Cost-effectiveness of a Novel Hypoglycaemia Programme: The 'HARPdoc vs BGAT' RCT.

AIMS: To assess the cost-effectiveness of HARPdoc (Hypoglycaemia Awareness Restoration Programme for adults with type 1 diabetes and problematic hypoglycaemia despite optimised care), focussed upon cognitions and motivation, versus BGAT (Blood Glucose Awareness Training), focussed on behaviours and education, as adjunctive treatments for treatment-resistant problematic hypoglycaemia in type 1 diabetes, in a randomised controlled trial. METHODS: Eligible adults were randomised to either intervention. Quality of life (QoL, measured using EQ-5D-5L); cost of utilisation of health services (using the adult services utilization schedule, AD-SUS) and of programme implementation and curriculum delivery were measured. A cost-utility analysis was undertaken using quality-adjusted life years (QALYs) as a measure of trial participant outcome and cost-effectiveness was evaluated with reference to the incremental net benefit (INB) of HARPdoc compared to BGAT. RESULTS: Over 24 months mean total cost per participant was £194 lower for HARPdoc compared to BGAT (95% CI: -£2498 to £1942). HARPdoc was associated with a mean incremental gain of 0.067 QALYs/participant over 24 months post-randomisation: an equivalent gain of 24 days in full health. The mean INB of HARPdoc compared to BGAT over 24 months was positive: £1521/participant, indicating comparative cost-effectiveness, with an 85% probability of correctly inferring an INB > 0. CONCLUSIONS: Addressing health cognitions in people with treatment-resistant hypoglycaemia achieved cost-effectiveness compared to an alternative approach through improved QoL and reduced need for medical services, including hospital admissions. Compared to BGAT, HARPdoc offers a cost-effective adjunct to educational and technological solutions for problematic hypoglycaemia.

A Graded Approach to Intravenous Dextrose for Neonatal Hypoglycemia Decreases Blood Glucose Variability, Time in the Neonatal Intensive Care Unit, and Cost of Stay.

OBJECTIVE: To determine associations between a graded approach to intravenous (IV) dextrose treatment for neonatal hypoglycemia and changes in blood glucose (BG), length of stay (LOS), and cost of care. STUDY DESIGN: Retrospective cohort study of 277 infants born at ≥35 weeks of gestation in an urban academic delivery hospital, comparing the change in BG after IV dextrose initiation, neonatal intensive care unit (NICU) LOS, and cost of care in epochs before and after a hospital protocol change. During epoch 1, all infants who needed IV dextrose for hypoglycemia were given a bolus and started on IV dextrose at 60 mL/kg/day. During epoch 2, infants received IV dextrose at 30 or 60 mL/kg/day based on the degree of hypoglycemia. Differences in BG outcomes, LOS, and cost of hospital care between epochs were compared using adjusted median regression. RESULTS: In epoch 2, the median (IQR) rise in BG after initiating IV dextrose (19 [10, 31] mg/dL) was significantly lower than in epoch 1 (24 [14,37] mg/dL; adjusted ß = -6.0 mg/dL, 95% CI -11.2, -0.8). Time to normoglycemia did not differ significantly between epochs. NICU days decreased from a median (IQR) of 4.5 (2.1, 11.0) to 3.0 (1.5, 6.5) (adjusted ß = -1.9, 95% CI -3.0, -0.7). Costs associated with NICU hospitalization decreased from a median (IQR) $14 030 ($5847, $30 753) to $8470 ($5650, $19 019) (adjusted ß = -$4417, 95% CI -$571, -$8263) after guideline implementation. CONCLUSIONS: A graded approach to IV dextrose was associated with decreased BG lability and length and cost of NICU stay for infants with neonatal hypoglycemia.

Cost-Utility Analysis of Prophylactic Dextrose Gel vs Standard Care for Neonatal Hypoglycemia in At-Risk Infants.

