Sodium-glucose co-transporter inhibitors have potential glycaemic and non-glycaemic benefits in people with type 1 diabetes (T1D). However, the increased risk of diabetic ketoacidosis (DKA) limits their widespread use. We hypothesise that dapagliflozin 10 mg daily, combined with the use of continuous ketone monitoring (CKM) and education strategies to mitigate progression to DKA, will demonstrate improved glycaemic control without increasing DKA events.

PARTNER is a multisite 6-month randomised crossover double-masked study involving Australian adults with T1D who have a Haemoglobin A1c (HbA1c) <85.8 mmol/mol (<10%), minimum total daily insulin dose ≥0.4 IU/kg, consume ≥100 g carbohydrates/day and have not had DKA in the last 3 months. All participants will undergo a 2-week run-in period wearing the Abbott FreeStyle Libre 2 Continuous Glucose Monitor (CGM) and Abbott CKM device. Following this, participants are randomised to receive dapagliflozin or placebo for 12 weeks, followed by crossover for a further 12 weeks separated by a 2-week washout period. The primary effectiveness outcome is the Abbott FreeStyle Libre 2 CGM time in range during the final 2 weeks of each stage. The primary safety outcome is the number of episodes of DKA requiring hospitalisation or emergency department presentation. 60 participants will be recruited across five sites.

The study has received ethical approval from the St Vincent's Hospital Melbourne Human Research Ethics Committee (HREC reference 302/23). The results will be published in peer-reviewed journals and presented at national and international diabetes conferences.

ACTRN12624000448549.

Many people with type 1 diabetes struggle to manage their glucose levels and experience stress related to the behavioral demands of the disease. The aim of this study is to investigate whether treatment with a diabetes-educated psychologist can improve glucose levels and decrease diabetes distress.

Individuals with HbA1c >62 mmol/mol (7.8%) were randomized to either psychological treatment or control group. The study duration for each participant was 52 weeks. Patients who received treatment met with a diabetes-educated psychologist a minimum of seven times. In total 6 outpatient diabetes units and 10 psychologists participated. Cognitive behavioral therapy was primarily the treatment of choice. Both groups met with a diabetes nurse and/or physician at the start of the study and at 3, 6, and 12 months. HbA1c, blood pressure, and weight were measured at scheduled visits. Diabetes distress, quality of life, hypoglycemia confidence, and treatment satisfaction were evaluated using questionnaires. The primary endpoint is the difference in HbA1c from baseline to week 52. Secondary endpoints are changes in diabetes distress and quality of life from baseline to week 52, as well as treatment satisfaction at 52 weeks.

This study seeks to improve knowledge about how to support patients who struggle to manage their diabetes. If the results of this study show that psychological treatment has an effect on HbA1c or on diabetes distress, it could indicate that psychologists should become more involved in diabetes care teams. Clinical trial registration: ClinicalTrials.gov ID NCT03753997.

Glycemic management in diabetes patients remains heavily reliant on multiple daily insulin injections, which often leads to poor patient compliance and an elevated risk of hypoglycemia. To overcome these limitations, injectable hydrogels capable of encapsulating insulin within polymeric networks have emerged as a promising alternative. Ideally, a single injection can form an in situ depot that allows prolonged glycemic control and lower injection frequency. This review summarizes recent advances in injectable hydrogels for controlled insulin delivery, focusing on the polymer sources, crosslinking strategies, and stimuli-responsive release mechanisms. Synthetic polymers such as PEG, PNIPAM, and Pluronics dominate the current research due to their highly tunable properties, whereas naturally derived polysaccharides and proteins generally require further modifications for enhanced functionality. The crosslinking types, ranging from relatively weak physical interactions (hydrogen bonds, hydrophobic interactions, etc.) to dynamic covalent bonds with higher binding strength (e.g., Schiff base, phenylboronate ester), significantly influence the shear-thinning behavior and stimuli-responsiveness of hydrogel systems. Hydrogels' responsiveness to temperature, glucose, pH, and reactive oxygen species has enabled more precise insulin release, offering new options for improved diabetic management. Beyond glycemic regulation, this review also explores insulin-loaded hydrogels for treating complications. Despite the progress, challenges such as burst release, long-term biocompatibility, and scalability remain. Future research should focus on optimizing hydrogel design, supported by robust and comprehensive data.

