The Cost-Effectiveness of Supplemental Carnosine in Type 2 Diabetes.

In this paper, we assess the cost-effectiveness of 1 g daily of carnosine (an over the counter supplement) in addition to standard care for the management of type 2 diabetes and compare it to standard care alone. Dynamic multistate life table models were constructed in order to estimate both clinical outcomes and costs of Australians aged 18 years and above with and without type 2 diabetes over a ten-year period, 2020 to 2029. The dynamic nature of the model allowed for population change over time (migration and deaths) and accounted for the development of new cases of diabetes. The three health states were 'Alive without type 2 diabetes', 'Alive with type 2 diabetes' and 'Dead'. Transition probabilities, costs, and utilities were obtained from published sources. The main outcome of interest was the incremental cost-effectiveness ratio (ICER) in terms of cost per year of life saved (YoLS) and cost per quality-adjusted life year (QALY) gained. Over the ten-year period, the addition of carnosine to standard care treatment resulted in ICERs (discounted) of AUD 34,836 per YoLS and AUD 43,270 per QALY gained. Assuming the commonly accepted willingness to pay threshold of AUD 50,000 per QALY gained, supplemental dietary carnosine may be a cost-effective treatment option for people with type 2 diabetes in Australia.

Glycemic control among patients with type 2 diabetes in a low resource setting in Rwanda: a prospective cohort study.

Introduction: diabetes is a leading cause of death, disability, and high healthcare costs, especially among patients with poor glycemic control. Providing decentralized diabetes care to patients in low-income countries remains a major challenge. We aimed to assess hemoglobin A1C (HbA1c) level of patients enrolled in primary-level non-communicable disease clinics of Rwamagana, Rwanda, and identify predictors associated with a) change in HbA1c level over a 6-month period or b) achieving HbA1c <7%. We also explored whether living in a community with a home-based care practitioner was associated with HbA1c-related outcomes. Methods: we conducted structured interviews and HbA1c testing among patients with type 2 diabetes at baseline and after six months. Multivariable linear regression and multivariable logistic regression were used. Results: hundred and thirty (130) participants enrolled at baseline, and 123 patients remained in the study after six months. At baseline, 26% of patients had HbA1c <7%. After 6-months, 37% of patients had HbA1c <7%. Factors correlated with the greatest improvements in HbA1c were having HbA1c >9% at baseline, while factors associated with having HbA1c <7% after six months included older age and having HbA1c <7% at baseline. We did not find significant associations between home-based care practitioners and improvement in HbA1c level or achieving HbA1c <7. Conclusion: the number of patients with well-controlled glycemia improved over time during this study but was still low overall. Care provided by home-based care practitioners was not associated with six-month HbA1c outcomes. Enhanced care is needed to achieve glycemia control in primary healthcare settings.

The cost implications of continuous glucose monitoring in pregnant women with type 1 diabetes in 3 Canadian provinces: a posthoc cost analysis of the CONCEPTT trial.

BACKGROUND: The Continuous Glucose Monitoring in Women with Type 1 Diabetes in Pregnancy Trial (CONCEPTT) found improved health outcomes for mothers and their infants among those randomized to self-monitoring of blood glucose (SMBG) with continuous glucose monitoring (CGM) compared with SMBG alone. In this study, we evaluated whether CGM or standard SMBG was more or less costly from the perspective of a third-party payer. METHODS: We conducted a posthoc analysis of data from the CONCEPTT trial (Mar. 25, 2013, to Mar. 22, 2016). Health care resource data from 215 pregnant women, randomized to CGM or SMBG, were collected from 31 hospitals in 7 countries. We determined resource costs posthoc based on prices from hospitals in 3 Canadian provinces (Ontario, British Columbia, Alberta). The primary outcome was the difference between groups in the mean total cost of care for mother and infant dyads, paid by each government (i.e., the third-party payer) from randomization to hospital discharge (time horizon). The secondary outcome included CGM and SMBG costs not paid by governments (e.g., glucose monitoring devices and supplies). RESULTS: The mean total cost of care was lower in the CGM group compared with the SMBG group in each province (Ontario: $13 270.25 v. $18 465.21, difference in mean total cost [DMT] -$5194.96, 95% confidence interval [CI] -$9841 to -$1395; BC: $13 480.57 v. $18 762.17, DMT -$5281.60, 95% CI -$9964 to -$1382; Alberta: $13 294.39 v. $18 674.45, DMT -$5380.06, 95% CI -$10 216 to -$1490). There was no difference in the secondary outcome. INTERPRETATION: Government health care costs are lower when CGM is paid by the patient, driven by lower costs from reduced use of the neonatal intensive care unit in the CGM group; however, when governments pay for CGM equipment, there is no overall cost difference between CGM and SMBG. Governments should consider paying for CGM, as it results in improved maternal and neonatal outcomes with no added overall cost. TRIAL REGISTRATION: ClinicalTrials.gov, no. NCT01788527.

