The Determination of Diabetes Utilities, Costs, and Effects Model: A Cost-Utility Tool Using Patient-Level Microsimulation to Evaluate Sensor-Based Glucose Monitoring Systems in Type 1 and Type 2 Diabetes: Comparative Validation.

OBJECTIVES: To assess the accuracy and validity of the Determination of Diabetes Utilities, Costs, and Effects (DEDUCE) model, a Microsoft-Excel-based tool for evaluating diabetes interventions for type 1 and type 2 diabetes. METHODS: The DEDUCE model is a patient-level microsimulation, with complications predicted based on the Sheffield and Risk Equations for Complications Of type 2 diabetes models for type 1 and type 2 diabetes, respectively. For this tool to be useful, it must be validated to ensure that its complication predictions are accurate. Internal, external, and cross-validation was assessed by populating the DEDUCE model with the baseline characteristics and treatment effects reported in clinical trials used in the Fourth, Fifth, and Ninth Mount Hood Diabetes Challenges. Results from the DEDUCE model were evaluated against clinical results and previously validated models via mean absolute percentage error or percentage error. RESULTS: The DEDUCE model performed favorably, predicting key outcomes, including cardiovascular disease in type 1 diabetes and all-cause mortality in type 2 diabetes. The model performed well against other models. In the Mount Hood 9 Challenge comparison, error was below the mean reported from comparator models for several outcomes, particularly for hazard ratios. CONCLUSIONS: The DEDUCE model predicts diabetes-related complications from trials and studies well when compared with previously validated models. The model may serve as a useful tool for evaluating the cost-effectiveness of diabetes technologies.

Use of the FreeStyle Libre system and diabetes treatment progression in T2DM: Results from a retrospective cohort study using a Canadian private payer claims database.

BACKGROUND: Up to one-third of Canadians are estimated to be living with prediabetes or diabetes. A retrospective study using Canadian private drug claims data was conducted to investigate whether flash glucose monitoring using the FreeStyle Libre system (FSL) among people with type 2 diabetes mellitus (T2DM) in Canada can be associated with changes in treatment intensification when compared with blood glucose monitoring (BGM) alone. MATERIALS AND METHODS: Using a Canadian national private drug claims database comprising approximately 50% coverage of insured individuals in Canada, cohorts of people with T2DM using FSL or BGM were identified algorithmically based on treatment history and followed over a 24-month study period, tracking their progression in diabetes treatment therapy. The Andersen-Gill model for recurrent time-to-event data was used to evaluate whether the rate of treatment progression differs between the FSL and BGM treatment cohorts. The survival function was used to calculate comparative treatment progression probabilities between the cohorts. RESULTS: In total, 373 871 people with T2DM met the inclusion criteria. Across treatment (FSL) and control (BGM) groups, people using FSL had a higher probability of treatment progression compared with BGM alone, with a relative risk ranging between 1.86 and 2.81 (p < .001). A higher probability of treatment progression was independent of the diabetes treatment at the enrolment date (index date) or the patient status, and independent of whether patients were treatment naïve or on established diabetes therapy. Assessment of the ending treatment relative to the starting therapy indicated that dynamic treatment changes were most evident for patients in the FSL cohort and that the FSL cohort had a much greater portion of patients who ended with insulin treatment (when they started with non-insulin treatment) compared with the BGM cohort. CONCLUSIONS: People with T2DM using FSL had a greater probability for treatment progression compared with BGM alone, irrespective of the starting therapy, which may suggest that FSL can be used to support escalation of diabetes therapy to improve therapeutic inertia in T2DM.

Reduced Rate of Hospitalizations for Acute Diabetes Events Before and After FreeStyle Libre® System Initiation in Some People With Type 2 Diabetes on Insulin-Secretagogue Oral Drug Therapy Without Insulin in France.

