Implementation rate of diabetic self-management education and support for Japanese people with diabetes using the National Database.

People with diabetes are encouraged to receive diabetes self-management education and support (DSMES) appropriately. However, in Japan, the implementation rates of DSMES are not known. DSMES implementation rates were calculated using the National Database of claims data, which included nearly all insurance-covered medical procedures. The study enrolled participants who received regular antidiabetic medications between April 2017 and March 2018. The implementation rates of DSMES-related care were calculated by characteristics, visiting medical facilities and prefectures. In 4,465,513 participants receiving antidiabetic medications (men, 57.8%; insulin use, 14.1%), nutrition guidance (5.6%) was the most frequently provided care type. Insulin users and participants visiting Japan Diabetes Society-certified and large medical institutions had higher implementation rates of nutrition guidance. DSMES-related care might not be provided adequately for Japanese people with diabetes. Further studies are needed to develop an optimal diabetes care system.

A case of type 2 diabetes mellitus with weight gain and worsening of glycemic management after tezepelumab administration for severe bronchial asthma.

Some cases of bronchial asthma are refractory to conventional therapies. As the pathogenesis of bronchial asthma has been clarified, new treatments, such as bronchial thermoplasty and biological drugs, have been developed. Tezepelumab, an anti-thymic stromal lymphopoietin antibody, has been reported to inhibit the exacerbation of severe asthma; however, its adverse effects on glucose metabolism have not yet been reported. We encountered a case of weight gain and worsening glycemic management in a patient with type 2 diabetes and refractory bronchial asthma after the initiation of tezepelumab treatment. It has been reported that the overexpression of thymic stromal lymphopoietin in mice resulted in an enhanced release of free fatty acids from adipose tissues and the liver; thus, the administration of anti-thymic stromal lymphopoietin antibodies in the present case might have caused obesity, fatty liver and lower glucose tolerance.

eGFR slope as a surrogate endpoint for end-stage kidney disease in patients with diabetes and eGFR > 30 mL/min/1.73 m2 in the J-DREAMS cohort.

BACKGROUND: An analysis of European and American individuals revealed that a reduction in estimated glomerular filtration rate (eGFR) slope by 0.5 to 1.0 mL/min/1.73 m2 per year is a surrogate endpoint for end-stage kidney disease (ESKD) in patients with early chronic kidney disease. However, it remains unclear whether this can be extrapolated to Japanese patients. METHODS: Using data from the Japan diabetes comprehensive database project based on an advanced electronic medical record system (J-DREAMS) cohort of 51,483 Japanese patients with diabetes and a baseline eGFR ≥ 30 mL/min/1.73 m2, we examined whether the eGFR slope could be a surrogate indicator for ESKD. The eGFR slope was calculated at 1, 2, and 3 years, and the relationship between each eGFR slope and ESKD risk was estimated using a Cox proportional hazards model to obtain adjusted hazard ratios (aHRs). RESULTS: Slower eGFR decline by 0.75 mL/min/1.73 m2/year reduction in 1-, 2-, and 3-year slopes was associated with lower risk of ESKD (aHR 0.93 (95% confidence interval (CI) 0.92-0.95), 0.84 (95% CI 0.82-0.86), and 0.77 (95% CI 0.73-0.82), respectively); this relationship became more apparent as the slope calculation period increased. Similar results were obtained in subgroup analyses divided by baseline eGFR or baseline urine albumin-creatinine ratio (UACR), with a stronger correlation with ESKD in the baseline eGFR < 60 mL/min/1.73 m2 group and in the baseline UACR < 30 mg/gCre group. CONCLUSION: We found that changes in the eGFR slope were associated with ESKD risk in this population.

Real-world use of glucagon-like peptide-1 receptor agonists in Japanese patients with type 2 diabetes: A retrospective database study (DEFINE-G).

