Page 260 - Glucose Monitoring Devices

Real-life evidence with TS system 267

Real-life evidence with TS system
A properly designed clinical trial unquestionably remains a gold standard for devel-
oping scientific evidence about the safety and efficacy of a medical device/product
while improving our understanding of the biological mechanisms involved in its
therapeutic action. However, clinical trials are often conducted with specific
populations and in specialized environments that differ from the real-life experi-
ences of clinical or home settings. Therefore, real-world evidence may be comple-
mentary to randomized controlled clinical trials [44].
There are very few studies published based on real-world evidence regarding
LGS systems and most of these studies were conducted and published by Medtronic.
In a retrospective data analysis involving 7 months of real-world use of the system
by 935 patients with diabetes from Europe, it is shown that LGS-mediated insulin
pump suspensions occurred approximately 0.55 times per patient per day (27,216
LGS events in total) [45]. However, the median duration of suspension was only
9 min, suggesting that most of these low glucose alerts were terminated by patients
either due to nonreliance on sensor glucose or to the treatment of hypoglycemia
based on alerts. Among the 27,216 LGS events, 11% of those LGS events lasted
for >115 min (which mainly happened during the night) where mean sensor glucose
was 58.8 mg/dL at LGS activation and rose to 102.2 mg/dL by the end of the LGS
session. In a subset of patients (n ¼ 278) who used the LGS system for more than
3 months, the LGS use significantly reduced the number of sensor glucose readings
below 50 mg/dL and greater than 300 mg/dL [45]. This real-life study comple-
mented the findings from the randomized controlled trial in documenting the
efficacy of the LGS system in reducing the severity of hypoglycemia, mainly
nocturnal hypoglycemia, without increasing hyperglycemia in patients with T1D.
Another hospital-based cohort study from Colombia analyzed T1D patients who
started on an LGS system between August 2009 and August 2014 and were followed
for a mean of 47 months [46]. HbA1c levels were reduced from a baseline mean
value of 8.8%e7.1% at follow-up. The incidence of severe hypoglycemia also
decreased significantly among patients with T1D using LGS systems (10.8% at
baseline vs. 2.7% at the end of the study) [46]. Most patients with T1D were initiated
on LGS in the study due to a history of severe hypoglycemia. Therefore, this study
showed an even greater reduction in the incidence of severe hypoglycemia. In
another real-world study from the United System, sensor glucose data from
20,973 patients with diabetes who enabled the LGS feature at their discretion and
uploaded pump and sensor data to CareLink between October 15, 2013 and July
21, 2014 were analyzed to evaluate safety and efficacy of the LGS system [47].
Patient-days in which the LGS feature was enabled had 69% fewer sensor glucose
values 50 mg/dL compared with patient-days in which the LGS was not enabled.
The reduction in hypoglycemia seen on LGS-enabled days was more pronounced
during nighttime than during daytime hours, which is consistent with other real-
world studies [47].