Atherosclerotic CVD is a major cause of death in individuals with type 1 diabetes mellitus (T1DM). However, conventional risk factors do not fully account for the increased risk. This study aimed to investigate whether serum proteins associate with diabetes status and the occurrence of CVD in T1DM. We used isotope dilution-MS/MS to quantify 28 serum proteins in 228 subjects participating in the prospective Coronary Artery Calcification in Type 1 Diabetes study. We used linear regression to analyze the association between serum protein levels and T1DM status using 47 healthy controls and 134 T1DM patients without CVD and Cox proportional hazards regression to assess their prediction for incident CVD by a case-cohort study using a subcohort of 145 T1DM subjects and a total of 47 CVD events. Of the 28 serum proteins studied, five of them-alpha-2-macroglobulin (A2M), apolipoprotein A-IV, apolipoprotein L1, insulin-like growth factor 2, and phospholipid transfer protein-were significantly associated with T1DM status, with A2M being 1.6-fold higher in T1DM. After adjusting for potential confounders, A2M independently predicted incident CVD, with a mean hazard ratio of 3.3 and 95% CI of 1.8-6.1. In our study, A2M showed the largest increase in serum levels when comparing patients with T1DM to control subjects. A2M also predicted incident CVD, suggesting that it could serve as both a marker and possibly a mediator of atherosclerosis in T1DM. These findings emphasize the importance of specific serum proteins in assessing and managing CVD risk in T1DM.

The American Diabetes Association (ADA) "Standards of Care in Diabetes" includes the ADA's current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, an interprofessional expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA's clinical practice recommendations and a full list of Professional Practice Committee members, please refer to Introduction and Methodology. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

Home-based approaches to type 2 diabetes (T2D) screening in youth may facilitate early diagnosis.

To evaluate feasibility, acceptability, and validity of a continuous glucose monitoring (CGM)-based oral glucose tolerance test (OGTT).

Prospective observational study.

Pediatric Clinical and Translational Research Center.

Youth 8-18-years old with overweight/obesity and prediabetes-range hemoglobin A1c (HbA1c), fasting glucose, or 2-hour glucose on OGTT, and/or ≥1 guideline-based T2D risk factors.

Participants completed two 75g 2-hour OGTT: 1) at research center using serum samples (research-OGTT), and 2) at home using blinded CGM (home-OGTT).

Feasibility: Percentage with valid home-OGTT data (date/time reported, transmitter returned). Acceptability: Survey and interview responses. Validity: Sensitivity, specificity, positive- and negative predictive value (PPV, NPV) of home- versus research-OGTT dysglycemia (fasting ≥100 mg/dL; 2-hour ≥140 mg/dL).

Thirty-nine youth (54% female; 33% Black, 8% Hispanic/Latinx, 13% multiracial, 46% non-Hispanic White; age 14.6 ± 2.0 years; mean BMI 37.0 ± 6.7 kg/m2) participated. HbA1c was 5.7% ± 0.4%, fasting glucose 85.7 ± 8.0 mg/dL, and 2-hour glucose 115.9 ± 25.9 mg/dL. Thirty (77%) had valid home-OGTT data. Acceptability was high (92% excellent/great, 8% neutral). Due to higher average values on home-OGTT, sensitivity and NPV were high (≥80%), while specificity (fasting: 10%; 2-hour: 25%) and PPV (fasting: 3.6%, 2-hour: 18.2%) were low.

Home-OGTT was acceptable, but strategies to precisely capture glucose ingestion timing could improve feasibility. Alternate dysglycemia thresholds may need to be defined prior to using CGM as a method for T2D screening in youth.

To assess the effect of comorbidities, risk classification for chronic kidney disease (CKD) according to albuminuria and eGFR, HbA1c and LDL-cholesterol levels on all-cause mortality in patients with type 1 diabetes (DM1).

The study included all 45,801 DM1 patients from the Finnish Diabetes Registry during 2018-2022. Mortality of patients with DM1 was compared with mortality in non-diabetic population in Finland by estimating standardized mortality rates (SMRs). Poisson regression model was used to estimate the effect of risk factors on the SMR.

A total of 2469 patients died during follow-up. SMR for the total cohort was 1.84 (95 % CI 1.77-1.92) peaking at the age of 30-49 years. The coverage of HbA1c values was 98 %, that of LDL-cholesterol 94 %, and U-ACR and eGFR 80 %. In a multivariate analysis, assessing the effect on mortality, the rate ratio for end-stage renal disease was 2.66, cardiovascular diseases 1.92, mental and behavioural disorders 1.64, foot complications 1.51, high or very high risk for CKD 3.64, LDL-cholesterol ≥2.6 mmol/l 1.33, and HbA1c ≥8 % (64 mmol/mol) 1.27.

There's substantial excess mortality due to DM1 in Finland. Interventions should focus on addressing both renal and cardiovascular risk factors but also pay more attention to mental health.

Insulin resistance (IR), a hallmark of type 2 diabetes mellitus, develops in a significant number of patients with type 1 diabetes mellitus (T1DM) despite the use of insulin therapy to control glycemia. However, little is currently understood regarding the underlying mechanisms of IR in T1DM, especially within the context of chronic insulin treatment. Recent evidence suggests an important influence of glucolipotoxicity in skeletal muscle on insulin sensitivity in T1DM. Thus, this review summarizes our current knowledge regarding impairments in skeletal muscle lipid, glucose, and oxidative metabolism in the development of IR in insulin-treated T1DM.