Objective: Glycemic management in people with type 2 diabetes mellitus (T2DM) on insulin-secretagogue regimens without insulin is of importance, as this group still represents a significant proportion of patients. Risks for acute diabetes events (ADEs), including diabetic ketoacidosis (DKA) or hypoglycemia, using insulin-secretagogue drugs are well established. Few studies have suggested that continuous glucose monitoring (CGM) could be useful for monitoring glucose dynamics associated with the use of such therapies. To document this point an exploratory analysis was conducted in a group of individuals with noninsulin treated T2DM in France who are managed with oral insulin-secretagogues and initiating the FreeStyle Libre® system (FSL). Methods: A retrospective study of the French national SNDS reimbursement claims database (≈66 million French people) was conducted to identify people with T2DM on oral insulin-secretagogues and receiving a first reimbursement of FSL between August 1, 2017 and December 31, 2018. The analysis included data for the 12 months before and up to 24 months after FSL initiation. Hospitalizations for diabetes-related acute events were identified using ICD-10 codes as main or related diagnosis, for: hypoglycemic events; DKA events; comas; and hyperglycemia-related admissions. Results: A total of 1272 people with T2DM on insulin-secretagogues without insulin initiated FSL during the selection period. Of these, 7.15% had at least one hospitalization for any ADE in the year before FSL initiation, compared with 2.52% at 12 months and 2.83% at 24 months following FSL initiation. Reductions in ADEs were driven by -73% fewer admissions for ADEs related to diabetic ketoacidosis (DKA) or other hyperglycemia-related events. These patterns of reduced ADEs persisted after 2 years. Conclusions: This study suggests the value of the FSL system in reducing ADEs in some people with T2DM in France being treated with insulin-secretagogues without insulin. Characteristics of these patients remain to be documented.

An Analysis of the Distribution of Direct Cost of Diabetes Care in Selected Districts in Italy.

INTRODUCTION: This study aims to define the distribution of direct healthcare costs for people with diabetes treated in two healthcare regions in Italy, based on number of comorbidities and treatment regimen. METHODS: This was a retrospective analysis using data from two local health authority administrative databases (Campania and Umbria) in Italy for the years 2014-2018. Data on hospital care, pharmaceutical and specialist outpatient and laboratory assistance were collected. All people with diabetes in 2014-2018 were identified on the basis of at least one prescription of hypoglycemic drugs (ATC A10), hospitalization with primary or secondary diagnosis of diabetes mellitus (ICD9CM 250.xx) or diabetes exemption code (code 013). Subjects were stratified into three groups according to their pharmaceutical prescriptions during the year: Type 1/type 2 diabetes (T1D/T2D) treated with multiple daily injections with insulin (MDI), type 2 diabetes on basal insulin only (T2D-Basal) and type 2 diabetes not on insulin therapy (T2D-Oral). RESULTS: We identified 304,779 people with diabetes during the period for which data was obtained. Analysis was undertaken on 288,097 subjects treated with glucose-lowering drugs (13% T1D/T2D-MDI, 13% T2D-Basal, 74% T2D-Oral). Average annual cost per patient for the year 2018 across the total cohort was similar for people with T1D/T2D-MDI and people with T2D-Basal (respectively €2580 and €2254) and significantly lower for T2D-Oral (€1145). Cost of hospitalization was the main driver (47% for T1D/T2D-MDI, 45% for T2D-Basal, 45% for T2D-Oral) followed by drugs/devices (35%, 39%, 43%) and outpatient services (18%, 16%, 12%). Average costs increased considerably with increasing comorbidities: from €459 with diabetes only to €7464 for a patient with four comorbidities. Similar trends were found across all subgroups analysis. CONCLUSION: Annual cost of treatment for people with diabetes is similar for those treated with MDI or with basal insulin only, with hospitalization being the main cost driver. This indicates that both patient groups should benefit from having access to scanning continuous glucose monitoring (CGM) technology which is known to be associated with significantly reduced hospitalization for acute diabetes events, compared to self-monitored blood glucose (SMBG) testing.