OBJECTIVE: To evaluate the long-term costs and impact on quality of life of using prophylactic dextrose gel in patients at increased risk of developing neonatal hypoglycemia. STUDY DESIGN: A cost-utility analysis was performed from the perspective of the health system, using a decision tree to model the long-term clinical outcomes of neonatal hypoglycemia, including cerebral palsy, epilepsy, vision disturbances, and learning disabilities, in patients at increased risk of neonatal hypoglycemia who received prophylactic dextrose gel vs standard care. Model parameters including likelihoods of hypoglycemia and admission to a neonatal intensive care unit, were based on the pre-Hypoglycemia Prevention with Oral Dextrose Study. Estimations of the likelihood of long-term condition(s), and their costs, were based on review of published literature. RESULTS: Patients who received prophylactic dextrose gel incurred costs to the health system of around US $14 000 over an 18-year time horizon, accruing 11.25 quality-adjusted life-years, whereas those who did not receive prophylactic treatment incurred cost of around $16 000 and experienced a utility of 11.10 quality-adjusted life-years. CONCLUSIONS: A prophylactic strategy of using dextrose gel in infants at increased risk of neonatal hypoglycemia is likely to be cost effective compared with standard care, to reduce the direct costs to the health system over an 18-year time horizon, and improve quality of life.

Reducing the burden of hypoglycaemia in people with diabetes through increased understanding: design of the Hypoglycaemia REdefining SOLutions for better liVEs (Hypo-RESOLVE) project.

BACKGROUND: Hypoglycaemia is the most frequent complication of treatment with insulin or insulin secretagogues in people with diabetes. Severe hypoglycaemia, i.e. an event requiring external help because of cognitive dysfunction, is associated with a higher risk of adverse cardiovascular outcomes and all-cause mortality, but underlying mechanism(s) are poorly understood. There is also a gap in the understanding of the clinical, psychological and health economic impact of 'non-severe' hypoglycaemia and the glucose level below which hypoglycaemia causes harm. AIM: To increase understanding of hypoglycaemia by addressing the above issues over a 4-year period. METHODS: Hypo-RESOLVE is structured across eight work packages, each with a distinct focus. We will construct a large, sustainable database including hypoglycaemia data from >100 clinical trials to examine predictors of hypoglycaemia and establish glucose threshold(s) below which hypoglycaemia constitutes a risk for adverse biomedical and psychological outcomes, and increases healthcare costs. We will also investigate the mechanism(s) underlying the antecedents and consequences of hypoglycaemia, the significance of glucose sensor-detected hypoglycaemia, the impact of hypoglycaemia in families, and the costs of hypoglycaemia for healthcare systems. RESULTS: The outcomes of Hypo-RESOLVE will inform evidence-based definitions regarding the classification of hypoglycaemia in diabetes for use in daily clinical practice, future clinical trials and as a benchmark for comparing glucose-lowering interventions and strategies across trials. Stakeholders will be engaged to achieve broadly adopted agreement. CONCLUSION: Hypo-RESOLVE will advance our understanding and refine the classification of hypoglycaemia, with the ultimate aim being to alleviate the burden and consequences of hypoglycaemia in people with diabetes.

Direct medical costs in the preceding, event and subsequent years of a first severe hypoglycaemia episode requiring hospitalization: A population-based cohort study.

AIMS: We aimed to estimate the use of healthcare services and the direct medical costs accrued by patients with diabetes mellitus (DM) during the year of the first severe hypoglycaemia (SH) event, as well as during the years before and after the event year. MATERIALS AND METHODS: We analysed a population-based, retrospective cohort including all adults with DM managed in the primary care setting from the Hong Kong Hospital Authority between 2006 and 2013. DM patients for whom SH was first recorded during the designated period were identified and matched to a control group of patients who had not experienced an SH event using the propensity score method. Direct medical costs in the years before, during and after the first SH event were determined by totalling the costs of health services utilized within respective years. RESULTS: After matching, a total of 22 694 DM patients were divided into the first recorded-SH group (n = 11 347) and the non-SH control group (n = 11 347). Patients for whom SH was first recorded, on average, made 7.85 outpatient clinic visits, made 1.89 emergency visits and spent 17.75 nights hospitalized during the event year. Mean direct medical costs during the event year were 11 751 US$, more than 2-fold that during the preceding year (4846 US$; P < 0.001) and subsequent years (4198-4700 US$; P < 0.001) and was 4.5 times that 2 years before the event (2481 US$; P < 0.001). Incremental costs of SH patients vs matched controls during the event year and the preceding year were 10 873 US$ (P < 0.001) and 3974 US$ (P < 0.001), respectively. CONCLUSIONS: SH is associated with excessive hospital admission rates and direct medical costs during the event year and, in particular, during the year before as compared to patients who had not experienced an SH event.

