A cluster randomized trial on the effect of a multifaceted intervention improved the technical quality of diabetes care by primary care physicians: The Japan Diabetes Outcome Intervention Trial-2 (J-DOIT2)
PubMed | Tokyo Women's Medical University, National Center for Global Health and Medicine, Kawai Clinic, Center Hospital and 2 more.
Type: Journal Article | Journal: Diabetic medicine : a journal of the British Diabetic Association | Year: 2016
To evaluate the effect of multifaceted interventions using the Achievable Benchmark of Care (ABC) method for improving the technical quality of diabetes care in primary care settings.We conducted a 1-year cluster randomized controlled trial in 22 regions divided into an intervention group (IG) or control group (CG). Physicians in the IG received a monthly report of their care quality, with the top 10% quality of diabetes care scores for all physicians being the achievable benchmark. The change in quality-of-care scores between the IG and CG during follow-up was analysed using a generalized linear model considering clustering.A total of 2199 patients were included. Their mean (sd) age was 56.5 5.9 years and the mean (sd) HbA1c level was 56.4 13.3 mmol/mol (7.4 1.2%). The quality-of-care score in the CG changed from 50.2%-point at baseline to 51%-point at 12 months, whereas the IG score changed from 49.9%-point to 69.6%-point, with statistically significant differences between the two groups during follow-up [the effect of intervention was 19.0%-point (95% confidence interval 16.7%- to 21.3%-point; P < 0.001)].Multifaceted intervention, measuring quality-of-care indicators and providing feedback regarding the quality of diabetes care to physicians with ABC, was effective for improving the technical quality of care in patients with Type 2 diabetes in primary care settings. (umin.ac.jp/ctr as UMIN000002186).
Kanatsuka A.,Diabetes Center |
Kawai K.,Kawai Clinic |
Hirao K.,H.E.C. Science Clinic |
Yokoyama H.,Jiugaoka Medical Clinic |
Kobayashi M.,Takaoka Social Insurance Hospital
Diabetology International | Year: 2012
Introduction: We examined the clinical characteristics of type 2 diabetes mellitus (T2D) patients requiring insulin therapy and evaluated the efficacy of adding insulin therapy regimens to oral anti-diabetic drugs. Materials and methods: Members of the Japan Diabetes Data Management Study Group across 55 institutes specializing in diabetes entered their clinical data into the CoDiC ® database. Of 19,800 patients treated with oral drugs from 1 May to 31 July 2006, we analyzed the data from 15,589 patients whose data input was continued until 31 July 2009. Results: A total of 1,014 patients out of those studied were started on insulin therapy during 2006-2009. Age and age-of-onset were lower in the insulin-initiated patients compared with patients who continued on oral drugs (P < 0.001). Insulin therapy was initiated at a mean HbA1c level of 9. 18 %. The HbA1c levels at 6 months after initiation of insulin treatment and at the end of the study were lowest in patients treated with a prandial rapid-acting insulin analog (RA) (P < 0.001). Only 7 patients were started on the basal-bolus therapy, while 95 patients were transferred to this therapy from their original insulin regimen. These patients had the lowest age and age-of-onset, and the highest body mass index (P < 0.001, P = 0.003 and P = 0.013, respectively). Conclusion: The initiation rate of insulin therapy in patients treated with oral drugs is estimated to be 2. 2/100 per year in Japan, and the therapy is initiated at an HbA1c level far from the target level. The significant characteristics of patients who started on insulin therapy were a relatively low age and age-of-onset, and long diabetes duration. Prandial RA insulin treatment is superior for glycemic control, and this therapy can be transferred to basal-bolus therapy based on the severity of T2D. © 2012 The Japan Diabetes Society.
Replication study for the association between four loci identified by a genome-wide association study on European American subjects with type 1 diabetes and susceptibility to diabetic nephropathy in Japanese subjects with type 2 diabetes
Maeda S.,RIKEN |
Maeda S.,Juntendo University |
Araki S.-I.,Shiga University of Medical Science |
Babazono T.,Tokyo Women's Medical University |
And 12 more authors.
