Once-weekly efsitora resulted in similar efficacy and safety compared with daily basal insulins glargine or degludec in the treatment of adults with type 2 diabetes in the QWINT phase 3 development program. To fully assess once-weekly insulin's potential and address common barriers associated with insulin therapy (e.g., clinical inertia, fear of injections, treatment complexity), other aspects of the participants' treatment experiences were investigated using patient-reported outcome (PRO) measurements. The results of these PROs from QWINT-1 to -4 are presented here. Six different PRO instruments were completed across the studies at primary timepoints and treatment period endpoint (QWINT-1, week 26/52; QWINT-2, week 26/52; QWINT-3, week 26/52/78; QWINT-4, week 26) by participants enrolled in the phase 3 QWINT clinical trials. The PRO instruments included Treatment Related Impact Measure-Diabetes (Trim-D) (QWINT-1, -2, and -3), Diabetes Treatment Satisfaction Questionnaire (DTSQ) (QWINT-1 and -3), Simplicity of Diabetes Treatment Questionnaire (SIM-Q) (QWINT-1, -2, and -3), Basal Insulin Experience (BIE) (all QWINTs), EQ-5D-5L (QWINT-2, -3, and -4), and Short Form-36 Health Survey Version 2(SF-36v2) (QWINT-2). Efsitora-treated participants demonstrated greater or similar improvements than comparators for most of the measured PROs at the primary timepoint in all four studies, particularly in QWINT-3 and -4 (prior insulin experience). Notably, for those treated with efsitora, there were significantly larger improvements than comparators in the PRO domains of treatment burden, daily life, diabetes management, compliance, satisfaction, and psychological health, as measured using the TRIM-D and DTSQc. Participants treated with efsitora had similar scores across both health-related quality of life measures, EQ-5D-5L and SF-36v2, at the primary endpoint when evaluated versus the comparator. Participants in the QWINT-1 to -4 studies demonstrated a strong preference for efsitora, along with improved overall functioning, well-being, and treatment burden compared to daily basal insulins. QWINT-1: NCT05662332; QWINT-2: NCT05362058; QWINT-3: NCT05275400; QWINT-4: NCT05462756. Insulin efsitora alfa (efsitora) is an innovative once-weekly basal insulin treatment evaluated in the Phase 3 QWINT clinical trials. The QWINT -1 to -4 clinical trials evaluated the efficacy and safety of efsitora, and the experience of adults with type 2 diabetes (T2D) treated with efsitora compared to daily insulin treatments. Efsitora had similar glycemic control and safety compared to daily basal insulin. Furthermore, patient-reported outcomes (PROs) showed greater improvements in treatment burden and satisfaction with efsitora, which was preferred more often compared to daily basal insulin. The PROs included six questionnaires: Treatment Related Impact Measure-Diabetes (TRIM-D) (QWINT-1, -2, and -3) measuring impact of diabetes treatment on a person’s functioning, wellbeing, and satisfaction with diabetes therapy; Diabetes Treatment Satisfaction Questionnaire (DTSQ) (QWINT-1, and -3) assessing treatment satisfaction; Simplicity of Diabetes Treatment Questionnaire (SIM-Q) (QWINT-1, -2, and -3) measuring simplicity of the treatment; Basal Insulin Experience (BIE) to evaluate participants’ preference (QWINT-3, and -4) for their insulin treatment and likelihood (all QWINTs) of incorporating into their diabetes management routine; EQ-5D-5L (QWINT-2,-3, and -4) measuring overall quality of life; and Short Form-36 Version 2 Health Survey Acute Form (SF-36v2) (QWINT-2) assessing health across eight domains. Participants reported that they would be very likely to incorporate efsitora into their diabetes management routine. With the positive results from the QWINT trials and strong PRO preferences, efsitora shows promise for treating people with T2D.
The 2023 iteration of the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) estimated prevalence, incidence, and health burden for 375 diseases and injuries, including 12 mental disorders. We assess past, current, and emerging trends in the prevalence and burden of mental disorders across sexes and age groups, for 21 regions, 204 countries and territories, and by Socio-demographic Index (SDI) quintile, from 1990 to 2023. Mental disorders included in GBD 2023 were anxiety disorders, major depressive disorder, dysthymia, bipolar disorder, schizophrenia, autism spectrum disorders, conduct disorder, attention-deficit hyperactivity disorder, anorexia nervosa, bulimia nervosa, idiopathic developmental intellectual disability, and a residual category of other mental disorders. A literature review identified epidemiological data for each disorder. These were analysed via a Bayesian meta-regression to estimate prevalence by disorder, sex, age, location, and year. Disorder-specific prevalence was multiplied by disability weights representing the severity of health loss associated with each disorder to estimate years lived with disability (YLDs). Deaths due to anorexia nervosa were assessed with a Cause of Death Ensemble modelling strategy to estimate deaths by sex, age, location, and year, and then multiplied by the standard life expectancy at age of death to estimate years of life lost (YLLs). YLDs equalled disability-adjusted life-years (DALYs) for all mental disorders except anorexia nervosa (the only mental disorder considered as an underlying cause of death in GBD), for which DALYs represented the sum of YLDs and YLLs. We presented prevalence, deaths, YLDs, YLLs, and DALYs as counts, age-specific rates per 100 000 population, and age-standardised rates per 100 000 population. We estimated 1·17 billion (95% uncertainty interval 1·06-1·31) prevalent cases of mental disorders globally in 2023, equivalent to an age-standardised prevalence rate of 14 210·7 cases (12 849·5-15 940·1) per 100 000 population. These estimates represented a 95·5% (75·0-121·2) increase in prevalent cases and 24·2% (11·4-41·4) increase in age-standardised prevalence rate between 1990 and 2023. All mental disorders showed increases in prevalent cases between 1990 and 2023, while notable increases were seen in age-standardised prevalence rates for anxiety disorders, major depressive disorder, dysthymia, anorexia nervosa, bulimia nervosa, schizophrenia, and conduct disorder. There were an estimated 171 million (127-228) DALYs due to mental disorders globally across sex and age in 2023, equivalent to an age-standardised DALY rate of 2070·5 DALYs (1519·1-2750·5) per 100 000 population. Mental