Hypoglycemia Emergencies: Factors Associated with Prehospital Care, Transportation Status, Emergency Department Disposition, and Cost.

Objectives: The objectives of this study were to evaluate demographic/clinical characteristics and treatment/transportation decisions by emergency medical services (EMS) for patients with hypoglycemia and link EMS activations to patient disposition, outcomes, and costs to the emergency medical system. This evaluation was to identify potential areas where improvements in prehospital healthcare could be made. Methods: This was a retrospective analysis of the National Emergency Medical Services Information System (NEMSIS) registry and three national surveys: Nationwide Emergency Department Sample (NEDS), National Hospital Ambulatory Medical Care Survey (NHAMCS), and Medical Expenditure Panel Survey (MEPS) from 2013, to examine care of hypoglycemia from the prehospital and the emergency department (ED) perspectives. Results: The study estimated 270,945 hypoglycemia EMS incidents from the NEMSIS registry. Treatments were consistent with national guidelines (i.e., oral glucose, intravenous [IV] dextrose, or glucagon), and patients were more likely to be transported to the ED if the incident was in a rural setting or they had other chief concerns related to the pulmonary or cardiovascular system. Use of IV dextrose decreased the likelihood of transportation. Approximately 43% of patients were not transported from the scene. Data from the NEDS survey estimated 258,831 ED admissions for hypoglycemia, and 41% arrived by ambulance. The median ambulance expenditure was $664 ± 98. From the ED, 74% were released. The average ED charge that did not lead to hospital admission was $3106 ± 86. Increased odds of overnight admission included infection and acute renal failure. Conclusions: EMS activations for hypoglycemia are sizeable and yet a considerable proportion of patients are not transported to or are discharged from the ED. Seemingly, these events resolved and were not medically complex. It is possible that implementation and appropriate use of EMS treat-and-release protocols along with utilizing programs to educate patients on hypoglycemia risk factors and emergency preparedness could partially reduce the burden of hypoglycemia to the healthcare system.

Cost Analysis of Treating Neonatal Hypoglycemia with Dextrose Gel.

OBJECTIVE: To evaluate the costs of using dextrose gel as a primary treatment for neonatal hypoglycemia in the first 48 hours after birth compared with standard care. STUDY DESIGN: We used a decision tree to model overall costs, including those specific to hypoglycemia monitoring and treatment and those related to the infant's length of stay in the postnatal ward or neonatal intensive care unit, comparing the use of dextrose gel for treatment of neonatal hypoglycemia with placebo, using data from the Sugar Babies randomized trial. Sensitivity analyses assessed the impact of dextrose gel cost, neonatal intensive care cost, cesarean delivery rate, and costs of glucose monitoring. RESULTS: In the primary analysis, treating neonatal hypoglycemia using dextrose gel had an overall cost of NZ$6863.81 and standard care (placebo) cost NZ$8178.25; a saving of NZ$1314.44 per infant treated. Sensitivity analyses showed that dextrose gel remained cost saving with wide variations in dextrose gel costs, neonatal intensive care unit costs, cesarean delivery rates, and costs of monitoring. CONCLUSIONS: Use of buccal dextrose gel reduces hospital costs for management of neonatal hypoglycemia. Because it is also noninvasive, well tolerated, safe, and associated with improved breastfeeding, buccal dextrose gel should be routinely used for initial treatment of neonatal hypoglycemia. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12608000623392.

Assessing the economic value of maintained improvements in Type 1 diabetes management, in terms of HbA1c , weight and hypoglycaemic event incidence.