AIMS: To understand glucagon-like peptide-1 receptor agonist (GLP-1RA) use in patients with type 2 diabetes (T2D) in Japan. METHODS: Characteristics of people receiving GLP-1RAs between 2016 and 2020 in the J-DREAMS database were investigated. Changes in HbA1c, body weight (BW), body mass index (BMI), and proportion reaching HbA1c targets were analysed in GLP-1RA-naïve patients 6-24 months after GLP-1RA initiation. RESULTS: The proportion of patients with GLP-1RA prescriptions increased from 3.6% to 9.6% during 2016-2020. Among GLP-1RA-naïve patients (n = 569), HbA1c reduced -|0.6% (95% confidence interval [CI] -0.7, -0.5; -6 mmol/mol [95% CI -7, -5]) 6 months after treatment initiation and stabilised until 24 months (P < 0.001); mean BW and BMI reduced -1.05 kg (95% CI -1.31, -0.80) and -0.43 kg/m2 (95% CI -0.53, -0.32), respectively, at 6 months (P < 0.001). The proportion of GLP-1RA-naïve patients with HbA1c < 7.0% (<53 mmol/mol) and <8.0% (<64 mmol/mol) increased from 16% to 27% and 43% to 65%, respectively, and an HbA1c reduction of ≥1.0% (≥11 mmol/mol) was observed in 33% of patients after 6 months (P < 0.001). CONCLUSIONS: This study shows increased GLP-1RA prescriptions over 5 years. HbA1c and BW reduced 6 months after GLP-1RA initiation in patients with T2D in a Japanese real-world setting.

Different incidences of diabetic retinopathy requiring treatment since diagnosis according to the course of diabetes diagnosis: a retrospective cohort study.

We aimed to estimate the cumulative incidence of treatment-requiring diabetic retinopathy since clinical diagnosis of diabetes based on the course of diagnosis in a retrospective cohort study using Japan's medical claims and health checkup data (JMDC Claims Database; 2009-2020). We included patients whose diabetes was first diagnosed at medical facilities (hospitals/clinics). We grouped them by health checkup participation before diagnosis, health checkup results, and antidiabetic medication promptly after the diagnosis. The incidence of treatment-requiring diabetic retinopathy (laser photocoagulation, intraocular injection, or vitrectomy) was compared among the groups. Of 126,696 patients, those who started an antidiabetic medication promptly after diabetes diagnosis without a recent health checkup faced the highest risk of treatment-requiring diabetic retinopathy (1-/5-year cumulative incidence: 3.1%/6.0%). This increased risk was consistently observed across various analyses, including the Cox proportional hazard model, sensitivity analysis restricting to those with an eye examination, and sensitivity analysis using vitrectomy as the outcome. Among patients with HbA1c ≥ 6.5% at recent health checkups, those who promptly started an antidiabetic medication had a higher risk (1.4%/3.8%) than those who did not (0.7%/2.7%). Taking the information about the course of diabetes diagnosis is important to manage risk stratification for diabetic retinopathy appropriately.

Patient referral flow between physician and ophthalmologist visits for diabetic retinopathy screening among Japanese patients with diabetes: A retrospective cross-sectional cohort study using the National Database.

AIMS/INTRODUCTION: Regular screening for diabetic retinopathy is essential. This study aimed to show the process and current situation of diabetic retinopathy screening prescribed by physicians (internists) and ophthalmologists for Japanese patients with diabetes. MATERIALS AND METHODS: This retrospective cohort study used data from the Japanese National Database of Insurance Claims between April 2016 and March 2018. Ophthalmology visits and fundus examinations are defined using specific medical procedure codes. The proportion of ophthalmology visits for patients with diabetic medication and for fundus examination among those who visited ophthalmologists was calculated in the fiscal year 2017. A modified Poisson regression analysis was carried out to identify factors associated with retinopathy screening. Similarly, quality indicators by prefectures were also calculated. RESULTS: Among 4,408,585 patients receiving diabetic medications (57.8% men, 14.1% insulin use), 47.4% visited the ophthalmology department and 96.9% of those underwent fundus examination. Regression analysis showed that female sex, older age, insulin use, medical facilities with Japan Diabetes Society certification and large medical facilities were predictors of fundus examination. By prefecture, the ophthalmology consultation rate and the fundus examination ranged 38.5-51.0% and 92.1-98.7%, respectively. CONCLUSIONS: Less than half of the patients who were prescribed antidiabetic medication by their physicians visited an ophthalmologist. However, most of the patients who visited an ophthalmologist had a fundus examination carried out. A similar tendency was noted for each prefecture. It is essential to reaffirm the necessity of recommending ophthalmologic examinations to physicians and healthcare professionals who care for patients with diabetes.

Impact of COVID-19 pandemic on behavioral changes and glycemic control and a survey of telemedicine in patients with diabetes: A multicenter retrospective observational study.

