The Health Economics of Automated Insulin Delivery Systems and the Potential Use of Time in Range in Diabetes Modeling: A Narrative Review.

Intensive therapy with exogenous insulin is the treatment of choice for individuals living with type 1 diabetes (T1D) and some with type 2 diabetes, alongside regular glucose monitoring. The development of systems allowing (semi-)automated insulin delivery (AID), by connecting glucose sensors with insulin pumps and algorithms, has revolutionized insulin therapy. Indeed, AID systems have demonstrated a proven impact on overall glucose control, as indicated by effects on glycated hemoglobin (HbA1c), risk of severe hypoglycemia, and quality of life measures.

Twelve-month results of the ADAPT randomized controlled trial: Reproducibility and sustainability of advanced hybrid closed-loop therapy outcomes versus conventional therapy in adults with type 1 diabetes.

Aims: To reassess the 6-month efficacy and to assess the 12-month sustained efficacy of the MiniMed™ 780G advanced hybrid closed-loop automated insulin delivery (AID) system compared to multiple daily injections plus intermittently scanned glucose monitoring (MDI+isCGM) in people with type 1 diabetes not meeting glucose targets.

Methods: The ADAPT study was a prospective, multicentre, open-label, randomized control trial in people with type 1 diabetes, with a glycated haemoglobin (HbA1c) concentration of at least 8.0% (64 mmol/mol), on MDI+isCGM therapy.

Advanced Hybrid Closed Loop in Adult Population With Type 1 Diabetes: A Substudy From the ADAPT Randomized Controlled Trial in Users of Real-Time Continuous Glucose Monitoring.

Background: This analysis reports the findings from a predefined exploratory cohort (cohort B) from the ADAPT (ADvanced Hybrid Closed Loop Study in Adult Population with Type 1 Diabetes) study. Adults with type 1 diabetes (T1D) with suboptimal glucose control were randomly allocated to an advanced hybrid closed-loop (AHCL) system or multiple daily injections of insulin (MDI) plus real-time continuous glucose monitoring (RT-CGM).

Methods: In this prospective, multicenter, exploratory, open-label, randomized controlled trial, 13 participants using MDI + RT-CGM and with HbA1c ≥8.

Advanced hybrid closed loop therapy versus conventional treatment in adults with type 1 diabetes (ADAPT): a randomised controlled study.

Background: Adults with type 1 diabetes who are treated with multiple daily injections of insulin plus intermittently scanned continuous glucose monitoring (isCGM) can have suboptimal glucose control. We aimed to assess the efficacy of an advanced hybrid closed loop (AHCL) system compared with such therapy in this population.

Methods: The Advanced Hybrid Closed Loop Study in Adult Population with Type 1 Diabetes (ADAPT) trial is a prospective, multicentre, open-label, randomised controlled trial that involved 14 centres in three European countries (France, Germany, and the UK).

Cost-Effectiveness of Hybrid Closed Loop Insulin Pumps Versus Multiple Daily Injections Plus Intermittently Scanned Glucose Monitoring in People With Type 1 Diabetes in The Netherlands.

Introduction: Hybrid closed loop (HCL) insulin pump systems and intermittently scanned continuous glucose monitoring (IS-CGM) are increasingly used by individuals with type 1 diabetes (T1D). The aim of the analysis was to compare the long-term cost-effectiveness of the MiniMed 670G HCL system versus IS-CGM plus multiple daily injections of insulin (MDI) or continuous subcutaneous insulin infusion (CSII) in adults with T1D in the Netherlands.

Methods: The analysis was performed using the IQVIA CORE Diabetes Model with clinical input data sourced from observational studies.

Randomised controlled trial of Advanced Hybrid Closed Loop in an Adult Population with Type 1 Diabetes (ADAPT): study protocol and rationale.

Introduction: For many people with type 1 diabetes who struggle to achieve glycaemic control with multiple daily injections of insulin (MDI) plus self-monitoring of blood glucose, MDI plus intermittently scanned continuous glucose monitoring (IS-CGM) or real-time continuous glucose monitoring (RT-CGM), or insulin administration using insulin pump therapy represent optimised care in many regions. Through technological advances an advanced hybrid closed loop (AHCL) system has been developed; studies of incremental effects relative to MDI plus IS-CGM are lacking.

Methods And Analysis: The Advanced Hybrid Closed Loop study in Adult Population with Type 1 Diabetes (ADAPT) study is a multinational, prospective, open-label, confirmatory and exploratory randomised controlled trial to examine outcomes with the MiniMed 670G version 4.

Cost-Effectiveness Analysis of an Advanced Hybrid Closed-Loop Insulin Delivery System in People with Type 1 Diabetes in Greece.