AIMS: Insulin therapy is indicated for people with Type 1 diabetes mellitus; however, treatment-related weight gain and hypoglycaemia represent barriers to optimal glycaemic management. This study assessed the health economic value of maintained reductions in HbA1c , BMI and hypoglycaemia incidence among the UK Type 1 diabetes population. METHODS: The Cardiff Type 1 Diabetes Model was used to estimate lifetime costs, life-years and quality-adjusted life-years (QALYs) for individuals with Type 1 diabetes at different baseline HbA1c , BMI and hypoglycaemic event rates. Results were discounted at 3.5%, and the net monetary benefit associated with improving Type 1 diabetes management was derived at £20 000/QALY gained. Per-person outputs were inflated to national levels using UK Type 1 diabetes prevalence estimates. RESULTS: Modelled subjects with an HbA1c of 86 mmol/mol (10.0%) were associated with discounted lifetime per-person costs of £23 795; £12 649 of which may be avoided by maintaining an HbA1c of 42 mmol/mol (6.0%). Combined with estimated QALY gains of 2.80, an HbA1c of 42 mmol/mol (6.0%) vs. 86 mmol/mol (10.0%) was associated with a £68 621 per-person net monetary benefit. Over 1 year, unit reductions in BMI produced £120 per-person net monetary benefit, and up to £197 for the avoidance of one non-severe hypoglyceamic event. CONCLUSIONS: Maintained reductions in HbA1c significantly alleviate the burden associated with Type 1 diabetes in the UK. Given the influence of weight and hypoglycaemia on health economic outcomes, they must also be key considerations when assessing the value of Type 1 diabetes technologies in clinical practice.

Flash forward: a review of flash glucose monitoring.

The FreeStyle Libre flash glucose monitor became available on prescription (subject to local health authority approval) in all four nations of the UK from November 2017, a watershed moment in the history of diabetes care. Calibration free, the FreeStyle Libre is a disc worn on the arm for 14 days which is designed largely to replace the recommended 4-10 painful finger-stick blood glucose tests required each day for the self-management of diabetes. This review discusses clinical data from randomized and observational studies, considers device accuracy metrics and deliberates its popularity and the potential challenges that this new device brings to diabetes care in the UK. In randomized trials, FreeStyle Libre use is associated with a reduction in hypoglycaemia and, in observational studies, improvements in HbA1c levels. User satisfaction is high and adverse events are low. Accuracy of the FreeStyle Libre is comparable to currently available real-time continuous glucose monitors in adults, children and during pregnancy; the cost of the FreeStyle Libre is lower. Glucose data can be visualized in multiple devices and platforms, and summarized in an ambulatory glucose profile to aid pattern recognition and insulin dose adjustment. There is a need for appropriate education, of both users and healthcare professionals, to harness the full benefits. Further randomized studies to assess the long-term impact on HbA1c , particularly in those with high baseline HbA1c and in specific age groups, such as adolescents and young adults, are warranted. The potential impact on complications, is yet to be realized.

Cost-effectiveness of the psycho-educational blended (group and online) intervention HypoAware compared with usual care for people with Type 1 and insulin-treated Type 2 diabetes with problematic hypoglycaemia: analyses of a cluster-randomized controlled trial.

AIMS: To evaluate the cost-effectiveness of HypoAware, a blended (group and online) psycho-educational intervention based on the evidence-based Blood Glucose Awareness Training, in comparison with usual care in people with Type 1 and Type 2 diabetes with a high risk of severe hypoglycaemia. METHODS: We performed an economic evaluation, from a societal and healthcare perspective, that used data from a 6-month, multicentre, cluster-randomized controlled trial (n = 137). RESULTS: The proportion of people with at least one severe hypoglycaemic event per 6 months was 0.22 lower (95% CI -0.39 to -0.06) and the proportion of people with impaired hypoglycaemia awareness was 0.16 lower (95% CI -0.34 to 0.02) in the HypoAware group. There was no difference in quality-adjusted life-years (-0.0; 95% CI -0.05 to 0.05). The mean total societal costs in the HypoAware group were EUR708 higher than in the usual care group (95% CI -951 to 2298). The mean incremental cost per severe hypoglycaemic event prevented was EUR2,233. At a willingness-to-pay threshold of EUR20,000 per event prevented, the probability that HypoAware was cost-effective in comparison with usual care was 54% from a societal perspective and 55% from a healthcare perspective. For quality-adjusted life-years the incremental cost-effectiveness ratio was EUR119,360/quality-adjusted life-year gained and the probability of cost-effectiveness was low at all ceiling ratios. CONCLUSIONS: Based on the present study, we conclude that HypoAware is not cost-effective compared to usual care. Further research in less well-resourced settings and more severely affected patients is warranted. (Clinical Trials Registry no: Dutch Trial Register NTR4538.).

