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We assessed the prescription patterns of oral antidiabetic drugs in Japanese patients with type 2 diabetes between 2002 and 2020 using data from the Computerized Diabetes Care database. Among 172,960 patients treated with oral antidiabetic drugs, both the sulfonylurea prescription rate and dose decreased from 2002 to 2020. Prescriptions of biguanides, dipeptidyl peptidase-4 inhibitors and sodium-glucose cotransporter 2 inhibitors increased; their dose and dose frequency remained relatively stable. Trends in oral antidiabetic drug prescriptions changed over time, reflecting guideline recommendations and existing evidence.

Aims Workplace demands, support, and relationships differ according to employment status (e.g., employment that is full-time, part-time, or self-employed) and may lead to unequal opportunities to keep diabetic appointments. We investigated the association between employment status and outpatient diabetic appointment non-attendance among working-age adults with type 2 diabetes. Methods This was a secondary analysis of a cluster-randomized trial (the Japan diabetes outcome intervention trial 2 large-scale trial). The analysis included 2010 trial participants (40–65 years old) with type 2 diabetes who were regularly followed by primary care physicians (PCPs). The outcome measure was the first non-attendance (defined as a failure to visit a PCP within 2 months of the original appointment) during the one-year follow-up. The association between baseline employment status and non-attendance was examined using Cox proportional hazard model in men and women. Results During the 1279 and 789 person-year follow-up periods, 90 men and 34 women, respectively, experienced their first appointment non-attendance. Among men, self-employed participants had a higher risk of non-attendance compared with full-time employees (adjusted HR, 1.84; 95% CI, 1.15, 2.95). The trial intervention (attendance promotion) was associated with a significantly reduced risk of non-attendance among self-employed participants (HR, 0.51; 95% CI, 0.26, 0.99). Among women, a significant association between employment status and non-attendance was not observed. Conclusions Self-employed men with type 2 diabetes had a twofold increased risk of non-attendance than did full-time employees. Our study suggests that self-employed men with type 2 diabetes should be targeted for interventions promoting appointment adherence.

AIMS: Continuity of diabetes care is relevant among elderly patients. The aim of this study is to investigate the impact of clinical characteristics on continuing outpatient visits to a specialized diabetes clinic in elderly Japanese patients with diabetes. METHODS: We included outpatients with type 2 diabetes aged ≥ 65 years who first visited our clinic from 2006 to 2009. The information of patients’ characteristics was obtained through medical record review from the CoDiC database. We have tracked whether the patients continued to visit the clinic until May 31, 2019. A Cox proportional hazards regression model identified variables related to withdrawal. RESULTS: Among 128 patients, 63 patients (49.2%) were withdrawn during the follow-up periods. The average visit duration of withdrawals was 4.6 (range 1, 10) years. The patients who discontinued to visit were older (72.6 vs. 69.5 years old, p = 0.005) compared with those who continued to visit. No significant differences in clinical conditions such as complication of diabetes, Charlson Comorbidity Index and polypharmacy between the first and last visit were observed in each group. Age (≥ 75 years) was significantly associated with withdrawal (hazard ratio 2.72 [95% confidence interval 1.59, 4.63], p

OBJECTIVE Nonalbuminuric diabetic kidney disease (DKD) has become the prevailing phenotype in patients with type 2 diabetes. However, it remains unclear whether its prognosis is poorer than that of other DKD phenotypes. RESEARCH DESIGN AND METHODS A total of 2,953 Japanese patients with type 2 diabetes and estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2, enrolled in an observational cohort study in 2004, were followed until 2015. On the basis of albuminuria (>30 mg/g creatinine) and reduced eGFR ( RESULTS During the mean follow-up of 9.7 years, 113 patients died and 263 developed CVD. In nonalbuminuric DKD, the risks of death or CVD were not higher than those in no-DKD (adjusted hazard ratio 1.02 [95% CI 0.66, 1.60]) and the annual decline in eGFR was slower than in other DKD phenotypes. The risks of death or CVD in nonalbuminuric DKD without prior CVD were similar to those in no-DKD without prior CVD, whereas the risks in nonalbuminuric DKD with prior CVD as well as other DKD phenotypes were higher. CONCLUSIONS Nonalbuminuric DKD did not have a higher risk of mortality, CVD events, or renal function decline than the other DKD phenotypes. In nonalbuminuric DKD, the presence of macrovascular complications may be a main determinant of prognosis rather than the renal phenotype.