AIMS/INTRODUCTION: To investigate whether the COVID-19 pandemic affected behavioral changes and glycemic control in patients with diabetes and to conduct a survey of telemedicine during the pandemic. MATERIALS AND METHODS: In this retrospective study, a total of 2,348 patients were included from 15 medical facilities. Patients were surveyed about their lifestyle changes and attitudes toward telemedicine. Hemoglobin A1c (HbA1c) levels were compared among before (from June 1 to August 31, 2019) and in the first (from June 1 to August 31, 2020) and in the second (from June 1 to August 31, 2021) year of the pandemic. A survey of physician attitudes toward telemedicine was also conducted. RESULTS: The HbA1c levels were comparable between 2019 (7.27 ± 0.97%), 2020 (7.28 ± 0.92%), and 2021 (7.25 ± 0.94%) without statistical difference between each of those 3 years. Prescriptions for diabetes medications increased during the period. The frequency of eating out was drastically reduced (51.7% in 2019; 30.1% in 2020), and physical activity decreased during the pandemic (48.1% in 2019; 41.4% in 2020; 43.3% in 2021). Both patients and physicians cited increased convenience and reduced risk of infection as their expectations for telemedicine, while the lack of physician-patient interaction and the impossibility of consultation and examination were cited as sources of concern. CONCLUSIONS: Our data suggest that glycemic control did not deteriorate during the COVID-19 pandemic with appropriate intensification of diabetes treatment in patients with diabetes who continued to attend specialized diabetes care facilities, and that patients and physicians shared the same expectations and concerns about telemedicine.

Proportion of subsequent clinic visits among persons without regular clinic visits who were screened as having hyperglycemia: A retrospective cohort study.

AIMS/INTRODUCTION: We aimed to examine the proportion of subsequent clinic visits for persons screened as having hyperglycemia based on glycated hemoglobin (HbA1c) levels at screening and the presence/absence of hyperglycemia at health checkups before 1 year of the screening among those without previous diabetes-related medical care and attending regular clinic visits. MATERIALS AND METHODS: This retrospective cohort study used the 2016-2020 data of Japanese health checkups and claims. The study analyzed 8,834 adult beneficiaries aged 20-59 years without regular clinic visits who had never received diabetes-related medical care and whose recent health checkups showed hyperglycemia. The rates of 6-month subsequent clinic visits after health checkups were evaluated according to HbA1c levels and the presence/absence of hyperglycemia at checkups a year before. RESULTS: The overall clinic visit rate was 21.0%. The HbA1c-specific rates were 17.0, 26.7, 25.4 and 28.4% for <7.0, 7.0-7.4, 7.5-7.9 and ≥8.0% (64 mmol/mol), respectively. Persons with hyperglycemia at a previous screening had lower clinic visit rates than those without hyperglycemia, particularly in the HbA1c category of <7.0% (14.4% vs 18.5%; P < 0.001) and 7.0-7.4% (23.6% vs 35.1%; P < 0.001). CONCLUSIONS: The overall rate of subsequent clinic visits among those without previous regular clinic visits was <30%, including for participants with HbA1c ≥8.0%. Persons with previously detected hyperglycemia had lower clinic visit rates, despite requiring more health counseling. Our findings might be useful for designing a tailored approach to encourage high-risk individuals to seek diabetes care through clinic visits.

False-positive 123I-metaiodobenzylguanidine scintigraphy in a patient with a gastrointestinal stromal tumor presenting as a left adrenal incidentaloma.