Diabetes has been indicated to be a risk factor for suicide. We aim to estimate the prevalence of suicide in patients with diabetes.

A meta-analysis using PRISMA methodology was adopted to examine the incidence of suicide in diabetic patients.

From inception to October 2022, three online databases (PubMed, China National Knowledge Infrastructure and Web of Science) were used to search studies.

We used random-effects model to analysis. And our primary outcome was the incidence of suicide death per 100 person-years, and other outcomes were prevalence of suicidal ideation and suicide attempt. To explore the sources of heterogeneity in our study, we performed subgroup and meta-regression analyses.

The suicide death rate in diabetic patients was 0.027 per 100 person-years, with a higher rate for Type 1 Diabetes Mellitus compared to Type 2 Diabetes Mellitus. The prevalence of suicidal ideation in diabetes patients was 0.175, with a higher prevalence in Type 1 Diabetes Mellitus compared to Type 2 Diabetes Mellitus. The prevalence of suicide attempts in diabetes patients was 0.033, indicating a higher rate for Type 2 Diabetes Mellitus compared to Type 1 Diabetes Mellitus.

The results indicate a high rate of suicide among people with diabetes, and this study identifies populations and regions at high risk for suicide. Our review emphasizes interventions in mental health and the improvement of suicide prevention programmes.

The study investigated suicide death, suicidal ideation and suicide attempt in diabetic individuals. Suicide rates are elevated among diabetic patients, and various patient groups face distinct suicide risks. It is important to prioritize the mental well-being of diabetic individuals and enhance interventions, including personalized approaches, to inform public health efforts aimed at preventing and addressing suicide among diabetic patients.

No patient or public involvement.

Objective: To date, there are no widely implemented machine learning (ML) models that predict progression from prediabetes to diabetes. Addressing this knowledge gap would aid in identifying at-risk patients within this heterogeneous population who may benefit from targeted treatment and management in order to preserve glucose metabolism and prevent adverse outcomes. The objective of this study was to utilize readily available laboratory data to train and test the performance of ML-based predictive risk models for progression from prediabetes to diabetes. Methods: The study population was composed of laboratory information services data procured from a large U.S. outpatient laboratory network. The retrospective dataset was composed of 15,029 adults over a 5-year period with initial hemoglobin A1C (A1C) values between 5.0% and 6.4%. ML models were developed using random forest survival methods. The ground truth outcome was progression to A1C values indicative of diabetes (i.e., ≥6.5%) within 5 years. Results: The prediabetes risk classifier model accurately predicted A1C ≥6.5% within 5 years and achieved an area under the receiver-operator characteristic curve of 0.87. The most important predictors of progression from prediabetes to diabetes were initial A1C, initial serum glucose, A1C slope, serum glucose slope, initial HDL, HDL slope, age, and sex. Conclusions: Leveraging readily obtainable laboratory data, our ML risk classifier accurately predicts elevation in A1C associated with progression from prediabetes to diabetes. Although prospective studies are warranted, the results support the clinical utility of the model to improve timely recognition, risk stratification, and optimal management for patients with prediabetes.

Islet transplantation has been associated with better metabolic control and quality of life than insulin treatment alone, but direct evidence of its effect on hard clinical endpoints is scarce. We aimed to assess the effect of islet transplantation on patient-graft survival in kidney transplant recipients with type 1 diabetes.

In this retrospective cohort study, we enrolled all patients with type 1 diabetes who received a kidney graft in France during the study period, identified from the CRISTAL nationwide registry. Non-inclusion criteria included recipients from transplant centres that never proposed islet transplantation during the study period, recipients with a functional pancreas throughout the follow-up duration, recipients with more than two kidney transplants, HLA-sensitised recipients, recipients with less than 1 year of follow-up after kidney transplantation, misclassified recipients with type 2 diabetes, recipients aged over 65 years, recipients of kidney grafts from Donation after Circulatory Death donors, recipient with HIV or hepatitis, recipients with cancer, and recipients of combined liver-kidney transplants. Patients who also received islet-after-kidney (IAK) transplantation were compared with controls who received kidney transplantation alone according to a 1:2 matching method based on time-dependent propensity scores, ensuring patients comparability at the time of islet transplantation. The primary outcome was patient-graft survival, a composite outcome defined by death, re-transplantation, or return to dialysis.

Between Jan 1, 2000, and Dec 31, 2017, 2391 patients with type 1 diabetes were identified as having received a kidney transplant, 47 patients of whom also received an islet transplantation. 2002 patients were not eligible for islet transplantation and 62 were excluded due to missing data. 327 eligible recipients from 15 centres were included in the study dataset for the target trial emulation. 40 patients who received IAK transplantation were successfully matched to 80 patients who received kidney transplantation alone. 13 (33%) of 40 patients in the IAK transplantation group returned to dialysis or died, compared with 36 (45%) of 80 patients in the kidney transplantation alone group. We found a significant benefit of islet transplantation compared with kidney transplantation alone on patient-graft survival, with a hazard ratio (HR) of 0·44 (95% CI 0·23-0·88; p=0·022), mainly explained by a protective effect on the risk of death (HR 0·41, 0·13-0·91; p=0·042). There was no meaningful association between IAK and death-censored graft survival (0·73, 0·30-1·89; p=0·36).