IntroductionWe investigated trends in the proportion of diabetes treatment and glycemic control, which may be altered by recent advances in insulin and non-insulin drugs, in Japanese patients with type 2 diabetes.Research design and methodsA serial cross-sectional study was performed using a multicenter large-population database from the Japan Diabetes Clinical Data Management study group. Patients with type 2 diabetes who attended clinics belonging to the study group between 2002 and 2018 were included to examine trends in glycated hemoglobin A1c (HbA1c) by treatment group using multivariable non-linear regression model.ResultsThe proportion of patients with insulin only decreased from 15.0% to 3.6%, patients with insulin+non-insulin drugs increased from 8.1% to 15.1%, patients with non-insulin drugs increased from 50.8% to 67.0%, and those with no drugs decreased from 26.1% to 14.4% from 2002 to 2018, respectively. The HbA1c levels of each group, except for no drugs, continued to decrease until 2014 (unadjusted mean HbA1c (%) from 2002 to 2014: from 7.89 to 7.45 for insulin only, from 8.09 to 7.63 for insulin+non-insulin, and from 7.51 to 6.98 for non-insulin) and remained unchanged thereafter. Among insulin-treated patients, use of human insulin decreased, use of long-acting analog insulin increased, and concomitant use of non-insulin drugs increased (from 35.1% in 2002 to 80.9% in 2018), which included increased use of dipeptidyl peptidase 4 inhibitors, sodium-glucose cotransporter 2 inhibitors, and glucagon-like peptide 1 receptor agonists, and the persistently high use of metformin.ConclusionsDuring the past two decades, combined use of insulin and non-insulin drugs increased and glycemic control improved and leveled off after 2014 in Japanese patients with type 2 diabetes. Further studies of the trend in association with age and factors related to metabolic syndrome are necessary to investigate strategies aiming at personalized medicine in diabetes care.

AIMS: The current study evaluated patient demographics and clinical characteristics that associated with HbA1c reduction following addition of one oral antidiabetic drug (OAD) to DPP4i monotherapy. METHODS: A retrospective study was conducted using CoDiC database. Adult T2DM patients treated with sitagliptin monotherapy for ≥ 6 months and adding one OAD were extracted. Association between patient characteristics at the time of add-on OAD and following HbA1c reduction was assessed. RESULTS: Of 444 included patients, mean age was 62 years and 33% were female. All add-on OAD classes demonstrated further HbA1c reduction (p

It is expected that a large amount of data related to diabetes and other chronic diseases will be generated. However, databases constructed without standardized data item sets can be limited in their usefulness. To address this, the Collaborative Committee of Clinical Informatization in Diabetes Mellitus was established in 2011 by the Japan Diabetes Society and Japan Association for Medical Informatics. The committee has developed core item sets and self-management item sets for diabetes mellitus, hypertension, dyslipidemia, and chronic kidney disease in collaboration with the Japanese Society of Hypertension, Japan Atherosclerosis Society, Japanese Society of Nephrology, and Japanese Society of Laboratory Medicine, as well as a mapping table that aligns the self-management item sets with the Japanese standardized codes for laboratory testing. The committee also determined detailed specifications for implementing the four self-management item sets in personal health record applications to facilitate risk stratification, the generation of alerts using information and communications technology systems, the avoidance of data input errors, and the generation of reminders to input the self-management item set data. The approach developed by the committee may be useful for combining databases for various purposes (such as for clinical studies, patient education, and electronic medical record systems) and for facilitating collaboration between personal health record administrators. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s13340-019-00389-7) contains supplementary material, which is available to authorized users.

Introduction The combined effects of energy intake (EI) and physical activity (PA) on obesity have been poorly investigated. We have investigated the combined effects of EI and PA quantitatively in Japanese men and women with type 2 diabetes. Methods Data on 1395 patients with type 2 diabetes who attended 25 diabetes clinics located throughout Japan, obtained by questionnaire, were analyzed. A logistic regression model was used to calculate the odds ratio for obesity. Results Multi-adjusted odds ratios for the top versus the bottom tertile of EI and the bottom versus the top tertile of PA were 1.39 (95% confidence interval [CI] 1.02–1.89) and 1.64 (95% CI 1.22–2.22), respectively. The combination of EI (kcal/day) ≥ 1967 and PA (metabolic equivalents [METs] h/week) ≤ 9.9 for men and of EI ≥ 1815 and PA ≤ 8.3 for women were significantly associated with obesity. Conclusions The existence of “allowable maximum EI” and “required minimum PA” that is significantly associated with “not being obese” is implied, suggesting the need for lifestyle education for Japanese patients with type 2 diabetes. Electronic Supplementary Material The online version of this article (10.1007/s13300-019-0610-x) contains supplementary material, which is available to authorized users.

