Cost-utility analysis of a flash continuous glucose monitoring system in the management of people with type 2 diabetes mellitus on basal insulin therapy-An Italian healthcare system perspective.

AIMS: To assess the cost-utility of the FreeStyle Libre flash continuous glucose monitoring (CGM) system from an Italian healthcare system perspective, when compared with self-monitoring of blood glucose (SMBG) in people living with type 2 diabetes mellitus (T2DM) receiving basal insulin. MATERIALS AND METHODS: A patient-level microsimulation model was run using Microsoft Excel for 10 000 patients over a lifetime horizon, with 3.0% discounting for costs and utilities. Inputs were based on clinical trials and real-world evidence, with patient characteristics reflecting Italian population data. The effect of flash CGM was modelled as a persistent 0.8% reduction in glycated haemoglobin versus SMBG. Costs (€ 2023) and disutilities were applied to glucose monitoring, diabetes complications, severe hypoglycaemia, and diabetic ketoacidosis. The health outcome was measured as quality-adjusted life-years (QALYs). RESULTS: Direct costs were €5338 higher with flash CGM than with SMBG. Flash CGM was associated with 0.51 more QALYs than SMBG, giving an incremental cost-effectiveness ratio (ICER) of €10 556/QALY. Scenario analysis ICERs ranged from €3825/QALY to €26 737/QALY. In probabilistic analysis, flash CGM was 100% likely to be cost effective at willingness-to-pay thresholds > €20 000/QALY. CONCLUSIONS: From an Italian healthcare system perspective, flash CGM is cost effective compared with SMBG for people living with T2DM on basal insulin.

Diabetes and COVID-19: Risks, Management, and Learnings From Other National Disasters.

Evidence relating to the impact of COVID-19 in people with diabetes (PWD) is limited but continuing to emerge. PWD appear to be at increased risk of more severe COVID-19 infection, though evidence quantifying the risk is highly uncertain. The extent to which clinical and demographic factors moderate this relationship is unclear, though signals are emerging that link higher BMI and higher HbA1c to worse outcomes in PWD with COVID-19. As well as posing direct immediate risks to PWD, COVID-19 also risks contributing to worse diabetes outcomes due to disruptions caused by the pandemic, including stress and changes to routine care, diet, and physical activity. Countries have used various strategies to support PWD during this pandemic. There is a high potential for COVID-19 to exacerbate existing health disparities, and research and practice guidelines need to take this into account. Evidence on the management of long-term conditions during national emergencies suggests various ways to mitigate the risks presented by these events.

Metabolic Surgery in the Treatment Algorithm for Type 2 Diabetes: A Joint Statement by International Diabetes Organizations.

BACKGROUND: Despite growing evidence that bariatric/metabolic surgery powerfully improves type 2 diabetes (T2D), existing diabetes treatment algorithms do not include surgical options. AIM: The 2nd Diabetes Surgery Summit (DSS-II), an international consensus conference, was convened in collaboration with leading diabetes organizations to develop global guidelines to inform clinicians and policymakers about benefits and limitations of metabolic surgery for T2D. METHODS: A multidisciplinary group of 48 international clinicians/scholars (75% nonsurgeons), including representatives of leading diabetes organizations, participated in DSS-II. After evidence appraisal (MEDLINE [1 January 2005-30 September 2015]), three rounds of Delphi-like questionnaires were used to measure consensus for 32 data-based conclusions. These drafts were presented at the combined DSS-II and 3rd World Congress on Interventional Therapies for Type 2 Diabetes (London, U.K., 28-30 September 2015), where they were open to public comment by other professionals and amended face-to-face by the Expert Committee. RESULTS: Given its role in metabolic regulation, the gastrointestinal tract constitutes a meaningful target to manage T2D. Numerous randomized clinical trials, albeit mostly short/midterm, demonstrate that metabolic surgery achieves excellent glycemic control and reduces cardiovascular risk factors. On the basis of such evidence, metabolic surgery should be recommended to treat T2D in patients with class III obesity (BMI≥40 kg/m(2)) and in those with class II obesity (BMI 35.0-39.9 kg/m(2)) when hyperglycemia is inadequately controlled by lifestyle and optimal medical therapy. Surgery should also be considered for patients with T2D and BMI 30.0-34.9 kg/m(2) if hyperglycemia is inadequately controlled despite optimal treatment with either oral or injectable medications. These BMI thresholds should be reduced by 2.5 kg/m(2) for Asian patients. CONCLUSIONS: Although additional studies are needed to further demonstrate long-term benefits, there is sufficient clinical and mechanistic evidence to support inclusion of metabolic surgery among antidiabetes interventions for people with T2D and obesity. To date, the DSS-II guidelines have been formally endorsed by 45 worldwide medical and scientific societies. Health care regulators should introduce appropriate reimbursement policies.

