RESUMEN
BACKGROUND: Use of Continuous Subcutaneous Insulin Infusion (CSII) has been shown to improve glycemic outcomes in Type 1 Diabetes (T1D), but high costs limit accessibility. To address this issue, an inter-operable, open-source Ultra-Low-Cost Insulin Pump (ULCIP) was developed and previously shown to demonstrate comparable delivery accuracy to commercial models in standardised laboratory tests. This study aims to evaluate the updated ULCIP in-vivo, assessing its viability as an affordable alternative for those who cannot afford commercially available devices. METHODS: This first-in-human feasibility study recruited six participants with T1D. During a nine-hour inpatient stay, participants used the ULCIP under clinical supervision. Venous glucose, insulin, and ß-Hydroxybutyrate were monitored to assess device performance. RESULTS: Participants displayed expected blood glucose and blood insulin levels in response to programmed basal and bolus insulin dosing. One participant developed mild ketosis, which was treated and did not recur when a new pump reservoir was placed. All other participants maintained ß-Hydroxybutyrate < 0.6 mmol/L throughout. CONCLUSION: The ULCIP safely delivered insulin therapy to users in a supervised inpatient environment. Future work should focus on correcting a pump hardware issue identified in this trial and extending device capabilities for use in closed loop control. Longer-term outpatient studies are warranted. TRIAL REGISTRATION: The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12623001288617) on the 11 December 2023.
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Glucemia , Diabetes Mellitus Tipo 1 , Estudios de Factibilidad , Hipoglucemiantes , Sistemas de Infusión de Insulina , Insulina , Humanos , Sistemas de Infusión de Insulina/economía , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 1/economía , Masculino , Femenino , Insulina/administración & dosificación , Insulina/economía , Adulto , Glucemia/análisis , Hipoglucemiantes/administración & dosificación , Hipoglucemiantes/economía , Persona de Mediana EdadRESUMEN
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.
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Automonitorización de la Glucosa Sanguínea , Análisis Costo-Beneficio , Diabetes Mellitus Tipo 1 , Hipoglucemiantes , Sistemas de Infusión de Insulina , Años de Vida Ajustados por Calidad de Vida , Humanos , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Diabetes Mellitus Tipo 1/economía , Diabetes Mellitus Tipo 1/sangre , Singapur , Hipoglucemiantes/economía , Hipoglucemiantes/administración & dosificación , Hipoglucemiantes/uso terapéutico , Sistemas de Infusión de Insulina/economía , Masculino , Femenino , Automonitorización de la Glucosa Sanguínea/economía , Insulina/administración & dosificación , Insulina/economía , Insulina/uso terapéutico , Adulto , Glucemia/análisis , Hemoglobina Glucada/análisis , Persona de Mediana EdadRESUMEN
AIM: To compare glycaemic control and adverse outcomes between transition-aged and early adults with type 1 diabetes, and the impact of continuous subcutaneous insulin infusion (CSII) therapy funded through a government Assisted Devices Program. METHODS: This retrospective cohort study using healthcare administrative databases from Ontario, Canada included adults aged 18-35 with type 1 diabetes between 1 April 2011 and 31 March 2014. Mean HbA1c was compared between transition-aged (18-24 years) and early adults (25-35 years), overall and stratified by whether or not they received government-funded CSII therapy (CSII vs. non-CSII). Secondary outcomes included rates of hospitalizations/emergency department visits for hyperglycaemia and hypoglycaemia over a 3-year follow-up. Comparisons were adjusted for relevant covariates. RESULTS: Among 7157 participants with type 1 diabetes, mean HbA1c was significantly higher for transition-aged compared to early adults (71 mmol/mol [8.68%] vs. 64 mmol/mol [8.04%], p < 0.0001). This difference was smaller among CSII compared to non-CSII users (p = 0.02 for interaction between age group and CSII use). The transition-age group were more likely to experience a hyperglycaemic event compared to early adults (adjusted risk ratio, aRR: 1.56, 95% confidence interval [CI]: 1.25-1.96), which was attenuated by CSII use (aRR: 1.13, 95% CI: 0.7-1.69). CONCLUSIONS: Transition-aged adults with type 1 diabetes had a significantly higher mean HbA1c and risk of hyperglycaemic events compared to early adults. This difference was attenuated for CSII users, indicating that a government-funded CSII programme is associated with narrowing of the gap in glycaemic control and associated adverse outcomes for this population.