In kidney transplant recipients with type 1 diabetes, IAK transplantation was associated with a significantly better patient-graft survival compared with kidney transplantation alone, mainly due to a protective effect on the risk of death. These results potentially serve as compelling grounds for advocating wider access to islet transplantation in patients with type 1 diabetes undergoing kidney transplant, as reimbursement of islet transplantation is provided in few countries worldwide.

Programme Hospitalier de la Recherche Clinique, Fondation pour la Recherche Medicale, and Fonds de Dotation Line Renaud-Loulou Gasté.

Atherosclerotic cardiovascular disease (ASCVD) is accelerated in people with diabetes. Dyslipidemia, hyperglycemia, oxidative stress, and inflammation play a role via a variety of mechanisms operative in the artery wall. In addition, some unique features predispose people with type 1 diabetes to accelerated atherosclerosis. Various organizations have created guidelines that provide advice regarding screening, risk assessment, and roadmaps for treatment to prevent ASCVD in diabetes. Management of dyslipidemia, especially with statins, has proven to be of immense benefit in the prevention of clinical CVD. However, since many patients fail to attain the low levels of low-density lipoproteins (LDL) recommended in these guidelines, supplemental therapy, such as the addition of ezetimibe, bempedoic acid or PCSK9 inhibitors, is often required to reach LDL goals. As a result, the upfront use of combination therapies, particularly a statin plus ezetimibe, is a rational initial approach. The addition to statins of drugs that specifically lower triglyceride levels has not proven beneficial, although the addition of icosapent-ethyl has been shown to be of value, likely by mechanisms independent of triglyceride lowering. Newer treatments in development, including apoC-III and ANGPTL3 inhibitors, seem promising in further reducing apoB-containing lipoproteins.

To describe trends in risk factor control and serious hypoglycaemia in people with type 1 diabetes and to assess the effect of starting continuous glucose monitoring (CGM) in the real-world setting.

Two cross-sectional surveys including 5746 individuals in 2012 and 18,984 individuals in 2020 based on data recorded in the Norwegian Diabetes Register for Adults (NDR-A) and an analysis of a longitudinal cohort of 2057 individuals where data on CGM and HbA1c were available in the NDR-A in 2012 and 2020.

In the cross-sectional surveys mean HbA1c decreased from 66 mmol/mol (99% CI 65, 66) (8.2%) in 2012 to 61 mmol/mol (99% CI 61, 61) (7.7%) in 2020 (p < 0.0001). The proportion reporting serious hypoglycaemia decreased from 16.9 to 6.2% in 2020 (p < 0.0001). Mean LDL-cholesterol decreased from 2.80 (99% CI 2.78, 2.83) to 2.63 (99% CI 2.61, 2.65) mmol/l in 2020 (p < 0.0001). Mean blood pressure increased slightly. In the CGM cohort, we found a 3 mmol/mol (0.3%) greater improvement in mean HbA1c and a greater reduction in serious hypoglycaemia (-12.3% vs. -6.2%) among individuals that had started using CGM between 2013 and 2020 when compared with individuals that had not started using CGM.

Between 2012 and 2020, we found marked improvements in glycaemic control and a considerable decrease in the proportion of individuals reporting serious hypoglycaemia. The proportion of individuals using CGM increased substantially and individuals that had started using CGM by 2020 showed greater improvement in glycaemic control and less serious hypoglycaemia.

Over the past decades, life expectancy of people with type 1 diabetes has increased considerably, which brings potential challenges due to the process of aging. Cognitive aging and dementia, as well as reductions in visual acuity, hearing and dexterity, can influence the frequency and quality of daily self-management activities, including medication taking and insulin dosing, glucose self-monitoring, and healthy eating. This can increase the risk for hypo- and hyperglycemic events, which, in turn, may contribute to cognitive decline. Because there is a gap in understanding the barriers and facilitators of self-management in older adults with type 1 diabetes and the relationship to cognitive functioning, the authors 1) review the available literature on cognitive aging and type 1 diabetes, 2) describe what self-management in later adulthood entails and the cognitive functions required for effective self-management behaviors, 3) analyze the interaction between type 1 diabetes, cognition, aging, and self-management behaviors, and 4) describe the barriers and facilitators for self-management throughout the life span and how they may differ for older people. Potential evidence-based practices that could be developed for older adults with type 1 diabetes are discussed. There is need for further studies that clarify the impact of aging on T1D self-management, ultimately to improve diabetes care and quality of life.