Diabetes | Year: 2010
OBJECTIVE - Genetic factors are believed to contribute to the development and progression of diabetic nephropathy. Recently, a genome-wide association study for diabetic nephropathy revealed four novel candidate loci in European American subjects with type 1 diabetes. In this study, we determined the association of the four loci with diabetic nephropathy in Japanese subjects with type 2 diabetes. RESEARCH DESIGN AND METHODS - We genotyped 11 singlenucleotide polymorphisms (SNPs) in four distinct loci (rs39059 and rs39075 in the CPVL/CHN2, rs1888747 and rs10868025 in FRMD3, rs739401 and rs451041 in CARS, and rs1041466, rs1411766, rs6492208, rs7989848, and rs9521445 in a chromosome 13q locus) in four independent Japanese populations. RESULTS - Six SNPs were nominally associated with diabetic nephropathy in one of the four Japanese populations (P < 0.05; rs451041 in study 1; rs39059 and rs1888747 in study 3; rs1411766 in studies 1 and 4; and rs7989848 and rs9521445 in study 4); however, no significant association was observed for any SNP after correction for multiple testing errors in the individual populations. Nevertheless, a meta-analysis performed for the data obtained from all four populations revealed that one SNP (rs1411766) in chromosome 13q was significantly associated with diabetic nephropathy in the Japanese populations (nominal P = 0.004, corrected P = 0.04, odds ratio 1.26 [95% CI = 1.07-1.47]). CONCLUSIONS - Our results suggest that the rs1411766 locus may be commonly involved in conferring susceptibility to diabetic nephropathy among subjects with type 1 or type 2 diabetes across different ethnic groups. © 2010 by the American Diabetes Association.
Oishi M.,Oishi Clinic |
Yamazaki K.,Kawai Clinic |
Okuguchi F.,Okuguchi Clinic |
Sugimoto H.,Sugimoto Clinic |
And 2 more authors.
Journal of Diabetes Investigation | Year: 2014
Aims/Introduction: Six kinds of oral antidiabetic drugs (OADs), including the new dipeptidyl peptidase 4 (DPP-4) inhibitors, are available. The present study aimed to define trends within the prescribing patterns of OADs, as well as changes in glycemic control in Japan over a 10-year period from 2002 to 2011. Materials and Methods: We carried out a cross-sectional study using data of type 2 diabetes mellitus patients from 24 clinics for 2002, 2005, 2008 and 2011. OAD use was analyzed combined with clinical data. Results: Sulfonylureas (SUs) were the most commonly used OAD, but their use for monotherapy markedly decreased over the study period. Biguanides (BGs) were the second most commonly used OAD, and their prescribing rate increased both for mono- and combination therapy. DPP-4 inhibitors (DPP-4I), released in 2009, were the third most commonly prescribed OAD in 2011 both for mono- and combination therapy. Among combination therapies, two OADs were mostly prescribed, but the use of three OADs and four OADs in 2011 was two- and 14.8-fold those in 2002. These trends were accompanied by an improvement in average glycated hemoglobin from 7.5 ± 1.2% in 2002 to 7.1 ± 0.9% in 2011. Conclusions: The OAD prescribing trend has moved away from monotherapy with SUs and toward combination therapies to achieve better glycemic control. Increased use of BGs and DPP-4I was predominant in 2011. These trends were accompanied by an improvement of the glycated hemoglobin level. © 2013 The Authors.
Yokoyama H.,Jiyugaoka Medical Clinic |
Araki S.,Shiga University of Medical Science |
Haneda M.,Asahikawa University |
Matsushima M.,Jikei University School of Medicine |
And 7 more authors.
Diabetologia | Year: 2012
Aims/hypothesis: In type 2 diabetic patients at low risk for cardiovascular disease (CVD), the relationship between the clinical course of nephropathy by stage of chronic kidney disease (CKD) and onset of CVD remains unclear. Clarification of this relationship is important for clinical decision-making for both low-and high-risk diabetic patients. Methods: This 4 year prospective study enrolled 2,954 type 2 diabetic patients with no prevalent CVD, and serum creatinine <176.8 μmol/l. The risk for CVD onset (non-fatal and fatal CVD and stroke, and peripheral arterial disease) was assessed according to CKD stage categorised by urinary albumin-to-creatinine ratio (ACR; mg/mmol) and estimated GFR (eGFR; ml min-1 1.73 m-2). Association of progression from žno CKD' stage (ACR <3.5 mg/mmol and eGFR ≥90 ml min 1.73 m-2) with risk for CVD onset was also evaluated. Results: During follow-up (median 3.8 years), 89 CVD events occurred. Compared with patients with žno CKD' as reference, those with ACR≥35.0 mg/mmol with coexisting eGFR 60-89 ml min-1 1.73 m-2 or <60 ml min-1 1.73 m-2 showed increased risk for CVD onset, whereas those with eGFR ≥90 ml min1- 1.73 m-2 did not. Those with ACR ≤3.5 mg/mmol and eGFR ≤60 ml min-1 1.73 m -2 did not show any increased risk. Among patients with žno CKD' stage at baseline, those who progressed to ACR ≥3.5 mg/mmol during follow-up showed an increased risk compared with those who did not, whereas those who progressed to eGFR ≥90 ml min-1 1.73 m-2 did not have increased risk. Conclusions/interpretation: The risk for CVD was associated with progression of albuminuria stage rather than eGFR stage in type 2 diabetic patients at relatively low risk for CVD. © Springer-Verlag 2012.