Real-world study of flash glucose monitoring among adults with type 2 diabetes within the Swedish National Diabetes Register.

BACKGROUND: The Swedish National Diabetes Register (NDR) initiated registration of the FreeStyle Libre® system and other continuous glucose monitoring (CGM) systems in June 2016. We investigated change in HbA1c for people with type 2 diabetes (T2DM) using FreeStyle Libre in Sweden. METHODS: We included adults with T2DM, registered in the NDR after January 1, 2014, and an index date for first use of FreeStyle Libre of June 2016 or later. Methodology was a before/after comparison of HbA1c within 6 months before the index date versus HbA1c around 6 and 12 months after the index date. RESULTS: 711 adults with T2DM using FreeStyle Libre had HbA1c measurements within the study period. Mean HbA1c was significantly reduced at 6 months (-0.50%-unit) and at 12 months (-0.52%-unit) in this group. Degree of change was negatively correlated to baseline HbA1c. Reductions in HbA1c were observed in incident users of FreeStyle Libre with T2DM who were truly naïve to CGM or had unknown prior experience of CGM, and aged 25-74 years. CONCLUSIONS: This real-world study on the Swedish NDR shows that people with T2DM using FreeStyle Libre system for 6 and 12 months significantly reduced their HbA1c.

Important Decrease in Hospitalizations for Acute Diabetes Events Following FreeStyle Libre System Initiation in People with Type 2 Diabetes on Basal Insulin Therapy in France.

Aims/Hypothesis: Initiation of insulin therapy in people with type 2 diabetes (T2DM) may be necessary to achieve glycemic targets but is associated with acute diabetes events (ADEs), including severe hypoglycemia (SH) or diabetic ketoacidosis (DKA). We assessed the impact of initiating FreeStyle Libre® system (FSL) on hospitalizations for ADEs in people with T2DM on basal insulin only regimen±noninsulin antidiabetic drugs. Materials and Methods: A retrospective study of the French national Système National des Données de Santé reimbursement claims database (≈66 million French people) identified people with T2DM on basal insulin therapy receiving a first reimbursement of FSL between August 1, 2017 and December 31, 2018. Claims data for the 12 months before, and up to 24 months after FSL initiation, were analyzed. Hospitalizations for ADEs were identified, using ICD-10 codes as main or related diagnosis, for: SH events; DKA events; comas; and hyperglycemia-related admissions. Results: A total of 5933 people with T2DM on basal insulin therapy initiated FSL during the selection period. Of the patients, 78.9% were on basal insulin and other hypoglycemic agents. Among the 5933 patients identified, 2.01% had at least one hospitalization for any ADE in the year before FSL initiation, compared to 0.75% (1 year) and 0.60% (2 years). Reductions in ADEs were driven by 75% fewer DKA admissions, with a 44% reduction in SH admissions. These patterns of reduced ADEs persisted after 2 years, with a further 43% reduction in DKA rates. Conclusions/Interpretation: This study emphasizes the value of the FSL system in reducing ADEs in people with T2DM in France not on intensive insulin therapy and initially treated with basal-only insulin therapy.

Reduced Acute Diabetes Events After FreeStyle Libre System Initiation in People 65 Years or Older with Type 2 Diabetes on Intensive Insulin Therapy in France.