Aims/Introduction:Type 2 diabetes mellitus is caused by a relative imbalance between insulin secretion and sensitivity related to the body mass index (BMI). Seven categories of oral antidiabetic drugs (OADs) are available in Japan. It is important to assess the OAD utilization patterns based on patients’ BMI levels., Materials and methods:OAD prescribing patterns from 2002 to 2019 were analyzed using the data collected in the computerized diabetes care database provided by the Japan Diabetes Clinical Data Management Study Group; OAD utilization patterns in 25,751 OAD-treated type 2 diabetes mellitus patients registered in 2019 were analyzed after classifying them into five categories of BMI., Results:Comparing OAD usage between 2002 and 2019, sulfonylureas decreased from 44.5 to 23.2%, and biguanides (BGs) increased from 19.3 to 50.3%. Dipeptidyl peptidase-4 inhibitors (DPP4is) increased to 56.9% in 2019. Sodium-glucose cotransporter 2 inhibitors (SGLT2is) increased to 23.6% in 2019. About 90% of type 2 diabetes mellitus patients had BMI < 30 kg/m2 . DPP4is were the most used OADs in 2019. When BMI exceeded 30 kg/m2 , use of BGs and sodium-glucose cotransporter 2 inhibitors increased, and use of sulfonylureas and DPP4is decreased. Although DPP4is were the most used OADs for patients with BMI 35 kg/m2 after BGs and sodium-glucose cotransporter 2 inhibitors ., Conclusions:DPP4i usage was as high as that of BG in the analysis of Japanese type 2 diabetes mellitus patients with relatively low BMI. This was considered to be a treatment option appropriate for the pathophysiology in Japanese patients.

Background: To examine the impact of lifestyle intervention by telephone (TSC) and face-to-face (FFA) according to the stages of lifestyle change (SLC) on the drop-out from regular medical care of diabetes Methods: Secondary analysis was performed on data from the Japan Diabetes Outcome Intervention Trial-2 large trial (J-DOIT2-LT), which was a 1-year, prospective, cluster randomized, intervention trial. 11 district medical associations were divided into two subregions (clusters), in which patients were registered, and then were randomized to an intervention group (TSC or FFA) or control group (CG). Lifestyle advisors reminded patients of medical visits to the primary care physician (PCP) and gave lifestyle advice by TSC or FFA. The CG received usual medical care. The outcome of this analysis was the drop-out rate from regular medical care. We estimated the HR and 95% CI of either TSC or FFA relative to CG according to the SLC (stage 1/2/3/4/5: pre-contemplation/contemplation/preparation/action/maintenance). Results: A total of 2,071 participants (mean age: 57 ± 6 years; 38% female) were studied. 1170, 616, and 285 patients were divided into CG, TSC, and FFA. In the stage 1-3 of diet, TSC (HR:0.47; 95% CI:0.27-0.82) and FFA (HR:0.20; 95% CI:0.07-0.55) were significantly associated with a low risk of the drop-out after adjusting for covariates. The similar association was observed in the stage 1-3 of exercise. In contrast, neither TSC nor FFA reduced the risk for drop-out in the stage 4-5 of diet. TSC (HR:0.12; 95% CI:0.02-0.95) but not FFA (HR:0.37; 95% CI:0.09-1.62) was associated with a low risk for the drop-out in the stage 4-5 of exercise. Conclusions: FFA could be more effective than TSC to reduce the risk for drop-out from regular medical care of diabetes at the stage 1-3. In contrast, TSC may be enough to reduce the risk for the drop-out in the stage 4-5. Disclosure R. Bouchi: None. M. Noda: None. Y. Hayashino: None. K. Yamazaki: None. H. Suzuki: None. A. Goto: None. T.A. Furukawa: None. K. Izumi: None. M. Kobayashi: None.