disorders contributed to 6·1% (4·8-7·6) of all-cause DALYs in 2023, making them the fifth leading cause of global DALYs (up from 12th in 1990). DALYs were almost entirely composed of YLDs. Mental disorders were the leading cause of YLDs in 2023 (up from second in 1990), explaining 17·3% (14·8-20·6) of all-cause global YLDs. Leading causes of mental disorder DALYs were anxiety disorders (ranked 11th among the 304 diseases and injuries at Level 4 of the GBD cause hierarchy), major depressive disorder (15th), and schizophrenia (41st). Globally in 2023, mental disorder age-standardised DALY rates were higher among females (2239·6 [1643·7-3014·1] per 100 000) than among males (1900·2 [1399·8-2510·8] per 100 000), and peaked in the 15-19 years age group (2617·3 [1850·6-3696·8] per 100 000). All locations showed increased mental disorder DALY rates in 2023 compared with 1990, ranging across countries and territories from 1302·4 (952·7-1683·7) per 100 000 in Viet Nam to 3555·8 (2661·9-4715·0) per 100 000 in the Netherlands. Across SDI quintiles, DALY rates ranged from 1853·0 (1352·1-2469·3) per 100 000 for middle SDI to 2184·1 (1606·1-2890·3) per 100 000 for high SDI. A significant health burden was imposed by mental disorders in all countries and territories in 2023, irrespective of the health resources available. In some instances, this burden has increased over time and is unevenly distributed across populations. Stronger surveillance systems, particularly in low-income and middle-income countries, are required. Additionally, we need more coordinated and inclusive policies to reduce the burden through early treatment and prevention, tailored to sex and age differences across locations. Responding to the mental health needs of our global population, especially those most vulnerable, is an obligation, not a choice. Gates Foundation, Queensland Health, and University of Queensland.
Diabetes mellitus presents a growing public health challenge across geographies including Asia, particularly in countries where blood glucose monitoring (BGM)-referring to capillary finger-prick self-monitoring of blood glucose (SMBG) using a meter and test strips-is underutilized. Having evolved and improved over recent decades, glucose monitoring (GM)-including SMBG and continuous glucose monitoring (CGM)-has become an essential tool for effective diabetes management, yet remains underutilized because of systemic, economic, and educational barriers. This work synthesizes expert insights and published evidence to develop best practice recommendations for BGM. A targeted literature review (TLR) was conducted across five thematic domains: monitoring practices, clinical decision-making, patient engagement and adherence, technology and innovation, and policy and reimbursement. Insights were complemented by a structured expert forum involving clinicians from seven Asian countries, underscoring larger implications in geographies where SMBG remains underutilized within the diabetes care continuum. The forum highlighted disparities in device access, affordability, and insurance coverage, and emphasized the need for structured diabetes self-management education (DSME) and digital integration. Findings support the use of structured SMBG for non-insulin-treated type 2 diabetes and CGM for insulin-treated individuals and those at risk of hypoglycemia. Evidence from the literature review also highlighted the importance of proper SMBG technique, with common errors such as inadequate handwashing, repeated lancet use, and excessive finger squeezing contributing to inaccurate readings and finger-site injuries. Hybrid models combining CGM and SMBG for calibration or confirmation are pragmatic solutions balancing clinical utility and affordability. Digital platforms, AI-driven analytics, and mobile apps enhance patient engagement and glycemic control but face challenges of scalability and regulation. Policy reforms, including inclusion of BGM in national health benefit packages, expanded insurance coverage, and public-private partnerships, are critical to improving access. The recommendations advocate for personalized, context-specific monitoring strategies that balance clinical efficacy with affordability and infrastructure realities. This consensus-based framework aims to guide healthcare professionals in optimizing BGM practices and improving long-term outcomes for people living with diabetes. FITTER BiG is a new extension of the long-standing FITTER initiative, which has provided insulin injection technique recommendations for more than two decades. FITTER BiG complements this work by focusing specifically on best practice recommendations for blood glucose monitoring. FITTER BiG will provide BGM-specific recommendations designed to complement the injection technique guidance outlined in the FITTER Forward consensus statement (Klonoff et al. Mayo Clin Proc 100:682-699, 2025 [1]). Diabetes is increasing rapidly across Asia, and many people do not monitor their glucose levels often enough, even though regular glucose checking helps prevent serious health problems. Glucose monitoring can be done in two main ways: through a finger-prick test using a glucose meter, or through a wearable sensor that measures glucose levels throughout the day. These tools help people understand how food, medicines, physical activity, illness, and daily routines affect their glucose levels. In this project, we reviewed published research and gathered insights from diabetes specialists from seven countries across Asia to better understand how glucose monitoring is used, what challenges people face, and what practical guidance would help improve care. Specialists highlighted important barriers, including cost, limited insurance coverage, lack of education about proper technique, and difficulties accessing digital tools that help interpret glucose patterns. The experts agreed that finger-prick monitoring is useful for people who do not use insulin, while continuous monitoring with sensors is most helpful for people who use insulin or are at high risk of low glucose episodes. Using both methods together either at the same time or at different times can balance usefulness and affordability. Our recommendations provide simple, practical guidance on when to use each method, how often to check, and how to interpret glucose readings. We also describe policy actions, such as expanding insurance benefits and strengthening public–private partnerships, to help more people access these monitoring tools and achieve better long-term health outcomes.
