Page 261 - Glucose Monitoring Devices

268 CHAPTER 13 Low glucose suspend systems

Overall, the findings of real-world experience studies were similar to what was
reported in randomized controlled trials. However, the results of real-world studies
need to be interpreted with caution because real-world studies are biased in terms of
patient selection. It is likely that patients with T1D who are likely to benefit from the
LGS system have been started on this system and, therefore, it is likely to exaggerate
its benefits. In addition, the real-word studies lack the information on the change in
HbA1c or difficulties in using the system. Moreover, there is no real-life data on
reduction in healthcare utilization with the use of the LGS system.

Cost-effectiveness
Cost-effectiveness analysis estimates the health costs and gains of alternative inter-
ventions, and it is a significant factor for prioritizing the distribution of resources by
the payer as well as policy decisions by government agencies [48]. Few studies have
reported on the cost-effectiveness of LGS systems.
The incremental cost-effectiveness ratio (ICER) based on the primary random-
ized study conducted in Australia [49] reported that the ICER per severe hypogly-
cemic event avoided was $18,257 for all patients and $14,944 for those aged 12
years and older. Additionally, the cost per quality-adjusted life-year gained was
$40,803 for patients aged 12 years and older over 6 months. Based on this study,
sensor-augmented insulin pump therapy with the LGS feature is a cost-effective
alternative to standard insulin pump therapy with self-monitoring of blood glucose
in patients with T1D who have hypoglycemia unawareness [49]. Similar
cost-effective analysis from the ASPIRE In-Home clinical trial suggested a savings
of $117 per patient, per year [50]. Studies from Hungary, France, and the United
Kingdom also found that sensor-augmented pump therapy with the LGS feature is
cost-effective compared to insulin pump therapy, especially for patients with T1D
who are at high risk for hypoglycemia [51e53].
In conclusion, most studies have found the LGS system to be cost-effective
compared to insulin pump therapy alone. The economic models are prone to
problems and errors [54]. Therefore, the results of these studies should be interpreted
cautiously. First, it is important to note that cost-effectiveness ratios based on
economic modeling are merely estimates, which are generally founded on assump-
tions and may document the potential value of one or more interventions. Second,
calculating ICER depends on the reference study used in the model and, consequently,
it may yield different results contingent on the study used for the analysis. Third, cost-
effectiveness analysis differs between countries, and the analysis may change during
the years depending on the economy of the country at any point in time.

The limitations of the low glucose suspend system
Any closed-loop system including the LGS system is prone to errors that can be due
to problems with the insulin pumps, infusion set, and sensor inaccuracies [55]. The