The Burden of Suboptimal Insulin Dosing in People with Diabetes in Spain: Barriers and Solutions from the Physician Perspective.

Background: This study aimed to determine physicians' perceptions of the extent of suboptimal insulin dosing and the barriers and solutions to optimal dosing in people with diabetes (PwD) treated with insulin. Methods: A cross-sectional online survey was conducted in four countries with primary care physicians and endocrinologists treating PwD using insulin pens, which included 53 questions on physicians' characteristics and their perceptions of the behaviors of PwD in relation to insulin dosing routines, unmet needs and potential solutions. Analyses were descriptive. Results: Of the 160 physicians (80 primary care physicians, 80 specialists) surveyed in Spain, 58.1% were male and 88.8% had been qualified to practice for more than five years. Most physicians (>65%) indicated that 0-30% of PwD missed or skipped, mistimed, or miscalculated an insulin dose in the last 30 days. Common reasons for these actions were that PwD forgot, were out of their normal routine, were too busy or distracted, or were unsure of how much insulin to take. To optimize insulin dosing, over 75% of physicians considered it very helpful for PwD to have real-time insulin dosing calculation guidance, mobile app reminders, a device automatically recording glucose measurements and/or insulin, having insulin and glucose data in one place, and having the time for more meaningful conversations about insulin dosing routines. Conclusion: According to physicians' perspectives, suboptimal insulin dosing remains common among PwD. This survey highlights the need for integrated and automated insulin dosing support to manage the complexity of insulin treatment, improve communications between PwD and physicians, and ultimately improve outcomes for PwD.

Disease and Economic Burden of Poor Metabolic and Weight Control in Type 2 Diabetes in Spain: A Systematic Literature Review.

INTRODUCTION: Poor metabolic control and excess body weight are frequently present in people with type 2 diabetes (PwT2D). METHODS: A systematic literature review was conducted to identify observational studies reporting clinical, economic, and health-related quality of life (HRQoL) outcomes associated with poor metabolic (according to HbA1c, blood pressure [BP] and low density lipoprotein cholesterol [LDL-C] levels) and/or weight control (defined by a body mass index [BMI] ≥ 30 kg/m2) in adults with T2D in Spain, including articles published in either Spanish or English between 2013 and 2022 and conference abstracts from the last 2 years. RESULTS: Nine observational studies were included in the analysis. Poor glycemic control (HbA1c ≥ 7%) was associated with cardiovascular disease (CVD), increased requirements for antidiabetic medications, higher and more frequent weight gain, a greater probability of hypoglycemia and dyslipidemia, and worse health-related quality of life (HRQoL). Uncontrolled BP in PwT2D was related with the presence of CVD, worse metabolic control, and higher BMI and abdominal perimeter values. Poor LDL-C control or dyslipidemia was associated with CVD, hypoglycemia, and elevated HbA1c and triglycerides levels. The presence of a BMI ≥ 30 kg/m2 was related to CVD and hypoglycemia, a higher prevalence of metabolic syndrome and worse BP control. Direct medical costs were found to be higher in PwT2D when coexisting with HbA1c levels ≥ 7%, uncontrolled BP or obesity. Increased total costs, including productivity losses, were also detected in those who presented uncontrolled BP and a BMI ≥ 30 kg/m2, and when poor weight control existed together with HbA1c ≥ 8% and poorly controlled BP. CONCLUSION: Gathered evidence supports the high clinical, economic and HRQoL burden of poor metabolic and/or weight control in PwT2D in Spain and reinforces the importance of prioritizing its control to reduce the associated burden, at both the individual and healthcare system levels.

Glycaemic Control and Weight Reduction: A Narrative Review of New Therapies for Type 2 Diabetes.

Early and intensive treatment of type 2 diabetes (T2D) has been associated with lower risk of diabetes-related complications. Control of overweight and obesity, which are strongly associated with T2D and many of its complications, is also key in the management of the disease. New therapies allow for individualised glycaemic control targets with greater safety. Thus, in patients with a higher cardiovascular and renal risk profile, current guidelines encourage early treatment with metformin together with glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and sodium-glucose co-transporter-2 inhibitors with proven cardiovascular benefit. GLP-1 RAs combine highly efficacious glucose-lowering activity with a reduced risk of hypoglycaemia. Recently, tirzepatide, a first-in-class drug that activates both glucose-dependent insulinotropic polypeptide and GLP-1 receptors, has demonstrated very high efficacy in glycated haemoglobin (HbA1c) and weight reduction in clinical trials. Tirzepatide has the potential to help people with T2D reach recommended glycaemic and weight targets (HbA1c < 7% and > 5% weight reduction) and to allow some patients to reach HbA1c measurements close to normal physiological levels and substantial weight reduction. In 2022, tirzepatide was approved by the US Food and Drug Administration and the European Medicines Agency for treatment of people with T2D and is currently in development for chronic weight management.