Summary: A 47-year-old man was diagnosed with a left adrenal incidentaloma at 40 years of age. The tumor had irregular margins and grew from 18 mm to 30 mm in maximum diameter over 7 years. On computed tomography scan, the mass appeared to localize within the tip of the lateral limb of the left adrenal gland, and between the left adrenal gland and the posterior wall of the stomach. The plasma corticotropin and cortisol concentrations and the 24-h urine fractionated metanephrine levels were normal. 123I-metaiodobenzylguanidine scintigraphy showed tumor avidity consistent with a hormonally inactive pheochromocytoma. A laparoscopic left adrenalectomy was performed; however, no tumor was present in the resected specimen. Abdominal computed tomography postoperatively showed that the tumor remained intact and appeared to connect to the posterior wall of the stomach. A laparotomy was performed and the tumor was removed. The tumor was localized to the intraperitoneal space and isolated from the posterior wall of the stomach. The pathological diagnosis was a gastrointestinal stromal tumor. Clinicians need to be aware of the limitations of diagnostic imaging studies in diagnosing non-functioning adrenal incidentalomas, which require a pathological analysis for the final diagnosis. Moreover, clinicians need to provide patients with sufficient informed consent when deciding on treatment strategies. Learning points: Anatomic structures and tumors that develop in neighboring tissues to the adrenal glands may be confused with primary adrenal tumors. 123I- metaiodobenzylguanidine (MIBG) scintigraphy is specific for diagnosing pheochromocytomas and paragangliomas; however, it has been reported that 123I-MIBG may accumulate in neuroendocrine tumors as well as other tumors. Clinicians should recognize the limitations of imaging studies and the uncertainty of an imaging-based preoperative diagnosis.

Clinical significance of tumor markers in patients with type 2 diabetes: a retrospective observational study.

Aim: To cross-sectionally and longitudinally investigate the association between tumor markers (Cancer embryonic antigen (CEA) Carbohydrate antigen 19-9 (CA19-9)) and malignancies in type 2 diabetes patients without evidence of malignancy. Materials and Methods: The study included 707 patients admitted for the treatment of diabetes from 1 August 2010 to 1 September 2018. Serum CEA and CA19-9 levels were measured for screening of malignancies at admission. Abdominal ultrasonography, computed tomography, and endoscopy were performed for close examination. The percentage of patients diagnosed with malignancy was calculated, and among those without malignancy, the incidence of malignancies was examined after discharge. Results: A total of 26 patients (3.7%) were newly diagnosed with malignancy during hospitalization. The optimal cut-off value of CEA and CA19-9 by receiver operating characteristic analysis was 5.0 ng/mL and 75 U/mL, and their positive predictive values (PPV) were 8.7% and 22.5%, respectively. The addition of CA19-9 to age, smoking status, body mass index, and glycated hemoglobin significantly improved classification performance for malignancy using net reclassification improvement (0.682, 95% CI 0.256-1.107) and integrated discrimination improvement (0.150, 95% CI 0.007-0.294). Among 681 patients without malignancies during hospitalization, 30 patients (4.4%) developed malignancies during an average follow-up of 3.9 years. CA19-9 (hazard ratio: 1.005, 95% CI: 1.003-1.008) was associated with the development of malignancies. Conclusions: PPV of serum CEA and CA19-9 for detecting malignancy was high in type 2 diabetes patients with poor glycemic control. Measuring CA19-9 was found to be valuable to cross-sectionally and longitudinally detect malignancies. Supplementary Information: The online version contains supplementary material available at 10.1007/s13340-022-00594-x.

New-onset type 1 diabetes and Graves' disease after antiretroviral therapy in a patient with human immunodeficiency virus infection.

Patients with human immunodeficiency virus (HIV) infection receiving antiretroviral therapy can develop autoimmune diseases, referred to as immune-inflammatory reconstitution syndrome. Nevertheless, only a few reports on the onset of type 1 diabetes as immune-inflammatory reconstitution syndrome are available. A 40-year-old Japanese man with HIV infection was initiated with antiretroviral therapy at the age of 29 years. He developed Graves' disease at 35 years and diabetes, with a hemoglobin A1c of 6.5%, and maintained insulin secretion at 38 years. His antiglutamic acid decarboxylase antibody level was >2,000 U/mL, and he was diagnosed with slowly progressive type 1 diabetes. At the age of 40 years, he was admitted to our hospital with diabetic ketosis. We retrospectively assayed his stored plasma samples for thyroid-stimulating hormone receptor antibody and antiglutamic acid decarboxylase antibody, which showed positive conversion after initiating antiretroviral therapy, suggesting that Graves' disease and type 1 diabetes developed as a probable result of immune-inflammatory reconstitution syndrome.

Association of acute-to-chronic glycemic ratio and outcomes in patients with COVID-19 and undiagnosed diabetes mellitus: A retrospective nationwide cohort study.