Healthcare expenditure for the treatment of type 2 diabetes mellitus (T2DM) in the Netherlands is high, mainly due to the cost of treating diabetes-related complications. Guidelines recommend sensor-based glucose monitoring systems for people living with T2DM and using insulin, but these are not reimbursed in the Netherlands for those using basal insulin only. The objective of this study was to assess the cost-effectiveness of glucose monitoring with FreeStyle Libre systems (FSL), compared with capillary-based self-monitoring of blood glucose (SMBG), for people living with T2DM on basal insulin, from the perspective of the Dutch publicly funded healthcare system. The patient-level microsimulation model DEDUCE (DEtermination of Diabetes Utilities, Costs, and Effects) was used to estimate the incidence of complications and acute diabetes events (ADEs; hypoglycemia and diabetic ketoacidosis). The effect of FSL was modeled as a 0.5% reduction in glycated hemoglobin level, which DEDUCE translates to a lower rate of complications, and as reductions in ADEs and absenteeism. Costs (in 2024 euros) and utilities were discounted at 3% and 1.5%, respectively. Outcomes were assessed as quality-adjusted life years (QALYs). FSL was associated with 0.53 more QALYs than SMBG (12.77 vs. 12.24), at an additional cost of €8021. The resulting incremental cost-effectiveness ratio (ICER) for FSL versus SMBG was €15,181/QALY. The increased acquisition cost of FSL (€19,738) was partially offset by reductions in costs associated with complications, ADEs, and absenteeism. Probabilistic sensitivity analysis showed that FSL was 52% likely to be cost-effective at a willingness-to-pay threshold of €20,000/QALY, and > 99% likely at thresholds ≥ €40,000/QALY. FSL had an ICER of below €50,000/QALY in all scenarios investigated. From a Dutch publicly funded healthcare system perspective, FSL can be considered to be cost-effective compared with SMBG for people living with T2DM on basal insulin therapy. Effective glucose monitoring is important for people living with type 2 diabetes mellitus, reducing the risk of experiencing high or low blood sugar levels and of developing long-term complications. Glucose monitoring can be done using finger sticks and test strips or sensor-based devices such as the FreeStyle Libre systems (FSL). In this study, we modeled the cost-effectiveness of FSL in people with type 2 diabetes mellitus on basal insulin in the Netherlands. FSL use was considered to reduce the risk of acute events related to high or low blood sugar and of diabetes complications, both based on published studies. The modeled costs included the costs of glucose monitoring, of treating complications, and of time off work due to diabetes. FSL use was predicted to lead to better outcomes for people with type 2 diabetes mellitus, measured as quality-adjusted life years (a measure of health which combines life expectancy with quality of life), while reducing the costs of treating acute events and complications. Overall, FSL is likely to be considered to be a cost-effective use of Dutch healthcare system resources.
Effective insulin therapy relies on proper injection technique and the correct use of insulin delivery devices. Despite recommendations for a single-use device, the pen needle reuse remains common. This study explored pen needle reuse patterns, reasons for reuse, and motivators to changing reuse behavior, in order to provide actionable insights for clinical education and patient-support interventions. A cross-sectional online survey was conducted with 500 U.S. adults with type 1 diabetes (T1D) or type 2 diabetes (T2D) who inject insulin at least twice daily using an insulin pen and use insulin pen needles at least twice before replacing. Approximately 70% of survey participants reported using needles 2-5 times before replacing, and about 30% used them six or more times, with higher reuse among participants with T1D. Despite most participants reporting initial insulin injection education (86.8%), the majority indicated limited follow-up regarding injection practices. Specifically, 73.6% indicated their injection sites were never examined by a healthcare professional (HCP), 72.8% reported their injection technique had never been reviewed, and 66.2% reported their HCP had never asked them about injection site problems. The main reported reasons for needle reuse include convenience (64.2%), habit (46.2%), environmental/waste concern (40.8%), and cost (40.6%). The most motivating educational messages for changing reuse include those around A1c improvement and lipohypertrophy prevention, with the most trusted sources of information being endocrinologists, followed by primary care physicians (PCP), diabetes educators (known in the U.S. as diabetes care and education specialists), and peers. Pen needle reuse is widespread and initial education alone is insufficient. Ongoing reinforcement and messaging from trusted HCPs, particularly around A1c and injection-site outcomes, provide a key opportunity to support behavior change. Giving insulin correctly is important for keeping blood glucose levels well managed and avoiding problems at the injection site (such as lumps, bleeding, bruising, or pain). Despite recommendations for single-use, many people with diabetes reuse their insulin pen needles. This study explored how often people reuse pen needles, why they do it, and what might motivate them to stop reusing. A total of 500 U.S. adults with type 1 or type 2 diabetes who reported reusing their insulin pen needles took an online survey. About 70% said they use their pen needles 2–5 times before replacing them, and about 30% use them six or more times. People with type 1 diabetes were more likely to use their needles ten or more times. Although most participants received injection technique education when starting on insulin, most have not had a healthcare professional review their injection technique or check their injection sites since. The main reasons for reusing pen needles were convenience, habit, concerns about waste or the environment, and cost. The messages that motivated people most to stop reusing were those about improved A1c levels and fewer injection-site problems. Endocrinologists, primary care doctors, diabetes educators, and peers were the most influential sources of information. These results show that needle reuse is common, and ongoing education and personalized messaging from trusted healthcare professionals about the benefits of using a new needle each time may help people change their behavior.