Adults with type 1 diabetes (T1D) are considered at increased risk for cognitive impairment and accelerated brain aging. However, longitudinal data on cognitive impairment and dementia in this population are scarce.

To identify risk factors associated with cognitive performance and cognitive impairment in a longitudinal sample of older adults with T1D.

We analyzed data collected as part of the Wireless Innovation for Seniors with Diabetes Mellitus (WISDM) Study, in which 22 endocrinology practices participated. Randomized participants with T1D ≥60 years of age who completed at least one cognitive assessment were included in this study (n = 203). Cognitive impairment was classified using published recommendations.

Older age, male sex, non-private health insurance, worse daily functioning, diagnosis of neuropathy, and longer duration of diabetes were associated with worse cognitive performance, but not cognitive impairment. 49 % and 39 % of the sample met criteria for cognitive impairment at baseline and 52 weeks respectively. Of the participants that had data at both time points, 10 % were normal at baseline and impaired at 52 weeks and 22 % of participants (44 % of those classified with cognitive impairment at baseline) reverted to normal over 52 weeks.

This study indicated that several demographic and clinical characteristics are associated with worse cognitive performance in older adults with T1D, but there were no associations between these characteristics and cognitive impairment defined by NIH Toolbox cognitive impairment criteria. Caution is warranted when assessing cognition in older adults with T1D, as a large percentage of those identified as having cognitive impairment at baseline reverted to normal after 52 weeks. There is need for future studies on the interrelationship of cognition and aging to better understand the effects of T1D on cognitive health, to improve clinical monitoring and help mitigate the risk of dementia in this population.

Microvascular complications increase the risk of cardiovascular disease and premature death in adults with type 1 diabetes. We examined the association between microvascular complications during adolescence, including cardiac autonomic nerve dysfunction and subsequent mortality. Research Design and Methods. We undertook data linkage with the Australian National Death Index in a cohort of 409 adolescents (diagnosed between 1973 and 1993), 48% male, median age at final complications assessment 17.4 years (interquartile range: 16.0-18.9), followed longitudinally for median 22.3 years (21.0-23.4) from diagnosis. Generalized estimating equations (GEE) were used to examine associations between mortality and adolescent complications. Mortality risk was calculated as standardized mortality ratio (SMR).

At final adolescent visit, 20% had CAN abnormality, 30% abnormal pupillary response, 20% albuminuria, 40% early elevation of albumin excretion rate (AER) and 45% retinopathy. Data linkage 8-13 years later showed 14 were deceased (3% of cohort), 57% male, median age 28.3 years (24.8-32.9). Acute or chronic diabetes complications accounted for 25% of deaths. In multivariable GEE, elevated AER (OR 4.54, 1.23-16.80, p=0.030), pupillary abnormality (OR 4.27, 1.20-15.22, p=0.023), systolic blood pressure SDS (OR 2.17, 1.26-3.74, p=0.005) and CAN (OR 4.65, 1.03-21.0, p=0.045) predicted mortality. HbA1c was not significant. SMR was 2.5 (1.4-4.2) and was higher in females (SMR 3.5, 1.3-7.8) but not in males (SMR 2.1, 0.9-4.0).

Mortality in young adults with type 1 diabetes is predicted by subclinical markers of autonomic neuropathy and elevated AER during adolescence, but not glycemia. Mortality was over twice that of the background population in females but not in males.

To evaluate real-world outcomes in people with Type 1 Diabetes (PwT1D) initiated on Omnipod DASH® Insulin Management System.

Anonymized clinical data were submitted to a secure web-based tool within the National Health Service network. Hemoglobin A1c (HbA1c), sensor-derived glucometrics, total daily dose of insulin (TDD), and patient-reported outcome changes between baseline and follow-up were assessed. Individuals were classified to "new-to-pump" (switched from multiple daily injections) and "established-on-pump" (switched from a tethered insulin pump) groups.

276 individuals from 11 centers [66.7 % female; 92 % White British; median age 41 years (IQR 20-50); diabetes duration 20 years (IQR 11-31); 49.3 % within "new-to-pump" group] were included. Baseline HbA1c was 8.0 ± 1.3 % (64 ± 14 mmol/mol). At follow-up [3 years (IQR 1.5-3.2)], HbA1c reduced by 0.3 % [(3 mmol/mol); p = 0.002] across the total population, 0.4 % [(5 mmol/mol); p = 0.001] in those "new-to-pump" and remained unchanged in those "established-on-pump". TDD decreased in the "new-to-pump" cohort (baseline:44.9 ± 21.0units vs follow-up:38.1 ± 15.4units, p = 0.002). Of those asked, 141/143 (98.6 %) stated Omnipod DASH had a positive impact on quality of life.

Omnipod DASH was associated with improvements in HbA1c in PwT1D "new-to-pump" and maintained previous HbA1c levels in those "established-on-pump". User satisfaction in all groups and TDD reduction in those "new-to-pump" were reported.

