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

Study Overview
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Brief Summary
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The purpose of the investigation is to evaluate the performance of the I3 CGM according to the FDA's special controls for iCGM.

Detailed Description
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Participants will attend a screening visit, 4 clinic visits with Frequent Sampling Testing (FST) at the beginning, 2 in the middle, and end of the I3 CGM sensor wear, and a visit for removal of the I3 CGM. Participants will wear 3 I3 CGM devices for up to 15 days and be instructed to continue their normal daily activities and manage their glucose as usual between in clinic FST per routine care. Participants will not have access to the I3 CGM data for the management of their blood glucose between clinic visits and will continue their usual care including CGM, if they are CGM users. At the clinic FST visits venous blood samples will be drawn from an intravenous cannula for FST for up to 10 hours for plasma glucose determination. During the clinic visits the investigative site staff will determine the participants' insulin doses and meals and may induce both hypoglycemia and hyperglycemia of up to an hour duration.

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: Continuous glucose monitoring device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| T1DM<br>Participants with type 1 diabetes mellitus | Device: Continuous glucose monitoring device<br>* Continuous glucose monitoring device<br>|
| T2DM<br>Participants with type 2 diabetes mellitus | Device: Continuous glucose monitoring device<br>* Continuous glucose monitoring device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy | percentage of iCGM values in the measuring range less than 70 mg/dL (3.9 mmol/l) within +/- 15 mg/dL (0.83 mmol/l) of the | 15 days |