Yokoyama H.,Jiyugaoka Medical Clinic |
Matsushima M.,Jikei University School of Medicine |
Kawai K.,Kawai Clinic |
Hirao K.,HEC Science Clinic |
And 6 more authors.
Diabetic Medicine | Year: 2011
Aims To investigate whether a reduced incidence of cardiovascular disease in Type2 diabetes can be achieved in a newly recruited cohort following the recently advanced concept of multifactorial treatment and followed in primary care settings as compared with earlier cohorts. Methods A prospective study was performed in primary care settings at multiple clinics nationwide in the Japan Diabetes Clinical Data Management (JDDM) study group. Subjects were 2984 patients with Type2 diabetes without prevalent cardiovascular disease. The main outcome measure was the first event of non-fatal or fatal coronary heart disease, ischaemic stroke or peripheral artery disease, and the incidence was compared with other representative cohorts. Results There were 90 cardiovascular events over 10827 person-years of follow-up with a dropout rate of 6%. The incidences (per 1000 person-years, 95% confidence interval) of composite, coronary heart disease, ischaemic stroke and peripheral artery disease in the JDDM study were 8.3 (6.6-10.0), 4.4 (3.2-5.6), 3.1 (2.1-4.2), and 0.7 (0.2-1.2), respectively. Each incidence was lowest in the JDDM study compared with other cohorts (P<0.01 vs. each cohort). In the JDDM study, significant variables predictive of the occurrence of a cardiovascular event were age, duration of diabetes, HbA 1c, HDL cholesterol and urinary albumin. Conclusion The novel finding of low cardiovascular disease occurrence in this study may be conferred by the feasibility at primary care settings for providing patients with Type2 diabetes with favourable control of blood glucose, blood pressure and lipids, coupled with unique ethnicity/country factors. © 2011 The Authors. Diabetic Medicine © 2011 Diabetes UK.
PubMed | HEC Science Clinic, Oishi Clinic, Kurihara Clinic, Shiga University of Medical Science and 5 more.
Type: Journal Article | Journal: BMJ open diabetes research & care | Year: 2016
The fact that population with type 2 diabetes mellitus and bodyweight of patients are increasing but diabetes care is improving makes it important to explore the up-to-date rates of achieving treatment targets and prevalence of complications. We investigated the prevalence of microvascular/macrovascular complications and rates of achieving treatment targets through a large-scale multicenter-based cohort.A cross-sectional nationwide survey was performed on 9956 subjects with type 2 diabetes mellitus who consecutively attended primary care clinics. The prevalence of nephropathy, retinopathy, neuropathy, and macrovascular complications and rates of achieving targets of glycated hemoglobin (HbA1c) <7.0%, blood pressure <130/80mmHg, and lipids of low-density/high-density lipoprotein cholesterol <3.1/1.0mmol/L and non-high-density lipoprotein cholesterol <3.8mmol/L were investigated.The rates of achieving targets for HbA1c, blood pressure, and lipids were 52.9%, 46.8% and 65.5%, respectively. The prevalence of microvascular complications was 28% each, 6.4% of which had all microvascular complications, while that of macrovascular complications was 12.6%. With an increasing duration of diabetes, the rate of achieving target HbA1c decreased and the prevalence of each complication increased despite increased use of diabetes medication. The prevalence of each complication decreased according to the number achieving the 3 treatment targets and was lower in subjects without macrovascular complications than those with. Adjustments for considerable covariates exhibited that each complication was closely inter-related, and the achievement of each target was significantly associated with being free of each complication.Almost half of the subjects examined did not meet the recommended targets. The risk of each complication was significantly affected by 1 on-target treatment (inversely) and the concomitance of another complication (directly). Total diabetes care including one-by-one management of modifiable risk factors and complications may be important for high-quality care. The future studies including more subjects and clinics with precise complication status are needed.
PubMed | HEC Science Clinic, Oishi Clinic, Shiga University of Medical Science, Niigata University and 3 more.