Background and Aims: Older people with type 2 diabetes (T2DM) on insulin are at increased risk of hypoglycemia and associated morbidity. Management of T2DM in older people must optimize glycemic control, while minimizing risks for hypoglycemia and diabetic ketoacidosis (DKA). In France, the FreeStyle Libre® (FSL) system has been reimbursed since June 2017 for T2DM on intensive insulin therapy. We assessed the impact of starting FSL on hospitalizations for acute diabetes events (ADEs) in people ≥65 years old, with T2DM on intensive insulin therapy. Materials and Methods: A retrospective study on the French Système National des Données de Santé (SNDS) claims database was conducted on people ≥65 years old with T2DM, treated with multiple daily injections (MDI) or insulin pump and starting FSL between August 1, 2017, to December 31, 2018. The analysis covered claims data for 12 months before, and up to 24 months after FSL initiation. Hospitalizations for severe hypoglycemia (SH), DKA, comas, and hyperglycemia were identified using ICD-10 codes. Results: We identified 38,312 people with T2DM ≥65 years old on intensive insulin therapy initiating FSL during the selection period. Hospitalizations for ADEs were observed in 1.6% of subjects in the 12 months before FSL initiation, compared to 1.05% after 12 months and 0.96% after 24 months, a -34% and -40% reduction, driven by fewer DKA admissions after 12 months and by fewer SH admissions at 24 months. Conclusions: These results indicate that FSL can reduce hospitalization for ADEs in this vulnerable older population of adults 65 years of age and older with T2DM on intensive insulin therapy, in whom optimal glycemic control must be achieved, while minimizing risk of hypoglycemia and other ADEs.

How Continuous Glucose Monitoring Can Motivate Self-management: Can Motivation Follow Behaviour?

OBJECTIVES: Motivation to adhere to clinical recommendations requires engagement, and the urgency to act is one of many factors that contribute to achieving glycemic benefits in people with type 2 diabetes (PwT2D). Continuous glucose monitoring (CGM) devices are associated with improved glycemic benefits. We conducted a qualitative assessment of PwT2D who found using CGM extremely beneficial and examined the potential for CGM to elicit motivation to engage in self-management behaviours. METHODS: Participants using CGM were recruited through social media and interviewed, and transcripts were analyzed (template analysis using thematic analysis) to generate coded responses and inductive themes by 2 raters. RESULTS: Thirteen participants (84.6% women, with a duration of T2D >5 years and CGM use for >6 months) were interviewed. Codes were organized around 3 themes: improved self-management, experience of glucose-sensing technology vis-à-vis general positive or negative experience, and positive impact of CGM on living with diabetes. Improved self-management was reflected in how the CGM technology provided personalized knowledge and ability to self-manage, particularly in contrast to finger pricking. Positive experience included motivation for behaviour changes as well as improved relationships with health-care providers and in social situations. This translated into a sense of improved health and an avoidance of complications. Negative experience included costs, concern over location of the sensor, and discomfort with the device. CONCLUSIONS: CGM technology profoundly impacts multiple aspects of self-management and care for PwT2D. Developing a validated instrument to assess identified constructs could contribute to developing interventions and leveraging benefits of this technology, particularly the motivational constructs of engagement and urgency.

Sensor-Based Technology: Bringing Value to People with Diabetes and the Healthcare System in an Evolving World.

PURPOSE: Evidence demonstrates that glucose-sensing technologies have enabled effective glycemic control for adults and children with type 1 diabetes (T1DM) or adults with type 2 diabetes (T2DM) on insulin therapy or non-insulin therapy. Here, we report on the wider value of glucose-sensing technology from the perspectives of person living with diabetes (PWD), healthcare providers (HCPs), and healthcare policy stakeholders. METHODOLOGY: Literature searches were conducted to identify published records and analysis, including across various healthcare organizations and agencies, of the impact of the FreeStyle Libre® flash glucose monitoring system in diabetes. These findings were combined with the outcomes of three healthcare attitudes surveys among PWD and diabetes healthcare professionals in Canada, including two commissioned for this purpose. RESULTS: Clinical trials data and real-world evidence have proven the benefits of the FreeStyle Libre system on limiting hypoglycemia, lowering HbA1c, optimizing metrics of glucose control and reducing hospital admissions. These benefits are accompanied by improvements in patients' quality of life, work productivity, and savings to the health system. The FreeStyle Libre system has created an opportunity to change the organization and delivery of care, including during COVID-19 restrictions on access to standard care, thus generating system-wide benefits in addition to those accrued by patients and HCPs. CONCLUSION: Evidence-based improvements in glucose control for PWD using flash glucose monitoring are accompanied by increased treatment satisfaction and quality of life. Telemedicine with such remote monitoring systems increases the opportunities for simultaneous review of glucose data with HCPs and shared decision-making, thus encouraging adherence with treatment.

