[Vegetable-first eating habits are associated with a reduced risk of mild cognitive impairment in elderly diabetic patients].

OBJECTIVE: To examine the relationship between vegetable-first eating habits and the cognitive function in elderly patients with diabetes. METHODS: The subjects were outpatients with diabetes ≥60 years old at Ise Red Cross Hospital. A self-administered dementia checklist was used to assess mild cognitive impairment and dementia. The participants were asked to fill out a questionnaire on their vegetable-first eating habits and were classified into 4 groups: 0, 1, 2, and 3 times a day. The dependent variables were mild cognitive impairment and dementia, and the explanatory variable was vegetable-first eating habits (0 as a reference). RESULTS: In total, 358 patients were included in the analysis. The number of vegetable-first meals was 0 in 153 (42.7%), 1 in 48 (13.4%), 2 in 46 (12.8%), and 3 in 111 (31.1%) patients. The adjusted odds ratios for 1, 2, and 3 times of mild cognitive impairment were 0.83 (95% confidence interval [CI], 0.35-1.94; P=0.680), 0.81 (95% CI, 0.32-2.00; P=0.653), and 0.37 (95% CI, 0.17-0.81; P=0.014), respectively. However, there was no significant association between vegetable-first eating habits and dementia. CONCLUSION: In elderly patients with diabetes, a vegetable-first eating habit at each meal was associated with a decreased risk of mild cognitive impairment.

[Decreased family caregiver satisfaction with diabetes treatment of elderly patients is associated with patient depressive symptoms].

OBJECTIVE: To examine the relationship between the dissatisfaction of family caregivers with diabetes treatment and depressive symptoms among the elderly. METHODS: The subjects were diabetic patients of 65 years of age or older and their family caregivers, who were outpatients at Ise Red Cross Hospital. The Japanese version of the Patient Health Questionnaire 9, which consists of nine items, was used to measure depressive symptoms. The Japanese version of the Treatment Satisfaction Scale for Caregivers of Dependent Diabetic Patients (STCD2-J) was used to measure the satisfaction of family caregivers with diabetes treatment. A logistic regression analysis was performed using depressive symptoms as dependent variable, satisfaction of the family caregiver with diabetes treatment as an explanatory variable, and adjustment variables. RESULTS: In total, 272 patients were included in the analysis. Taking the quintiles of STCD2-J scores, the adjusted odds ratios for patient depressive symptoms in Q2 (27-29), Q3 (24-26), Q4 (22-23) and Q5 (14-21) based on Q1 (30-36) (the group with the highest STCD2-J scores) were 2.44 (95% confidence interval (CI), 0.69-8.61; P=0.163), 3.08 (95% CI, 0.93-10.12; P=0.063), 2.69 (95% CI, 0.68-10.65; P=0.156), and 4.54 (95% CI, 1.44-14.32; P=0.010), respectively. CONCLUSION: We found that family caregivers' decreased satisfaction with diabetes treatment was associated with depressive symptoms. It is important to alert primary care physicians about depressive symptoms when they see family caregivers who show decreased satisfaction with diabetes treatment.

[A low phase angle is a factor independently associated with falls in elderly diabetic patients].

OBJECTIVE: To examine the relationship between a low phase angle (PA) and falls in elderly diabetic patients. METHODS: The subjects were diabetic patients ≥65 years old who were outpatients at Ise Red Cross Hospital. Patients were asked about their fall history using a self-administered questionnaire. The PA was measured by the multi-frequency bioelectrical impedance method, and the subjects were classified into two groups: the first quartile with the smallest PA (T1 group) and the second and third quartiles (T2/3 groups). A logistic regression analysis with falls as the dependent variable, PA as the explanatory variable, and adjustment variables was used to calculate the odds ratio of the PA for falls. RESULTS: A total of 255 patients were included in the analysis of this study. Of these, 33.3% were in the T1 group, 66.7% were in the T2/3 group, and 28.2% had fallen. The unadjusted and adjusted odds ratios for falls in the PA were 2.92 (95% confidence interval [CI], 1.31-4.07; P=0.004) and 2.34 (95% CI, 1.07-5.09; P=0.031), respectively. CONCLUSION: A low PA was associated with falls in elderly diabetic patients.