Variability in the clinical presentation of patients with type 2 diabetes (T2D) is high and underlines the need for more personalized patient care. This nationwide study aimed to describe characteristics, treatment patterns, and disease progression of Finnish patients with T2D (N = 302,987), and to identify patient clusters with distinct progression patterns based on the occurrence of diabetes-related complications. The study included all adult patients with incident T2D in Finland between 2010 and 2019. Data were collected from national health and social care registers, data lakes, and a private healthcare provider between 1996 and 2021. Patient clusters were identified based on disease progression, defined by the occurrence of 22 pre-defined end-points, using likelihood-based growth mixture modeling. Five patient clusters with stable (C1; n = 133,951), mild (C2; n = 52,819), moderate (C3, n = 43,488), rapid (C4; n = 10,159), and extremely rapid progression (C5; n = 1973) were identified. The mean number of end-point complications per patient at baseline ranged from 0.2 to 2.3 across clusters and remained stable in C1-C3 over the first 5 years. In C5, the number increased to 5.5 and 7.2 during the first and third follow-up years, respectively, with a similar but more modest annual increase observed in C4. Cardiovascular complications increased more rapidly in C5 and C4 than C1-C3. T2D medication use was more common in milder clusters, whereas 31.4% and 48.2% of patients in C4 and C5, respectively, had no T2D medication. The rate of certain infections and values of creatinine, hemoglobin, and erythrocytes, increased with cluster severity. Diagnosis of several other new conditions, particularly cardiovascular complications, at or soon after incident T2D diagnosis predicts poor prognosis. The results further support a comprehensive approach in diabetes care, including evaluation and treatment of cardiovascular diseases alongside glycemic control. It is well known that people with type 2 diabetes can experience the disease in different ways, with wide variation in symptoms and disease progression. To support more personalized care, clinically useful tools that can predict how the disease will develop are needed. The researchers analyzed nationwide health register data from Finland, including all patients who received their first diagnosis of type 2 diabetes between 2010 and 2019. Their goal was to group patients into clusters with different long-term disease progression patterns, based on the development of diabetes-related complications after diagnosis. In total, the study included 302,987 patients with type 2 diabetes. These patients were divided into five clusters showing either stable (cluster 1), mild (cluster 2), moderate (cluster 3), rapid (cluster 4), or extremely rapid (cluster 5) disease progression. Further analysis showed that having additional conditions diagnosed at, or shortly after, the onset of diabetes was linked to a worse prognosis. Notably, 18.6% of patients did not purchase any diabetes medication during the follow-up period. This proportion was particularly high in patients allocated to cluster 4 (31.4%) and cluster 5 (48.2%). This study shows that patients with type 2 diabetes can be classified into meaningful groups with different progression patterns. This approach may help clinicians make timely and cost-effective decisions, focusing resources on patients most likely to benefit from early and intensive treatment.
Type 2 diabetes mellitus (T2DM) prevalence in Iraq is projected to rise significantly by 2045, creating urgent need for optimized use of latest insulin therapies. An expert panel of eleven diabetes specialists convened to assess the evolving landscape of insulin therapies and explore how each option fits into current strategies to optimize T2DM management in Iraq. The panel reviewed international guidelines and local practice patterns through pre-meeting surveys. Discussions focused on initiation and intensification of insulin-based treatment in Iraq's context, considering accessibility challenges and patient characteristics. When hemoglobin A1c (HbA1c) is < 2% above target, basal insulin (BI) is recommended for patients with body mass index (BMI) ≤ 30. For BMI > 30, either GLP-1 receptor agonist (GLP-1 RA) monotherapy or a fixed ratio combination (FRC) of GLP-1 RA and BI is preferred. When HbA1c is ≥ 2% above target, initiation with BI and GLP-1 RA is advised across BMI groups. If glycemic targets are not achieved despite reaching 0.5 U/kg of BI, prandial insulin may be added via premixed regimen or basal-bolus regimens based on individual factors. Premix insulin remains an alternative when other options are unavailable. Key barriers in Iraq include high cost and limited availability of GLP-1 RAs, therapeutic inertia, and gaps in healthcare infrastructure. Final treatment decisions should consider disease severity, cardiovascular and renal comorbidities, and weight goals. The panel curated clinical practical recommendations about injectable insulin therapies and proposed a structured treatment algorithm tailored to Iraq's healthcare setting, prioritizing simplicity, efficacy, tolerability and accessibility. The panel emphasized the critical role of second-generation BIs and FRCs of BI and GLP-1 RA in Iraq's T2DM treatment algorithm, providing clear guidance on their optimal use and place in therapy, overcoming barriers, alongside enhanced education for healthcare providers and patients.