In people newly diagnosed with type 2 diabetes, early and intensive treatment of the disease can help control blood sugar and reduce the risk of later complications. The need to control weight in people with obesity and diabetes has also recently become a priority. New drugs developed in recent years allow for better and more individualised management of blood sugar without the risk of blood sugar levels dropping too low. In patients at risk of kidney or heart disease, the current recommendation is early treatment with metformin and drugs with proven cardiovascular benefit. Tirzepatide is a new drug that has also demonstrated very high efficacy in reducing blood glucose and body weight. It has the potential to help people with type 2 diabetes achieve their goals and prevent other diabetes-related complications. It is likely that some patients will even be able to bring their blood glucose to normal levels and lose substantial amounts of weight. The US and European regulatory agencies approved tirzepatide in 2022 for the treatment of type 2 diabetes and it is currently being tested for chronic weight management.

GLP-1 RAs in Spain: A Short Narrative Review of Their Use in Real Clinical Practice.

Glucagon-like peptide 1 receptor agonists (GLP-1 RAs) are a class of drugs with potent glucose-lowering activity. Additionally, some GLP-1 RAs have demonstrated cardiovascular and renal benefits. Current guidelines recommend their use in patients with type 2 diabetes (T2D) at high risk of or with established cardiovascular disease (CVD), regardless of glycaemic control, with lifestyle modification and metformin. However, several studies have recently highlighted the limited number of patients with T2D benefiting from these medications worldwide. Given the huge burden of CVD among patients with T2D, efforts should be made to bring clinical practice closer to expert guidelines. This review describes the current situation of GLP-1 RA use in Spain and the reasons behind the gap between guidelines and real-world practice and suggests possible solutions. Administrative issues, lack of awareness of the cardiovascular benefits, clinical inertia, rejection of injectable medication and costs could be some of the reasons for the current situation. Possible strategies that could help to close the gap include encouraging a multidisciplinary approach to the treatment of diabetes which involves cardiologists, endocrinologists, nephrologists, primary care providers and pharmacists; improved awareness of comorbidities and earlier evaluation and treatment or risks; and better education of healthcare providers regarding the cardioprotective benefits of these drugs.

The glucagon-like peptide 1 receptor agonists (GLP-1 RAs) are a class of drugs that can be beneficial for patients with type 2 diabetes who are at high risk of cardiovascular complications, such as heart attacks. For this reason, the current clinical guidelines strongly recommend their use in these patients. Unfortunately, many patients with type 2 diabetes and high cardiovascular risk still do not benefit from these drugs. This review analyses the reasons for this situation in Spain, and proposes some possible solutions. The reasons for the low use of GLP-1 RAs could be related to doctors not updating a patient's diabetes medicine as often as they should, lack of awareness about the cardiovascular benefits of these drugs, fear of medicines that involve needles, administrative issues, and costs. Some of the possible strategies to improve the use of GLP-1 RAs among patients with type 2 diabetes with high cardiovascular risk could be to foster greater cooperation among specialists, increase awareness of the need to treat cardiovascular risk in patients with diabetes, and better education of doctors regarding the benefits of these drugs.

A Retrospective Observational Study Examining the Generalizability of Glucagon-Like Peptide 1 Receptor Agonist Cardiovascular Outcome Trials to the Real-World Population with Type 2 Diabetes in Spain: The REPRESENT Study.

INTRODUCTION: The REPRESENT study aims to examine whether participants enrolled in glucagon-like peptide 1 receptor agonist cardiovascular outcome trials (CVOTs) LEADER (liraglutide), REWIND (dulaglutide), and SUSTAIN-6 (injectable semaglutide) are representative of the Spanish population with type 2 diabetes (T2D). METHODS: This retrospective observational study used the IQVIA Electronic Medical Records database in Spain to identify adults aged 18 years and older with T2D diagnosed before/between January 2013 and December 2015. Demographic and clinical characteristics were analyzed descriptively. The proportions of individuals in the Spanish cohort who met the key selection criteria of each CVOT were calculated from individuals with available database entries for estimated glomerular filtration rate and body mass index using proxies. RESULTS: A total of 24,268 adults with T2D were identified from the IQVIA database. The Spanish cohort was predominantly male (55.5%) and had a mean (± SD) age of 66.8 ± 12.5 years and HbA1c of 7.2 ± 1.5%, with 14.0% having established cardiovascular disease and 2.9% having prior myocardial infarction. The characteristics of the Spanish cohort were more similar to that of REWIND than LEADER or SUSTAIN-6. The proportions of subjects in the Spanish cohort who met the CVOTs key selection criteria were 10.1% for LEADER, 53.6% for REWIND, and 10.4% for SUSTAIN-6. CONCLUSIONS: Although none of the CVOTs was fully representative of the Spanish cohort, the REWIND population was found to be more representative of the real-world Spanish population with T2D than those of LEADER and SUSTAIN-6. These findings reinforce the applicability of the results of REWIND in clinical practice.

Profile of Patients with Diabetes Treated with Insulin Lispro 200 U/ml: A Real-World Study from Spain.

