Barriers to adoption of biosimilar insulins in Europe: A mixed-methods study.

Background: Despite the introduction of biosimilar insulins to improve affordability and enhance patient access, their adoption remains limited in Europe.

Objectives: This study aims to (i) provide an up-to-date overview of EMA-approved insulin products and their reimbursement status across selected European countries, and (ii) explore the k,ey factors influencing physicians' prescribing decisions regarding biosimilar and originator insulin.

Methods: A mixed-method design was applied, comprising (i) a quantitative analysis of EMA-approved insulin products and their reimbursement status in nine European countries, and (ii) semi-structured interviews with physicians (N = 20).

Waste Reduction With Diabetes Devices: Barriers and Ways Ahead.

Reducing the environmental footprint of medical devices used by people with diabetes remains a challenge within the constraints of current regulatory frameworks. These frameworks, which rightly prioritize patient safety, sterility, and traceability, introduce substantial scientific, operational, and legal barriers to sustainable innovation. Efforts to integrate recycled or biodegradable materials, minimize packaging, or redesign products are often impeded by the complexity of revalidation processes, extensive documentation requirements, and a general lack of regulatory precedent.

Call for Standardization of C-Peptide Measurement.

Background: An impaired β-cell function is a key contributor to the pathophysiology of diabetes mellitus that can be estimated by the biomarker C-peptide. Measurement of C-peptide can therefore be used for prediction, diagnosis, and subclassification of diabetes. Furthermore, C-peptide assists in the prediction of therapeutic response and guiding therapeutic decisions.

Recycling Insulin Pens: A Call for Action!

Insulin pens are widely used by people with diabetes for insulin application. Most often ready-to-use pens are used; however, disposal of these pens generates a considerable amount of plastic waste. Until now such pens have almost always been disposed of with household waste.

Heat as a prognostic factor for the development and progression of diabetes: a systematic review and meta-analysis.

This is a protocol for a Cochrane Review (prognosis). The objectives are as follows: To assess the prognostic value of ambient heat exposures as a risk factor for diabetes and diabetes progression. This objective can be framed in two syntheses following the PICOTS scheme as demonstrated in Table 1.

The need to transition from paper to electronic instructions for use for diabetes devices.

Regulatory agencies, such as the European Commission and the U.S. Food and Drug Administration, are now permitting electronic instructions for use (eIFUs) to be distributed alongside paper instructions for use (IFUs) for medical devices.

Direct-to-Consumer Testing: Relevance for Diabetes Therapy.

The performance of laboratory measurements by the people with diabetes (PwD) themselves ("direct-to-consumer testing"; DTCT) is conceptually not new for diabetology. The number of parameters for which such tests are available might increase in the next years, ie, it might go beyond glucose and glycated hemoglobin (HbA). One has to consider several pro and con arguments for DTCT.

The Use of Continuous Glucose Monitoring to Diagnose Stage 2 Type 1 Diabetes.

This consensus report evaluates the potential role of continuous glucose monitoring (CGM) in screening for stage 2 type 1 diabetes (T1D). CGM offers a minimally invasive alternative to venous blood testing for detecting dysglycemia, facilitating early identification of at-risk individuals for confirmatory blood testing. A panel of experts reviewed current evidence and addressed key questions regarding CGM's diagnostic accuracy and screening protocols.

One Size Does Not Fit All: The Need for Sex-Specific Precision Medicine in Diabetes Technology.

Incorporating sex-specific factors in diabetes research and treatment is essential for advancing precision medicine. There are critical gaps in understanding and applying sex-related differences. Female-specific diabetes pathophysiology manifests in three major areas: life cycle phases (including puberty, pregnancy, and menopause), lifestyle factors (such as responses to nutrition and physical activity), and insulin pharmacology.

Continuous glucose monitoring as equinox of nocturnal and daytime hypoglycaemia in type 1 diabetes: insights from the randomized controlled HypoDE trial.

Aims: This study re-analysed data from the HypoDE trial to assess the prevalence of nocturnal hypoglycaemia, evaluate the impact of continuous glucose monitoring (CGM) on nocturnal and daytime hypoglycaemia, and explore their influence on severe hypoglycaemia (SH).

Methods: The HypoDE trial was a randomized controlled trial involving 141 adults with type 1 diabetes, impaired hypoglycaemia awareness, or prior SH. Participants were randomized to CGM (Dexcom G5) or self-monitoring of blood glucose (control).

