Evaluation of the Accuracy and Safety of a Continuous Glucose Monitoring System
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSiBionics, Co, Ltd
About this trial
The study is to evaluate the accuracy and safety of a real-time CGM system among adult patients with type 1 diabetes with respect to reference venous plasma sample measurements.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Diagonsed with T1D
Venous blood sampling access can be established in the forearm
Capable of independently reading instructions and complying with the clinical trial requirements
Disqualifiers
Severe hypoglycemia within the past 6 month
Heart failure or hemiplegic sequelae due to prior cerebrovascular disease
Severe skin conditions at the sensor wear site
Extensive systemic skin disorders
Trial design
Design model
Single group
Treatments tested in this trial
GS3 CGM
DeviceWearing CGM for a consecutive 14 days
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: Adult patients with T1DMExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
System performance
The CGM system performance will be assessed by comparing to the Yellow Springs Instrument comparator venous plasma measurements
Time frame
15 days2
System-related Safety
The CGM system will be characterized by adverse device effects experienced by the study participants
Time frame
15 daysSponsors and contacts
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Source ClinicalTrials.gov