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Diabetes Mellitus Tipo 1/tratamiento farmacológico , Control Glucémico/métodos , Gobierno , Sistemas de Infusión de Insulina/economía , Insulina/administración & dosificación , Vigilancia de la Población , Adolescente , Adulto , Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 1/epidemiología , Diseño de Equipo , Femenino , Hemoglobina Glucada/metabolismo , Humanos , Hipoglucemiantes/administración & dosificación , Incidencia , Inyecciones Subcutáneas/instrumentación , Masculino , Ontario/epidemiología , Estudios Retrospectivos , Adulto JovenRESUMEN
Objectives: To evaluate the clinical and economic consequences of continuous subcutaneous insulin infusion (CSII) vs. multiple daily injections (MDI) in children and adolescents with type 1 diabetes mellitus (T1DM) from a public health care system in developed areas of developing country, considering changes in glycemic Control, daily insulin requirements, lipid profile, body mass index (BMI), frequency of severe hypoglycemia and Diabetic Ketoacidosis (DKA) and diabetic complications. Methods: This was a retrospective cohort study of children and adolescents with T1DM. Data were collected at baseline and the end of every year including glycated hemoglobin (HbA1c), insulin dose, lipid profile, blood pressure, and adverse events (severe hypoglycemia and DKA). The Cost-effectiveness analysis was performed using the IQVIA CORE Diabetes Model (CDM) to simulate diabetes progression by utilizing the clinical data obtained from the two groups. The main outcome measures were Life Expectancy, Quality adjusted life years (QALYs), Total Costs and Incremental Costs and Effectiveness Ratio (ICER) of CSII compared with MDI in Chinese pediatric patients with T1DM in Qingdao City (60 years). Results: Mean HbA1c values and daily insulin doses were significantly lower in those receiving CSII therapy throughout follow-up. Mean direct lifetime costs were ¥ 67,137 higher with CSII treatment than with MDI for pediatric patients. Treatment with CSII was associated with an improvement in life expectancy of 0.41 years for pediatric patients compared with MDI based on CORE diabetes model simulation. The corresponding gains in QALYs were 0.42. These data produced corresponding ICER is ¥ 161,815 per QALY for pediatric T1DM patients in Qingdao. Sensitivity analyses suggested that our base-case assumptions were mostly robust. Conclusions: CSII is associated with improved long-term clinical outcomes compared with MDI. Based on this model analysis, CSII appears to be more cost-effective for the Qingdao TIDM pediatric population and health care system.
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Diabetes Mellitus Tipo 1/tratamiento farmacológico , Sistemas de Infusión de Insulina , Insulina/administración & dosificación , Adolescente , Niño , Preescolar , China/epidemiología , Estudios de Cohortes , Análisis Costo-Beneficio , Atención a la Salud/economía , Atención a la Salud/organización & administración , Diabetes Mellitus Tipo 1/economía , Diabetes Mellitus Tipo 1/epidemiología , Esquema de Medicación , Femenino , Humanos , Inyecciones Subcutáneas , Insulina/economía , Sistemas de Infusión de Insulina/economía , Masculino , Salud Pública/economía , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
INTRODUCTION: Disadvantaged and minority youth with type 1 diabetes are less likely to be on insulin pump therapy compared to the majority population. Little is known about how pediatric endocrinology providers determine eligibility for insulin pump. We aimed to identify provider factors influencing the decision to initiate insulin pump therapy. METHODS: We conducted a survey of Pediatric Endocrine Society members who prescribe insulin pump therapy to pediatric patients with type 1 diabetes. The survey collected information about prescriber characteristics, use and adherence to guidelines, eligibility criteria, and objective and subjective factors that influence insulin pump prescription. RESULTS: The survey was completed by 192 individuals who met eligibility criteria (14.1% response rate). The majority of respondents were attending providers, and were white, non-Hispanic females. A minority of providers (22%) reported following written insulin pump guidelines, and many (70%) reported using personal guidelines to guide patient selection. Most providers had no objective eligibility criteria, aside from standard glucose monitoring. Providers identified patient lifestyle and increased risk of hypoglycemia, as well as patient and family factors such as motivation, realistic expectations of insulin pump use, ability to demonstrate carbohydrate counting, patient request, and ability to communicate as important in the decision to initiate insulin pump. CONCLUSION: Pediatric endocrinology providers place significant importance on subjective factors and utilize few objective criteria in determining eligibility for insulin pump. In the setting of the known disparities in insulin pump use, providers should utilize objective, consistent criteria to determine which patients are safe to initiate insulin pump.
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Diabetes Mellitus Tipo 1/tratamiento farmacológico , Sistemas de Infusión de Insulina , Insulina/administración & dosificación , Pautas de la Práctica en Medicina/estadística & datos numéricos , Adolescente , Adulto , Automonitorización de la Glucosa Sanguínea/economía , Niño , Preescolar , Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 1/economía , Endocrinología/estadística & datos numéricos , Femenino , Humanos , Insulina/economía , Sistemas de Infusión de Insulina/economía , Sistemas de Infusión de Insulina/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Pediatría/estadística & datos numéricos , Relaciones Médico-Paciente , Autoinforme , Encuestas y CuestionariosRESUMEN
BACKGROUND: Cost is a major consideration in the uptake and continued use of diabetes technology. With increasing use of automated insulin delivery systems, it is important to understand the specific cost-related barriers to technology adoption. In this qualitative analysis, we were interested in understanding and examining the decision-making process around cost and diabetes technology use. MATERIALS AND METHODS: Four raters coded transcripts of four stakeholder groups using inductive coding for each stakeholder group to establish relevant themes/nodes. We applied the Social Ecological Model in the interpretation of five thematic levels of cost. RESULTS: We identified five thematic levels of cost: policy, organizational, insurance, interpersonal and individual. Equitable diabetes technology access was an important policy-level theme. The insurance-level theme had multiple subthemes which predominantly carried a negative valence. Participants also emphasized the psychosocial burden of cost specifically identifying diabetes costs to their families, the guilt of diabetes related costs, and frustration in the time and involvement required to ensure insurance coverage. CONCLUSION: We found broad consensus in how cost is experienced by stakeholder groups. Cost considerations for diabetes technology uptake extended beyond finances to include time, cost to society, morality and interpersonal relationships. Cost also reflected an important moral principle tied to the shared desire for equitable access to diabetes technology. Knowledge of these considerations can help clinicians and researchers promote equitable device uptake while anticipating barriers for all persons living with type 1 diabetes and their families.