The phase 3 QWINT-2 study demonstrated that once-weekly insulin efsitora alfa (efsitora) was noninferior to once-daily insulin degludec (degludec) in reducing glycated hemoglobin (HbA1c) at week 52 when added to existing noninsulin glucose-lowering agents in adults with type 2 diabetes who were insulin-naïve. A Japan subgroup analysis of QWINT-2 using two dosing algorithms is presented here. Participants from Japan were randomized 1:1 to efsitora or degludec and followed one of two dosing algorithms: a general dosing algorithm or an optional alternative dosing algorithm available for participants anticipated to require less insulin, characterized by a body weight ≤ 60 kg or HbA1c level ≤ 7.5% at baseline. Assessments included changes in HbA1c and fasting blood glucose from weeks 0-52, time spent in target glucose range (TIR) from weeks 48-52, and hypoglycemia from weeks 0-52. In total, 144 participants from Japan were included (efsitora, n = 71; degludec, n = 73). Demographic and baseline characteristics were generally balanced between treatment groups. From weeks 0-52, mean HbA1c decreased from 8.04% to 6.63% with efsitora and from 8.00% to 6.64% with degludec (estimated treatment difference, -0.01%). TIR was similar between efsitora and degludec from weeks 48-52. Rates of combined level 2 or 3 hypoglycemia were low overall (weeks 0-52) and during the initial dosing period (weeks 0-12). Level 3 hypoglycemia was not reported in any participants with efsitora and two participants with degludec. The incidence of adverse events was similar between efsitora and degludec. The efficacy and safety of efsitora were comparable with degludec using the general and alternative dosing algorithms in Japanese participants. Once-weekly efsitora was comparable to once-daily degludec in reducing HbA1c in Japanese participants who were insulin-naïve. The efficacy and safety of efsitora in Japanese participants were consistent with the overall QWINT-2 study population. NCT05362058. Japanese people with type 2 diabetes tend to have a lower body mass index and less impairment of the effects of insulin than Western people. Thus, they require less insulin to achieve comparable reductions in blood sugar. This study looked at Japanese participants who had not used insulin before in a clinical trial called QWINT-2. This trial compared two types of insulin: (1) efsitora, a new insulin taken once a week, and (2) degludec, a widely used insulin taken once a day. Some participants received a lower dose of insulin efsitora or degludec if they weighed 60 kg or less or had relatively good blood sugar control (blood sugar less than or equal to 7.5%). Once-weekly insulin (efsitora) worked just as well and was just as safe as once-daily insulin (degludec) in Japanese people with type 2 diabetes. This was true regardless of which of the two different methods was used to optimize the insulin dose. These results were also similar to those seen in the overall QWINT-2 trial. This study shows that once-weekly insulin efsitora could help people, including Japanese people, with type 2 diabetes initiate and continue insulin treatment. The study also shows that adjusting insulin doses on the basis of individual factors—such as body mass index or blood sugar levels—has benefit for some Japanese people.
Precision diabetes care is an evolving evidence-based, personalised approach that uses an individual's clinical, metabolic, and genetic data to accurately classify them into distinct subgroups and tailor diabetes prevention, treatment, and monitoring strategies. The use of genomics data, advanced biomarker testing, and artificial intelligence-driven diagnostics has improved precision diabetes care in high-income countries. This has enabled accurate identification of diabetes subtypes and targeted treatment. Despite the rising burden of diabetes, high rates of undiagnosed cases, and emerging evidence of atypical manifestations of diabetes in Africa, such advancements in precision diabetes care remain unavailable in many low-resource settings, directly impacting treatment outcomes. To improve precision diabetes care in low-resource settings in Africa, we suggest using a structured clinical phenotyping approach based on routinely collected clinical characteristics. In this review, we explore how using a combination of readily available clinical characteristics, such as age at diagnosis, body mass index, clinical presentation, family history of diabetes, and coexisting medical conditions, can help healthcare professionals in Africa to diagnose and treat different diabetes subtypes accurately. By adopting a pragmatic, structured clinical phenotyping approach, African healthcare systems can deliver region-specific, cost-effective precision diabetes care without overreliance on advanced laboratory tests and digital technologies.
Diabetes related Charcot neuro-osteoarthropathy (CN) of the foot is associated with increased risks of amputation and premature mortality. We aimed to report the amputation and mortality rates of people with active CN and identify participant and CN characteristics associated with these adverse outcomes. A single-center retrospective study. Participants were included if they were diagnosed with an active CN with type 1 or type 2 diabetes mellitus presenting to a specialist foot clinic between January 2007 and September 2022. Participant and CN characteristics were analyzed to determine relationships with amputation or mortality. 186 participants were included with 195 CN feet. Median follow-up was 8.2 years (IQR 5.3, 12.2). Male sex (p = 0.026) and previous amputation (p = 0.003) were associated with a significantly increased risk of amputation. The 1-year, 5-year, and 10-year mortality rates were 2.7% (5/186), 18.9% (23/122), and 40% (24/60), respectively. Previous amputation and worsening chronic kidney disease stage were associated with a significantly increased mortality risk (p = 0.005 and p = 0.027, respectively). Participants with CN had high amputation and mortality rates. The causes of death were multifactorial, suggesting clinicians should focus on early aggressive multiple risk factor intervention to reduce these adverse outcomes. Diabetes related nerve disease can lead to foot problems. One of these is where the joints of the foot become disrupted and the bones no longer align correctly – this is called a Charcot foot. It occurs in about 1 in 200 people with diabetes. Having a Charcot foot is recognized as a predictor of ulceration and amputation and also premature death. In this study, we looked at the data from 186 people with a new onset Charcot followed up at 1 hospital specialist diabetes foot clinic over 15 years, and looked at what factors determined the increased risk of having an amputation or early death. We found that being male and having a previous amputation were the strongest predictors of having an amputation, and having a previous amputation and long-term kidney disease were the factors most predictive of an early death. We recommend that people with a Charcot have their cardiovascular risk factors optimized as soon as possible to help prevent amputations and early death.
