Diabetes Therapy最新文献

Introduction: Time in tight range (TITR) is an emerging and valuable metric for assessing normoglycemia. The latest advancement in automated insulin delivery (AID) systems, the advanced hybrid closed-loop (AHCL) systems, are particularly noteworthy for managing type 1 diabetes (T1D) and enhancing glycemic control.

Methods: In a real-world clinical setting, we carried out a retrospective evaluation of TITR in 42 adult subjects with T1D using the AHCL Minimed™ 780G system over a 12-month period.

Results: Within just 14 days of activating the automatic mode, the AHCL Minimed™ 780G system showed rapid improvement in TITR, and in the other continuous glucose monitoring (CGM) metrics. This improvement persisted over 12 months, achieving the proposed 45-50% range for effective glycemic control.

Conclusion: The AHCL Minimed™ 780G system significantly enhances TITR, demonstrating continuous improvement throughout a 12-month follow-up period.

Introduction: A sizeable minority of commercially available blood glucose monitoring (BGM) systems fail to satisfy regulatory accuracy requirements, such as ISO 15197:2013, after approval. This study assessed whether the BGMs tested could consistently meet these ISO requirements by investigating their accuracy in a non-standardized setting.

Methods: In this 18-month post-market performance study, using the ISO criteria, healthcare professionals tested the accuracy of four CE-marked BGM systems (Roche Diabetes Care, Mannheim, Germany) on European adults with diabetes mellitus. ISO criteria included 95% of blood glucose (BG) values being within ± 15 mg/dl of a reference measurement for BG < 100 mg/dl or ± 15% for BG ≥ 100 mg/dl and, in the Parkes Consensus Error grid for type 1 diabetes comparing capillary BGM measurements versus reference method, 99% of BG values falling within zone A (no effect on clinical action or outcome) and zone B (altered clinical action with little or no effect on clinical outcome).

Results: BGM readings were obtained from 1650 participants, and the number of readings per BGM system was between 1712 and 2376. The percentage of BGM readings that fell within ISO 15197:2013 limits ranged from 99.4 to 99.9%. For all meter types, 100% of data points fell within zone A or zone B, and most data points for each meter (≥ 99.9%) were in zone A.

Conclusion: All four CE-marked BGM models showed results within the accuracy limits defined by ISO 15197 in a non-standardized setting and thus consistently met regulatory accuracy requirements.

Introduction: The safety and efficacy of liraglutide as a weight loss intervention in individuals who remain obese within 1 year post-metabolic surgery remain unclear. This study aimed to evaluate the effects and safety of liraglutide (1.8 mg) in patients with persistent obesity at 6 months postoperatively.

Methods: This retrospective cohort study included 61 patients who remained obese (body mass index [BMI] ≥ 28.0 kg/m²) at 6 months postoperatively. Among these patients, 27 were treated with 1.8 mg of liraglutide for 12 weeks, whereas 34 served as controls. The primary endpoint was the change in total weight loss (%TWL) after 24 weeks. Changes in weight, BMI, complications, and adverse events were also assessed.

Results: The liraglutide group showed a greater reduction in %TWL than the control group (11.6% ± 1.1% vs. 4.9% ± 1.0%), with an estimated treatment difference of 6.6% (95% confidence interval [CI], 3.7-9.6%, P < 0.01). The adjusted mean differences in the reduction of weight and BMI between the liraglutide and control groups were - 6.2 kg (95% CI - 8.9 to - 3.4, P < 0.01) and - 3.0 kg/m² (95% CI - 4.2 to - 1.7, P < 0.01), respectively. The liraglutide group exhibited increased rates of remission in non-alcoholic fatty liver disease and hypertension. No serious adverse reactions were observed.

Conclusions: For patients who remained obese at 6 months postoperatively, 12-week liraglutide treatment resulted in increased weight loss, improved metabolic control, and high rate of remission for obesity-related metabolic diseases after 24 weeks. Earlier and more timely adjuvant weight loss medication intervention based on BMI within 1 year postoperatively may enhance weight loss after metabolic surgery. Graphical abstract available for this article.

Introduction: This survey assessed the perspectives of physicians, people with diabetes (PWD), and caregivers in Japan regarding initiation barriers and treatment burden associated with insulin therapy, and expectations for new insulin therapies.

Methods: An online survey, conducted May-June 2023, was completed by physicians (n = 411), PWD (type 1 diabetes, n = 108; type 2 diabetes [T2D]: insulin-naive, n = 114; insulin-treated, n = 108), and caregivers (family members, n = 107; nurses, n = 117; care workers, n = 104). Agreement with statements regarding initiation barriers, current feelings, and burden of insulin therapy was assessed. Physicians' views on ideal glycated hemoglobin (HbA_1c) levels and actual levels in PWD at insulin initiation were captured.