The LIFT-YA (leveraging intensive follow-up treatment in young adults) quality improvement program was developed to address clinical and social barriers in young adults (YA) with type 1 diabetes (T1D), using telehealth visits to promote clinic attendance and improve diabetes care.

LIFT-YA enrolled YA aged 18-30 with T1D and HbA1c >8% (64 mmol/mol) who had established adult care in our diabetes clinic. The 6-month, 7-visit hybrid program was facilitated by a case manager serving as the liaison between participants and the care team. The primary end-points were within-group and between-group changes from the baseline in HbA1c at the last visit and adoption of continuous glucose monitoring (CGM).

Of the 57 eligible YA, 24 were enrolled and 33 were unable to participate (UTP). Thirteen of the enrolled participants attended at least 4/7 visits ("completers", C), whereas 11 were noncompleters (NC). HbA1c at the end of the program was significantly lower in the C versus UTP group [median -1.0; IQR (-0.6, -2.5) vs -0.25 (0.2, -1.0) in UTP; P < .05]. The percentage of CGM users significantly increased by 70% in the C group (P < .05), but did not change in the NC and UTP groups. Limited access to telehealth and the high cost of frequent visits were the main hurdles preventing enrollment into or completion of the program.

The LIFT-YA pathway was associated with a significant HbA1c reduction and an increase in the adoption of CGM. Policy changes are necessary to expand access to LIFT-YA and other programs for high-risk YA with T1D in underserved communities and across all backgrounds.

The American Diabetes Association (ADA) "Standards of Care in Diabetes" includes the ADA's current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, an interprofessional expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA's clinical practice recommendations and a full list of Professional Practice Committee members, please refer to Introduction and Methodology. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

A steady rise in cardiovascular morbidity and mortality has been observed in young adults within the last decades. This trend corresponds to an increasing prevalence of traditional cardiovascular risk factors such as obesity and diabetes mellitus type 2 among young adults living in developed countries. Moreover, age-specific risk factors, such as substance abuse, contraceptive medication, and pregnancy-related diseases also correlate with an increased incidence of cardiovascular diseases. In this review, we discuss the available data for young adults on the epidemiology and the rationale for the causality of traditional and newly emerging risk factors of atherosclerotic cardiovascular diseases. We focus on gender-related differences in the exposure to these risk factors, investigate the recent data regarding screening and risk stratification in the young adult population, and describe the current state of the art on lifestyle and therapeutic intervention strategies in the primary prevention setting.

The objective was to identify candidate patient reported outcomes with potential to inform individual patient care and service development for inclusion in a digital outcome set to be collected in routine care, as part of an international project to enhance care outcomes for people with diabetes.

PubMed, COSMIN and COMET databases were searched. Published studies were included if they recommended patient reported outcomes that were clinically useful and/or important to people with diabetes. To aid selection decisions, recommended outcomes were considered in terms of the evidence endorsing them and their importance to people with diabetes.

Twenty-seven studies recommending 53 diabetes specific outcomes, and patient reported outcome measures, were included. The outcomes reflected the experience of living with diabetes (e.g. psychological well-being, symptom experience, health beliefs and stigma) and behaviours (e.g. self-management). Diabetes distress and self-management behaviours were most endorsed by the evidence.

The review provides a comprehensive list of candidate outcomes endorsed by international evidence and informed by existing outcome sets, and suggestions for measures.

The review offers evidence to guide clinical application. Integrated measurement of these outcomes in care settings holds enormous potential to improve provision of care and outcomes in diabetes.

To evaluate presence of treatment effect heterogeneity of intensive insulin therapy (INT) on occurrence of major adverse cardiovascular events (MACE) in individuals with type 1 diabetes.

In participants from the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) study, individual treatment effect of INT (≥3 daily insulin injections/insulin pump therapy) versus conventional therapy (once/twice daily insulin) on the risk of MACE was estimated using a penalized Cox regression model including treatment-by-covariate interaction terms.

In 1441 participants, 120 first MACE events were observed and 1279 individuals (89%) were predicted to benefit from INT with regard to MACE risk reduction. The study population was divided into four groups based on predicted treatment effect: one group with no predicted benefit and three tertiles with predicted treatment benefit. The median absolute reduction in 30-year risk of MACE across groups of predicted treatment effect ranged from -0.2% (i.e. risk increase; interquartile range [IQR] -0.1% to -0.3%) in the group with no predicted benefit to 6.6% (i.e. risk reduction; IQR 3.8%-10.9%; number needed to treat 15) in the highest tertile of predicted benefit. The observed benefit of preventing microvascular complications was stable across all subgroups of predicted MACE benefit.

Although INT reduces the risk of MACE in the majority of individuals with type 1 diabetes, benefit varies substantially. These individual differences in the effect of INT underline the necessity for a better understanding of the individual response to intensive treatment.