Cost-effectiveness of financial incentives to improve glycemic control in adults with diabetes: A pilot randomized controlled trial.

PURPOSE: Determine the cost-effectiveness of three financial incentive structures in obtaining a 1% within group drop in HbA1c among adults with diabetes. METHODS: 60 African Americans with type 2 diabetes were randomized to one of three financial incentive structures and followed for 3-months. Group 1 (low frequency) received a single incentive for absolute HbA1c reduction, Group 2 (moderate frequency) received a two-part incentive for home testing of glucose and absolute HbA1c reduction and Group 3 (high frequency) received a multiple component incentive for home testing, attendance of weekly telephone education classes and absolute HbA1c reduction. The primary clinical outcome was HbA1c reduction within each arm at 3-months. Cost for each arm was calculated based on the cost of the intervention, cost of health care visits during the 3-month time frame, and cost of workdays missed from illness. Incremental cost effectiveness ratios (ICER) were calculated based on achieving a 1% within group drop in HbA1c and were bootstrapped with 1,000 replications. RESULTS: The ICER to decrease HbA1c by 1% was $1,100 for all three arms, however, bootstrapped standard errors differed with Group 1 having twice the variation around the ICER coefficient as Groups 2 and 3. ICERs were statistically significant for Groups 2 and 3 (p<0.001) indicating they are cost effective interventions. CONCLUSIONS: Given ICERs of prior diabetes interventions range from $1,000-$4,000, a cost of $1,100 per 1% within group decrease in HbA1c is a promising intervention. Multi-component incentive structures seem to have the least variation in cost-effectiveness.

Cost-Effectiveness of the New 2018 American College of Physicians Glycemic Control Guidance Statements Among US Adults With Type 2 Diabetes.

OBJECTIVES: This study aims to estimate the national impact and cost-effectiveness of the 2018 American College of Physicians (ACP) guidance statements compared to the status quo. METHODS: Survey data from the 2011-2016 National Health and Nutrition Examination were used to generate a national representative sample of individuals with diagnosed type 2 diabetes in the United States. Individuals with A1c <6.5% on antidiabetic medications are recommended to deintensify their A1c level to 7.0% to 8.0% (group 1); individuals with A1c 6.5% to 8.0% and a life expectancy of <10 years are recommended to deintensify their A1c level >8.0% (group 2); and individuals with A1c >8.0% and a life expectancy of >10 years are recommended to intensify their A1c level to 7.0% to 8.0% (group 3). We used a Markov-based simulation model to evaluate the lifetime cost-effectiveness of following the ACP recommended A1c level. RESULTS: 14.41 million (58.1%) persons with diagnosed type 2 diabetes would be affected by the new guidance statements. Treatment deintensification would lead to a saving of $363 600 per quality-adjusted life-year (QALY) lost for group 1 and a saving of $118 300 per QALY lost for group 2. Intensifying treatment for group 3 would lead to an additional cost of $44 600 per QALY gain. Nationally, the implementation of the guidance would add 3.2 million life-years and 1.1 million QALYs and reduce healthcare costs by $47.7 billion compared to the status quo. CONCLUSIONS: Implementing the new ACP guidance statements would affect a large number of persons with type 2 diabetes nationally. The new guidance is cost-effective.