Diabetes mellitus is the leading global cause of chronic kidney disease (CKD) and end-stage renal disease. Although cardiovascular outcomes have improved substantially, renal risk remains high. Glucagon-like peptide 1 (GLP-1) receptor agonists and the dual GLP-1/GIP agonist tirzepatide have demonstrated potential cardiorenal benefits, but renal evidence has not been systematically mapped across CKD stages and metabolic phenotypes. This scoping review aimed to identify and describe clinical evidence on renal outcomes associated with GLP-1-based therapies in adults with type 2 diabetes and/or overweight/obesity, with or without CKD. Following the Joanna Briggs Institute framework and PRISMA-ScR guidelines (protocol: OSF.IO/SZ87J), we searched PubMed, Embase, and CENTRAL from inception to October 2025. Eligible studies included phase 2-4 randomized controlled trials (RCTs), post hoc RCT analyses, and comparative observational studies reporting kidney outcomes. Data were charted using a structured extraction form with AI-assisted screening and manual validation. Risk of bias and certainty were appraised using RoB 2, ROBINS-I, and GRADE frameworks. Of 607 records identified, 35 studies met inclusion criteria. Randomized evidence supports renal benefits for semaglutide, dulaglutide, and liraglutide, including reductions in composite kidney outcomes and slower eGFR decline. Tirzepatide demonstrated consistent albuminuria reductions and attenuation of eGFR decline compared with insulin glargine. Efpeglenatide, cotadutide, exenatide, and lixisenatide showed class-consistent antiproteinuric effects. Observational data extended findings to real-world and advanced CKD populations. Across agents, renal benefits were partly independent of glycemic and weight effects. GLP-1-based therapies demonstrate consistent renoprotective signals across CKD stages and metabolic phenotypes, particularly in type 2 diabetes. Evidence is strongest for semaglutide and dulaglutide, with emerging data for tirzepatide and other incretin-based agents. These findings provide a structured evidence map to inform future consensus and clinical decision-making.
This study aimed to examine psychosocial well-being, quality of life (QoL), and productivity in people with type 1 diabetes (pwT1D) who were experiencing recurrent severe hypoglycemic events (SHEs) and impaired awareness of hypoglycemia (IAH), despite using continuous glucose monitors (CGMs). The study utilized a cross-sectional, observational design which incorporated an online survey about SHE experiences, diabetes-related complications, psychosocial burden, QoL, and productivity in a sample of adult pwT1D who use CGM in the United States. Participants completed measures of IAH status (modified Gold score ≥ 4 = IAH), diabetes distress (DDS-17), fear of hypoglycemia (HFS-II), QoL (DIDP and EQ-5D-5L), and productivity (DPM). Participants were categorized into two cohorts based on self-reported history of SHEs and IAH: the cohort of recurrent SHE [≥ 2 SHEs in the past 12 months] with IAH, and the cohort of No SHE and No IAH to provide context. Unadjusted comparisons (Welch's t test, Pearson's chi-squared test) were conducted to describe differences across cohorts. In this US study population of adult CGM users, the recurrent SHE (≥ 2) with IAH cohort included 174 participants, and the No SHE and No IAH cohort included 689 participants. On average, participants with recurrent SHEs and IAH reported 8.6 SHEs in the past year. Compared to those with No SHE and No IAH, those with recurrent SHEs and IAH had a higher psychosocial burden (fear of hypoglycemia and diabetes distress), lower QoL, worse overall health status, and reduced productivity (all p < 0.001). Despite using CGM, adults with T1D with recurrent SHEs and IAH experienced lower psychosocial well-being, QoL, and reduced productivity compared to adults with T1D with no SHEs and no IAH, highlighting the unmet need for novel therapies for this group.
Heart failure is a growing major public health concern. Total medical costs for heart failure in the USA are expected to rise to more than US $70 billion by 2030, and this is expected to rise as the prevalence of heart failure increases owing to an aging population and the concurrent increase in risk factors for heart failure such as obesity, diabetes, and chronic kidney disease. Heart failure affects 22% of patients with type 2 diabetes and is frequently the first presentation of cardiovascular disease in these patients. One of the key challenges in heart failure treatment is early detection and diagnosis. Heart failure can present similarly to chronic obstructive pulmonary disease and is often misdiagnosed. Late diagnosis of heart failure can lead to delays in treatment initiation and poor patient outcomes. Clinicians other than specialist cardiologists, particularly endocrinologists and primary care physicians in the case of patients with diabetes, can play a key role in the early detection and diagnosis of heart failure. In this podcast series of three episodes, a cardiovascular specialist, an endocrinologist, and a primary care physician will provide practical guidance for primary care physicians on optimal identification and management of heart failure in patients with diabetes. In the first episode, we give a pragmatic overview of heart failure and practical guidance on how clinicians can identify patients most at risk of developing heart failure, tips for early detection and screening, and ultimately, how to prevent progression of heart failure in these patients. Podcast available for this article.
Type 2 diabetes is a leading cause of chronic kidney disease (CKD). Individuals with both conditions have increased risk of poor cardiorenal outcomes and mortality. The rapidly evolving landscape for CKD-protective therapies in type 2 diabetes currently includes sodium-glucose cotransporter 2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1 RA), both of which demonstrate cardiorenal outcome benefits. As part of the FOUNTAIN platform (ClinicalTrials.gov ID: NCT05526157; EUPAS ID: EUPAS48148), this study aimed to better understand changes in patient characteristics and treatment patterns corresponding with updates to clinical guideline recommendations and drug labeling and the emergence of new CKD-protective therapies such as finerenone in the US in 2021-2022. An observational real-world data study assessed patient characteristics and drug utilization in separate SGLT2i and GLP-1 RA new-user cohorts of adults with CKD and type 2 diabetes in an earlier (1 January 2012-30 June 2021) and a later (9 July 2021-30 September 2023) period using Optum's de-identified Clinformatics® Data Mart Database (Optum® CDM). Compared with the earlier period new users, later period new users in both cohorts were older, had more severe CKD, used less intensive type 2 diabetes medication, and had better metabolic control; SGLT2i new users more frequently had no type 2 diabetes therapy before the index date and greater congestive heart failure prevalence; and GLP-1 RA new users had increased SGLT2i use and decreased insulin use. These findings inform and contextualize future studies assessing cardiorenal outcomes for these and additional treatments, including finerenone, for individuals with CKD and type 2 diabetes.