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Costo de Enfermedad , Diabetes Mellitus Tipo 1/economía , Diabetes Mellitus Tipo 1/psicología , Familia/psicología , Costos de la Atención en Salud , Sistemas de Infusión de Insulina/economía , Toma de Decisiones , Diabetes Mellitus Tipo 1/terapia , Frustación , Cobertura del Seguro , Relaciones Interpersonales , Investigación CualitativaRESUMEN
BACKGROUND: The Nova Scotia Insulin Pump Program (NSIPP) subsidizes the cost of insulin pump therapy for young patients (≤25 years) with type 1 diabetes. The first NSIPP evaluation focused on clinical outcomes rather than quality of life. Existing research on insulin pumps and quality of life is mostly survey based, with limited first-voice experiences. In this qualitative study, we examined patient and parent perspectives on how insulin pumps affect quality of life in the context of a government-funded program. METHODS: In this investigation, we used a phenomenological approach, guided by a conceptual model. In-depth semistructured telephone interviews (median, 37 minutes) were completed with NSIPP enrollees and/or their parents. Saturation was reached after 23 interviews. Verbatim transcripts were coded independently by 2 researchers. Coding discrepancies were discussed and resolved using concept mapping to clarify relationships between codes and to identify main themes. RESULTS: There were 2 main themes: 1) NSIPP financial support was necessary for those without private insurance and 2) control over life and diabetes with subthemes of social experiences and worry. Participants expressed this theme differently depending on their stage of life. For example, some children experienced shame and even hid their pump, whereas teens were more self-confident with the discreetness of pumps and young adults wore their pump with pride. CONCLUSIONS: Insulin pump therapy, subsidized through the NSIPP, led to improved quality of life, which was experienced differently depending on stage of life.
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Diabetes Mellitus Tipo 1/tratamiento farmacológico , Programas de Gobierno/estadística & datos numéricos , Sistemas de Infusión de Insulina/economía , Calidad de Vida , Adolescente , Adulto , Niño , Femenino , Financiación Gubernamental , Humanos , Masculino , Nueva Escocia , Padres/psicología , Pacientes/psicología , Pacientes/estadística & datos numéricos , Evaluación de Programas y Proyectos de Salud , Investigación Cualitativa , Adulto JovenRESUMEN
AIMS: Uptake of continuous subcutaneous insulin infusion (CSII) by people with diabetes (PwD) in Ireland is low and exhibits regional variation. This study explores barriers and facilitators to accessing CSII by adults with Type 1 diabetes mellitus. RESEARCH DESIGN AND METHODS: A qualitative study employing focus groups with adults with Type 1 diabetes mellitus (n = 26) and semi-structured interviews with health care professionals (HCP) and other key stakeholders (n = 21) was conducted. Reflexive thematic analysis was used to analyze data, using NVivo. RESULTS: Four main themes comprising barriers to or facilitators of CSII uptake were identified. These included: (1) awareness of CSII and its benefits, (2) the structure of diabetes services, (3) the capacity of the diabetes service to deliver the CSII service, and (4) the impact of individuals' attitudes and personal characteristics-both PwD, and HCP. Each of these themes was associated with a number of categories, of which 18 were identified and explored. If the structure of the health-service is insufficient and capacity is poor (e.g., under-resourced clinics), CSII uptake appears to be impacted by individuals': interest, attitude, willingness and motivation, which may intensify the regional inequality in accessing CSII. CONCLUSIONS: This study identified factors that contribute to gaps in the delivery of diabetes care that policy-makers may use to improve access to CSII for adult PwD.
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Diabetes Mellitus Tipo 1/tratamiento farmacológico , Equipos y Suministros , Accesibilidad a los Servicios de Salud , Sistemas de Infusión de Insulina , Insulina/administración & dosificación , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Concienciación , Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 1/economía , Diabetes Mellitus Tipo 1/epidemiología , Equipos y Suministros/economía , Equipos y Suministros/estadística & datos numéricos , Femenino , Conocimientos, Actitudes y Práctica en Salud , Accesibilidad a los Servicios de Salud/economía , Accesibilidad a los Servicios de Salud/estadística & datos numéricos , Humanos , Hipoglucemiantes/administración & dosificación , Sistemas de Infusión de Insulina/economía , Sistemas de Infusión de Insulina/psicología , Sistemas de Infusión de Insulina/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Investigación Cualitativa , Factores Socioeconómicos , Adulto JovenRESUMEN
Background: Hybrid closed-loop systems may offer improved HbA1c levels, more time-in-range, and less hypoglycemia than alternative treatment strategies. However, it is unclear if glycemic improvements offset this technology's higher acquisition costs. Among adults with type 1 diabetes in Australia, we sought to evaluate the cost-effectiveness of a hybrid closed-loop system in comparison with the current standard of care, comprising insulin injections and capillary glucose testing. Methods: Cost-effectiveness analysis was performed using decision analysis in combination with a Markov model to simulate disease progression in a cohort of adults with type 1 diabetes and compare the downstream health and economic consequences of hybrid closed-loop therapy versus current standard of care. Transition probabilities and utilities were sourced from published studies. Costs were considered from the perspective of the Australian health care system. A lifetime horizon was considered, with annual discount rates of 5% applied to future costs and outcomes. Uncertainty was assessed with probabilistic and deterministic sensitivity analyses. Results: Use of a hybrid closed-loop system resulted in an incremental cost-effectiveness ratio of Australian dollars (AUD) 37,767 per quality-adjusted life year (QALY) gained. This is below the traditionally cited willingness to pay a threshold of $50,000 per QALY gained in the Australian setting. Sensitivity analyses that varied baseline glycemic control, treatment effects, technology costs, age, discount rates, and time horizon indicated the results to be robust. Conclusions: For adults with type 1 diabetes, hybrid closed-loop therapy is likely to be cost-effective compared with multiple daily injections and capillary glucose testing in Australia.