Usage of automated insulin delivery systems is increasing for the treatment of people with type 1 diabetes (T1D). This study compared long-term cost-effectiveness of the Advanced Hybrid Closed Loop MiniMed 780G (AHCL) system versus sensor augmented pump (SAP) system with predictive low glucose management (PLGM) or multiple daily injections (MDI) plus intermittently scanned continuous glucose monitoring (isCGM) in people with T1D in Greece. Analyses were performed using the IQVIA CORE Diabetes Model, with clinical input data sourced from various studies.

Cost-effectiveness of a novel hybrid closed-loop system compared with continuous subcutaneous insulin infusion in people with type 1 diabetes in the UK.

Aims: The MiniMed 670 G insulin pump system is the first commercially available hybrid closed-loop (HCL) insulin delivery system and clinical studies have shown that this device is associated with incremental benefits in glycemic control relative to continuous subcutaneous insulin infusion (CSII) with or without continuous glucose monitoring (CGM). The aim was to evaluate the long-term cost-effectiveness of the MiniMed 670 G system versus CSII alone in people with type 1 diabetes (T1D) in the UK.

Materials And Methods: Cost-effectiveness analysis was performed using the IQVIA CORE Diabetes Model.

Cost-Effectiveness of Sensor-Augmented Insulin Pump Therapy Versus Continuous Insulin Infusion in Patients with Type 1 Diabetes in Turkey.

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.

Efficacy and safety of suspend-before-low insulin pump technology in hypoglycaemia-prone adults with type 1 diabetes (SMILE): an open-label randomised controlled trial.

Background: Hypoglycaemia unawareness and severe hypoglycaemia can increase fear of hypoglycaemia and the risk of subsequent hypoglycaemic events. We aimed to assess the safety and efficacy of insulin pump therapy with integrated continuous glucose monitoring (CGM) and a suspend-before-low feature (Medtronic MiniMed 640G with SmartGuard) in hypoglycaemia-prone adults with type 1 diabetes.

Methods: SMILE was an open-label randomised controlled trial done in people aged 24-75 years with type 1 diabetes for 10 years or longer, HbA values of 5·8-10·0% (40-86 mmol/mol), and at high risk of hypoglycaemia (recent severe hypoglycaemia or hypoglycaemia unawareness defined by a Clarke or Gold score ≥4).

Cost-Effectiveness Analysis of the MiniMed 670G Hybrid Closed-Loop System Versus Continuous Subcutaneous Insulin Infusion for Treatment of Type 1 Diabetes.

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.

Cost-Effectiveness of Continuous Subcutaneous Insulin Infusion Versus Multiple Daily Injections in Patients with Poorly Controlled Type 2 Diabetes in Finland.

Introduction: Although primarily utilized in type 1 diabetes, continuous subcutaneous insulin infusion (CSII) represents a useful treatment alternative for patients with type 2 diabetes who are unable to achieve good glycemic control despite optimization of multiple daily injections (MDI). The aim of the analysis reported here was to investigate the long-term cost-effectiveness of CSII versus MDI in type 2 diabetes patients with poor glycemic control in Finland.

Methods: The IQVIA CORE Diabetes Model was used to make long-term projections of the clinical and economic outcomes associated with CSII use in type 2 diabetes, based on clinical input data from the OpT2mise trial, which showed that CSII was associated with a 1.

Cost-effectiveness of sensor-augmented insulin pump therapy vs continuous subcutaneous insulin infusion in patients with type 1 diabetes in the Netherlands.

Aim: The aim of this study was to perform a cost-effectiveness analysis to establish the cost-effectiveness of sensor-augmented pump therapy (SAP) with automated insulin suspension vs continuous subcutaneous insulin infusion (CSII) alone in patients with type 1 diabetes in the Netherlands.

Patients And Methods: The analysis was performed using the IQVIA CORE Diabetes Model (CDM) in two different patient cohorts: one with suboptimal glycemic control at baseline (mean age 27 years, mean baseline HbA1c 8.0% [64 mmol/mol]) and the other at increased risk of hypoglycemic events (mean age 18.

Study of MiniMed 640G Insulin Pump with SmartGuard in Prevention of Low Glucose Events in Adults with Type 1 Diabetes (SMILE): Design of a Hypoglycemia Prevention Trial with Continuous Glucose Monitoring Data as Outcomes.

Background: Sensor-integrated pump systems with low-glucose suspend (also known as threshold suspend) functions have markedly transformed the management of type 1 diabetes, but most studies to date have excluded patients at high risk of hypoglycemia. The SMILE study is investigating the efficacy of the MiniMed™ 640G insulin pump with the SmartGuard™ predictive low-glucose management (PLGM) feature in the prevention of hypoglycemia in adults with type 1 diabetes, who are at high risk of hypoglycemia.

Methods: SMILE is a prospective, randomized, open-label, controlled trial being undertaken in four European countries and Canada.