Association of hypoglycaemia severity with clinical, patient-reported and economic outcomes in US patients with type 2 diabetes using basal insulin.

AIMS: To evaluate the clinical and patient-reported outcomes and healthcare utilization and costs associated with patient-reported hypoglycaemia in US adults with type 2 diabetes (T2D) treated with basal insulin. MATERIALS AND METHODS: This was an observational, cross-sectional, survey-based study of adults with T2D on basal insulin ± oral antidiabetes drugs (OADs) or rapid-acting/premixed insulin, who had in the past ever experienced hypoglycaemia, using US data from the National Health and Wellness Survey. Eligible patients were categorized as having no hypoglycaemia (38.7%), non-severe hypoglycaemia (55.1%), or severe hypoglycaemia (6.2%) in the preceding 3 months. Outcomes included health-related quality of life (HRQoL), work productivity and activity impairment, healthcare resource utilization, and estimated direct and indirect costs. Multivariable regression models were performed to control for patient characteristics. RESULTS: Patients who experienced severe hypoglycaemia had significantly (P < .05) lower HRQoL scores, greater overall impairment of work productivity and activity, greater healthcare resource utilization, and higher costs compared with those who experienced non-severe or no hypoglycaemia. Patients with non-severe hypoglycaemia also reported an impact on the number of provider visits, indirect costs, and HRQoL. CONCLUSIONS: Patients with T2D using basal insulin ± OADs or rapid-acting/premixed insulin in the United States who experienced severe hypoglycaemia had greater impairment of activity and work productivity, utilized more healthcare resources, and incurred higher associated costs than those with non-severe or no hypoglycaemia. The study also demonstrated the impact that non-severe hypoglycaemic events have on economic and HRQoL outcomes. Reducing the incidence and severity of hypoglycaemia could lead to clinically meaningful improvements in HRQoL and may result in lower healthcare utilization and associated costs.

Real-world evidence concerning clinical and economic outcomes of switching to insulin glargine 300 units/mL vs other basal insulins in patients with type 2 diabetes using basal insulin.

This retrospective cohort study compared real-world clinical and healthcare-resource utilization (HCRU) data in patients with type 2 diabetes using basal insulin (BI) who switched to insulin glargine 300 units/mL (Gla-300) or another BI. Data from the Predictive Health Intelligence Environment database 12 months before (baseline) and 6 months after (follow-up) the switch date (index date, March 1, 2015 to May 31, 2016) included glycated haemoglobin A1c (HbA1c), hypoglycaemia, HCRU and associated costs. Baseline characteristics were balanced using propensity score matching. Change in HbA1c from baseline was similar in both matched cohorts (n = 1819 in each). Hypoglycaemia incidence and adjusted event rate were significantly lower with Gla-300. Patients switching to Gla-300 had a significantly lower incidence of HCRU related to hypoglycaemia. All-cause and diabetes-related hospitalization and emergency-department HCRU were also favourable for Gla-300. Lower HCRU translated to lower costs in patients using Gla-300. In this real-world study, switching to Gla-300 reduced the risk of hypoglycaemia in patients with type 2 diabetes when compared with those switching to another BI, resulting in less HCRU and potential savings of associated costs.

Switching from sitagliptin to liraglutide to manage patients with type 2 diabetes in the UK: A long-term cost-effectiveness analysis.