ObjectiveWe examined changes in prevalence of diabetic microvascular/macrovascular complications and diabetes care indicators for adults in Japan with type 2 and type 1 diabetes over one decade.Research design and methodsTwo independent cohorts were recruited with the same inclusion criteria in 2004 (cohort 1: 3319 with type 2 and 286 with type 1 diabetes) and in 2014 (cohort 2: 3932 with type 2 and 308 with type 1 diabetes). Prevalence of complications and care indicators including achieving treatment targets for glycemia, blood pressure, lipid control, body mass index (BMI), and smoking were compared. In addition, patients in cohort 1 were re-examined in 2014 and their data were compared with the baseline data of each cohort.ResultsIn type 2 diabetes, the prevalence of nephropathy, retinopathy, neuropathy, chronic kidney disease, current smoking and stroke significantly decreased, with improvements in achieving treatment target rates in cohort 2 two as compared with cohort 1. In type 1 diabetes, the prevalence of nephropathy, retinopathy, chronic kidney disease, and hemoglobin A1Cvalues significantly decreased. Decreases in prevalence of microvascular complications in type 2 diabetes were similarly found in each age-matched and sex-matched group, whereas younger patients exhibited marked increase in BMI and lower treatment target achieving rates compared with elderly patients. Regarding normoalbuminuric renal impairment, only a slight increase in the prevalence was observed both in type 2 and type 1 diabetes. In cohort 1, re-examined in 2014, care indicators were significantly improved from 2004, while complications increased with getting 10 years older.ConclusionsWe observed declining trends of diabetic microvascular complications with improvement in diabetes care indicators in type 2 and type 1 diabetes. Younger patients with type 2 diabetes exhibited marked increase in BMI and lower rates of achieving treatment targets compared with elderly patients, which remains a concern.

Aims/Introduction We carried out an observational cohort study to examine the relationship between the efficacy of oral antidiabetic drugs and clinical features in type 2 diabetics. Materials and Methods We analyzed the CoDiC® database of the Japan Diabetes Data Management Study Group across 67 institutions in Japan. In a total of 3,698 drug‐naïve patients who were initiated with metformin, dipeptidyl peptidase‐4 inhibitor (DPP‐4i) or sulfonylurea (SU) from 2007 to 2012, we evaluated body mass index (BMI) and hemoglobin A1c (HbA1c). The patients were stratified according to their clinical features, and matched using a propensity score to adjust for baseline factors. Results HbA1c was reduced with all drugs, with the largest effect elicited by DPP‐4i and the smallest by SU (P = 0.00). HbA1c increased with SU after 6 months in the patients stratified by an age‐of‐onset of 25 (P = 0.00). The reduction in HbA1c was larger in patients with HbA1c of ≥8%, compared with that in patients with HbA1c of

Regular clinic visits are essential for keeping diabetes well controlled. Nevertheless, about half of the known diabetic patients do not receive regular medical care, as estimated by the National Survey in Japan. From the viewpoint of medical resources, primary care physicians (PCPs) should provide regular medical care to the many diabetic patients in Japan. Therefore, maintaining regular care and improving care quality are expected for diabetes treatment at the PCP level. The Japan Diabetes Outcome Intervention Trial-2 (J-DOIT2) is a cluster-randomized two-armed intervention study. Fifteen district medical associations (DMAs) and 300 PCPs will participate. The PCPs in each DMA will be divided into two groups and randomized, with each group acting as a cluster within the DMA. Then, 3,750 type 2 diabetes patients (aged 40–64 years) will be recruited. In the intervention group, patients will receive reminders for medical visits to their PCP and lifestyle advice over the telephone or face to face. The PCPs will be provided with benchmark indicators of his/her own diabetes treatment activities. In the control group, the PCPs will provide ordinary medical treatment to his/her patients. With a 1-year intervention and follow-up period, the primary outcome will be the rate of patient dropout from regular medical care of both groups. The quality of diabetes treatment provided by the PCPs will also be evaluated. The J-DOIT2 is a large-scale trial for improvement of diabetes care in an ordinary primary care setting and is expected to contribute to establishing widely adoptable countermeasures for diabetes.

There is no recent study on the prevalence of overweight and obesity in patients with type 1 diabetes mellitus (T1DM) in Japan. Being overweight has a significant effect on the metabolic condition and glycemic control of such patients. In the present cross-sectional study, we investigated the effects of body mass index (BMI) on lipid profile, blood pressure, and glycemic control in patients with T1DM. In total, 1486 patients with T1DM (including 401 patients with early onset T1DM who were20 years of age at diagnosis) were included. Patients were divided into four groups according to their BMI, and glycosylated hemoglobin (HbA1c), daily insulin dose per kg body weight, lipid profile, and blood pressure were compared between groups. We found that 15.7% of all patients were overweight (BMIor= 25.0 kg/m(2)) and 2.0% were obese (BMIor= 30.0 kg/m(2)), compared with 17.5% and 2.0%, respectively, in the early onset T1DM subgroup. Significant changes in lipid profiles and blood pressure were found with increasing BMI in both the entire population and the early onset T1DM subgroup. In the entire study population HbA1c and the body weight-adjusted daily insulin dose were significantly higher in patients with a BMIor= 23 kg/m(2) compared with those with a BMI23 kg/m(2); however, this was not the case in the early onset T1DM subgroup. This difference may be due to the relatively small number of patients in that subgroup. In conclusion, the prevalence of overweight and obesity in patients with T1DM was less than that in the normal Japanese population. For patients with T1DM, being overweight was associated with higher blood pressure and dyslipidemia. Furthermore, we cannot exclude an association between being overweight and the need for higher daily doses of insulin.

