The Cost-Effectiveness of an Advanced Hybrid Closed-Loop System Compared to Standard Management of Type 1 Diabetes in a Singapore Setting.

Background: Despite advances in technology, glycemic outcomes in people with type 1 diabetes (T1D) remain suboptimal. The MiniMed 780G (MM780G) advanced hybrid closed-loop (AHCL) system is the latest technology for T1D management with established safety and efficacy. This study explores the cost-effectiveness of MM780G AHCL compared against multiple daily injections (MDI) plus intermittently scanned continuous glucose monitor (isCGM). Methods: A cost-utility analysis was conducted, simulating lifetime outcomes for 1000 T1D individuals, with baseline hemoglobin A1c of 8.4%, using the IQVIA Core Diabetes Model (CDM) v9.5. A Singapore health care payer perspective was taken with 2023 costs applied. Treatment effects were taken from the ADAPT study and treatment-related events from a combination of sources. T1D complication costs were derived from local literature, and health state utilities and disutilities from published literature. Scenario analyses and probabilistic sensitivity analyses (PSAs) explored uncertainty. Cost-effectiveness was assessed based on willingness-to-pay (WTP) thresholds set to Singapore Dollars (SGD) 45,000 (United States Dollars [USD] 33,087) per quality-adjusted life year (QALY) and Singapore's gross domestic product (GDP) per capita of SGD 114,165 (USD 83,941) per QALY. Results: A switch from MDI plus isCGM to MM780G resulted in expected gains in life-years (+0.78) and QALYs (+1.45). Cost savings through reduction in T1D complications (SGD 25,465; USD 18,723) partially offset the higher treatment costs in the AHCL arm (+SGD 74,538; +USD 54,805), resulting in an estimated incremental cost-effectiveness ratio of SGD 33,797 (USD 24,850) per QALY gained. Findings were robust, with PSA outputs indicating 81% and 99% probabilities of cost-effectiveness at the stated WTP thresholds. Conclusion: MM780G is a cost-effective option for people with T1D managed in a Singapore setting.

The Feasibility and Applicability of Stem Cell Therapy for the Cure of Type 1 Diabetes.

Stem cell therapy using islet-like insulin-producing cells derived from human pluripotent stem cells has the potential to allow patients with type 1 diabetes to withdraw from insulin therapy. However, several issues exist regarding the use of stem cell therapy to treat type 1 diabetes. In this review, we will focus on the following topics: (1) autoimmune responses during the autologous transplantation of stem cell-derived islet cells, (2) a comparison of stem cell therapy with insulin injection therapy, (3) the impact of the islet microenvironment on stem cell-derived islet cells, and (4) the cost-effectiveness of stem cell-derived islet cell transplantation. Based on these various viewpoints, we will discuss what is required to perform stem cell therapy for patients with type 1 diabetes.

Factors associated with non-attendance in the Irish national diabetic retinopathy screening programme (INDEAR study report no. 2).

AIMS: We aimed to determine the patient and screening-level factors that are associated with non-attendance in the Irish National Diabetic Retinal screening programme (Diabetic RetinaScreen). To accomplish this, we modelled a selection of predictors derived from the historical screening records of patients with diabetes. METHODS: In this cohort study, appointment data from the national diabetic retinopathy screening programme (RetinaScreen) were extracted and augmented using publicly available meteorological and geospatial data. A total of 653,969 appointments from 158,655 patients were included for analysis. Mixed-effects models (univariable and multivariable) were used to estimate the influence of several variables on non-attendance to screening appointments. RESULTS: All variables considered for analysis were statistically significant. Variables of note, with meaningful effect, were age (OR: 1.23 per decade away from 70; 95% CI: [1.22-1.24]), type 2 diabetes (OR: 1.10; 95% CI: [1.06-1.14]) and socio-economic deprivation (OR: 1.12; 95% CI: [1.09-1.16]). A majority (52%) of missed appointments were from patients who had missed three or more appointments. CONCLUSIONS: This study is the first to outline factors that are associated with non-attendance within the Irish national diabetic retinopathy screening service. In particular, when corrected for age and other factors, patients with type 2 diabetes had higher rates of non-attendance. Additionally, this is the first study of any diabetic screening programme to demonstrate that weather may influence attendance. This research provides unique insight to guide the implementation of an optimal and cost-effective intervention strategy to improve attendance.