[Loneliness is associated with the risk of low nutrition in elderly diabetic patients].

OBJECTIVE: The purpose of this study was to examine the relationship between loneliness and malnutrition in elderly diabetic patients. METHODS: The subjects were diabetic patients ≥65 years old who were outpatients at Ise Red Cross Hospital. The nutritional status was assessed using the Mini Nutritional Assessment Short Form (MNA-SF), and patients were defined as being undernourished if their total score was <11 points. Loneliness was assessed using the Japanese version of the short form of the loneliness scale, a self-administered questionnaire, and a total score of ≥6 was considered to indicate loneliness. A logistic regression analysis was used to calculate the adjusted odds ratio of loneliness to undernutrition, with the dependent variable being undernutrition, the explanatory variable being loneliness, and the adjustment variable being loneliness. RESULTS: A total of 163 patients were included in the analysis of this study. Of these, 25.8% were lonely, and 33.7% were undernourished. The unadjusted and adjusted odds ratios of loneliness to undernutrition were 2.55 (95% confidence interval [CI], 1.24-5.27; P=0.011) and 3.81 (95% CI, 1.27-11.39; P=0.017), respectively. CONCLUSION: Loneliness is associated with a low nutritional status in elderly diabetic patients. It is important to alert diabetic patients with loneliness to their low nutritional status when they are diagnosed.

["Koshi-heso" (waist-umbilicus) test: A novel screening method for visceral fatty obesity].

OBJECTIVE: To evaluate the screening performance and validity of the "Koshi-heso" (waist-umbilicus) test for visceral fatty obesity in elderly diabetic patients. METHODS: Subjects were diabetic patients ≥65 years old visiting our outpatient clinic. As a "Koshi-heso" test, the distance between the umbilicus and the superior border of the iliac crest (waist) was measured with the patient's own finger. When the index finger reached the umbilicus and there was a gap between the finger and the abdominal wall, the patient was classified as "smaller"; when the index finger reached the umbilicus and there was no gap between the finger and the abdominal wall, the patient was classified as "just fit"; and when the index finger did not reach the umbilicus, the patient was classified as "bigger". Abdominal circumference was used to assess visceral fat obesity, with a cut-off value of ≥85 cm for men and ≥90 cm for women. Visceral fat mass and body fat percentage were evaluated by the multi-frequency bioelectrical impedance method. The sensitivity and specificity of the waist-umbilical test for visceral fat obesity were calculated. Pearson's correlation coefficients between the "Koshi-heso" test and visceral fat mass and body fat percentage were calculated to evaluate the validity of the test. Furthermore, the association between the "Koshi-heso" test and risk factors for vascular disease, microvascular complications and cardiovascular disease was assessed by a logistic analysis. RESULTS: A total of 221 patients were included in the analysis population of the study. The cut-off values of "just fit" in men (sensitivity 0.96, specificity 0.62) and "bigger" in women (sensitivity 0.76, specificity 0.78) were optimal. Furthermore, the "Koshi-heso" test was significantly correlated with abdominal visceral fat mass and body fat percentage as well as with vascular disease risk factors and microvascular complications. CONCLUSION: The "Koshi-heso" test was able to be used as a screening method for visceral fatty obesity in elderly diabetic patients.

Incidence of sarcopenic obesity in older patients with diabetes and association between sarcopenic obesity and higher-level functional capacity: evaluation based on a consensus statement.