Telmisartan, a new angiotensin II type 1 receptor blocker (ARB), was recently reported to stimulate PPARgamma, and stronger effects of Telmisartan on insulin sensitivity has been expected than the class effect of ARB. In the present study, we examined the effects of Telmisartan on insulin sensitivity and adipokine levels in hypertensive and type 2 diabetic patients. Outpatients with both hypertension and type 2 diabetes mellitus (n=36; male 23, female 13), received 20-40mg Telmisartan orally once daily for 6 months. Physical examinations and blood or urine tests were performed before and 3 or 6 months after starting Telmisartan treatment. Results were statistically compared using Wilcoxon analysis. Telmisartan treatment for 3 or 6 months reduced systolic and diastolic blood pressure and urinary albumin excretion. Fasting plasma glucose, HbA1c, total and HDL-cholesterol, triglyceride, body weight, BMI and waist length were not changed. Fasting IRI and HOMA-IR were significantly decreased after Telmisartan treatment, suggesting the improved insulin sensitivity. Total and high molecular adiponectin were not changed. Interestingly, serum leptin was significantly increased by 3 months Telmisartan treatment, suggesting a possible involvement of leptin in improved insulin sensitivity. In conclusion, Telmisartan improved insulin resistance with increased serum leptin level in hypertensive and type 2 diabetic patients.

The number of diabetic patients has been increasing in Japan and consequently diabetic complications are the most important target to be prevented through improving glycemic control. In order to describe the glycemic control status and treatment of diabetic patients by specialists in Japan over three years, from 2000 to 2002, we examined HbA1c, other laboratory data and the modality of drug therapy in the study population, 8170 in 2000, 11,831 in 2001, and 16,934 in 2002. Patients were registered at clinics and hospitals that were members of the Japan Diabetes Clinical Data Management Study Group (JDDM). HbA1c levels, other laboratory data, and details of drug therapy were collected and analyzed using SPSS and MS Access. The mean HbA1c levels were essentially unchanged during the study periods, ranging from 7.9% to 7.8%, and from 7.1% to 7.0%, in type 1 and type 2 diabetic patients, respectively. In type 2 diabetes, the frequency of oral hypoglycemic agents (OHA) use increased from 44.9% to 51.4%, while the use of diet-only therapy decreased from 29.9% to 25.4% over the study period. Although the systolic blood pressure was slightly above target, the mean blood pressure and the mean lipid profile were mostly within the treatment goals set by the Japan Diabetes Society. This first report from a large scale study of the daily management of diabetes in Japan revealed that the average HbA1c level was superior to most of the results reported from other countries. Nonetheless, 66% of the patients still had HbA1c levels and half of the patients had other laboratory parameters including blood pressure and lipid profile that were greater than those recommended by the Japan Diabetes Society. The nature of diabetes drug therapy in Japan has gradually changed as new drugs have appeared in the market.

A vitamin E-deficient diet containing fish oil is known to afford a protection against malaria in mice. In the present study we examined whether the dietary supplementation with α-tocopherol—fortified n-3 polyunsaturated fatty acid (PUFA) ethyl esters (eicosapentaenoic acid (EPA) ethyl ester and docosahexaenoic acid (DHA) ethyl ester) had a protective effect against malaria. Four groups of mice were each given one of the following diets: (1). powered standard chow (REF group); (2). 90% (wt) lipid-free diet with 8% lard and 2% safflower oil (SAF group); (3). 90% lipid-free diet with 8% lard and 2% EPA ethyl ester (EPA group); and (4). 90% lipid-free diet with 8% lard and 2% DHA ethyl ester (DHA group). Safflower oil, EPA, and DHA were fortified with 0.2% α-tocopherol before mixing dietary components. After 6 weeks on these diets, mice were inoculated with Plasmodium yoelii, and the same diets were continued until the end of the experiment. The survival rates of the four groups 46 days after the inoculation were 12, 012, 512, and 410 in the REF, SAF, EPA, and DHA groups, respectively. There was a significant difference in the survival rates (P < 0.025) among the groups. It may be possible to conduct a clinical trial with malarial patients using EPA or DHA ethyl ester fortified with α-tocopherol.