This study sought to evaluate the association between the degree of hypertension and subclinical coronary atherosclerosis in asymptomatic subjects with and without diabetes mellitus (DM). We retrospectively analyzed 7,352 asymptomatic subjects (mean age 52.8 ± 7.8 years; 4,689 [63.8%] men) with no history of coronary artery disease who voluntarily underwent coronary computed tomography angiography as part of a general health examination. The classification of hypertension was adapted from the American College of Cardiology and American Heart Association 2017 guideline. Subclinical coronary atherosclerosis was defined as the presence of coronary plaque by coronary computed tomography angiography. In subjects without DM (n = 6,598), after the adjustment for cardiovascular risk factors, subclinical coronary atherosclerosis was significantly associated with both stage 1 hypertension (adjusted odds ratio [aOR] 1.356; 95% confidence interval [CI], 1.167 to 1.575; p <0.001) and stage 2 hypertension (aOR, 1.614; 95% CI, 1.329 to 1.961; p <0.001) groups compared with the normal group. In contrast, in subjects with DM (n = 754), there was no statistical difference in the aOR of the stage 1 hypertension group for the presence of coronary plaque (aOR, 1.449; 95% CI, 0.982 to 2.136; p = 0.061). However, the stage 2 hypertension group had a significant association with subclinical coronary atherosclerosis (aOR, 2.067; 95% CI, 1.287 to 3.322; p = 0.003). In subjects without DM, both stages 1 and 2 hypertension were associated with subclinical coronary atherosclerosis. However, in subjects with DM, stage 2 hypertension was only associated with an increased risk of subclinical coronary atherosclerosis.

Whereas islet autoantibodies (AAs) are well-established risk factors for developing type 1 diabetes (T1D), there is a lack of biomarkers endorsed by regulators to enrich clinical trial populations for those at risk of developing T1D. As such, the development of therapies that delay or prevent the onset of T1D remains challenging. To address this drug development need, the Critical Path Institute's T1D Consortium (T1DC) acquired patient-level data from multiple observational studies and used a model-based approach to evaluate the utility of islet AAs as enrichment biomarkers in clinical trials. An accelerated failure time model was developed, discussed in our previous publication, which provided the underlying evidence required to receive a qualification opinion for islet AAs as enrichment biomarkers from the European Medicines Agency (EMA) in March 2022. To further democratize the use of the model for scientists and clinicians, we developed a Clinical Trial Enrichment Graphical User Interface. The interactive tool allows users to specify trial participant characteristics, including the percentage of participants with a specific AA combination. Users can specify ranges for participant baseline age, sex, blood glucose measurement from the 120-minute timepoints of an oral glucose tolerance test, and HbA1c. The tool then applies the model to predict the mean probability of a T1D diagnosis for that trial population and renders the results to the user. To ensure adequate data privacy and to make the tool open-source, a deep learning-based generative model was used to generate a cohort of synthetic subjects that underpins the tool.

Background: Peripheral artery disease (PAD) is a risk factor for adverse limb events (LE) and cardiovascular events (CVE) that coexists with type 1 (T1) and 2 (T2) diabetes mellitus (DM). Little is known about comparative risk of LE and CVE in T1/T2 DM patients with PAD. Patients and methods: We queried our database of 40,144 patients ≥18 years old who underwent ankle brachial index (ABI) measurement from 01/1996-02/2020. We isolated T1/T2 DM patients with PAD diagnosed by ankle brachial index (ABI; low [<1.0] or elevated [>1.4]) and retrieved demographics including glycated hemoglobin (HbA1c). Primary outcomes were LE (critical limb ischemia/vascular amputation) and CVE (myocardial infarction/ischemic stroke). All-cause mortality was a secondary outcome. Multivariable Cox proportional regression yielded hazard ratios (HR) with 95% confidence intervals (CI) after adjusting for pertinent risk factors including age, hypertension, hyperlipidemia, smoking, and HbA1c. Results: Our study found 10,156 patients with PAD and DM (34% T1DM, 66% T2DM) with median follow-up time 34 mo (IQR 85 mo). T1DM patients were younger than T2DM (mean age 67 vs. 70 years), with higher median HbA1c (7.7 [IQR 1.9] vs. 6.7% [IQR 1.6]), and more prevalent hypertension, hyperlipidemia, CAD, and CKD. Antiplatelet and statin use was equivocal. Elevated ABI was more common in T1DM (47 vs. 28%). LE occurred in 23% and CVE in 12% patients. LE risk was higher in T1 than T2 DM patients (HR 1.58 [95% CI 1.44, 1.73], p<0.0001), but CVE and all-cause mortality were equivocal. These observations were preserved across ABI and HbA1c subgroup analyses. Conclusions: PAD patients with T1DM had a higher LE risk than those with T2DM, even after adjustment for glycemic control and pertinent risk factors, but CVE risk and all-cause mortality were equivocal. These data suggest a potential role for more intensive LE risk modification in PAD patients with T1DM, but further investigation is needed.

