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Performance results in adults

The performance of the Guardian RT in adults was evaluated in a clinical study. Guardian RT results were

compared to plasma glucose values from a reference method, the YSI 2300 STAT Plus™ glucose analyzer

(referred to as YSI). Sixteen subjects with Type I diabetes participated in a single-site in-clinic study. Subjects

ranged in age from 18 to 65 years old. Each subject wore two Guardian RT systems simultaneously. One

Guardian system was calibrated an average of 3.5 times per day, and the other was calibrated approximately

five times per day using the Paradigm Link blood glucose meter. YSI measurements were taken every thirty

(30) minutes.

Users and their healthcare professionals should consider that performance in this study may be idealized,

and that performance may be worse when the Guardian RT is used in a less controlled home setting. For

example:

• The mean Hemoglobin A1c among the 16 participants was 8.2 percent. As hemoglobin A1c levels rise,

conditions often occur which are most challenging to test systems measuring glucose in interstitial fluid,

i.e., higher glucose levels, more rapid changes in glucose concentrations, and often more hypoglycemic

episodes.

• Subjects saw, on average, between 4 and 5 fingerstick values per day. This enables subjects to better

manage their diabetes when compared to those who perform less fingersticks per day. Agreement

between Guardian RT and YSI values is shown to be closer at mid-range glucose levels, as compared to

agreement at low or high glucose concentrations.

• Subjects were more limited in their activities than what may exist in home use, and they were provided

with all their meals. Sensors were also inserted by clinic staff rather than the subjects themselves.

Subjects who are more active, or with poor eating habits, may create more challenging conditions for

the Guardian RT.

• Performance of the Guardian RT may vary depending on the glucose meter used and how well the meter

is maintained. It is important to carry out quality-control checks on the meter and code the meter

according to the manufacturer's instructions to optimize performance of the Guardian RT.

Appendix A

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Medtronic Paradigm Link Guida Utente Pagina 227