We used a consensus statement to diagnose sarcopenic obesity, evaluated incidence of sarcopenic obesity in older patients with diabetes, and examined whether sarcopenic obesity was associated with their higher-level functional capacity. Outpatients with diabetes (age, ≥65 years) undergoing treatment at Ise Red Cross Hospital were included. The Tokyo Metropolitan Institute of Gerontology Index of Competence (TMIG-IC)-a self-administered questionnaire-was used to assess their higher-level functional capacity. Sarcopenic obesity was evaluated based on the consensus statement diagnostic criteria-i.e., presence or absence of decreased skeletal muscle mass was evaluated based on appendicular skeletal muscle mass/body weight and obesity was assessed based on body fat mass percentage. To calculate the adjusted ß coefficient of sarcopenic obesity for higher-level functional capacity, multiple regression analyses were performed using TMIG-IC scores as the dependent variable and four categories (non-sarcopenia/non-obesity was used as a reference) that included sarcopenia and obesity as the predictor and moderator variables. Among the 310 patients included, the sarcopenic obesity incidence was 13.1% and 14.2% in men and women, respectively. When the non-sarcopenia/non-obesity group was used as a reference, the adjusted ß coefficient of sarcopenic obesity for scores of the TMIG-IC was -2.09 (p = 0.014) in men. However, the women showed no relationship between sarcopenic obesity and TMIG-IC scores. In older men with diabetes, sarcopenic obesity was associated with a decline in higher-level functional capacity.

[A study of the frequency of cachexia and its associated factors in elderly patients with diabetes mellitus].

OBJECTIVE: To investigate the frequency of cachexia and its associated factors in elderly diabetic patients. METHODS: The subjects were diabetic patients ≥65 years old attending the outpatient diabetes clinic of Ise Red Cross Hospital. Cachexia was evaluated as having three or more of the following: (1) muscle weakness, (2) fatigue, (3) anorexia, (4) decreased lean body mass, and (5) biochemical abnormalities. A logistic regression analysis was used to identify factors associated with cachexia, with the dependent variable as cachexia and explanatory variables as various variables (basic attributes, glucose-related parameters, comorbidities, and treatment). RESULTS: A total of 404 patients (233 males and 171 females) were included in the study. Twenty-two (9.4%) and twenty-two (12.8%) male and female patients, respectively, had cachexia. A logistic regression analysis showed that the HbA1c value (odds ratio [OR], 0.26,95% confidence interval [CI], 0.08-0.81; P=0.021) and cognitive and functional decline (OR, 11.81, 95% CI, 1.81-76.95; P = 0.010) were factors associated with cachexia. In women, type 1 diabetes (OR, 12.39, 95% CI, 2.33-65.87; P=0.003), the HbA1c value (OR, 1.71, 95% CI, 1.07-2.74; P=0.024), and insulin usage (OR, 0.14, 95% CI, 0.02-0.71; P=0.018) were cachexia-related factors. CONCLUSIONS: The frequency of cachexia in elderly diabetic patients and its associated factors were identified. It is important to increase awareness of the risk of cachexia in elderly diabetic patients with poor glycemic control, cognitive and functional decline, type 1 diabetes mellitus, and insulin non-use.

[Loneliness is associated with a reduced higher-level-function capacity in older diabetic patients].

OBJECTIVE: The present study examined the relationship between loneliness and higher-level functions in elderly diabetic patients. METHODS: The subjects were diabetic patients ≥65 years old who were outpatients at Ise Red Cross Hospital. The Tokyo Metropolitan Institute of Gerontology Index of Competence (TMIG-IC), a self-administered questionnaire, was used to assess higher-level functions. To evaluate loneliness, we used a shortened version of the Japanese version of the loneliness scale, a self-administered questionnaire. A multiple regression analysis with TMIG-IC scores as the dependent variable, loneliness as the explanatory variable, and adjustment variables was used to calculate the adjusted partial regression coefficients of loneliness on higher-level functions. RESULTS: One hundred and seventy patients were included in the present analysis. Ninety-one patients (53.5%) had loneliness, and the mean TMIG-IC score was 11.3. The unadjusted and adjusted partial regression coefficients of loneliness on higher-level functions were -1.61 (95% confidence interval [CI], -2.31 to -0.91; < 0.001) and -0.88 (95% CI, -1.52 to -0.23; P=0.008), respectively. CONCLUSION: Loneliness in elderly diabetic patients was found to be associated with lower higher-level functions. It is important to remind patients with diabetes mellitus who have loneliness about the risk of a decline in their higher-level functions.