Reduced Rate of Acute Diabetes Events with Flash Glucose Monitoring Is Sustained for 2 Years After Initiation: Extended Outcomes from the RELIEF Study.

Background: The RELIEF study has previously shown a fall in the rate of acute diabetes events (ADEs) in people living with type 1 diabetes (PwDT1) or people living with type 2 diabetes (PwDT2) in the 12 months after initiation of flash glucose monitoring (FLASH) in France. The 2-year follow-up has provided new insights on the frequency of ADEs, including severe hypoglycemia and diabetic ketoacidosis (DKA), during use of FLASH. Methods: The RELIEF study included 31,446 PwDT1 and 41,027 PwDT2 with a first delivery of FreeStyle Libre (FSL) between August 1 and December 31, 2017. Hospitalizations for DKA, severe hypoglycemia, diabetes-related coma, and hyperglycemia were recorded for the 12 months before and 24 months after FSL initiation. Persistence of the FSL system use was estimated through a Kaplan-Meier survival curve. Change in usual blood glucose monitoring was estimated through acquisition of blood glucose test strips. Results: In the 2 years after FSL initiation, hospitalizations for ADEs were reduced by 49% and by 48% in PwDT1 or PwDT2, respectively, driven by reductions in DKA. After 2 years, 88% of patients persisted with the system and estimated mean consumption of blood glucose test strips had fallen after 2 years by -82% and by -84% in type 1 diabetes mellitus and type 2 diabetes mellitus, respectively. Conclusion: Use of FSL consistently reduces the rates of hospitalization for ADEs, mainly DKA, 2 years after initiation, confirming this is not a transitory effect. Use of FSL also results in a clear and progressive drop in use of blood glucose test strips over the 2-year period.

FreeStyle Libre Flash Glucose Monitoring system for people with type 1 diabetes in the UK: a budget impact analysis.

INTRODUCTION: This study aims to estimate the budget impact of increased uptake of the FreeStyle Libre Flash Glucose Monitoring system in people with type 1 diabetes mellitus (T1DM) in the UK. RESEARCH DESIGN AND METHODS: A budget impact model was developed, applying real-world data collected in the Association of British Clinical Diabetologists (ABCD) FreeStyle Libre Nationwide Audit. Costs of diabetes glucose monitoring in a T1DM population (n=1790) using self-monitoring of blood glucose (SMBG) or the FreeStyle Libre system were compared with a scenario with increased use of the FreeStyle Libre system. RESULTS: The ABCD audit demonstrates FreeStyle Libre system use reduces diabetes-related resource utilization. The cost analysis found that higher acquisition costs are offset by healthcare costs avoided (difference £168 per patient per year (PPPY)). Total costs were £1116 PPPY with FreeStyle Libre system compared with £948 PPPY with SMBG. In an average-sized UK local health economy, increasing FreeStyle Libre system uptake from 30% to 50% increased costs by 3.4% (£1 787 345-£1 847 618) and when increased to 70% increased by a further 3.3%. CONCLUSION: Increased uptake of the FreeStyle Libre system in the T1DM population marginally increases the cost to UK health economies and offers many system benefits.

Cost-Effectiveness of the FreeStyle Libre® System Versus Blood Glucose Self-Monitoring in Individuals with Type 2 Diabetes on Insulin Treatment in Sweden.