AIMS: The recent LIRA-SWITCH trial showed that switching from sitagliptin 100 mg to liraglutide 1.8 mg led to statistically significant and clinically relevant improvements in glycated haemoglobin (HbA1C) and body mass index (BMI). Based on these findings, the aim of the present study was to assess the long-term cost-effectiveness of switching from sitagliptin to liraglutide in patients with type 2 diabetes in the UK. MATERIALS AND METHODS: The IQVIA CORE Diabetes Model Version 8.5+ was used to project costs and clinical outcomes over patients' lifetimes. Baseline cohort characteristics and treatment effects were derived from the LIRA-SWITCH trial. Future costs and clinical benefits were discounted at 3.5% annually. Costs were accounted in pounds sterling (GBP) and expressed in 2016 values. One-way and probabilistic sensitivity analyses were performed. RESULTS: Model projections showed improved quality-adjusted life expectancy for patients with poorly controlled HbA1c upon switching from sitagliptin to liraglutide, compared with continuing sitagliptin treatment (9.18 vs 9.02 quality-adjusted life years [QALYs]). Treatment switching was associated with increased overall costs (GBP 24737 vs GBP 22362). Higher pharmacy costs were partially offset by reduced diabetes-related complication costs in patients who switched to liraglutide. Switching to liraglutide was associated with an incremental cost-effectiveness ratio of GBP 15423 per QALY gained vs continuing with sitagliptin treatment. CONCLUSIONS: Switching from sitagliptin 100 mg to liraglutide 1.8 mg in patients with poor glycaemic control was projected to improve clinical outcomes and is likely to be considered cost-effective in the UK setting and, therefore, a good use of limited NHS resources.

Transient neonatal hyperinsulinaemic hypoglycaemia: perinatal predictors of length and cost of stay.

Admission to neonatal care causes separation of infants from their parents, can adversely affect breast-feeding and is associated with painful procedures. Our aim was to identify perinatal factors and cost of care associated with transient neonatal hyperinsulinaemic hypoglycaemia (HH). Infants born after 35 weeks of gestation admitted because of hypoglycaemia were studied. The neonates were divided into two groups (HH and non-HH), and their length and cost of care were compared and perinatal factors predicting those outcomes explored. Forty of the 474 infants admitted with hypoglycaemia were diagnosed with HH. The HH group had a lower median (IQR) glucose level on admission compared to the non-HH group (p < 0.001). The median (IQR) cost of stay was higher in the HH group (p < 0.001). In the HH group, the GIRmax was significantly correlated with cost of stay (p < 0.001). GIRmax predicted a cost of stay > £9140 with an area under the ROC curve of 0.956. GIRmax > 13.9 mg/kg/min predicted admission cost > £9140 with 86% sensitivity and 93% specificity.Conclusion: Transient neonatal HH was associated with a higher length and cost of stay in infants admitted for hypoglycaemia. The GIRmax can predict the length and cost of stay. What is Known: • Neonatal hypoglycaemia is the leading cause of term and late preterm neonatal admissions. • Hyperinsulinism (HH) is the commonest cause of persistent hypoglycaemia, and delay in the diagnosis and management can have a detrimental impact on long-term development. What is New: • We have demonstrated prior to NICU admission that blood glucose concentrations were lower in infants with HH compared to those without. • The maximum GIR had a stronger correlation with total length and cost of hospital stay compared to insulin levels in HH infants.

The Monthly Cycle of Hypoglycemia: An Observational Claims-based Study of Emergency Room Visits, Hospital Admissions, and Costs in a Commercially Insured Population.

BACKGROUND: Multipayer initiatives have sought to address social determinants of health, such as food insecurity, by linking primary care patients to social services. It remains unclear whether such social determinants contribute to avoidable short-term health care costs. OBJECTIVES: We sought to quantify costs and mitigating factors for the increased risk of hypoglycemia at the end of each month among low-income Americans, a phenomenon related to exhaustion of food budgets. RESEARCH DESIGN: We used claims data on 595,770 commercially insured American adults aged 19 through 64 years old from 2004 through 2015 to estimate the risks and costs of emergency room visits and inpatient hospitalizations for hypoglycemia during the last week of each month versus prior weeks. RESULTS: Although persons with household incomes greater than the national median did not experience a monthly cycle of hypoglycemia, those with incomes less than the national median had an odds ratio of 1.07 (95% confidence interval, 1.02-1.12; P=0.005) for emergency room visits or inpatient hospitalizations for hypoglycemia during the last week of each month, compared with earlier weeks. The risk of end-of-the-month hypoglycemia was mitigated to statistical insignificance during a period of increased federal nutrition program benefits from 2009 through 2013. Eliminating the monthly cycle of hypoglycemia among commercially insured nonelderly adults would be expected to avert $54.1 million per year (95% confidence interval, $0.8-$204.0) in emergency department and inpatient hospitalization costs. CONCLUSIONS: Addressing the end-of-the-month increase in hypoglycemia risk among lower-income populations may avert substantial costs from emergency department visits and inpatient hospitalizations.