Cost and Cost-effectiveness of Large-scale Screening for Type 1 Diabetes in Colorado.

OBJECTIVE: To assess the costs and project the potential lifetime cost-effectiveness of the ongoing Autoimmunity Screening for Kids (ASK) program, a large-scale, presymptomatic type 1 diabetes screening program for children and adolescents in the metropolitan Denver region. RESEARCH DESIGN AND METHODS: We report the resource utilization, costs, and effectiveness measures from the ongoing ASK program compared with usual care (i.e., no screening). Additionally, we report a practical screening scenario by including utilization and costs relevant to routine screening in clinical practice. Finally, we project the potential cost-effectiveness of ASK and routine screening by identifying clinical benchmarks (i.e., diabetic ketoacidosis [DKA] events avoided, HbA1c improvements vs. no screening) needed to meet value thresholds of $50,000-$150,000 per quality-adjusted life-year (QALY) gained over a lifetime horizon. RESULTS: Cost per case detected was $4,700 for ASK screening and $14,000 for routine screening. To achieve value thresholds of $50,000-$150,000 per QALY gained, screening costs would need to be offset by cost savings through 20% reductions in DKA events at diagnosis in addition to 0.1% (1.1 mmol/mol) improvements in HbA1c over a lifetime compared with no screening for patients who develop type 1 diabetes. Value thresholds were not met from avoiding DKA events alone in either scenario. CONCLUSIONS: Presymptomatic type 1 diabetes screening may be cost-effective in areas with a high prevalence of DKA and an infrastructure facilitating screening and monitoring if the benefits of avoiding DKA events and improved HbA1c persist over long-run time horizons. As more data are collected from ASK, the model will be updated with direct evidence on screening effects.

Economics of Beta-Cell Replacement Therapy.

PURPOSE OF REVIEW: Type 1 diabetes impacts 1.3 million people in the USA with a total direct lifetime medical cost of $133.7 billion. Management requires a mix of daily exogenous insulin administration and frequent glucose monitoring. Decision-making by the individual can be burdensome. RECENT FINDINGS: Beta-cell replacement, which involves devices protecting cells from autoimmunity and allo-rejection, aims at restoring physiological glucose regulation and improving clinical outcomes in patients. Given the significant burden of T1D in the healthcare systems, cost-effectiveness analyses can drive innovation and policymaking in the area. This review presents the health economics analyses performed for donor-derived islet transplantation and the possible outcomes of stem cell-derived beta cells. Long-term cost-effectiveness of islet transplantation depends on the engraftment of these transplants, and the expenses and thresholds assumed by healthcare systems in different countries. Early health technology assessment analyses for stem cell-derived beta-cell replacement suggest manufacturing optimization is necessary to reduce upfront costs.

Lifetime benefits of early detection and treatment of diabetic kidney disease.

OBJECTIVES: Diabetic kidney disease (DKD) is a frequent complication of diabetes with potentially devastating consequences that may be prevented or delayed. This study aimed to estimate the health and economic benefit of earlier diagnosis and treatment of DKD. METHODS: Life expectancy and medical spending for people with diabetes were modeled using The Health Economics Medical Innovation Simulation (THEMIS). THEMIS uses data from the Health and Retirement Study to model cohorts of individuals over age 50 to project population-level lifetime health and economic outcomes. DKD status was imputed based on diagnoses and laboratory values in the National Health and Nutrition Examination Survey. We simulated the implementation of a new biomarker identifying people with diabetes at an elevated risk of DKD and DKD patients at risk of rapid progression. RESULTS: Compared to baseline, the prevalence of DKD declined 5.1% with a novel prognostic biomarker test, while the prevalence of diabetes with stage 5 chronic kidney disease declined 3.0%. Consequently, people with diabetes gained 0.2 years in life expectancy, while per-capita annual medical spending fell by 0.3%. The estimated cost was $12,796 per life-year gained and $25,842 per quality-adjusted life-year. CONCLUSIONS: A biomarker test that allows earlier treatment reduces DKD prevalence and slows DKD progression, thereby increasing life expectancy among people with diabetes while raising healthcare spending by less than one percent.