[Association between the history of falls and being homebound in elderly diabetic patients].

OBJECTIVE: The purpose of this study was to investigate the relationship between a history of falls and being homebound in elderly diabetic patients. METHODS: The subjects were diabetic patients ≥65 years old visiting the outpatient clinic of Ise Red Cross Hospital. Patients were defined as being confined if they went out less than once a day, and their history of falls in the past year was investigated. Adjusted odds ratios for being homebound were calculated using a logistic regression analysis with a dependent variable of being homebound and explanatory variables of a history of falls and adjustment factors (age, sex, duration of diabetes, HbA1c, cardiovascular disease, cognitive and functional decline, depression, living alone, isolation, and diabetes treatment). RESULTS: A total of 564 patients (319 men and 245 women) were included in the study. The numbers of patients with a history of falls and who were homebound were 198 (35.1%) and 88 (15.6%), respectively. The adjusted odds ratio for being homebound to a history of falls was 2.69 (95% confidence interval, 1.31 to 5.52; P=0.007). CONCLUSION: In this study, a history of falls was significantly associated with being homebound. It is important to pay close attention to homebound elderly diabetic patients with a history of falls.

[Multimodal treatment program for elderly diabetic patients with sarcopenia improves the muscle strength and physical function].

OBJECTIVE: To evaluate the effects of a multimodal treatment program on the muscle strength, physical function, and skeletal muscle mass in elderly diabetic patients with sarcopenia. METHODS: Diabetic patients over 65 years old attending the Department of Diabetes and Metabolism, Ise Red Cross Hospital, were included. The diagnosis of sarcopenia was based on the Asian Working Group for Sarcopenia 2019. The measurement of extremity skeletal muscle mass was assessed by the multi-frequency bioelectrical impedance method, muscle strength was assessed by the grip strength, and the physical function was assessed by the 5-time chair stand test. The muscle strength, physical function, extremity skeletal muscle mass, and other parameters were assessed before and after 12 weeks of the multimodal treatment program (optimization of protein intake, resistance training, and patient education on sarcopenia) and then compared. Paired t-tests were used for the statistical analysis. RESULTS: Fourteen patients (3 men and 11 women) were included in the analysis of this study. The mean age was 74.4±4.7 years old. Significant improvements in the grip strength (male, 23.2±5.6 kg to 25.6±5.5 kg, P=0.014; female, 15.5±5.0 kg to 18.9±5.0 kg, P<0.001) and 5-time chair stand test (11.2±2.5 seconds to 8.6±1.7 seconds, P=0.002) were found with the multimodal treatment program. There was also a significant decrease in HbA1c (8.1±0.7% to 7.7±0.9%, P=0.004). However, although an increasing trend in the amount of extremity skeletal muscle mass was noted, there was no significant difference. CONCLUSIONS: A multimodal treatment program for elderly diabetic patients with sarcopenia showed an improvement in the muscle strength and physical function.

Diversity unearthed by the estimated molecular phylogeny and ecologically quantitative characteristics of uncultured Ehrlichia bacteria in Haemaphysalis ticks, Japan.