INTRODUCTION: Insulin lispro 200 U/ml (IL200) is a rapid-acting concentrated insulin used for the treatment of adults with diabetes requiring daily doses of > 20 units of rapid-acting insulin. The aim of this study was to describe the clinical/demographic and treatment characteristics of patients who initiated insulin IL200 therapy in Spain in a real-world setting (PROFILE-IL200). METHODS: This retrospective observational study based on the IQVIA database included adult (≥ 18 years) patients with type 1 (T1D) or type 2 (T2D) diabetes who initiated IL200 between June 2015 and December 2019. Demographic and clinical characteristics were analyzed descriptively. RESULTS: Main characteristics for the T1D/T2D groups (N = 65/167) were as follows: male, 63.1/55.7%; mean (standard deviation [SD]) age, 46.5 (15.5)/62.6 (12.8) years; time since first diabetes record, 6.6 (4.2)/7.9 (2.9) years; body mass index (BMI), 30.9 (5.8)/33.1 (5.5) kg/m2; glycated hemoglobin, 8.3 (2.1)/8.8 (1.8)%; and diabetes-associated comorbidity, 55.4/92.8%. Among patients with T1D/T2D and a prior diagnosis (N = 54/164), 96.3/90.2% had received previous insulin (rapid insulin in 81.5/62.2%), and 13.0/97.6% had received previous noninsulin antihyperglycemic therapy. The mean (SD) total insulin dose before IL200 initiation for T1D/T2D was 98.0 (73.9)/95.2 (59.8) U/day; IL200 was initiated at a dose of 56.3 (43.8)/51.5 (34.3) U/day, with basal insulin in 86.2/83.2% of the patients. IL200 was first prescribed by an endocrinologist or a primary care physician in 48.7% and 46.6% of patients, respectively. CONCLUSIONS: PROFILE-IL200 described the profile of patients treated with IL200 in clinical practice in Spain. Patients were middle-aged, with poor glycemic control, high BMI and associated comorbidities, and received high doses of insulin at IL200 initiation.

Insulin is one of the main treatments for people with diabetes. More concentrated versions of a fast-acting insulin such as insulin lispro 200 U/ml (IL200) can be better for people with diabetes who need large daily amounts of a fast-acting insulin to keep their blood glucose at appropriate levels, because the injection volume is smaller, and so one IL200 insulin pen lasts longer than other pens. However, there is limited information on the types of patients who start treatment with this type of insulin in the real world. By using a database of medical records, we studied the profile of patients who started treatment with IL200 between 2015 and 2019 in Spain. The study found that patients starting treatment with IL200 were middle-aged, overweight or obese, and with a poor control of blood glucose levels. The patients also had other conditions common in patients with diabetes, such as high blood pressure, high cholesterol and triglycerides, and heart disease, and were receiving high doses of insulin before starting treatment with IL200. Patients were generally prescribed IL200 by their diabetes specialist or general practitioner. The findings of this study could help identify the patients who may benefit the most from the characteristics of IL200, such as a smaller injection volume and longer duration of use for each insulin pen, which may result in patients using IL200 as directed for longer.

Cost of Severe Hypoglycemia and Budget Impact with Nasal Glucagon in Patients with Diabetes in Spain.

INTRODUCTION: Severe hypoglycemic events (SHE) represent a clinical and economic burden in patients with diabetes. Nasal glucagon (NG) is a novel treatment for SHEs with similar efficacy, but with a usability advantage over injectable glucagon (IG) that may translate to improved economic outcomes. The economic implications of this usability advantage on SHE-related spending in Spain were explored in this analysis. METHODS: A cost-offset and budget impact analysis (BIA) was conducted using a decision tree model, adapted for the Spanish setting. The model calculated average costs per SHE over the SHE treatment pathway following a treatment attempt with IG or NG. Analyses were performed separately in three populations with insulin-treated diabetes: children and adolescents (4-17 years) with type 1 diabetes (T1D), adults with T1D and adults with type 2 diabetes (T2D), with respective population estimates applied in BIA. Treatment probabilities were assumed to be equal for IG and NG, except for treatment success following glucagon administration. Epidemiologic and cost data were obtained from Spanish-specific sources. BIA results were presented at a 3-year time horizon. RESULTS: On a per SHE level, NG was associated with lower costs compared to IG (children and adolescents with T1D, EUR 820; adults with T1D, EUR 804; adults with T2D, EUR 725). Lower costs were attributed to reduced costs of professional medical assistance in patients treated with NG. After 3 years, BIA showed that relative to IG, the introduction of NG was projected to reduce SHE-related spending by EUR 1,158,969, EUR 142,162,371, and EUR 6,542,585 in children and adolescents with T1D, adults with T1D, and adults with insulin-treated T2D, respectively. CONCLUSIONS: In Spain, the usability advantage of NG over IG translates to potential cost savings per SHE in three populations with insulin-treated diabetes, and the introduction of NG was associated with a lower budget impact versus IG in each group.