AIMS/INTRODUCTION: To assess the association of undiagnosed diabetes mellitus and its acute-to-chronic glycemic ratio with clinical outcome in patients hospitalized with coronavirus disease 2019 (COVID-19) using a large-scale nationwide registry in Japan. MATERIALS AND METHODS: Overall, 4,747 patients were included between July 2021 and January 2022. We evaluated blood glucose and glycated hemoglobin levels at admission, and calculated the acute-to-chronic glycemic ratio for each non-diabetes mellitus, undiagnosed diabetes mellitus and pre-existing diabetes mellitus group. The primary composite outcome comprised in-hospital mortality, invasive mechanical ventilation, extracorporeal membrane oxygenation support, intensive care unit admission and transfer to a more advanced medical facility. RESULTS: Compared with the non-diabetes mellitus group, the undiagnosed diabetes mellitus group was significantly associated with a worse COVID-19 outcome (odds ratio 2.18, 95% confidence interval 1.50-3.18). In patients with undiagnosed diabetes mellitus, the 3rd tertile of the acute-to-chronic glycemic ratio was linked with a worse COVID-19 outcome compared with the 1st tertile (odds ratio 3.33, 95% confidence interval 1.43-7.77), whereas glycated hemoglobin levels were not; among patients with pre-existing diabetes mellitus, glycated hemoglobin levels were linked with a worse outcome. CONCLUSIONS: Among patients with undiagnosed diabetes mellitus with COVID-19, the magnitude of elevation of blood glucose from chronic to acute levels is associated with worse outcomes.

Extensive gut virome variation and its associations with host and environmental factors in a population-level cohort.

Indigenous bacteriophage communities (virome) in the human gut have a huge impact on the structure and function of gut bacterial communities (bacteriome), but virome variation at a population scale is not fully investigated yet. Here, we analyse the gut dsDNA virome in the Japanese 4D cohort of 4198 deeply phenotyped individuals. By assembling metagenomic reads, we discover thousands of high-quality phage genomes including previously uncharacterised phage clades with different bacterial hosts than known major ones. The distribution of host bacteria is a strong determinant for the distribution of phages in the gut, and virome diversity is highly correlated with anti-viral defence mechanisms of the bacteriome, such as CRISPR-Cas and restriction-modification systems. We identify 97 various intrinsic/extrinsic factors that significantly affect the virome structure, including age, sex, lifestyle, and diet, most of which showed consistent associations with both phages and their predicted bacterial hosts. Among the metadata categories, disease and medication have the strongest effects on the virome structure. Overall, these results present a basis to understand the symbiotic communities of bacteria and their viruses in the human gut, which will facilitate the medical and industrial applications of indigenous viruses.

The patient-centered diabetes management during the COVID-19 pandemic.

Since December 2019, in the fight against the coronavirus disease 2019 (COVID-19) pandemic, we observed that glycemic control in people with diabetes is easily affected by lifestyle changes. To maintain a good health condition, a patient-centered approach with mental support and close monitoring is required. For these, telemedicine and online continuous glucose monitoring (CGM), are effective systems. Therefore, based on our experience during the two-year period, we reviewed the literature for appropriate actions required for the management of diabetes to prevent COVID-19 infection and avoid unfavorable outcomes in COVID-19 cases. Once infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), there is a high risk of a poor prognosis in patients with diabetes. Glucocorticoid therapy in severe COVID-19 cases leads to further hyperglycemia. Since good glycemic control has been shown to improve outcomes, strict glycemic control using CGM is recommended. Using CGM data, insulin can be adequately titrated without causing hypoglycemia, and remote data monitoring can reduce the risk of infection for health care professionals, by reducing the frequency of patient contact. Among patients with COVID-19, some are found to have newly-diagnosed diabetes at admission. Those newly diagnosed patients present with a higher risk of poor prognosis compared to those with pre-existing diabetes. Therefore, glycemic status should be evaluated in all patients with COVID-19 admitted to hospitals.

Population-level Metagenomics Uncovers Distinct Effects of Multiple Medications on the Human Gut Microbiome.