Ehrlichia species are obligatory intracellular bacteria transmitted by arthropods, and some of these species cause febrile diseases in humans and livestock. Genome sequencing has only been performed with cultured Ehrlichia species, and the taxonomic status of such ehrlichiae has been estimated by core genome-based phylogenetic analysis. However, many uncultured ehrlichiae exist in nature throughout the world, including Japan. This study aimed to conduct a molecular-based taxonomic and ecological characterization of uncultured Ehrlichia species or genotypes from ticks in Japan. We first surveyed 616 Haemaphysalis ticks by p28-PCR screening and analyzed five additional housekeeping genes (16S rRNA, groEL, gltA, ftsZ, and rpoB) from 11 p28-PCR-positive ticks. Phylogenetic analyses of the respective genes showed similar trees but with some differences. Furthermore, we found that V1 in the V1-V9 regions of Ehrlichia 16S rRNA exhibited the greatest variability. From an ecological viewpoint, the amounts of ehrlichiae in a single tick were found to equal approx. 6.3E+3 to 2.0E+6. Subsequently, core-partial-RGGFR-based phylogenetic analysis based on the concatenated sequences of the five housekeeping loci revealed six Ehrlichia genotypes, which included potentially new Ehrlichia species. Thus, our approach contributes to the taxonomic profiling and ecological quantitative analysis of uncultured or unidentified Ehrlichia species or genotypes worldwide.

Verification of the predictive validity for mortality of the SARC-F questionnaire based on a meta-analysis.

BACKGROUND: Although the association between SARC-F questionnaire positivity and mortality has previously been studied, the results are inconsistent. Testing the predictive validity of the SARC-F questionnaire for clinically relevant outcomes of vital prognoses is important. AIM: The objective of this study was to test the predictive validity of SARC-F by conducting a meta-analysis on the association between SARC-F, a screening tool for sarcopenia, and mortality. METHODS: This meta-analysis used the MEDLINE, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, and Google Scholar databases for literature searches. Studies that examined the relationship between SARC-F questionnaire positivity and mortality and reported hazard ratios or odds ratios and 95% confidence intervals were included. A random-effects model was used for statistical analyses, and pooled hazard ratios, pooled odds ratios, and 95% confidence intervals were calculated. RESULTS: Through the literature search, we found five studies (7501 individuals) that met the eligibility criteria for this study. The pooled hazard ratio for SARC-F questionnaire positivity and mortality was 1.87 (95% confidence interval 1.41-2.46; P < 0.001), indicating a significant association. The pooled odds ratio for SARC-F questionnaire positivity and mortality was 1.97 (95% confidence intervals 1.10-3.53; P = 0.02), showing a significant association. CONCLUSIONS: There was a significant association between SARC-F positivity and future mortality, indicating the predictive validity of the SARC-F questionnaire. TRIAL REGISTRATION: Not applicable.

Effects of Antidiabetic Drugs on Muscle Mass in Type 2 Diabetes Mellitus.

BACKGROUND: When considering the administration of glucagon-like peptide-1 receptor agonists (GLP-1RAs), sodium-glucose cotransporter-2 (SGLT2) inhibitors, or metformin, it is important to understand their weight loss effect as well as the degree of muscle loss caused by each drug in clinical practice. OBJECTIVE: To comparatively examine the effects of GLP-1RAs and oral antidiabetic drugs, including SGLT2 inhibitors and metformin, on muscle mass and body weight in patients with type 2 diabetes via a network meta-analysis of randomized controlled trials. METHODS: We included randomized controlled trials evaluating the effects of antidiabetic drugs on muscle mass and body weight. Mean difference (MD) and 95% confidence intervals (CIs) were calculated using a random-effects network meta-analysis. RESULTS: Of the studies identified, 18 randomized controlled trials (1, 363 subjects) satisfied the eligibility criteria. In all studies, the effects of these drugs on fat-free mass (FFM) were evaluated. Therefore, FFM, which is used as an alternative index of muscle mass, was included in the study. Semaglutide (MD: -1.68, 95% CI: -2.84 to -0.52), dapagliflozin (-0.53, -0.93 to -0.13), and canagliflozin (-0.90, -1.73 to -0.07) showed a significant decrease in FFM compared with the placebo. Metformin did not show a significant decrease in FFM compared with the placebo. When compared with the placebo, semaglutide, dapagliflozin, ipragliflozin, and canagliflozin showed a significant weight loss. CONCLUSION: Although semaglutide, dapaglifrozin, and canagliflozin have a large weight loss effect, it is important to pay attention to muscle loss because a decrease in FFM was observed.