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Glucemia/análisis , Diabetes Mellitus Tipo 1 , Sistemas de Infusión de Insulina , Insulina/administración & dosificación , Adulto , Australia , Análisis Costo-Beneficio , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Diabetes Mellitus Tipo 1/economía , Humanos , Sistemas de Infusión de Insulina/economía , Años de Vida Ajustados por Calidad de VidaRESUMEN
BACKGROUND: Modern therapy for type 1 diabetes (T1D) increasingly utilizes technology such as insulin pumps and continuous glucose monitors (CGMs). Prior analyses suggest that T1D costs are driven by preventable hospitalizations, but recent escalations in insulin prices and use of technology may have changed the cost landscape. METHODS: We conducted a retrospective analysis of T1D medical costs from 2012 to 2016 using the OptumLabs Data Warehouse, a comprehensive database of deidentified administrative claims for commercial insurance enrollees. Our study population included 9445 individuals aged ≤18 years with T1D and ≥13 months of continuous enrollment. Costs were categorized into ambulatory care, hospital care, insulin, diabetes technology, and diabetes supplies. Mean costs for each category in each year were adjusted for inflation, as well as patient-level covariates including age, sex, race, census region, and mental health comorbidity. RESULTS: Mean annual cost of T1D care increased from $11 178 in 2012 to $17 060 in 2016, driven primarily by growth in the cost of insulin ($3285 to $6255) and cost of diabetes technology ($1747 to $4581). CONCLUSIONS: Our findings suggest that the cost of T1D care is now driven by mounting insulin prices and growing utilization and cost of diabetes technology. Given the positive effects of pumps and CGMs on T1D health outcomes, it is possible that short-term costs are offset by future savings. Long-term cost-effectiveness analyses should be undertaken to inform providers, payers, and policy-makers about how to support optimal T1D care in an era of increasing reliance on therapeutic technology.
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Diabetes Mellitus Tipo 1/economía , Diabetes Mellitus Tipo 1/terapia , Costos de la Atención en Salud/tendencias , Adolescente , Automonitorización de la Glucosa Sanguínea/economía , Automonitorización de la Glucosa Sanguínea/instrumentación , Automonitorización de la Glucosa Sanguínea/métodos , Niño , Preescolar , Análisis Costo-Beneficio , Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 1/epidemiología , Femenino , Costos de la Atención en Salud/historia , Disparidades en Atención de Salud/economía , Disparidades en Atención de Salud/estadística & datos numéricos , Disparidades en Atención de Salud/tendencias , Historia del Siglo XXI , Humanos , Lactante , Sistemas de Infusión de Insulina/economía , Sistemas de Infusión de Insulina/estadística & datos numéricos , Sistemas de Infusión de Insulina/tendencias , Masculino , Estudios Retrospectivos , Estados Unidos/epidemiologíaRESUMEN
OBJECTIVE: In 2016, nationwide reimbursement of intermittently scanned continuous glucose monitoring (isCGM) for people living with type 1 diabetes treated in specialist diabetes centers was introduced in Belgium. We undertook a 12-month prospective observational multicenter real-world study to investigate impact of isCGM on quality of life and glycemic control. RESEARCH DESIGN AND METHODS: Between July 2016 and July 2018, 1,913 adults with type 1 diabetes were consecutively recruited in three specialist diabetes centers. Demographic, metabolic, and quality of life data were collected at baseline, 6 months, and 12 months of standardized clinical follow-up. The primary end point was evolution of quality of life from baseline to 12 months. Secondary outcome measures were, among others, change in HbA1c, time spent in different glycemic ranges, occurrence of acute diabetes complications, and work absenteeism. RESULTS: General and diabetes-specific quality of life was high at baseline and remained stable, whereas treatment satisfaction improved (P < 0.0001). Admissions for severe hypoglycemia and/or ketoacidosis were rare in the year before study (n = 63 out of 1,913; 3.3%), but decreased further to 2.2% (n = 37 out of 1,711; P = 0.031). During the study, fewer people reported severe hypoglycemic events (n = 280 out of 1,913 [14.6%] vs. n = 134 out of 1,711 [7.8%]; P < 0.0001) or hypoglycemic comas (n = 52 out of 1,913 [2.7%] vs. n = 18 out of 1,711 [1.1%]; P = 0.001) while maintaining HbA1c levels. Fewer people were absent from work (n = 111 out of 1,913 [5.8%] vs. n = 49 out of 1,711 [2.9%]; P < 0.0001). Time spent in hypoglycemia significantly decreased in parallel with less time in range and more time in hyperglycemia. Eleven percent (n = 210) of participants experienced skin reactions, leading to stopping of isCGM in 22 participants (1%). CONCLUSIONS: Nationwide unrestricted reimbursement of isCGM in people with type 1 diabetes treated in specialist diabetes centers results in higher treatment satisfaction, less severe hypoglycemia, and less work absenteeism, while maintaining quality of life and HbA1c.
