapy alone, concomitant treatment with an additional hypoglycemic agent that differs in its mechanism of action from insulin may be considered. We conducted this clinical trial to explore whether further control of increased blood glucose level can be achieved with concomitant use of sodium glucose co-transporter 2 (SGLT2) inhibitor as concomitant with other hypoglycemic therapy, as compared to SGLT2 inhibitor monotherapy, in patients with type 2 diabetes mellitus showing decrease in blood glucose level but less than the effect of insulin monotherapy and there was no significant differences. In the SGLT2 inhibitor monotherapy group, decreases of the serum hemoglobin A1c (HbA1c) level, body weight, body mass index (BMI) and serum triglyceride, and elevation of the serum high density lipoprotein cholesterol concentration were observed as compared to the baseline values. In the type 2 diabetic patients under insulin therapy who received combined insulin plus SGLT2 inhibitor therapy, however decreases in the body weight and BMI, with only a tendency towards decrease of the serum HbA1c value, not reaching statistical significance, were observed. The combined therapy group also showed no appreciable changes of the serum triglyceride level, while the serum adiponectin level increased. The present study data indicate that combined insulin plus SGLT2 inhibitor treatment failed to afford any further improvement of the blood glucose control, as compared to SGLT2 monotherapy, in Japanese type 2 diabetic patients.
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The effectiveness of theory- and model-based lifestyle interventions on HbA1c among patients with type 2 diabetes: a systematic review and meta-analysis.
Doshmangir, P, Jahangiry, L, Farhangi, MA, Doshmangir, L, Faraji, L
Public health. 2018;:133-141
Abstract
OBJECTIVES The prevalence of type 2 diabetes is rising rapidly around the world. A number of systematic reviews have provided evidence for the effectiveness of lifestyle interventions on diabetic patients. The effectiveness of theory- and model-based education-lifestyle interventions for diabetic patients are unclear. The systematic review and meta-analysis aimed to evaluate and quantify the impact of theory-based lifestyle interventions on type 2 diabetes. STUDY DESIGN A literature search of authentic electronic resources including PubMed, Scopus, and Cochrane collaboration was performed to identify published papers between January 2002 and July 2016. METHODS The PICOs (participants, intervention, comparison, and outcomes) elements were used for the selection of studies to meet the inclusion and exclusion criteria. Mean differences and standard deviations of hemoglobin A1c (HbA1c [mmol/mol]) level in baseline and follow-up measures of studies in intervention and control groups were considered for data synthesis. A random-effects model was used for estimating pooled effect sizes. To investigate the source of heterogeneity, predefined subgroup analyses were performed using trial duration, baseline HbA1c (mmol/mol) level, and the age of participants. Meta-regression was performed to examine the contribution of trial duration, baseline HbA1c (mmol/mol) level, the age of participants, and mean differences of HbA1c (mmol/mol) level. The significant level was considered P < 0.05. RESULTS Eighteen studies with 2384 participants met the inclusion criteria. The pooled main outcomes by random-effects model showed significant improvements in HbA1c (mmol/mol) -5.35% (95% confidence interval = -6.3, -4.40; P < 0.001) with the evidence of heterogeneity across studies. CONCLUSION The findings of this meta-analysis suggest that theory- and model-based lifestyle interventions have positive effects on HbA1c (mmol/mol) indices in patients with type 2 diabetes. Health education theories have been applied as a useful tool for lifestyle change among people with type 2 diabetes.
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Increased self-care activities and glycemic control rate in relation to health education via Wechat among diabetes patients: A randomized clinical trial.