Continuous glucose monitoring: A review of the evidence in type 1 and 2 diabetes mellitus.

CONTEXT AND AIM: Continuous glucose monitoring (CGM) is becoming widely accepted as an adjunct to diabetes management. Compared to standard care, CGM can provide detailed information about glycaemic variability in an internationally standardised ambulatory glucose profile, enabling more informed user and clinician decision making. We aimed to review the evidence, user experience and cost-effectiveness of CGM. METHODS: A literature search was conducted by combining subject headings 'CGM' and 'flash glucose monitoring', with key words 'type 1 diabetes' and 'type 2 diabetes', limited to '1999 to current'. Further evidence was obtained from relevant references of retrieved articles. RESULTS: There is a strong evidence for CGM use in people with type 1 diabetes, with benefits of reduced glycated haemoglobin and hypoglycaemia, and increased time in range. While the evidence for CGM use in type 2 diabetes is less robust, similar benefits have been demonstrated. CGM can improve diabetes-related satisfaction in people with diabetes (PWD) and parents of children with diabetes, as well as the clinician experience. However, CGM does have limitations including cost, accuracy and perceived inconvenience. Cost-effectiveness analyses have indicated that CGM is a cost-effective adjunct to type 1 diabetes management that is associated with reduced diabetes-related complications and hospitalisation. CONCLUSIONS: Continuous glucose monitoring is revolutionising diabetes management. It is a cost-effective adjunct to diabetes management that has the potential to improve glycaemic outcomes and quality of life in PWD, especially type 1 diabetes.

Using 2nd generation basal insulins in type 2 diabetes: Costs and savings in a comparative economic analysis in Italy, based on the BRIGHT study.

BACKGROUND AND AIMS: To evaluate the economic impact of using 2nd generation basal insulin analogs, Glargine 300 Units/ml (Gla-300) vs Degludec 100 Units/ml (IDeg-100), in patients with type 2 diabetes (T2D). METHODS AND RESULTS: An economic analysis was conducted using findings from the BRIGHT study (the first controlled, head-to-head study comparing Gla-300 vs IDeg-100), and costs for the Italian National Healthcare Service (NHS). A cost-minimization analysis (CMA) and a budget impact analysis (BIA) were conducted. Only pharmacological costs were included in the analysis. The CMA estimated patient treatment costs at 24 weeks and 1 year; the BIA assessed the economic impact of treating the overall Italian population of T2D insulin-naïve patients, who initiated insulin treatment during the period September 2017-August 2018 (N = 55 318). In the BIA, four different scenarios were compared: i) all patients receive IDeg-100 (Scenario A); ii) 61% of patients receive Gla-300, 39% IDeg-100 (Scenario B); iii) 80% of patients receive Gla-300, 20% IDeg-100 (Scenario C); iv) all patients treated with Gla-300 (Scenario D). The average treatment costs per patient were lower with Gla-300 vs IDeg-100 (at 24 weeks: €129 vs €161; at 1 year: €324 vs €409, respectively). Results of the BIA showed that comparing Scenario D vs Scenario A, total savings would amount to €1.76 million at 24 weeks, €4.73 million at 1 year, €5.53 million at 2 years. CONCLUSION: A larger use of Gla-300 vs IDeg-100 for the treatment of T2D patients would lead to a relevant reduction of therapy costs in Italy.

Long-term Cost-Effectiveness of Dexcom G6 Real-time Continuous Glucose Monitoring Versus Self-Monitoring of Blood Glucose in Patients With Type 1 Diabetes in the U.K.