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Glucemia/metabolismo , Diabetes Mellitus Tipo 1 , Reembolso de Seguro de Salud , Calidad de Vida , Adulto , Factores de Edad , Bélgica/epidemiología , Glucemia/análisis , Automonitorización de la Glucosa Sanguínea/economía , Automonitorización de la Glucosa Sanguínea/instrumentación , Automonitorización de la Glucosa Sanguínea/métodos , Estudios de Cohortes , Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Diabetes Mellitus Tipo 1/economía , Diabetes Mellitus Tipo 1/epidemiología , Equipos y Suministros/economía , Equipos y Suministros/estadística & datos numéricos , Femenino , Hospitalización/economía , Hospitalización/estadística & datos numéricos , Humanos , Hiperglucemia/sangre , Hiperglucemia/complicaciones , Hiperglucemia/economía , Hiperglucemia/epidemiología , Hipoglucemia/sangre , Hipoglucemia/economía , Hipoglucemia/epidemiología , Hipoglucemia/etiología , Hipoglucemiantes/administración & dosificación , Hipoglucemiantes/efectos adversos , Hipoglucemiantes/economía , Insulina/administración & dosificación , Insulina/efectos adversos , Insulina/economía , Sistemas de Infusión de Insulina/economía , Sistemas de Infusión de Insulina/estadística & datos numéricos , Reembolso de Seguro de Salud/economía , Reembolso de Seguro de Salud/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Estudios ProspectivosRESUMEN
BACKGROUND: The Centers for Medicare and Medicaid Services (CMS) has numerous requirements for coverage of continuous subcutaneous insulin infusion (CSII; insulin pump). Due to recent improvements in diabetes treatment, people with type 1 diabetes are living longer, resulting in an increase in the number of individuals who are eligible for Medicare and are impacted by CMS policies regarding CSII. METHODS: Two hundred forty-one adults with type 1 diabetes who had been on CSII with CMS coverage for at least 6 months were surveyed. Median age was 67 years, mean A1c was 7.0%, 64% were women, 93% were white, and the median type 1 diabetes duration was 42 years. Participants reported median CSII use of 15 years and 82% were on CSII before starting CMS. RESULTS: Of those starting CSII while on CMS, challenges included cost of supplies (29%) or the insulin pump (24%). The majority (57.5%) reported issues with obtaining supplies, the most common problems being delays in release of supplies (29%), difficulty getting paperwork completed (23.5%), and seeing a health care provider every 90 days (18%). Participants reported changing their CSII behaviors because of supply delays (39%) including leaving site in place >3 days (64%), and reusing pump supplies (34%). Consequently, participants reported adverse outcomes including more erratic (48%) or higher (42%) blood glucose and pain or irritation at sites (34%). CONCLUSION: This study concluded that current CMS CSII policies promote adverse CSII behaviors and outcomes in type 1 diabetes and thus call for changes in the CMS CSII policies.
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Diabetes Mellitus Tipo 1/tratamiento farmacológico , Política de Salud , Insulina/administración & dosificación , Medicare , Adulto , Anciano , Anciano de 80 o más Años , Actitud Frente a la Salud , Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 1/economía , Diabetes Mellitus Tipo 1/epidemiología , Femenino , Política de Salud/economía , Humanos , Reacción en el Punto de Inyección/epidemiología , Inyecciones Subcutáneas/economía , Sistemas de Infusión de Insulina/economía , Cobertura del Seguro/economía , Cobertura del Seguro/organización & administración , Masculino , Medicare/economía , Medicare/organización & administración , Cumplimiento de la Medicación/estadística & datos numéricos , Persona de Mediana Edad , Percepción , Evaluación de Programas y Proyectos de Salud , Estados Unidos/epidemiología , Adulto JovenRESUMEN
BACKGROUND: Coping with discomfort and the uncertainties of daily adjustments are prominent challenges confronting individuals with type 2 diabetes mellitus (T2DM) who require multiple daily injections (MDI) of insulin. For this growing population, wearable, disposable devices capable of delivering consistent and sustained doses of basal-bolus therapy may help to alleviate concerns and improve outcomes. However, studies on the comparative effectiveness of new, innovative delivery systems versus MDI on insulin requirements, glycemic control, and health care costs are sparse. OBJECTIVE: To examine glycemic control, insulin use, and diabetes medication costs for users of the V-Go Wearable Insulin Delivery device compared with MDI insulin therapy among individuals with T2DM in a commercially insured population in the United States. METHODS: This retrospective cohort study queried administrative claims data from the HealthCore Integrated Research Database from July 1, 2011, through July 31, 2017. Cohorts included individuals with T2DM aged 21-80 years either newly initiating V-Go or using MDI for basal/bolus insulin. The date of earliest claim for V-Go prescription fill or for bolus insulin was defined as the index date, depending on the cohort. Previous insulin therapy was required in both cohorts. Baseline hemoglobin A1c (A1c) values were identified during the 6 months before and 15 days after the index date; results closest to 12 months after the index date were selected as follow-up. Insulin use and diabetes medication cost data were examined during the 6 months baseline and the second half of the 1-year follow-up. V-Go and MDI users were 1:1 matched on baseline insulin exposure, A1c level, and other characteristics of interest. Univariate and multivariate tests were used to compare follow-up outcomes. RESULTS: Matched cohorts included 118 well-balanced pairs (mean age: 56 years; mean baseline A1c: 9.2%). During follow-up, both cohorts experienced improvements in glycemic control relative to baseline (% with A1c ≤ 9%, baseline/follow-up: V-Go 49/69, P < 0.001; MDI 50/60, P = 0.046). With similar baseline insulin prescription fills and diabetes medication costs, V-Go users required fewer insulin prescription