Clinical Assessment of Individualized Glycemic Goals in Patients With Type 2 Diabetes: Formulation of an Algorithm Based on a Survey Among Leading Worldwide Diabetologists.

OBJECTIVE: Observations over the past few years have demonstrated the need to adjust glycemic targets based on parameters pertaining to individual patient characteristics and comorbidities. However, the weight and value given to each parameter will clearly vary depending on the experience of the provider, the characteristics of the patient, and the specific clinical situation. RESEARCH DESIGN AND METHODS: To determine if there is current consensus on a global level with regard to identifying these parameters and their relative importance, we conducted a survey among 244 key worldwide opinion-leading diabetologists. Initially, the physicians were to rank the factors they take into consideration when setting their patients' glycemic target according to their relative importance. Subsequently, six clinical vignettes were presented, and the experts were requested to suggest an appropriate glycemic target. The survey results were used to formulate an algorithm according to which an estimate of the patient's glycemic target based on individualized parameters can be computed. Three additional clinical cases were submitted to a new set of experts for validation of the algorithm. RESULTS: A total of 151 (61.9%) experts responded to the survey. The parameters "life expectancy" and "risk of hypoglycemia from treatment" were considered to be the most important. "Resources" and "disease duration" ranked the lowest. An algorithm was constructed based on survey results. It was validated by presenting three new cases to 57 leading diabetologists who suggested glycemic targets that were similar to those calculated by the algorithm. CONCLUSIONS: The resultant suggested algorithm is an additional decision-making tool offered to the clinician to supplement clinical decision making when considering a glycemic target for the individual patient with diabetes.

The addition of E (Empowerment and Economics) to the ABCD algorithm in diabetes care.

The ABCD (Age, Body weight, Complications, Duration of disease) algorithm was proposed as a simple and practical tool to manage patients with type 2 diabetes. Diabetes treatment, as for all chronic diseases, relies on patients' ability to cope with daily problems concerning the management of their disease in accordance with medical recommendations. Thus, it is important that patients learn to manage and cope with their disease and gain greater control over actions and decisions affecting their health. Healthcare professionals should aim to encourage and increase patients' perception about their ability to take informed decisions about disease management and to improve patient self-esteem and feeling of self-efficacy to become agents of their own health. E for Empowerment is therefore an additional factor to take into account in the management of patients with type 2 diabetes. E stands also for Economics to be considered in diabetes care. Attention should be paid to public health policies as well as to the physician faced with the dilemma of delivering the best possible care within the problem of limited resources. The financial impact of the new treatment modalities for diabetes represents an issue that needs to be addressed at multiple strata both globally and nationally.

Cardiovascular risk assessment in low-resource settings: a consensus document of the European Society of Hypertension Working Group on Hypertension and Cardiovascular Risk in Low Resource Settings.

The Global Burden of Diseases, Injuries, and Risk Factors Study 2010 confirms ischemic heart disease and stroke as the leading cause of death and that hypertension is the main associated risk factor worldwide. How best to respond to the rising prevalence of hypertension in resource-deprived settings is a topic of ongoing public-health debate and discussion. In low-income and middle-income countries, socioeconomic inequality and cultural factors play a role both in the development of risk factors and in the access to care. In Europe, cultural barriers and poor communication between health systems and migrants may limit migrants from receiving appropriate prevention, diagnosis, and treatment. To use more efficiently resources available and to make treatment cost-effective at the patient level, cardiovascular risk approach is now recommended. In 2011, The European Society of Hypertension established a Working Group on 'Hypertension and Cardiovascular risk in low resource settings', which brought together cardiologists, diabetologists, nephrologists, clinical trialists, epidemiologists, economists, and other stakeholders to review current strategies for cardiovascular risk assessment in population studies in low-income and middle-income countries, their limitations, possible improvements, and future interests in screening programs. This report summarizes current evidence and presents highlights of unmet needs.

Cardiovascular risk assessment beyond Systemic Coronary Risk Estimation: a role for organ damage markers.

