Dataset Information

Economic Value of Improved Accuracy for Self-Monitoring of Blood Glucose Devices for Type 1 and Type 2 Diabetes in England.

ABSTRACT:

Objective

The objective was to model clinical and economic outcomes of self-monitoring blood glucose (SMBG) devices with varying error ranges and strip prices for type 1 and insulin-treated type 2 diabetes patients in England.

Methods

We programmed a simulation model that included separate risk and complication estimates by type of diabetes and evidence from in silico modeling validated by the Food and Drug Administration. Changes in SMBG error were associated with changes in hemoglobin A1c (HbA1c) and separately, changes in hypoglycemia. Markov cohort simulation estimated clinical and economic outcomes. A SMBG device with 8.4% error and strip price of £0.30 (exceeding accuracy requirements by International Organization for Standardization [ISO] 15197:2013/EN ISO 15197:2015) was compared to a device with 15% error (accuracy meeting ISO 15197:2013/EN ISO 15197:2015) and price of £0.20. Outcomes were lifetime costs, quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs).

Results

With SMBG errors associated with changes in HbA1c only, the ICER was £3064 per QALY in type 1 diabetes and £264 668 per QALY in insulin-treated type 2 diabetes for an SMBG device with 8.4% versus 15% error. With SMBG errors associated with hypoglycemic events only, the device exceeding accuracy requirements was cost-saving and more effective in insulin-treated type 1 and type 2 diabetes.

Conclusions

Investment in devices with higher strip prices but improved accuracy (less error) appears to be an efficient strategy for insulin-treated diabetes patients at high risk of severe hypoglycemia.

SUBMITTER: McQueen RB

PROVIDER: S-EPMC6134622 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Publications

Economic Value of Improved Accuracy for Self-Monitoring of Blood Glucose Devices for Type 1 and Type 2 Diabetes in England.

McQueen Robert Brett RB Breton Marc D MD Craig Joyce J Holmes Hayden H Whittington Melanie D MD Ott Markus A MA Campbell Jonathan D JD

Journal of diabetes science and technology 20180421 5

<h4>Objective</h4>The objective was to model clinical and economic outcomes of self-monitoring blood glucose (SMBG) devices with varying error ranges and strip prices for type 1 and insulin-treated type 2 diabetes patients in England.<h4>Methods</h4>We programmed a simulation model that included separate risk and complication estimates by type of diabetes and evidence from in silico modeling validated by the Food and Drug Administration. Changes in SMBG error were associated with changes in hemo ...[more]

PMID: 29681171

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Project description:Intravascular continuous glucose monitoring (CGM) may facilitate glycemic control in the intensive care unit (ICU). We compared the accuracy of a CGM device (OptiScanner®) with a standard reference method.Adult patients who had blood glucose (BG) levels >150 mg/dl and required insertion of an arterial and central venous catheter were included. The OptiScanner® was inserted into a multiple-lumen central venous catheter. Patients were treated using a dynamic-scale insulin algorithm to achieve BG values between 80 and 150 mg/dl. The BG values measured by the OptiScanner® were plotted against BG values measured using a reference analyzer. The correlation between the BG values measured using the two methods and the clinical relevance of any differences were assessed using the coefficient of determination (r 2) and the Clarke error grid, respectively; bias was assessed by the mean absolute relative difference (MARD). Three different standards of glucose monitoring were used to assess accuracy. Glycemic control was assessed using the time in range (TIR). Six indices of glycemic variability were calculated.The analysis included 929 paired samples from 88 patients, monitored for a total of 2584 hours. Reference BG values ranged between 60 and 484 mg/dl. The r 2 value was 0.89. The percentage of BG values within zones A and B of the Clarke error grid was 99.9%; the MARD was 7.7%. Using the ISO 15197 standard and Food and Drug Administration and consensus standards, respectively, 80.4% of measurements were within 15 mg/dl and 88.2% within 15% of reference values, 40% of measurements were within 7 mg/dl and 72.5% within 10% of reference values, and 65.2% of measurements were within 10 mg/dl and 82.7% within 12.5% of reference values. The TIR was slightly lower with the OptiScanner® than with the reference method. The J-index, standard deviation and maximal glucose change were the indices of glycemic variability least affected by the measurement device.Based on the MARD, the performance of the OptiScanner® is adequate for use in ICU patients. Because recent standards for accuracy were not met, the OptiScanner® should not be used as a sole monitor. The assessment of glycemic variability is influenced by the time interval between BG determinations.Clinicaltrials.gov NCT01720381 . Registered 31 October 2012.

Dataset Information

Economic Value of Improved Accuracy for Self-Monitoring of Blood Glucose Devices for Type 1 and Type 2 Diabetes in England.

Objective

Methods

Results

Conclusions

Publications

Economic Value of Improved Accuracy for Self-Monitoring of Blood Glucose Devices for Type 1 and Type 2 Diabetes in England.

Similar Datasets

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