Accuracy and Precision of the True Vie I3 Continuous Glucose Monitoring System: an Open Label, Multi-Center Trial
Completed
Conditions studied: Diabetes Mellitus
In brief
The purpose of the investigation is to evaluate the performance of the I3 CGM according to the FDA's special controls for iCGM.
Key facts
- Study ID
- NCT05806554
- Run by
- Sinocare
- People needed
- 159
- Starts
- 2023-07-19
- Expected to finish
- 2024-10-22
- Last updated by the study team
- 2025-11-25
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
- Participant has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to enrollment.
- 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.
- Planned MRI, CT scan or diathermia procedure for the duration of the study.
Where it is running
- Woodland Research Northwest — Rogers, Arkansas, United States
- Diablo Clinical Research — Walnut Creek, California, United States
- Atlanta Diabetes Associates — Atlanta, Georgia, United States
- Rainier Clinical Research Center — Renton, Washington, United States
- PSHI Praxis GmbH — Mainz, Germany
- Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm — Ulm, Germany
Full record on ClinicalTrials.gov
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