Accuracy and Precision of the True Vie I3 Continuous Glucose Monitoring System: an Open Label, Multi-Center Trial

Launched by SINOCARE · Mar 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a device called the True Vie I3 Continuous Glucose Monitoring System, which helps people with diabetes keep track of their blood sugar levels continuously. The goal is to see how well this device works in measuring glucose levels, following specific guidelines set by the FDA. The researchers are currently looking for participants aged 18 to 80 who have been diagnosed with type 1 or type 2 diabetes for at least six months and are using a stable insulin treatment plan.

If you decide to participate, you’ll wear the glucose monitor for a set period. Before enrolling, you’ll need to meet certain criteria, such as being on a specific insulin regimen and having a stable health condition. However, there are some reasons you might not be eligible, like having high blood sugar levels or a recent history of serious diabetes-related health issues. This trial is an opportunity to contribute to diabetes research while receiving close monitoring of your glucose levels.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with T1DM or T2DM diagnosed for at least 6 months. 2. Individual is 18-80 years old, inclusive, at the time of screening. 3. Must be and have been in stable treatment regimen for at least 1 month with a multiple daily insulin dosing regimen (at least two insulin doses with meals daily) or CSII using at least two bolus doses a day with meals, irrespective of delivery device(s).
• Exclusion Criteria:
• • 1. History of skin adhesive tolerance issues in the area of sensor placement. 2. HbA1c \> 9%. 3. Insulin meal dosing based on fixed dose regimens. 4. Absence of established correction factor for high glucose. 5. Hematocrit below 10% under the lower limit of the normal range. 6. Body mass index \< 18.5 kg/m2. 7. Inadequate intravenous access on arms. 8. Participant has had a hypoglycemic seizure within the past 6 months prior to enrollment.
• • 9. Participant has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to enrollment.
• • 10. Participant has a history of a seizure disorder. 11. Pregnancy, planned pregnancy within the study period, or unwillingness to use reliable contraception during the study period.
• • 12. Planned MRI, CT scan or diathermia procedure for the duration of the study.