BACKGROUND & AIMS: Medication is a major determinant of human gut microbiome structure, and its overuse increases the risks of morbidity and mortality. However, effects of certain commonly prescribed drugs and multiple medications on the gut microbiome are still underinvestigated. METHODS: We performed shotgun metagenomic analysis of fecal samples from 4198 individuals in the Japanese 4D (Disease, Drug, Diet, Daily life) microbiome project. A total of 759 drugs were profiled, and other metadata, such as anthropometrics, lifestyles, diets, physical activities, and diseases, were prospectively collected. Second fecal samples were collected from 243 individuals to assess the effects of drug initiation and discontinuation on the microbiome. RESULTS: We found that numerous drugs across different treatment categories influence the microbiome; more than 70% of the drugs we profiled had not been examined before. Individuals exposed to multiple drugs, polypharmacy, showed distinct gut microbiome structures harboring significantly more abundant upper gastrointestinal species and several nosocomial pathobionts due to additive drug effects. Polypharmacy was also associated with microbial functions, including the reduction of short-chain fatty acid metabolism and increased bacterial stress responses. Even nonantibiotic drugs were significantly correlated with an increased antimicrobial resistance potential through polypharmacy. Notably, a 2-time points dataset revealed the alteration and recovery of the microbiome in response to drug initiation and cessation, corroborating the observed drug-microbe associations in the cross-sectional cohort. CONCLUSION: Our large-scale metagenomics unravels extensive and disruptive impacts of individual and multiple drug exposures on the human gut microbiome, providing a drug-microbe catalog as a basis for a deeper understanding of the role of the microbiome in drug efficacy and toxicity.

Influence of the COVID-19 Pandemic on Overall Physician Visits and Telemedicine Use Among Patients With Type 1 or Type 2 Diabetes in Japan.

BACKGROUND: Regular visits with healthcare professionals are important for preventing serious complications in patients with diabetes. The purpose of this retrospective cohort study was to clarify whether there was any suppression of physician visits among patients with diabetes during the spread of the novel coronavirus 2019 (COVID-19) in Japan and to assess whether telemedicine contributed to continued visits. METHODS: We used the JMDC Claims database, which contains the monthly claims reported from July 2018 to May 2020 and included 4,595 (type 1) and 123,686 (type 2) patients with diabetes. Using a difference-in-differences analysis, we estimated the changes in the monthly numbers of physician visits or telemedicine per 100 patients in April and May 2020 compared with the same months in 2019. RESULTS: For patients with type 1 diabetes, the estimates for total overall physician visits were -2.53 (95% confidence interval [CI], -4.63 to 0.44) in April and -8.80 (95% CI, -10.85 to -6.74) in May; those for telemedicine visits were 0.71 (95% CI, 0.47-0.96) in April and 0.54 (95% CI, 0.32-0.76) in May. For patients with type 2 diabetes, the estimates for overall physician visits were -2.50 (95% CI, -2.95 to -2.04) in April and -3.74 (95% CI, -4.16 to -3.32) in May; those for telemedicine visits were 1.13 (95% CI, 1.07-1.20) in April and 0.73 (95% CI, 0.68-0.78) in May. CONCLUSION: The COVID-19 pandemic was associated with suppression of physician visits and a slight increase in the utilization of telemedicine among patients with diabetes during April and May 2020.

Incidence of interventions for diabetic retinopathy and serious lower-limb complications and its related factors in patients with type 2 diabetes using a real-world large claims database.

Aims: To examine the incidence of interventions for diabetic retinopathy and serious limb complications and to elucidate the patient attributes related to the incidence of each intervention based on real-world claims data from Japan. Materials and methods: A retrospective longitudinal study design involving a 9 year (2009-2018) claims database obtained from the JMDC Inc. Patients with type 2 diabetes aged 20-74 years taking antidiabetic medications were divided into two groups: "patients with newly initiated antidiabetic medication" (Group 1, n = 47,201) and "patients with continuing antidiabetic medication" (Group 2, n = 82,332). The incidence rate for each intervention was analyzed. We also divided Group 1 into the former and latter periods and investigated temporal changes. Results: The incidences of the first retinopathy intervention (laser photocoagulation, vitrectomy, or intraocular injection), vitrectomy, and lower-limb amputations in Group 1 were 7.46, 2.37, and 0.31 /1000 person-years, respectively. Those in Group 2 were about 1.2-1.5 times higher. Older age, insulin use, and being dependents rather than insured persons were associated with a higher incidence in both groups after adjustment. While the incidence of the interventions for retinopathy hardly changed during the observation period, that of lower-limb amputations decreased by 40%, with less statistical significance (p = 0.11). Conclusions: We showed the incidences of the first retinopathy interventions and lower-limb amputations and their secular trends in patients with diabetes, stratified by whether the antidiabetic medication was newly initiated or not. Older age, insulin use, and being dependents were risk factors of these interventions for diabetic complications. Supplementary Information: The online version contains supplementary material available at 10.1007/s13340-021-00566-7.