Diabetes remains a global public health concern, with increased prevalence and a significant economic burden. Yet, most studies do not differentiate between type 1 (T1D) and type 2 diabetes (T2D), despite distinct clinical trajectories and care needs. This study aimed to provide up-to-date data on healthcare use and diabetes care-related costs in France from 2011 to 2019 by type of diabetes. A 10-year retrospective study was conducted on adults identified with T1D and T2D between 1 January 2010, and 31 December 2019, in a 1/10th sample of the French nationwide claims database (SNDS, Système National des Données de Santé). In the hospital database, reimbursement data are available only from 2011, so resource use and cost analyses were conducted starting from 2011 to 2019 in this present study. Diabetes was identified through hospital diagnoses, specific treatments, and/or long-term conditions. A machine-learning algorithm was specifically developed through a linkage between SNDS data and primary data from a network of French general practitioners to better predict the type of diabetes. In 2019, among the 290,486 treated individuals, 12,102 (4.2%) had T1D, 62,479 (21.5%) had insulin-treated type 2 diabetes (T2Di), and 215,905 (74.3%) had noninsulin-treated type 2 diabetes (T2Dni). Average total reimbursed costs per individual varied significantly by diabetes group: €10,033 (T1D), €13,424 (T2Di), and €5091 (T2Dni), primarily owing to primary care settings (63.6% to 71.8% of the total cost). Between 2011 and 2019, total reimbursement costs increased (+ 9.6% for T1D, + 29.8% for T2Di, and + 13.8% for T2Dni), while average cost per individual decreased (-9.6% for T1D, -7.7% for T2Di, and -1.0% for T2Dni). As its prevalence continues to rise, the economic burden of diabetes also grows overall, despite the reduction in individual costs.
In patients with type 2 diabetes mellitus (T2DM), cardiovascular (CV) disease and chronic kidney disease (CKD) drive excess morbidity and mortality. Beyond glucose-lowering, incretin-based therapies may provide organ protection across the cardiorenal axis. Narrative review of mechanistic pathways and randomized trials of GLP-1 receptor agonists (GLP-1RA), DPP-4 inhibitors, and newer dual/triple agonists, with targeted updates from recent pivotal programs (SELECT, FLOW, SOUL, SURPASS-CVOT) and emerging oral small-molecule GLP-1R agonists. Long-acting GLP-1RA reduces major adverse CV events (MACE), all-cause and CV death, heart-failure hospitalization, and kidney composites across CV outcome trials and meta-analyses. A 2019 pooled analysis and a 2025 update confirm consistent reductions in MACE and hard kidney outcomes independent of baseline HbA1c. In obesity without diabetes, semaglutide 2.4 mg lowered MACE in SELECT, expanding prevention beyond glycemia. In CKD with T2DM, FLOW showed that semaglutide reduced major kidney disease events and death from CV/kidney causes. In T2DM with ASCVD and/or CKD, the SOUL cardiovascular outcome trial (CVOT) demonstrated that oral semaglutide reduced three-point MACE versus placebo. In head-to-head CVOT, tirzepatide was non-inferior to dulaglutide on MACE while achieving greater weight and HbA1c reductions. Mechanistically, GLP-1R signaling spans Gs-cAMP/PKA, β-arrestin-dependent pathways, and additional routes (including Gq contexts), aligning with anti-inflammatory, natriuretic, and antifibrotic effects observed preclinically and clinically. Oral non-peptide GLP-1R agonists (e.g., orforglipron) show phase 2 efficacy but lack long-term CV/renal outcome data. Incretin-based therapy has shifted care from glucose-centric targets to cardiorenal risk reduction. GLP-1RA are guideline-endorsed for patients with T2DM and high CV/renal risk irrespective of HbA1c; dual agonists and oral small-molecule agents may broaden indications pending definitive outcome evidence.
The True Vie I3 continuous glucose monitoring system (i3 CGM, Sinocare Meditech Inc., also approved in Europe as GlucoMen® iCan or iCan CGM system) is a new real-time continuous glucose monitoring system (CGM) intended for the management of diabetes mellitus. This pivotal study evaluated the performance of the factory-calibrated CGM system. In this center-specific dataset, 35 adults with type 1 diabetes (T1D) and type 2 diabetes (T2D) wore sensors on the abdomen and arm for 15 days. Four in-clinic visits were scheduled, during which frequent comparator sampling of venous blood was performed every 5-15 min for up to 10 h, and a glucose manipulation was performed. CGM performance compared to Yellow Springs Instrument 2300 Stat Plus Glucose and Lactate Analyzer (Yellow Springs, OH) glucose analyzer was evaluated for abdomen and arm sensors separately, regarding mean absolute relative difference (MARD) and agreement rates (AR) stratified by glucose range and rate of change (RoC). Additionally, clinical accuracy, sensor attachment rate, pain, and safety were assessed. This single-center analysis was developed with the intention to provide European-and particularly German-data. The presented site was the highest-enrolling center in the study and, as such, can be considered representative of the overall study population-an assumption that the analysis confirmed. 20/20 AR and MARD were 95.5% and 9.4% for abdomen sensors, and 95.3% and 9.8% for arm sensors, respectively. Consensus error grid (CEG) analyses revealed that 100% of CGM-comparator pairs fell in zones A and B for abdomen and arm sensors. Accuracy of sensors remained stable throughout the wearing time. Adhesion rate was 100% for abdomen sensors and 97.1% for arm-worn sensors, without the use of any over-tape during the 15-day study period. Pain during insertion and removal was reported as minimal, and no unexpected safety issues were identified. Data from a single study center showed that the performance of the i3 CGM is comparable to that published for other established CGM devices, and accuracy results were within limits specified for integrated continuous glucose monitoring systems (iCGM). The i3 CGM showed reliability, and its safety was validated during the 15 study days. The study was registered under ClinicalTrials.gov (ID: NCT05806554).