Monocyte chemoattractant protein-1 (MCP-1) and angiotensin II (Ang II) in adipose tissue are thought to induce systemic insulin resistance in rodents; but the precise mechanism is not fully clarified. We examined the mechanism of Ang II-induced and/or tumor necrosis factor-alpha (TNF-alpha)-induced MCP-1 production from 3T3-L1 preadipocytes. The MCP-1 protein and MCP-1 mRNA expression in 3T3-L1 preadipocytes were increased significantly by stimulation with TNF-alpha. We found no significant increase in MCP-1 concentrations by Ang II alone; but it enhanced the TNF-alpha-induced MCP-1 mRNA expression in a dose-dependent manner. Then, we examined the effect of Ang II and/or TNF-alpha on phosphorylation of extracellular signal-regulated kinase (ERK), p38MAPK, and IkappaB-alpha. Ang II and TNF-alpha clearly enhanced ERK and p38MAPK phosphorylation. IkappaB-alpha phosphorylation was enhanced by TNF-alpha, but not by Ang II. The MCP-1 mRNA expression induced by TNF-alpha and co-stimulation with Ang II was inhibited by either ERK inhibitor, p38MAPK inhibitor or NF-kappaB inhibitor. Moreover, Ang II enhanced the activation of AP-1 (c-fos) induced by TNF-alpha. Our results suggest that Ang II may serve as an additional stimulus on the TNF-alpha-induced MCP-1 production through the ERK-and p38MAPK-dependent pathways probably due to AP-1 activation.

We evaluated the clinical usability of a microtapered needle (TN3305, "Needle T," Terumo Corp., Tokyo, Japan) by comparing it with a standard needle (Micro-Fine +, 31 gauge, 5 mm, thin wall, "Needle B," Nippon Becton Dickinson Co., Ltd., Tokyo) in a multicenter study.Ninety-nine patients with diabetes mellitus being treated in 11 Japanese hospitals were enrolled in the study. Written consent was obtained from all patients. They were allocated randomly to two groups by an envelope (crossover) method. Injections were performed using one needle first, followed by the other needle 4 or 5 days later. Pain caused by injection was evaluated using a visual analogue scale (VAS).In the overall evaluation, Needle T was chosen by 40 patients (44.4%) and Needle B by 17 (18.8%); 33 patients (36.7%) expressed no preference. VAS scores for Needles T and B were 1.48 +/- 0.18 and 2.47 +/- 0.24 cm, respectively (P0.001). In this study, lower VAS indicated less pain.The preferences and VAS scores suggested that Needle T caused less pain than Needle B. The incidence of adverse events and safety were equivalent for both needles. We believe that usability of Needle T by patients for self-injection is better.

Many diabetic patients carry a portable self-monitoring of blood glucose (SMBG)-analyzer in order to collect their own blood and examine their glucose levels; this allows them to determine such factors as insulin dose, diet and exercise to stay healthy. However, the test causes physical and mental stress for the subjects. The authors aim to develop a semi-invasive blood-collecting needle which does not need a power source for the pump mechanism. In this study, we fabricated a capillary action needle that can collect the blood sample automatically. A blood-collecting needle was fabricated from 25 gage sized medical needle (diameter of 0.5 mm, stainless steel) by cutting process, and it had a half-opened crevice in the tip. In order to evaluate the physical characteristics of the blood-collecting needle, the relationship between the size and suction time and/or suction volume were measured using an isotonic sodium chloride solution, whole rabbit blood, and whole human blood with anticoagulant. Next, in order to evaluate the degree of invasion, the diameters of erythema in auricles of rabbits were observed for 2 days using a CCD camera-type microscope. The mean suction time of the isotonic sodium chloride solution and the whole rabbit blood were 1.5 s (n = 10) and 9.0 s (n = 5), respectively. Selection of a suitable size of the blood-collecting needle enabled the collection of 0.1 microL of whole human blood in 10 s. Moreover, it was shown, by comparing the observed diameter of the erythema, that the invasiveness of the blood-collecting needle was smaller than for commercial needles of the equal diameter. It became clear that this fulfils the fundamental functions of a semi-invasive blood-collecting needle.