fills (mean change: -0.8 vs. +1.8 fills, P < 0.001; -17% vs. +38%); had a smaller increase in diabetes medication costs (mean change in 2016 USD: $341 vs. $1,628, P = 0.012; +10% vs. +47%); and a decrease in insulin total daily dose (mean change in insulin units per day: -29.2 vs. +5.8, P < 0.001; -21% vs. +4%), compared with MDI users, during the last 6 months of follow-up. CONCLUSIONS: This study was the first to evaluate clinical and economic outcomes associated with the use of V-Go for up to a 1-year follow-up period. Relative to MDI users, V-Go users had similar glycemic control but lower insulin use and lower diabetes medication costs during follow-up. V-Go therapy may provide an opportunity to improve quality measures more cost-effectively in people with T2DM who require basal-bolus therapy. DISCLOSURES: This study was funded by Valeritas. Nguyen is an employee of Valeritas. Zhou, Grabner, Barron, and Quimbo are employees of HealthCore, which received funding for this study from Valeritas. Raval was an employee of HealthCore at the time the study was conducted. Partial findings from this study were presented at the International Society of Pharmacoeconomics and Outcomes Research 23rd Annual International Meeting; May 19-23, 2018; Baltimore, MD; and the 54th European Association for the Study of Diabetes Annual Meeting; October 1-5, 2018; Berlin, Germany.
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Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hipoglucemiantes/administración & dosificación , Sistemas de Infusión de Insulina/economía , Insulina/administración & dosificación , Dispositivos Electrónicos Vestibles/economía , Adulto , Anciano , Anciano de 80 o más Años , Glucemia/análisis , Diabetes Mellitus Tipo 2/sangre , Diabetes Mellitus Tipo 2/economía , Costos de los Medicamentos/estadística & datos numéricos , Femenino , Hemoglobina Glucada/análisis , Humanos , Hipoglucemiantes/economía , Insulina/economía , Sistemas de Infusión de Insulina/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del Tratamiento , Estados Unidos , Dispositivos Electrónicos Vestibles/estadística & datos numéricos , Adulto JovenRESUMEN
Background and Aims: Sensor-augmented pump therapy (SAP) combines continuous glucose monitoring with continuous subcutaneous insulin infusion (CSII). SAP is costlier than CSII but provides additional clinical benefits relative to CSII alone. A long-term cost-effectiveness analysis was performed to determine whether SAP is cost-effective relative to CSII in patients with type 1 diabetes (T1D) in Turkey. Methods: Analyses were performed in two different patient cohorts, one with poor glycemic control at baseline (mean glycated hemoglobin 9.0% [75 mmol/mol]) and a second cohort considered to be at increased risk of hypoglycemic events. Clinical input data and direct medical costs were sourced from published literature. The analysis was performed from a third-party payer perspective over patient lifetimes and future costs and clinical outcomes were discounted at 3.5% per annum. Results: In both patient cohorts, SAP was associated with a gain in quality-adjusted life expectancy but higher costs relative to CSII (incremental gain of 1.40 quality-adjusted life years [QALYs] in patients with poor baseline glycemic control and 1.73 QALYs in patients at increased risk of hypoglycemic events). Incremental cost-effectiveness ratios for SAP versus CSII were TRY 76,971 (EUR 11,612) per QALY gained for patients with poor baseline glycemic control and TRY 69,534 (EUR 10,490) per QALY gained for patients at increased risk for hypoglycemia. Conclusions: SAP is associated with improved long-term clinical outcomes versus CSII, and in Turkey, SAP is likely to represent good value for money compared with CSII in T1D patients with poor glycemic control and/or with frequent severe hypoglycemic events.
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Automonitorización de la Glucosa Sanguínea/economía , Glucemia/análisis , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Hipoglucemiantes/administración & dosificación , Sistemas de Infusión de Insulina/economía , Insulina/administración & dosificación , Adolescente , Adulto , Niño , Análisis Costo-Beneficio , Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 1/economía , Femenino , Hemoglobina Glucada/análisis , Humanos , Hipoglucemiantes/economía , Hipoglucemiantes/uso terapéutico , Insulina/economía , Insulina/uso terapéutico , Masculino , Años de Vida Ajustados por Calidad de Vida , Turquía , Adulto JovenRESUMEN
BACKGROUND: Frequent use of modern diabetes technologies increases the chance for optimal type 1 diabetes (T1D) control. Limited reimbursement influences the access of patients with T1D to these modalities and could worsen their prognosis. We aimed to describe the situation of reimbursement for insulins, glucometers, insulin pumps (CSII) and continuous glucose monitoring (CGM) for children with T1D in European countries participating in the SWEET Project and to compare data from EU countries with data from our previous study in 2009. METHODS: The study was conducted between March 2017 and August 2017. First, we approached diabetes technology companies with a survey to map the reimbursement of insulins and diabetic devices. The data collected from these companies were then validated by members of the SWEET consortium. RESULTS: We collected data from 29 European countries, whereas all types of insulins are mostly fully covered, heterogeneity was observed regarding the reimbursement of strips for glucometers (from 90 strips/month to no limit). CSII is readily available in 20 of 29 countries. Seven countries reported significant quota issues or obstacles for CSII prescription, and two countries had no CSII reimbursement. CGM is at least partially reimbursed in 17 of 29 countries. The comparison with the 2009 study showed an increasing availability of CSII and CGM across the EU. CONCLUSIONS: Although innovative diabetes technology is available, a large proportion of children with T1D still do not benefit from it due to its limited reimbursement.