INTRODUCTION: Frequent glucose monitoring is essential to obtain glucose control. This is done by periodic self-monitoring of blood glucose (SMBG) using finger-prick testing, or by using continuous glucose monitoring devices, wherein a sensor records interstitial glucose data automatically. This study assessed the cost-effectiveness of using the FreeStyle Libre Flash Continuous Glucose Monitoring System (FSL) compared to SMBG in individuals with type 2 diabetes (T2D) treated with insulin from a Swedish societal perspective. METHODS: Cost-effectiveness analysis was conducted using the IQVIA Core Diabetes model v9.5, with demographic and clinical inputs from a real-world study using Swedish National Diabetes Register data. Two cohorts of individuals with T2D were considered based on baseline HbA1C (HbA1c: 8-9% [64-75 mmol/mol]; HbA1c: 9-12% [75-108 mmol/mol]). HbA1c reductions with FSL were - 0.41% (- 4 mmol/mol; SD: 0.94%-10 mmol/mol) and - 1.30% (- 14 mmol/mol; SD: 1.40%-15 mmol/mol) for the two cohorts, respectively. Utilities, treatment costs and diabetes-related complication costs were obtained from published sources. Analyses were conducted over a lifetime horizon, applying annual discounting of 3% on costs and effects. Scenario analyses and probabilistic sensitivity analyses were performed. RESULTS: Individuals with T2D who had a baseline HbA1c of 8-9% (64-75 mmol/mol) and 9-12% (75-108 mmol/mol) and used FSL gained 0.50 and 0.57 quality-adjusted life-years (QALYs), respectively, at an incremental cost of SEK109,957 and SEK82,170 compared to SMBG, generating an incremental cost-utility ratio of SEK219,127 and SEK144,412 per QALY gained. Assuming a willingness-to-pay threshold of SEK300,000 per QALY gained, FSL use was considered cost-effective compared to SMBG for the majority of the individuals in both the lower and higher HbA1c cohorts. The key driver identified was the additional quality-of-life benefit that applied to FSL use. CONCLUSION: The FreeStyle Libre Flash Continuous Glucose Monitoring System is a cost-effective glucose monitoring alternative to SMBG for individuals with T2D in Sweden who are treated with insulin but are not reaching their glycaemic goals.

Important Drop in Rate of Acute Diabetes Complications in People With Type 1 or Type 2 Diabetes After Initiation of Flash Glucose Monitoring in France: The RELIEF Study.

OBJECTIVE: The RELIEF study assessed rates of hospitalization for acute diabetes complications in France before and after initiation of the FreeStyle Libre system. RESEARCH DESIGN AND METHODS: A total of 74,011 patients with type 1 diabetes or type 2 diabetes who initiated the FreeStyle Libre system were identified from the French national claims database with use of ICD-10 codes, from hospitalizations with diabetes as a contributing diagnosis, or the prescription of insulin. Patients were subclassified based on self-monitoring of blood glucose (SMBG) strip acquisition prior to starting FreeStyle Libre. Hospitalizations for diabetic ketoacidosis (DKA), severe hypoglycemia, diabetes-related coma, and hyperglycemia were recorded for the 12 months before and after initiation. RESULTS: Hospitalizations for acute diabetes complications fell in type 1 diabetes (-49.0%) and in type 2 diabetes (-39.4%) following FreeStyle Libre initiation. DKA fell in type 1 diabetes (-56.2%) and in type 2 diabetes (-52.1%), as did diabetes-related comas in type 1 diabetes (-39.6%) and in type 2 diabetes (-31.9%). Hospitalizations for hypoglycemia and hyperglycemia decreased in type 2 diabetes (-10.8% and -26.5%, respectively). Before initiation, hospitalizations were most marked for people noncompliant with SMBG and for those with highest acquisition of SMBG, which fell by 54.0% and 51.2%, respectively, following FreeStyle Libre initiation. Persistence with FreeStyle Libre at 12 months was at 98.1%. CONCLUSIONS: This large retrospective study on hospitalizations for acute diabetes complications shows that a significantly lower incidence of admissions for DKA and for diabetes-related coma is associated with use of flash glucose monitoring. This study has significant implications for patient-centered diabetes care and potentially for long-term health economic outcomes.