Dong, Y, Wang, P, Dai, Z, Liu, K, Jin, Y, Li, A, Wang, S, Zheng, J
Medicine. 2018;(50):e13632
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Abstract
BACKGROUND Health education has been considered as the effectiveness method to increase the self-care skills of diabetes patients. However, limited studies to investigate the association of health education via Wechat platform on increased the basic self-care skills and glycemic control rate in patients with type 2 diabetes. METHODS A total number of 120 type 2 diabetes patients were randomized into intervention (health education by Wechat platform plus usual care) and the control group (usual care). Biochemical parameters including fasting plasma glucose (FPG), 2-hour plasma glucose (2hPG), glycosylated hemoglobin A1c (HbA1c) were measured among the 2 groups at baseline 6-month and 12-month. Diabetes Management Self-Efficacy (SE) Scale was completed at baseline 6-month and 12-month. RESULTS Significant difference of HbA1c concentration and SE were found between intervention and control groups at 6-month and 12-month (P <.05). The effect of groups and health education duration times was found on reduced HbA1c concentration and increased the total score of SE (P <.05). No significant difference of FPG and 2hPG concentrations were found between intervention and control groups at 6 months and 12 months (P >.05). CONCLUSION Health education of diabetic individuals via Wechat platform in conjunction with conventional diabetes treatment could improve glycemic control and positively influence other aspects of diabetes self-care skills.
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Structured tool to improve clinical outcomes of type 2 diabetes mellitus patients: A randomized controlled trial.
Ayadurai, S, Sunderland, VB, Tee, LBG, Md Said, SN, Hattingh, HL
Journal of diabetes. 2018;(12):965-976
Abstract
BACKGROUND Reviewing pharmacist diabetes intervention studies revealed a lack of structured process in providing diabetes care, leading to varied results from increased to minimal improvements. The aim of this study was to determine the effectiveness of the Simpler tool, a structured clinical guidelines tool, in the delivery of diabetes care. The primary outcome was significant improvement in HbA1c. Secondary outcomes were improved lipid profiles and blood pressure (BP). METHODS A 6-month parallel multicenter two-arm, single-blind randomized controlled trial involving 14 pharmacists at seven primary care clinics was conducted in Johor, Malaysia. Pharmacists without prior specialized diabetes training were trained to use the tool. Patients were randomized within each center to either Simpler care (SC), receiving care from pharmacists who used the tool (n =55), or usual care (UC), receiving usual care and dispensing services (n = 69). RESULTS Compared with UC, SC significantly reduced HbA1c (mean reduction 1.59% [95% confidence interval {CI} -2.2, -0.9] vs 0.25% [95% CI -0.62, 0.11], respectively; P ≤ 0.001), and significantly improved systolic BP (-6.28 mmHg [95% CI -10.5, 2.0] vs 0.26 mmHg [95% CI -3.74, 0.43], respectively; P = 0.005). A significantly higher proportion of patients in the SC than UC arm reached the Malaysian guideline treatment goals for HbA1c (14.3% vs 1.5%; P = 0.020), systolic BP (80% vs 42%; P = 0.001), and low-density lipoprotein cholesterol (60.5% vs 40.4%; P = 0.046). CONCLUSIONS Using the Simpler tool facilitated the delivery of comprehensive evidence-based diabetes management and significantly improved clinical outcomes. The Simpler tool supported pharmacists in providing enhanced structured diabetes care.
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Utility of HbA1c and fasting plasma glucose for screening of Type 2 diabetes: a meta-analysis of full ROC curves.
Hoyer, A, Rathmann, W, Kuss, O
Diabetic medicine : a journal of the British Diabetic Association. 2018;(3):317-322
Abstract
AIMS: There is still debate on the optimal threshold for population-based screening of diabetes (diagnosed by the oral glucose tolerance test) using tests like HbA1c or fasting plasma glucose. Meta-analyses provide meaningful input in such situations. The aim of this article is to perform a meta-analysis that includes the complete information reported in the individual studies of two existing systematic reviews. METHODS We screened the individual studies from two systematic reviews and reconstructed the full four-fold tables for every reported threshold. Using a recently proposed meta-analysis model for the comparison of two diagnostic tests, we compared HbA1c with fasting plasma glucose, and estimated meta-analytic receiver operating characteristic curves for both tests using the 11.1 mmol/l threshold of the 2-h post-challenge glucose level (2 h-PG) as the gold standard. RESULTS We included nine studies from two existing systematic reviews in our analysis. Based on our data set, the optimal threshold lies between 42 and 44 mmol/mol (6.0-6.2%) for HbA1c , and 6.2-6.4 mmol/l for fasting plasma glucose choosing the Youden index as the technical criterion. In addition, we found that there is no relevant difference in the performance of HbA1c and fasting plasma glucose. CONCLUSIONS In our meta-analysis, we found that the optimal threshold with reference to the 2 h-PG should be chosen between 42 and 44 mmol/mol (6.0-6.2%) for HbA1c , and 6.2-6.4 mmol/l for fasting plasma glucose on the basis of maximal sensitivity and specificity.