Bringing Stem Cell-Based Therapies for Type 1 Diabetes to the Clinic: Early Insights from Bioprocess Economics and Cost-Effectiveness Analysis.

Differentiation of pluripotent stem cells (PSCs) into ß cells could provide insulin independence for type 1 diabetes (T1D) patients. This approach would reduce the clinical complications that most patients managed on intensive insulin therapy (IIT) face. However, bottlenecks of PSC manufacturing and limited engraftment of encapsulated cells hinder the long-term effectiveness of these therapies. A bioprocess decision-support tool is combined with a disease state-transition model to evaluate the cost-effectiveness of the stem cell-based therapy against IIT. Clinical effectiveness is assessed in quality-adjusted life years (QALYs). Manufacturing costs per patient reduce from $430 000 to $160 000 with optimization of batch size and annual demand. For 96% of the patients, cell therapy improves the quality of life compared to IIT. Cost savings are achieved for 2% of the population through prevention of renal disease. The therapy is cost-effective for 3.4% of patients when a willingness to pay (WTP) of up to $150 000 per QALY is considered. A 75% cost reduction in the cell therapy price increases cost-effectiveness likelihood to 51% at $100 000 per QALY. This study highlights the need for scalable manufacturing platforms for stem cell therapies, as well as to prioritizing access to the therapy to patients with an increased likelihood of costly complications.

Eye Care Utilization Among Insured People With Diabetes in the U.S., 2010-2014.

OBJECTIVE: Diabetic retinopathy (DR) is the leading cause of blindness among working-age adults, and although screening with eye exams is effective, screening rates are low. We evaluated eye exam visits over a 5-year period in a large population of insured patients 10-64 years of age with diabetes. RESEARCH DESIGN AND METHODS: We used claims data from IBM Watson Health to identify patients with diabetes and continuous insurance coverage from 2010 to 2014. Diabetes and DR were defined using ICD-9 Clinical Modification codes. We calculated eye exam visit frequency by diabetes type over a 5-year period and estimated period prevalence and cumulative incidence of DR among those receiving an eye exam. RESULTS: Among the 298,383 insured patients with type 2 diabetes and no diagnosed DR, almost half had no eye exam visits over the 5-year period and only 15.3% met the American Diabetes Association (ADA) recommendations for annual or biennial eye exams. For the 2,949 patients with type 1 diabetes, one-third had no eye exam visits and 26.3% met ADA recommendations. The 5-year period prevalence and cumulative incidence of DR were 24.4% and 15.8%, respectively, for patients with type 2 diabetes and 54.0% and 33.4% for patients with type 1 diabetes. CONCLUSIONS: The frequency of eye exams was alarmingly low, adding to the abundant literature that systemic changes in health care may be needed to detect and prevent vision-threatening eye disease among people with diabetes.

Stem cells and beta cell replacement therapy: a prospective health technology assessment study.

BACKGROUND: Although current beta cell replacement therapy is effective in stabilizing glycemic control in highly selected patients with refractory type 1 diabetes, many hurdles are inherent to this and other donor-based transplantation methods. One solution could be moving to stem cell-derived transplant tissue. This study investigates a novel stem cell-derived graft and implant technology and explores the circumstances of its cost-effectiveness compared to intensive insulin therapy. METHODS: We used a manufacturing optimization model based on work by Simaria et al. to model cost of the stem cell-based transplant doses and integrated its results into a cost-effectiveness model of diabetes treatments. The disease model simulated marginal differences in clinical effects and costs between the new technology and our comparator intensive insulin therapy. The form of beta cell replacement therapy was as a series of retrievable subcutaneous implant devices which protect the enclosed pancreatic progenitors cells from the immune system. This approach was presumed to be as effective as state of the art islet transplantation, aside from immunosuppression drawbacks. We investigated two different cell culture methods and several production and delivery scenarios. RESULTS: We found the likely range of treatment costs for this form of graft tissue for beta cell replacement therapy. Additionally our results show this technology could be cost-effective compared to intensive insulin therapy, at a willingness-to-pay threshold of $100,000 per quality-adjusted life year. However, results also indicate that mass production has by far the best chance of providing affordable graft tissue, while overall there seems to be considerable room for cost reductions. CONCLUSIONS: Such a technology can improve treatment access and quality of life for patients through increased graft supply and protection. Stem cell-based implants can be a feasible way of treating a wide range of patients with type 1 diabetes.