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Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Equipos y Suministros/economía , Sistemas de Infusión de Insulina/economía , Reembolso de Seguro de Salud , Adolescente , Adulto , Glucemia/análisis , Automonitorización de la Glucosa Sanguínea/economía , Automonitorización de la Glucosa Sanguínea/instrumentación , Niño , Preescolar , Costo de Enfermedad , Costos y Análisis de Costo , Diabetes Mellitus Tipo 1/economía , Diabetes Mellitus Tipo 1/epidemiología , Europa (Continente)/epidemiología , Humanos , Hipoglucemiantes/administración & dosificación , Hipoglucemiantes/economía , Lactante , Recién Nacido , Insulina/administración & dosificación , Insulina/economía , Reembolso de Seguro de Salud/economía , Reembolso de Seguro de Salud/estadística & datos numéricos , Reembolso de Seguro de Salud/tendencias , Invenciones/economía , Invenciones/estadística & datos numéricos , Invenciones/tendencias , Estudios Longitudinales , Adulto JovenRESUMEN
BACKGROUND: Hybrid closed-loop (HCL) systems combine continuous glucose monitoring with continuous subcutaneous insulin infusion (CSII) to continuously self-adjust basal insulin delivery. Relative to CSII, HCL improves glycemic control and reduces the risk of hypoglycemia but has higher acquisition costs. The aim of this analysis was to assess the cost-effectiveness of the MiniMed™ 670G HCL system versus CSII in people with type 1 diabetes (T1D) in Sweden. METHODS: Cost-effectiveness analysis, from a societal perspective, was performed over patient lifetimes using the IQVIA CORE Diabetes Model. Clinical data were sourced from a study comparing the MiniMed 670G system with CSII in people with T1D. Cost data, expressed in 2018 Swedish krona (SEK), were obtained from Swedish reference prices and published literature. RESULTS: The MiniMed 670G system was associated with a quality-adjusted life-year (QALY) gain of 1.90 but higher overall costs versus CSII, leading to an incremental cost-effectiveness ratio (ICER) of SEK 164,236 per QALY gained. Use of the HCL system resulted in a lower cumulative incidence of diabetes-related complications. Higher HCL system acquisition costs were partially offset by reduced complication costs and productivity losses. In people with T1D poorly controlled at baseline, the MiniMed 670G system was associated with 2.25 incremental QALYs versus CSII, yielding an ICER of SEK 15,830 per QALY gained. CONCLUSIONS: The MiniMed 670G system was associated with clinical benefits and quality-of-life improvements in people with T1D relative to CSII. At a willingness-to-pay threshold of SEK 300,000 per QALY gained, this HCL system likely represents a cost-effective treatment option for people with T1D in Sweden.
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Automonitorización de la Glucosa Sanguínea/economía , Diabetes Mellitus Tipo 1/economía , Hipoglucemiantes/economía , Sistemas de Infusión de Insulina/economía , Insulina/economía , Adulto , Glucemia/análisis , Automonitorización de la Glucosa Sanguínea/instrumentación , Análisis Costo-Beneficio , Complicaciones de la Diabetes/economía , Complicaciones de la Diabetes/epidemiología , Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Femenino , Humanos , Hipoglucemiantes/administración & dosificación , Insulina/administración & dosificación , Masculino , Calidad de Vida , Años de Vida Ajustados por Calidad de Vida , Suecia/epidemiologíaRESUMEN
OBJECTIVE: To investigate real-world costs of continuous insulin pump therapy compared with multiple daily injection (MDI) therapy for type 1 diabetes. RESEARCH DESIGN AND METHODS: Individuals with type 1 diabetes and pump therapy in the Swedish National Diabetes Register (NDR) since 2002 were eligible. Control subjects on MDI were matched 2:1 using time-varying propensity scores. Longitudinal data on health care resource use, antidiabetes treatment, sickness absence, and early retirement were taken from national registers for 2005-2013. Mean annual costs were analyzed using univariate analysis. Regression analyses explored the role of sociodemographic factors. Subgroup and sensitivity analyses were performed. RESULTS: A total of 14,238 individuals with type 1 diabetes entered in the NDR between 2005 and 2013 (insulin pump n = 4,991, MDI n = 9,247, with switches allowed during the study) were included. Mean age at baseline was 34 years, with 21 years of diabetes duration and a mean HbA1c of 8.1% (65 mmol/mol). We had 73,920 person-years of observation with a mean follow-up of 5 years per participant. Mean annual costs were higher for pump therapy than for MDI therapy ($12,928 vs. $9,005, respectively; P < 0.001; mean difference $3,923 [95% CI $3,703-$4,143]). Health care costs, including medications and disposables, accounted for 73% of the costs for pump therapy and 63% of the costs for MDI therapy. Regression analyses showed higher costs for low education, low disposable income, women, and older age. CONCLUSIONS: Nine years of real-world data on all measurable diabetes-related resource use show robust results for additional costs of insulin pump therapy in adults by subgroup and alternative propensity score specifications. Identification of tangible and intangible benefits of pump therapy over time remain important to support resource allocation decisions.
