Evaluating the Cost-Utility of Continuous Glucose Monitoring in Individuals with Type 1 Diabetes: A Systematic Review of the Methods and Quality of Studies Using Decision Models or Empirical Data.

INTRODUCTION: This review presents a critical appraisal of differences in the methodologies and quality of model-based and empirical data-based cost-utility studies on continuous glucose monitoring (CGM) in type 1 diabetes (T1D) populations. It identifies key limitations and challenges in health economic evaluations on CGM and opportunities for their improvement. METHODS: The review and its documentation adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for systematic reviews. Searches for articles published between January 2000 and January 2023 were conducted using the MEDLINE, Embase, Web of Science, Cochrane Library, and Econlit databases. Published studies using models and empirical data to evaluate the cost utility of all CGM devices used by T1D patients were included in the search. Two authors independently extracted data on interventions, populations, model settings (e.g., perspectives and time horizons), model types and structures, clinical outcomes used to populate the model, validation, and uncertainty analyses. They subsequently met to confirm consensus. Quality was assessed using the Philips checklist for model-based studies and the Consensus Health Economic Criteria (CHEC) checklist for empirical studies. Model validation was assessed using the Assessment of the Validation Status of Health-Economic decision models (AdViSHE) checklist. The extracted data were used to generate summary tables and figures. The study protocol is registered with PROSPERO (CRD42023391284). RESULTS: In total, 34 studies satisfied the selection criteria, two of which only used empirical data. The remaining 32 studies applied 10 different models, with a substantial majority adopting the CORE Diabetes Model. Model-based studies often lacked transparency, as their assumptions regarding the extrapolation of treatment effects beyond available evidence from clinical studies and the selection and processing of the input data were not explicitly stated. Initial scores for disagreements concerning checklists were relatively high, especially for the Philips checklist. Following their resolution, overall quality scores were moderate at 56%, whereas model validation scores were mixed. Strikingly, costing approaches differed widely across studies, resulting in little consistency in the elements included in intervention costs. DISCUSSION AND CONCLUSION: The overall quality of studies evaluating CGM was moderate. Potential areas of improvement include developing systematic approaches for data selection, improving uncertainty analyses, clearer reporting, and explaining choices for particular modeling approaches. Few studies provided the assurance that all relevant and feasible options had been compared, which is required by decision makers, especially for rapidly evolving technologies such as CGM and insulin administration. High scores for disagreements indicated that several checklists contained questions that were difficult to interpret consistently for quality assessment. Therefore, simpler but comprehensive quality checklists may be needed for model-based health economic evaluation studies.

The impact of socioeconomic factors, social determinants, and ethnicity on the utilization of glucose sensor technology among persons with diabetes mellitus: a narrative review.

Continuous glucose monitoring (CGM) usage has been shown to improve disease outcomes in people living with diabetes by facilitating better glycemic management. However, previous research has suggested that access to these devices can be influenced by nonmedical factors such as socioeconomic status and ethnicity. It is critical that equitable access to CGM devices is ensured as people from those groups experience poorer diabetes-related health outcomes. In this narrative review, we provide an overview of the various healthcare systems worldwide and how socioeconomic status, social context, and ethnicity shape device usage and the associated health outcomes. In general, we found that having a lower socioeconomic status and belonging to an ethnic minority group negatively impact CGM usage. While financial means proved to be an important mediator in this process, it was not the sole driver as disparities persisted even after adjustment for factors such as income and insurance status. Recommendations to increase CGM usage for people of a lower socioeconomic status and ethnic minorities include increasing the availability of financial, administrative, and educational support, for both patients and healthcare providers. However, recommendations will vary due to local country-specific circumstances, such as reimbursement criteria and healthcare ecosystems.

The effects of income, education, social factors and ethnicity on the use of glucose sensors by people with diabetes mellitus: a narrative review Over the recent years, glucose sensors have transformed the monitoring of glucose levels in people with diabetes. However, access to these devices has been determined by the healthcare systems and the associated rules and regulations, as well as perceptions from providers and patients about who would benefit most from these devices. In this narrative review, we performed an expansive literature search into what is known about factors that negatively impact the access to glucose sensors, and how these factors might be addressed. From this, we learn that, depending on the healthcare system, financial means form a major driver behind the disparities in glucose sensor use. However, factors such as ethnicity and provider and patient perceptions also can negatively affect one's chances to obtain a glucose sensor. Furthermore, we found that a successful program aimed at resolving the found disparities in glucose sensor use must be multi-faceted, and must include measures aimed at financial support, the use of objective and simple criteria for sensor eligibility, as well as educational support for both patients and providers.

Evaluation of Healthcare Utilisation and Expenditures in Persons with Type 2 Diabetes Undergoing Bariatric-Metabolic Surgery.