Type: Journal Article | Journal: Diabetes research and clinical practice | Year: 2015
The protective association of pioglitazone with cardiovascular events and death was investigated over 6-years in large-scale type 2 diabetic subjects without established cardiovascular disease in a primary care setting.A six-year observational cohort study including 2864 subjects with type 2 diabetes without established cardiovascular disease was performed. The primary endpoint was a composite of first occurrence of cardiovascular disease or death. The effect of pioglitazone use at a baseline year with a Cox proportional hazard model and the time-dependent use in each one-year examination interval with a pooled logistic regression model were analyzed.Baseline use of pioglitazone (n=493) did not show a statistically protective effect on the primary endpoint (n=175), although it tended to reduce the risk (adjusted hazard ratio 0.67 [95% CI: 0.43-1.05]). However, pooled logistic regression analysis indicated a significant protective association of pioglitazone with the primary endpoint (0.58 [0.38 to 0.87] and cardiovascular disease (0.54 [0.33-0.88]), independent of concurrent levels of blood glucose, blood pressure, lipids, albuminuria, and renal function. In particular, this protective association was observed in those with diabetic nephropathy regardless of the daily dose of pioglitazone. Among a total of 898 subjects who took pioglitazone during the period, 43% experienced a discontinuation at least once; however, serious adverse effects were rare.This observational study indicated a protective association of pioglitazone with cardiovascular disease and death in type 2 diabetic subjects without established vascular disease, particularly those with nephropathy.
Katakami N.,Osaka University |
Kaneto H.,Osaka University |
Matsuoka T.-A.,Osaka University |
Takahara M.,Osaka University |
And 8 more authors.
Atherosclerosis | Year: 2015
Objective: Oxidative stress, which is provoked in patients with diabetes, plays critical roles in the pathogenesis of coronary heart disease (CHD). We simultaneously determined 5 relatively common genetic variants related to oxidative stress and evaluated the combined effect on CHD. Methods: We enrolled 1977 Japanese type 2 diabetic subjects without history of CVD (males 66.1%, 59.5±10.0 years old), determined their genotypes regarding glutamate-cysteine ligase modifier subunit (GCLM) C-588T, manganese superoxide dismutase (SOD2) Val16Ala, endothelial nitric oxide synthase (NOS3) G894T, NAD(P)H oxidase p22phox (CYBA) C242T, and myeloperoxidase (MPO) G-463A polymorphisms, and prospectively evaluated the association between these polymorphisms and CHD events. Results: The median follow-up period was 7.5 years and there were 85 new CHD events. The single association analysis revealed that there were no statistically significant associations between each polymorphism and the prevalence of CHD. Interestingly, the risk of CHD event was higher with the increase of the total number of 10 concomitant unfavorable "pro-oxidant alleles" in each subject (p for trend=0.018, log-rank test). Especially, the carriers of <8 pro-oxidant alleles had a significantly increased risk as compared to the carriers of <8 pro-oxidant alleles, whether the other clinical variables were adjusted (HR 2.92 with 95%CI 1.50-5.67, p=0.002) or not (HR 2.89 with 95%CI 1.49-5.59, p=0.002). Conclusions: Accumulation of gene polymorphisms related to oxidative stress is likely associated with the development of CHD in patients with type 2 diabetes, suggesting that the combined information about these variants is useful to assess the risk of CHD. © 2014 Elsevier Ireland Ltd.
Sugawara A.,University of Tsukuba |
Kawai K.,Kawai Clinic |
Motohashi S.,Kawai Clinic |
Saito K.,University of Tsukuba |
And 6 more authors.
Diabetologia | Year: 2012
Aims/hypothesis: The aim of this study was to examine the association between HbA1c variability and the development of microalbuminuria as defined by an albumin/creatinine ratio ≥3.4 mg/mmol (≥30 mg/g) in at least two of three consecutive urine samples in Japanese patients with type 2 diabetes. Methods: HbA1c level was measured in 812 serially registered normoalbuminuric adults aged 21-79 years with type 2 diabetes. After registration, a 1-year period to establish baseline values for mean HbA 1c and HbA1c variability (measured as the intrapersonal SD of serially collected HbA1c) was decided upon. The association between HbA1c variability and the development of microalbuminuria was determined by Cox regression analysis after adjustment for other risk factors for microalbuminuria. Results: Microalbuminuria occurred in 193 patients during the observation period of (mean±SD) 4.3±2.7 years. Even after adjustment for mean HbA1c, HbA1c variability was a significant predictor of microalbuminuria independently of the mean HbA 1c; the HR for every 1% (95% CI) increase in mean HbA1c was 1.22 (1.06, 1.40) (p=0.005), and that for HbA1c variability was 1.35 (1.05, 1.72) (p=0.019). The effects of these two variables were quite similar when 1 SD was used; the HR for every 1 SD increase (95% CI) in HbA 1c was 1.23 (1.07, 1.43) (p=0.005), and that for HbA1c variability was 1.20 (1.03, 1.39) (p=0.019). Conclusions/interpretation: HbA1c variability affects the development of microalbuminuria independently of mean HbA1c in type 2 diabetes. Further studies should be performed to evaluate the influence of HbA1c variability on other complications and in individuals of other ethnicities with type 2 diabetes. © Springer-Verlag 2012.