Cost calculation for a flash glucose monitoring system for UK adults with type 1 diabetes mellitus receiving intensive insulin treatment.

AIMS: To estimate the costs associated with a flash glucose monitoring system as a replacement for routine self-monitoring of blood glucose (SMBG) in patients with type 1 diabetes mellitus (T1DM) using intensive insulin, from a UK National Health Service (NHS) perspective. METHODS: The base-case cost calculation was created using the maximum frequency of glucose monitoring recommended by the 2015 National Institute for Health and Care Excellence guidelines (4-10 tests per day). Scenario analyses considered SMBG at the frequency observed in the IMPACT clinical trial (5.6 tests per day) and at the frequency of flash monitoring observed in a real-world analysis (16 tests per day). A further scenario included potential costs associated with severe hypoglycaemia. RESULTS: In the base case, the annual cost per patient using flash monitoring was £234 (19%) lower compared with routine SMBG (10 tests per day). In scenario analyses, the annual cost per patient of flash monitoring compared with 5.6 and 16 SMBG tests per day was £296 higher and £957 lower, respectively. The annual cost of severe hypoglycaemia for flash monitoring users was estimated to be £221 per patient, compared with £428 for routine SMBG users (based on 5.6 tests/day), corresponding to a reduction in costs of £207. CONCLUSIONS: The flash monitoring system has a modest impact on glucose monitoring costs for the UK NHS for patients with T1DM using intensive insulin. For people requiring frequent tests, flash monitoring may be cost saving, especially when taking into account potential reductions in the rate of severe hypoglycaemia.

Healthcare utilization and costs associated with gastroparesis.

AIM: To use a national database of United States hospitals to evaluate the incidence and costs of hospital admissions associated with gastroparesis. METHODS: We analyzed the National Inpatient Sample Database (NIS) for all patients in whom gastroparesis (ICD-9 code: 536.3) was the principal discharge diagnosis during the period, 1997-2013. The NIS is the largest publicly available all-payer inpatient care database in the United States. It contains data from approximately eight million hospital stays each year. The statistical significance of the difference in the number of hospital discharges, length of stay and hospital costs over the study period was determined by regression analysis. RESULTS: In 1997, there were 3978 admissions with a principal discharge diagnosis of gastroparesis as compared to 16460 in 2013 (P < 0.01). The mean length of stay for gastroparesis decreased by 20 % between 1997 and 2013 from 6.4 d to 5.1 d (P < 0.001). However, during this period the mean hospital charges increased significantly by 159 % from $13350 (after inflation adjustment) per patient in 1997 to $34585 per patient in 2013 (P < 0.001). The aggregate charges (i.e., "national bill") for gastroparesis increased exponentially by 1026 % from $50456642 ± 4662620 in 1997 to $568417666 ± 22374060 in 2013 (P < 0.001). The percentage of national bill for gastroparesis discharges (national bill for gastroparesis/total national bill) has also increased over the last 16 years (0.0013% in 1997 vs 0.004% in 2013). During the study period, women had a higher frequency of gastroparesis discharges when compared to men (1.39/10000 vs 0.9/10000 in 1997 and 5.8/10000 vs 3/10000 in 2013). There was a 6-fold increase in the discharge diagnosis of gastroparesis amongst type 1 DM and 3.7-fold increase amongst type 2 DM patients over the study period (P < 0.001). CONCLUSION: The number of inpatient admissions for gastroparesis and associated costs have increased significantly over the last 16 years. Inpatient costs associated with gastroparesis contribute significantly to the national healthcare bill. Further research on cost-effective evaluation and management of gastroparesis is required.

Incidence, prevalence, costs and quality of care of type 1 diabetes in Italy, age 0-29 years: The population-based CINECA-SID ARNO Observatory, 2002-2012.

