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

Phase

N/A

Condition

Diabetes Prevention

Diabetes And Hypertension

Treatment

Continuous glucose monitoring device

Clinical Study ID

NCT05806554

NPI031-CIP-002F

Ages 18-80
All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 instable treatment regimen for at least 1 month with a multiple daily insulin dosingregimen (at least two insulin doses with meals daily) or CSII using at least twobolus doses a day with meals, irrespective of delivery device(s).

Exclusion

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 ofestablished correction factor for high glucose. 5. Hematocrit below 10% under thelower limit of the normal range. 6. Body mass index < 18.5 kg/m2. 7. Inadequateintravenous access on arms. 8. Participant has had a hypoglycemic seizure within thepast 6 months prior to enrollment.

Participant has had an episode of diabetic ketoacidosis (DKA) within the past 6months prior to enrollment.
Participant has a history of a seizure disorder. 11. Pregnancy, plannedpregnancy within the study period, or unwillingness to use reliable contraceptionduring the study period.
Planned MRI, CT scan or diathermia procedure for the duration of the study.

Study Design

Continuous glucose monitoring device

July 19, 2023

October 22, 2024

Study Description

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.

Connect with a study center

PSHI Praxis GmbH
Mainz 2874225, 55128
Germany
Site Not Available
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Ulm 2820256, D-89081
Germany
Site Not Available
Woodland Research Northwest
Rogers 4128894, Arkansas 4099753 72758
United States
Site Not Available
Diablo Clinical Research
Walnut Creek, California 94598
United States
Site Not Available
Diablo Clinical Research
Walnut Creek 5406990, California 5332921 94598
United States
Site Not Available
Atlanta Diabetes Associates
Atlanta, Georgia 30318
United States
Site Not Available
Atlanta Diabetes Associates
Atlanta 4180439, Georgia 4197000 30318
United States
Site Not Available
Rainier Clinical Research Center
Renton, Washington 98057
United States
Site Not Available
Rainier Clinical Research Center
Renton 5808189, Washington 5815135 98057
United States
Site Not Available

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