OBJECTIVE: A long-term health economic analysis was performed to establish the cost-effectiveness of real-time continuous glucose monitoring (RT-CGM) (Dexcom G6) versus self-monitoring of blood glucose (SMBG) alone in U.K.-based patients with type 1 diabetes (T1D). RESEARCH DESIGN AND METHODS: The analysis used the IQVIA CORE Diabetes Model. Clinical input data were sourced from the DIAMOND trial in adults with T1D. Simulations were performed separately in the overall population of patients with baseline HbA1c ≥7.5% (58 mmol/mol), and a secondary analysis was performed in patients with baseline HbA1c ≥8.5% (69 mmol/mol). The analysis was performed from the National Health Service health care payer perspective over a lifetime time horizon. RESULTS: In the overall population, G6 RT-CGM was associated with a mean incremental gain in quality-adjusted life expectancy of 1.49 quality-adjusted life years (QALYs) versus SMBG (mean [SD] 11.47 [2.04] QALYs versus 9.99 [1.84] QALYs). Total mean (SD) lifetime costs were also pounds sterling (GBP) 14,234 higher with RT-CGM (GBP 102,468 [35,681] versus GBP 88,234 [39,027]) resulting in an incremental cost-effectiveness ratio of GBP 9,558 per QALY gained. Sensitivity analyses revealed that the findings were sensitive to changes in the quality-of-life benefit associated with reduced fear of hypoglycemia and avoidance of fingerstick testing as well as the HbA1c benefit associated with RT-CGM use. CONCLUSIONS: For U.K.-based T1D patients, the G6 RT-CGM device is associated with significant improvements in clinical outcomes and, over patient lifetimes, is a cost-effective disease management option relative to SMBG on the basis of a willingness-to-pay threshold of GBP 20,000 per QALY gained.

The Association Between Poor Glycemic Control and Health Care Costs in People With Diabetes: A Population-Based Study.

OBJECTIVE: To analyze the differences in health care costs according to glycemic control in people with type 2 diabetes. RESEARCH DESIGN AND METHODS: Data on health care resource utilization from 100,391 people with type 2 diabetes were extracted from the electronic database used at the Catalan Health Institute. Multivariate regression models were carried out to test the impact of glycemic control (HbA1c) on total health care, hospital admission, and medication costs; model 1 adjusted for a variety of covariates, and model 2 also included micro- and macrovascular complications. Glycemic control was classified as good for HbA1c <7%, fair for ≥7% to <8%, poor for ≥8% to <10%, and very poor for ≥10%. RESULTS: Mean per patient annual direct medical costs were €3,039 ± SD €6,581. Worse glycemic control was associated with higher total health care costs: compared with good glycemic control, health care costs increased by 18% (€509.82) and 23% (€661.35) in patients with very poor and poor glycemic control, respectively, when unadjusted and by €428.3 and €395.1, respectively, in model 2. Medication costs increased by 12% in patients with fair control and by 28% in those with very poor control (model 2). Patients with poor control had a higher probability of hospitalization than those with good control (5% in model 2) and a greater average cost when hospitalization occurred (€811). CONCLUSIONS: Poor glycemic control was directly related to higher total health care, hospitalization, and medication costs. Preventive strategies and good glycemic control in people with type 2 diabetes could reduce the economic impact associated with this disease.

The Longitudinal Influence of Social Determinants of Health on Glycemic Control in Elderly Adults With Diabetes.