BACKGROUND AND AIMS: To assess temporal trend in incidence (2003-12) and prevalence (2002-12) of type 1 diabetes in children and young adults, direct costs and selected indicators of quality of care under the coverage of the universalistic Italian National Health System (NHS). METHODS AND RESULTS: The ARNO Observatory, a healthcare monitoring system based on administrative data, identified a population-based multiregional cohort of subjects aged 0-29 years. Type 1 diabetes was defined by at least two prescriptions of insulin over 12 months and continuous insulin-treatment in the following year. Indicators of quality of care and directs costs were assessed in persons with diabetes and in people without diabetes, individually matched for age, gender and health unit (1:4 ratio). We identified 2357 incident cases of type 1 diabetes aged 0-29 years (completeness of ascertainment, 99%). Incidence rates were similar in ages 0-14 (15.8, 95% CI 14.9-16.8) and 15-29 years (16.3, 15.4-17.2), with no significant trend. Prevalence increased from 137 to 166.9/100,000, particularly in the age 15-29 years. Direct costs accounted for € 2117 in persons with diabetes and € 292 in control individuals. A statistically significant decreasing trend in hospitalization for acute complications was evident (p < 0.001), which was almost completely due to ketoacidosis. People with at least one HbA1c measurement over the year were 48.5%. CONCLUSION: We showed high incidence and increasing prevalence of type 1 diabetes in young adults in Italy, which impact on direct costs under the universalistic coverage of the NHS.

COST-EFFECTIVENESS OF STRUCTURED EDUCATION IN CHILDREN WITH TYPE-1 DIABETES MELLITUS.

OBJECTIVES: Kids in Control OF Food (KICk-OFF) is a 5-day structured education program for 11- to 16-year-olds with type 1 diabetes mellitus (T1DM) who are using multiple daily insulin injections. This study evaluates the cost-effectiveness of the KICk-OFF education program compared with the usual care using data from the KICk-OFF trial. METHODS: The short-term within-trial analysis covers the 2-year postintervention period. Data on glycated hemoglobin (HbA1c), severe hypoglycemia, and diabetic ketoacidosis (DKA) were collected over a 2-year follow-up period. Sub-group analyses have been defined on the basis of baseline HbA1c being below 7.5 percent (58.5 mmol/mol) (low group), between 7.5 percent and 9.5 percent (80.3 mmol/mol) (medium group), and over 9.5 percent (high group). The long-term cost-effectiveness evaluation has been conducted by using The Sheffield Type 1 Diabetes Policy Model, which is a patient-level simulation model on T1DM. It includes long-term microvascular (retinopathy, neuropathy, and nephropathy) and macrovascular (myocardial infarction, stroke, revascularization, and angina) diabetes-related complications and acute adverse events (severe hypoglycemia and DKA). RESULTS: The most favorable within-trial scenario for the KICk-OFF arm led to an incremental cost-effectiveness ratio (ICER) of £23,688 (base year 2009) with a cost-effectiveness probability of 41.3 percent. Simulating the long-term complications using the full cohort data, the mean ICER for the base case was £28,813 (base year 2011) and the probability of the KICk-OFF intervention being cost-effective at £20,000/QALY threshold was 42.6 percent, with considerable variation due to treatment effect duration. For the high HbA1c sub-group, the KICk-OFF arm was "dominant" (meaning it provided better health gains at lower costs than usual care) over the usual care arm in each scenario considered. CONCLUSIONS: For the whole study population, the cost-effectiveness of KICk-OFF depends on the assumption for treatment effect duration. For the high baseline HbA1c sub-group, KICk-OFF arm was estimated to be dominant over the usual care arm regardless of the assumption on the treatment effect duration.

[Changes in features of diabetes care in Hungary in the period of years 2001-2014. Aims and methods of the database analysis of the National Health Insurance Fund]. / A cukorbeteg-ellátás mutatóinak alakulása Magyarországon 2001-2014 között. Az Országos Egészségbiztosítási Pénztár adatbázis-elemzésének célja és módszertana.

In the last couple of years, database analyses have become increasingly popular among clinical-epidemiological investigations. In Hungary, the National Health Insurance Fund serves as central database of all medical attendances in state departments and purchases of drug prescriptions in pharmacies. Data from in- and outpatient departments as well as those from pharmacies are regularly collected in this database which is public and accessible on request. The aim of this retrospective study was to investigate the database of the National Health Insurance Fund in order to analyze the diabetes-associated morbidity and mortality in the period of years 2001-2014. Moreover, data of therapeutic costs, features of hospitalizations and practice of antidiabetic treatment were examined. The authors report now on the method of the database analysis. It is to be hoped that the upcoming results of this investigation will add some new data to recent knowledge about diabetes care in Hungary. Orv. Hetil., 2016, 157(32), 1259-1265.