Effects of oral antidiabetic drugs and glucagon-like peptide-1 receptor agonists on left ventricular diastolic function in patients with type 2 diabetes mellitus: a systematic review and network meta-analysis.

The present study aimed to compare the effects of oral antidiabetic drugs (OADs) and glucagon-like peptide-1 receptor agonists (GLP-1RAs) on left ventricular diastolic function in patients with type 2 diabetes mellitus using a network meta-analysis of randomized controlled trials (RCTs). Literature searches were conducted on Medline, the Cochrane Controlled Trials Registry, and ClinicalTrials.gov . RCTs that assessed the effects on left ventricular diastolic function of OADs and GLP-1RAs in patients with type 2 diabetes were included. The outcome was the value (E/e') obtained by dividing peak early diastolic transmitral flow velocity (E) by the mitral annular early diastolic velocity (e'). Standardized mean differences (SMD) and 95% confidence intervals (CIs) were calculated from a random-effects network meta-analysis. Eight RCTs (592 patients) identified in a literature search met the eligibility criteria for this study and were included in the network meta-analysis. Compared with placebo, liraglutide was the only drug that caused a significant improvement in left ventricular diastolic function (SMD, - 0.65; 95% CI, - 1.23 to - 0.08). In addition, when the effects on left ventricular diastolic function were evaluated across drugs, liraglutide alone caused a significant improvement in left ventricular diastolic function compared with OADs (sitagliptin, linagliptin, pioglitazone, rosiglitazone, voglibose, and glimepiride). From the perspective of preventing the onset of heart failure, the administration of liraglutide for type 2 diabetes is promising.

Factors associated with social isolation and being homebound among older patients with diabetes: a cross-sectional study.

OBJECTIVE: We aimed at investigating factors associated with social isolation and being homebound in older patients with diabetes. DESIGN: Cross-sectional study. SETTINGS: Those undergoing outpatient treatments at Ise Red Cross Hospital, Mie Prefecture. PARTICIPANTS: Patients with diabetes aged ≥65 years. PRIMARY AND SECONDARY OUTCOME MEASURES: Social isolation was defined as indulging in less than one interaction per week with individuals other than cohabiting family members. We defined homebound as going outside home less than once a day. To identify factors associated with social isolation and being homebound, we performed logistic regression analysis. The dependent variable was social isolation or homebound and independent variables were basic attributes, glycaemic parameters, complications and treatment details. RESULTS: We analysed 558 cases (320 men and 238 women). Among these, 174 (31.2%) were socially isolated; meanwhile, 87 (15.6%) were homebound. The glycoalbumin/haemoglobin A1c ratio (OR 4.52; 95% CI 1.07 to 19.1; p=0.040) and the Tokyo Metropolitan Institute of Gerontology Index of Competence (TMIG-IC) scores (OR 0.72; 95% CI 0.57 to 0.90; p=0.006) had significant associations with social isolation. TMIG-IC scores (OR 0.78; 95% CI 0.66 to 0.92; p=0.003) and insulin use (OR 4.29; 95% CI 1.14 to 16.1; p=0.031) were associated with being homebound. CONCLUSION: In older patients with diabetes, glycaemic fluctuations and insulin use are associated with social isolation and being homebound, respectively. In addition, a decline in higher level functional capacity is a common factor associated with social isolation and being homebound. Thus, it is important to pay attention to social isolation and being homebound when a decline in higher level functional capacity, increased glycaemic fluctuations and insulin use in older patients with diabetes are observed.

Preparation of the Japanese Version of the Diabetes Caregiver Activity and Support Scale and Verification of Its Reliability and Validity.