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Diabetes Mellitus Tipo 1/tratamiento farmacológico , Diabetes Mellitus Tipo 1/economía , Costos de los Medicamentos , Sistemas de Infusión de Insulina/economía , Insulina/administración & dosificación , Insulina/economía , Adulto , Estudios de Casos y Controles , Estudios de Cohortes , Diabetes Mellitus Tipo 1/epidemiología , Esquema de Medicación , Costos de los Medicamentos/estadística & datos numéricos , Femenino , Estudios de Seguimiento , Costos de la Atención en Salud/estadística & datos numéricos , Humanos , Hipoglucemiantes/administración & dosificación , Hipoglucemiantes/economía , Inyecciones Subcutáneas/economía , Insulina/efectos adversos , Sistemas de Infusión de Insulina/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Sistema de Registros , Suecia/epidemiología , Adulto JovenRESUMEN
Insulin pumps are used by a steadily increasing number of patients with diabetes. Avoiding certain disadvantages of conventional pumps (ie, the insulin infusion set) might make pump therapy even more attractive. Patch pumps are usually attached by means of an adhesive layer to the skin and have several additional advantages (smaller, more discrete, easier to use, and cheaper than conventional insulin pumps). This review provides a general overview of patch pumps, the technologies used, basic clinical requirements, why a number of developments failed, which clinical studies are needed to provide sufficient evidence for their usage, which costs are associated, what the patient preferences are (which might differ between certain patient groups), and what is the future of patch pumps (ie, artificial pancreas systems).
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Diabetes Mellitus Tipo 1/tratamiento farmacológico , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hipoglucemiantes/administración & dosificación , Sistemas de Infusión de Insulina/tendencias , Parche Transdérmico , Glucemia , Diseño de Equipo , Humanos , Insulina/administración & dosificación , Sistemas de Infusión de Insulina/economía , Prioridad del Paciente , Resultado del Tratamiento , Tecnología InalámbricaRESUMEN
Reimbursement by payers (policy makers and budget holders) is critical for the uptake and use of new diabetes technologies. The purpose of this article is to describe the different reimbursement pathways that exist for new diabetes technologies in five selected European countries using examples of recent reimbursement decisions. Countries can be grouped into one of three categories: "top-down" (where reimbursement decisions are usually made by policy makers, eg, France), "bottom-up" (where reimbursement decisions are usually made by budget holders, eg, Italy and Spain) and "mixed" (where reimbursement decisions can be made by both policy makers and budget holders, eg, Germany and England). Whatever category a specific country falls into will have different implications from a market access perspective.
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Diabetes Mellitus/tratamiento farmacológico , Diabetes Mellitus/economía , Costos de la Atención en Salud , Mecanismo de Reembolso , Automonitorización de la Glucosa Sanguínea/economía , Toma de Decisiones , Europa (Continente) , Política de Salud , Humanos , Sistemas de Infusión de Insulina/economíaRESUMEN
BACKGROUND: The economic impact of both continuous glucose monitoring (CGM) and insulin pumps (continuous subcutaneous insulin infusion [CSII]) in type 1 diabetes (T1D) have been evaluated separately. However, the cost-effectiveness of adding CSII to existing CGM users has not yet been assessed. OBJECTIVE: The aim of this study was to evaluate the societal cost-effectiveness of CSII versus continuing multiple daily injections (MDI) in adults with T1D already using CGM. METHODS: In the second phase of the DIAMOND trial, 75 adults using CGM were randomized to either CGM+CSII or CGM+MDI (control) and surveyed at baseline and 28 weeks. We performed within-trial and lifetime cost-effectiveness analyses (CEAs) and estimated lifetime costs and quality-adjusted life-years (QALYs) via a modified Sheffield T1D model. RESULTS: Within the trial, the CGM+CSII group had a significant reduction in quality of life from baseline (-0.02 ± 0.05 difference in difference [DiD]) compared with controls. Total per-person 28-week costs were $8,272 (CGM+CSII) versus $5,623 (CGM+MDI); the difference in costs was primarily attributable to pump use ($2,644). Pump users reduced insulin intake (-12.8 units DiD) but increased the use of daily number of test strips (+1.2 DiD). Pump users also increased time with glucose in range of 70 to 180 mg/dL but had a higher HbA1c (+0.13 DiD) and more nonsevere hypoglycemic events. In the lifetime CEA, CGM+CSII would increase total costs by $112,045 DiD, decrease QALYs by 0.71, and decrease life expectancy by 0.48 years. CONCLUSIONS: Based on this single trial, initiating an insulin pump in adults with T1D already using CGM was associated with higher costs and reduced quality of life. Additional evidence regarding the clinical effects of adopting combinations of new technologies from trials and real-world populations is needed to confirm these findings.