Clinical relevance and cost-effectiveness of HLA genotyping in children with Type 1 diabetes mellitus in screening for coeliac disease in the Netherlands.

AIMS: To investigate the clinical relevance and cost-effectiveness of human leukocyte antigen (HLA)-genotyping in the Netherlands as a screening tool for the development of coeliac disease in children with Type 1 diabetes mellitus. METHODS: A retrospective analysis was performed in 110 children with Type 1 diabetes mellitus diagnosed between January 1996 and January 2013. All children were screened for coeliac disease using coeliac disease-specific antibodies and HLA genotyping was performed in all children. RESULTS: One hundred and ten children were screened for coeliac disease, and coeliac disease could be confirmed in seven. Eighty-six per cent of the children with Type 1 diabetes mellitus had one of the variants of HLA-DQ2.5 and DQ8. HLA genotypes observed in children with Type 1 diabetes mellitus children and coeliac disease were heterozygote DQ2.5, homozygote DQ2.5 and heterozygote DQ2.5/DQ8. HLA genotyping in coeliac disease screening in children with Type 1 diabetes mellitus is more expensive than screening for coeliac disease with antibodies alone (€326 vs. €182 per child). CONCLUSIONS: The risk of coeliac disease development in children with Type 1 diabetes mellitus is increased when they are heterozygote DQ2.5/DQ8, homozygote or heterozygote DQ2.5. The implementation of HLA genotyping as a first-line screening tool has to be reconsidered because it is not distinctive or cost-effective.

Identifying knowledge deficits of food insecure patients with diabetes.

UNLABELLED: The purpose of this project was to identify the self-care needs of adults with diabetes who experience food insecurity. A cross-sectional study design and methodology were used to attain the study data. We invited 153 adults with diabetes who utilized the St Vincent de Paul Food Pantry to complete the diabetes knowledge test. The reliability of the sample was calculated using Cronbach's coefficient α. To determine validity, differences in test scores were examined by diabetes type and treatment, educational attainment, and receipt of diabetes education. RESULTS: The coefficient α for the general test and the insulin-use subscale indicated that both were moderately reliable, α> 0.60. General test scores were significantly associated with educational attainment (p<0.01) and prior diabetes education (p<0.05). We found that participants who attained education beyond high school or previously received diabetes education scored significantly higher on the test compared to those with less than high school education or not receiving diabetes education (p<0.05). Adults with type 1 diabetes had higher general and insulin use scores compared to adults with type 2 diabetes, however the difference was not statistically significant. While general knowledge about diabetes is not a predictor of self-care behavior, it is needed to perform daily self-care activities. Health care providers should assess diabetes knowledge in low income patients who experience food insecurity regularly to identify any gaps in knowledge that can compromise self-care behaviors.

Expanding the indications of pancreas transplantation alone.

OBJECTIVES: Total pancreatectomy (TP) is associated with postoperative endocrine and exocrine insufficiency. Especially, insulin therapy reduces quality of life and may lead to long-term complications. We review the literature with regard to the potential option of pancreas transplantation alone (PTA) after TP in patients with chronic pancreatitis or benign tumors. METHODS: A MEDLINE search (1958-2013) using the terminologies pancreas transplantation, pancreas transplantation alone, total pancreatectomy, morbidity, mortality, insulin therapy, and quality of life was performed. In addition, the current book and congress publications were reviewed. RESULTS: Total pancreatectomy after benign and borderline tumors as well as chronic pancreatitis is continuously increasing. Despite improvement of exogenous insulin therapy, more than 50% of these patients experience severe glucose control problems, which cause up to 50% long-term mortality. Pancreas transplantation alone can cure both endocrine and exocrine insufficiency and reduce the associated risks. The 3-year graft and patient survival rates after PTA are up to 73% and 100%, respectively. CONCLUSIONS: Pancreas transplantation alone after TP in patients with pancreatitis or benign tumors improves the recipient's quality of life and reduces long-term mortality. Considering the amount of available organs and potential candidates, PTA can be a treatment option for patients after TP with chronic pancreatitis or benign tumors.