Results: Most PWD agreed with the statements "I don't want to be bothered with doing injections" (77.8-92.1%) and "I don't want to inject myself for the rest of my life" (78.7-91.2%). Physicians also considered these factors to be of high importance for PWD; however, physician and PWD (insulin-naive T2D) responses were significantly different for 11 statements. The greatest underestimation by physicians was for the statement "my family will be worried" (41.8% vs. 66.7%), whereas social factors (e.g., "my friendships may suffer," "if I take insulin I will be discriminated against") were overestimated by physicians (49.1% vs. 33.3% and 46.5% vs. 24.6%, respectively). Although > 70% of physicians considered HbA_1c < 9.0% (< 75 mmol/mol) ideal for insulin initiation, only ~ 30% of PWD started insulin at HbA_1c < 9.0% (< 75 mmol/mol). Nurses rated the burden of assisting with insulin injections significantly lower than family members or care workers. Respondents agreed the need for less frequent injections and improved glycemic control were important attributes expected from future insulin therapies.

Conclusion: Differences in perceptions between physicians and PWD in Japan regarding insulin therapy persist, but this gap may be narrowing. Both groups agreed that future insulin therapies should be simpler and provide better glycemic control.

The growing prevalence of overweight/obesity, the persistence of inadequate glycemic control among the majority of affected individuals, and the still unacceptably high risk of cardiovascular morbidity and mortality among population with type 1 diabetes mellitus (T1D), impose an urgent need for the introduction of non-insulin glucose-lowering agents in the therapeutic armamentarium. Given that their antihyperglycemic mechanism of action is independent of endogenous insulin secretion and that the observed cardio-renal benefits are unrelated to their glucose-lowering properties, one can speculate that the use of sodium-glucose co-transporter-2 inhibitors (SGLT2is) could provide benefits in T1D, similar to the ones observed among individuals with type 2 diabetes mellitus, chronic kidney disease (CKD), and heart failure. Available evidence from randomized controlled trials suggests that treatment with SGLT2is as adjunct to insulin in T1D results in modest reductions in glycated hemoglobin and body weight. Additionally, SGLT2is ameliorate albuminuria, and thus delay or prevent the development of CKD in T1D. However, use of SGLT2is is associated with an increased risk of diabetic ketoacidosis (DKA) in T1D. This commentary aims at providing a framework for practical recommendations regarding the potential use of SGLT2is in adults with T1D, based on the individual's risk level for DKA development, the presence of inadequate glycemic control and related cardio-renal complications.

Introduction: Microvascular and macrovascular complications in type 1 diabetes (T1D) may be linked to endothelial stress due to glycaemic variability. Continuous glucose monitoring systems (CGMs) provide new opportunities to quantify this variability, utilising the amplitude of glucose change summated over time. The aim of this study was to examine whether this determination of glucose variability (GV) is associated with microvascular clinical sequelae.

Methods: Continuous glucose monitoring values were downloaded for 89 type 1 diabetes mellitus (T1D) individuals for up to 18 months from 2021 to 2023. Data for patient demographics was also taken from the patient record which included Sex, Date of Birth, and Date of Diagnosis. The recorded laboratory glycated haemoglobin (HbA1c) test results were also recorded. The glucose management index (GMI) was calculated from average glucose readings for 18 months using the formula GMI (%) = (0.82-(Average glucose/100)). This was then adjusted to give GMI (mmol/mol) = 10.929 * (GMI (%) - 2.15). Average Glucose Fluctuation (AGF) was calculated by adding up the total absolute change value between all recorded results over 18 months and dividing by the number of results minus one. The % Above Critical Threshold (ACT) was calculated by summing the total number of occurrences for each result value. A cumulative 95% limit was then applied to identify the glucose value that only 5% of results exceeded in the overall population. Using this value, we estimated the percentage of total tests that were above the Critical Threshold (ACT).

Results: Results for the 89 individuals (44 men and 45 women) were analysed over 18 months. The mean age of participants was 43 years and the mean duration of diabetes was 18 years. A total of 3.22 million readings were analysed, giving an average of 10.3 mmol/L blood glucose. Those with the largest change in glucose from reading to reading, summated over time, showed the greatest change in eGFR of 3.12 ml/min/1.73 m² (p = 0.007). People with a higher proportion of glucose readings > 18 mmol/L showed a fall in eGFR of 2.8 ml/min/1.73 m² (p = 0.009) and experienced higher rates of sight-threatening retinopathy (44% of these individuals) (p = 0.01) as did 39% of individuals in the highest tertile of glucose levels (p = 0.008).

Conclusion: Those individuals with T1D in the highest tertile of reading-to-reading glucose change showed the greatest change in eGFR. Those with a higher proportion of glucose readings > 18 mmol/L also showed a fall in eGFR and experienced higher rates of sight-threatening retinopathy, as did people with higher mean glucose. Discussions with T1D individuals could reflect on how the percentage recorded glucose above a critical level and degree of change in glucose are important in avoiding future tissue complications.