Lack of Awareness of Own Hypercholesterolemia or Statin Medication among Adult Statin Users in the United States: Prevalence and Patient Characteristics in a Repeated Cross-Sectional Study.

Knowledge of a patient's medication is important in treating hyperlipidemia; however, little is known about this in practice. We carried out a repeated cross-sectional study to analyze a nationally representative sample of US adult statin users from the National Health and Nutrition Examination Survey, 1999−2018. We used medication bottle checks and self-reported survey data to estimate the percentage of individuals who are unaware of their hypercholesterolemia, type of medication, or how to take their medication. We used logistic regression to examine their characteristics. We included 8798 statin users; however, 17.6% were unaware of their hypercholesterolemia or statin use. Being older, male, non-Hispanic Black, taking a wider range of prescription medications, and previous diabetes or cardiovascular disease diagnosis were associated with lack of awareness. Serum low-density lipoprotein cholesterol level was lower among those lacking awareness (85.5 vs. 100.7 mg/dL; p < 0.001). Many of those unaware of drug type had been given little information about statins; 34.0% had no diagnosis of diabetes or cardiovascular disease, and of these, 27.1% were >75 years old. Roughly one in six lacked awareness, but no association was found with hypercholesterolemia control. Healthcare providers should ascertain a patient's understanding and consider the risks and benefits of statin medication.

Metagenomic Identification of Microbial Signatures Predicting Pancreatic Cancer From a Multinational Study.

BACKGROUND & AIMS: To identify gut and oral metagenomic signatures that accurately predict pancreatic ductal carcinoma (PDAC) and to validate these signatures in independent cohorts. METHODS: We conducted a multinational study and performed shotgun metagenomic analysis of fecal and salivary samples collected from patients with treatment-naïve PDAC and non-PDAC controls in Japan, Spain, and Germany. Taxonomic and functional profiles of the microbiomes were characterized, and metagenomic classifiers to predict PDAC were constructed and validated in external datasets. RESULTS: Comparative metagenomics revealed dysbiosis of both the gut and oral microbiomes and identified 30 gut and 18 oral species significantly associated with PDAC in the Japanese cohort. These microbial signatures achieved high area under the curve values of 0.78 to 0.82. The prediction model trained on the Japanese gut microbiome also had high predictive ability in Spanish and German cohorts, with respective area under the curve values of 0.74 and 0.83, validating its high confidence and versatility for PDAC prediction. Significant enrichments of Streptococcus and Veillonella spp and a depletion of Faecalibacterium prausnitzii were common gut signatures for PDAC in all the 3 cohorts. Prospective follow-up data revealed that patients with certain gut and oral microbial species were at higher risk of PDAC-related mortality. Finally, 58 bacteriophages that could infect microbial species consistently enriched in patients with PDAC across the 3 countries were identified. CONCLUSIONS: Metagenomics targeting the gut and oral microbiomes can provide a powerful source of biomarkers for identifying individuals with PDAC and their prognoses. The identification of shared gut microbial signatures for PDAC in Asian and European cohorts indicates the presence of robust and global gut microbial biomarkers.

Understanding the quality of diabetes care in Japan: a systematic review of the literature.

BACKGROUND: Among chronic diseases, diabetes is a frequent focus of performance measurement. Disease-specific indicators based on evidence-based clinical guidelines have been used to evaluate the quality of care. There are worldwide efforts to improve the quality of diabetes care. Measuring the gap is an essential first step toward improving the quality of care. METHODS: In order to better understand the status of quality of diabetes care in Japan, a country with a universal healthcare system, we performed a literature search looking for all studies reporting on quality indicators. In this review, we summarized the studies that have looked at the status of the quality of diabetes care over the last decade. RESULTS: There were a total of 6 studies that reported on process including HbA1c, blood pressure, lipid screening, retinopathy and nephropathy screening and intermediate clinical measures which included percentages of patients reaching targets for HbA1c, blood pressure and LDL-C. Overall, the process measures continue to improve, however the clinical intermediate outcome measures remain suboptimal. CONCLUSION: Despite the improvement in diabetes related process measures, there is limited data on clinical measures. It is necessary to shed more light on the assessment of the quality of diabetes care.