BACKGROUND: Cardiovascular risk assessment in the clinical practice is mostly based on risk charts, such as Framingham risk score and Systemic Coronary Risk Estimation (SCORE). These enable clinicians to estimate the impact of cardiovascular risk factors and assess individual cardiovascular risk profile. Risk charts, however, do not take into account subclinical organ damage, which exerts independent influence on risk and may amplify the estimated risk profile. Inclusion of organ damage markers in the assessment may thus contribute to improve this process. OBJECTIVE: Our aim was to evaluate the influence of implementation of SCORE charts with widely available indexes of organ damage, with the purpose to ameliorate individual risk assessment. METHODOLOGY: We searched www.Pubmed.gov for evidence about the predictive value of left ventricular hypertrophy (LVH), estimated glomerular filtration rate (eGFR), microalbuminuria (MAU) and metabolic syndrome on different risk profiles estimated by SCORE. Interventional and observational trials including at least 200 patients and published after 2000 were selected. RESULTS: The presence of organ damage as well as the number of abnormal parameters indicating organ damage is associated with increased cardiovascular risk, independently of SCORE. In the area of high risk, the impact of different markers of organ damage is heterogeneous. Combined risk models of SCORE and subclinical organ damage have major impact on risk stratification and may impact on recommendation in primary prevention in all SCORE categories. CONCLUSION: Available evidence suggests a tangible clinical advantage of adding the evaluation of simple organ damage markers to risk charts in cardiovascular risk prediction.

Optimizing insulin glargine plus one injection of insulin glulisine in type 2 diabetes in the ELEONOR study: similar effects of telecare and conventional self-monitoring of blood glucose on patient functional health status and treatment satisfaction.

OBJECTIVE: To determine the functional health status and treatment satisfaction in patients with type 2 diabetes from the Evaluation of Lantus Effect ON Optimization of use of single dose Rapid insulin (ELEONOR) study that investigated whether a telecare program helps optimization of basal insulin glargine with one bolus injection of insulin glulisine. RESEARCH DESIGN AND METHODS: Functional health status and treatment satisfaction were investigated using the 36-Item Short-Form (SF-36) Health Survey, the World Health Organization Well-Being Questionnaire (WBQ), and the Diabetes Treatment Satisfaction Questionnaire. RESULTS: Of 291 randomized patients, 238 completed the study (telecare: 114; self-monitoring blood glucose: 124). Significant improvements were detected in most SF-36 domains, in WBQ depression and anxiety scores, and in treatment satisfaction, without differences between study groups. CONCLUSIONS: An insulin regimen that substantially improves metabolic control, while minimizing the risk of hypoglycemia, can positively affect physical and psychologic well-being and treatment satisfaction irrespective of the educational support system used.

Pancreas preservation with University of Wisconsin and Celsior solutions: a single-center, prospective, randomized pilot study.

BACKGROUND: Celsior is an extracellular-type, low-viscosity, preservation solution already used for heart, lung, liver, and kidney transplantation. We report the results of a single-center, prospective, randomized pilot study specifically designed to compare the safety profile of Celsior solution with University of Wisconsin (UW) solution in clinical pancreas transplantation. METHODS: A total of 105 consecutive procurements were randomized to graft preservation with UW (n=53) solution or Celsior (n=52) solution. The groups were comparable with regard to all donor and recipient characteristics. RESULTS: Five grafts were discarded and 100 grafts (50 UW vs. 50 Celsior) were transplanted. Mean cold and warm ischemia times were 11.0 +/- 2.1 hr and 37.2 +/- 6.0 min for UW compared with 10.8 +/- 1.8 hr and 38.1 +/- 5.9 min for Celsior (P =not significant). Delayed endocrine pancreas function was recorded in one graft preserved with UW solution. Eleven recipients (UW 12% vs. Celsior 10%, P =not significant) required a relaparotomy. The mean serum levels of glucose, amylase, and lipase remained comparable between the study arms at equivalent intervals after transplantation. One recipient died with functioning grafts in each study arm; two further grafts were lost to arterial thrombosis (Celsior) and chronic rejection (UW), respectively. Actuarial 1-year patient and graft survival rates overlapped in the two study arms (98% and 96%, respectively). CONCLUSIONS: Within the range of cold ischemia time reported in this study, UW and Celsior solutions have similar safety profiles for pancreas preservation.