Introduction: Imeglimin is a first-in-class, novel, oral glucose-lowering agent for the treatment of type 2 diabetes mellitus. The efficacy and safety of imeglimin as an antidiabetic agent have been investigated in clinical trials. However, its metabolic effects in humans have not yet been fully elucidated.

Methods: The Study to InveStIgate the Metabolic Action of Imeglimin on patients with type 2 diabetes mellitus (SISIMAI) is a single-arm intervention study. In this study, we have recruited 25 patients with type 2 diabetes to receive 2000 mg/day imeglimin for 20 weeks. We perform a 75-g oral glucose tolerance test (OGTT) with double-glucose tracers, a two-step hyperinsulinemic-euglycemic clamp with glucose tracer, ectopic fat measurement by proton magnetic resonance spectroscopy, visceral/subcutaneous fat area measurement by magnetic resonance imaging, muscle biopsy, and evaluation of fitness level by cycle ergometer before and after imeglimin administration.

Planned outcomes: The primary outcome is the change in area under the curve of glucose levels during the OGTT after 20 weeks of imeglimin treatment. We also calculate the endogenous glucose production, rate of oral glucose appearance, and rate of glucose disappearance from the data during the 75-g OGTT and compare them between pre- and post-treatment. Additionally, we will compare other parameters, such as the changes in tissue-specific insulin sensitivity, ectopic fat accumulation, visceral/subcutaneous fat area accumulation, and fitness level between each point. This is the first study to investigate the organ-specific metabolic action of imeglimin in patients with type 2 diabetes mellitus using the 75-g OGTT with the double tracer method. The results of this study are expected to provide useful information for drug selection based on the pathophysiology of individual patients with type 2 diabetes mellitus.

Trial registration: jRCTs031210600.

Peripheral neuropathy (PN) significantly impacts the quality of life, causing substantial morbidity and increased mortality, as well as escalating healthcare costs. While PN can have various causes, the most common form, diabetic peripheral neuropathy, poses considerable risks for potential complications. Diabetic peripheral neuropathy (DPN) affects over 50% of people with prediabetes and diabetes. Despite its prevalence, a global gap in diagnosis and management exists, exacerbated by the COVID-19 pandemic. This expert consensus was formulated through a comprehensive evaluation by a panel of experts, informed by a focused literature review, aiming to establish a clinically robust approach to diagnosing and managing pre- and diabetic PN with the early utilization of neurotropic B vitamins. This document offers a consensus perspective on the existing challenges in diagnosing and managing PN, focusing on DPN. The expert panel proposes measures to address this underdiagnosed burden, highlighting the importance of early intervention through innovative screening methods, integrated care approaches, and therapeutic strategies. The document advocates for increased awareness, targeted campaigns, and proactive care strategies to bridge gaps in the patient care of individuals with diabetes, emphasizing the importance of early detection and timely management to improve overall health outcomes. Specific recommendations include incorporating simplified questionnaires and innovative screening methods into routine care, prioritizing neurotropic B vitamin supplementation, optimizing glucagon-like peptide 1 (GLP-1) receptor agonist treatments, and adopting a holistic approach to neuropathy management. The consensus underscores the urgent need to address the underdiagnosis and undertreatment of PN, offering practical measures to enhance early detection and improve health outcomes for individuals with DPN.

Introduction: When switching from premixed insulin to insulin degludec/aspart (IDegAsp), IDegAsp usually starts at the same dose as the premixed insulin according to limited clinical experience or at a dose according to clinician discretion. The dose of insulin degludec used in the real world after switching has been poorly investigated.

Methods: A retrospective analysis was conducted on patients with type 2 diabetes who switched from premixed insulin to IDegAsp from October 2016 to December 2023. Repeated measures analysis of variance was used to compare changes in insulin dose, glycated hemoglobin (HbA1c), fasting blood glucose (FBG), and postprandial blood glucose (PBG) before and after switching.

Results: Sixty-six patients with prior low-ratio premixed insulin and 22 with prior mid-ratio premixed insulin were included. Among the low-ratio insulin users, the total daily dose of insulin degludec (IDeg) decreased by 21.43% and 19.05% at 3 and 6 months, respectively, after switching, compared with prior basal insulin dose (both p < 0.001). Conversely, among mid-ratio insulin users, the IDeg daily dose increased by 10.71% and 32.14% at 3 and 6 months, respectively, after switching, compared with prior basal insulin dose (both p < 0.001). In all patients, HbA1c levels decreased by 0.70%, FBG decreased by 1.00 mmol/l, and PBG decreased by 1.61 mmol/l after 6 months of switching (all p < 0.05); the total daily insulin dose and injection frequency significantly decreased after switching (both p < 0.05); age and disease duration did not affect IDegAsp effects on HbA1c reduction.

Conclusions: In the setting of transition to IDegAsp from premixed insulin, the dose of basal insulin in the premixed formulation can be a valuable reference for adjusting insulin degludec dose. IDegAsp is superior to premixed insulin in blood glucose control with reduced total daily dose and injection frequency. IDegAsp could be the best choice for the management of diabetes in elderly patients.