PURPOSE: The purpose of the study was to adapt and psychometrically evaluate a Japanese language version of the Diabetes Caregiver Activity and Support Scale (D-CASS-J) to be culturally relevant for people with diabetes living in Japan. METHODS: A Japanese translation of the original version of the D-CASS was prepared, corrected, and back-translated. Family caregivers of patients with diabetes mellitus ages ≥65 years who visited the outpatient diabetes clinic of Ise Red Cross Hospital were included. Cronbach's α coefficients were calculated as an assessment of internal consistency. Exploratory factor analyses were performed to verify construct validity. Hierarchical multiple regression analyses were performed using depression as the dependent variable and D-CASS-J and other variables as explanatory variables. Pearson's correlation coefficients between D-CASS-J scores and the support burden scale scores were calculated to verify criterion-related validity. RESULTS: This analysis included 268 subjects. Cronbach's α coefficient was .86. Factor analyses showed the same single-factor structure as the original version of the D-CASS. Hierarchical multiple regression analyses based on the conceptual model demonstrated construct validity. D-CASS-J scores were significantly correlated with support burden scale scores. CONCLUSIONS: For family caregivers of elderly patients with diabetes in Japan, D-CASS-J can be used as a tool to evaluate difficulties experienced while providing support to patients.

Frequency of Social Isolation and Homeboundness and Their Relationships with High-Level Functional Capacity in Elderly Diabetic Patients.

PURPOSE: To determine the frequency of social isolation (hereinafter, isolation) and homeboundness in elderly diabetic patients and to investigate their relationships with high-level functional capacity. PATIENTS AND METHODS: Subjects were diabetic outpatients aged 65 years and older who were visiting the Japanese Red Cross Ise Hospital. Tokyo Metropolitan Institute of Gerontology Index of Competence (TMIG-IC) was used to evaluate high-level functional capacity. Isolation was defined as having less than one interaction per week with someone other than co-habiting family members. Homeboundness was defined as leaving the house less than once a day. Multiple regression analysis was performed with the TMIG-IC score as the dependent variable and isolation and homeboundness as independent variables. RESULTS: Four hundred fifty-one patients were included in the analysis. The frequency of isolation and homeboundness affected 37% and 13.3% of men and 28.9% and 20.6% of women, respectively. The adjusted partial regression coefficient of the TMIG-IC scores of isolated, homebound, and isolated+homebound men was -0.94 [95% confidence interval (CI), -1.68 to -0.21; P = 0.012], -0.27 (95% CI, -1.93 to 1.39; P = 0.746), and -4.03 (95% CI, -5.37 to -2.68; P < 0.001) in relation to that of the non-isolated and non-homebound group as reference. In women, the respective coefficients to the reference were -1.33 (95% CI, -2.93 to 0.25; P = 0.099), -0.65 (95% CI, -2.56 to 1.26; P = 0.501), and -3.01 (95% CI, -4.92 to -1.1; P = 0.002), respectively. CONCLUSION: The frequency of isolation was high in both female and male elderly diabetic patients. In men, there was a significant relationship between isolation and decline in high-level functional capacity. In both men and women, there was a significant relationship between isolation+homeboundness and decline in high-level functional capacity.

Preparation, Reliability, and Validity of a Japanese Version of the "Satisfaction of Treatment among Caregivers of Dependent Type 2 Diabetic Patients" Questionnaire.