Projected long-term outcomes in patients with type 1 diabetes treated with fast-acting insulin aspart vs conventional insulin aspart in the UK setting.

AIM: To assess the impact of faster aspart vs insulin aspart on long-term clinical outcomes and costs for patients with type 1 diabetes mellitus (T1DM) in the UK setting. METHODS: The QuintilesIMS CORE Diabetes Model was used to project clinical outcomes and costs over patient lifetimes in a cohort with data on baseline characteristics from the "onset 1" trial. Treatment effects were taken from the 26-week main phase of the onset 1 trial, with costs and utilities based on literature review. Future costs and clinical benefits were discounted at 3.5% annually. RESULTS: Projections indicated that faster aspart was associated with improved discounted quality-adjusted life expectancy (by 0.13 quality-adjusted life-years) vs insulin aspart. Improved clinical outcomes resulted from fewer diabetes-related complications and a delayed time to their onset with faster aspart. Faster aspart was found to be associated with reduced costs vs insulin aspart (cost savings of £1715), resulting from diabetes-related complications avoided and reduced treatment costs. CONCLUSIONS: Faster aspart was associated with improved clinical outcomes and cost savings vs insulin aspart for patients with T1DM in the UK setting.

Cost-effectiveness of exenatide twice daily vs insulin glargine as add-on therapy to oral antidiabetic agents in patients with type 2 diabetes in China.

AIMS: To estimate the long-term cost-effectiveness of exenatide twice daily vs insulin glargine once daily as add-on therapy to oral antidiabetic agents (OADs) for Chinese patients with type 2 diabetes (T2DM). METHODS: The Cardiff Diabetes Model was used to simulate disease progression and estimate the long-term effects of exenatide twice daily vs insulin glargine once daily. Patient profiles and treatment effects required for the model were obtained from literature reviews (English and Chinese databases) and from a meta-analysis of 8 randomized controlled trials comparing exenatide twice daily with insulin glargine once daily add-on to OADs for T2DM in China. Medical expenditure data were collected from 639 patients with T2DM (aged ≥18 years) with and without complications incurred between January 1, 2014 and December 31, 2015 from claims databases in Shandong, China. Costs (2014 Chinese Yuan [¥]) and benefits were estimated, from the payers' perspective, over 40 years at a discount rate of 3%. A series of sensitivity analyses were performed. RESULTS: Patients on exenatide twice daily + OAD had a lower predicted incidence of most cardiovascular and hypoglycaemic events and lower total costs compared with those on insulin glargine once daily + OAD. A greater number of quality-adjusted life years (QALYs; 1.94) at a cost saving of ¥117 706 gained was associated with exenatide twice daily vs insulin glargine once daily. (i.e. cost saving of ¥60 764/QALY) per patient. CONCLUSIONS: In Chinese patients with T2DM inadequately controlled by OADs, exenatide twice daily is a cost-effective add-on therapy alternative to insulin glargine once daily, and may address the problem of an excess of medical needs resulting from weight gain and hypoglycaemia in T2DM treatment.

Multivariate Prediction Equations for HbA1c Lowering, Weight Change, and Hypoglycemic Events Associated with Insulin Rescue Medication in Type 2 Diabetes Mellitus: Informing Economic Modeling.

BACKGROUND: Type 2 diabetes mellitus (T2DM) is chronic and progressive and the cost-effectiveness of new treatment interventions must be established over long time horizons. Given the limited durability of drugs, assumptions regarding downstream rescue medication can drive results. Especially for insulin, for which treatment effects and adverse events are known to depend on patient characteristics, this can be problematic for health economic evaluation involving modeling. OBJECTIVES: To estimate parsimonious multivariate equations of treatment effects and hypoglycemic event risks for use in parameterizing insulin rescue therapy in model-based cost-effectiveness analysis. METHODS: Clinical evidence for insulin use in T2DM was identified in PubMed and from published reviews and meta-analyses. Study and patient characteristics and treatment effects and adverse event rates were extracted and the data used to estimate parsimonious treatment effect and hypoglycemic event risk equations using multivariate regression analysis. RESULTS: Data from 91 studies featuring 171 usable study arms were identified, mostly for premix and basal insulin types. Multivariate prediction equations for glycated hemoglobin A1c lowering and weight change were estimated separately for insulin-naive and insulin-experienced patients. Goodness of fit (R2) for both outcomes were generally good, ranging from 0.44 to 0.84. Multivariate prediction equations for symptomatic, nocturnal, and severe hypoglycemic events were also estimated, though considerable heterogeneity in definitions limits their usefulness. CONCLUSIONS: Parsimonious and robust multivariate prediction equations were estimated for glycated hemoglobin A1c and weight change, separately for insulin-naive and insulin-experienced patients. Using these in economic simulation modeling in T2DM can improve realism and flexibility in modeling insulin rescue medication.

