Diabetes Mellitus Clinical Trial
Official title:
Randomised, Controlled, Multi-centric, Clinical Study to Assess Whether Type 1 Diabetic Patients in Poor Glycemic Control Can Improve Using the Real-time Values of Guardian T Versus Conventional Self-Monitoring Blood Glucose
The objective of the study is to determine whether patients with poor glycemic control can improve metabolic control using the real-time values of the Guardian® RT compared to conventional self-monitoring blood glucose finger-sticks.
Finger-stick based self-testing (SBGM), as well as diagnostic continuous glucose monitoring
(CGMS®) allow diabetic patients to find a balance between the two hyper- and hypoglycemic
extremes. Nevertheless, there are still patients who fail to achieve good control due to fear
of hypoglycemia, or who underestimate post-prandial hyperglycemias.
The Guardian® RT Telemetered Glucose Monitoring System is indicated for continuous or
periodic monitoring of real-time interstitial blood glucose values and low/high blood glucose
alarms (when pre-set levels are reached) in persons with diabetes mellitus. The glucose
values calculated by the device will be used to trigger hypo- and hyperglycemia alerts and
will be displayed every 5 minutes. The Guardian® RT stores up to 21 days of data.
The overall primary objective of the study is to determine whether patients with poor
glycemic control as evidenced by HbA1c > 8.1% can achieve improved metabolic control using
the real-time values of the Guardian® RT compared to conventional self-monitoring blood
glucose finger-sticks (control group) after 12 weeks of continuous use.
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