The aim of this study was to prepare a Japanese version of the "Satisfaction of Treatment among Caregivers of Dependent Type 2 Diabetic Patients" (STCD2-J) questionnaire, which is used to assess the satisfaction of family caregivers with respect to the treatment for elderly patients with type 2 diabetes mellitus who require support. In addition, the reliability and validity of the STCD2-J questionnaire were analyzed. A Japanese version of the original STCD2 questionnaire was prepared, revised, and back-translated; the back-translated version was sent to the authors of the original version for confirmation. Family caregivers of patients with type 2 diabetes mellitus aged ≥65 years who regularly underwent medical examinations at the diabetes mellitus outpatient clinic of Ise Red Cross Hospital were included. Cronbach's α coefficient was calculated to assess internal consistency. Exploratory factor analyses were performed to assess construct validity, and Pearson's correlation coefficients between STCD2-J score and HbA1c as well as the degree of satisfaction with patients' blood glucose levels, depression, and negative self-assessment of nursing care were calculated to assess criterion-related validity. This study included 208 individuals (55 males and 153 females). Cronbach's α coefficient was 0.88. Factor analyses showed a single-factor structure both with and without rotation. The STCD2-J scores were significantly inversely correlated with HbA1c (r = -0.27, P < 0.001). Significant correlations were observed between the STCD2-J scores and degree of satisfaction with patients' blood glucose levels (r = 0.43, P < 0.001), depression (r = -0.20, P = 0.003), and negative self-assessment of nursing care (r = -0.19, P = 0.004). The reliability and validity of the STCD2-J questionnaire were confirmed. The STCD2-J questionnaire can be used in Japan as a tool to assess the satisfaction of family caregivers with the treatment of elderly patients with type 2 diabetes mellitus requiring support.

Effects of Flash Glucose Monitoring on Dietary Variety, Physical Activity, and Self-Care Behaviors in Patients with Diabetes.

The aim of this study was to evaluate the effects of flash glucose monitoring on dietary variety, physical activity, and self-care behavior in patients with diabetes. This study included outpatients with diabetes using insulin who presented at the Department of Diabetes and Metabolism of the Ise Red Cross Hospital. Before initiating flash glucose monitoring and 12 weeks after its initiation, blood glucose-related parameters were assessed and self-administered questionnaires were completed (Dietary Variety Score (DVS), the International Physical Activity Questionnaire (IPAQ), the Summary of Diabetes Self-Care Activities Measure (SDSCA), and the Diabetes Treatment Satisfaction Questionnaire (DTSQ)) and compared between the two time points. We analyzed 42 patients with type 1 diabetes mellitus and 48 patients with type 2 diabetes mellitus. In patients with type 2 diabetes mellitus, but not type 1 diabetes mellitus, there was an increase in moderate/high category scores for IPAQ (P < 0.001) and for treatment satisfaction reported via DTSQ. Furthermore, in patients with type 2 diabetes mellitus, the glycemic excursion index improved significantly and HbA1c decreased significantly (from 7.7 (1.2) to 7.4 (0.8), P = 0.025). Results showed that standard deviation and mean amplitude of glycemic excursions significantly decreased in patients with type 1 diabetes mellitus (from 71.2 (20.4) to 66.2 (17.5), P = 0.033 and from 124.6 (31.9) to 108.1 (28.4), P < 0.001, respectively). Flash glucose monitoring is a useful tool to improve physical activity in patients with type 2 diabetes.

Recent policies that support clinical application of induced pluripotent stem cell-based regenerative therapies.

In Japan, a research center network consisting of Kyoto University to provide clinical-grade induced Pluripotent Stem Cells (iPSC) and several major research centers to develop iPSC-based regenerative therapies was formed for the clinical application of iPSCs. This network is under the supervision of a newly formed funding agency, the Japan Agency for Medical Research and Development. In parallel, regulatory authorities of Japan, including the Ministry of Health, Labour and Welfare, and Pharmaceuticals and Medical Devices Agency, are trying to accelerate the development process of regenerative medicine products (RMPs) by several initiatives: 1) introduction of a conditional and time-limited approval scheme only applicable to RMPs under the revised Pharmaceuticals and Medical Devices Act, 2) expansion of a consultation program at the early stage of development, 3) establishment of guidelines to support efficient development and review and 4) enhancement of post-market safety measures such as introduction of patient registries and setting user requirements with cooperation from relevant academic societies and experts. Ultimately, the establishment of a global network among iPSC banks that derives clinical-grade iPSCs from human leukocyte antigens homozygous donors has been proposed. In order to share clinical-grade iPSCs globally and to facilitate global development of iPSC-based RMPs, it will be necessary to promote regulatory harmonization and to establish common standards related to iPSCs and differentiated cells based on scientific evidence.