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Retrospective analysis of liraglutide and basal insulin combination therapy in Japanese type 2 diabetes patients: The association between remaining β-cell function and the achievement of the glycated hemoglobin target 1 year after initiation.
Usui, R, Sakuramachi, Y, Seino, Y, Murotani, K, Kuwata, H, Tatsuoka, H, Hamamoto, Y, Kurose, T, Seino, Y, Yabe, D
Journal of diabetes investigation. 2018;(4):822-830
Abstract
AIMS/INTRODUCTION The glucose-lowering effects of the glucagon-like peptide-1 receptor agonist, liraglutide, have been shown to rely on remaining β-cell function. However, the possible associations of remaining β-cell function with the glucose-lowering effects of liraglutide in combination with basal insulin remain unknown and warrant investigation. MATERIALS AND METHODS This was a single-center, retrospective, observational study carried out in a private hospital in Osaka, Japan. Type 2 diabetes patients who received a prescription change from insulin therapy, both multiple-dose insulin and basal insulin-supported oral therapy, to liraglutide and basal insulin combination and continued the therapy for 54 weeks without additional oral antidiabetic drugs or bolus insulin were retrospectively analyzed. RESULTS Among the 72 participants who received a prescription change from multiple-dose insulin and basal insulin-supported oral therapy to liraglutide and basal insulin combination, 57 continued the therapy for 54 weeks. Of those who continued the therapy without receiving additional oral antidiabetic drugs or bolus insulin, seven participants achieved glycated hemoglobin < 7.0% at 54 weeks, but 30 participants did not. The participants who achieved glycated hemoglobin < 7.0% at 54 weeks had a significantly higher C-peptide immunoreactivity index, a β-cell function-related index frequently used in Japanese clinical settings. The receiver operating curve analysis showed that the C-peptide immunoreactivity index cut-off value for the achievement of glycated hemoglobin <7.0% at 54 weeks is 1.103. CONCLUSIONS The current findings show that the glucose-lowering effects of liraglutide rely on remaining β-cell function, even when used with basal insulin; and suggest that liraglutide and basal insulin combination might require additional bolus insulin to fully compensate insulin insufficiency in individuals with reduced β-cell function.
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Plant-based Diet for HbA1c Reduction in Type 2 Diabetes Mellitus: an Evidence-based Case Report.
Utami, DB, Findyartini, A
Acta medica Indonesiana. 2018;(3):260-267
Abstract
BACKGROUND diabetes has become a major public health concern with an estimated 180 million cases worldwide. Nutritional changes are one of the key aspects in the management of type 2 diabetes mellitus. Previous studies have suggested an association between vegetarian diets and improvements in glycemic control in type 2 diabetes mellitus, however the relationship is not well established. The aim of this report is to perform a critical appraisal to analyze whether plant-based diet reduces the HbA1c level compared to conventional diet. METHODS a comprehensive computer-based literature search was performed on June 20, 2016 using PubMed, Ovid, EBSCO, and the Cochrane Library. All abstracts and titles from the initial search results were screened, reviewed, and appraised using critical appraisal worksheets by Center of Evidence-Based Medicine, University of Oxford. RESULTS one systematic review and two RCTs met the inclusion criteria and were considered eligible for this case report. In patients with type 2 diabetes mellitus, HbA1c significantly yielded greater reduction in the plant-based group compared to conventional diet group after 22 weeks of follow up. Similarly, there was a statistically greater reduction in HbA1c level in the plant-based group after 72 weeks. Furthermore, consumption of plant-based diet was associated with a significant reduction in HbA1c. CONCLUSION in patients with type 2 diabetes mellitus, HbA1c reduction was greater in patients with plant-based diet compared to patients with conventional diet. Further research should be conducted with larger sample size and longer follow-up period.