CVOT summit report 2024: new cardiovascular, kidney, and metabolic outcomes.

The 10th Cardiovascular Outcome Trial (CVOT) Summit: Congress on Cardiovascular, Kidney, and Metabolic Outcomes was held virtually on December 5-6, 2024. This year, discussions about cardiovascular (CV) and kidney outcome trials centered on the recent findings from studies involving empagliflozin (EMPACT-MI), semaglutide (STEP-HFpEF-DM and FLOW), tirzepatide (SURMOUNT-OSA and SUMMIT), and finerenone (FINEARTS-HF). These studies represent significant advances in reducing the risk of major adverse cardiovascular events (MACE) and improving metabolic outcomes in heart failure with preserved ejection fraction (HFpEF), chronic kidney disease (CKD), and obstructive sleep apnea (OSA).

Accuracy and Reliability of Intermittent Scanning and Real-Time Continuous Glucose Monitoring Systems in Diabetes Emergencies.

Background: Diabetes care is a major challenge of patients treated in hospitals. A continuous glucose monitoring system (CGM) provides a more comprehensive assessment of glucose control than capillary blood glucose measurements. Especially in emergencies, data on CGM use in inpatients are limited.

Advance Insulin Injection Technique and Education With FITTER Forward Expert Recommendations.

Injectable insulin therapy is a valuable therapeutic option for millions of people with diabetes worldwide. However, many people with diabetes undergoing insulin therapy experience suboptimal outcomes and/or have complications because of inadequate injection technique and training. Practical, current, evidence-based recommendations are mandatory for primary care practitioners and diabetes specialists alike to address unmet needs in insulin injection technique, education, and consequent outcomes.

Existing Knowledge Gaps in Risk Factors and Consequences of Lipohypertrophy in People Using Continuous Subcutaneous Insulin Infusion Therapy: A Systematic Review and Meta-analysis.

Background: Lipohypertrophy is a common skin complication in individuals with insulin-treated diabetes, but this condition in those using insulin pumps (continuous subcutaneous insulin infusion, CSII) remains poorly understood. This study aimed to identify and summarize scientific evidence regarding the risk factors and clinical consequences of lipohypertrophy in people using CSII.

Methods: Medical databases (MEDLINE/PubMed, Embase, CENTRAL) were searched to identify relevant studies published in English from 1990 to March 19, 2024.

Risk factors for Lipohypertrophy in People With Insulin-Treated Diabetes: A Systematic Meta-Analysis.

Background: Lipohypertrophy is a common skin complication in people with insulin-treated diabetes. Despite its high prevalence and potential impact on diabetes management and outcomes, published data regarding the risk factors for the development of this complication are contradictory. The study aimed to determine risk factors for lipohypertrophy related to patient characteristics and insulin therapy.

Environment, Climate, and Diabetes: An International Topic.

Every person with diabetes is affected by changes in the environment and climate. At the same time, the therapy of many people itself has a negative impact on these factors. One might assume that the relevant professional associations and health organizations, as well as health policymakers, have initiated appropriate activities.

Quantification of Different Types of Waste and Batteries Associated With the Widespread Usage of Continuous Glucose Monitoring Systems.

Background: People with diabetes benefit from continuous glucose monitoring (CGM) systems. A downside of these valuable aids for diabetes management is the generation of a tremendous amount of waste. This study aimed to quantify this CGM-related waste.

Heat-Stable Insulins: Any Progress?

Millions of people with diabetes have no or only limited access to electricity that limits their ability to store insulin according to the recommendations of the insulin manufacturer in general. At the same time, environmental temperatures are increasing in many countries which have a negative impact on the glucose-lowering effect of insulin not stored adequately. Therefore, the availability of heat-stable insulin formulations that do not require constant cooling would be of help for many patients; however, despite this clinical need, apparently not many are in clinical development.

Predicting Glucose Values: A New Era for Continuous Glucose Monitoring.

The last 25 years of CGM have been characterized above all by providing better and more accurate glucose values in real time and analyzing the measured glucose values. Trend arrows are the only way to look into the future, but they are often too imprecise for therapy adjustment. While AID systems provide algorithms to use glucose values for glucose control, this has not been possible with stand-alone CGM systems, which are most used by people with diabetes.