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Reduced test strip price would likely also improve cost-effectiveness. Self-monitoring of blood glucose in patients with diabetes who use insulin may contribute to improved glycemic control and reduced hypoglycemia by allowing for self-adjustments in insulin dose to be made based on meter readings.

However, the benefits of self-monitoring of blood glucose for patients not using insulin are less clear. Hypoglycemia is less frequent in this population 2 and is confined mainly to those taking secretagogues. The degree to which patients can adjust the dose of oral antidiabetes drugs in response to readings is limited. Nevertheless, self-monitoring of blood glucose is routinely recommended for patients who are not using insulin.

Decisions about the prescribing and reimbursement of blood glucose test strips require consideration of information about the costs and clinical benefits. This computer simulation model forecasts long-term health outcomes and cost consequences in patients with type 2 diabetes Appendix 1, available at www. Projections from this model have been validated using published clinical and epidemiological studies.

Relevant clinical outcomes associated with self-monitoring of blood glucose in adults with type 2 diabetes not using insulin were derived from our systematic review 11 of randomized controlled trials and observational studies comparing self-monitoring with no self-monitoring. We assessed a number of outcomes, including hemoglobin A 1C HbA 1C , hypoglycemia, quality of life, long-term complications of diabetes and mortality. The methodology and results of the review have been reported in full.

The UKPDS model simulates the occurrence of clinical events over the expected remaining lifetime of a patient with type 2 diabetes maximum 40 years. Simulated patients were characteristic of those enrolled in randomized controlled trials included in the systematic review.

Therefore, we assumed that patients in the hypothetical cohort in the base-case analysis did not have a history of these complications. We performed this analysis from the perspective of a Canadian ministry of health. We assumed an average daily consumption of 1.

This estimate closely coincided with the results of a recent utilization study of Ontario Public Drug Program beneficiaries. Resource utilization and costs Table 1 associated with managing diabetes-related complications were obtained from the Ontario Ministry of Health and Long-term Care.

The primary outcome measure in the current analysis was quality-adjusted life-years, which capture both quantity and quality of life. We performed 1-, 2- and multi-way sensitivity analyses to examine the robustness of the results to changes in the parameters and model assumptions.

A number of randomized controlled trials included in the systematic review included patients who were taking either oral antidiabetes agents or made lifestyle interventions. We therefore assessed the effect of HbA 1C inputs derived from pooling across the subset of randomized controlled trials in which all patients received oral antidiabetic agents or those in which all patients received non-pharmacological interventions.

We tested the effect of varying the cost of the test strips, testing frequency, baseline HbA 1C levels and patient characteristics. We also tested including a utility decrement for symptomatic hypoglycemia. The detailed results from additional sensitivity analyses are reported elsewhere.

Our systematic review 11 identified 7 randomized controlled trials, 29 — 35 enrolling a total of patients with type 2 diabetes managed with oral antidiabetes agents or lifestyle measures alone. These trials compared self-monitoring of blood glucose with no self-monitoring. The results were similar in a number of subgroup analyses, including the intensity of education about the interpretation and application of the test results, testing frequency, diabetes duration and baseline HbA 1C level.

Based on limited evidence, self-monitoring has failed to show consistent benefits in terms of quality of life, patient satisfaction, hypoglycemia, long-term complications of diabetes and mortality. These outcomes were therefore not included in the cost-effectiveness analysis of the reference case. The numbers of patients who would need to perform self-monitoring to avert 1 diabetes-related complication over a year period ranged from to Table 2.

Self-monitoring of blood glucose was associated with an additional 0. Cost-effectiveness acceptability curves for different prices per blood glucose test strip. Cost-effectiveness acceptability curves for 2-way sensitivity analyses, in which HbA 1C estimates of effect and self-monitoring of blood glucose SMBG testing frequencies were both varied. Cumulative incidence of diabetes-related complications over a year period among patients with type 2 diabetes who do not use insulin who self-monitor their blood glucose levels and those who do not self-monitor.

The results were highly sensitive to the price of the test strips and, to a lesser extent, testing frequency Table 4 ; Figure 1 and Figure 2 , 1 , 2 , 7 , 14 — 16 , 23 , 29 — 42 but the results were largely unchanged if we varied most other parameters and assumptions.

Incremental cost-utility ratios for the comparison of self-monitoring of blood glucose with no self-monitoring in patients with type 2 diabetes not using insulin.

Our cost-effectiveness analysis was based on a systematic review of the available clinical evidence, 11 which showed a clinically modest 43 benefit in HbA 1C levels among patients with type 2 diabetes who self-monitored their blood glucose levels. This result translated into a small reduction in diabetes-related complications in the economic model.

Thus, the clinical benefits of self-monitoring and the associated cost-savings do not offset the cost of the blood glucose test strips.

In our sensitivity analyses, we explored conditions under which cost-effectiveness estimates may vary. The results did not change substantially with changes in the assumed HbA 1C benefit of self-monitoring, higher baseline HbA 1C levels, or when the cohort was modified to reflect patient characteristics e.

Cost-effectiveness estimates, however, were highly sensitive to changes in the price per test strip and testing frequency. Results from 1- and 2-way sensitivity analyses also suggested that lower testing frequencies e.

This is not surprising because the incremental HbA 1C benefit of each subsequent test per day is likely to be progressively smaller, while the cost of test strips increases linearly with the number used.

Further well-designed randomized controlled trials are needed to assess the role of self-monitoring at lower testing frequencies in patients with type 2 diabetes who are not using insulin. Our results differ from those reported in earlier incremental cost-utility analyses. Conversely, the other economic study 45 reported results less favourable to self-monitoring primarily because the HbA 1C results were from a single clinical trial. Differences in utility decrements may also explain some of the differences in the results between these studies.

Health-related quality-of-life scores in 2 earlier analyses 36 , 44 were based on data from patients with type 2 diabetes 24 and the authors did not control for nondiabetes-related complications and other confounding variables such as income, education, ethnicity and number of comorbidities, all of which affect health-related quality of life.

In contrast, we obtained utility decrements from a community-based EQ-5D catalogue in the United States, 21 , 22 which was adjusted for determinants of health e.

The choice of economic model may also contribute to differences between our analysis and previous studies. Our study had several limitations. First, cost-effectiveness results are limited by available clinical evidence.

The validity of this outcome continues to be debated in the literature, particularly for cardiovascular outcomes in patients with type 2 diabetes. Fostering Drug Competition Increasing the availability of generic drugs helps to create competition in the marketplace, helping make treatment more affordable and increasing access to healthcare for more patients.

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