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The glycaemic sixer [glycaemic hexad].
Kalra, S
JPMA. The Journal of the Pakistan Medical Association. 2018;(10):1541-1542
Abstract
This opinion piece describes a cricket-based analogy, the Glycaemic Sixer, for diabetes care. The hexad lists six glycaemic parameters which must be targeted to achieve optimal cardiovascular outcomes. All six parameters, i.e., fasting glucose, post prandial glucose, glycosylated haemoglobin, avoidance of hypoglycaemia, avoidance of nocturnal hypoglycaemia, and minimization of glycaemic variability, are associated with cardiovascular outcomes. Hence, equal attention must be paid to all these while planning strategies and choosing drugs for diabetes management. The Glycaemic Sixer promotes safety along with efficacy, and supports institution of individualized, patient centred care, using evidence-based therapeutic agents.
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Glycemic Variation and Cardiovascular Risk in the Veterans Affairs Diabetes Trial.
Zhou, JJ, Schwenke, DC, Bahn, G, Reaven, P, ,
Diabetes care. 2018;(10):2187-2194
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Abstract
OBJECTIVE There is uncertainty about the importance of glycemic variability in cardiovascular complications in patients with type 2 diabetes. Using the Veterans Affairs Diabetes Trial (VADT), we investigated the association between variation in fasting glucose and glycated hemoglobin (HbA1c) over time and the incidence of cardiovascular disease (CVD) and assessed whether this is influenced by intensive or standard glycemic control. RESEARCH DESIGN AND METHODS During the VADT, fasting glucose and HbA1c were measured every 3 months for up to 84 months in 1,791 individuals. Variability measures included coefficient of variation (CV) and average real variability (ARV) for fasting glucose and HbA1c. Overall mean glucose and HbA1c measures as well as their maximum and the most recent measurement were also examined. RESULTS Variability measures (CV and ARV) of fasting glucose were significantly associated with CVD even after adjusting for other risk factors, including mean fasting glucose. When considering separately groups receiving intensive and standard glycemic control, this relationship was evident in the intensive treatment group but not in the standard group. Additional adjustment for severe hypoglycemic episodes did not alter the relationship between fasting glucose variability and CVD. Interestingly, no HbA1c measures were associated with CVD after adjusting for multiple baseline risk factors. CONCLUSIONS Our analysis indicates that in the VADT, variability of fasting glucose plays a role in the development of CVD complications beyond the influence of standard fasting glucose measures. The adverse consequences of fasting glucose variability on CVD appear greatest in those receiving intensive glucose control.
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Efficacy of oral vitamin D on glycated haemoglobin (HbA1c) in type 2 diabetics having vitamin D deficiency - A randomized controlled trial.
Khan, DM, Jamil, A, Randhawa, FA, Butt, NF, Malik, U
JPMA. The Journal of the Pakistan Medical Association. 2018;(5):694-697
Abstract
OBJECTIVE To study the efficacy of oral vitamin D in improving glycaemic control of patients with type 2 diabetes by reducing glycated haemoglobin levels. METHODS This randomised control trial was carried out at Mayo Hospital, Lahore, from February 5 to August 5, 2016, and comprised type 2 diabetes patients aged 40-70 years visiting the outpatient clinics. They were randomly divided into two groups by using the lottery method. Group A received oral vitamin D along with metformin and group B received metformin only. Blood samples of both the groups were tested for glycated haemoglobin at three months to assess the change. SPSS 21 was used for data analysis. RESULTS There were 140 patients divided into two groups of 70(50%) each. Mean age in Group A was 54.80±8.55 years and 58.40±7.98 years in Group B. No significant difference was seen in glycated haemoglobin levels at baseline (p>0.05). However, after 3 months post-treatment the levels significantly differed (p<0.05) in favour of Group A. CONCLUSIONS Vitamin D supplementation had a significant effect in lowering glycated haemoglobin level in patients with type 2 diabetes.