This retrospective database study investigated trends in insulin and use of concomitant noninsulin glucose-lowering medication (NIGLM) among Japanese individuals with diabetes. The study comprised two analyses: (1) a serial cross-sectional analysis of patterns in insulin treatment by year (database: Real World Data); and (2) a longitudinal retrospective cohort analysis that examined insulin treatment and individuals' characteristics (database: DeSC). Individuals initiating insulin in an inpatient or outpatient setting were followed up for 9 months (type 2 diabetes [T2D]) or 21 months (type 1 diabetes [T1D]) to evaluate treatment changes over time. The serial cross-sectional analysis included 4953 individuals (T2D, n = 4693; T1D, n = 260). The proportion of participants with T2D receiving concomitant NIGLMs increased from 31% in 2002 to 61% in 2021; from 2014 onwards, more than 30% of insulin-treated and basal-insulin-treated individuals treated with concomitant NIGLMs received dipeptidyl peptidase-4 inhibitors. Since 2018, use of concomitant NIGLMs in T1D has increased. The longitudinal retrospective cohort analysis included 27,492 individuals (T2D, n = 27,031; T1D, n = 461). Among participants with T2D who initiated insulin in an inpatient setting, 70.8% received bolus insulin at initiation, with this proportion declining to 17.3% after 9 months; proportions of participants receiving basal insulin and of those receiving basal-bolus insulin increased over the same period (6.3-31.1% and 17.0-23.4%, respectively). The majority of participants with T2D who initiated insulin in an outpatient setting received basal insulin at initiation (hospital, 53.9%; clinic, 58.9%). Among participants with T1D who initiated insulin in an inpatient setting, 57.9% received bolus insulin, and basal-bolus insulin was the predominant regimen after 1 month (85.0%); in outpatient settings, basal-bolus insulin was the predominant regimen throughout the study. In Japan, the most prominent insulin regimen at initiation varied across settings in T2D but not in T1D; use of concomitant NIGLMs increased over time in both.
Although there is a recognized negative interplay between metabolic dysfunction-associated steatohepatitis (MASH) and type 2 diabetes (T2D), the extent to which comorbid MASH exacerbates T2D complications is not well understood. This real-world cohort study evaluated whether the coexistence of these diseases is associated with increased risk of microvascular and macrovascular complications. We identified eligible adults with T2D from the Optum® Clinformatics® Data Mart Database (2016-2024). Presence of MASH was determined using International Classification of Diseases, Tenth Revision, Clinical Modification coding, requiring ≥ 1 primary inpatient or outpatient diagnosis code. Patients with T2D and MASH were matched 1:1 with patients with T2D without MASH using propensity score matching to balance baseline characteristics. Fine-Gray models were used to estimate subdistribution hazard ratios (sHR) comparing the risk of microvascular and macrovascular T2D complications between both groups, while accounting for death as a competing risk. Stratified analyses were performed by glycemic control (glycated hemoglobin < 7% and ≥ 7%) and age (< 65 and ≥ 65 years). The study comprised 7396 and 6207 matched pairs in the microvascular and macrovascular complications cohorts, respectively. In this T2D population, mean (standard deviation) follow-up was 2.8 (2.0) years for patients with MASH and 2.4 (1.8) years for patients without MASH in both cohorts. Compared with patients with T2D without MASH, those with T2D and MASH had increased hazards of microvascular (sHR 1.19 [95% confidence interval (CI) 1.12-1.26]) and macrovascular complications (sHR 1.15 [95% CI 1.08-1.23]). A similar trend was observed for the stratified subgroup analyses. Patients with T2D and MASH had higher hazards of microvascular and macrovascular complications versus those with T2D without MASH. These findings suggest that the presence of MASH accelerates T2D-related complications, creating a clinical imperative for integrated screening and management approaches to identify this high-risk population among patients with T2D.
As a leading complication of diabetes mellitus, diabetic neuropathy (DN) represents a major public health challenge due to its high prevalence and impact on patients' quality of life. The most common form, diabetic peripheral neuropathy (DPN), is characterized by progressive sensory loss, neuropathic pain, and autonomic dysfunction, all of which can significantly increase the risk of serious complications, such as foot ulcers and amputations. Traditionally, therapeutic strategies for DN have been largely limited to symptomatic management. However, recent advancements in diabetes therapy have opened promising avenues for disease-modifying interventions. In particular, incretin-based therapies and sodium-glucose co-transporter 2 (SGLT2) inhibitors have attracted increasing interest not only for their glucose-lowering effects, but also for their broader metabolic, renal, and cardiovascular benefits. In this narrative review, we synthesize emerging evidence on the potential role of these innovative therapies in the management of DN. Preclinical models, clinical trials and real-world observational studies strongly support the hypothesis that glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and SGLT2 inhibitors may confer neuroprotective benefits. Beyond these established classes, novel agents such as dual and triple receptor agonists are currently being investigated. Although clinical data on their effects in DN are still limited, the simultaneous activation of multiple metabolic pathways suggests the potential for synergistic neuroprotective effects through enhanced regulation of glucose and lipid metabolism, attenuation of systemic inflammation and oxidative stress, improvement of mitochondrial function and reduction of neuronal damage. Although innovative diabetes therapies are still in early stages of development, they reflect a rapidly evolving landscape in the management of DN in the future.