At a glance
ClinicalIndex Comparison RecordN/ACompleted· 72 enrolled
Drug / intervention
Guardian™ Sensor (3)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pivotal Study to Evaluate Guardian™ Connect CGM System Performance in China
In Brief
A clinical study evaluating Guardian™ Sensor (3) for Diabetes Mellitus. Completed, enrolled 72 participants across 3 sites.
Detailed Summary
The purpose of this study is to demonstrate the performance and safety of the Guardian™ Sensor (3) over 170 hours (7 days) when inserted in the abdomen used in subjects age 14 - 75 years with the Guardian™ Connect System.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus
CountriesChina
Collaborators--
Timeline
N/ACompletedFinished
20192020202120222023202420252026
First PostedOct 2018
Enrollment StartFeb 2019
Primary CompletionJul 2019
TodayJul 2026
First PostedOct 17, 2018
Enrollment StartFeb 28, 2019
Primary CompletionJul 25, 2019
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 7.7 years ago
Interventions
Guardian™ Sensor (3)device
Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days.