In May 2023, the Committee of Clinical Practice Guidelines of the Korean Diabetes Association published the revised clinical practice guidelines for Korean adults with diabetes and prediabetes. We incorporated the latest clinical research findings through a comprehensive systematic literature review and applied them in a manner suitable for the Korean population. These guidelines are designed for all healthcare providers nationwide, including physicians, diabetes experts, and certified diabetes educators who manage patients with diabetes or individuals at risk of developing diabetes. Based on recent changes in international guidelines and the results of a Korean epidemiological study, the recommended age for diabetes screening has been lowered. In collaboration with the relevant Korean medical societies, recently revised guidelines for managing hypertension and dyslipidemia in patients with diabetes have been incorporated into this guideline. An abridgment containing practical information on patient education and systematic management in the clinic was published separately.

Many factors influence disease management and glycemic levels in children with type 1 diabetes (T1D). However, these concepts are hard to examine in children using only a qualitative or quantitative research paradigm. Mixed methods research (MMR) offers creative and unique ways to study complex research questions in children and their families.

A focused, methodological literature review revealed 20 empirical mixed methods research (MMR) studies that included children with T1D and/or their parents/caregivers. These studies were examined and synthesized to elicit themes and trends in MMR. Main themes that emerged included disease management, evaluation of interventions, and support. There were multiple inconsistencies between studies when reporting MMR definitions, rationales, and design. Limited studies use MMR approaches to examine concepts related to children with T1D. Findings from future MMR studies, especially ones that use child-report, may illuminate ways to improve disease management and lead to better glycemic levels and health outcomes.

Nature-derived polymers, or biopolymers, are among the most employed materials for the development of nanocarriers. Chitosan (CS) is derived from the acetylation of chitin, and this biopolymer displays features such as biocompatibility, biodegradability, low toxicity, and ease of modification. CS-based nano-scale delivery systems have been demonstrated to be promising carriers for drug and gene delivery, and they can provide site-specific delivery of cargo. Owing to the high biocompatibility of CS-based nanocarriers, they can be used in the future in clinical trials. On the other hand, diabetes mellitus (DM) is a chronic disease that can develop due to a lack of insulin secretion or insulin sensitivity. Recently, CS-based nanocarriers have been extensively applied for DM therapy. Oral delivery of insulin is the most common use of CS nanoparticles in DM therapy, and they improve the pharmacological bioavailability of insulin. Moreover, CS-based nanostructures with mucoadhesive features can improve oral bioavailability of insulin. CS-based hydrogels have been developed for the sustained release of drugs and the treatment of DM complications such as wound healing. Furthermore, CS-based nanoparticles can mediate delivery of phytochemicals and other therapeutic agents in DM therapy, and they are promising compounds for the treatment of DM complications, including nephropathy, neuropathy, and cardiovascular diseases, among others. The surface modification of nanostructures with CS can improve their properties in terms of drug delivery and release, biocompatibility, and others, causing high attention to these nanocarriers in DM therapy.

Patients with type 1 diabetes mellitus (T1DM) and poor glycaemic control are at high risk of developing microvascular and macrovascular complications. The aim of this study was to determine if a quality improvement collaborative (QIC) initiated by the Norwegian Diabetes Register for adults (NDR-A) could reduce the proportion of patients with T1DM with poor glycaemic control (defined as glycated haemoglobin (HbA1c)≥75 mmol/mol) and reduce mean HbA1c at participating clinics compared with 14 control clinics.

Multicentre study with controlled before and after design. Representatives of 13 diabetes outpatient clinics (n=5145 patients with T1DM) in the intervention group attended four project meetings during an 18-month QIC. They were required to identify areas requiring improvement at their clinic and make action plans. Continuous feedback on HbA1c outcomes was provided by NDR-A during the project. In total 4084 patients with type 1 diabetes attended the control clinics.

Between 2016 and 2019, the overall proportion of patients with T1DM and HbA1c≥75 mmol/mol in the intervention group were reduced from 19.3% to 14.1% (p<0.001). Corresponding proportions in the control group were reduced from 17.3% (2016) to 14.4% (2019) (p<0.001). Between 2016 and 2019, overall mean HbA1c decreased by 2.8 mmol/mol (p<0.001) at intervention clinics compared with 2.3 mmol/mol (p<0.001) at control clinics. After adjusting for the baseline differences in glycaemic control, there were no significant differences in the overall improvement in glycaemic control between intervention and control clinics.

The registry linked QIC did not result in a significantly greater improvement in glycaemic control at intervention clinics compared with control clinics. However, there has been a sustained improvement in glycaemic control and importantly a significant reduction in the proportion of patients with poor glycaemic control at both intervention and control clinics during and after the QIC time frame. It is possible that some of this improvement may be due to a spillover effect from the QIC.