OBJECTIVE: This study aimed to understand the longitudinal relationship between financial, psychosocial, and neighborhood social determinants and glycemic control (HbA1c) in older adults with diabetes. RESEARCH DESIGN AND METHODS: Data from 2,662 individuals with self-reported diabetes who participated in the Health and Retirement Study (HRS) were used. Participants were followed from 2006 through 2014. Financial hardship, psychosocial, and neighborhood-level social determinant factors were based on validated surveys from the biennial core interview and RAND data sets. All social determinant factors and measurements of HbA1c from the time period were used and treated as time varying in analyses. SAS PROC GLIMMIX was used to fit a series of hierarchical linear mixed models. Models controlled for nonindependence among the repeated observations using a random intercept and treating each individual participant as a random factor. Survey methods were used to apply HRS weighting. RESULTS: Before adjustment for demographics, difficulty paying bills (ß = 0.18 [95% CI 0.02, 0.24]) and medication cost nonadherence (0.15 [0.01, 0.29]) were independently associated with increasing HbA1c over time, and social cohesion (-0.05 [-0.10, -0.001]) was independently associated with decreasing HbA1c over time. After adjusting for both demographics and comorbidity count, difficulty paying bills (0.13 [0.03, 0.24]) and religiosity (0.04 [0.001, 0.08]) were independently associated with increasing HbA1c over time. CONCLUSIONS: Using a longitudinal cohort of older adults with diabetes, this study found that financial hardship factors, such as difficulty paying bills, were more consistently associated with worsening glycemic control over time than psychosocial and neighborhood factors.

Universal drug coverage and income-related disparities in glycaemic control.

AIMS: To examine whether income-related disparities in glycaemic control decline after the age of 65 years, when publicly funded universal drug insurance is acquired in Ontario, Canada. METHODS: We conducted a population-based cross-sectional study using linked administrative healthcare databases. Adults with diabetes, aged 40-89 years, with available HbA1c data were included (N = 716 297). Income was based on median neighbourhood household income. Multiple linear regression was used to test for effect modification of age ≥65 years on the relationship between income and HbA1c . RESULTS: There was a significant inverse association between income and HbA1c level. After adjusting for baseline factors, the effect of income on HbA1c level was significantly greater for individuals aged <65 years (mean difference HbA1c for lowest vs highest income group +2.5 mmol/mol, 95% CI +2.3 to +2.7 [+0.23%, 95% CI 0.21 to 0.24]) than for those aged ≥65 years (+1.2 mmol/mol, 95% CI +1.0 to +1.3 [+0.11%, 95% CI 0.10 to 0.12]; P < 0.0001 for interaction). CONCLUSIONS: Despite universal access to healthcare, people with diabetes with lower incomes had significantly worse glycaemic control compared with their counterparts on higher incomes. However, income gradients in glycaemic control were markedly reduced after the age of 65 years, possibly as a result of access to prescription drug coverage.

Budget Impact of Improved Diabetes Management by Utilization of Glucose Meters With a Color-Range Indicator-Comparison of Five European Healthcare Systems.

BACKGROUND AND AIM: Costs for the treatment of diabetes and its comorbidities are a major international issue. A recent randomized clinical trial showed that the introduction of color range indicator (CRI)-based glucose meters (GMs) positively affects the HbA1c of patients with type 1 and type 2 diabetes, when compared to GMs without a CRI. This budget impact analysis aimed to translate this beneficial effect of CRI-based GMs, OneTouch Verio Flex and OneTouch Verio, into potential monetary impact for the healthcare systems of five European countries, Germany, Spain, Italy, France, and the United Kingdom. MATERIAL AND METHODS: Data from a randomized controlled trial, evaluating the effect of CRI-based GMs, were used to estimate the ten-year risk of patients for fatal myocardial infarction (MI) as calculated by the UK Prospective Diabetes Study (UKPDS) risk engine. On the basis of assessed risks for MI, the potential monetary impact for the healthcare systems in five European countries was modeled. RESULTS: Based on a mean HbA1c reduction of 0.36%, as demonstrated in a randomized controlled trial, the UKPDS risk engine estimated a reduction of 2.4% of the ten-year risk of patients for fatal MI. When applied to our economic model, substantial potential cost savings for the healthcare systems of five European countries were calculated: €547 472 (France), €9.0 million (Germany), €6.0 million (Italy), €841 799 (Spain), and €421 069 (United Kingdom) per year. CONCLUSION: Improving metabolic control in patients with diabetes by the utilization of CRI-based GMs may have substantial positive effects on the expenditure of the healthcare systems of several European countries.