Cost-Effectiveness Analysis of Sensor-Augmented Insulin Pump Therapy with Automated Insulin Suspension Versus Standard Insulin Pump Therapy in Patients with Type 1 Diabetes in Sweden.

Introduction: In Sweden an estimated 10,000 people with type 1 diabetes use continuous subcutaneous insulin infusion (CSII). Sensor-augmented pump therapy (SAP) is associated with higher acquisition costs but provides additional clinical benefits (e.g.

Factors associated with improved glycemic control following continuous subcutaneous insulin infusion therapy in patients with type 2 diabetes uncontrolled with bolus-basal insulin regimens: An analysis from the OpT2mise randomized trial.

This analysis investigated factors associated with the decrease in HbA1c in patients receiving continuous subcutaneous insulin infusion (CSII) in the OpT2mise randomized trial. In this study, patients with type 2 diabetes and HbA1c >8% following multiple daily injections (MDI) optimization were randomized to receive CSII (n = 168) or MDI (n = 163) for 6 months. Patient-related and treatment-related factors associated with decreased HbA1c in the CSII arm were identified by univariate and multivariate analyses.

Cost-Effectiveness of Sensor-Augmented Pump Therapy with Low Glucose Suspend Versus Standard Insulin Pump Therapy in Two Different Patient Populations with Type 1 Diabetes in France.

Background: Sensor-augmented pump therapy (SAP) provides a useful adjunct relative to continuous subcutaneous insulin infusion (CSII) alone. It can provide early warning of the onset of hyperglycemia and hypoglycemia and has the functionality to suspend insulin delivery if sensor glucose levels fall below a predefined threshold. The aim was to assess the cost-effectiveness of SAP with low glucose suspend (LGS) versus CSII alone in type 1 diabetes.

Long-term costs and outcomes in psoriatic arthritis patients not responding to conventional therapy treated with tumour necrosis factor inhibitors: the extension of the Psoriatic Arthritis Cost Evaluation (PACE) study.

Objectives: Poor information on long-term outcomes and costs on tumour necrosis factor (TNF) inhibitors in psoriatic arthritis (PsA) are available. Our aim was to evaluate long-term costs and benefits of TNF- inhibitors in PsA patients with inadequate response to conventional treatment with traditional disease-modifying anti-rheumatic drugs (tDMARDs).

Methods: Fifty-five out of 107 enrolled patients included in the study at one year, completed the 5-year follow-up period.

Long-term health economic benefits of sensor-augmented pump therapy vs continuous subcutaneous insulin infusion alone in type 1 diabetes: a U.K. perspective.

Aims/hypothesis: Continuous subcutaneous insulin infusion (CSII) is an important treatment option for type 1 diabetes patients unable to achieve adequate glycemic control with multiple daily injections (MDI). Combining CSII with continuous glucose monitoring (CGM) in sensor-augmented pump therapy (SAP) with a low glucose-suspend (LGS) feature may further improve glycemic control and reduce the frequency of hypoglycemia. A cost-effectiveness analysis of SAP + LGS vs.

The Impact of Insulin Pump Therapy on Glycemic Profiles in Patients with Type 2 Diabetes: Data from the OpT2mise Study.

Background: The OpT2mise randomized trial was designed to compare the effects of continuous subcutaneous insulin infusion (CSII) and multiple daily injections (MDI) on glucose profiles in patients with type 2 diabetes.

Research Design And Methods: Patients with glycated hemoglobin (HbA1c) levels of ≥8% (64 mmol/mol) and ≤12% (108 mmol/mol) despite insulin doses of 0.7-1.

Short-term cost analysis of complications related to glycated hemoglobin in patients with type 1 diabetes in the Italian setting.

Aims: The aim of this study is to assess the impact of the diabetes-related complications on costs and to shed light on the potential savings that could be obtained by the National Healthcare System if better glycemic control was to be achieved in the type 1 diabetes population.

Methods: Epidemiologic data were used to distribute diabetes type 1 patients into A1c levels, and the relative risk of diabetes-related complications associated with the level of A1c was extrapolated from published risk curves. The costs associated with all complications in the Italian settings, retrieved from published literature, were used to estimate the economic impact of complications in each A1c level from the NHS perspective and the potential savings that could be obtained should a treatment strategy allow to achieve better metabolic control.

OpT2mise: a randomized controlled trial to compare insulin pump therapy with multiple daily injections in the treatment of type 2 diabetes-research design and methods.

Background: In insulin-requiring type 2 diabetes patients, current insulin therapy approaches such as basal-alone or basal-bolus multiple daily injections (MDI) have not consistently provided achievement of optimal glycemic control. Previous studies have suggested a potential benefit of continuous subcutaneous insulin infusion (CSII) in these patients. The OpT2mise study is a multicenter, randomized, trial comparing CSII with MDI in a large cohort of subjects with evidence of persistent hyperglycemia despite previous MDI therapy.