PURPOSE: Changes in healthcare utilisation and expenditures after bariatric-metabolic surgery (BMS) for people with type 2 diabetes mellitus (T2DM) are unclear. We used the Dutch national all-payer claims database (APCD) to evaluate utilisation and expenditures in people with T2DM who underwent BMS. METHODS: In this cohort study, patients with T2DM who had BMS in 2016 were identified in the APCD. This group was matched 1:2 to a control group with T2DM who did not undergo BMS based on age, gender and healthcare expenditures. Data on healthcare expenditures and utilisation were collected for 2013-2019. RESULTS: In total, 1751 patients were included in the surgery group and 3502 in the control group. After BMS, total median expenditures in the surgery group stabilised (€ 3156 to € 3120) and increased in the control group (€ 3174 to € 3434). Total pharmaceutical expenditures decreased 28% in the surgery group (€957 to €494) and increased 55% in the control group (€605 to €936). In the surgery group, 67.1% did not use medication for T2DM in 2019 compared to 13.3% in the control group. Healthcare use for microvascular complications increased in the control group, but not in the surgery group. CONCLUSION: BMS in people with T2DM stabilises healthcare expenditures and decreases medication use and care use for microvascular complications. In contrast, healthcare use and expenditures in T2DM patients who do not undergo surgery gradually increase over time. Due to the progressive nature of T2DM, it is expected that these differences will become larger in the long-term.

Personalizing the Use of a Intermittently Scanned Continuous Glucose Monitoring (isCGM) Device in Individuals With Type 1 Diabetes: A Cost-Effectiveness Perspective in the Netherlands (FLARE-NL 9).

AIMS: Intermittently scanned continuous glucose monitoring (isCGM) is a method to monitor glucose concentrations without using a finger prick. Among persons with type 1 diabetes (T1D), isCGM results in improved glycemic control, less disease burden and improved health-related quality of life (HRQoL). However, it is not clear for which subgroups of patients isCGM is cost-effective. We aimed to provide a real-world cost-effectiveness perspective. METHODS: We used clinical data from a 1-year nationwide Dutch prospective observational study (N = 381) and linked these to insurance records. Health-related quality of life was assessed with the EQ-5D-3L questionnaire. Individuals were categorized into 4 subgroups: (1) frequent hypoglycemic events (58%), (2) HbA1c > 70 mmol/mol (8.5%) (19%), (3) occupation that requires avoiding finger pricks and/or hypoglycemia (5%), and (4) multiple indications (18%). Comparing costs and outcomes 12 months before and after isCGM initiation, incremental cost-effectiveness ratios (ICERs) were calculated for the total cohort and each subgroup from a societal perspective (including healthcare and productivity loss costs) at the willingness to pay of €50,000 per quality-adjusted life year (QALY) gained. RESULTS: From a societal perspective, isCGM was dominant in all subgroups (ie higher HRQoL gain with lower costs) except for subgroup 1. From a healthcare payer perspective, the probabilities of isCGM being cost-effective were 16%, 9%, 30%, 98%, and 65% for the total cohort and subgroup 1, 2, 3, and 4, respectively. Most sensitivity analyses confirmed these findings. CONCLUSIONS: Comparing subgroups of isCGM users allows to prioritize them based on cost-effectiveness. The most cost-effective subgroup was occupation-related indications, followed by multiple indications, high HbA1c and the frequent hypoglycemic events subgroups. However, controlled studies with larger sample size are needed to draw definitive conclusions.

Health-related quality of life of people with HIV: an assessment of patient related factors and comparison with other chronic diseases.

OBJECTIVES: The health-related quality of life (HRQOL) of people with HIV is lower than in the general population, but it is unknown how it compares with that of persons with other chronic medical conditions. We compared HRQOL in HIV with HRQOL in diabetes mellitus type 1, diabetes mellitus type 2 and rheumatoid arthritis (RA). In addition, we investigated factors associated with HRQOL in HIV. DESIGN: Cross-sectional study. METHODS: HRQOL was measured with the Medical Outcomes Study Short Form 36-item Health Survey in a nationwide sample of people with HIV in care in the Netherlands and on combination antiretroviral therapy for at least 6 months. We added data from studies in diabetes mellitus types 1 and 2, and RA. Logistic regression analysis was used to examine: the association between disease group and a poor HRQOL, and patient factors associated with poor HRQOL in HIV. RESULTS: The odds of a poor physical HRQOL in the HIV group were comparable with the odds in diabetes mellitus types 1 and 2, but lower than in RA patients. The odds of a poor mental HRQOL in HIV were higher than in the other groups. In HIV, a history of AIDS, longer duration of combination antiretroviral therapy and severe comorbidity were associated with a poor physical HRQOL. Sub-Saharan African descent and CD4 cell count of less than 350 cells/µl were associated with poor mental HRQOL. CONCLUSION: People with HIV were more likely to have a poor mental HRQOL than patients with other chronic conditions. Addressing mental health should be an integral part of outpatient HIV care.