A cohort of children with type 1 diabetes in Greece: predictors of direct costs of care.

AIM: To examine the predictors of direct costs of pediatric type 1 diabetes (T1D) in a hospital-based outpatient clinic in Greece. METHODS: The outpatient records of 89 children and adolescents (mean age: 12.05 ± 5.15 y) with T1D followed in the Second Department of Pediatrics, University of Athens Medical School, were analyzed. RESULTS: The mean ± SD diabetes duration was 4.9 ± 3.88 y (range: 0.25-17) and glycated hemoglobin (HbA1c) was 8.2 ± 1.09% (66 ± 11.9 mmol/mol). A total of 80% of patients were on multiple daily injections regimen, 10% on pump therapy, and 10% on conventional regimen. Total direct costs per patient-year (ppy) were estimated at €2.712 [95% confidence interval (CI): 2.468-2.956]. Supply costs accounted for 73.7% of total costs and were the highest for pump therapy (P < .001). Multivariate linear regression analysis showed that costs were significantly higher for children (1) on multiple daily injections or pump therapy (r = 0.364, P < .001), (2) of older age (r = 0.25, P < .001) and (3) higher daily insulin dose (r = 0.46, P < .001). Patients on pump therapy had significantly higher costs €5.538 (95%CI 4480-6597) compared with patients on multiple daily injections €2.447 (95% CI 2320-2574) and conventional regimen €1.978.5 (95%CI 1682-2275) (P = .0001). Patients on pump therapy had better glycemic control compared with all other patients [HbA1c (mean ± SD): 7.2% ± 1.0 vs 8.3% ±1.5, P = .039]. CONCLUSION: The total T1D cost in this cohort of Greek children was €2712 ppy. The main factor that predicted direct cost was the use of pump. However, pump therapy was associated with better glycaemic control, which may decrease the risk of total long-term diabetes care cost.

Healthcare resource use, direct and indirect costs of hypoglycemia in type 1 and type 2 diabetes, and nationwide projections. Results of the HYPOS-1 study.

BACKGROUND AND AIMS: To obtain an accurate picture of the total costs of hypoglycemia, including the indirect costs and comparing the differences between type 1 (T1DM) and type 2 diabetes mellitus (T2DM). METHODS AND RESULTS: HYPOS-1 was a multicenter, retrospective cohort study which analyzed the data of 2229 consecutive patients seen at 18 diabetes clinics. Data on healthcare resource use and indirect costs by diabetes type were collected via a questionnaire. The domains of inpatient admission and hospital stay, work days lost, and third-party assistance were also explored. Resource utilization was reported as estimated incidence rates (IRs) of hypoglycemic episodes per 100 person-years and estimated costs as IRs per person-years. For every 100 patients with T1DM, 9 emergency room (ER) visits and 6 emergency medical service calls for hypoglycemia were required per year; for every 100 patients with T2DM, 3 ER visits and 1 inpatient admission were required, with over 3 nights spent in hospital. Hypoglycemia led to 58 work days per 100 person-years lost by the patient or a family member in T1DM versus 19 in T2DM. The costs in T1DM totaled €90.99 per person-year and €62.04 in T2DM. Direct and indirect costs making up the total differed by type of diabetes (60% indirect costs in T1DM versus 43% in T2DM). The total cost associated with hypoglycemia in Italy is estimated to be €107 million per year. CONCLUSIONS: Indirect costs meaningfully contribute to the total costs associated with hypoglycemia. As compared with T1DM, T2DM requires fewer ER visits and incurs lower indirect costs but more frequent hospital use.